medication_name
stringlengths 6
170
| section_title
stringclasses 42
values | text
stringlengths 0
47.1k
|
|---|---|---|
Gabapentin Brown & Burk 300 mg Capsules, hard
|
Date of revision of the text
|
17/01/2023
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Name of the medicinal product
|
Gabapentin Brown & Burk 400 mg Capsules, hard
2.
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Qualitative and quantitative composition
|
Each 400 mg hard capsule contains 400 mg of gabapentin.
For a full list of excipients, see section 6.1.
3.
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Pharmaceutical form
|
Capsule, hard (capsule)
A two-piece, orange opaque hard gelatine capsule, containing a white crystalline powder.
Capsule size'0'.
Capsule length: 21.20 mm.
4.
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Clinical particulars - Therapeutic indications
|
Therapeutic indications
Epilepsy
Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults and children aged 6 years and above (see section 5.1).
Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above.
Treatment of peripheral neuropathic pain
Gabapentin is indicated for the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults.
4.2
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Clinical particulars - Posology and method of administration
|
Posology and method of administration
Posology
For all indications a titration scheme for the initiation of therapy is described in Table 1, which is recommended for adults and adolescents aged 12 years and above. Dosing instructions for children under 12 years of age are provided under a separate sub-heading later in this section.
Table 1
DOSING CHART – INITIAL TITRATION
Day 1
Day 2
Day 3
300 mg once a day
300 mg two times a day
300 mg three times a day
Discontinuation of gabapentin
In accordance with current clinical practice, if gabapentin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication.
Epilepsy
Epilepsy typically requires long-term therapy. Dosage is determined by the treating physician according to individual tolerance and efficacy.
Adults and adolescents:
In clinical trials, the effective dosing range was 900 to 3600 mg/day. Therapy may be initiated by titrating the dose as described in Table 1 or by administering 300 mg three times a day (TID) on Day 1. Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/day increments every 2-3 days up to a maximum dose of 3600 mg/day. Slower titration of gabapentin dosage may be appropriate for individual patients. The minimum time to reach a dose of 1800 mg/day is one week, to reach 2400 mg/day is a total of 2 weeks, and to reach 3600 mg/day is a total of 3 weeks. Dosages up to 4800 mg/day have been well tolerated in long-term open-label clinical studies. The total daily dose should be divided in three single doses, the maximum time interval between the doses should not exceed 12 hours to prevent breakthrough convulsions.
Children aged 6 years and above:
The starting dose should range from 10 to 15 mg/kg/day and the effective dose is reached by upward titration over a period of approximately three days. The effective dose of gabapentin in children aged 6 years and older is 25 to 35 mg/kg/day. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The total daily dose should be divided in three single doses, the maximum time interval between doses should not exceed 12 hours.
It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin therapy. Further, gabapentin may be used in combination with other antiepileptic medicinal products without concern for alteration of the plasma concentrations of gabapentin or serum concentrations of other antiepileptic medicinal products.
Peripheral neuropathic pain
Adults
The therapy may be initiated by titrating the dose as described in Table 1. Alternatively, the starting dose is 900 mg/day given as three equally divided doses. Thereafter, based on individual patient response and tolerability, the dose can be further increased in 300 mg/day increments every 2-3 days up to a maximum dose of 3600 mg/day. Slower titration of gabapentin dosage may be appropriate for individual patients. The minimum time to reach a dose of 1800 mg/day is one week, to reach 2400 mg/day is a total of 2 weeks, and to reach 3600 mg/day is a total of 3 weeks.
In the treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia, efficacy and safety have not been examined in clinical studies for treatment periods longer than 5 months. If a patient requires dosing longer than 5 months for the treatment of peripheral neuropathic pain, the treating physician should assess the patient's clinical status and determine the need for additional therapy.
Instruction for all areas of indication
In patients with poor general health, i.e., low body weight, after organ transplantation etc., the dose should be titrated more slowly, either by using smaller dosage strengths or longer intervals between dosage increases.
Use in elderly (over 65 years of age)
Elderly patients may require dosage adjustment because of declining renal function with age (see Table 2). Somnolence, peripheral oedema and asthenia may be more frequent in elderly patients.
Renal impairment
Dosage adjustment is recommended in patients with compromised renal function as described in Table 2 and/or those undergoing haemodialysis. Gabapentin 100 mg capsules can be used to follow dosing recommendations for patients with renal insufficiency.
Table 2
DOSAGE OF GABAPENTIN IN ADULTS BASED ON RENAL FUNCTION
Creatinine Clearance (mL/min)
Total Daily Dosea (mg/day)
≥80
900-3600
50-79
600-1800
30-49
300-900
15-29
150b -600
<15c
150b -300
a Total daily dose should be administered as three divided doses. Reduced dosages are for patients with renal impairment (creatinine clearance < 79 mL/min).
b The 150 mg daily dose to be administered as 300 mg every other day.
c For patients with creatinine clearance <15 mL/min, the daily dose should be reduced in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).
Use in patients undergoing haemodialysis
For anuric patients undergoing haemodialysis who have never received gabapentin, a loading dose of 300 to 400 mg, then 200 to 300 mg of gabapentin following each 4 hours of haemodialysis, is recommended. On dialysis-free days, there should be no treatment with gabapentin.
For renally impaired patients undergoing haemodialysis, the maintenance dose of gabapentin should be based on the dosing recommendations found in Table 2. In addition to the maintenance dose, an additional 200 to 300 mg dose following each 4-hour haemodialysis treatment is recommended.
Method of administration
For oral use.
Gabapentin can be given with or without food and should be swallowed whole with sufficient fluid-intake (e.g. a glass of water).
4.3
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Clinical particulars - Contraindications
|
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Clinical particulars - Special warnings and precautions for use
|
Special warnings and precautions for use
Suicidal ideation and behaviour
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known.Cases of suicidal ideation and behaviour have been observed in patients treated with gabapentin in the post-marketing experience (see section 4.8).
Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Patients should be monitored for signs of suicidal ideation and behaviour and appropriate treatment should be considered. Discontinuation of gabapentin treatment should be considered in case of suicidal ideation and behaviour.
Acute pancreatitis
If a patient develops acute pancreatitis under treatment with gabapentin, discontinuation of gabapentin should be considered (see section 4.8).
Seizures
Although there is no evidence of rebound seizures with gabapentin, abrupt withdrawal of anticonvulsant agents in epileptic patients may precipitate status epilepticus (see section 4.2).
As with other antiepileptic medicinal products, some patients may experience an increase in seizure frequency or the onset of new types of seizures with gabapentin.
As with other anti-epileptics, attempts to withdraw concomitant anti-epileptics in treatment refractive patients on more than one anti-epileptic, in order to reach gabapentin monotherapy have a low success rate.
Gabapentin is not considered effective against primary generalized seizures such as absences and may aggravate these seizures in some patients. Therefore, gabapentin should be used with caution in patients with mixed seizures including absences.
Gabapentin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall). There have also been post-marketing reports of confusion, loss of consciousness and mental impairment. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicinal product.
Concomitant use with opioids and other CNS depressants
Patients who require concomitant treatment with central nervous system (CNS) depressants, including opioids should be carefully observed for signs of central nervous system (CNS) depression, such as somnolence, sedation and respiratory depression. Patients who use gabapentin and morphine concomitantly may experience increases in gabapentin concentrations. The dose of gabapentin, or concomitant treatment with CNS depressants including opioids should be reduced appropriately (see section 4.5).
Caution is advised when prescribing gabapentin concomitantly with opioids due to risk of CNS depression. In a population-based, observational, nested case-control study of opioid users, co prescription of opioids and gabapentin was associated with an increased risk for opioid-related death compared to opioid prescription use alone (adjusted odds ratio [aOR], 1.49 [95% CI, 1.18 to 1.88, p<0.001]).
Respiratory depression
Gabapentin has been associated with severe respiratory depression. Patients with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of CNS depressants and the elderly might be at higher risk of experiencing this severe adverse reaction. Dose adjustments might be necessary in these patients.
Use in elderly (over 65 years of age)
No systematic studies in patients 65 years or older have been conducted with gabapentin. In one double blind study in patients with neuropathic pain, somnolence, peripheral oedema and asthenia occurred in a somewhat higher percentage in patients aged 65 years or above, than in younger patients. Apart from these findings, clinical investigations in this age group do not indicate an adverse event profile different from that observed in younger patients.
Paediatric population
The effects of long-term (greater than 36 weeks) gabapentin therapy on learning, intelligence, and development in children and adolescents have not been adequately studied. The benefits of prolonged therapy must therefore be weighed against the potential risks of such therapy.
Misuse, abuse potential and dependence
Gabapentin can cause drug dependence, which may occur at therapeutic doses. Cases of abuse and misuse have been reported. Patients with a history of substance abuse may be at higher risk for gabapentin misuse, abuse and dependence, and gabapentin should be used with caution in such patients. Before prescribing gabapentin, the patient's risk of misuse, abuse or dependence should be carefully evaluated.
Patients treated with gabapentin should be monitored for symptoms of gabapentin misuse, abuse or dependence, such as development of tolerance, dose escalation and drug-seeking behaviour.
Withdrawal symptoms
After discontinuation of short-term and long-term treatment with gabapentin, withdrawal symptoms have been observed. Withdrawal symptoms may occur shortly after discontinuation, usually within 48 hours. Most frequently reported symptoms include anxiety, insomnia, nausea, pains, sweating, tremor, headache, depression, feeling abnormal, dizziness, and malaise. The occurrence of withdrawal symptoms following discontinuation of gabapentin may indicate drug dependence (see section 4.8). The patient should be informed about this at the start of the treatment. If gabapentin should be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication (see section 4.2).
Severe cutaneous adverse reactions (SCARs)
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and Drug rash with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in association with gabapentin treatment. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, gabapentin should be withdrawn immediately and an alternative treatment considered (as appropriate).
If the patient has developed a serious reaction such as SJS, TEN or DRESS with the use of gabapentin, treatment with gabapentin must not be restarted in this patient at any time.
Anaphylaxis
Gabapentin can cause anaphylaxis. Signs and symptoms in reported cases have included difficulty breathing, swelling of the lips, throat, and tongue, and hypotension requiring emergency treatment. Patients should be instructed to discontinue gabapentin and seek immediate medical care should they experience signs or symptoms of anaphylaxis (see section 4.8).
Laboratory tests
False positive readings may be obtained in the semi-quantitative determination of total urine protein by dipstick tests. It is therefore recommended to verify such a positive dipstick test result by methods based on a different analytical principle such as the Biuret method, turbidimetric or dye-binding methods, or to use these alternative methods from the beginning.
Excipients with known effect
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially 'sodium-free'.
4.5
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Clinical particulars - Interaction with other medicinal products and other forms of interaction
|
Interaction with other medicinal products and other forms of interaction
There are spontaneous and literature case reports of respiratory depression sedation and death associated with gabapentin when co-administered with CNS depressants, including opioids. In some of these reports, the authors considered the combination of gabapentin with opioids, to be a particular concern in frail patients, in elderly, in patients with serious underlying respiratory disease, with polypharmacy, and in those with substance abuse disorders .
In a study involving healthy volunteers (N=12), when a 60 mg controlled-release morphine capsule was administered 2 hours prior to a 600 mg gabapentin capsule, mean gabapentin AUC increased by 44% compared to gabapentin administered without morphine. Therefore, patients who require concomitant treatment with opioids should be carefully observed for signs of CNS depression, such as somnolence, sedation and respiratory depression and the dose of gabapentin or opioid should be reduced appropriately.
No interaction between gabapentin and phenobarbital, phenytoin, valproic acid, or carbamazepine has been observed.
Gabapentin steady-state pharmacokinetics are similar for healthy subjects and patients with epilepsy receiving these anti-epileptic agents.
Co-administration of gabapentin with oral contraceptives containing norethindrone and/or ethinyl estradiol does not influence the steady-state pharmacokinetics of either component.
Co-administration of gabapentin with antacids containing aluminium and magnesium, reduces gabapentin bioavailability up to 24%.. It is recommended that gabapentin be taken at the earliest two hours following antacid administration.
Renal excretion of gabapentin is unaltered by probenecid.
A slight decrease in renal excretion of gabapentin that is observed when it is coadministered with cimetidine is not expected to be of clinical importance.
4.6
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Clinical particulars - Fertility, pregnancy and lactation
|
Fertility, pregnancy and lactation
Fertility
There is no effect on fertility in animal studies (see section 5.3).
Pregnancy
Risk related to epilepsy and antiepileptic medicinal products in general
The risk of birth defects is increased by a factor of 2 – 3 in the offspring of mothers treated with an antiepileptic medicinal product. Most frequently reported are cleft lip, cardiovascular malformations and neural tube defects. Multiple antiepileptic drug therapy may be associated with a higher risk of congenital malformations than monotherapy, therefore it is important that monotherapy is practised whenever possible. Specialist advice should be given to women who are likely to become pregnant or who are of childbearing potential and the need for antiepileptic treatment should be reviewed when a woman is planning to become pregnant. No sudden discontinuation of antiepileptic therapy should be undertaken as this may lead to breakthrough seizures, which could have serious consequences for both mother and child. Developmental delay in children of mothers with epilepsy has been observed rarely. It is not possible to differentiate if the developmental delay is caused by genetic, social factors, maternal epilepsy or the antiepileptic therapy. Neonatal withdrawal syndrome has been reported in newborns exposed in utero to gabapentin. Co-exposure to gabapentin and opioids during pregnancy may increase the risk of neonatal withdrawal syndrome. Newborns should be monitored carefully.
Risk related to gabapentin
Gabapentin crosses the human placenta.
There are no or limited amount of data from the use of gabapentin in pregnant women.
Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Gabapentin should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the foetus.
No definite conclusion can be made as to whether gabapentin is causally associated with an increased risk of congenital malformations when taken during pregnancy, because of epilepsy itself and the presence of concomitant antiepileptic medicinal products during each reported pregnancy.
Breast-feeding
Gabapentin is excreted in human milk. Because the effect on the breast-fed infant is unknown, caution should be exercised when gabapentin is administered to a breast-feeding mother. Gabapentin should be used in breast-feeding mothers only if the benefits clearly outweigh the risks.
4.7
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Clinical particulars - Effects on ability to drive and use machines
|
Effects on ability to drive and use machines
Gabapentin may have minor or moderate influence on the ability to drive and use machines. Gabapentin acts on the central nervous system and may cause drowsiness, dizziness or other related symptoms. Even, if they were only of mild or moderate degree, these undesirable effects could be potentially dangerous in patients driving or operating machinery. This is especially true at the beginning of the treatment and after increase in dose.
4.8
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Clinical particulars - Undesirable effects
|
Undesirable effects
The adverse reactions observed during clinical studies conducted in epilepsy (adjunctive and monotherapy) and neuropathic pain have been provided in a single list below by class and frequency (very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). Where an adverse reaction was seen at different frequencies in clinical studies, it was assigned to the highest frequency reported.
Additional reactions reported from post-marketing experience are included as frequency Not known (cannot be estimated from the available data) in italics in the list below.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Body System
Adverse drug reactions
Infections and infestations
Very Common
viral infection
Common
pneumonia, respiratory infection, urinary tract infection, infection, otitis media
Blood and the lymphatic system disorders
Common
leucopenia
Not known
thrombocytopenia
Immune system disorders
Uncommon
allergic reactions (e.g. urticaria)
Not Known
hypersensitivity syndrome, a systemic reaction with a variable presentation that can include fever, rash, hepatitis, lymphadenopathy, eosinophilia, and sometimes other signs and symptom, anaphylaxis (see section 4.4)
Metabolism and Nutrition Disorders
Common
anorexia, increased appetite
Uncommon
hyperglycemia (most often observed in patients with diabetes)
Rare
hypoglycaemia (most often observed in patients with diabetes)
Not known
hyponatraemia
Psychiatric disorders
Common
hostility, confusion and emotional lability, depression, anxiety, nervousness, thinking abnormal
Uncommon
agitation
Not known
Hallucinations, suicidal ideation, Drug dependence
Nervous system disorders
Very Common
somnolence, dizziness, ataxia
Common
convulsions, hyperkinesias, dysarthria, amnesia, tremor, insomnia, headache, sensations such as paresthesia, hypaesthesia, coordination abnormal, nystagmus, increased, decreased, or absent reflexes
Uncommon
Hypokinesia, mental impairment
Rare
loss of consciousness
Not known
other movement disorders (e.g. choreoathetosis, dyskinesia, dystonia)
Eye disorders
Common
visual disturbances such as amblyopia, diplopia
Ear and Labyrinth disorders
Common
vertigo
Not known
tinnitus
Cardiac disorders
Uncommon
palpitations
Vascular disorders
Common
hypertension, vasodilatation
Respiratory, thoracic and mediastinal disorders
Common
dyspnoea, bronchitis, pharyngitis, cough, rhinitis
Rare
respiratory depression
Gastrointestinal disorders
Common
vomiting, nausea, dental abnormalities, gingivitis, diarrhoea, abdominal pain, dyspepsia, constipation, dry mouth or throat, flatulence
Uncommon
dysphagia
Not known
pancreatitis
Hepatobiliary disorders
Not known
hepatitis, jaundice
Skin and subcutaneous tissue disorders
Common
facial oedema, purpura most often described as bruises resulting from physical trauma, rash, pruritus, acne
Not known
Stevens-Johnson syndrome, , toxic epidermal necrolysis, angioedema, erythema multiforme, alopecia drug rash with eosinophilia and systemic symptoms (see section 4.4)
Musculoskeletal, connective tissue and bone disorders
Common
arthralgia, myalgia, back pain, twitching
Not known
rhabdomyolysis, myoclonus
Renal and urinary disorder
Not known
acute renal failure, incontinence
Reproductive system and breast disorders
Common
impotence
Not known
breast hypertrophy, gynaecomastia sexual dysfunction (including changes in libido, ejaculation disorders and anorgasmia)
General disorders and administration site conditions
Very Common
fatigue, fever
Common
peripheral oedema, abnormal gait, asthenia, pain, malaise, flu syndrome
Uncommon
generalized oedema
Not known
withdrawal reactions*), chest pain. Sudden unexplained deaths have been reported where a causal relationship to treatment with gabapentin has not been established.
Investigations
Common
WBC (white blood cell count) decreased, weight gain
Uncommon
elevated liver function tests SGOT (AST), SGPT (ALT) and bilirubin
Not known
blood creatine phosphokinase increased
Injury, poisoning and procedural complications
Common
accidental injury, fracture, abrasion
Uncommon
fall
*After discontinuation of short-term and long-term treatment with gabapentin, withdrawal symptoms have been observed. Withdrawal symptoms may occur shortly after discontinuation, usually within 48 hours. Most frequently reported symptoms include anxiety, insomnia, nausea, pains, sweating, tremor, headache, depression, feeling abnormal, dizziness, and malaise (see section 4.4). The occurrence of withdrawal symptoms following discontinuation of gabapentin may indicate drug dependence (see section 4.8). The patient should be informed about this at the start of the treatment. If gabapentin should be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication (see section 4.2).
Under treatment with gabapentin cases of acute pancreatitis were reported. Causality with gabapentin is unclear (see section 4.4).
In patients on haemodialysis due to end-stage renal failure, myopathy with elevated creatine kinase levels has been reported.
Respiratory tract infections, otitis media, convulsions and bronchitis were reported only in clinical studies in children. Additionally, in clinical studies in children, aggressive behaviour and hyperkinesias were reported commonly.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Clinical particulars - Overdose
|
Overdose
Acute, life-threatening toxicity has not been observed with gabapentin overdoses of up to 49 grams. Symptoms of the overdoses included dizziness, double vision, slurred speech, drowsiness, loss of consciousness, lethargy and mild diarrhoea. All patients recovered fully with supportive care. Reduced absorption of gabapentin at higher doses may limit drug absorption at the time of overdosing and, hence, minimise toxicity from overdoses.
Overdoses of gabapentin, particularly in combination with other CNS depressant medications, may result in coma.
Although gabapentin can be removed by haemodialysis, based on prior experience it is not usually required. However, in patients with severe renal impairment, haemodialysis may be indicated.
An oral lethal dose of gabapentin was not identified in mice and rats given doses as high as 8000 mg/kg. Signs of acute toxicity in animals included ataxia, laboured breathing, ptosis, hypoactivity, or excitation.
5. Pharmacological properties
5.1
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Pharmacodynamic properties - Pharmacodynamic properties
|
Pharmacokinetic properties
Absorption
Following oral administration, peak plasma gabapentin concentrations are observed within 2 to 3 hours. Gabapentin bioavailability (fraction of dose absorbed) tends to decrease with increasing dose. Absolute bioavailability of a 300 mg capsule is approximately 60%. Food, including a high-fat diet, has no clinically significant effect on gabapentin pharmacokinetics.
Gabapentin pharmacokinetics are not affected by repeated administration. Although plasma gabapentin concentrations were generally between 2 μg/ml and 20 μg/ml in clinical studies, such concentrations were not predictive of safety or efficacy. Pharmacokinetic parameters are given in Table 3.
Table 3 Summary of gabapentin mean (%CV) steady-state pharmacokinetic parameters following every eight hours administration
Pharmacokinetic parameter
300 mg (N = 7)
400 mg (N = 14)
800 mg (N=14)
Mean
%CV
Mean
%CV
Mean
%CV
Cmax (μg/mL)
4.02
(24)
5.74
(38)
8.71
(29)
tmax (hr)
2.7
(18)
2.1
(54)
1.6
(76)
T1/2 (hr)
5.2
(12)
10.8
(89)
10.6
(41)
AUC (0-8) μg•hr/mL)
24.8
(24)
34.5
(34)
51.4
(27)
Ae% (%)
NA
NA
47.2
(25)
34.4
(37)
Cmax = Maximum steady state plasma concentration
tmax = Time for Cmax
T1/2 = Elimination half-life
AUC(0-8) = Steady state area under plasma concentration-time curve from time 0 to 8 hours postdose
Ae% = Percent of dose excreted unchanged into the urine from time 0 to 8 hours postdose
NA = Not available
Distribution
Gabapentin is not bound to plasma proteins and has a volume of distribution equal to 57.7 litres. In patients with epilepsy, gabapentin concentrations in cerebrospinal fluid (CSF) are approximately 20% of corresponding steady-state trough plasma concentrations. Gabapentin is present in the breast milk of breast-feeding women.
Biotransformation
There is no evidence of gabapentin metabolism in humans. Gabapentin does not induce hepatic mixed function oxidase enzymes responsible for drug metabolism.
Elimination
Gabapentin is eliminated unchanged solely by renal excretion. The elimination half-life of gabapentin is independent of dose and averages 5 to 7 hours.
In elderly patients, and in patients with impaired renal function, gabapentin plasma clearance is reduced. Gabapentin elimination-rate constant, plasma clearance, and renal clearance are directly proportional to creatinine clearance.
Gabapentin is removed from plasma by haemodialysis. Dosage adjustment in patients with compromised renal function or undergoing haemodialysis is recommended (see section 4.2).
Gabapentin pharmacokinetics in children were determined in 50 healthy subjects between the ages of 1 month and 12 years. In general, plasma gabapentin concentrations in children> 5 years of age are similar to those in adults when dosed on a mg/kg basis.
In a pharmacokinetic study in 24 healthy paediatric subjects aged between 1 month and 48 months, an approximately 30% lower exposure (AUC), lower Cmax and higher clearance per body weight have been observed in comparison to available reported data in children older than 5 years.
Linearity/Non-linearity
Gabapentin bioavailability (fraction of dose absorbed) decreases with increasing dose which imparts non-linearity to pharmacokinetic parameters which include the bioavailability parameter (F) e.g. Ae%, CL/F, Vd/F. Elimination pharmacokinetics (pharmacokinetic parameters which do not include F such as CLr and T1/2), are best described by linear pharmacokinetics. Steady state plasma gabapentin concentrations are predictable from single-dose data.
5.3
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Pharmacodynamic properties - Pharmacokinetic properties
|
Preclinical safety data
Carcinogenesis
Gabapentin was given in the diet to mice at 200, 600, and 2000 mg/kg/day and to rats at 250, 1000, and 2000 mg/kg/day for two years. A statistically significant increase in the incidence of pancreatic acinar cell tumours was found only in male rats at the highest dose. Peak plasma drug concentrations in rats at 2000 mg/kg/day are 10 times higher than plasma concentrations in humans given 3600 mg/day. The pancreatic acinar cell tumours in male rats are low-grade malignancies, did not affect survival, did not metastasize or invade surrounding tissue, and were similar to those seen in concurrent controls. The relevance of these pancreatic acinar cell tumours in male rats to carcinogenic risk in humans is unclear.
Mutagenesis
Gabapentin demonstrated no genotoxic potential. It was not mutagenic in vitro in standard assays using bacterial or mammalian cells. Gabapentin did not induce structural chromosome aberrations in mammalian cells in vitro or in vivo, and did not induce micronucleus formation in the bone marrow of hamsters.
Impairment of Fertility
No adverse effects on fertility or reproduction were observed in rats at doses up to 2000 mg/kg (approximately five times the maximum daily human dose on a mg/m2 of body surface area basis).
Teratogenesis
Gabapentin did not increase the incidence of malformations, compared to controls, in the offspring of mice, rats, or rabbits at doses up to 50, 30 and 25 times respectively, the daily human dose of 3600 mg, (four, five or eight times, respectively, the human daily dose on a mg/m2 basis).
Gabapentin induced delayed ossification in the skull, vertebrae, forelimbs, and hindlimbs in rodents, indicative of foetal growth retardation. These effects occurred when pregnant mice received oral doses of 1000 or 3000 mg/kg/day during organogenesis and in rats given 2000 mg/kg prior to and during mating and throughout gestation. These doses are approximately 1 to 5 times the human dose of 3600 mg on a mg/m2 basis.
No effects were observed in pregnant mice given 500 mg/kg/day (approximately 1/2 of the daily human dose on a mg/m2 basis).
An increased incidence of hydroureter and/or hydronephrosis was observed in rats given 2000 mg/kg/day in a fertility and general reproduction study, 1500 mg/kg/day in a teratology study, and 500, 1000, and 2000 mg/kg/day in a perinatal and postnatal study. The significance of these findings is unknown, but they have been associated with delayed development. These doses are also approximately 1 to 5 times the human dose of 3600 mg on a mg/m2 basis.
In a teratology study in rabbits, an increased incidence of post-implantation foetal loss, occurred in pregnant rabbits given 60, 300, and 1500 mg/kg/day during organogenesis. These doses are approximately 0.3 to 8 times the daily human dose of 3600 mg on a mg/m2 basis. The margins of safety are insufficient to rule out the risk of these effects in humans.
6.
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Pharmaceutical particulars - List of excipients
|
List of excipients
Capsule content:
Maize starch
Talc
Capsule shell:
Gelatin
Sodium laurilsulfate
Titanium dioxide (E171)
Red iron oxide (E172)
Yellow iron oxide (E172)
6.2
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Pharmaceutical particulars - Incompatibilities
|
Incompatibilities
Not applicable
6.3
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Pharmaceutical particulars - Shelf life
|
Shelf life
3 years
6.4
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Pharmaceutical particulars - Special precautions for storage
|
Special precautions for storage
Do not store above 30°C.
6.5
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Pharmaceutical particulars - Nature and contents of container
|
Nature and contents of container
PVC/PVDC/aluminium foil blister packs
Polypropylene container with polypropylene cap
Blister packs of 10, 20, 30, 50, 60, 84, 90, 98, 100, 200, 500, 1000 capsules.
Polypropylene container of 300, 400, 500 capsules
Not all pack sizes may be marketed.
6.6
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Pharmaceutical particulars - Special precautions for disposal and other handling
|
Special precautions for disposal and other handling
No special requirements.
7.
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Marketing authorisation holder
|
Brown & Burk UK Ltd
5, Marryat Close
Hounslow West
Middlesex
TW4 5DQ
UK
8. Marketing authorisation number(s)
PL 25298/0078
9.
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Date of first authorisation/renewal of the authorisation
|
21/11/2011 / 10/10/2016
10.
|
Gabapentin Brown & Burk 400 mg Capsules, hard
|
Date of revision of the text
|
17/01/2023
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Name of the medicinal product
|
Gaviscon Advance Peppermint Flavour
Oral Suspension.
2.
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Qualitative and quantitative composition
|
Each 10 ml dose contains sodium alginate 1000 mg and potassium hydrogen carbonate 200 mg. 1 ml contains sodium alginate 100 mg and potassium hydrogen carbonate 20.0 mg.
Each 10 ml dose is equivalent to two 5 ml measuring spoons.
Excipient(s) with known effect:
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
For a full list of excipients, see section 6.1.
3.
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Pharmaceutical form
|
Oral suspension.
Off-white viscous suspension.
4.
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Clinical particulars - Therapeutic indications
|
Therapeutic indications
Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. It can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.
4.2
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Clinical particulars - Posology and method of administration
|
Posology and method of administration
Adults and children 12 years and over: 5-10 ml after meals and at bedtime (one to two 5 ml measuring spoons).
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modification is required for this age group.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).
4.3
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Clinical particulars - Contraindications
|
Contraindications
The medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients listed in section 6.1, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4).
4.4
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Clinical particulars - Special warnings and precautions for use
|
Special warnings and precautions for use
If symptoms do not improve after 7 days, the clinical situation should be reviewed.
This medicinal product contains 57.85 mg sodium per 5 ml, equivalent to 2.9 % of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 23.14 % of the WHO recommended maximum daily intake for sodium.
This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet (e.g. in some cases of congestive heart failure and renal impairment).
Potassium: This medicine contains 1.0 mmol (39.06 mg) Potassium per 5 ml. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Each 10 ml contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
This medicinal product contains Methyl hydroxybenzoate and Propyl hydroxybenzoate, which may cause allergic reactions (possibly delayed).
4.5
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Clinical particulars - Interaction with other medicinal products and other forms of interaction
|
Interaction with other medicinal products and other forms of interaction
A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.
4.6
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Clinical particulars - Fertility, pregnancy and lactation
|
Fertility, pregnancy and lactation
Pregnancy:
Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor foeto/neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed.
Breast feeding:
No known effect on breast fed infants. Gaviscon can be used during breast feeding.
Fertility:
No known effect on human fertility.
4.7
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Clinical particulars - Effects on ability to drive and use machines
|
Effects on ability to drive and use machines
Not relevant.
4.8
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Clinical particulars - Undesirable effects
|
Undesirable effects
Adverse reactions have been ranked under headings of frequency using the following convention: very common (1/10), common (1/100 and <1/10), uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
System Organ Class
Frequency
Adverse Event
Immune System Disorders
Very rare
Anaphylactic and anaphylactoid reactions. Hypersensitivity reactions such as urticaria.
Respiratory, Thoracic and Mediastinal Disorders
Very rare
Respiratory effects such as bronchospasm.
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Clinical particulars - Overdose
|
Overdose
Symptoms
Symptoms are likely to be minor; some abdominal discomfort may be experienced.
Management
In the event of overdose, symptomatic treatment should be given.
5. Pharmacological properties
5.1
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Pharmacodynamic properties - Pharmacodynamic properties
|
Pharmacokinetic properties
The mechanism of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
5.3
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Pharmacodynamic properties - Pharmacokinetic properties
|
Preclinical safety data
No preclinical findings of relevance to the prescriber have been reported.
6.
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Pharmaceutical particulars - List of excipients
|
List of excipients
Calcium carbonate
Carbomer 974P
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Saccharin sodium
Peppermint flavour
Sodium hydroxide for pH adjustment
Purified water
6.2
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Pharmaceutical particulars - Incompatibilities
|
Incompatibilities
Not applicable.
6.3
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Pharmaceutical particulars - Shelf life
|
Shelf life
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Pharmaceutical particulars - Special precautions for storage
|
Shelf life: 2 years.
Shelf-life after opening: 6 months.
6.4
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Pharmaceutical particulars - Nature and contents of container
|
Special precautions for storage
Do not refrigerate.
6.5
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Pharmaceutical particulars - Special precautions for disposal and other handling
|
Nature and contents of container
Amber glass bottles with moulded polypropylene cap having a tamper evident strip and lined with an expanded polyethylene wad. The bottles are enclosed in a cardboard outer containing either a measuring device (natural polypropylene) containing 5, 10, 15 and 20 ml graduations or a clear injection moulded crystal polystyrene measuring spoon with one bowl containing 2.5 ml and 5 ml measure. The pack sizes are 80, 100, 125, 140, 150, 180, 200, 250, 300, 400, 500, 560 or 600 ml suspension. Not all pack sizes may be marketed. The carton and measuring device or spoon may not be made available in all markets/pack sizes.
6.6
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Pharmaceutical particulars - Subsection 7
|
Special precautions for disposal and other handling
No special requirements.
7.
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Marketing authorisation holder
|
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.
8. Marketing authorisation number(s)
PL 00063/0612.
9.
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Date of first authorisation/renewal of the authorisation
|
11/10/2010
10.
|
Gaviscon Advance Peppermint Flavour Oral Suspension
|
Date of revision of the text
|
15/05/2021
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Name of the medicinal product
|
Gaviscon Advance Peppermint Flavour Oral Suspension
2.
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Qualitative and quantitative composition
|
Each 10 ml dose contains sodium alginate 1000 mg and potassium hydrogen carbonate 200 mg. 1 ml contains sodium alginate 100 mg and potassium hydrogen carbonate 20.0 mg.
Each 10 ml dose is equivalent to two 5 ml measuring spoons.
Excipient(s) with known effect:
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
For a full list of excipients, see section 6.1.
3.
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Pharmaceutical form
|
Oral suspension.
Off-white viscous suspension.
4.
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Clinical particulars - Therapeutic indications
|
Therapeutic indications
Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. It can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.
4.2
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Clinical particulars - Posology and method of administration
|
Posology and method of administration
Adults and children 12 years and over: 5-10 ml after meals and at bedtime (one to two 5 ml measuring spoons).
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modification is required for this age group.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).
4.3
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Clinical particulars - Contraindications
|
Contraindications
The medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients listed in section 6.1, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4).
4.4
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Clinical particulars - Special warnings and precautions for use
|
Special warnings and precautions for use
If symptoms do not improve after 7 days, the clinical situation should be reviewed.
This medicinal product contains 57.85 mg sodium per 5 ml, equivalent to 2.9 % of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 23.14 % of the WHO recommended maximum daily intake for sodium.
This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet (e.g. in some cases of congestive heart failure and renal impairment).
Potassium: This medicine contains 1.0 mmol (39.06 mg) Potassium per 5 ml. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Each 10 ml contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
This medicinal product contains Methyl hydroxybenzoate and Propyl hydroxybenzoate, which may cause allergic reactions (possibly delayed).
4.5
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Clinical particulars - Interaction with other medicinal products and other forms of interaction
|
Interaction with other medicinal products and other forms of interaction
A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.
4.6
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Clinical particulars - Fertility, pregnancy and lactation
|
Fertility, pregnancy and lactation
Pregnancy:
Clinical studies in more than 500 pregnant women as well as a large amount of data from post-marketing experience indicate no malformative nor foeto/neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed.
Breast feeding:
No known effect on breast fed infants. Gaviscon can be used during breast feeding.
Fertility:
No known effect on human fertility.
4.7
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Clinical particulars - Effects on ability to drive and use machines
|
Effects on ability to drive and use machines
Not relevant.
4.8
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Clinical particulars - Undesirable effects
|
Undesirable effects
Adverse reactions have been ranked under headings of frequency using the following convention: very common (1/10), common (1/100 and <1/10), uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
System Organ Class
Frequency
Adverse Event
Immune System Disorders
Very rare
Anaphylactic and anaphylactoid reactions. Hypersensitivity reactions such as urticaria.
Respiratory, Thoracic and Mediastinal Disorders
Very rare
Respiratory effects such as bronchospasm.
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Clinical particulars - Overdose
|
Overdose
Symptoms
Symptoms are likely to be minor; some abdominal discomfort may be experienced.
Management
In the event of overdose, symptomatic treatment should be given.
5. Pharmacological properties
5.1
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Pharmacodynamic properties - Pharmacodynamic properties
|
Pharmacokinetic properties
The mechanism of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
5.3
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Pharmacodynamic properties - Pharmacokinetic properties
|
Preclinical safety data
There are no preclinical findings of relevance to the prescriber which are additional to those already included in other section of the SmPC.
6.
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Pharmaceutical particulars - List of excipients
|
List of excipients
Calcium carbonate
Carbomer 974P
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Saccharin sodium
Peppermint flavour
Sodium hydroxide for pH adjustment
Purified water
6.2
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Pharmaceutical particulars - Incompatibilities
|
Incompatibilities
Not applicable.
6.3
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Pharmaceutical particulars - Shelf life
|
Shelf life
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Pharmaceutical particulars - Special precautions for storage
|
Shelf life: 2 years.
Shelf-life after opening: 6 months.
6.4
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Pharmaceutical particulars - Nature and contents of container
|
Special precautions for storage
Do not refrigerate.
6.5
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Pharmaceutical particulars - Special precautions for disposal and other handling
|
Nature and contents of container
Amber glass bottles with moulded polypropylene cap having a tamper evident strip and lined with an expanded polyethylene wad. The bottles are enclosed in a cardboard outer containing either a measuring device (natural polypropylene) containing 5, 10, 15 and 20 ml graduations or a clear injection moulded crystal polystyrene measuring spoon with one bowl containing 2.5 ml and 5 ml measure. The pack sizes are 80, 100, 125, 140, 150, 180, 200, 250 or 300 ml suspension. Not all pack sizes may be marketed. The carton and measuring device or spoon may not be made available in all markets/pack sizes.
6.6
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Pharmaceutical particulars - Subsection 7
|
Special precautions for disposal and other handling
No special requirements.
7.
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Marketing authorisation holder
|
Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS,
United Kingdom.
8. Marketing authorisation number(s)
PL 00063/0748
9.
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Date of first authorisation/renewal of the authorisation
|
05/02/2018
10.
|
Gaviscon Advance Peppermint Flavour Oral Suspension (GSL)
|
Date of revision of the text
|
08/05/2021
|
Gaviscon Double Action Aniseed Oral suspension
|
Name of the medicinal product
|
Gaviscon Double Action Aniseed.
2.
|
Gaviscon Double Action Aniseed Oral suspension
|
Qualitative and quantitative composition
|
Each 10 ml dose contains sodium alginate 500 mg, sodium bicarbonate 213mg and calcium carbonate 325 mg.
Excipient(s) with known effect:
Methyl parahydroxybenzoate (E218) 40 mg/ 10ml
Propyl parahydroxybenzoate (E216) 6 mg/10ml
Sodium 127.88 mg (5.56 mmol) / 10ml
Benzyl Alcohol* 1.05 mg/10ml *present in fennel flavour
For a full list of excipients, see Section 6.1.
3.
|
Gaviscon Double Action Aniseed Oral suspension
|
Pharmaceutical form
|
Oral suspension.
Opaque, off-white to cream viscous suspension.
4.
|
Gaviscon Double Action Aniseed Oral suspension
|
Clinical particulars - Therapeutic indications
|
Therapeutic indications
Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy, and for symptoms of excess stomach acid (hyperacidity). Can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.
4.2
|
Gaviscon Double Action Aniseed Oral suspension
|
Clinical particulars - Posology and method of administration
|
Posology and method of administration
For oral administration.
Adults and children 12 years and over: 10-20 ml after meals and at bedtime, up to four times per day.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).
4.3
|
Gaviscon Double Action Aniseed Oral suspension
|
Clinical particulars - Contraindications
|
Contraindications
Hypersensitivity to sodium alginate, sodium bicarbonate, calcium carbonate, the esters of hydroxybenzoates (parabens) or to any of the excipients listed in section 6.1.
4.4
|
Gaviscon Double Action Aniseed Oral suspension
|
Clinical particulars - Special warnings and precautions for use
|
Special warnings and precautions for use
If symptoms persist, or treatment is required for more than 7 days continuously, medical advice should be sought.
As with other antacid products, taking this product can mask the symptoms of other more serious, underlying medical conditions.
Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.
Excipient warnings:
This medicinal product contains 127.88 mg sodium per dose, equivalent to 6.4 % of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 51.15% of the WHO recommended maximum daily intake for sodium.
This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet (e.g. in some cases of congestive heart failure and renal impairment).
Each 20 ml contains 260 mg (6.5mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
This medicine contains 1.05 mg benzyl alcohol (from Fennel flavour) per 10 ml. Benzyl alcohol may cause allergic reactions.
Large amounts of benzyl alcohol can build up in the body and may cause side effects (called "metabolic acidosis"). This should be taken into consideration by patients who have a liver or kidney disease or are pregnant or breast-feeding.
4.5
|
Gaviscon Double Action Aniseed Oral suspension
|
Clinical particulars - Interaction with other medicinal products and other forms of interaction
|
Interaction with other medicinal products and other forms of interaction
Due to the presence of calcium and carbonates which act as an antacid, a time-interval of 2 hours should be considered between intake of this product and the administration of other medicinal products, especially H2-antihistaminics, tetracyclines, digoxine, fluoroquinolones, iron salts, thyroid hormones, ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, diphosphonates, and estramustine. See also section 4.4.
4.6
|
Gaviscon Double Action Aniseed Oral suspension
|
Clinical particulars - Fertility, pregnancy and lactation
|
Fertility, pregnancy and lactation
Pregnancy
Open controlled studies in 281 pregnant women did not demonstrate any significant adverse effects of Gaviscon on the course of pregnancy or on the health of the foetus/new-born child. Based on this and previous experience the medicinal product may be used during pregnancy, if clinically needed.
Breastfeeding:
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. This product can be used during breast-feeding if clinically needed.
Fertility
Clinical data do not suggest that this product has an effect on human fertility.
4.7
|
Gaviscon Double Action Aniseed Oral suspension
|
Clinical particulars - Effects on ability to drive and use machines
|
Effects on ability to drive and use machines
This product has no or negligible influence on the ability to drive and use machines.
4.8
|
Gaviscon Double Action Aniseed Oral suspension
|
Clinical particulars - Undesirable effects
|
Undesirable effects
Adverse events which have been associated with sodium alginate, sodium bicarbonate and calcium carbonate are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
System Organ Class
Frequency
Adverse Events
Immune System Disorders
Very Rarely
Anaphylactic reaction, anaphylactoid reaction. Hypersensitivity reactions such as urticaria.
Metabolism and Nutritional Disorders
Not Known
Alkalosis1, acid rebound1, Hypercalcaemia1, Milk-alkali Syndrome1
Respiratory, Thoracic and Mediastinal Disorders
Very Rarely
Respiratory effects such as bronchospasm.
Gastrointestinal Disorders
Not Known
Constipation1
Description of Selected Adverse Reactions
1 Usually occurs following larger than recommended dosages.
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9
|
Gaviscon Double Action Aniseed Oral suspension
|
Clinical particulars - Overdose
|
Overdose
Symptoms
Symptoms are likely to be minor in acute overdose; some abdominal distension may be noticed. Milk-alkali syndrome has occurred in individuals taking large doses of calcium carbonate per day for prolonged periods.
Management
In the event of overdosage symptomatic treatment should be given.
5. Pharmacological properties
5.1
|
Gaviscon Double Action Aniseed Oral suspension
|
Pharmacodynamic properties - Pharmacodynamic properties
|
Pharmacokinetic properties
The mode of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
5.3
|
Gaviscon Double Action Aniseed Oral suspension
|
Pharmacodynamic properties - Pharmacokinetic properties
|
Preclinical safety data
No pre-clinical findings of any relevance to the prescriber have been reported.
6.
|
Gaviscon Double Action Aniseed Oral suspension
|
Pharmaceutical particulars - List of excipients
|
List of excipients
Carbomer
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Saccharin sodium
Benzyl Alcohol*present in fennel flavour
Sodium hydroxide
Purified water
6.2
|
Gaviscon Double Action Aniseed Oral suspension
|
Pharmaceutical particulars - Incompatibilities
|
Incompatibilities
Not applicable.
6.3
|
Gaviscon Double Action Aniseed Oral suspension
|
Pharmaceutical particulars - Shelf life
|
Shelf life
Two years.
Use within six months of opening.
6.4
|
Gaviscon Double Action Aniseed Oral suspension
|
Pharmaceutical particulars - Special precautions for storage
|
Special precautions for storage
Do not store above 30°C. Do not refrigerate or freeze.
6.5
|
Gaviscon Double Action Aniseed Oral suspension
|
Pharmaceutical particulars - Nature and contents of container
|
Nature and contents of container
Amber glass bottles or Pink coated Amber glass bottles
With a polypropylene cap with a polyethylene tamper-evident band lined with expanded polyethylene wad.
Pack sizes: 150, 200, 300 and 600 ml.
Not all pack sizes may be marketed.
6.6
|
Gaviscon Double Action Aniseed Oral suspension
|
Pharmaceutical particulars - Special precautions for disposal and other handling
|
Special precautions for disposal and other handling
No special requirements.
7.
|
Gaviscon Double Action Aniseed Oral suspension
|
Marketing authorisation holder
|
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.
8. Marketing authorisation number(s)
PL 00063/0543.
9.
|
Gaviscon Double Action Aniseed Oral suspension
|
Date of first authorisation/renewal of the authorisation
|
24/06/2008 / 07/08/2019
10.
|
Gaviscon Double Action Aniseed Oral suspension
|
Date of revision of the text
|
12/12/2022
|
Gaviscon Double Action Liquid Sachets
|
Name of the medicinal product
|
Gaviscon Double Action Liquid Sachets.
2.
|
Gaviscon Double Action Liquid Sachets
|
Qualitative and quantitative composition
|
Each 10 ml dose contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg.
Excipient(s) with known effect:
Methyl parahydroxybenzoate (E218) 40 mg/ 10ml
Propyl parahydroxybenzoate (E216) 6 mg/10ml
Sodium 127.88 mg / 10ml
For full list of excipients, see Section 6.1.
3.
|
Gaviscon Double Action Liquid Sachets
|
Pharmaceutical form
|
Oral suspension in sachets.
4.
|
Gaviscon Double Action Liquid Sachets
|
Clinical particulars - Therapeutic indications
|
Therapeutic indications
Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy, and for symptoms of excess stomach acid (hyperacidity). Can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy.
4.2
|
Gaviscon Double Action Liquid Sachets
|
Clinical particulars - Posology and method of administration
|
Posology and method of administration
For oral administration.
Adults and children 12 years and over: One to two sachets (10-20 ml) after meals and at bedtime, up to four times per day.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).
4.3
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.