medication_name stringlengths 6 170 | section_title stringclasses 42
values | text stringlengths 0 47.1k |
|---|---|---|
Kytril 2 mg film-coated tablets | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproductive toxicity and genotoxicity. Carcinogenicity studies revealed no special hazard for humans when used in the recommended human dose. However, when admini... |
Kytril 2 mg film-coated tablets | Pharmaceutical particulars - List of excipients | List of excipients
Lactose monohydrate
Hypromellose
Sodium starch glycolate
Cellulose, microcrystalline
Magnesium stearate
Film-coat:
Hypromellose
Titanium dioxide (E171)
Macrogol 400
Polysorbate 80
6.2 |
Kytril 2 mg film-coated tablets | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable.
6.3 |
Kytril 2 mg film-coated tablets | Pharmaceutical particulars - Shelf life | Shelf life
5 years
6.4 |
Kytril 2 mg film-coated tablets | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 |
Kytril 2 mg film-coated tablets | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Opaque PVC blisters sealed with an aluminium foil containing 2 or 10 tablets (1mg) or 1, 5 or 10 tablets (2mg). Not all pack sizes may be marketed.
6.6 |
Kytril 2 mg film-coated tablets | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. |
Kytril 2 mg film-coated tablets | Marketing authorisation holder | Atnahs Pharma UK Limited
Sovereign House
Miles Gray Road
Basildon
Essex
SS14 3FR
United Kingdom
8. Marketing authorisation number(s)
PL 43252/0017
9. |
Kytril 2 mg film-coated tablets | Date of first authorisation/renewal of the authorisation | Date of first authorisation: 15 September 2001
Date of latest renewal: 13 January 2006
10. |
Kytril 2 mg film-coated tablets | Date of revision of the text | 17-July-2017
Detailed information on this medicinal product is available on the Medicines and Healthcare Products Regulatory Agency (MHRA) website : http://www.mhra.gov.uk |
Gaalin 16mg prolonged release capsules | Name of the medicinal product | Gaalin 16 mg prolonged-release capsules, hard
2. |
Gaalin 16mg prolonged release capsules | Qualitative and quantitative composition | Each prolonged-release capsule contains 16 mg galantamine (as hydrobromide).
For the full list of excipients, see section 6.1.
3. |
Gaalin 16mg prolonged release capsules | Pharmaceutical form | Prolonged-release capsule, hard.
Gaalin 16 mg prolonged-release capsules, hard:
Pink opaque, Size “1” hard gelatin capsules with inscription “A” over the cap & “16” over the body containing two white to off white round, biconvex mini tablets.
4. |
Gaalin 16mg prolonged release capsules | Clinical particulars - Therapeutic indications | Therapeutic indications
Galantamine is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type.
4.2 |
Gaalin 16mg prolonged release capsules | Clinical particulars - Posology and method of administration | Posology and method of administration
Posology
Adults/Elderly
Before start of treatment
The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines (see section 4.4).
Starting dose
The recommended starting dose is 8 mg/day for 4 weeks.
Maintenanc... |
Gaalin 16mg prolonged release capsules | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Because no data are available on the use of galantamine in patients with severe hepatic impairment (Child-Pugh score greater than 9) and in patients with creatinine clearance less than 9 ml/min, galantamine is ... |
Gaalin 16mg prolonged release capsules | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
Types of dementia
Galantamine is indicated for a patient with mild to moderately severe dementia of the Alzheimer type. The benefit of galantamine in patients with other types of dementia or other types of memory impairment has not been demonstrated. In 2 clinical trials of 2 ... |
Gaalin 16mg prolonged release capsules | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions
Because of its mechanism of action, galantamine should not be given concomitantly with other cholinomimetics (such as ambenonium, donepezil, neostigmine, pyridostigmine, rivastigmine or systemically administered pi... |
Gaalin 16mg prolonged release capsules | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Pregnancy
For galantamine no clinical data on exposed pregnancies are available. Studies in animals have shown reproductive toxicity (see section 5.3). Caution should be exercised when prescribing to pregnant women.
Breastfeeding
It is not known whether galantamine is excreted in ... |
Gaalin 16mg prolonged release capsules | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Galantamine has a minor to moderate influence on the ability to drive and use machines. Symptoms include dizziness and somnolence, especially during the first weeks after initiation of treatment.
4.8 |
Gaalin 16mg prolonged release capsules | Clinical particulars - Undesirable effects | Undesirable effects
The table below reflects data obtained with Galantamine in eight placebo-controlled, double-blind clinical trials (N=6,502), five open-label clinical trials (N=1,454), and from postmarketing spontaneous reports. The most commonly reported adverse reactions were nausea (21%) and vomiting (11%). They ... |
Gaalin 16mg prolonged release capsules | Clinical particulars - Overdose | Overdose
Symptoms
Signs and symptoms of significant overdosing of galantamine are predicted to be similar to those of overdosing of other cholinomimetics. These effects generally involve the central nervous system, the parasympathetic nervous system, and the neuromuscular junction. In addition to muscle weakness or f... |
Gaalin 16mg prolonged release capsules | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Galantamine is an alkalinic compound with one ionisation constant (pKa 8.2). It is slightly lipophilic and has a partition coefficient (Log P) between n-octanol/ buffer solution (pH 12) of 1.09. The solubility in water (pH 6) is 31 mg/ml. Galantamine has three chiral centres. The S, R, S-form... |
Gaalin 16mg prolonged release capsules | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Non-clinical data suggest no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Reproduction toxicity studies showed a slight delay in development in rats and rabbits, at doses that are below the thresh... |
Gaalin 16mg prolonged release capsules | Pharmaceutical particulars - List of excipients | List of excipients
Capsule Fill:
Cellulose, Microcrystalline (Grade -102)
Talc
Hydroxy Propyl Cellulose
Silica, Colloidal Anhydrous
Magnesium Stearate
Capsule Shell:
Titanium Dioxide (E171)
Iron Oxide Red (E172)
Sodium Lauryl Sulfate
Gelatin
Printing ink:
Shellac
Black iron oxide (E172)
6.2 |
Gaalin 16mg prolonged release capsules | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable
6.3 |
Gaalin 16mg prolonged release capsules | Pharmaceutical particulars - Shelf life | Shelf life
3 years
6.4 |
Gaalin 16mg prolonged release capsules | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 |
Gaalin 16mg prolonged release capsules | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Gaalin prolonged-release capsules, hard are available in clear PVC/PE/PVdC-Alu foil blister pack.
Pack sizes:
Blister packs: 28 and 30 prolonged-release capsules, hard
Not all pack sizes may be marketed.
6.6 |
Gaalin 16mg prolonged release capsules | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. |
Gaalin 16mg prolonged release capsules | Marketing authorisation holder | Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
8. Marketing authorisation number(s)
PL 16363/0538
9. |
Gaalin 16mg prolonged release capsules | Date of first authorisation/renewal of the authorisation | 19/04/2018 / 07/12/2022
10. |
Gaalin 16mg prolonged release capsules | Date of revision of the text | 07/12/2022 |
Gaalin 24mg prolonged release capsules | Name of the medicinal product | Gaalin 24 mg prolonged-release capsules, hard
2. |
Gaalin 24mg prolonged release capsules | Qualitative and quantitative composition | Each prolonged-release capsule contains 24 mg galantamine (as hydrobromide).
For the full list of excipients, see section 6.1.
3. |
Gaalin 24mg prolonged release capsules | Pharmaceutical form | Prolonged-release capsule, hard.
Gaalin 24 mg prolonged-release capsules, hard:
Caramel opaque, Size “1” hard gelatin capsules filled with inscription “A” over the cap & “24” over the body containing three white to off white round, biconvex mini tablets.
4. |
Gaalin 24mg prolonged release capsules | Clinical particulars - Therapeutic indications | Therapeutic indications
Galantamine is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type.
4.2 |
Gaalin 24mg prolonged release capsules | Clinical particulars - Posology and method of administration | Posology and method of administration
Posology
Adults/Elderly
Before start of treatment
The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines (see section 4.4).
Starting dose
The recommended starting dose is 8 mg/day for 4 weeks.
Maintenanc... |
Gaalin 24mg prolonged release capsules | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Because no data are available on the use of galantamine in patients with severe hepatic impairment (Child-Pugh score greater than 9) and in patients with creatinine clearance less than 9 ml/min, galantamine is ... |
Gaalin 24mg prolonged release capsules | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
Types of dementia
Galantamine is indicated for a patient with mild to moderately severe dementia of the Alzheimer type. The benefit of galantamine in patients with other types of dementia or other types of memory impairment has not been demonstrated. In 2 clinical trials of 2 ... |
Gaalin 24mg prolonged release capsules | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions
Because of its mechanism of action, galantamine should not be given concomitantly with other cholinomimetics (such as ambenonium, donepezil, neostigmine, pyridostigmine, rivastigmine or systemically administered pi... |
Gaalin 24mg prolonged release capsules | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Pregnancy
For galantamine no clinical data on exposed pregnancies are available. Studies in animals have shown reproductive toxicity (see section 5.3). Caution should be exercised when prescribing to pregnant women.
Breastfeeding
It is not known whether galantamine is excreted in ... |
Gaalin 24mg prolonged release capsules | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Galantamine has a minor to moderate influence on the ability to drive and use machines. Symptoms include dizziness and somnolence, especially during the first weeks after initiation of treatment.
4.8 |
Gaalin 24mg prolonged release capsules | Clinical particulars - Undesirable effects | Undesirable effects
The table below reflects data obtained with Galantamine in eight placebo-controlled, double-blind clinical trials (N=6,502), five open-label clinical trials (N=1,454), and from postmarketing spontaneous reports. The most commonly reported adverse reactions were nausea (21%) and vomiting (11%). They ... |
Gaalin 24mg prolonged release capsules | Clinical particulars - Overdose | Overdose
Symptoms
Signs and symptoms of significant overdosing of galantamine are predicted to be similar to those of overdosing of other cholinomimetics. These effects generally involve the central nervous system, the parasympathetic nervous system, and the neuromuscular junction. In addition to muscle weakness or f... |
Gaalin 24mg prolonged release capsules | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Galantamine is an alkalinic compound with one ionisation constant (pKa 8.2). It is slightly lipophilic and has a partition coefficient (Log P) between n-octanol/ buffer solution (pH 12) of 1.09. The solubility in water (pH 6) is 31 mg/ml. Galantamine has three chiral centres. The S, R, S-form... |
Gaalin 24mg prolonged release capsules | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Non-clinical data suggest no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Reproduction toxicity studies showed a slight delay in development in rats and rabbits, at doses that are below the thresh... |
Gaalin 24mg prolonged release capsules | Pharmaceutical particulars - List of excipients | List of excipients
Capsule Fill:
Cellulose, Microcrystalline (Grade -102)
Talc
Hydroxy Propyl Cellulose
Silica, Colloidal Anhydrous
Magnesium Stearate
Capsule Shell:
Titanium Dioxide (E171)
Iron Oxide Red (E172)
Iron Oxide Yellow (E172)
Sodium Lauryl Sulfate
Gelatin
Printing ink:
Shellac
Black iron oxide (E172)
... |
Gaalin 24mg prolonged release capsules | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable
6.3 |
Gaalin 24mg prolonged release capsules | Pharmaceutical particulars - Shelf life | Shelf life
3 years
6.4 |
Gaalin 24mg prolonged release capsules | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 |
Gaalin 24mg prolonged release capsules | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Gaalin prolonged-release capsules, hard are available in clear PVC/PE/PVdC-Alu foil blister pack.
Pack sizes:
Blister packs: 28 and 30 prolonged-release capsules, hard
Not all pack sizes may be marketed.
6.6 |
Gaalin 24mg prolonged release capsules | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. |
Gaalin 24mg prolonged release capsules | Marketing authorisation holder | Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
8. Marketing authorisation number(s)
PL 16363/0539
9. |
Gaalin 24mg prolonged release capsules | Date of first authorisation/renewal of the authorisation | 19/04/2018 / 07/12/2022
10. |
Gaalin 24mg prolonged release capsules | Date of revision of the text | 07/12/2022 |
Gaalin 8mg prolonged release capsules | Name of the medicinal product | Gaalin 8 mg prolonged-release capsules, hard
2. |
Gaalin 8mg prolonged release capsules | Qualitative and quantitative composition | Each prolonged-release capsule contains 8 mg galantamine (as hydrobromide).
For the full list of excipients, see section 6.1.
3. |
Gaalin 8mg prolonged release capsules | Pharmaceutical form | Prolonged-release capsule, hard.
Gaalin 8 mg prolonged-release capsules, hard:
White opaque, Size “1” hard gelatin capsules with inscription “A” over the cap & “8” over the body containing one white to off white round, biconvex mini tablet.
4. |
Gaalin 8mg prolonged release capsules | Clinical particulars - Therapeutic indications | Therapeutic indications
Galantamine is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type.
4.2 |
Gaalin 8mg prolonged release capsules | Clinical particulars - Posology and method of administration | Posology and method of administration
Posology
Adults/Elderly
Before start of treatment
The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines (see section 4.4).
Starting dose
The recommended starting dose is 8 mg/day for 4 weeks.
Maintenanc... |
Gaalin 8mg prolonged release capsules | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Because no data are available on the use of galantamine in patients with severe hepatic impairment (Child-Pugh score greater than 9) and in patients with creatinine clearance less than 9 ml/min, galantamine is ... |
Gaalin 8mg prolonged release capsules | Clinical particulars - Special warnings and precautions for use | Special warnings and precautions for use
Types of dementia
Galantamine is indicated for a patient with mild to moderately severe dementia of the Alzheimer type. The benefit of galantamine in patients with other types of dementia or other types of memory impairment has not been demonstrated. In 2 clinical trials of 2 ... |
Gaalin 8mg prolonged release capsules | Clinical particulars - Interaction with other medicinal products and other forms of interaction | Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions
Because of its mechanism of action, galantamine should not be given concomitantly with other cholinomimetics (such as ambenonium, donepezil, neostigmine, pyridostigmine, rivastigmine or systemically administered pi... |
Gaalin 8mg prolonged release capsules | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
Pregnancy
For galantamine no clinical data on exposed pregnancies are available. Studies in animals have shown reproductive toxicity (see section 5.3). Caution should be exercised when prescribing to pregnant women.
Breastfeeding
It is not known whether galantamine is excreted in ... |
Gaalin 8mg prolonged release capsules | Clinical particulars - Effects on ability to drive and use machines | Effects on ability to drive and use machines
Galantamine has a minor to moderate influence on the ability to drive and use machines. Symptoms include dizziness and somnolence, especially during the first weeks after initiation of treatment.
4.8 |
Gaalin 8mg prolonged release capsules | Clinical particulars - Undesirable effects | Undesirable effects
The table below reflects data obtained with Galantamine in eight placebo-controlled, double-blind clinical trials (N=6,502), five open-label clinical trials (N=1,454), and from postmarketing spontaneous reports. The most commonly reported adverse reactions were nausea (21%) and vomiting (11%). They ... |
Gaalin 8mg prolonged release capsules | Clinical particulars - Overdose | Overdose
Symptoms
Signs and symptoms of significant overdosing of galantamine are predicted to be similar to those of overdosing of other cholinomimetics. These effects generally involve the central nervous system, the parasympathetic nervous system, and the neuromuscular junction. In addition to muscle weakness or f... |
Gaalin 8mg prolonged release capsules | Pharmacodynamic properties - Pharmacodynamic properties | Pharmacokinetic properties
Galantamine is an alkalinic compound with one ionisation constant (pKa 8.2). It is slightly lipophilic and has a partition coefficient (Log P) between n-octanol/ buffer solution (pH 12) of 1.09. The solubility in water (pH 6) is 31 mg/ml. Galantamine has three chiral centres. The S, R, S-form... |
Gaalin 8mg prolonged release capsules | Pharmacodynamic properties - Pharmacokinetic properties | Preclinical safety data
Non-clinical data suggest no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Reproduction toxicity studies showed a slight delay in development in rats and rabbits, at doses that are below the thresh... |
Gaalin 8mg prolonged release capsules | Pharmaceutical particulars - List of excipients | List of excipients
Capsule Fill:
Cellulose, Microcrystalline (Grade -102)
Talc
Hydroxy Propyl Cellulose
Silica, Colloidal Anhydrous
Magnesium Stearate
Capsule Shell:
Titanium Dioxide (E171)
Sodium Lauryl Sulfate
Gelatin
Printing ink:
Shellac
Black iron oxide (E172)
6.2 |
Gaalin 8mg prolonged release capsules | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable
6.3 |
Gaalin 8mg prolonged release capsules | Pharmaceutical particulars - Shelf life | Shelf life
3 years
6.4 |
Gaalin 8mg prolonged release capsules | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 |
Gaalin 8mg prolonged release capsules | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
Gaalin prolonged-release capsules, hard are available in clear PVC/PE/PVdC-Alu foil blister pack.
Pack sizes:
Blister packs: 28 and 30 prolonged-release capsules, hard
Not all pack sizes may be marketed.
6.6 |
Gaalin 8mg prolonged release capsules | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. |
Gaalin 8mg prolonged release capsules | Marketing authorisation holder | Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
8. Marketing authorisation number(s)
PL 16363/0537
9. |
Gaalin 8mg prolonged release capsules | Date of first authorisation/renewal of the authorisation | 19/04/2018 / 07/12/2022
10. |
Gaalin 8mg prolonged release capsules | Date of revision of the text | 07/12/2022 |
Gabapentin 100 mg capsules | Name of the medicinal product | Gabapentin 100 mg capsules.
2. |
Gabapentin 100 mg capsules | Qualitative and quantitative composition | Each 100 mg capsule contains 100 mg gabapentin.
Excipients:
Each 100 mg capsule contains 16.83 mg lactose (as monohydrate).
For a full list of excipients, see section 6.1.
3. |
Gabapentin 100 mg capsules | Pharmaceutical form | Hard capsules (capsules):
White hard capsule, imprinted “100” and containing a white crystalline powder.
4. |
Gabapentin 100 mg capsules | 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 se... |
Gabapentin 100 mg capsules | Clinical particulars - Posology and method of administration | Posology and method of administration
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 sect... |
Gabapentin 100 mg capsules | Clinical particulars - Contraindications | Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 |
Gabapentin 100 mg capsules | 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 su... |
Gabapentin 100 mg capsules | 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 and/or sedation associated with gabapentin and opioid use. In some of these reports, the authors considered this a particular concern with the combination of gabapentin an... |
Gabapentin 100 mg capsules | Clinical particulars - Fertility, pregnancy and lactation | Fertility, pregnancy and lactation
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 malforma... |
Gabapentin 100 mg capsules | 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 effect... |
Gabapentin 100 mg capsules | 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 ( 1/1000 to < 1/100); rare ( 1/10000 to < 1/1000); ... |
Gabapentin 100 mg capsules | 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 ... |
Gabapentin 100 mg capsules | 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... |
Gabapentin 100 mg capsules | 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 plas... |
Gabapentin 100 mg capsules | Pharmaceutical particulars - List of excipients | List of excipients
Capsules fill:
lactose monohydrate;
maize starch;
talc.
Capsule shell:
gelatin;
titanium dioxide (E171).
Printing ink:
shellac;
Iron oxide black (E172);
propylene glycol.
6.2 |
Gabapentin 100 mg capsules | Pharmaceutical particulars - Incompatibilities | Incompatibilities
Not applicable
6.3 |
Gabapentin 100 mg capsules | Pharmaceutical particulars - Shelf life | Shelf life
Three years
6.4 |
Gabapentin 100 mg capsules | Pharmaceutical particulars - Special precautions for storage | Special precautions for storage
Do not store above 30°C.
6.5 |
Gabapentin 100 mg capsules | Pharmaceutical particulars - Nature and contents of container | Nature and contents of container
PVC/aluminium foil blister packs
Supplied in packs of 100 capsules.
6.6 |
Gabapentin 100 mg capsules | Pharmaceutical particulars - Special precautions for disposal and other handling | Special precautions for disposal and other handling
No special requirements.
7. |
Gabapentin 100 mg capsules | Marketing authorisation holder | Rivopharm UK Ltd
30th Floor, 40 Bank Street
Canary Wharf,
London E14 5NR
United Kingdom
8. Marketing authorisation number(s)
PL 33155/0091
9. |
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