medication_name stringlengths 6 170 | section_title stringclasses 42
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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 seco... |
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 i... |
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 su... |
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 combinatio... |
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 antiepilepti... |
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 effect... |
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/... |
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 ... |
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... |
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 plas... |
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... |
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 ref... |
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 n... |
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.... |
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... |
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:
... |
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 ... |
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... |
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... |
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 ref... |
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 n... |
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.... |
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... |
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:
... |
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 Orga... |
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... |
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
Fo... |
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 g... |
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 dos... |
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 1... |
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,... |
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, ... |
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 <1/1... |
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. Pharmaco... |
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 g... |
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.... |
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