GAVISCON COOL LIQUID
Active substance: SODIUM BICARBONATE
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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Cool Liquid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION Gaviscon Cool Liquid contains 250mg sodium alginate BP, 133.5 mg sodium bicarbonate Ph. Eur. and 80 mg calcium carbonate Ph. Eur. per 5 ml.
3.
PHARMACEUTICAL FORM Oral suspension.
4.
4.1.
CLINICAL PARTICULARS
Therapeutic indications Gastric reflux, hearburn, flatulence associated with gastric reflux, heartburn of pregnancy, all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.
4.2.
Posology and method of administration For oral administration. Adults and children over 12: 10-20 ml after meals and at bedtime. Elderly: No dose modification is required in this age group. Children 6-12 years: 5-10 ml after meals and at bedtime. Children under 6 years: Not recommended. If symptoms persist consult your doctor.
4.3
Contraindications
This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.
4.4
Special warnings and precautions for use
Each 10 ml dose has a sodium content of 141 mg (6.2 mmol). This should be taken into account when a highly restricted salt diet is recommended. e.g. in some cases of congestive cardiac failure and renal impairment. Each 10 ml dose contains 160 mg (1.6 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. There is a possibility of reduced efficacy in patients with very low levels of gastric acid. If symptoms do not improve after seven days, the clinical situation should be reviewed.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
4.5.
Interactions with other medicaments and other forms of interaction
Due to the presence of calcium carbonate which act as an antacid, a time-interval of 2 hours should be considered between Gaviscon intake an the administration of other medicinal products, especially H2-antihistaminics tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroxine, penicilamine, betablockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, and diphosphonates.
. 4.6. Pregnancy and lactation 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 this medicine may be used during pregnancy and lactation.
4.7.
Effects on ability to drive and use machines None.
4.8
Undesirable effects Very rarely (<1/10,000) patients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions.
4.9.
Overdose In the event of overdosage symptomatic treatment should be given. The patient may notice abdominal distension.
5
PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties On ingestion the product reacts rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents, quickly and effectively impeding gastro-oesophageal reflux, for up to 4 hours. In severe cases the raft itself may be refluxed into the oesophagus, in preference to the stomach contents, and exert a demulcent effect.
5.2.
Pharmacokinetic properties The mode of action of Gaviscon Cool Liquid is physical and does not depend on absorption into the systemic circulation.
5.3.
Preclinical safety data No preclinical findings of relevance to the prescriber have been reported
6.
6.1.
PHARMACEUTICAL PARTICULARS
List of excipients
Carbomer E218 (Methyl parahydroxybenzoate) E216 (Propyl parahydroxybenzoate) Saccharin sodium Mint flavour no. 4 Mint flavour no. 5 Sodium hydroxide Purified water
6.2.
Incompatibilities None known.
6.3.
Shelf life Two years.
6.4.
Special precautions for storage Do not store above 30C. Do not refrigerate or freeze.
6.5.
Nature and content of container Amber glass bottles with a polypropylene cap with a polyethylene tamperevident band lined with expanded polyethylene wad and containing 100, 150, 200, 300, 500 or 600 ml.
6.6.
Instruction for use, handling and disposal To be taken orally. If desired the standard dose of Gaviscon Cool Liquid may be taken diluted with not more than an equal quantity of water well stirred.
7.
MARKETING AUTHORISATION HOLDER Hamol Limited
103-105 Bath Road Slough Berkshire SL1 3UH United Kingdom
8.
MARKETING AUTHORISATION NUMBER PL 01839/0003
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/02/2006
10
DATE OF REVISION OF THE TEXT
23/04/2012
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION Gaviscon Cool Liquid contains 250mg sodium alginate BP, 133.5 mg sodium bicarbonate Ph. Eur. and 80 mg calcium carbonate Ph. Eur. per 5 ml.
3.
PHARMACEUTICAL FORM Oral suspension.
4.
4.1.
CLINICAL PARTICULARS
Therapeutic indications Gastric reflux, hearburn, flatulence associated with gastric reflux, heartburn of pregnancy, all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.
4.2.
Posology and method of administration For oral administration. Adults and children over 12: 10-20 ml after meals and at bedtime. Elderly: No dose modification is required in this age group. Children 6-12 years: 5-10 ml after meals and at bedtime. Children under 6 years: Not recommended. If symptoms persist consult your doctor.
4.3
Contraindications
This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.
4.4
Special warnings and precautions for use
Each 10 ml dose has a sodium content of 141 mg (6.2 mmol). This should be taken into account when a highly restricted salt diet is recommended. e.g. in some cases of congestive cardiac failure and renal impairment. Each 10 ml dose contains 160 mg (1.6 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. There is a possibility of reduced efficacy in patients with very low levels of gastric acid. If symptoms do not improve after seven days, the clinical situation should be reviewed.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
4.5.
Interactions with other medicaments and other forms of interaction
Due to the presence of calcium carbonate which act as an antacid, a time-interval of 2 hours should be considered between Gaviscon intake an the administration of other medicinal products, especially H2-antihistaminics tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroxine, penicilamine, betablockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, and diphosphonates.
. 4.6. Pregnancy and lactation 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 this medicine may be used during pregnancy and lactation.
4.7.
Effects on ability to drive and use machines None.
4.8
Undesirable effects Very rarely (<1/10,000) patients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions.
4.9.
Overdose In the event of overdosage symptomatic treatment should be given. The patient may notice abdominal distension.
5
PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties On ingestion the product reacts rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents, quickly and effectively impeding gastro-oesophageal reflux, for up to 4 hours. In severe cases the raft itself may be refluxed into the oesophagus, in preference to the stomach contents, and exert a demulcent effect.
5.2.
Pharmacokinetic properties The mode of action of Gaviscon Cool Liquid is physical and does not depend on absorption into the systemic circulation.
5.3.
Preclinical safety data No preclinical findings of relevance to the prescriber have been reported
6.
6.1.
PHARMACEUTICAL PARTICULARS
List of excipients
Carbomer E218 (Methyl parahydroxybenzoate) E216 (Propyl parahydroxybenzoate) Saccharin sodium Mint flavour no. 4 Mint flavour no. 5 Sodium hydroxide Purified water
6.2.
Incompatibilities None known.
6.3.
Shelf life Two years.
6.4.
Special precautions for storage Do not store above 30C. Do not refrigerate or freeze.
6.5.
Nature and content of container Amber glass bottles with a polypropylene cap with a polyethylene tamperevident band lined with expanded polyethylene wad and containing 100, 150, 200, 300, 500 or 600 ml.
6.6.
Instruction for use, handling and disposal To be taken orally. If desired the standard dose of Gaviscon Cool Liquid may be taken diluted with not more than an equal quantity of water well stirred.
7.
MARKETING AUTHORISATION HOLDER Hamol Limited
103-105 Bath Road Slough Berkshire SL1 3UH United Kingdom
8.
MARKETING AUTHORISATION NUMBER PL 01839/0003
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/02/2006
10
DATE OF REVISION OF THE TEXT
23/04/2012
Source: Medicines and Healthcare Products Regulatory Agency
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