GAVISCON STRAWBERRY FLAVOUR TABLETS
Active substance: SODIUM HYDROGEN CARBONATE
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gaviscon Strawberry Flavour Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate 133.5 mg, calcium carbonate 80 mg. For excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Chewable tablet. (Tablet) Pale pink, circular, flat with bevelled edges with the odour and flavour of strawberry.
4
4.1
CLINICAL PARTICULARS
Therapeutic indications Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example, following meals or during pregnancy.
4.2
Posology and method of administration For oral administration, after being thoroughly chewed.
Adults and children 12 years and over: Two to four tablets after meals and at bedtime. Children under 12 years: Should be given only on medical advice.
Elderly:
No
dose
modifications
necessary
for
this
age
group.
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 The sodium content of a four tablet dose is 246 mg (10.6 mmol). This should be taken into account when a highly restricted salt diet is required, e.g. in some cases of congestive cardiac failure and renal impairment. Each four-tablet dose contains 320 mg (3.2 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. Due to its aspartame content this product should not be given to patients with phenylketonuria. 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. Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.
4.5
Interaction with other medicinal products and other forms of interaction Due to the presence of calcium carbonate which act as an antacid, a timeinterval 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, beta-blockers (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, Gaviscon Strawberry Flavour Tablets 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
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic classification: A02E A01 Anti-regurgitant. On ingestion Gaviscon Strawberry 250 mg Tablets react 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 Strawberry Flavour Tablets is physical and does not depend on absorption into the systemic circulation.
5.3
Preclinical safety data No pre-clinical findings of any relevance to the prescriber have been reported.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Mannitol Macrogol 20,000 Aspartame Magnesium stearate Xylitol and Carmellose sodium Red iron oxide Strawberry cream flavour (Strawberry cream PHS-048481) Ingredients of the strawberry cream flavour: Maltodextrin Modified starch E1450 Vegetable oil Propylene glycol E1520
6.2
Incompatibilities Not applicable.
6.3
Shelf life Two years.
6.4
Special precautions for storage Do not store above 25C.
6.5
Nature and contents of container Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blisters packed into cartons. Pack sizes: 2, 4, 6, 8,16, 24, 32, 48, 60, 64, 72, 80. Polypropylene container. Pack sizes 8, 12, 16, 32. Not all pack sizes may be marketed.
6.6
Special precautions for disposal No special instructions.
7
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.
8
MARKETING AUTHORISATION NUMBER(S)
PL 00063/0155.
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/12/2009
10
DATE OF REVISION OF THE TEXT
11/05/2010
1
NAME OF THE MEDICINAL PRODUCT
Gaviscon Strawberry Flavour Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate 133.5 mg, calcium carbonate 80 mg. For excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Chewable tablet. (Tablet) Pale pink, circular, flat with bevelled edges with the odour and flavour of strawberry.
4
4.1
CLINICAL PARTICULARS
Therapeutic indications Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example, following meals or during pregnancy.
4.2
Posology and method of administration For oral administration, after being thoroughly chewed.
Adults and children 12 years and over: Two to four tablets after meals and at bedtime. Children under 12 years: Should be given only on medical advice.
Elderly:
No
dose
modifications
necessary
for
this
age
group.
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 The sodium content of a four tablet dose is 246 mg (10.6 mmol). This should be taken into account when a highly restricted salt diet is required, e.g. in some cases of congestive cardiac failure and renal impairment. Each four-tablet dose contains 320 mg (3.2 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi. Due to its aspartame content this product should not be given to patients with phenylketonuria. 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. Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.
4.5
Interaction with other medicinal products and other forms of interaction Due to the presence of calcium carbonate which act as an antacid, a timeinterval 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, beta-blockers (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, Gaviscon Strawberry Flavour Tablets 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
5.1
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic classification: A02E A01 Anti-regurgitant. On ingestion Gaviscon Strawberry 250 mg Tablets react 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 Strawberry Flavour Tablets is physical and does not depend on absorption into the systemic circulation.
5.3
Preclinical safety data No pre-clinical findings of any relevance to the prescriber have been reported.
6
6.1
PHARMACEUTICAL PARTICULARS
List of excipients Mannitol Macrogol 20,000 Aspartame Magnesium stearate Xylitol and Carmellose sodium Red iron oxide Strawberry cream flavour (Strawberry cream PHS-048481) Ingredients of the strawberry cream flavour: Maltodextrin Modified starch E1450 Vegetable oil Propylene glycol E1520
6.2
Incompatibilities Not applicable.
6.3
Shelf life Two years.
6.4
Special precautions for storage Do not store above 25C.
6.5
Nature and contents of container Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blisters packed into cartons. Pack sizes: 2, 4, 6, 8,16, 24, 32, 48, 60, 64, 72, 80. Polypropylene container. Pack sizes 8, 12, 16, 32. Not all pack sizes may be marketed.
6.6
Special precautions for disposal No special instructions.
7
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.
8
MARKETING AUTHORISATION NUMBER(S)
PL 00063/0155.
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/12/2009
10
DATE OF REVISION OF THE TEXT
11/05/2010
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
