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

CLINICAL PARTICULARS

4.1

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:

4.3

No

dose

modifications

necessary

for

this

age

group.

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

PHARMACOLOGICAL PROPERTIES

5.1

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

PHARMACEUTICAL PARTICULARS

6.1

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 25°C.

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

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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