Gaviscon Double Action chewable tablets mint

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium alginate; Sodium bicarbonate; Calcium carbonate

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

A02BX

INN (International Name):

Sodium alginate; Sodium bicarbonate; Calcium carbonate

Dosage:

250mg ; 106.5mg ; 187.5mg

Pharmaceutical form:

Chewable tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 01010201; GTIN: 5000158065987 5000158065994 5000158066007 5000158071377 5000158071346 5000158071353

Patient Information leaflet

HOW TO TAKE GAVISCON DOUBLE ACTION MINT FLAVOUR CHEWABLE TABLETS:
For oral administration. Chew thoroughly before swallowing.
ADULTS AND CHILDREN 12 YEAR AND OVER:
When symptoms occur take two to four
tablets after meals and at bedtime, up to four times a day.
CHILDREN UNDER 12
YEARS:
Should only be taken on medical advice.
If you forget a dose, it is not necessary to double the dose next
time, just carry on
taking as before.
If you take too many tablets you may feel bloated. It is unlikely to
cause you any
harm, but please consult your doctor or pharmacist.
Taking large doses of calcium carbonate every day for prolonged
periods can lead
to high levels of calcium in the blood.
AFTER TAKING GAVISCON DOUBLE ACTION MINT FLAVOUR CHEWABLE TABLETS:
If symptoms persist, or treatment is required for more than seven days
continuously, seek medical advice.
POSSIBLE SIDE EFFECTS:
Very rarely (less than 1 in 10,000 patients treated) an allergic
reaction to the
ingredients may occur. Symptoms of this may include: skin rash
itching, difficulty
breathing, dizziness, swelling of the face, tongue or throat. If you
experience these
or any other side effects, stop taking the product and consult your
doctor
immediately. Other side effects of unknown frequency may include
constipation,
irritability, muscle twitching or muscle cramps, indigestion that
comes back when
you stop taking the tablets and high levels of calcium in the blood.
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. You can also
report side effects
directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or
search
for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the
safety of
this medicine.
STORING YOUR MEDICINE:
Do not use this product after the expiry date (EXP: month/year) shown.
Keep out
of the sight and reach of children. Do not store above 30°C. Store in
the original
package.
FURTHER INF

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gaviscon Double Action Mint Flavour Chewable Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 250 mg, sodium bicarbonate 106.5
mg
and calcium carbonate 187.5 mg.
Excipient(s) with known effect:
Aspartame
Carmoisine Lake (E122)
For full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Chewable tablet.
A flat, circular, bi-layer tablet with bevelled edges. One layer of
the tablet is pink and
slightly mottled, and the other white.
4
CLINICAL PARTICULARS
4.1
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
gastro-
oesophageal reflux during concomitant treatment with or following
withdrawal
of acid suppressing therapy.
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, 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 dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is
necessary (see
section 4.4).
4.3
CONTRAINDICATIONS
Hypersensitivity to sodium alginate, sodium bicarbonate, calcium
carbonate or to any
of the excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This medicinal product contains 223.56 mg (9.72 mmol) sodium per 4
tablet
dose, equivalent to 11.18 % of the WHO recommended maximum daily
intake
for sodium.
The maximum daily dose of this product is equivalent to 44.71% of the
WHO
recommended maximum daily intake for sodium.
This product is considered high in sodium. This should be particularly
taken
into account