Gaviscon Cool Liquid

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Calcium carbonate; Sodium alginate; Sodium bicarbonate

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

A02BX13

INN (International Name):

Calcium carbonate; Sodium alginate; Sodium bicarbonate

Dosage:

16mg/1ml ; 50mg/1ml ; 26.7mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01010201; GTIN: 5000158065475

Patient Information leaflet

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING (LABEL)
1. NAME OF THE MEDICINAL PRODUCT
Gaviscon Cool Liquid
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each chewable 10 ml of oral suspension contains 500 mg sodium
alginate, 267 mg
sodium bicarbonate and 160 mg calcium carbonate as the active
ingredients.
3. LIST OF EXCIPIENTS
This product is sugar free and gluten free. Contains sodium, methyl
(E218) and
propyl (E2016) parahydroxybenzoates. High in sodium – see leaflet
for further
information.
4. PHARMACEUTICAL FORM AND CONTENTS
Oral suspension.
5. METHOD AND ROUTE(S) OF ADMINISTRATION
For oral use. Adults and children 12 years an over: Take 10-20 ml (two
to four 5 ml
spoonfuls) after meals and at bedtime. Children under 12 years: Should
be given
only on medical advice.
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
You can take this product if you are pregnant or breast feeding.
Gaviscon Cool Liquid brings up to 4 hours relief from the pain and
discomfort of
heartburn and acid indigestion.
8. EXPIRY DATE
Do not use this product after the expiry date (EXP: month/year shown).
9. SPECIAL STORAGE CONDITIONS
Do not store above 30°C. Do not refrigerate or freeze.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd.,103-105 Bath Road, Slough, SL1
3UH,
United Kingdom
12. MARKETING AUTHORISATION NUMBER(S)
PL 00063/0739
13. BATCH NUMBER
Batch: BN
14. GENERAL CLASSIFICATION FOR SUPPLY
GSL
15. INSTRUCTIONS ON USE
Shake well before use.
•
Heartburn & Indigestion
•
Cool mint flavour
PATIENT INFORMATION LEAFLET
GAVISCON COOL LIQUID
Sodium alginate, Sodium hydrogen carbonate, Calcium carbonate
Please read this leaflet carefully before you take this medicine. If
you are not sure about
anything ask your pharmaci

Summary of Product characteristics

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, 133.5 mg sodium
bicarbonate and 80 mg calcium carbonate per 5 ml.
Excipient(s) with known effect:
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Sodium
For excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Oral suspension.
4
CLINICAL PARTICULARS
4.1
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.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modification is required in this age group.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is
necessary (see
section 4.4).
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
listed in
section 6.1, including methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) (see section 4.4).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms do not improve after 7 days, the clinical situation should
be
reviewed.
This medicinal product contains 285.2 mg (12.4 mmol) of sodium per 20
ml
dose, equivalent to 14.26 % of the WHO recommended maximum daily
intake
for sodium. The maximum daily dose of this product is equivalent to
57% of
the WHO recommended maximum daily intake for sodium. This product is
considered high in sodium. This should be particularly taken into
account for
those on a low salt diet (e.g. in some cases of congestive heart
failure and renal
impairment).
Each 10 ml dose contains 160 mg (1.6 mmol) of calcium