Gaviscon Advance oral suspension peppermint

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium alginate; Potassium bicarbonate

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

INN (International Name):

Sodium alginate; Potassium bicarbonate

Dosage:

100mg/1ml ; 20mg/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: 5000158064515 5000158065109 5000158065635

Patient Information leaflet

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING (TUBE)
1. NAME OF THE MEDICINAL PRODUCT
Gaviscon Advance Peppermint Flavour Oral Suspension
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Each 10 ml contains sodium alginate 1000 mg and potassium hydrogen
carbonate
200 mg.
3. LIST OF EXCIPIENTS
Contains sodium, potassium, calcium, methyl (E218) and propyl (E216)
para-
hydroxybenzoates.
High in sodium - see leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
Oral suspension
300 ml
5. METHOD AND ROUTE(S) OF ADMINISTRATION
For oral use. Adults, including elderly and children 12 years and
over: Take 5-10 ml
(one to two 5 ml spoonfuls) after meals and at bedtime.
Children under 12 years: Should only be taken 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 sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
If symptoms persist after 7 days consult your doctor.
8. EXPIRY DATE
Do not use this product after the expiry date (EXP: month/year shown).
9. SPECIAL STORAGE CONDITIONS
Do not refrigerate.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
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11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS
12. MARKETING AUTHORISATION NUMBER(S)
PL 00063/0748
13. BATCH NUMBER
Batch: BN
14. GENERAL CLASSIFICATION FOR SUPPLY
GSL
15. INSTRUCTIONS ON USE
Check that the cap seal is unbroken before first using this product.
Shake well before
use.
•
Heartburn & Indigestion
•
Extra Strength Formula
Reckitt Benckiser
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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gaviscon Advance Peppermint Flavour
Oral Suspension.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml dose contains sodium alginate 1000 mg and potassium
hydrogen
carbonate 200 mg. 1 ml contains sodium alginate 100 mg and potassium
hydrogen carbonate 20.0 mg.
Each 10 ml dose is equivalent to two 5 ml measuring spoons.
Excipient(s) with known effect:
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Sodium
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral suspension.
Off-white viscous suspension.
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, indigestion
(occurring due to the
reflux of stomach contents), for instance, after gastric surgery, as a
result of hiatus
hernia, during pregnancy, accompanying reflux oesophagitis, including
symptoms of
laryngopharyngeal reflux such as hoarseness and other voice disorders,
sore throats
and cough. It 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
Adults and children 12 years and over: 5-10 ml after meals and at
bedtime
(one to two 5 ml measuring spoons).
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modification is required 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
CONTRINDICATIONS
The 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 d