GAVISCON LIQUID PEPPERMINT

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

ALGINIC ACID AS SODIUM; CALCIUM CARBONATE; SODIUM BICARBONATE

Fáanlegur frá:

RECKITT BENCKISER (NEAR EAST) LTD

ATC númer:

A02BX13

Lyfjaform:

SUSPENSION

Samsetning:

ALGINIC ACID AS SODIUM 50 MG/ML; SODIUM BICARBONATE 26.7 MG/ML; CALCIUM CARBONATE 16 MG/ML

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Not required

Framleitt af:

RECKITT & BENCKISER HEALTHCARE (UK) LTD

Meðferðarhópur:

SALT SOLUTIONS

Lækningarsvæði:

ALGINIC ACID

Ábendingar:

Gastro reflux, heartburn, flatulence associated with gastric reflux, heartburn of pregnancy, all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.

Leyfisdagur:

2014-09-30

Vara einkenni

PHYSICIAN'S PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
Gaviscon Liquid Peppermint.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gaviscon Liquid Peppermint contains 250mg sodium alginate, 133.5mg
sodium bicarbonate
and 80mg calcium carbonate per 5ml.
Excipient(s) with known effect:
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Sodium
For excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Off-white suspension with an odour and flavour of peppermint.
4
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Gastro reflux, heartburn, 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 years: 10-20ml after meals and at bedtime.
Elderly: No dosage modification is required in this age group.
Children 6 to 12 years: 5-10ml after meals and at bedtime.
Children under 6 years: Not recommended.
Hepatic Impairment: No dose modification necessary.
Renal Insufficiency: Caution if highly restricted salt diet is
necessary (see section 4.4).
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) 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 ona low salt diet (e.g. in some cases of congestive heartfailure
and renal impairment