Gaviscon Original Aniseed

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM HYDROGEN

Mevcut itibaren:

Reckitt Benckiser Healthcare (UK) Limited 103-105 Bath Road Slough SL1 3UH, United Kingdom

ATC kodu:

A02BX

INN (International Adı):

SODIUM ALGINATE 250 mg/5ml SODIUM HYDROGEN CARBONATE 133.5 mg/5ml CALCIUM CARBONATE 80 mg/5ml

Farmasötik formu:

ORAL SUSPENSION

Kompozisyon:

SODIUM ALGINATE 250 mg/5ml SODIUM HYDROGEN CARBONATE 133.5 mg/5ml CALCIUM CARBONATE 80 mg/5ml

Reçete türü:

OTC

Terapötik alanı:

DRUGS FOR ACID RELATED DISORDERS

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2006-04-24

Ürün özellikleri

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gaviscon Original Aniseed Relief
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gaviscon Original Aniseed Relief contains 250mg sodium alginate,
133.5mg
sodium bicarbonate and 80mg calcium carbonate per 5ml.
For excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Oral suspension.
An opaque, pink suspension with the odour and flavour of fennel.
4
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Gastric 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.
4.3.
CONTRA-INDICATIONS
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 SPECIAL PRECAUTIONS FOR USE
If symptoms do not improve after seven days, the clinical situation
should be
reviewed.
Page 2 of 5
Each 10 ml dose has a sodium content of 141 mg (6.2 mmol). This should
be
taken into account when a highly restricted salt diet is recommended.
e.g. in
some cases of congestive cardiac failure and renal impairment.
Each 10 ml dose contains 160 mg (1.6 mmol) of calcium carbonate. Care
needs to be taken in treating patients with hypercalcaemia,
nephrocalcinosis
and recurrent calcium containing renal calculi.
Contains
methyl
parahydroxybenzoate
(E218)
and
propyl
parahydroxybenzoate (E216) which may cause allergic reactions
(possibly
delayed).
4.5.
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
A time-interval