Gaviscon Original Aniseed Relief

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: 5000158065352 5000158064584 5000158065574 5000158065086

Patient Information leaflet

_RELIEF_
_HEARTBURN & INDIGESTION_
_HEARTBURN & INDIGESTION_
_SODIUM ALGINATE_
_SODIUM BICARBONATE_
_CALCIUM CARBONATE_
_SODIUM ALGINATE_
_SODIUM BICARBONATE_
_CALCIUM CARBONATE_
_ORAL SUSPENSION_
WHAT IS THIS PRODUCT?
Each 10ml of oral suspension
contains 500mg sodium alginate,
267mg sodium bicarbonate and
160mg calcium carbonate as the
active ingredients.
PATIENT INFORMATION LEAFLET
GAVISCON ORIGINALANISEED RELIEF
Sodium alginate
Sodium bicarbonate
Calcium carbonate
Please read this leaflet carefully before you take this medicine. If
you are not sure
about anything ask your pharmacist or doctor.
WHAT IS GAVISCON ORIGINAL ANISEED RELIEF AND WHAT IS IT USED FOR?
Gaviscon Original Aniseed Relief belongs to a group of medicines
called ‘reflux
suppressants’, which form a protective layer on top of the stomach
contents to
prevent stomach acid escaping from the stomach where it works in the
food pipe
causing pain and discomfort. Gaviscon Original Aniseed Relief is used
for the
treatment of symptoms of gastro-oesophageal reflux such as acid
regurgitation,
heartburn and indigestion, which may occur for example following meals
or
during pregnancy.
BEFORE USING GAVISCON ORIGINAL ANISEED RELIEF
DO NOT TAKE THIS PRODUCT IF:
• You know you are allergic to any of the ingredients as very rarely
difficulty in
breathing and skin rashes have occur (see further information for a
full list of
ingredients)
TAKE SPECIAL CARE BEFORE TREATMENT WITH GAVISCON ORIGINAL ANISEED
RELIEF :
This medicine contains 142.6 mg sodium (main component of
cooking/table salt)
in each 10 ml. This is equivalent to 7.1 % of the recommended maximum
daily
dietary intake of sodium for an adult. If you have been advised to
follow a low
sodium (salt) diet ask your doctor before taking this product. The
maximum
recommended daily dose of this medicinal product contains 1140.8 mg
sodium
(found in table salt). This is equivalent to 57 % of the adult
recommended
maximum daily dietary intake for sodium. Talk to your doctor or
pharmacist if
you need this produc

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gaviscon Original Aniseed Relief.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gaviscon Original Aniseed Relief contains 250 mg sodium alginate,
133.5 mg
sodium bicarbonate and 80 mg calcium carbonate per 5 ml.
Excipient(s) with known effect:
Methyl parahydroxybenzoate E218:
40 mg/ 10ml
Propyl parahydroxybenzoate E216:
6 mg/10ml
Benzyl alcohol* (1.1 mg/10ml)
Sodium 142.6 mg (6.2 mmol)/ 10ml
*present in fennel flavour
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.
Children under 12 years: Should be given only on medical advice.
Elderly: No dosage 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).
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 142.6 mg sodium per 10 ml, equivalent
to 7.1
% 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