Gaviscon Liquid – Aniseed Flavour Oral Suspension

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Reckitt Benckiser Ireland Ltd 7 Riverwalk Citywest Business Campus Dublin 24 , Ireland

ATC code:

A02BX

INN (International Name):

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

Pharmaceutical form:

ORAL SUSPENSION

Composition:

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

Prescription type:

OTC

Therapeutic area:

DRUGS FOR ACID RELATED DISORDERS

Authorization status:

Authorised

Authorization date:

2006-04-24

Patient Information leaflet

LEAFLET TEXT
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gaviscon Liquid Aniseed Flavour Oral Suspension
Sodium alginate 500mg/10ml, Sodium bicarbonate 267mg/10ml, Calcium
carbonate 160mg/10ml
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However you still
need to take this medicine carefully to
get the best results from it.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse has
told you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to you doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See Section 4.
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
What is in this leaflet
1. What is Gaviscon Liquid and what is it used for?
2. What you need to know before taking Gaviscon Liquid
3. How to take Gaviscon Liquid
4. Possible side-effects
5. How to store Gaviscon Liquid
6. Contents of the pack and other information.
1. WHAT GAVISCON LIQUID IS AND WHAT IT IS USED FOR?
Gaviscon Liquid belongs to a group of medicines called “reflux
suppressants”. This product forms a
protective layer that floats on top of the stomach contents. This
layer prevents reflux and keeps the
stomach contents away from the lining of the food pipe to relieve the
symptoms of heartburn and acid
indigestion.
This medicine is used for the treatment of symptoms of
gastro-oesophageal reflux such as acid
regurgitation, heartburn and indigestion (related to reflux), for
example, following meals, or during
pregnancy, or in patients with symptoms related to reflux
oesophagitis.
2. WHAT YOU NEED TO KNOW BEFORE TAKING GAVISCON LIQUID
DO NOT TAKE GAVISCON LIQUID:
If you know you are allergic (hypersensitive) to any of the
ingredients in this product (see “further
information” for a full list of ingre

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Gaviscon Liquid – Aniseed Flavour Oral Suspension
Sodium alginate 500mg,
Sodium bicarbonate 267mg,
Calcium carbonate 160mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS MG/10ML
Sodium alginate 500
Sodium bicarbonate 267
Calcium carbonate 160
Excipients with known effect:
Sodium 142.6mg (6.2 mmol) / 10ml.
Benzyl alcohol 1.1mg /10ml, present in fennel flavour
Methyl parahydroxybenzoate (E218) 40mg /10ml
Propyl parahydroxybenzoate (E216) 6mg / 10ml
For a full list of excipients, see Section 6.1
3. PHARMACEUTICAL FORM
Oral suspension.
Pink, opaque suspension with an odour and flavour of aniseed.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
500 AND 600ML
For the management of gastric reflux, reflux oesophagitis, hiatus
hernia, heartburn (including
heartburn of pregnancy) and similar gastric distress.
150 AND 300ML
For the relief of stomach upset due to hyperacidity and heartburn
(including heartburn of
pregnancy).
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
500 AND 600 ML
ADULTS AND CHILDREN OVER 12 YEARS:
10-20 ml (two to four 5ml spoonfuls) after meals and
before retiring.
CHILDREN 6 TO 12 YEARS
: 5-10 ml (one to two 5ml spoonfuls) after meals and before retiring. 150 ML AND 300 ML
ADULTS AND CHILDREN OVER 12 YEARS:
10-20 ml (two to four 5 ml spoonfuls) after meals and
before retiring.
CHILDREN UNDER 12 YEARS:
Should be given only on medical advice. Not for use in children of
6 years or under.
SPECIAL PATIENT GROUPS:
ELDERLY
: No dosage modification is required in this age group.
HEPATIC IMPAIRMENT
: No modifications necessary.
RENAL INSUFFICIENCY:
Caution if highly restricted salt diet is necessary
(see section 4.4).
METHOD OF ADMINISTRATION
For oral administration.
DURATION OF TREATMENT
If symptoms do not improve after seven days, the clinical situation
should be reviewed.
4.3. CONTRAINDICATIONS
Hypersensitivity to the active substance or any of the excipients
listed in 6.1, including methyl
parahydroxybenzoate (E218) and