Gaviscon Advance oral suspension aniseed

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: 5000158063693 5000158065116 5000158065130 5000158065628 5011417576229

Patient Information leaflet

TR1665245
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CUSTOMER INFO:
Minimum Point Size =
_Leaflet Point Size = 9pt_
7.00pt
GAVISCON ADVANCE
ANISEED FLAVOUR ORAL
SUSPENSION
T B R 2 6 8 7 - D 8 3 4 6 1 4 2 – E n g l i s h
GAVISCON ADVANCE ANISEED FLAVOUR ORAL SUSPENSION.
Sodium alginate and potassium hydrogen carbonate.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR 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 your pharmacist. This includes
any possible side effects not
listed in this leaflet. See section 4.
•
You must talk to your doctor if you do not feel better or if you feel
worse after 7 days.
IN THIS LEAFLET:
1.
What is this medicine and what is it used for?
2.
What you need to know before you take this medicine.
3.
How to take this medicine.
4.
Possible side effects.
5.
How to store this medicine.
6.
Contents of the pack and other information.
PREGNANCY AND BREAST-FEEDING:
You can take this product if you are pregnant or breast-feeding. As
with all medicines, the treatment duration
should be limited as much as possible.
IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF GAVISCON
ADVANCE ANISEED FLAVOUR ORAL SUSPENSION:
This product contains methyl (E218) and propyl (E216)
para-hydroxybenzoates which may cause allergic
reactions (possibly delayed).
DRIVING AND USING MACHINES:
This medicine has no influence on the ability to drive and use
machines.
3. HOW TO TAKE THIS MEDICINE
Check that the cap seal is unbroken before first using this product.
Shake well before use.
ADULTS INCLUDING THE ELDERLY AND CHILDREN 12 YEARS AND OVER: 5-10 ml
(one to two 5ml spoonfuls) after meals
and at bedtime.
Children under 12 years: Should only be taken on medical advice.
If you forget a dose it is not necessary to double the dose next time,
just carry on taking as before.
If you tak

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gaviscon Advance Aniseed flavour Oral Suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
MG/10ML
Sodium alginate
1000.0
Potassium hydrogen carbonate
200.0
Excipient(s) with known effect:
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Sodium
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral suspension.
An 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.
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: 5-10ml after meals and at
bedtime
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
CONTRAINDICATIONS
This medicinal product is contraindicated in patients with known or
suspected
hypersensitivity to any of the ingredients, or 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 106 mg (5.0 mmol) sodium per 10 ml
dose,
equivalent to 5.3% of the WHO recommended maximum daily intake for