Gastrocote liquid

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Magnesium trisilicate; Sodium alginate; Sodium bicarbonate; Aluminium hydroxide gel dried

Available from:

Actavis UK Ltd

ATC code:

n/a

INN (International Name):

Magnesium trisilicate; Sodium alginate; Sodium bicarbonate; Aluminium hydroxide gel dried

Dosage:

8mg/1ml ; 44mg/1ml ; 14mg/1ml ; 16mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 01010201; GTIN: 5011309892017

Patient Information leaflet

6. FURTHER INFORMATION
WHAT IS IN THIS MEDICINE
THE ACTIVE INGREDIENTS PER 5ML ARE:
sodium alginate 220mg, dried
aluminium hydroxide gel 80mg, magnesium trisilicate 40mg,
sodium hydrogen carbonate 70mg.
THE OTHER INGREDIENTS ARE: aluminium magnesium silicate,
sunset yellow (E110), butterscotch flavour, peppermint liquid,
saccharin sodium, sodium methyl hydroxybenzoate (E219),
sodium propyl hydroxybenzoate and purified water.
WHAT THE MEDICINE LOOKS LIKE
Gastrocote Liquid is a peach coloured suspension which
smells of butterscotch and mint.
It is supplied in 500ml bottles.
MARKETING AUTHORISATION HOLDER
Actavis Group PTC ehf, Reykjavikurvegi 76-78
220 Hafnarfjordur, Iceland.
MANUFACTURER
Thornton and Ross Ltd,
Huddersfield, HD7 5QH, UK.
Gastrocote is a trade mark of
Actavis Group PTC ehf
THIS LABEL WAS REVISED IN APRIL 2012
PL 30306/0076 AAAD6166
1. WHAT THE MEDICINE IS FOR
Gastrocote Liquid is used for heartburn, including
•
Heartburn in pregnancy.
•
Reflux oesophagitis.
•
Gastric reflux.
•
Acid indigestion.
2. BEFORE YOU USE THIS MEDICINE
DO NOT USE THE MEDICINE IF YOU OR YOUR CHILD HAVE
•
An ALLERGY to any of the ingredients listed in section 6.
TALK TO YOUR DOCTOR OR PHARMACIST IF YOU OR YOUR
CHILD HAVE
•
Kidney problems.
•
Or are on a controlled salt or phosphate diet.
TALK TO YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING
•
Antibiotics such as ciprofloxacin or tetracycline.
Do not take Gastrocote Liquid within two hours of any other medicine.
IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS
•
This product contains 2.13 mmol (49mg) of sodium per
5ml dose. This should be taken into account by people
on a controlled sodium diet.
•
It contains sunset yellow and hydroxybenzoates which
may cause allergic reactions (possibly delayed).
3. HOW TO USE THIS MEDICINE
•
Take this medicine by mouth.
•
Shake the bottle well before use.
•
Take after main meals and at bedtime.
ADULTS AND THE ELDERLY
•
Take one to three 5ml spoonfuls four times a day.
CHILDREN 6 TO 12 YEARS OLD
•
Take one to two

Summary of Product characteristics

GASTROCOTE LIQUID
Summary of Product Characteristics Updated 19-Dec-2012 | Actavis UK
Ltd
1. Name of the medicinal product
Gastrocote Liquid
2. Qualitative and quantitative composition
Sodium Alginate 220mg
Dried aluminium hydroxide gel 80mg
Magnesium trisilicate 40mg
Sodium hydrogen carbonate 70mg
ALSO CONTAINS:
Sodium Methylhydroxybenzoate (E219)
Sodium Propylhydroxybenzoate (E217)
3. Pharmaceutical form
Oral suspension
4. Clinical particulars
4.1 Therapeutic indications
Gastrocote Liquid is indicated in heartburn, including heartburn of
pregnancy, reflux oesophagitis,
particularly where associated with hiatus hernia and in all cases of
epigastric distress with gastric reflux
or regurgitations. It is also indicated in acid indigestion.
4.2 Posology and method of administration
Oral
Adults and children over 12: One - three 5ml spoonfuls to be taken
four times daily, that is, after main
meals and at bedtime.
Children 6 to 12 years: One – two 5ml spoonfuls to be taken four
times daily, that is, after main meals
and at bedtime.
Not recommended for children under 6 years of age.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Should be used with caution in patients with renal dysfunction due to
increased risk of aluminium toxicity
(e.g. aluminium induced encephalopathy).
Caution should also be taken in patients on a low phosphate diet.
The content of sodium should also be taken into account by patients on
a sodium controlled diet. This
medicinal product contains 2.13mmol (or 49mg) sodium per 5ml dose.
If symptoms persist consult your doctor.
Gastrocote liquid contains sunset yellow (E110) and hydroxybenzoates
which may cause allergic
reactions (possibly delayed).
4.5 Interaction with other medicinal products and other forms of
interaction
The absorption of the following substances may be decreased by
simultaneous use of antacids:
- Quinolones (e.g. ciprofloxacin, norfloxacin and ofloxacin)
- Tetracycline derivatives (e.g. tetracycline and doxycycline)
A