Gastrocote chewable tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Alginic acid; Magnesium trisilicate; Sodium bicarbonate; Aluminium hydroxide gel dried

Available from:

Actavis UK Ltd

ATC code:

n/a

INN (International Name):

Alginic acid; Magnesium trisilicate; Sodium bicarbonate; Aluminium hydroxide gel dried

Dosage:

200mg ; 40mg ; 70mg ; 80mg

Pharmaceutical form:

Chewable tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 01010201; GTIN: 5011309892116 5012617019967

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE.
• Keep this leaflet. You may
need to read it again
• If you have any further
questions, ask your doctor or
pharmacist.
INDEX
1. WHAT GASTROCOTE TABLETS ARE
AND WHAT THEY ARE USED FOR
2. BEFORE YOU TAKE
3. HOW TO TAKE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE
6. FURTHER INFORMATION
1. WHAT GASTROCOTE TABLETS ARE
AND WHAT THEY ARE USED FOR
Gastrocote tablets contain a
combination of medicines called
antacids and alginates. Antacids
work by neutralising the stomach
acids and alginates help to protect
the lining of the gullet from stomach
acid.
Gastrocote tablets ease the
discomfort of indigestion and
heartburn including:
• heartburn in pregnancy
• gastric reflux and reflux
oesophagitis (when acid from your
stomach escapes into your food
pipe and causes inflammation)
• acid indigestion.
2. BEFORE YOU TAKE
DO NOT TAKE GASTROCOTE TABLETS IF
YOU OR YOUR CHILD:
• are ALLERGIC (hypersensitive) to
alginic acid, dried aluminium
hydroxide, magnesium trisilicate,
sodium bicarbonate or any of the
other ingredients (see section 6).
CHECK WITH YOUR DOCTOR OR
PHARMACIST BEFORE TAKING
GASTROCOTE TABLETS IF YOU:
• are DIABETIC, as this product
contains 1g of sucrose per tablet
• have been told by your doctor that
you have an INTOLERANCE TO SOME
SUGARS
• are on a LOW SODIUM DIET as this
product contains 0.91mmols (21mg)
of sodium per tablet
• have KIDNEY PROBLEMS
• are on a CONTROLLED PHOSPHATE DIET
• are taking ANTIBIOTICS such as
ciprofloxacin or tetracycline
DO NOT TAKE Gastrocote tablets
WITHIN TWO HOURS of any OTHER
MEDICINE.
3. HOW TO TAKE
CHEW THE TABLETS BEFORE SWALLOWING.
DOSES:
ADULTS, THE ELDERLY AND CHILDREN OVER
6 YEARS:
1 or 2 tablets to be chewed four
times a day, after main meals and at
bedtime.
DO NOT GIVE TO CHILDREN UNDER 6
unless your doctor tells you to.
L19185CUS-30
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TABLETS
MOCK UP
ONLY
dimensions:
pharmacode:
date sent:
TECHNICAL APPROVAL
min pt size:
1. PMS 2748

Summary of Product characteristics

GASTROCOTE TABLETS
Summary of Product Characteristics Updated 11-Oct-2011 | Actavis UK
Ltd
1. Name of the medicinal product
Gastrocote Tablets
2. Qualitative and quantitative composition
Alginic acid BP
200mg/tablet
Dried aluminium hydroxide gel
BP
80mg/tablet
Magnesium trisilicate BP
40mg/tablet
Sodium bicarbonate BP
70mg/tablet
3. Pharmaceutical form
Tablet uncoated
4. Clinical particulars
4.1 Therapeutic indications
Gastrocote 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 older children
One to two tablets to be chewed four times a day, that is, after main
meals and at bedtime.
Not to be given to children under six years of age.
IMPORTANT: Tablets must be chewed before swallowing.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Care should be exercised in treating diabetic patients as the tablets
contain approximately 1 g of sugar.
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. Each
tablet also contains 21mg (0.91Meq) of sodium.
If symptoms persist consult your doctor.
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 minimum interval of two hours is recommended between taking
Gastrocote tablets and other
substances.
Low doses of Gastrocote tablets are less likely to cause interactions.
4.6