Magnesium trisilicate compound tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Magnesium trisilicate; Aluminium hydroxide dried

Available from:

A A H Pharmaceuticals Ltd

INN (International Name):

Magnesium trisilicate; Aluminium hydroxide dried

Dosage:

250mg ; 120mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01010100; GTIN: 5025903002154

Patient Information leaflet

PATIENT INFORMATION LEAFLET
COMPOUND MAGNESIUM TRISILICATE TABLETS
(Magnesium trisilicate 250 mg and dried aluminium hydroxide gel 120
mg)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
THIS MEDICINE IS AVAILABLE WITHOUT PRESCRIPTION. HOWEVER, YOU STILL
NEED TO TAKE COMPOUND MAGNESIUM
TRISILICATE TABLETS CAREFULLY TO GET THE BEST RESULTS FROM IT.
KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
ASK YOUR PHARMACIST IF YOU NEED MORE INFORMATION OR ADVICE.
YOU MUST CONTACT A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO NOT IMPROVE
AFTER 7 DAYS.
IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR DOCTOR, PHARMACIST OR NURSE.
THIS INCLUDES ANY POSSIBLE SIDE EFFECTS
NOT LISTED IN THIS LEAFLET. SEE SECTION 4.
IN THIS LEAFLET:
1.
What Compound Magnesium Trisilicate Tablets are and what they are used
for
2.
Before you take Compound Magnesium Trisilicate Tablets
3.
How to take Compound Magnesium Trisilicate Tablets
4.
Possible side effects
5.
How to store Compound Magnesium Trisilicate Tablets
6.
Further information
1.
WHAT COMPOUND MAGNESIUM TRISILICATE TABLETS ARE AND WHAT THEY ARE USED
FOR
These tablets contain two active ingredients, magnesium trisilicate
and dried aluminium hydroxide gel. These are
antacids which work by neutralising acid in your stomach.
These tablets are used to relieve the symptoms of dyspepsia
(indigestion).
2.
BEFORE YOU TAKE COMPOUND MAGNESIUM TRISILICATE TABLETS
DO NOT TAKE THESE TABLETS IF YOU:

are allergic (hypersensitive) to magnesium trisilicate, dried
aluminium hydroxide gel or to any of the other
ingredients in the tablets (these are listed in Section 6)

have kidney failure

have a blood condition called hypophosphataemia (low concentration of
phosphate in the blood).
CHECK WITH YOUR DOCTOR BEFORE TAKING THESE TABLETS IF YOU:

have kidney problems as this may result in hypermagnesaemia (high
blood levels of magnesium). For
symptoms of hypermagnesaemia see section 4 - Possible Side Effects.
CHECK WITH YOUR DOCTOR OR

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Magnesium Trisilicate Compound Tablets BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Magnesium Trisilicate 250 mg
Hydrated Aluminium Oxide 120 mg.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
Plain white, uncoated round tablet.
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the relief of dyspepsia (heartburn and indigestion), and reflux
oesophagitis. Can have a beneficial effect in promoting healing of
duodenal
ulcers.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration. The tablets should be sucked or chewed before
swallowing.
Adults: One or two tablets to be sucked or chewed when required
(usually
between meals and at bedtime).
Not recommended for use in children.
4.3.
CONTRA-INDICATIONS
Hypersensitivity to any of the constituents.
Acute porphyria or hypophosphataemia.
4.4.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Use with caution in cases of renal impairment.
Frequent or regular use should only be on the advice of a physician.
Patients with rare hereditary problems of fructose or galactose
intolerance, the
LAPP lactase deficiency, glucose-galactose malabsorption or sucrase-
isomaltase insufficiency should not take this medicine as it contains
sucrose
and lactose.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
May reduce the absorption and effect of other medicines, therefore,
should not
be taken at the same time as other medicines. Examples of other
medications
which may be affected include, but are not limited to ACE inhibitors,
salicylates e.g. aspirin, atazanavir, azithromycin, barbiturates, bile
acids,
bisphosphonates, cephalosporin antibiotics, fluoroquinolone
antibiotics,
chloroquine and hydroxychloroquine, deflazacort, digoxin,
dipyridamole,
eltrombopag, erlotinib, fexofenadine, gabapentin, iron preparations,
isoniazid,
itraconazole, ketoconazole, lansoprazole, levothyroxine, lithium,
methenamine, mycophenolate, nitrofurantoin, penicillamine,
phenothiazi