Magnesium trisilicate compound tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Parsisiųsti Pakuotės lapelis (PIL)
31-03-2023
Parsisiųsti Prekės savybės (SPC)
31-03-2023

Veiklioji medžiaga:

Magnesium trisilicate; Aluminium hydroxide dried

Prieinama:

Kent Pharma (UK) Ltd

INN (Tarptautinis Pavadinimas):

Magnesium trisilicate; Aluminium hydroxide dried

Dozė:

250mg ; 120mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 01010100; GTIN: 5039290001218

Pakuotės lapelis

                                L3801/1
Read the package leaflet before use.
SURAFAF130KPB
MA HOLDER: Kent Pharma UK Limited, 2nd Floor, Connect 38,
1 Dover Place, Ashford, Kent, England, TN23 1FB.
PL 51463/0130
Page 1
Package Leaflet : Information for the patient
MAGNESIUM
TRISILICATE COMPOUND
TABLETS BP
(magnesium trisilicate and hydrated
aluminium oxide)
•
Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.
•
Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your doctor or pharmacist if you need more advice.
•
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.
•
You must talk to a doctor if you continue to have the
same symptoms or if you find you need to take the
tablets frequently.
1. WHAT MAGNESIUM TRISILICATE TABLETS
ARE AND WHAT THEY ARE USED FOR
Magnesium Trisilicate Tablets contain two active
ingredients, magnesium trisilicate and hydrated
aluminium oxide.
These are antacids which work by neutralising acid in
your stomach.
These tablets are used to treat dyspepsia (heartburn or
indigestion) and reflux. They can also help to heal
duodenal ulcers.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE MAGNESIUM TRISILICATE TABLETS
DO NOT TAKE MAGNESIUM TRISILICATE TABLETS IF:
•
You know you are allergic to magnesium trisilicate
or aluminium oxide or to any of the other
ingredients (these are listed in section 6)
•
You suffer from acute porphyria
•
You have a blood condition called
hypophosphataemia (low concentration of
phosphate in the blood).
WARNINGS AND PRECAUTIONS
Check with your doctor before taking this medicine if:
•
You have kidney problems.
OTHER MEDICINES AND MAGNESIUM TRISILICATE
TABLETS
These tablets can affect some other medicines you
may be taking, and they should not be taken at the
same time of day as other medicines.
Tell your
                                
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Prekės savybės

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Magnesium Trisilicate Compound Tablets BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Magnesium Trisilicate 250 mg & Hydrated Aluminium
Oxide 120 mg.
Excipients with known effect:
Sucrose 500 mg and Lactose 250 mg.
For the full list of excipients, see section 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
Posology
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.
Method of administration
For oral use.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in
section 6.1.
Acute porphyria or hypophosphataemia.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use with caution in cases of renal impairment.
Frequent or regular use should only be on the advice of a physician.
This product contains sucrose and lactose.
Patients with rare hereditary problems of fructose or galactose
intolerance,
total lactase deficiency, glucose-galactose malabsorption or
sucrase-isomaltase
insufficiency should not take this medicine.
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, gabapen
                                
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