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Compound Magnesium Trisilicate Tablets Bp

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Document: leaflet MAH GENERIC_PL 20416-0216 change

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 pharmacist before taking these tablets if you are taking any other medicines, including any that you can buy without a prescription. This is especially important if you are taking:

•    the following medicines to treat infections: ciprofloxacin, pivampicillin, rifampicin, medicines called tetracyclines e.g. oxytetracycline, itraconazole or ketoconazole

•    flecainide or mexiletine (to treat irregular heartbeat)

•    quinine, chloroquine or hydroxychloroquine (to treat malaria)

•    phenothiazines e.g. chlorpromazine, pericyazine (to treat schizophrenia and other mental disorders)

•    phenytoin (to treat epilepsy)

•    oral iron e.g. ferrous sulphate (to treat iron-deficiency anaemia)

•    penicillamine (to treat severe rheumatoid arthritis)

•    diflunisal or aspirin (painkillers)

•    sucralfate (to treat stomach ulcers).

Other special warnings

Pregnancy and breast-feeding: Check with your doctor before taking this medicine if you are pregnant or breast feeding.

Important information about some of the ingredients of this medicine: Contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    How to take Compound Magnesium Trisilicate Tablets

Suck or chew the tablets before swallowing.

If this medicine has been given to you by your doctor, he/she will decide what dose you need to take and the dose will be on the pharmacist’s label. Carry on taking them for as long as you have been told unless you have any problems. In that case, check with your doctor.

The usual doses are as follows:

Adults, elderly and children over 14 years:

Take 1 or 2 tablets three times a day, one hour after meals and at bedtime or as required

Children 10 to 14 years:

Take 1 tablet three times a day.

Do not take more than the dose stated above.

If symptoms persist for more than 7 days, or if you find that you need to take the tablets frequently, consult your doctor. If you have taken too many tablets:

Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.

4.    Possible side effects

Compound Magnesium Trisilicate Tablets are suitable for most people if they are taken at the recommended dose, but, like all medicines they can sometimes cause side effects, although not everybody gets them.

Feeling or being sick, constipation and diarrhoea have been reported.

Patients who have kidney problems may experience hypermagnesaemia (an abnormally high level of magnesium in the blood). Symptoms may include flushing of the skin, thirst, low blood pressure, drowsiness, confusion, loss of tendon reflexes, muscle weakness, breathing difficulties, irregular heart beat, coma and cardiac arrest (heart stops pumping blood around the body).

Patients taking large doses of this medicine, or those with low phosphate diets taking normal doses, may experience problems with the levels of phosphate and calcium in their bodies. This may increase the risk of softening of the bones (osteomalacia).

Kidney stones may occur if the tablets are taken for a long time by patients who have kidney problems. If you have a kidney stone the main symptom is severe pain felt in the belly area or side of the back which may move to the groin area or the testicles. Other symptoms include unusual urine colour, blood in the urine, chills, fever, feeling or being sick.

Do not be concerned by this list of side effects, you may not get any of them.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Compound Magnesium Trisilicate Tablets

Keep the tablets in the pack provided and protect from heat, light and moisture.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal

6.    Further information

Ingredients:

Each tablet contains 250mg magnesium trisilicate and 120mg dried aluminium hydroxide gel as the active ingredients. They also contain the following other ingredients: lactose, sucrose, maize starch, peppermint oil and magnesium stearate.

What the medicine looks like:

Compound Magnesium Trisilicate Tablets are white, round tablets engraved with the company logo on one side and ‘A193’ on the other. The tablets are available in pack sizes of 28, 42, 50, 56, 84, 100, 112, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.

Who makes this medicine and holds the Product Licence:

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED.

Date leaflet revised: June 2015

If you would like this leaflet in a different format please contact the licence holder at the above address.