METCHEK 500 & 850

WHAT THIS MEDICINE CONTAINS:

METCHEK 500:
Each tablet contains 500 mg of metformin hydrochloride.

METCHEK 850:
Each tablet contains 850 mg of metformin hydrochloride.

The other ingredients are colloidal anhydrous silica, hypromellose, macrogol, magnesium stearate, maize starch, povidone, propylene glycol, purified talc, sodium starch glycollate, and titanium dioxide

WHAT METCHEK IS USED FOR:

METCHEK is used to treat type II diabetes (high blood sugar). This medicine is only available with a doctor’s prescription.

BEFORE YOU TAKE METCHEK:

ALLERGIES:

• If you have any allergies to any foods, or if you experienced any allergies such as red itchy skin, or severe skin rash or swelling of the skin when you have taken this medicine before, tell your doctor or health care professional.

PREGNANCY:

• The use of METCHEK has not been studied in pregnant women. It is therefore important to tell your doctor if you are pregnant, so that he / she may look at giving you other medication to control your blood sugar.

BREAST-FEEDING:

• It is not known whether METCHEK passes into breast milk. Therefore mothers using this medicine and who wish to breast-feed should first consult with their doctors.

CHILDREN:

• METCHEK is not recommended for use in children 10 years and younger.

ELDERLY PATIENTS:

• METCHEK can be safely used, provided that you are not suffering from any blood disorders, kidney and hepatic (liver) problems.

Do not take METCHEK:

It is important that you tell your doctor or healthcare professional if you suffer from any of the conditions mentioned below, if you are taking METCHEK or have been prescribed METCHEK.

• If you are hypersensitive to METCHEK or to any of the ingredients.
• If you have any heart or blood vessel problems.
• If you are dehydrated or have had a heart attack.
• If you have a severe infection.
• If you need to undergo an x-ray or a CT-scan or any other diagnostic test or medical exam, tell your doctor that you are on METCHEK. Your doctor will stop the METCHEK before the procedure and restart your medicine 48 hours after the procedure, once he / she is satisfied that your kidney is functioning normally.
• Hepatic / liver function impairment.
• Renal function impairment.

Large amounts of alcohol consumption can result in low blood sugar levels when you are also taking METCHEK.

Take special care with METCHEK:

• If you have severe diarrhoea.
• If you have very high fever, severe stress.
• If you have a thyroid, adrenal or pituitary problem.
• If you have any stomach or intestinal problems.

The above conditions can either result in high or low sugar levels and it is therefore important to tell your doctor if you are suffering from any of the above conditions, so that he / she may adjust your dose of METCHEK accordingly.

HOW TO TAKE METCHEK:

METCHEK is not recommended for use in children 10 years and younger.

The dose of METCHEK will be different for different patients. The below dose is only the average dose for METCHEK. If your dose is different, do not change it unless your doctor tells you to do so.

Initially, 850 – 1 000 mg twice a day, or 500 mg three times a day, with or after food. Control is usually achieved within a few days but can be delayed for up to 2 weeks for the full effect. If control is still not achieved or is incomplete, a cautious increase in the dose to a maximum of 3 g a day can be given. A possible reduction in the dose can be made once control is achieved.

METCHEK can be given to the elderly but not if renal function is impaired.

If you have the impression that the effect of METCHEK is too strong or too weak, talk to your doctor or pharmacist.

If you take more METCHEK than you should:

Too much METCHEK can cause lactic acidosis. Symptoms include: diarrhoea, fast and shallow breathing, severe muscle pain or cramping, unusual sleepiness and unusual tiredness or weakness.

Too much METCHEK can also cause low blood sugar (hypoglycaemia). Symptoms of low blood sugar include: anxious feeling, behaviour change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, drowsiness, shakiness, slurred speech, fast heartbeat, tiredness or weakness.

If any of the above symptoms occur, get medical help immediately by calling your nearest doctor or healthcare professional.

If you forget to take METCHEK:

If you have missed a dose of METCHEK tablets, take it as soon as you remember. However if it is almost time for your next dose, skip the missed dose and go back to your regular scheduling. Never double your dose.

Not taking your medicine can result in high blood sugar levels. The signs and symptoms include: blurred vision, drowsiness, dry mouth, increased urination, loss of appetite, nausea and vomiting, stomachache, tiredness. Severe symptoms where immediate medical help is required include: flushed dry skin, fruit-like odour, ketones in the urine, passing out, rapid and deep breathing. If high blood sugar is not treated, it can lead to diabetic coma and death.

In the case of emergencies – where you would need help due to a problem caused by your diabetes, it is important that you, your family and friends know about the signs and symptoms of low and high blood sugar levels as mentioned above and is prepared for the emergency.

It is advisable that you wear a medical identification bracelet or chain at all times.

Have a glucagon kit available in case severe low blood sugar levels occur. Always replace any expired glucagon kits.

Keep some quick acting sugar at hand all the time to treat low blood sugar.

POSSIBLE SIDE-EFFECTS

A medicine may cause some unwanted effects. Although not all the effects listed below may occur, if they do occur, they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Lactic acidosis, including diarrhoea fast shallow breathing, muscle pain or cramping, unusual sleepiness, unusual tiredness or weakness.
• Low blood sugar, including anxious feeling, behaviour similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, excessive hunger, fast heartbeat, headache, nervousness, nightmares, shakiness, slurred speech.
• Loss of appetite
• Metallic taste in mouth
• Passing of gas
• Stomachache
• Vomiting
• Weight loss

Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice

STORAGE & DISPOSAL INORMATION FOR METCHEK:

Store this medicine away from heat and direct light.

Do not refrigerate or freeze this medicine.

Any expired or outdated medicines and unused medicines can be returned to your nearest pharmacy.

Store all medicines out of reach and sight of children.

PRESENTATION:

METCHEK 500:

Single blister strips backed with an aluminium foil containing 10 tablets. 9 blister strips are packed in a carton containing 90 tablets. White, round, plastic container containing 500 tablets closed with a white HDPE snap on lid. For tender market only: Plastic bags (patient ready packs) or blister strips of 14 tablets containing 56 and 84 tablets.

METCHEK 850:

Single blister strips backed with an aluminium foil containing 10 tablets. 6 blister strips are packed in a carton containing 60 tablets. White, round, plastic container containing 300 tablets closed with a white HDPE snap on lid. For tender market only: Plastic bags (patient ready packs) or blister strips of 14 tablets containing 28, 56 and 84 tablets.

IDENTIFICATION:

METCHEK 500

White to off white, round/circular, biconvex, film coated tablet with beveled edge.

METCHEK 850

White to off white, round/circular, biconvex, film coated tablet with beveled edge. The tablet is larger as compared to the METCHEK 500 and has “850” embossed on it.

REGISTRATION NUMBER:

METCHEK 500: A40/21.2/0232

METCHEK 850: A40/21.2/0233

NAME AND BUSINESS ADDRESS OF HOLDER OF THE CERTIFICATE OF REGISTRATION:

Epiglo Pharmaceuticals (Pty) Ltd
Allandale Building First Floor
23 Magwa Crescent
Waterfall City
Gauteng
1685

DATE OF PUBLICATION OF THE PATIENT INFORMATION LEAFLET:

4 December 2009