Glucodor®

Patient Information

Metformin is a medicine to treat diabetes. It belongs to a group of medicines called biguanides.

Insulin is a hormone produced by the pancreas that makes your body take in glucose (sugar) from the blood. Your body uses glucose to produce energy or stores it for future use.

If you have diabetes, your pancreas does not make enough insulin or your body is not able to use

properly the insulin it produces. This leads to a high level of glucose in your blood. Glucodor^® helps to lower your blood glucose to as normal a level as possible.

What Glucodor^® is used for:

If you are an overweight adult, taking Glucodor^® over a long period of time also helps to lower the risk of complications associated with diabetes. Glucodor^® is associated with either a stable body weight or modest weight loss.

Glucodor^® is used to treat patients with type 2 diabetes (also called 'non-insulin dependent diabetes') when diet and exercise alone have not been enough to control your blood glucose levels. It is used particularly in overweight patients.

Adults can take Glucodor^® on its own or together with other medicines to treat diabetes medicines taken by mouth or insulin. Children 10 years and over and adolescents can take Glucodor^® on its own or together with insulin.

Who should not take Glucodor^®:

• if you are allergic (hypersensitive) to metformin or any of the other ingredients of this medicine
• if you have liver problems
• if you have severely reduced kidney function
• if you have uncontrolled diabetes.
• if you lost too much water from your body.
• if you have a severe infection.
• if you are treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation (such as shock) or have breathing difficulties.
• if you drink a lot of alcohol.

How to take your Glucodor^®:

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Glucodor^® cannot replace the benefits of a healthy lifestyle. Continue to follow any advice about diet that your doctor has given you and get some regular exercise.

Take Glucodor^® with or after a meal. This will avoid you having side effects affecting your

digestion.

Do not crush or chew the tablets. Swallow each tablet with a glass of water.

• If you take one dose a day, take it in the morning (breakfast)
• If you take two divided doses a day, take them in the morning (breakfast) and evening (dinner)
• If you take three divided doses a day, take them in the morning (breakfast), at noon (lunch) and

in the evening (dinner)

If, after some time, you think that the effect of Glucophage is too strong or too weak, talk to your

doctor or pharmacist.

What to do if you forget to take a dose :

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

 While taking your medicine :

• Avoid excessive alcohol intake while taking Glucodor^® since this may increase the risk of lactic acidosis.
• This medicine is not recommended if you are breast-feeding or if you are planning to breast-feed your baby.
• Glucodor^® on its own does not cause hypoglycaemia (a blood glucose level which is too low). This means that it will not affect your ability to drive or use machines. However, take special care if you take Glucodor^® together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, fast heart beat, vision disorders or difficulty in concentration. Do not drive or use machines if you start to feel these symptoms.

What to do if you take too many tablets :

If you have taken more Glucodor^® that you should have, you may experience lactic acidosis.

Symptoms of lactic acidosis are non-specific such as vomiting, bellyache (abdominal pain) with

muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Further symptoms are reduced body temperature and heart beat.

If you experience some of these symptoms, you should seek immediately medical attention, as lactic acidosis may lead to coma. Stop taking Glucodor^® immediately and contact a doctor or the nearest hospital straight away.

 Side effects :

Glucodor^® may cause a very rare (may affect up to 1 user in 10,000), but very serious side effect called lactic acidosis. If this happens you must stop taking Glucodor^® and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

Very common side effects:

• digestive problems, such as feeling sick (nausea), being sick (vomiting), diarrhoea, bellyache

(abdominal pain) and loss of appetite. These side effects most often happen at the beginning of

the treatment with Glucodor^®. It helps if you spread the doses over the day and if you take

Glucodor^® with or straight after a meal. If symptoms continue, stop taking Glucodor^® and

talk to your doctor.

Common side effects:

• changes in taste.
• decreased or low vitamin B₁₂ levels in the blood (symptoms may include extreme tiredness

(fatigue), a sore and red tongue (glossitis), pins and needles (paraesthesia) or pale or yellow

skin). Your doctor may arrange some tests to find out the cause of your symptoms because some

of these may also be caused by diabetes or due to other unrelated health problems.

Very rare side effects:

• lactic acidosis. This is a very rare but serious complication particularly if your kidneys are not

working properly.

Symptoms of lactic acidosis are non-specific.

• abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause

tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the

eyes). If this happens to you, stop taking Glucodor^® and talk to your doctor.

• skin reactions such as redness of the skin (erythema), itching or an itchy rash (hives).

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 here.

You can also report side effects directly via the Yellow Card Scheme at: www.dorsapharma.com/ (ADR form)

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