METFORMIN DENK 1000 Tablet

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 metformin Denk 1000 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 Metformin Denk 1000 on its own or together with insulin.

Dosage

Metformin Denk 1000 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.

Children 10 years and over and adolescents

Usually start with 500mg or 850mg once a day.

The maximum daily dose is 2000mg taken as 2-3 divided doses.

Treatment of children 10-12 years of age is only recommended on specific advice from your doctor, as experience in this age group is limited.

Adults

Usually start with 500mg or 850mg 2-3 times a day.

The maximum daily dose is 3000mg taken as 3 divided doses.

If you have reduced kidney function, your doctor may prescribe a lower dose.

If you use insulin too, your doctor will tell you how to start Metformin Denk 1000.

Monitoring

- Your doctor will perform regular blood glucose tests and will adapt your dose of Metformin Denk 1000 to your blood glucose levels. Make sure that you talk to your doctor regularly. This is particularly important for children and adolescents or if you are an older person.

- Your doctor will also check at least once a year how well your kidneys work. You may need more frequent checks if you are an older person or if your kidneys are not working normally.

How to take Metformin Denk 1000

Take Metformin Denk 1000 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 Metformin Denk 1000 is too strong or too weak, talk to your doctor or pharmacist.

- if you are allergic 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, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis or ketoacidosis. Ketoacidosis is a condition in which substances called ‘ketone bodies’ accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell.

- if you lost too much water from your body (dehydration), such as due to long-lasting or severe diarrhoea, or if you have vomited several times in a low. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis.

- if you have severe infection, such as an infection affecting your lung or bronchial system or your kidney. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis.

- 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. This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis.

- if you drink a lot of alcohol.

Very common

- 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 metformin. It helps if you spread the doses over the day and if you take Metformin Denk 1000 with or straight after a meal. If symptoms continue, stop taking Metformin Denk 1000 and talk to your doctor.

Common

-changes in taste

Very rare

- 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 Metformin Denk 1000 and talk to your doctor.

- skin reactions such as redness of the skin (erythema), itching in the blood.

Children and adolescents

Limited data in children and adolescents showed that adverse events were similar in nature and severity to those reported in adults.

If you need to have an injection of a contrast medium that contains iodine into your blood-stream, for example in the context of an X-ray or scan, you must stop taking Metformin Denk 1000 before or at the time of the infection. Your doctor will decide when you must stop and when to restart your treatment with Metformin Denk 1000.

See the package insert about the details:

- Diuretics

- NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib

- ACE inhibitors ad angiotensinⅡreceptor antagonists

- Beta-2 agonists such as salbutamol or terbutaline

- Corticosteroids

- Verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib

- Other medicines used to treat diabetes.

Pregnancy

You need insulin to treat your diabetes.

Lactation

This medicine is not recommended if you are breast-feeding or if you are planning to breast-feed your baby.

Risk of lactic acidosis

Metformin Denk 1000 may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration, liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).

If any of the above applies to you, talk to your doctor for further instructions.

Stop taking Metformin Denk 1000 for a short time if you have a condition that may be associated with dehydration (Significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.

Stop taking Metformin Denk 1000 and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

- vomiting,

- stomach ache (abdominal pain),

- muscle cramps

- a general feeling of not being well with severe tiredness

- difficulty in breathing

- reduced body temperature and heartbeat.

Lactic acidosis is a medical emergency and must be treated in a hospital.

If you need to have major surgery you must stop taking Metformin Denk 1000 during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Metformin Denk 1000.

Metformin Denk 1000 on its own does not cause hypoglycaemia. However, if you take Metformin Denk 1000 together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heart beating, vision disorders or difficulty in concentration, it usually helps to eat or drink something containing sugar.

During treatment with Metformin Denk 1000, your doctor will check your kidney function at least once a year or more frequency if you are elderly and/or if you have worsening kidney function.

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 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. Metformin Denk 1000 helps to lower your blood glucose to as normal levels as possible.

If you are an overweight adult, taking Metformin Denk 1000 over a long period of time also helps to lower the risk of complications associated with diabetes. Metformin Denk 1000 is associated with either a stable body weight or modest weight loss.

Pharmacotherapeutic group: Oral antidiabetic agent

Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and post-prandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.

Metformin may act via 3 mechanisms:

- Reduction of hepatic glucose production by inhibition gluconeogenesis and glycogenolysis.

- In muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilization.

- Delay of intestinal glucose absorption.

Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.

Metformin increases the transport capacity of all known types of membrane glucose transporters.

In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism. This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies. Metformin reduces total cholesterol, LDL cholesterol and triglyceride levels.