Mitforgen – Metformin hydrochloride uses, dose and side effects

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500 mg, 850 mg, 1000 mg film-coated tablets
metformin hydrochloride

What Mitforgen is and what it is used for

What Mitforgen is

Mitforgen contains the active substance metformin hydrochloride, a medicine used to treat diabetes. It belongs to a group of drugs called biguanides.

Insulin is a hormone produced in the pancreas that helps the body absorb glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for future needs. If you have diabetes, the pancreas does not produce enough insulin or the body cannot use the insulin that is produced well enough. This leads to high glucose levels in the blood. Metformin helps to lower the blood glucose level to a level that is as close to the normal level as possible.

If you are an adult and overweight, taking Mitforgen for a long time can also help reduce the risk of complications associated with diabetes.

Mitforgen is associated with stable body weight or a slight weight loss.

What Mitforgen is used for

Mitforgen is used to treat patients with type 2 diabetes (also known as “non-insulin-dependent diabetes”) when diet and exercise alone are not sufficient to control blood glucose levels, especially for obese patients.

Adults can take Mitforgen as the only treatment or together with other medicines to treat diabetes (medicines taken by mouth or insulin ).

Children aged 10 years or older and adolescents can take Mitforgen as their only treatment or with insulin.

metformin hydrochloride contained in Mitforgen may also be approved for the treatment of other diseases not mentioned in this leaflet. Ask your doctor, pharmacist or another healthcare professional if you have any further questions and always follow their instructions.

What you need to know before taking Mitforgen

Do not take Mitforgen

  • if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6)
  • if you have liver problems
  • if you have severe renal impairment
  • if you have uncontrolled diabetes , with e.g. severe hyperglycaemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see ‘Risk of lactic acidosis’ below) or ketoacidosis . Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or that your breath has a different, fruity odor.
  • if the body has lost too much water (dehydration), e.g. due to prolonged or severe diarrhea, or if you have vomited several times in a row. Dehydration can lead to kidney problems which can cause lactic acidosis (See “Warnings and Precautions” below)
  • if you have a severe infection , e.g. an infection that affects the lungs, trachea or kidneys. Severe infections can lead to kidney problems which can cause lactic acidosis (See “Warnings and Precautions” below).
  • if you are being treated for heart failure or have recently had a heart attack, if you have severe circulatory problems (such as shock ) or difficulty breathing. This can lead to a lack of oxygen in tissue one, which can cause lactic acidosis (see “Warnings and Precautions” below).
  • if you drink a lot of alcohol

If any of these apply to you, do not take this medicine but talk to a doctor.

Warnings and cautions

Talk to your doctor or pharmacist before taking Mitforgen.

Risk of lactic acidosis

Mitforgen can cause the very rare, but very serious, side effect of lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infections, long-term fasting or alcohol intake, dehydration (see more information below), liver problems and conditions where part of the body has reduced oxygen supply (including acute severe heart disease).

If any of the above apply to you, talk to your doctor for further information

Stop taking Mitforgen for a short time if you have a condition that may be associated with dehydration, such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to a doctor for further instructions.

Stop taking Mitforgen and contact a doctor or nearest hospital immediately if you get any of the symptoms of lactic acidosis as the condition may lead to coma.

The symptoms of lactic acidosis include:

  • vomiting
  • abdominal pain (stomach pain)
  • muscle cramps
  • a general feeling of not feeling well and pronounced fatigue
  • hard to breathe
  • lowered body temperature and heart rate .

Lactic acidosis is an acute medical condition that must be treated in a hospital.

You need to eat carbs regularly during the day. If your doctor has given you dietary advice, you should continue to follow these.

Mitforgen itself does not cause hypoglycaemia (too low blood sugar) but if you take Mitforgen with other antidiabetic medicines that can cause hypoglycaemia (eg sulphonylureas, insulin, meglitinides) there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia, such as weakness, dizziness, sweating, rapid heartbeat, visual disturbances or difficulty concentrating, eating or drinking something containing sugar usually helps.

If you are going to undergo a major operation, you must stop taking Mitfogen during the operation and a certain time after it. The doctor decides when you must stop taking Mitforgen and when you should start taking it again.

Your doctor should examine your kidneys before starting treatment, especially if you have heart failure that is being treated with medication.

During treatment with Mitforgen, your doctor will check your kidney function at least once a year or more often if you are older and/or if your kidney function is deteriorating.

Children and young people

Mitforgen is not recommended for children under 10 years. Treatment of children between the ages of 10 and 12 is only recommended according to the doctor’s instructions as experience in this age group is limited.

Other medicines and Mitforgen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You may need to do more blood sugar and kidney function tests, or your doctor may need to adjust the dose of one of Mitforgen. You must mention the following:

  • drugs that increase urine production ( diuretics )
  • drugs used to treat pain and inflammation ( NSAIDs and COX 2 inhibitors, such as ibuprofen and celecoxib)
  • certain medicines for high blood pressure ( ACE inhibitors and angiotensin II receptor antagonists)
  • beta-2 agonists such as salbutamol or terbutaline (used to treat asthma )
  • corticosteroids (used to treat a variety of conditions, such as severe dermatitis or asthma )
  • medicines that can change the amount of metformin in your blood, especially if you have renal impairment (eg verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
  • other diabetes drugs

If you need to get an injection in the blood with contrast media that contain iodine, for example in connection with X-rays or computed tomography, you must stop taking Mitforgen before or at the time of injection. The doctor decides when you must stop taking Mitforgen and when you should start taking it again.

Mitforgen with alcohol

Avoid high alcohol intake while taking Mitforgen as alcohol may increase the risk of lactic acidosis (see

section “Warnings and Precautions”). 

Pregnancy and breastfeeding

During pregnancy, you need insulin to treat your diabetes. Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby, so he or she can change your treatment.

It is not recommended to take this medicine if you are breastfeeding or if you are planning to breastfeed your baby.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Mitforgen alone does not cause hypoglycaemia (too low a blood glucose level). This means that it does not affect your ability to drive or use machines.

However, you should be especially careful if you take Mitforgen with other antidiabetic medicines that can cause hypoglycaemia (eg sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, sweating, rapid heartbeat, visual disturbances or difficulty concentrating. Do not drive or use machines if you experience such symptoms.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to take Mitforgen

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Mitforgen can not replace the beneficial effects of a healthy lifestyle. Continue to follow any dietary advice your doctor has given you and exercise regularly.

The recommended dose for adults is 500 mg or 850 mg Mitforgen two or three times a day. The maximum daily dose is 3,000 mg divided into three doses.

If you are also taking insulin, your doctor will tell you how to start treatment with Mitforgen.

Use in children aged 10 years or older and adolescents

Children aged 10 years or older and adolescents usually start with 500 mg or 850 mg Mitforgen once a day. The maximum daily dose is 2,000 mg divided into two or three doses. Treatment of children aged 10-12 years is only recommended according to your doctor’s instructions, as experience in this age group is limited.

Check

  • Your doctor will continuously test the glucose level in your blood and, if necessary, adjust your dose of Mitforgen to the blood glucose level. You need to talk to your doctor regularly. This is especially important for children and adolescents or if you are older.
  • Your doctor will also examine your kidney function at least once a year. You may need more frequent check-ups if you are older or if your kidneys are not working properly.

How to take Mitforgen

Take the tablets with or after a meal. This way you avoid side effects that affect digestion.

The tablets must not be crushed or chewed. 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 doses a day, take one dose in the morning (breakfast) and one in the evening (dinner).
  • If you take three doses a day, take one in the morning (breakfast), one in the middle of the day (lunch) and one in the evening (dinner).

The 1000 mg tablet can be divided into two equal doses.

If after a while you think that the effect of Mitforgen is too strong or too weak, talk to your doctor or pharmacist.

If you take more Mitforgen than you should

If you take more Mitforgen than you should, lactic acidosis may occur. The symptoms of lactic acidosis are vomiting, stomach pain with muscle cramps, general malaise with great fatigue, and difficulty breathing. If you get these symptoms you may need immediate hospital treatment, as lactic acidosis can lead to coma. Contact a doctor or nearest hospital immediately.

If you forgot to take Mitforgen

Do not take a double dose to make up for a forgotten dose. Take the next dose at the time you would normally take it.

If you stop taking Mitforgen

If you suddenly stop taking Mitforgen, your blood sugar level may be higher. Talk to your doctor before stopping this medicine.

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

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you think you have any of the following side effects, stop taking this medicine immediately and go to the nearest emergency department.

These side effects are very rare (may affect up to 1 in 10,000 people)

  • lactic acid . This is a very rare but very serious side effect (see section “Warnings and precautions”). Lactic acidosis can lead to coma .
  • Deviations in liver function tests or hepatitis (this may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes).

Very common side effects (may affect more than 1 user in 10)

  • Digestive problems, e.g. nausea, vomiting, diarrhea, stomach pain and loss of appetite. These side effects usually occur at the beginning of treatment with Mitforgen. It helps if you distribute the doses throughout the day and if you take the tablets with or immediately after a meal. If symptoms persist, stop taking Mitforgen and talk to your doctor.

Common side effects (may affect up to 1 in 10 people)

  • Taste changes.

Very rare side effects (may affect up to 1 in 10,000 people)

  • Skin reactions such as redness, itching or hives .
  • Low levels of vitamin B12 in the blood.

Children and young people

Limited information shows that the type and severity of side effects are similar for children and adolescents as for adults.

How to store Mitforgen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister or jar after “EXP”. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

– The active substance is metformin (as hydrochloride).

Each 500 mg tablet contains 500 mg of metformin hydrochloride equivalent to 390 mg of metformin base.

Each 850 mg tablet contains 850 mg of metformin hydrochloride equivalent to 663 mg of metformin base.

Each 1000 mg tablet contains 1000 mg of metformin hydrochloride equivalent to 780 mg of metformin base.

– The other ingredients are:

Tablet core: povidone K-30, magnesium stearate

Film coating: hypromellose, hydroxypropyl cellulose, macrogol 400 and 8000.

What the medicine looks like and contents of the pack

500 mg: White, cupped, film-coated tablet, smooth on both sides.

850 mg: White, round, cupped, film-coated tablet, smooth on both sides. 

1000 mg: White, oval, biconvex, film-coated tablet with “MF” and “3” embossed on each side of the tablet notch and “G” embossed on the other side.

Mitforgen tablets are packed in blister packs (PVC aluminum) containing 10, 15, 20, 28, 30, 40, 50, 56, 60, 84, 90, 100, 120 and 180 tablets and can (high density polyethylene) with lid (polypropylene) containing 30, 100, 180, 200, 300, 400, 500 and 1000 tablets.

Mitforgen 850 mg and 1000 mg film-coated tablets are also available in multipacks of 180 tablets, containing 2 cartons of 90 tablets each.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan AB

Box 23033

104 35 Stockholm

Manufacturer

McDermott Laboratories trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

Generics [UK] Ltd

Station Close

Potters Bar

Hertfordshire

EN6 1TL

UK

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