500 mg and 850 mg film-coated tablets
metformin hydrochloride

What Metformin Actavis is and what it is used for

What Metformin Actavis is

Metformin Actavis contains metformin, 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 blood glucose levels. Metformin Actavis helps to lower blood glucose levels to a level that is as close to normal as possible.

If you are an adult and overweight, taking Metformin Actavis for a long time can also help reduce the risk of complications associated with diabetes. Metformin is associated with either stable body weight or a slight weight loss.

What Metformin Actavis is used for

Metformin Actavis 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 Metformin Actavis as the only treatment or with other medicines to treat diabetes (medicines taken by mouth or insulin ).

Children 10 years of age or older and adolescents can take Metformin Actavis as their only treatment or with insulin.

Metformin contained in Metformin Actavis may also be approved for the treatment of other conditions 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 you use Metformin Actavis

Do not use Metformin Actavis

  • if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6)
  • if you have a liver injury.
  • if you have severe renal impairment.
  • if you have uncontrolled diabetes with, for example, 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 gets a different fruity scent.
  • 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 acute 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 the above apply to you, talk to a doctor before taking this medicine.

You need to consult a doctor about

  • you need to undergo an examination, such as an X-ray or computed tomography , which means that you are given contrast agents that contain iodine injected into the blood.
  • you will undergo major surgery.

You must stop taking Metformin Actavis for a certain period before and after the examination or operation. Your doctor will decide if you need any other treatment during this time. You must follow your doctor’s instructions carefully.

Warnings and cautions

Risk of lactic acidosis

Metformin Actavis 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, prolonged 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 Metformin Actavis 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 Metformin Actavis and contact your doctor or nearest hospital immediately if you experience 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.

Operation

If you are going to have a major operation, you must stop taking Metformin Actavis during the operation and for a certain period after it. Your doctor will decide when you need to stop taking Metformin Actavis and when you should start taking it again.

Low blood sugar ( hypoglycaemia )

Metformin Actavis itself does not cause hypoglycaemia (too low blood sugar) but if you take Metformin Actavis together 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, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating, it usually helps to eat or drink something that contains sugar.

Control of renal function

During treatment with Metformin Actavis, 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 impaired.

Other medicines and Metformin Actavis

If you need to get an injection into the bloodstream with contrast media that contain iodine, for example in connection with X-rays or computed tomography, you must stop taking Metformin Actavis before or at the time of injection. Your doctor will decide when you need to stop taking Metformin Actavis and when you should start taking it again.

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 Metformin Actavis. 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 the treatment of 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 may alter the amount of metformin in your blood, especially if you have impaired kidney function (eg verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).
  • other drugs used to treat diabetes .

Metformin Actavis with alcohol

Avoid high alcohol intake while taking Metformin Actavis, 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 or think you may be pregnant or are planning to have a baby so that he or she can change your treatment.

This medicine is not recommended if you are breastfeeding or planning to breastfeed your baby.

Driving and using machines

Metformin Actavis 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 are taking Metformin Actavis 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 use Metformin Actavis

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

Metformin Actavis cannot replace the beneficial effects of a healthy lifestyle. Continue to follow any dietary advice your doctor has given you and exercise regularly.

Recommended dose

Children 10 years of age or older and adolescents usually start with 500 mg or 850 mg metformin hydrochloride once daily. The maximum daily dose is 2000 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.

Adults usually start with 500 mg or 850 mg metformin hydrochloride two or three times a day. The maximum daily dose is 3000 mg divided into three doses.

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

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

Check

  • Your doctor will take regular blood glucose tests and adjust your dose of Metformin Actavis to your 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 Metformin Actavis

Take Metformin Actavis 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).

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

If you use more Metformin Actavis than you should

If you take more Metformin Actavis than you should, lactic acidosis may occur. The symptoms of lactic acidosis are non-specific such as vomiting, stomach pain with muscle cramps, general malaise with great tiredness and difficulty breathing. Additional symptoms are decreased body temperature and decreased heart rate. If you experience any of these symptoms, seek immediate medical attention as lactic acidosis may lead to coma. Stop taking Metformin Actavis immediately and contact your doctor or nearest hospital immediately.

If you forget to take Metformin Actavis

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 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.

The following side effects are very serious and if you experience any of them you should seek emergency medical attention:

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

  • Metformin Actavis can cause the very rare but very serious side effect of lactic acidosis , especially if your kidneys do not work properly. If this happens to you, you must stop taking Metformin Actavis and contact a doctor or nearest hospital immediately , as lactic acidosis can lead to coma . Symptoms of lactic acidosis are described in the section Warnings and Precautions.
  • 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). If this happens to you, stop taking this medicine and consult a doctor.

Other side effects:

Very common (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 Metformin Actavis. It helps if you distribute the doses throughout the day and if you take Metformin Actavis with or immediately after a meal. If symptoms persist, stop taking Metformin Actavis and talk to your doctor.

Common (may affect up to 1 in 10 people)

  • Taste changes.

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

  • Skin reactions such as redness of the skin ( erythema ), itching or hives ( urticaria ).
  • 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 Metformin Actavis

Keep this medicine out of the sight and reach of children. If a child is being treated with Metformin Actavis, parents and caregivers should monitor the use of this medicine.

Do not use this medicine after the expiry date which is stated on the carton or label 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 hydrochloride.
    500 mg tablets: Each film-coated tablet contains 500 mg metformin hydrochloride equivalent to 390 mg metformin .
    850 mg tablets: Each film-coated tablet contains 850 mg metformin hydrochloride equivalent to 662.9 mg metformin .
  • The other ingredients are:
    Tablet core: povidone, stearic acid, anhydrous colloidal silica.
    Film coating: hypromellose, titanium dioxide (E 171), macrogol 400.

What the medicine looks like and contents of the pack

500 mg tablets: White, round, biconvex, film-coated tablet marked “MF” on one side.

850 mg tablets: White, round, biconvex, film-coated tablet marked “MH” on one side.

Metformin Actavis 500 mg is available in the following packs:

Blister pack containing 30, 50, 100 film-coated tablets.

Plastic jar containing 30, 50, 100, 300, 400 film-coated tablets.

Metformin Actavis 850 mg is available in the following packs:

Blister pack containing 20, 30, 60, 100 film-coated tablets.

Plastic jar containing 20, 30, 60, 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC EHF.

Reykjavikurvegur 76-78

IS-220 Hafnarfjordur

Iceland

Muhammad Nadeem

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