METFORMIN TEVA 1000MG FC TBL N120

ATC code: A10BA02 

Active substances: Metformini Hydrochloridum

Vendor, principal: Teva Pharmaceutical. 

 Prescription drug (℞) 

METFORMIN TEVA 1000MG N120

Package leaflet: Information for the patient

Metformin Teva 1000 mg film-coated tablets

Metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-   Keep this leaflet. You may need to read it again.
-   If you have any further questions, ask your doctor, pharmacist or nurse.
-   This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-   If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.   What Metformin Teva is and what it is used for
2.   What you need to know before you take Metformin Teva
3.   How to take Metformin Teva
4.   Possible side effects
5.   How to store Metformin Teva
6.   Contents of the pack and other information

1. What Metformin Teva is and what it is used for What Metformin Teva is

Metformin Teva contains metformin, 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. Metformin Teva helps to lower your blood glucose to as normal a level as possible.
If you are an overweight adult, taking Metformin Teva over a long period of time also helps to lower the risk of complications associated with diabetes.
Metformin Teva is associated with either a stable body weight or modest weight loss.

What Metformin Teva is used for

Metformin Teva 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 Metformin Teva 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 Teva on its own or together with insulin.

Do not take Metformin Teva

-   if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6).
-   if you have severely reduced kidney function.
-   if you have liver problems.
-   if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, 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 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 row. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see ‘Warnings and precautions’ below).
-   if you have a 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 (see ‘Warnings and precautions’ below).
-   if you are treated for 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 (see ‘Warnings and precautions’ below).
-   if you drink a lot of alcohol.
If any of the above applies to you, talk to your doctor before you start taking this medicine.
Make sure you ask your doctor for advice:
-   if you need to have an examination such as X-ray or scan involving the injection of contrast medicines that contain iodine into your bloodstream
-   if you need to have major surgery.
You must stop taking Metformin Teva for a certain period of time before and after the examination or the surgery. Your doctor will decide whether you need any other treatment for this time. It is important that you follow your doctor’s instructions precisely.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Metformin Teva.

Risk of lactic acidosis

Metformin Teva 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 (see further information below), 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 Teva 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 Teva 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 Teva during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Metformin Teva.
During treatment with Metformin Teva, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
-   Metformin Teva on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take it 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.

Other medicines and Metformin Teva

If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Metformin Teva before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Metformin Teva.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Metformin Teva. It is especially important to mention the following:
-   medicines which increase urine production (diuretics)
-   medicines used to treat pain and inflammation (NSAID 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 inflammation of the skin or in asthma).
-   Other medicines used to treat diabetes.

Metformin Teva with alcohol

Avoid excessive alcohol intake while taking Metformin Teva since this may increase the risk of lactic acidosis (see section “Warnings and precautions”). This also applies to medicines that contain alcohol.

Pregnancy, breast-feeding and fertility

During pregnancy, you need insulin to treat your diabetes. Tell your doctor if you are, think you might be or are planning to become pregnant, so that he/she may change your treatment.
Metformin Teva is not recommended if you are breast-feeding or if you are planning to breast-feed your baby.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Metformin Teva 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 Metformin Teva together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin and 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.

3. How to take Metformin Teva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Metformin Teva 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.
Recommended dose
Children 10 years and over and adolescents usually start with 500 mg or 850 mg Metformin Teva once a day. The maximum daily dose is 2000 mg taken as 2 or 3 divided doses. Treatment of children between 10 and 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 500 mg or 850 mg Metformin Teva two or three times a day. The maximum daily dose is 3000 mg taken as 3 divided doses.
If you have reduced kidney function, your doctor may prescribe a lower dose.
If you take insulin too, your doctor will tell you how to start Metformin Teva.
Monitoring
-   Your doctor will perform regular blood glucose tests and adapt your dose of Metformin Teva 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 Teva
Take the tablets 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. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
-   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 Teva is too strong or too weak, talk to your doctor or pharmacist.
If a child is treated with Metformin Teva, parents and caregivers are advised to oversee how this medicine is used.

If you take more Metformin Teva than you should

If you have taken more Metformin Teva than you should have, you may experience lactic acidosis. Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Contact a doctor or the nearest hospital straight away.

If you forget to take Metformin Teva

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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following is very serious and if you experience it you should seek urgent medical attention:
Very rare: may affect up to 1 in 10,000 people
-   Metformin Teva may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens you must stop taking Metformin Teva and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
-   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).
Other side effects include:
Very common: may affect more than 1 in 10 people
-   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 Teva. It helps if you spread the doses over the day and if you take the tablets with or straight after a meal. If symptoms continue, stop taking Metformin Teva and talk to your doctor.
Common: may affect up to 1 in 10 people
-   Changes in taste.
Very rare: may affect up to 1 in 10,000 people
-   Skin reactions such as redness of the skin (erythema), itching or an itchy rash (urticaria).
-   Low vitamin B12 levels 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.

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 in this leaflet. You can also report side effects directly via www.ravimiamet.ee . By
reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Metformin Teva

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 blister and the carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Metformin Teva contains

The active substance is metformin hydrochloride. Each tablet contains 1000 mg metformin hydrochloride corresponding to 780 mg metformin.
The other ingredients are as follows:
Core: povidone (K30/K90), anhydrous colloidal silica, magnesium stearate Film-coating: hypromellose (E464), macrogol 400 and the colour titanium dioxide (E171).

What Metformin Teva looks like and contents of the pack

White to off white film-coated, scored, oval shaped tablet, debossed with “9/3” on one side and “72/14” on the other, of dimensions 18.6 mm x 9.3mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Metformin Teva 1000 mg comes in packs of 15, 28, 30, 50, 60, 84, 90, 120 and 180 film-coated tablets.
Hospital pack: 50x1, 600 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Teva Pharma B.V.
Swensweg 5 2031 GA Haarlem The Netherlands

Manufacturers

TEVA Pharmaceutical Works Private Limited Company Pallagi ut 13 4042 Debrecen Hungary
Or
Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Teva Eesti esindus UAB Sicor Biotech Estonian branch Hallivanamehe 4 11317 Tallinn Phone.: +372 6610801

This leaflet was last revised in June 2018.