Metformin Teva

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metformina Teva 500 mg film-coated tablets, 850 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

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

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

What Metformina Teva is
Metformina Teva contains the active substance metformin, a medicine used to treat diabetes. It belongs to a group of active substances called biguanides.

Insulin is a hormone produced by the pancreas that enables the body to absorb glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for future use.

If you have diabetes, your pancreas does not produce enough insulin, or your body cannot properly use the insulin it produces. This leads to high levels of glucose in the blood. Metformina Teva helps lower blood glucose levels to bring them as close as possible to normal.

If you are overweight, long-term use of Metformina Teva also helps reduce the risk of diabetes-related complications.
Metformina Teva has been associated with stabilization of body weight or moderate weight loss.

What Metformina Teva is used for
Metformina Teva is used to treat patients with type 2 diabetes (also known as “non-insulin-dependent diabetes”) when diet and exercise alone have not been sufficient to control blood glucose levels. It is particularly used in overweight patients.

Adults may take Metformina Teva alone or in combination with other antidiabetic medicines (oral medications or insulin).

Children aged 10 years and older and adolescents may take Metformina Teva alone or in combination with insulin.

2. What you should know before taking Metformina Teva

Do not take Metformina Teva

• if you are allergic to metformin or to any of the other excipients of this medicine (listed in section 6).
• if you have severely reduced kidney function.
• if you have liver problems.
• if you have uncontrolled diabetes associated, for example, with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, and breath with an unusually fruity odour.
• if you have lost too much body fluid (dehydration), e.g. due to severe or prolonged diarrhoea or repeated vomiting. Dehydration may cause kidney problems which could increase your risk of lactic acidosis (see section “Warnings and precautions” below).
• if you have a serious infection, such as an infection affecting the lungs, bronchial system or kidneys. Serious infections may cause kidney problems which could increase your risk of lactic acidosis (see section “Warnings and precautions” below).
• if you are being treated for heart failure or have recently had a heart attack, have severe circulatory problems (such as shock) or breathing difficulties. These conditions may cause inadequate oxygen supply to tissues, which could increase your risk of lactic acidosis (see “Warnings and precautions” below).
• if you drink large amounts of alcohol.

If you are in any of the above conditions, consult your doctor before starting to take this medicine.
Consult your doctor:

• if you are scheduled for tests such as X-rays or diagnostic scans requiring injection into the bloodstream of iodine-containing contrast agents;
• if you are scheduled for surgery.

You must stop taking Metformina Teva for a certain period of time before and after the test or surgery. Your doctor will decide whether you need another treatment during this time. It is important that you follow your doctor’s instructions precisely.

Warnings and precautions

Talk to your doctor or pharmacist before taking Metformina Teva.

Risk of lactic acidosis

Metformina Teva may cause a very rare but very serious side effect called lactic acidosis. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, serious infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterized by reduced oxygen supply to part of the body (such as severe heart disease).

If you have any of the medical conditions described above, consult your doctor for further instructions.

Stop taking Metformina Teva temporarily if you develop a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, heat exposure, or if you are drinking less fluids than normal. Consult your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking Metformina Teva and contact your doctor or the nearest hospital immediately, because lactic acidosis can lead to coma.

Symptoms of lactic acidosis include:

• vomiting
• stomach ache (abdominal pain)
• muscle cramps
• a general feeling of being unwell associated with severe fatigue
• difficulty breathing
• reduced body temperature and slower heart rate

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

If you are undergoing major surgery, you must stop taking Metformina Teva during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart treatment with Metformina Teva.

During treatment with Metformina Teva, your doctor will check your kidney function at least once a year, or more frequently if you are elderly and/or if kidney function worsens.

Metformina Teva alone does not cause hypoglycaemia (low blood glucose levels). However, if you take it together with other diabetes medicines 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, rapid heartbeat, blurred vision, or difficulty concentrating, it is usually helpful to eat or drink something containing sugar.

Other medicines and Metformina Teva

If you are scheduled to receive an injection of iodinated contrast medium into the bloodstream, for example for an X-ray, you must stop taking Metformina Teva before or during the injection. Your doctor will decide when to stop and when to restart treatment with Metformina Teva.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You may need to have more frequent blood glucose and kidney function tests, or your doctor may decide to adjust the dose of Metformina Teva.

It is particularly important to mention the following:

• medicines that increase urine production (diuretics)
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• some medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• beta2-agonists such as salbutamol or terbutaline (used to treat asthma)
• corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma)
• other medicines used to treat diabetes.

Metformina Teva and alcohol

Avoid excessive alcohol consumption during treatment with Metformina Teva, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”). This also applies to medicines containing alcohol.

Pregnancy, breastfeeding and fertility

During pregnancy, insulin is required to treat diabetes. Inform your doctor if you are, think you may be, or plan to become pregnant, so that your doctor can adjust your treatment.

• Metformina Teva is not recommended if you are breastfeeding or intend to breastfeed your baby. If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Metformina Teva alone does not cause hypoglycaemia (low blood glucose levels). This means it does not impair your ability to drive or operate machinery. However, take particular care if you take Metformina Teva together with other diabetes medicines that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, rapid heartbeat, blurred vision, or difficulty concentrating. Do not drive or operate machinery if you begin to experience these symptoms.

3. How to take Metformin Teva

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Metformin Teva cannot replace the benefits of a healthy lifestyle. Continue to follow all dietary advice given to you by your doctor and exercise regularly.

Dose recommended
Children aged 10 years and older and adolescents usually start treatment with 500 mg or 850 mg of metformin hydrochloride once daily. The maximum daily dose is 2000 mg, taken in 2 or 3 divided doses. Treatment of children aged between 10 and 12 years is recommended only on the specific advice of the doctor, as experience in this age group is limited.
Adults usually start with 500 mg or 850 mg of metformin hydrochloride two or three times daily. The maximum daily dose is 3000 mg, taken in 3 divided doses.
If you have reduced kidney function, your doctor may prescribe a lower dose.
If you are also taking insulin, your doctor will advise you on how to start Metformin Teva.

Monitoring

• Your doctor will carry out regular blood glucose tests and adjust your dose of Metformin Teva according to your blood glucose levels. You should consult your doctor regularly. This is particularly important for children and adolescents, or if you are elderly.
• Your doctor will check at least once a year how well your kidneys are working. You may need more frequent checks if you are elderly or if your kidneys do not function normally.

How to take Metformin Teva
Take the tablets during or after a meal. This will help you avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow each tablet with a glass of water.

• If you take one dose per day, take it in the morning (with breakfast).
• If you take two doses per day, take them in the morning (with breakfast) and in the evening (with dinner).
• If you take three doses per day, take them in the morning (with breakfast), at midday (with lunch), and in the evening (with dinner).

If, after some time, you think that the effect of Metformin Teva is too strong or too weak, consult your doctor or pharmacist.
If a child is being treated with Metformin Teva, parents and caregivers are advised to supervise the use of this medicine.

If you take more Metformin Teva than you should
If you have taken more Metformin Teva than you should have, you may develop lactic acidosis.
Symptoms of lactic acidosis include vomiting, stomach pain (abdominal pain) with muscle cramps, a general feeling of being unwell with profound fatigue and difficulty breathing.
If these symptoms occur, you must be treated in hospital immediately, as lactic acidosis can lead to coma. Contact a doctor or the nearest hospital immediately.

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 scheduled time.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are very serious; if they occur, contact your doctor urgently:
Very rare (may affect up to 1 in 10,000 people)

• Metformin Teva may cause a very rare (may affect up to 1 in 10,000 people) but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Metformin Teva and seek immediate medical advice from your doctor or the nearest hospital, as lactic acidosis can lead to coma.
• Liver function abnormalities or hepatitis (liver inflammation; this may cause fatigue, 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)

• Gastrointestinal problems such as nausea, vomiting, diarrhoea, stomach ache (abdominal pain) and loss of appetite are very common side effects (may affect up to 1 in 10 people). These side effects most often occur at the beginning of treatment with Metformin Teva. It helps to divide the doses throughout the day and take the tablets during or immediately after meals. If symptoms persist, stop taking Metformin Teva and consult your doctor.

Common (may affect up to 1 in 10 people):

• Taste disturbances.

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

• Skin reactions such as redness of the skin (erythema), itching or itchy rash (urticaria).
• Low levels of vitamin B12 in the blood.

Children and adolescents
Limited data in children and adolescents have shown that adverse events were similar in nature and severity to those reported in adults.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metformina Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging after EXP. The expiry date refers to the last day of that month.
No special storage conditions are required for this medicine.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Metformina Teva contains

• The active substance is metformin hydrochloride.
  Metformina Teva 500 mg: each tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
  Metformina Teva 850 mg: each tablet contains 850 mg of metformin hydrochloride, equivalent to 662.9 mg of metformin.
• The excipients are:
  Core: povidone (K30/K90), anhydrous colloidal silica, magnesium stearate.
  Coating: hypromellose (E464), macrogol 400, titanium dioxide (E171).

Description of the appearance of Metformina Teva and contents of the pack
Metformina Teva is available as film-coated tablets in two different strengths, which can be identified by the following imprints:

• Metformin hydrochloride 500 mg film-coated tablets: oval, film-coated tablets, white to off-white in colour, imprinted with "93" on one side and "48" on the other.
• Metformin hydrochloride 850 mg film-coated tablets: oval, film-coated tablets, white to off-white in colour, imprinted with "93" on one side and "49" on the other.

Metformin hydrochloride 500 mg is available in packs containing 20, 28, 30, 50, 56, 60, 84, 90, 100, 120, 180, 200, 400 and 500 tablets.
Metformin hydrochloride 850 mg is available in packs containing 10, 20, 28, 30, 40, 50, 56, 60, 90, 100, 120, 180, 200, 250 and 300 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano, Italy

Manufacturer responsible for batch release
Teva UK Ltd – Brampton Road, Hampden Park – BN22 9AG Eastbourne – East Sussex (United Kingdom)
Pharmachemie B.V. – Swensweg, 5 – 2031 RN Haarlem (The Netherlands)
Teva Santé SA – Rue Bellocier – BP 713 – 89107 Sens Cedex (France)
Teva Pharmaceutical Works Private Limited Company – Pallagi ùt. 13 – H-4042 Debrecen (Hungary)
Teva Pharmaceutical Works Private Limited Company - Tàncsics Mihàly st. 82 – H-2100 Gödöllő (Hungary)
Merkle GmbH – Ludwig-Merkle-Strasse 3 – 89143 Blaubeuren – Weiler (Germany)