Metformin Teva 1,000 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Metormina Teva 1,000 mg film-coated tablets EFG

metformin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 others, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

Metformina Teva contains metformin, a medicine used to treat diabetes. It belongs to a group of medicines called biguanides.

Insulin is a hormone produced by the pancreas that enables your body to take up 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 produce enough insulin or your body cannot properly use the insulin it produces. This leads to high levels of glucose in the blood. This medicine helps to reduce your blood glucose to as near normal levels as possible.

If you are an overweight adult, taking metformin over a prolonged period also helps to reduce the risk of diabetes-related complications. Metformin is associated with maintenance of body weight or a slight reduction in body weight.

Metformin is used to treat patients with type 2 diabetes (also called “non-insulin-dependent diabetes”) when diet and exercise alone are not sufficient to control blood glucose levels. It is especially used in overweight patients.

Adults may take metformin alone or together with other antidiabetic medicines (oral medications or insulin).

Children aged 10 years and older, and adolescents, may take metformin alone or together with insulin.

2. What you need to know before taking Metformina Teva

Do not take Metformina Teva

• If you are allergic (hypersensitive) to metformin or to any of the other ingredients of this medicine (listed in section 6).
• If you have liver problems.
• If you have severely reduced kidney function.
• If you have uncontrolled diabetes, for example with severe hyperglycemia (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, potentially leading to diabetic pre-coma. Symptoms include stomach pain, deep and rapid breathing, drowsiness, or breath developing an unusual fruity odor.
• If you have lost a large amount of fluid from your body (dehydration), for example due to prolonged or severe diarrhea, or if you have vomited repeatedly. Dehydration may trigger kidney problems, which could put you at risk of developing lactic acidosis (see “Warnings and precautions”).
• If you have a serious infection, for example, an infection affecting your lungs, bronchi, or kidneys. Serious infections may trigger kidney problems, which could put you at risk of developing lactic acidosis (see “Warnings and precautions”).
• If you are receiving treatment for acute heart failure or have recently had a heart attack, if you have severe circulatory problems (such as shock), or if you have difficulty breathing. These conditions may lead to tissue hypoxia (lack of oxygen in tissues), which could put you at risk of developing lactic acidosis (see “Warnings and precautions” below).
• If you drink large amounts of alcohol.

If any of the above situations apply to you, consult your doctor before starting this medicine.

Make sure to consult your doctor if

• you require an examination such as an X-ray or scan involving the injection into the bloodstream of iodine-containing contrast agents.
• you require major surgery.

You must stop taking metformin for a certain period of time before and after the examination or surgery. Your doctor will decide whether you need alternative treatment during this time. It is important that you follow your doctor's instructions exactly.

Warnings and precautions

Stop taking this medicine and contact a doctor or go to the nearest hospital immediately if you experience any of the symptoms of lactic acidosis, as this condition can lead to coma.

Symptoms of lactic acidosis include:

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

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

Contact your doctor promptly for advice on what to do if:

• You are known to have a genetic mitochondrial disorder (the components inside cells that produce energy), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You develop any of the following symptoms after starting treatment with metformin: seizures, cognitive decline, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, or deafness.

If you need to undergo major surgery, you must stop taking metformin during the procedure and for some time afterwards. Your doctor will decide when you should stop and when you should restart treatment with metformin.

Metformina Teva alone does not cause hypoglycaemia (low blood glucose levels). However, if you take metformin together with other diabetes medicines that can cause hypoglycaemia (such as sulphonylureas, insulin, or meglitinides), there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia, such as weakness, dizziness, increased sweating, increased heart rate, vision disturbances, or difficulty concentrating, it is usually helpful to eat or drink something containing sugar.

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

Other medicines and Metformina Teva

If you need to receive an injection of an iodine-containing contrast medium into your bloodstream, for example during an X-ray or scan, you must stop taking metformin before or at the time of the injection. Your doctor will decide when you should stop and when you should restart treatment with metformin.

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust your dose of metformin. It is especially 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)
• certain medicines used to treat 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 various conditions, such as severe skin inflammation or asthma)
• medicines that may alter the amount of metformin in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
• other medicines used to treat diabetes.

Taking Metformina Teva with alcohol

Avoid excessive alcohol consumption while taking metformin, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor about whether changes to your treatment or monitoring of your blood glucose levels are needed.

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

Driving and using machines

Metformin alone does not cause hypoglycaemia (low blood glucose levels). This means it will not affect your ability to drive or operate machinery.

However, take special care if you take metformin together with other diabetes medicines that can cause hypoglycaemia (such as sulphonylureas, insulin, or meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, increased heart rate, vision disturbances, or difficulty concentrating. Do not drive or operate machinery if you begin to experience these symptoms.

3. How to take Metformin Teva

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

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

Recommended dose

Children aged 10 years and older and adolescents usually start with 500 mg or 850 mg of metformin once daily. The maximum daily dose is 2000 mg divided into 2 or 3 doses. Treatment of children between 10 and 12 years of age is only recommended under specific advice from your doctor, as clinical experience in this patient group is limited.

Adults usually start with 500 mg or 850 mg of metformin two or three times daily. The maximum daily dose is 3000 mg divided into 3 doses.

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

If insulin is also being administered, your doctor will advise you on how to start taking metformin.

Monitoring

• Your doctor will regularly perform blood glucose tests and adjust your metformin dose according to your blood glucose levels. Make sure to speak regularly with your doctor. This is particularly important for children, adolescents, or if you are elderly.
• Your doctor will also check at least once a year how well your kidneys are functioning. You may need more frequent checks if you are elderly or if your kidneys do not function normally.

How to take Metformin Teva

Take metformin with meals or immediately after meals. This will help prevent gastrointestinal side effects. Do not chew or crush 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 (breakfast) and in the evening (dinner).
• If you take three doses per day, take them in the morning (breakfast), at midday (lunch), and in the evening (dinner).

If, after some time, you think that the effect of metformin is too strong or too weak, consult your doctor or pharmacist.

If you take more Metformin Teva than you should

If you have taken more metformin than you should, you may develop lactic acidosis. Symptoms of lactic acidosis are nonspecific and include vomiting, stomach pain (abdominal pain) with cramps, a general feeling of malaise with severe fatigue, and difficulty breathing. Additional symptoms may include a decrease in body temperature and heart rate. If you experience any of these symptoms, you must seek immediate medical attention, as lactic acidosis can progress to coma. Stop taking Metformin Teva immediately and contact your doctor or the nearest hospital right away.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 91 562 04 20, stating the medication and the amount ingested.

If you forget to take Metformin Teva

Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur:

Metformin may cause a very rare (may affect up to 1 in 10,000 people), but very serious adverse effect called lactic acidosis (see section “Warnings and precautions”). If this happens to you, you must stop taking this medicine and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Very common adverse effects (may affect more than 1 in 10 people):

• gastrointestinal problems such as nausea, vomiting, diarrhoea, stomach pain (abdominal pain), and loss of appetite. These adverse effects occur most frequently at the beginning of metformin treatment. Spreading the doses throughout the day and taking metformin during or immediately after a meal may help reduce these adverse effects. If symptoms persist, stop taking this medicine and consult your doctor.

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

• changes in taste sensation.
• low or decreased levels of vitamin B12 in the blood (symptoms may include extreme tiredness (fatigue), red and painful tongue (glossitis), tingling (paraesthesia), or yellowish or pale skin). Your doctor may schedule some tests to determine the cause of your symptoms, as some of them may be caused by diabetes or due to other health problems unrelated to this medicine.

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

• lactic acidosis. This is a very rare but serious complication, especially if your kidneys are not functioning properly. The symptoms of lactic acidosis are nonspecific (see section “Warnings and precautions”).
• 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 occurs, stop taking this medicine and speak to your doctor.
• skin reactions such as redness of the skin (erythema), itching, or an itchy rash (urticaria).

Children and adolescents

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metformin Teva

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

If a child is being treated with metformin, parents and caregivers are advised to supervise how this medicine is used.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metformina Teva

• The active substance is metformin hydrochloride.

Each Metformina Teva 1,000 mg film-coated tablet contains 1,000 mg of metformin hydrochloride, equivalent to 780 mg of metformin base.

• The other components are povidone, magnesium stearate, hypromellose and macrogol.

Appearance of the product and contents of the pack

Metformina Teva 1,000 mg film-coated tablets are white or yellowish, biconvex, oval, marked on one side with “MC” and with a score line on the other side. The tablet can be divided into equal doses.

Available in blister packs of 30, 50 and 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

The Netherlands

Manufacturer

SAG Manufacturing S.L.U.

Crta. N-I, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

Or

Galenicum Health, S.L.

Avda. Cornellá 144, 7º-1ª, Edificio Lekla

Esplugues de Llobregat

08950 Barcelona

Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Date of the most recent review of this leaflet: March 2025

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89277/P_89277.html