METFORMIN TEVA 850 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Metformin Teva 850 mg Film-Coated Tablets EFG

Metformin Hydrochloride

Contents of the Package Leaflet:

1. What is Metformin Teva 850 mg and what is it used for
2. What you need to know before you take Metformin Teva 850 mg
3. How to take Metformin Teva 850 mg
4. Possible side effects

5 Storage of Metformin Teva 850 mg

1. Contents of the pack and other information

1. What is Metformin Teva 850 mg and what is it used for

What is Metformin Teva 850 mg:

Metformin 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 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 produce enough insulin or your body cannot use the insulin it produces properly. This causes a high level of glucose in the blood. Metformin helps reduce your blood glucose to as normal a level as possible.

If you are an adult with overweight, taking metformin for a long time also helps reduce the risk of complications associated with diabetes.

What Metformin Teva 850 mg is used for

Metformin 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 their blood glucose level. It is especially used in patients with overweight.

Adults can take metformin alone or with other medicines to treat diabetes (medicines taken by mouth or insulin).

Children from 10 years old and adolescents can take metformin alone or with insulin.

2. What you need to know before you take Metformin Teva 850 mg

Do not take Metformin Teva 850 mg

• if you are allergic (hypersensitive) to metformin hydrochloride or any of the other ingredients of this medicine (see section 6).
• if you have liver problems.
• if you have a severe reduction in kidney function.
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Ketoacidosis is a disorder in which substances called "ketone bodies" accumulate in the blood, which can lead to a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or an unusual fruity odor in your breath.
• if you have lost too much water from your body (dehydration), for example due to prolonged or severe diarrhea or if you have vomited several times in a row. Dehydration can trigger kidney problems, which can put you at risk of developing lactic acidosis (see "Warnings and precautions" below).
• if you have a severe infection, for example, an infection that affects your lungs, bronchi, or kidneys. Severe infections can trigger kidney problems, which can put you at risk of developing lactic acidosis (see "Warnings and precautions" below).
• if you are receiving treatment for heart failure or if you have recently had a heart attack, if you have severe circulation problems or if you have difficulty breathing. This can reduce the supply of oxygen to the tissues, which can put you at risk of developing lactic acidosis (see "Warnings and precautions" below).
• if you drink a lot of alcohol.

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

Please note the risk of lactic acidosis:Make sure to consult your doctor if

• you need an examination such as an X-ray or a scan that involves injecting a contrast medium into your blood that contains iodine.
• you need major surgery.

You should stop taking Metformin Teva for a certain period before and after the examination or surgery. Your doctor will decide if you need any other treatment during this time. It is essential that you follow your doctor's instructions precisely.

Warnings and precautions

Risk of lactic acidosis

Metformin Teva can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys do not work properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see more information below), liver problems, and any medical disorder in which a part of the body has a reduced oxygen supply (such as acute and severe heart diseases).

If any of the above applies to you, consult your doctor for further instructions.

Stop taking Metformin Teva for a short period if you have a disorder that may be associated with dehydration(significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you drink less fluid than usual. Consult your doctor for further instructions.

Stop taking Metformin Teva and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that lactic acidosis produces, as this disorder can lead to a coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort, with intense fatigue
• difficulty breathing
• reduction in body temperature and heart rate

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

Consult your doctor promptly so that they can tell you how to proceed if:

• You know you have a genetic disease that affects the mitochondria (the energy-producing components within cells), such as MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You present any of the following symptoms after starting treatment with metformin: seizure, cognitive impairment, difficulty with body movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Metformin Teva alone does not cause hypoglycemia (a blood glucose level that is too low). However, if you take Metformin Teva with other diabetes medicines that can cause hypoglycemia (such as sulfonylureas, insulin, or meglitinides), there is a risk of hypoglycemia. If you experience symptoms of hypoglycemia, such as weakness, dizziness, increased sweating, increased heart rate, vision disorders, or difficulty concentrating, it is usually helpful to eat or drink something that contains sugar.

If you need to undergo major surgery, you should stop taking Metformin Teva during the procedure and for a period after it. Your doctor will decide when you should stop taking Metformin Teva and when you can restart it.

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

Other medicines and Metformin Teva

If you need to be given an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you should stop taking Metformin Teva before the injection or at the time of the injection. Your doctor will decide when you should stop taking Metformin Teva and when you can restart it.

Tell your doctor 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 dose of Metformin Teva. 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 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 can 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 to treat diabetes.

Taking Metformin Teva with alcohol

Avoid excessive alcohol consumption while taking Metformin Teva, as this can increase the risk of lactic acidosis (see "Warnings and precautions" section).

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor, as it may be necessary to change your treatment or monitor your blood glucose levels.

Do not take this medicine if you are breastfeeding or plan to breastfeed your baby.

Driving and using machines

Metformin Teva alone does not cause hypoglycemia (a blood glucose level that is too low). This means it will not affect your ability to drive or use machines.

However, be especially careful if you take Metformin Teva with other diabetes medicines that can cause hypoglycemia (such as sulfonylureas, insulin, or meglitinides). The symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, vision disorders, or difficulty concentrating. Do not drive or use machines if you start to feel these symptoms.

3. How to take Metformin Teva 850 mg

Follow exactly the administration instructions of this medicine given by your doctor.

Consult your doctor or pharmacist if you have any doubts.

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

The recommended dose is

Children from 10 years old and adolescents usually start with 500 mg or 850 mg of metformin once a day. The maximum daily dose is 2000 mg divided into 2 or 3 doses. Treatment of children between 10 and 12 years old 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 a day. The maximum daily dose is 3000 mg divided into 3 doses.

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

If you are also using insulin, your doctor will tell you how to start taking metformin.

Monitoring:

• Your doctor will perform tests to control your blood glucose and adjust your metformin dose according to your blood glucose level. Make sure to talk to your doctor regularly. This is especially important for children, adolescents, or if you are an elderly person.

• Your doctor will also check how well your kidneys are working at least once a year. You may need more frequent checks if you are an elderly person or if your kidneys are not working normally.

How to take Metformin Teva 850 mg

Take the tablets with meals or after meals. This will help prevent digestive side effects.

Do not break or chew the tablets. Swallow each tablet with a glass of water.

• If you take one dose a day, take it in the morning (at breakfast).
• If you take two doses a day, take them in the morning (at breakfast) and at night (at dinner).
• If you take three doses a day, take them in the morning (at breakfast), at noon (at lunch), and at night (at dinner).

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

If you take more Metformin Teva 850 mg than you should

If you have taken more metformin than you should, you may suffer from lactic acidosis. The symptoms of lactic acidosis are vomiting, stomach pain (abdominal pain) with cramps, a feeling of discomfort with intense fatigue, and difficulty breathing. If this happens to you, you may need immediate treatment in a hospital, as lactic acidosis can lead to a coma. Contact a doctor or the nearest hospital immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone: 91562 04 20, and indicate the amount ingested.

If you forget to take Metformin Teva 850 mg

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

If you have any other questions about 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.

Metformin Teva can cause a very rare but very serious side effect called lactic acidosis (see "Warnings and precautions" section), if this happens to you, stop taking Metformin Teva and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to a coma.

The following side effects may occur.

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

• Digestive problems, such as nausea, vomiting, diarrhea, stomach pain (abdominal pain), and loss of appetite. These side effects occur more frequently at the start of treatment with Metformin Teva. It helps to spread the doses throughout the day and if you take the tablets during or immediately after a meal. If the symptoms persist, stop taking Metformin Teva and consult your doctor.

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

• Changes in taste.
• Low or reduced vitamin B12 levels in the blood (symptoms may include extreme fatigue, red and painful tongue, numbness or tingling, or yellowish or pale skin). Your doctor may schedule some tests to find the reason for your symptoms because some of them may be caused by diabetes or other unrelated health problems.

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

• Lactic acidosis. It is a very rare but serious complication, especially if your kidneys do not work properly. The symptoms of lactic acidosis are not specific (see "Warnings and precautions" section).
• Abnormalities in liver function tests or hepatitis (inflammation of the liver; this can cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or the whites of the eyes). If this happens to you, stop taking Metformin Teva and consult your doctor immediately.
• Skin reactions such as skin redness (erythema), itching, or an itchy rash (urticaria).

Children and adolescents

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Metformin Teva 850 mg

Keep this medicine out of the sight and reach of children. If a child is being treated with metformin, it is advised that parents and caregivers supervise how this medicine is used.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Metformina Teva 850 mg film-coated tablets.

The active ingredient is metformin hydrochloride.

Each film-coated tablet contains 850 mg of metformin hydrochloride, corresponding to 662.9 mg of metformin.

The other components (excipients) are:

Core: povidone, magnesium stearate,

Coating: hypromellose, macrogol

Appearance of the Product and Container Content

White, biconvex, oval-shaped film-coated tablets, marked with "I" and "92" separated by a score line on one side and scored on the other.

Each container contains 50 tablets, with each blister pack containing 10 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta, Alcobendas

28108 Madrid

Spain

Manufacturer:

Galenicum Health, S.L.U.

C/ Sant Gabriel, 50, Esplugues de Llobregat.

08950 Barcelona

Spain

SAG MANUFACTURING S.L.U.

Carretera Nacional I, Km. 36

San Agustin de Guadalix.

28750 Madrid

Spain

Date of the Last Revision of this Leaflet:July 2025

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

You can access detailed and updated information on this medicinal product by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71399/P_71399.html