Metformin Teva 850 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Metformina Teva 850 mg film-coated tablets EFG

Metformin hydrochloride

Package leaflet:

1. What Metformin Teva 850 mg is and what it is used for
2. What you need to know before taking Metformin Teva 850 mg
3. How to take Metformin Teva 850 mg
4. Possible side effects
5. How to store Metformin Teva 850 mg
6. Contents of the pack and other information

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

What is Metformina Teva 850 mg:

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 helps your body 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. Metformin helps lower your blood glucose to as near normal levels as possible.

If you are an overweight adult, taking metformin over a prolonged period may also help reduce the risk of diabetes-related complications.

What Metformina Teva 850 mg is used for:

Metformin 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 especially used in overweight patients.

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

Children from the age of 10 years and adolescents may take metformin alone or in combination with insulin.

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

Do not take Metformin Teva 850 mg

• if you are allergic (hypersensitive) to metformin hydrochloride or to any of the other ingredients of this medicine (see section 6).
• if you have liver problems.
• if you have severely reduced kidney function.
• 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 disorder in which substances called “ketone bodies” accumulate in the blood, which may lead to diabetic pre-coma. Symptoms include stomach pain, deep and rapid breathing, drowsiness, or fruity-smelling breath.
• if you have lost too much fluid from your body (dehydration), for example due to prolonged or severe diarrhoea or repeated vomiting. Dehydration may trigger kidney problems, which could put you at risk of developing lactic acidosis (see below “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 below “Warnings and precautions”).
• if you are being treated for heart failure or have recently had a heart attack, if you have serious circulation problems, or if you have difficulty breathing. These conditions may reduce oxygen supply to tissues, which could put you at risk of developing lactic acidosis (see below “Warnings and precautions”).
• if you drink large amounts of alcohol.

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

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

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

You must stop taking Metformin Teva for a certain period before and after the examination or surgical procedure. 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

Risk of lactic acidosis

Metformin Teva may cause a very rare but very serious adverse effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems, and any medical condition in which part of the body receives reduced oxygen supply (such as severe acute heart conditions).

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

Stop taking Metformin Teva temporarily if you develop a 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 fluid than usual. Consult your doctor for further instructions.

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

Symptoms of lactic acidosis include:

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

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

Contact your doctor promptly for advice if:

• You are known to have a genetic mitochondrial disease (the components that produce energy inside cells), 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, movement difficulties, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Metformin Teva alone does not cause hypoglycaemia (low blood glucose). However, if you take Metformin Teva together with other antidiabetic medicines that can cause hypoglycaemia (such as sulfonylureas, 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 generally helpful to eat or drink something containing sugar.

If you need to undergo major surgery, you must stop taking Metformin Teva during the procedure and for a period afterwards. Your doctor will decide when to stop and when to restart 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 your kidney function is deteriorating.

Other medicines and Metformin Teva

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

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 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 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 Metformin Teva with alcohol

Avoid excessive alcohol consumption while taking Metformin Teva, 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 have a baby, talk to your doctor about whether changes to your treatment are needed or whether your blood glucose levels should be monitored.

Do not take this medicine if you are breastfeeding or planning to breastfeed.

Driving and using machines

Metformin Teva alone does not cause hypoglycaemia (low blood glucose). This means it will not affect your ability to drive or use machines.

However, take special care if you take Metformin Teva together with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylureas, 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 850 mg

Follow exactly the instructions for use of this medicine as given by your doctor.

If you have any doubts, consult your doctor or pharmacist.

Metformin cannot replace the benefits derived from 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 you are also using insulin, your doctor will advise you on how to start taking metformin.

Monitoring:

• Your doctor will perform blood tests to monitor your blood glucose and will adjust your metformin dose according to your blood glucose levels. Be 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 working. You may need more frequent checks if you are elderly or if your kidneys do not function normally.

How to take Metformin Teva 850 mg

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

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

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

If, after some time, you feel that 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 develop lactic acidosis. Symptoms of lactic acidosis include vomiting, stomach pain (abdominal pain) with cramps, feeling unwell with severe tiredness, and difficulty breathing. If this happens, you may need immediate treatment in hospital, as lactic acidosis can lead to coma. Contact a doctor or the nearest hospital immediately.

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

If you forget to take Metformin Teva 850 mg

Do not take a double dose to make up for the missed dose. 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 experiences them.

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

The following adverse effects may occur.

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

• Gastrointestinal problems, such as nausea, vomiting, diarrhoea, stomach ache (abdominal pain), and loss of appetite. These adverse effects occur most frequently at the beginning of treatment with Metformin Teva. It helps to spread the doses throughout the day and to take the tablets during or immediately after a meal. If symptoms persist, stop taking Metformin Teva 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 arrange for you to have some tests to determine the cause of your symptoms, as some of them may be caused by diabetes or due to other health problems not related 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 not specific (see section “Warnings and precautions”).
• Abnormal liver function test results 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 happens to you, stop taking Metformin Teva and consult your doctor immediately.
• Skin reactions such as redness of the skin (erythema), itching, or an itchy rash (urticaria).

Children and adolescents

Limited clinical 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: https://www.notificaram.es. By reporting adverse 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, parents and caregivers are advised to supervise how this medicine is used.

No special storage conditions are required.

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. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metformina Teva 850 mg film-coated tablets.

The active substance is metformin hydrochloride.

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

The other components (excipients) are:

Core: povidone, magnesium stearate,

Coating: hypromellose, macrogol

Appearance of the product and pack contents

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 pack contains 50 tablets, with each blister 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, 1st floor, 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 most recent revision of this leaflet: July 2025

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