Prospecto: Information for the User

Metformina Teva 850 mg Film-Coated Tablets

Metformin Hydrochloride

1. What isMetformina Teva 850 mgand for what it is used

2. What you need to know before starting to takeMetformina Teva 850 mg

3. How to takeMetformina Teva 850 mg

4. Possible adverse effects

5. Storage ofMetformina Teva 850 mg

6. Contents of the package and additional information

What is Metformina Teva 850 mg:

Metformina Tevacontains metformin, a medication for treating diabetes. It belongs to a group of medications called biguanides.

Insulin is a hormone produced by the pancreas that makes your body capture 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 effectively. This causes a high concentration of glucose in the blood. Metformin helps to reduce your blood glucose to a normal level as possible.

If you are an adult with obesity, taking Metformin for a prolonged period also helps to reduce the risk of complications associated with diabetes.

What is Metformina Teva 850 mg used for

Metformina Tevais 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 their blood glucose level. It is used especially in patients with obesity.

Adults can takeMetformina Tevaalone or accompanied by other diabetes medications (oral medications or insulin).

Children aged 10 years and above, and adolescents can takeMetformina Tevaalone or accompanied by insulin.

Do not take Metformin Teva 850 mg

• if you are allergic (hypersensitive) to hydrochloride metformin or to any of the other components of this medication (see section 6).
• if you have liver problems.
• if you have a severe reduction in renal function.
• if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood glucose), 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 diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or if your breath develops an unusual fruity odor.
• 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 below "Be especially careful with Metformin Teva").
• if you have a severe infection, for example, an infection affecting your lungs, bronchi, or kidneys. Severe infections can trigger kidney problems, which can put you at risk of developing lactic acidosis (see below "Be especially careful with Metformin Teva").
• 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 oxygen supply to tissues, which can put you at risk of developing lactic acidosis (see below "Be especially careful with Metformin Teva").
• if you drink a lot of alcohol.

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

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 the injection of contrast media containing iodine into your bloodstream.
• you need a major surgical intervention.

You must stop taking Metformin Teva for a certain period before and after the examination or surgical intervention. 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 acidosisMetformin Tevamay cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys do not function properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see below "Be especially careful with Metformin Teva"), liver problems, and any medical condition 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 of time if you have a condition that may be associated with dehydration(significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat, or if you drink less liquid than normal. 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 cause lactic acidosis, as this condition can lead to coma.

The symptoms of lactic acidosis include:

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

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

Consult your doctor immediately to determine how to proceed if:

• you know you have a genetic disease that affects the mitochondria (the components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes) or maternal diabetes and hearing loss (MIDD).
• you experience any of the following symptoms after starting treatment with metformin: convulsions, cognitive decline, difficulty with motor movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

Metformin Tevaby itself does not cause hypoglycemia (low blood glucose). However, if you take Metformin Tevaalong with other diabetes medications 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 disturbances, or difficulty concentrating, it is usually helpful to eat or drink something containing sugar.

If you need to undergo major surgery, you should stop taking Metformin Teva while the procedure is being performed and for a period of time afterward. 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 an older person and/or if your renal function is deteriorating.

Other medications and Metformin Teva

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

Inform your doctor if you are taking, have taken recently, or may need to take any other medication. You may need more frequent blood glucose and renal function tests, or your doctor may need to adjust the dose of Metformin Teva. It is especially important to mention the following:

• diuretics that increase urine production.
• medications used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
• medications 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).
• other diabetes medications.

Taking Metformin Teva with alcohol

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

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

Driving and operating machinery

Metformin Tevaby itself does not cause hypoglycemia (low blood glucose). This means it will not affect your ability to drive or operate machinery.

However, be especially careful if you take Metformin Tevaalong with other diabetes medications that can cause hypoglycemia (such as sulfonylureas, insulin, or meglitinides). The symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, vision disturbances, or difficulty concentrating. Do not drive or operate machinery if you start to experience these symptoms.

Follow exactly the administration instructions forTeva Metforminprescribed by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Teva Metformincannot replace the benefits derived from a healthy lifestyle. Continue following any dietary advice given by your doctor and exercise regularly:

The recommended dose is

Children aged 10 and above, and adolescents usually start with 500 mg or 850 mg ofTeva Metforminonce a day. The maximum daily dose is 2000 mg divided into 2 or 3 doses. Treatment of children between 10 and 12 years 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 ofTeva Metformintwice or three times a day. The maximum daily dose is 3000 mg divided into 3 doses.

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

If you are also using insulin, your doctor will instruct you on how to start takingTeva Metformin.

Monitoring:

• Your doctor will perform tests to control your blood glucose levels and adjust yourTeva Metformindose 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 an elderly person.

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

How to take Teva Metformin 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 a daily dose, take it in the morning (breakfast).
• If you take two doses a day, take them in the morning (breakfast) and in the evening (dinner).
• If you take three doses a day, take them in the morning (breakfast), at noon (lunch), and in the evening (dinner).

If, after some time, you believe the effect ofTeva Metforminis too intense or too weak, consult your doctor or pharmacist.

If you take more Teva Metformin 850 mg than you should

If you have taken moreTeva Metforminthan you should, you may experience lactic acidosis. Symptoms of lactic acidosis include 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 the 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, phone: 91562 04 20 and indicate the amount ingested.

If you forgot to take Teva Metformin 850 mg

Do not take a double dose to compensate for the missed dose. Take the next dose at the usual time.

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

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

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

The following side effects may occur.

Very common side effects (can 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 beginning of treatment withTeva Metformin. Help distribute the doses throughout the day and if you take the tablets during or immediately after a meal.If symptoms persist, stop taking Teva Metformin and consult your doctor.

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

• Taste alteration.

Rare side effects (can affect up to 1 in 10,000 people):

• Lactic acidosis. It is a rare but serious complication, especially if your kidneys do not function 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 can cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or the white of the eyes). If this happens to you,stop taking Teva Metformin and consult your doctor immediately.
• Skin reactions such as skin redness (erythema), itching or a itchy rash (urticaria).
• Low blood vitamin B12 levels.

Children and adolescents

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children. If a child is being treated withMetformina Teva, parents and caregivers are advised to supervise how this medication is used.

This medication does not require special conditions for conservation.

Do not useMetformina Tevaafter the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drains or in the trash.Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medications you no longer need.By doing so, you will help protect the environment.

Composition of Metformina Teva 850 mg film-coated tablets.

The active ingredient is hydrochloride of metformin.

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

The other components (excipients) are:

Core: povidone, magnesium stearate,

Coating: hypromellose, macrogol

Appearance of the product and contents of the packaging

Metformina Teva 850 mgis presented in the form of film-coated tablets.

The tablets are white, biconvex, oval-shaped, marked with “I” and “92” separated by a groove on one face and scored on the other.

Each package contains 50 tablets, containing each blister 10 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor, Alcobendas

28108 Madrid

Spain

Responsible for manufacturing:

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

Last review date of this leaflet: March 2025

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”