Leaflet: information for the user

Metormina Teva 1,000 mg film-coated tablets EFG

metformin hydrochloride

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take Metormina Teva

3.How to take Metormina Teva

4.Possible side effects

5.Storage of Metormina Teva

6.Contents of the pack and additional information

Metformina Teva contains 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 high levels of glucose in the blood. This medication helps to reduce your blood glucose to a level as normal 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. Metformin is associated with maintaining body weight or a slight decrease in it.

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

Adults can take metformin alone or with other medications for treating diabetes (oral medications or insulin).

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

Do not take Metformin Teva

• If you are allergic (hypersensitive) to metformin, or to any of the other components of this medication (listed in section6).
• 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 diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or if your breath develops an unusual fruity odor.
• If you have lost a lot of water from your body (dehydration), for example due to prolonged or intense 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”).
• If you have a severe infection, for example, a lung, bronchial, or kidney infection. Severe infections can trigger kidney problems, which can 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 circulation problems (such as shock) or if you have difficulty breathing. This can lead to a lack of oxygen in the tissues, which can put you at risk of developing lactic acidosis (see below “Warnings and precautions”).
• 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.

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 should stop taking metformin for a certain period of time, 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

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

The symptoms of lactic acidosis include:

• Vomiting
• Abdominal pain (stomach pain)
• Muscle cramps
• General feeling of discomfort, with intense fatigue
• Difficulty breathing
• Reduced body temperature and heart rate

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

Consult your doctor quickly to find out what to do if:

• You know you have a genetic disorder 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.

If you need to undergo a major surgery, you should stop takingmetforminwhile the procedure is being performed and for a time after it. Your doctor will decide when to interrupt treatment withmetforminand when to resume it.

Metformin Teva by itself does not cause hypoglycemia (low blood sugar). However, if you take metformin along 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.

During treatment withmetformin, 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 kidney 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 takingmetforminbefore the injection or at the time of the injection. Your doctor will decide when to interrupt treatment withmetforminand when to resume it.

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 kidney function tests, or your doctor may need to adjust the dose ofmetformin. 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)
• Certain 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)
• Medications 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, or olaparib).
• Other medications used to treat diabetes.

Taking Metformin Teva with alcohol

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor to determine if you need to make any changes to your treatment or monitor your blood glucose levels.

This medication is not recommended if you are breastfeeding or plan to breastfeed your baby.

Driving and operating machinery

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

However, be cautious if you take metformin along 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 of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Metformin cannot replace the benefits of a healthy lifestyle. Continue following any dietary advice given by your doctor and practice regular exercise.

Recommended dose

Children aged 10 years and above and adolescentsgenerally start with 500mg or 850mg of metformin once a day. The maximum daily dose is 2000mg divided into 2or 3doses. 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.

Adultsgenerally start with 500mg or 850mg of metformin, two or three times a day. The maximum daily dose is 3000mg divided into 3doses.

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

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

Monitoring

• Your doctor will perform regular blood glucose tests and 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 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 after meals. This will prevent you from experiencing adverse effects that affect your digestion. Do not bite 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 midday (lunch) and in the evening (dinner).

If, after some time, you believe the effect of metformin is too intense 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 experience lactic acidosis. The symptoms of lactic acidosis are non-specific such as vomiting, stomach pain (abdominal pain) with nausea, a general feeling of discomfort with intense fatigue and difficulty breathing.Additional symptoms may be a decrease in body temperature and heart rate.If you experience any of these symptoms, you must seek immediate medical attentionas lactic acidosis can lead to coma.Stop taking Metformin Teva immediately and contact your doctor or the nearest hospital immediately.

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

If you forgot to take Metformin Teva

Do not take a double dose to compensate for the missed doses. 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 medicine can cause side effects, although not everyone will experience them. The following side effects may occur:

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

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 beginning of treatment with metformin. Taking metformin during or immediately after a meal may help reduce these side effects.If symptoms persist, stop takingthis medicineand consult your doctor.

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

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

Rare side effects (may affect up to1 in 10,000 people):

• lactic acidosis. This is a rare but serious complication, especially if your kidneys do not function properly. The symptoms of lactic acidosis are nonspecific (see the "Warnings and precautions" section).
• abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause fatigue, loss of appetite, weight loss, with or without a yellowish tone of the skin orthe whiteof the eyes). If this happens to you,stop taking this medicine and talk to your doctor.
• skin reactions such as skin redness (erythema), itching or a itchy rash (urticaria).

Children and adolescents

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

Reporting 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 Pharmacovigilance of Medicines for Human Use: 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 with metformina, parents and caregivers are advised to supervise how this medication is used.

This medication does not require special storage conditions.

Do not use this medication after 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 disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition of Metformin Teva

• The active ingredient is hydrochloride of metformin.

Each film-coated tablet of Metformin Teva 1.000mg contains1.000mgofhydrochloride of metformin, corresponding to780mg of metformin base.

• Theother components are povidone, magnesium stearate,hypromelloseand macrogol.

Appearance of the product and contents of the package

Metformin Teva 1.000mg film-coated tablets are white or yellowish, biconvex, oval-shaped,marked on one face with “MC” and with a groove on the other face. The tablet can be divided into equal doses.

It is available in blister packs of30, 50 and 60tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Responsible 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

Further information about this medicine can be obtained by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas Madrid

Spain

Last review date of this leaflet: March 2025

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/89277/P_89277.html