METFORMIN VIATRIS 1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Metformin Viatris 1000 mg Film-Coated Tablets EFG

Metformin Hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Metformin Viatris and what is it used for

What is Metformin Viatris

Metformin Viatris contains the active substance metformin hydrochloride, 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 leads to a high level of glucose in the blood. Metformin hydrochloride helps to lower your blood glucose to as normal a level as possible.

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

Metformin hydrochloride is associated with body weight stability or moderate weight loss.

What Metformin Viatris 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 of age and adolescents can take metformin alone or with insulin.

2. What you need to know before you take Metformin Viatris

Do not take Metformin Viatris:

• If you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6).
• If you have liver problems.
• If you have a severe reduction in kidney function.
• If you have uncontrolled diabetes, for example, with severe hyperglycemia (high blood glucose levels), 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, which can lead to diabetic precoma. The symptoms include stomach pain, rapid and deep breathing, drowsiness or an unusual fruity odor of the 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 (such as shock) 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 large amount of alcohol.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Metformin Viatris.

Risk of lactic acidosis

Metformin can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working 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 condition in which a part of the body has a reduced supply of oxygen (such as acute and severe heart disease).

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

Stop taking Metformin Viatris for a short period of time if you have a condition 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 Viatris and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that lactic acidosis produces, 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
• Decreased body temperature and heart rate.

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

Consult your doctor quickly 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.

You need to take carbohydrates regularly throughout the day. It is necessary that you follow the dietary advice provided by your doctor.

Metformin alone does not cause hypoglycemia (a blood glucose level that is too low). However, if you take metformin 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 disturbances, 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 Viatris during the procedure and for a period of time after it. Your doctor will decide when you should stop taking Metformin Viatris and when you can restart it.

Your doctor should check your kidney function before starting treatment with this medicine, especially if you have controlled heart failure treated with medicines.

During treatment with Metformin Viatris, 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 worsening.

Children and adolescents

Metformin is not recommended for use in children under 10 years of age. Treatment in 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.

Taking Metformin Viatris with other medicines

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 Viatris. 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 change 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.

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 Viatris before the injection or at the time of the injection. Your doctor will decide when you should stop taking Metformin Viatris and when you can restart it.

Taking Metformin Viatris with alcohol

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

Pregnancy and breastfeeding

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.

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

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Metformin 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 with other diabetes medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). The symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, vision disturbances, or difficulty concentrating. Do notdrive or use machines if you start to feel these symptoms.

3. How to take Metformin Viatris

Follow the instructions for administration of this medicine exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

The recommended dose in adults is 500 mg or 850 mg of metformin hydrochloride, two or three times a day. The maximum daily dose is 3,000 mg divided into 3 doses.

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

Use in children from 10 years of age and adolescents

Children from 10 years of age and adolescents usually start with 500 mg or 850 mg of metformin hydrochloride once a day. The maximum daily dose is 2,000 mg divided into 2 or 3 doses. Treatment in 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.

Monitoring

• Your doctor will perform regular tests to check your blood glucose and adjust your dose of metformin hydrochloride 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 kidney function is not normal.

Method of administration

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

Do notcrush 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).

The 1000 mg tablet can be divided into equal doses.

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

If you take more Metformin Viatris than you should

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

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone: 91 562 04 20, and indicate the amount ingested.

If you forget to take Metformin Viatris

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

If you stop taking Metformin Viatris

If you stop taking metformin hydrochloride suddenly, your blood glucose levels may increase. Consult your doctor before stopping this medicine.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you think you may have any of the following side effects, stop taking this medicine immediately and go to the emergency department of the nearest hospital. These side effects are very rare (may affect up to 1 in 10,000 people):

• Lactic acidosis. This is a very rare but serious side effect (see "Warnings and precautions"). Lactic acidosis can lead to coma.
• 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).

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

• Digestive problems, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms usually appear at the beginning of treatment with Metformin Viatris. It helps to spread the doses throughout the day and take the tablets during or immediately after a meal If the symptoms persist, stop taking Metformin Viatris and inform 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, numbness or tingling, or pale or yellowish skin). Your doctor may schedule some tests to find the reason for your symptoms because some of them may be caused by diabetes or due to other unrelated health problems.

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

• 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 the side effects were similar in nature and severity to those observed in adults.

Reporting of side effects

If you experience any side effects, consult 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 Viatris

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

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

This medicine does not require any special storage conditions.

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 to protect the environment.

6. Packaging Content and Additional Information

Composition ofMetformin Viatris

The active ingredient is metformin (as hydrochloride).

Each tablet contains 1,000 mg of metformin hydrochloride equivalent to 780 mg of metformin.

The other components (excipients) are:

Core: povidone K-30, magnesium stearate.

Coating: hypromellose, hydroxypropylcellulose, macrogol 400 and 8000.

Appearance of the Product and Packaging Content:

White, oval, film-coated tablets with the letters "MF" and the number "3" printed on both sides of the score line on the scored face and the letter "G" on the other face. The tablet can be divided into two equal halves.

Blisters (PVC/Aluminum) with 10, 15, 20, 28, 30, 40, 50, 56, 60, 84, 90, 100, 120, 180 film-coated tablets and also, in a multiple packaging of 180 tablets which consists of 2 packs (each containing 90 tablets).

Bottles (HPDE) with a cap (polypropylene) containing each bottle 30, 100, 180, 200, 300, 400, 500 or 1000 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan Hungary Kft.

Mylan utca 1.

Komárom, 2900

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Belgium Metformine Mylan 1000 mg film-coated tablets

Denmark Mitforgen

Slovakia Metformin Mylan

Spain Metformina Viatris 1000 mg film-coated tablets EFG

France METFORMINE Mylan PHARMA 1000 mg, scored film-coated tablet

Netherlands Metformine HCl Mylan 1000 mg film-coated tablets

Portugal Metformina Mylan

Czech Republic Metformin Mylan

United Kingdom (Northern Ireland) Metformin hydrochloride 1000 mg film-coated tablets

Sweden Mitforgen

Date of the Last Revision of this Leaflet:March 2025

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