Metformin Viatris 1000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Metformina 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Metformin Viatris is and what it is 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 enables your body to 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 hydrochloride helps lower your blood glucose to as near normal levels as possible.

If you are an overweight adult, taking metformin hydrochloride for a prolonged period also helps reduce the risk of diabetes-related complications.

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 sufficient to control blood glucose levels. It is especially used in overweight patients.

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

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

2. What you need to know before taking Metformina Viatris

Do not take Metformina Viatris:

• If you are allergic to metformin or any of the other components of this medicine (listed in section 6).
• If you have liver problems.
• If you have severely reduced 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” build up in the blood, potentially leading to diabetic pre-coma. Symptoms include stomach pain, deep and rapid breathing, drowsiness, or a fruity odor on your breath.
• If you have lost too much fluid from your body (dehydration), for example, due to prolonged or severe diarrhea, or if you have vomited repeatedly. Dehydration can trigger kidney problems, which may put you at risk of developing lactic acidosis (see below “Warnings and precautions”).
• If you have a severe infection, for example, an infection affecting your lungs, bronchi, or kidneys. Severe infections can trigger kidney problems, which may put you at risk of developing lactic acidosis (see below “Warnings and precautions”).
• If you are receiving treatment for heart failure or have recently had a heart attack, if you have serious circulation problems (such as shock), or if you have difficulty breathing. These conditions can reduce oxygen supply to tissues, which may 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.

Warnings and precautions

Talk to your doctor or pharmacist before starting Metformina Viatris.

Risk of lactic acidosis

Metformin may cause a very rare but 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, severe infections, prolonged fasting or alcohol consumption, dehydration (see further information below), liver problems, and any medical condition in which part of the body has reduced oxygen supply (such as acute and severe heart diseases).

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

Stop taking Metformina Viatris temporarily if you develop an illness that could lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than usual. Consult your doctor for further instructions.

Stop taking Metformina Viatris and contact a doctor or 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 discomfort with severe fatigue.
• Difficulty breathing.
• Decreased body temperature and reduced heart rate.

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

Contact your doctor urgently for guidance 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 experience any of the following symptoms after starting metformin treatment: seizures, cognitive decline, difficulty with body movements, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

You need to consume carbohydrates regularly throughout the day. You must follow your doctor's dietary advice.

Metformin alone does not cause hypoglycemia (blood glucose levels too low). However, if you take metformin together 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 generally helpful to eat or drink something containing sugar.

If you require major surgery, you must stop taking Metformina Viatris during the procedure and for a period afterward. Your doctor will decide when to interrupt and when to restart treatment with Metformina Viatris.

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

During treatment with Metformina Viatris, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or if your kidney function is deteriorating.

Children and adolescents

The use of metformin is not recommended in children under 10 years of age. Treatment in children aged between 10 and 12 years is only recommended under specific advice from your doctor, as clinical experience in this patient group is limited.

Taking Metformina Viatris with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

You may require more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Metformina 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 for treating 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 for treating diabetes.

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

Taking Metformina Viatris with alcohol

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

Pregnancy and breastfeeding

During pregnancy, insulin is required to treat 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 (blood glucose levels too low). This means it will not affect your ability to drive or operate machinery.

However, take special care if you take metformin together with other diabetes medications that may cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycemia 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 Metformina Viatris

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

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

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

If you are also using insulin, your doctor will advise you on how to start taking Metformina Viatris.

Use in children aged 10 years and older and adolescents

Children aged 10 years and older and adolescents usually start with 500 mg or 850 mg of metformin hydrochloride once daily. The maximum daily dose is 2,000 mg, divided into two or three doses. Treatment in children aged 10 to 12 years is recommended only under specific advice from your doctor, as clinical experience in this patient group is limited.

Monitoring

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

Method of administration

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

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

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

The 1000 mg tablet may be divided into equal doses.

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

If you take more Metformina Viatris than you should

If you have taken more metformin hydrochloride than you should, you may develop lactic acidosis. Symptoms of lactic acidosis include vomiting, abdominal pain with cramps, a general feeling of discomfort with severe fatigue, and difficulty breathing. If this occurs, you may require 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 at telephone: 91 562 04 20 and report the amount ingested.

If you forget to take Metformina Viatris

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

If you stop taking Metformina Viatris

If you stop treatment with metformin hydrochloride suddenly, your blood glucose levels may rise. Consult your doctor before stopping this medicine.

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 will experience them.

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

• Lactic acidosis. This is a very rare but serious adverse effect (see section “Warnings and precautions”). Lactic acidosis may lead to coma.
• 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).

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

• Digestive problems, such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. These symptoms usually occur at the beginning of treatment with Metformina Viatris. It may help to spread the doses throughout the day and take the tablets during or immediately after a meal**. If symptoms persist, stop taking Metformina Viatris and inform your doctor.**

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

• Changes in taste sensation.
• Low or reduced 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 some tests to determine the cause of your symptoms, as some of them may be caused by diabetes or other unrelated health problems.

Very rare adverse 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 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, consult 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 Viatris

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

Do not use this medicine after the expiry date stated on the container after “CAD” or “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metformina Viatris

The active substance 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 contents of the pack:

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

Blister packs (PVC/Aluminum) containing 10, 15, 20, 28, 30, 40, 50, 56, 60, 84, 90, 100, 120, 180 film-coated tablets, and also a multiple pack of 180 tablets comprising 2 boxes (each containing 90 tablets).

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

Only certain 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

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorized in the European Economic Area countries under the following names:

Belgium: Metformine Mylan 1000 mg filmomhulde tabletten
Denmark: Mitforgen
Slovakia: Metformin Mylan
Spain: Metformina Viatris 1000 mg comprimidos recubiertos con película EFG
France: METFORMINE Mylan PHARMA 1000 mg, comprimé pelliculé sécable
Netherlands: Metformine HCl Mylan 1000 mg filmomhulde tabletten
Portugal: Metformina Mylan
Czech Republic: Metformin Mylan
United Kingdom (Northern Ireland): Metformin hydrochloride 1000 mg film-coated tablets
Sweden: Mitforgen

Date of the most recent review of this leaflet: March 2025

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