Package Insert: Information for the Patient

Metformin Viatris 1000 mg Film-Coated Tablets EFG

Metformin Hydrochloride

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

3. How to take Metformin Viatris

4. Possible adverse effects

5. Storage of Metformin Viatris

6. Contents of the package and additional information

What is Metformina Viatris

Metformina Viatriscontains the active ingredient hydrochloride of 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 the body capture glucose (sugar) from the blood. The 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. Hydrochloride of metformin helps to reduce your blood glucose to a normal level as possible.

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

Hydrochloride of metforminis associated with weight stability or moderate weight loss.

What is Metformina Viatris used for

Metforminis 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 take metformin alone or accompanied by other diabetes medications (oral medications or insulin).

Children aged 10 years and above and adolescents can take metformin alone or accompanied by insulin.

Do not takeMetformin Viatris:

• If you are allergic to metformin or any of the other ingredients in this medication (listed in section 6).
• If you have liver problems.
• If you have severe kidney function reduction.
• 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. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor in your 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 below "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 below "Warnings and precautions").
• If you are receiving treatment for heart failure or have recently had a heart attack, if you have severe circulation problems (such as shock) or difficulty breathing. This can reduce oxygen supply to tissues, which can put you at risk of developing lactic acidosis (see below "Warnings and precautions").
• 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 medication.

Warnings and precautions

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

Risk of lactic acidosis

Metformin can cause a rare but serious side effect called lactic acidosis, especially if your kidneys are not functioning properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (see below for more information), liver problems, and any medical condition in which a part of the body has 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 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 intense vomiting, diarrhea, fever, exposure to heat, or if you drink less liquid than normal. 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 cause 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.

You need to take carbohydrates regularly throughout the day. You should follow the dietary advice provided by your doctor.

Metformin alone does not cause hypoglycemia (low blood glucose levels). However, if you take metformin 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, stop taking Metformin Viatris while the procedure is being performed and for a period of time afterwards. Your doctor will decide when to interrupt treatment with Metformin Viatris and when to restart it.

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

During treatment with Metformin Viatris, 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 worsening.

Children and adolescents

Metformin is not recommended for children under 10 years old.Treatment in children aged 10 to 12 years is only recommended under specific advice from your doctor, as clinical experience in this patient group is limited.

Taking Metformin Viatris with other medications

Inform your doctor if you are taking, have recently taken, 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 of Metformin Viatris. 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 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 diabetes medications.

If you need to receive an intravenous injection of a contrast medium containing iodine, for example, in the context of a radiograph or examination, stop taking Metformin Viatris before the injection or at the time of the injection. Your doctor will decide when to interrupt treatment with Metformin Viatris and when to 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 section "Warnings and precautions").

Pregnancy and breastfeeding

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

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

Consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

Metforminalone does not cause hypoglycemia (low blood glucose levels). This means that it will not affect your ability to drive or operate machinery.

However, be cautious if you take metformin with other diabetes medications that can 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 start to feel these symptoms.

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

Hydrochloride metformin cannot replace the benefits derived from a healthy lifestyle. Continue following any dietary advice given by your doctor and exercise regularly.

The recommended dose in adults is 500 mg or 850 mg of hydrochloride metformin, 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 instruct you on how to start taking Metformina Viatris.

Use in children aged 10 years and above and adolescents

Children aged 10 years and above and adolescents usually start with 500 mg or 850 mg of hydrochloride metformin 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 is only recommended under specific advice from your doctor, as clinical experience in this patient group is limited.

Monitoring

• Your doctor will perform regular analyses to control your blood glucose levels and adjust your hydrochloride metformin dose 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 check-ups if you are an elderly person or if your kidneys do not function normally.

Administration form

Take the tablets with meals or after meals. This will prevent you from experiencing adverse effects that affect your digestion.

Do notcrush 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).

The 1000 mg tablet can be divided into equal doses.

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

If you take more Metformina Viatris than you should

If you have taken more hydrochloride metformin than you should, you may experience 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 the hospital, as lactic acidosis can lead to coma. Contact your doctor or the nearest hospital immediately.

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

If you forgot to takeMetformina Viatris

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

If you interrupt treatment with Metformina Viatris

If you interrupt treatment with hydrochloride metformin suddenly, your blood glucose levels may increase. Consult your doctor before stopping this medication.

If you have any other doubts 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.

If you think you may be experiencing any of the following side effects, stop taking this medicine immediately and go to the nearest hospital emergency department. 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" section). Lactic acidosis can lead to coma.
• 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).

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.Dividing the doses throughout the day and taking the tablets during or immediately after a meal may be helpful.If 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 (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.

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

• Skin reactions such as skin redness (erythema), itching, or a itchy rash (urticaria).

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 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 Vigilance of Medicines 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.

Do not use this medicationafter the expiration date that appears on the packaging after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofMetformin Viatris

The active ingredient is metformin (as hydrochloride).

Each tablet contains 1,000 mg of hydrochloride of metformin 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 package:

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

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for Manufacturing

McDermott Laboratories Limited t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

Or

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 countries of the European Economic Area with the following names:

BelgiumMetformineMylan1000 mg film-coated tablets

DenmarkMitforgen

SlovakiaMetforminMylan

SpainMetformin Viatris 1000 mg coated tablets EFG

FranceMETFORMINEMylanPHARMA 1000 mg, scored tablet

NetherlandsMetformine HClMylan1000 mg film-coated tablets

PortugalMetforminMylan

Czech RepublicMetforminMylan

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

SwedenMitforgen

Last review date of this leaflet:January 2023

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