Metformin Vir 1000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metformina Vir 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 as 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; do not give it to others, 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 it is a side effect not listed in this leaflet. (See section 4.)

Contents of this leaflet

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

1. What MetforminaVir is and what it is used for

Metformina Vir is a medication used to treat diabetes. It belongs to a group of medicines called biguanides (a class of oral antidiabetic agents).

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. Metformina Vir helps lower your blood glucose to as near-normal levels as possible.

If you are an overweight adult, taking Metformina Vir over a prolonged period may also help reduce the risk of diabetes-related complications. Metformina Vir is associated with weight maintenance or a slight reduction in body weight.

Metformina Vir is used to treat patients with type 2 diabetes (also called "non-insulin-dependent diabetes") when diet and exercise alone are not sufficient to control blood glucose levels. It is particularly used in overweight patients.

Adults may take Metformina Vir alone or in combination with other antidiabetic medications (either oral agents or insulin).

Children aged 10 years and older, and adolescents, may take Metformina SAG Manufacturing alone or in combination with insulin.

2. What you need to know before starting Metformina Vir

Do not take Metformina Vir

• If you are allergic (hypersensitive) to metformin or to any of the other ingredients 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, 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, potentially leading to diabetic pre-coma. Symptoms include stomach pain, deep and rapid breathing, drowsiness, or a fruity, unusual odor on your breath.
• If you have lost a large amount of fluid from your body (dehydration), for example due to prolonged or severe diarrhea, or if you have vomited repeatedly. Dehydration may trigger kidney problems, which could put you at risk of developing lactic acidosis (see "Warnings and precautions").
• If you have a severe infection, such as an infection affecting your lungs, bronchi, or kidneys. Severe infections may trigger kidney problems, increasing your risk of 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 serious circulation problems (such as shock), or if you have difficulty breathing. These conditions may lead to inadequate oxygen supply to tissues, increasing your risk of lactic acidosis (see "Warnings and precautions" below).
• If you consume large amounts of alcohol.

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

Make sure to consult your doctor if

• you require an imaging procedure such as an X-ray or scan involving the injection of iodine-containing contrast agents into your bloodstream.
• you need major surgery.

You must stop taking metformin for a certain period before and after the procedure or surgery. Your doctor will decide whether you need alternative treatment during this time.

It is important that you follow your doctor's instructions precisely.

Warnings and precautions

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 involving reduced oxygen supply to body tissues (such as severe acute heart conditions). If any of these apply to you, consult your doctor for further instructions.

Stop taking Metformina Vir temporarily if you develop an illness that may lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or reduced fluid intake. Consult your doctor for further instructions.

Stop taking Metformina Vir and contact a doctor or go to 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 heart rate

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

Contact your doctor promptly for advice if:

• You are known to have a genetic mitochondrial disorder (the cellular components responsible for energy production), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• You develop any of the following symptoms after starting metformin treatment: seizures, cognitive decline, movement difficulties, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

If you need to undergo major surgery, you must stop taking metformin during the procedure and for a period afterward. Your doctor will decide when to interrupt and when to restart metformin treatment.

This medicine alone does not cause hypoglycemia (low blood glucose levels). 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.

During treatment with metformin, 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.

Other medicines and Metformina Vir

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

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 your metformin dose. 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 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)
• medicines that may alter the levels 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 used to treat diabetes

Taking Metformina Vir with alcohol

Avoid excessive alcohol consumption while taking metformin, 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 adjusted.

It is not recommended to take this medicine while breastfeeding or if you plan to breastfeed.

Driving and using machines

This medicine alone does not cause hypoglycemia (low blood glucose levels). 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, or 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 Vir

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist.

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

Recommended dose

Children aged 10 years and older and adolescents usually start with 500 mg or 850 mg of metformin once daily. The maximum daily dose is 2000 mg, divided into 2 or 3 doses. Treatment of children between 10 and 12 years of age is recommended only under specific advice from your doctor, as clinical experience in this patient group is limited.

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

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

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

Monitoring

• Your doctor will regularly perform blood glucose tests and adjust your dose of metformin 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 elderly.
• Your doctor will also check your kidney function at least once a year. You may need more frequent checks if you are elderly or if your kidneys do not function properly.

How to take Metformina Vir

Take metformin with meals or immediately after meals. This will help prevent gastrointestinal side effects. Do not chew or crush 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).

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

If you take more Metformina Vir than you should

If you have taken more metformin than you should, you may develop lactic acidosis. Symptoms of lactic acidosis are nonspecific and may include vomiting, stomach pain (abdominal pain) with cramps, a general feeling of discomfort with severe fatigue, and difficulty breathing. Additional symptoms may include a decrease in body temperature and heart rate. If you experience any of these symptoms, you must seek immediate medical attention, as lactic acidosis can lead to coma. Stop taking this medicine immediately and contact your doctor or the nearest hospital right away.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Metformina Vir

Do not take a double dose to make up for missed doses. Take the next dose at the usual time. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The following side effects may occur:

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

Very common side effects (affects more than 1 in 10 people):

• gastrointestinal problems such as nausea, vomiting, diarrhoea, stomach pain (abdominal pain), and loss of appetite. These side effects occur most frequently at the beginning of treatment with metformin. Spreading the doses throughout the day and taking metformin during or immediately after a meal may help reduce these side effects. If symptoms persist, stop taking this medicine and consult your doctor.

Common side effects (affects less than 1 in 10 people):

• changes in taste sensation.

Very rare side effects (affects less than 1 in 10,000 people):

• lactic acidosis. This is a very rare but serious complication, especially if your kidneys are not working properly. The symptoms of lactic acidosis are nonspecific (see section “Warnings and precautions”).
• abnormalities in liver function tests or hepatitis (liver inflammation; this may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this occurs, stop taking this medicine and speak to your doctor.
• skin reactions such as redness of the skin (erythema), itching, or itchy rash (urticaria).
• low blood levels of vitamin B12.

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 of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Metformin Vir

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging, following "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and other information

Composition of Metformina Vir

• The active substance is metformin hydrochloride. One film-coated tablet of Metformina Vir contains 1000 mg of metformin hydrochloride, equivalent to 780 mg of metformin base.
• The other components (excipients) are: povidone K90, magnesium stearate, hypromellose, macrogol 400 and macrogol 6000.

Appearance of the medicinal product and contents of the pack

Metformina Vir is presented as film-coated tablets, white-yellow in colour, oval and biconvex, marked with "MC" on one side and a score line on the other.

Blister packs (PVC/PVdC Aluminium) containing 30 and 50 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Manufacturer

SAG MANUFACTURING S.L.U.

Carretera Nacional I, Km 36

San Agustin de Guadalíx 28750

Madrid, Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

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

Detailed and up-to-date information about this medication is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.