METFORMIN AUROVITAS 850 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Metformin Aurovitas 850 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 symptoms are the same as yours.
• If you experience 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 Package Leaflet

1. What is Metformin Aurovitas and what is it used for
2. What you need to know before you take Metformin Aurovitas
3. How to take Metformin Aurovitas
4. Possible side effects

5 Conservation of Metformin Aurovitas

1. Contents of the pack and further information

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

Metformin Aurovitas contains metformin, 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 high levels of glucose in the blood. Metformin helps reduce your blood glucose to as normal a level as possible.

If you are an adult with overweight, taking metformin for a long time also helps reduce the risk of complications associated with diabetes. Metformin is associated with maintaining body weight or a slight decrease in body weight.

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

Adults can take metformin alone or with other medicines to treat diabetes (oral medicines or insulin).

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

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

Do not take Metformin Aurovitas:

• 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 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 a pre-diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or an unusual fruity odor in your breath.
• If you have lost a lot of 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 acute 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 lead to a lack of oxygenation in the tissues, which can put you at risk of developing lactic acidosis (see "Warnings and precautions" below).
• If you drink a lot of alcohol.

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

Make sure to consult your doctor if

• you need an examination such as an X-ray or a scan that involves injecting a contrast medium into your blood that contains iodine.
• you need major surgery.

You should stop taking metformin for a certain period before and after the examination or surgery. Your doctor will decide if you need any other treatment during this time. It is important that you follow your doctor's instructions precisely.

Warnings and precautions

Consult your doctor or pharmacist before starting to take metformin.

Risk of lactic acidosis

Metformin can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys do not work 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 disorder in which a part of the body has a 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 for a short period if you have a disorder 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 and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that lactic acidosis produces, as this disorder can lead to a coma.

The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• general feeling of discomfort, with intense fatigue
• difficulty breathing
• decrease in 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 disorder 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 experience any of the following symptoms after starting treatment with metformin: seizure, cognitive impairment, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

If you need to undergo major surgery, you should stop taking metformin during the procedure and for a period after it. Your doctor will decide when you should stop taking metformin and when you can restart it.

Metformin alone does not cause hypoglycemia (a concentration of glucose in the blood 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.

During treatment with metformin, your doctor will check your kidney function regularly, at least once a year, or more frequently if you are an elderly person and/or if your kidney function is worsening.

Other medicines and Metformin Aurovitas

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

Tell your doctor or pharmacist 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 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 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 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 used to treat diabetes.

Using Metformin Aurovitas with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines

Metformin alone does not cause hypoglycemia (a level of glucose in the blood that is too low). This means it will not affect your ability to drive or use machines.

However, be 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 not drive or use machines if you start to feel these symptoms.

3. How to take Metformin Aurovitas

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist again.

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 a day. The maximum daily dose is 2000 mg divided into 2 or 3 doses. 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.

Adults usually start with 500 mg or 850 mg of metformin, 2 or 3 times a day. 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 given, your doctor will tell you how to start taking metformin.

Monitoring

• Your doctor will regularly perform blood glucose tests and adjust your metformin dose according to your blood glucose levels. 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, or more frequently if you are an elderly person or if your kidney function is not normal.

How to take Metformin Aurovitas

Take metformin with meals or after meals. This will prevent you from experiencing side effects that affect your digestion. Do not chew or crush the tablets. Swallow each tablet with a glass of water. The tablet can be divided into equal doses.

• 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).

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

If you take more Metformin Aurovitas 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 cramps, a general feeling of discomfort with intense fatigue, and difficulty breathing. Additional symptoms may include a decrease in body temperature and heart rate. If you experience any of these symptoms, seek medical attention immediately, as lactic acidosis can lead to a coma. Stop taking metformin immediately and contact your doctor or the nearest hospital as soon as possible.

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

If you forget to take Metformin Aurovitas

Do not take a double dose to make up for forgotten 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 everybody gets them. The following side effects may occur:

Metformin can cause a very rare but very serious side effect called lactic acidosis (see "Warnings and precautions" section). If this happens to you, stop taking metformin and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to a 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 start of treatment with metformin. Spreading the doses throughout the day and taking metformin during or immediately after a meal can help reduce these side effects. If the symptoms persist, stop taking metformin and 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, numbness or tingling, or yellowish or pale skin). Your doctor may schedule some tests to find the reason for your symptoms because some of them may be caused by diabetes or other health problems unrelated to this medicine.

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

• Lactic acidosis. It is a very rare but serious complication, especially if your kidneys do not work properly. The symptoms of lactic acidosis are non-specific (see "Warnings and precautions" section).
• 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). If this happens to you, stop taking metformin and talk to your doctor.
• 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 side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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. Conservation of Metformin Aurovitas

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

If a child is being treated with metformin, it is recommended that parents and caregivers supervise how this medicine is used.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Packaging Contents and Additional Information

Composition ofMetformina Aurovitas

• The active ingredient is metformin hydrochloride.

Each film-coated tablet contains 850 mg of metformin hydrochloride, equivalent to 663 mg of metformin.

• The other components (excipients) are:

Core: povidone, magnesium stearate.

Coating: hypromellose, macrogol.

Appearance of the Product and Packaging Contents

Film-coated tablets, white in color, biconvex, oval in shape, with a score line separating the marks "I" and "92" on one side.

Metformina Aurovitas film-coated tablets are available in PVC/PVdC/aluminum and PVC-aluminum foil blister packs, each blister containing 10 film-coated tablets.

Package sizes:50 and 500 (clinical package) film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Date of the Last Revision of thisProspectus:February 2025

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