Metformin Aurovitas 850 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metformina Aurovitas 850 mg film-coated tablets EFG

metformin hydrochloride

Read the entire 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, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

5 Storage of Metformina Aurovitas

1. Contents of the pack and other information

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

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

If you are an overweight adult, taking metformin over a prolonged period also helps reduce the risk of diabetes-related complications. Metformin is associated with weight maintenance or a slight reduction 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 sufficient to control blood glucose levels. It is especially used in overweight patients.

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

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

2. What you need to know before taking Metformina Aurovitas

Do not take Metformina 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 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, which may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or unusual fruity 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 below “Warnings and precautions”).
• If you have a severe infection, for example, an infection affecting your lungs, bronchi, or kidneys. Severe infections may trigger kidney problems, which could put you at risk of developing lactic acidosis (see below “Warnings and precautions”).
• If you are being treated for acute heart failure or have recently had a heart attack, if you have serious circulation problems (such as shock), or if you have breathing difficulties. These conditions may lead to tissue hypoxia (lack of oxygen in tissues), which could 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.

Make sure to consult your doctor if:

• You need an imaging procedure such as an X-ray or scan involving the injection into the bloodstream of iodine-containing contrast media.
• 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

Talk to your doctor or pharmacist before starting metformin.

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 causing reduced oxygen supply to body tissues (such as acute and severe heart disorders).

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

Stop taking metformin temporarily if you develop an illness that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, fever, heat exposure, or if you are drinking less fluid than normal. Consult your doctor for further instructions.

Stop taking metformin 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 promptly for advice if:

• You are known to have a hereditary disease affecting mitochondria (the energy-producing components 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 treatment with metformin: seizures, cognitive decline, movement disorders, 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 treatment with metformin.

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

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

Other medicines and Metformina Aurovitas

If you need to receive an injection of iodine-containing contrast media into your bloodstream, for example during an X-ray or 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 treatment with metformin.

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

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 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.

Use of Metformina Aurovitas with food, drinks, and 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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is not recommended to take this medicine if you are breastfeeding or plan to breastfeed your baby.

Driving and using machines

Metformin alone does not cause hypoglycemia (blood glucose level 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 medicines 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 Metformin Aurovitas

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult 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 daily. The maximum daily dose is 2,000 mg, divided into 2 or 3 doses. Treatment of children between 10 and 12 years of age is only recommended under specific medical advice, 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 3,000 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 perform regular blood glucose tests and adjust your 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 elderly.
• Your doctor will also check how your kidneys are functioning at least once a year. You may need more frequent checks if you are elderly or if your kidneys do not function normally.

How to take Metformin Aurovitas

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. The tablet may be divided into equal doses.

• 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 at night (dinner).
• If you take three doses per day, take them in the morning (breakfast), at midday (lunch), and at night (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 Metformin Aurovitas 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 being unwell 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 metformin 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 at 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 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The following adverse effects may occur:

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

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

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

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

• Changes in taste sensation.
• Low or decreased 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):

• Lactic acidosis. This is a very rare but serious complication, especially if your kidneys are not functioning properly. The symptoms of lactic acidosis are nonspecific (see section “Warnings and precautions”).
• Abnormalities in liver function tests 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). If this occurs, stop taking metformin and speak 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 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, talk to 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Metformin Aurovitas

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.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at the pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Metformina Aurovitas

• The active substance 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 medicinal product and contents of the pack

Film-coated tablets, white in colour, biconvex, oval-shaped, with a score line separating the markings “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.

Pack sizes: 50 and 500 (hospital pack) film-coated tablets.

Only some pack 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 latest revision of the package leaflet: February 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)