Prospect: information for the user

Metformina Aurovitas 850 mg film-coated tablets EFG

hydrochloride of metformin

Read this prospect carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to other people 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 prospect.See section 4.

1.What isMetformina Aurovitasand for what it is used

2.What you need to know before starting to takeMetformina Aurovitas

3.How to takeMetformina Aurovitas

4.Possible adverse effects

5Storage ofMetformina Aurovitas

6.Contents of the package and additional information

Metformina Aurovitascontains 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 high levels of glucose in the blood. Metformin helps to reduce your blood glucose levels to as normal a level as possible.

If you are an adult with obesity, taking metformin for a prolonged period also helps to reduce the risk of complications associated with diabetes.Metforminis associated with maintaining body weight or a slight decrease in it.

Metforminis used to treat patients with type 2 diabetes (also known as “non-insulin-dependent diabetes”) when diet and exercise alone are not sufficient to control their blood glucose levels. It is used especially in patients with obesity.

Adults can takemetforminalone or with other medications for treating diabetes (oral medications or insulin).

Children aged 10 years and older and adolescents can takemetforminalone or with insulin.

Do not take Metformina Aurovitas:

• If you are allergic to metformin or any of the other components of this medication (listed in section6).
• If you have liver problems.
• If you have severe kidney function reduction.
• If you have uncontrolled diabetes with, 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 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 a lot of water from your body (dehydration), for example, due to prolonged or intense 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 acute heart failure or 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 tissue hypoxia, which can put you at risk of developing lactic acidosis (see below “Warnings and precautions”).
• If you drink a lot of alcohol.

If any of the above circumstances apply to you, consult your doctor before starting to take this medication.

Make sure to consult your doctor if

• You need an examination such as an X-ray or a scan that involves the injection of contrast media containing iodine into your bloodstream.
• You need a major surgical intervention.

You should stop taking metformin for a certain period of time before and after the examination or surgical intervention. Your doctor will decide if you need any other treatment during this time. It is essential to 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 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 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 condition associated with dehydration(significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat, or if you drink less than normal. 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 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.

Consult your doctor quickly to determine how to proceed if:

• You know you have a genetic disorder that affects the mitochondria (the components that produce energy inside cells), such as MELAS syndrome (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes) or maternal diabetes and hearing loss (MIDD).
• You experience any of the following symptoms after starting treatment with metformin: convulsions, cognitive decline, difficulty with motor movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

If you need to undergo a major surgical procedure, stop taking metformin during the procedure and for a period of time afterwards. Your doctor will decide when to interrupt metformin treatment and when to resume it.

Metforminby itself does not cause hypoglycemia (low blood glucose). However, if you takemetforminalong 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, visual disturbances, or difficulty concentrating, it is usually helpful to eat or drink something containing sugar.

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 deteriorating.

Other medications and Metformina Aurovitas

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

Inform your doctor or pharmacist if you are taking, have taken recently, 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. 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 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, or olaparib).
• Other medications used to treat diabetes.

Use of Metformina Aurovitas with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

Metformin by itself does not cause hypoglycemia (low blood glucose). This means it will not affect your ability to drive or operate machinery.

However, be cautious if you takemetforminalong with other diabetes medications that can cause hypoglycemia (such as sulfonylureas, insulin, or meglitinides). The symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, visual disturbances, or difficulty concentrating. Do not drive or operate machinery if you start to feel these symptoms.

Followexactly theadministration instructionsfor this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Metformin cannot replace the benefits of a healthy lifestyle. Continuefollowing any dietary advice given by your doctor and practice regular exercise.

Recommended Dose

Children aged 10 years and older and adolescentsusually start with 500 mg or 850 mg of metformin once a day. The maximum daily dose is 2,000 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.

Adultsusually start with 500 mg or 850 mg ofmetformin,twice or three times a day. The maximum daily dose is 3,000 mg divided into 3 doses.

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

If insulin is also administered, your doctor will instruct you on how to start takingmetformin.

Monitoring

• Your doctor will perform regular blood glucose tests and adjust your metformin dose according to your blood glucose levels. 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 your kidneys are functioning. You may need more frequent checks if you are an elderly person or if your kidneys do not function normally.

How to take Metformin Aurovitas

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

• 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).

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

If you take more Metformin Aurovitas than you should

If you have taken moremetforminthan you should, you may experience lactic acidosis. The symptoms of lactic acidosis are nonspecific such as vomiting, stomach pain (abdominal pain) with nausea, a general feeling of discomfort with intense fatigue and difficulty breathing. Additional symptoms may be 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 immediately.

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

If you forgot to take Metformin Aurovitas

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

If you have any other questions about the use ofthismedication, ask your doctor or pharmacist.

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.The followingside effects may occur:

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

Very common side effects (affecting 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 beginning of treatment withmetformin. Taking metformin during or immediately after a meal and dividing the doses throughout the day may help reduce these side effects.If symptoms persist, stop takingmetforminand consult your doctor.

Common side effects (affecting 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.

Rare side effects (affecting up to 1 in 10,000 people):

• Lactic acidosis. This is a rare but serious complication, especially if your kidneys do not function properly. The symptoms of lactic acidosis are non-specific (see section “Warnings and precautions”).
• Abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause fatigue, loss of appetite, weight loss, with or without yellow discoloration of the skin or the white 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 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 Pharmacovigilance 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.

If a child is being treated withmetformina, parents and caregivers are advised to supervise how this medication is used.

This medication does not require special storage conditions.

Do not usethis medicationafter the expiration date that appears on the box and the blister pack after “CAD”. The expiration date is the last day of the month indicated.

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

Composition ofMetformina Aurovitas

• The active ingredient is hydrochloride of metformin.

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

• The other components (excipients) are:

Core:povidone, magnesium stearate.

Coating: hypromellose, macrogol.

Appearance of the product and contents of the packaging

Film-coated tablets, white in color, biconvex, oval in shape, with a groove separating the marks “I” and “92” on one face.

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

Packaging sizes:50 and 500 (clinical packaging) film-coated tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

Last revision date of thisleaflet:February 2025

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