Metformin Tarbis 850 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Metformina Tarbis 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, and you should 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.

Leaflet contents:

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

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

What Metformina Tarbis is

Metformina Tarbis 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.

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

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

What Metformina Tarbis is used for

Metformina Tarbis 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 Tarbis alone or in combination with other antidiabetic medicines (oral medications or insulin).

Children aged 10 years and older, and adolescents, may take Metformina Tarbis alone or together with insulin.

2. What you need to know before taking Metformin Tarbis

Do not take Metformin Tarbis

• If you are allergic 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, which may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or breath developing an unusual fruity odor.
• If you have lost too much 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 "Take special care with Metformin Tarbis").
• If you have a serious infection, for example, an infection affecting your lungs, bronchi, or kidneys. Serious infections may trigger kidney problems, which could put you at risk of developing lactic acidosis (see "Take special care with Metformin Tarbis").
• If you are being treated for heart failure or have recently had a heart attack, if you have serious circulation problems (such as shock), or if you have difficulty breathing. This may result in tissue hypoxia (lack of oxygen in tissues), which could put you at risk of developing lactic acidosis (see "Take special care with Metformin Tarbis").
• If you drink large amounts of alcohol.
• If you are breastfeeding.

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 injection into the bloodstream of iodine-containing contrast agents.
• You require major surgery.

You must stop taking Metformin Tarbis 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 Tarbis.

Risk of lactic acidosis

Metformin Tarbis may cause a very rare but very 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, serious 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 diseases).

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

Stop taking Metformin Tarbis temporarily if you develop a condition 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 usual. Consult your doctor for further instructions.

Stop taking Metformin Tarbis 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 malaise with profound 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 genetic 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 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 deafness.

Metformin Tarbis alone does not cause hypoglycemia (blood glucose level too low). However, if you take Metformin Tarbis together with other diabetes medications that can cause hypoglycemia (such as sulfonylureas, insulin, or glinides), 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.

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

During treatment with Metformin Tarbis, 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 deteriorating.

Taking Metformin Tarbis with other medicines

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

Inform your doctor 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 the dose of Metformin Tarbis. It is especially important to mention the following:

• Medications that increase urine production (diuretics)
• Medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• Certain medicines for treating 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)

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Taking Metformin Tarbis with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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.

Do not take this medicine if you are breastfeeding or plan to breastfeed your baby.

Driving and using machines

Metformin Tarbis 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 Tarbis together with other diabetes medications that may cause hypoglycemia (such as sulfonylureas, insulin, glinides). 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 Tarbis

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

Metformina Tarbis 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 Metformina Tarbis 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 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 Metformina Tarbis, two or three times daily. The maximum daily dose is 3000 mg, divided into three doses.

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

If you are also using insulin, your doctor will advise you on how to start taking Metformina Tarbis.

Monitoring

• Your doctor will adjust your dose of Metformina Tarbis 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 at least once a year how well your kidneys are working.
  You may need more frequent checks if you are elderly or if your kidneys do not function normally.

How to take Metformina Tarbis

Take Metformina Tarbis 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 Metformina Tarbis is too strong or too weak, consult your doctor or pharmacist.

The score line on the tablet is only intended to help you divide the tablet if you have difficulty swallowing it whole.

If you take more Metformina Tarbis than you should

If you have taken more Metformina Tarbis than you should, you may develop lactic acidosis. Symptoms of lactic acidosis include vomiting, stomach pain (abdominal pain) with cramps, a general feeling of malaise with severe fatigue, and difficulty breathing. If this happens to you, you may require immediate hospital treatment, as lactic acidosis can lead to coma. Contact a doctor or the nearest hospital immediately. In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20, and state the amount ingested.

If you forget to take Metformina Tarbis

Do not take a double dose to make up for the missed dose. Take your 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 will experience them. The following adverse effects may occur:

Metformina Tarbis 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 Metformina Tarbis and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Very common adverse effects (affects 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 Metformina Tarbis. It helps to spread the doses throughout the day and to take Metformina Tarbis during or immediately after a meal. If symptoms persist, stop taking Metformina Tarbis and consult your doctor.

Common adverse effects (affects between 1 and 10 in 100 people):

• Changes in taste sensation.

Very rare adverse 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 functioning properly. The symptoms of lactic acidosis are non-specific (see section “Warnings and precautions”).
• Skin reactions such as redness of the skin (erythema), itching, or an itchy rash (urticaria).
• Low blood levels of vitamin B12.

Frequency of the following adverse effects is unknown:

• Abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking this medicine.

Children and adolescents

Limited data in children and adolescents showed that adverse effects were similar in nature and severity to those observed in adults.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult 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 Tarbis

Keep this medicine out of the sight and reach of children. If a child is being treated with Metformin Tarbis, 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 returned to the SIGRE collection point at your pharmacy. If in doubt, please ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metformina Tarbis

• The active substance is metformin hydrochloride. Each coated tablet contains 850 mg of metformin hydrochloride, equivalent to 662.9 mg of metformin base.
• The other components are hypromellose (15000 mPas), povidone K 25, magnesium stearate, hypromellose (5 mPas), macrogol 6000 and titanium dioxide (E171).

Appearance of the product and pack contents

Metformina Tarbis 850 mg are white, oblong tablets, scored on both sides.

Metformina Tarbis 850 mg is available in packs of 50 and 60 film-coated tablets.

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32, 2252TR Voorschoten,

The Netherlands

Date of the most recent revision of this leaflet: May 2025.

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