METFORMIN TARBIS 850 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Metformin Tarbis 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 signs of illness are the same as yours.
• If you get 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 pack and other information

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

5. Storage of Metformin Tarbis

1. Contents of the pack and further information

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

What is Metformin Tarbis

Metformin 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 makes your body take 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 causes a high concentration of glucose in the blood.

Metformin Tarbis helps to reduce your blood glucose to as normal a level as possible.

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

What is Metformin Tarbis used for

Metformin Tarbis 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 Tarbis alone or with other medicines to treat diabetes (oral medicines or insulin).

Children aged 10 years and older, and adolescents can take Metformin Tarbis alone or with insulin.

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

Do not take Metformin Tarbis

• 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 too much 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 "Be careful with Metformin Tarbis").
• 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 "Be careful with Metformin Tarbis").
• If you are receiving treatment for 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 oxygen in the tissues, which can put you at risk of developing lactic acidosis (see "Be careful with Metformin Tarbis").
• If you drink a lot of alcohol.
• If you are breastfeeding.

If any of the above circumstances apply 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 a major surgical intervention.

You should stop taking Metformin Tarbis for a certain period before and after the examination or surgical intervention. 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 Tarbis.

Risk of lactic acidosis

Metformin Tarbis 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 Tarbis 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 Tarbis and contact a doctor or the nearest hospital immediately if you experience any of the symptoms that produce lactic acidosis, 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

reduction of body temperature and heart rate

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

Consult your doctor quickly so that he can indicate how to proceed 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 present any of the following symptoms after starting treatment with metformin: seizure, cognitive impairment, difficulty with body movements, symptoms indicative of nerve damage (e.g., pain or numbness), migraine, and deafness.

Metformin Tarbis alone does not cause hypoglycemia (a concentration of glucose in the blood that is too low). However, if you take Metformin Tarbis with other diabetes medicines 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 disorders, or difficulty concentrating, it is usually helpful to eat or drink something that contains sugar.

If you need to undergo major surgery, you should stop taking Metformin Tarbis while the procedure is being performed and for a period after it. Your doctor will decide when you should stop taking Metformin Tarbis and when you can restart it.

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

Use of Metformin Tarbis with other medicines

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

Tell your doctor 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 the dose of Metformin Tarbis. 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).

Tell your doctor or pharmacist if you are using or have recently used 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 can increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy, breastfeeding, and fertility

During pregnancy, you need insulin to treat the diabetes you have. Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, so that your treatment can be changed.

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 (a concentration of glucose in the blood that is too low). This means that it will not affect your ability to drive or use machines.

However, be careful if you take Metformin Tarbis with other diabetes medicines that can cause hypoglycemia (such as sulfonylureas, insulin, glinides). The symptoms of hypoglycemia include weakness, dizziness, increased sweating, increased heart rate, vision disorders, or difficulty concentrating. Do not drive or use machines if you start to feel these symptoms.

3. How to take Metformin Tarbis

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Usual dose

Children aged 10 years and older and adolescents usually start with 500 mg or 850 mg of Metformin Tarbis 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 Tarbis, 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 you are also using insulin, your doctor will tell you how to start taking Metformin Tarbis.

Monitoring

• Your doctor will adjust your dose of Metformin Tarbis 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.

You may need more frequent checks if you are an elderly person or if your kidneys are not working normally.

How to take Metformin Tarbis

Take Metformin Tarbis with meals or after meals. This will prevent you from suffering from side effects that affect your digestion. Do not chew or crush the tablets. Swallow each tablet with a glass of water.

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

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

If you take more Metformin Tarbis than you should

If you have taken more Metformin Tarbis than you should, you may suffer from lactic acidosis. The symptoms of lactic acidosis are vomiting, stomach pain (abdominal pain) with cramps, a feeling of discomfort with intense fatigue, and difficulty breathing. If this happens to you, you may need immediate treatment in a hospital, as lactic acidosis can lead to a coma. Contact a doctor or the nearest hospital immediately. In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91 562 04 20 and indicate the amount ingested.

If you forget to take Metformin Tarbis

Do not take a double dose to make up for the forgotten dose. Take the next dose at the usual time.

If you have any other 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 Tarbis can cause a very rare but very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this happens to you, you must stop taking Metformin Tarbis and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to a 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 start of treatment with Metformin Tarbis. It helps to spread the doses throughout the day and if you take Metformin Tarbis during or immediately after a meal. If the symptoms continue, stop taking Metformin Tarbis and consult your doctor.

Common side effects (affecting between 1 and 10 in 100 people):

• Changes in taste.

Very rare side effects (affecting less than 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 section "Warnings and precautions").
• Skin reactions such as skin redness (erythema), itching, or an itchy rash (urticaria).
• Low vitamin B12 levels in the blood.

The frequency of the following side effects is not known:

• 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 this medicine.

Children and adolescents

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

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them 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. Storage of Metformin Tarbis

Keep this medicine out of the sight and reach of children. If a child is being treated with Metformin Tarbis, it is recommended that parents and caregivers supervise how this medicine is used.

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Metformina Tarbis

• The active ingredient is metformin hydrochloride. Each coated tablet contains 850 mg of metformin hydrochloride, corresponding 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 Container Content

Metformina Tarbis 850 mg are white, oblong tablets with a score line on both sides.

Metformina Tarbis 850 mg is presented in containers of 50 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,

Netherlands

Date of the Last Revision of this Leaflet: May 2025.

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