Prospect: information for the user

Metformina Tarbis 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.

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

2.What you need to know before starting to take Metformina Tarbis

3.How to take Metformina Tarbis

4.Possible adverse effects

5Storage of Metformina Tarbis

6.Contents of the package and additional information

What is Metformina Tarbis

Metformina Tarbis contains 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 a high concentration of glucose in the blood.

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

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

What is Metformina Tarbis used for

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

Adults can take Metformina Tarbis alone or with other diabetes medications (oral medications or insulin).

Children aged 10 years and older, and adolescents can take Metformina Tarbis alone or accompanied by insulin.

Do not take Metformina 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 a severe reduction in kidney function.
• If you have uncontrolled diabetes, for example, with severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Ketoacidosis is a condition 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 too much 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 "Be careful with Metformina Tarbis").
• 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 "Be careful with Metformina Tarbis").
• If you are receiving treatment for heart failure or have recently had a heart attack, if you have severe circulation problems (such as shock) or difficulty breathing. This can lead to tissue hypoxia, which can put you at risk of developing lactic acidosis (see "Be careful with Metformina 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 the injection of a contrast medium containing iodine into your bloodstream.
• You need a major surgical intervention.

You should stop taking Metformina 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 essential to follow your doctor's instructions precisely.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Metformina Tarbis.

Risk of lactic acidosis

Metformina Tarbis may 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 "Be careful with Metformina Tarbis"), liver problems, and any medical condition in which a part of the body has a reduced oxygen supply (such as acute and severe heart disease).

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

Stop taking Metformina Tarbis for a short period if you have a condition that may be associated with dehydration(significant loss of body fluids), such as intense vomiting, diarrhea, fever, exposure to heat, or if you drink less liquid than normal. Consult your doctor for further instructions.

Stop taking Metformina Tarbis 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.

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

If you need to undergo a major surgical procedure, you should stop taking Metformina Tarbis while the procedure is being performed and for a period after it. Your doctor will decide when to interrupt treatment with Metformina Tarbis and when to restart it.

During treatment with Metformina Tarbis, 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.

Use of Metformina Tarbis with other medicines

If you need to receive an injection of a contrast medium containing iodine into your bloodstream, for example, in the context of an X-ray or a scan, you should stop taking Metformina Tarbis before the injection or at the time of the injection. Your doctor will decide when to interrupt treatment with Metformina Tarbis and when to restart it.

Inform your doctor 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 Metformina Tarbis. It is especially important to mention the following:

• Diuretics that increase urine production
• 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).

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

Taking Metformina Tarbis with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

During pregnancy, you need insulin to treat your diabetes. Inform 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 operating machinery

Metformina Tarbis itself does not cause hypoglycemia (low blood sugar). This means it will not affect your ability to drive or operate machinery.

However, be careful if you take Metformina Tarbis with other diabetes medications that can cause hypoglycemia (such as sulfonylureas, insulin, or glinides). 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.

Follow exactly the administration instructions of this medication as 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 following any dietary advice given by your doctor and practice regular exercise.

Usual Dose

Children 10 years of age or 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 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 Metformin Tarbis, two or three times a day. The maximum daily dose is 3000 mg divided into three doses.

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

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

Monitoring

• Your doctor will adjust your Metformin Tarbis 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 an elderly person.

• Your doctor will also check, at least once a year, how your kidneys are functioning.

You may need more frequent check-ups if you are an elderly person or if your kidneys do not function normally.

How to Take Metformin Tarbis

Take Metformin Tarbis 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.

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

The groove is only for breaking the tablet if it is difficult for you 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 experience 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 the hospital, as lactic acidosis can lead to coma. Contact a doctor or the nearest hospital immediately. In case of overdose or accidental ingestion, consult the Toxicological 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 compensate for the missed dose. Take the next dose at the usual time.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The following side effects may occur:

Metformin Tarbis may cause a very rare but serious side effect called lactic acidosis (see "Warnings and precautions" section). If this happens to you,you should stop taking Metformin Tarbis 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 with Metformin Tarbis. Help distribute the doses throughout the day and if you take Metformin Tarbis during or immediately after a meal.If symptoms persist, 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 rare but serious complication, especially if your kidneys do not function properly. The symptoms of lactic acidosis are non-specific (see "Warnings and precautions" section).

•Skin reactions such as skin redness (erythema), itching or a pruritic rash (urticaria).

•Low levels of vitamin B12 in the blood.

The frequency of the following side effects is unknown:

•Abnormal liver function test results or hepatitis (inflammation of the liver; this can cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or the white of the eyes). If this happens to you,stop taking this medicine.

Children and adolescents

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

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 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 with Metformina Tarbis, parents and caregivers are advised to supervise how this medication is used.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging, 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 point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Metformina Tarbis

• The active ingredient is hydrochloride of metformin. Each coated tablet contains 850 mg of hydrochloride of metformin, 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 content of the container

Metformina Tarbis 850 mg are white, oblong tablets with a notch on both faces.

Metformina Tarbis 850 mg is presented in containers of 50 coated tablets.

Holder of the marketing authorization

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32 2252TR Voorschoten,

Netherlands

Date of the last review of this leaflet: May 2017.

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