Metformin Vitabalans

Leaflet accompanying the packaging: patient information

Metformin Vitabalans, 500 mg, film-coated tablets

Metformin Vitabalans, 1000 mg, film-coated tablets

Metformin hydrochloride

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult a doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If any of the side effects get worse, or if you notice any not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Metformin Vitabalans and what is it used for
• 2. Important information before taking Metformin Vitabalans
• 3. How to take Metformin Vitabalans
• 4. Possible side effects
• 5. How to store Metformin Vitabalans
• 6. Contents of the packaging and other information

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

Metformin Vitabalans contains metformin, a substance used to treat diabetes. It belongs to a group of medicines called biguanides. Insulin is a hormone produced in the pancreas that allows the body to use glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for later use. In diabetic patients, the pancreas does not produce enough insulin or the body is unable to use the produced insulin properly. This leads to an increase in blood glucose levels. Metformin Vitabalans helps to reduce blood glucose levels to as close to normal as possible.

In adults with overweight, long-term use of Metformin Vitabalans also helps to reduce the risk of complications associated with diabetes. The use of Metformin Vitabalans is associated with both weight maintenance and a slight weight loss.

Metformin Vitabalans is used:

to treat type 2 diabetes when diet and physical exercise alone cannot achieve proper blood glucose control. It is used especially in patients with overweight.

Adults can take Metformin Vitabalans alone or with other anti-diabetic medicines (oral or insulin).

Children aged 10 and above and adolescents can take Metformin Vitabalans alone or with insulin.

2. Important information before taking Metformin Vitabalans

When not to take Metformin Vitabalans

• if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6);
• if you have significantly reduced kidney function;
• if you have liver disease;
• if you have uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or a fruity odor from the mouth.
• if your body is dehydrated due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney dysfunction, which can cause lactic acidosis (see "Warnings and precautions" below);
• if you have a severe infection, such as pneumonia, bronchitis, or kidney infection. Severe infections can cause kidney dysfunction, which can lead to lactic acidosis (see "Warnings and precautions" below);
• if you are being treated for heart failure or have recently had a heart attack, have severe circulatory disorders (stroke) or breathing difficulties. They can cause inadequate oxygen supply to tissues, which can increase the risk of lactic acidosis (see "Warnings and precautions" below);
• in case of excessive alcohol consumption.

If any of the above situations apply to you, you should consult your doctor before starting treatment.

You should consult your doctor if:

• you need to undergo tests, such as radiological examination (X-ray) or coronary angiography, which require the introduction of contrast agents containing iodine into the bloodstream.
• you are going to undergo major surgery.

You should stop taking Metformin Vitabalans for a while before the test and after the test, as well as before and after surgery. Your doctor will decide whether you need to use another treatment during this time. It is essential to follow your doctor's recommendations.

Warnings and precautions

Risk of lactic acidosis

Metformin Vitabalans may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis increases in case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more information below), liver dysfunction, and any conditions in which a part of the body is not adequately supplied with oxygen (e.g., acute severe heart disease).

If any of the above circumstances apply to you, you should consult your doctor for more detailed instructions.

You should temporarily stop taking Metformin Vitabalans if you have

a condition that may be associated with dehydration(significant water loss from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. You should consult your doctor for more detailed instructions.

You should stop taking Metformin Vitabalans and immediately contact your doctor or the nearest hospital if you experience any symptoms of

lactic acidosis, as it can lead to coma.

Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general poor condition with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.

If you are going to have major surgery, you should not take Metformin Vitabalans during and for some time after surgery. Your doctor will decide when you should stop and resume treatment with Metformin Vitabalans.

Metformin Vitabalans does not cause hypoglycemia (low blood sugar). However, if Metformin Vitabalans is used in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, and meglitinides), there is a risk of hypoglycemia. If hypoglycemia symptoms occur, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, eating or drinking a sugary drink usually helps.

During treatment with Metformin Vitabalans, your doctor will monitor your kidney function at least once a year or more often if you are elderly and/or have impaired kidney function.

Metformin Vitabalans and other medicines

If you are going to be injected with a contrast agent containing iodine into your bloodstream, for example, for an X-ray examination or computed tomography, you should stop taking Metformin Vitabalans before or at the latest at the time of injection. Your doctor will decide when you should stop and resume treatment with Metformin Vitabalans.

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood glucose monitoring and kidney function tests or dose adjustments of Metformin Vitabalans by your doctor. It is especially important to inform about the following medicines:

• 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 adrenergic receptor agonists, such as salbutamol or terbutaline (used to treat asthma),
• corticosteroids (used to treat various diseases, such as severe skin inflammation or asthma),
• medicines that may change the level of Metformin Vitabalans in the blood, especially if you have impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other medicines used to treat diabetes.

Using Metformin Vitabalans with alcohol

You should avoid consuming excessive amounts of alcohol while taking Metformin Vitabalans, as it may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, so your doctor can change your treatment.

During pregnancy, diabetes should be treated with insulin. You should not take Metformin Vitabalans during breastfeeding or if you plan to breastfeed.

Driving and using machines

Metformin Vitabalans itself does not cause hypoglycemia (low blood sugar). This means it does not affect your ability to drive or use machines.

However, if Metformin Vitabalans is used in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, and meglitinides), you should be careful. Symptoms of hypoglycemia include weakness, dizziness, excessive sweating, rapid heartbeat, vision disturbances, or difficulty concentrating. You should not drive or use machines if you experience these symptoms.

3. How to take Metformin Vitabalans

You should always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Metformin Vitabalans cannot replace the benefits of a healthy lifestyle. You should follow your doctor's recommendations regarding diet and regularly exercise.

Recommended dose

For adults, the usual starting dose is 500 mg of Metformin Vitabalans 2-3 times a day. The maximum daily dose is 1000 mg in 3 divided doses.

For children over 10 years and adolescents, the usual starting dose is 500 mg of Metformin Vitabalans once a day. Use in children aged 10-12 is possible only on special recommendation by a doctor, as experience with the use of the medicine in this age group is limited.

If you are taking insulin, your doctor will inform you how to start taking Metformin Vitabalans.

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

Control

• Your doctor will adjust the dose of Metformin Vitabalans based on your blood glucose levels, according to the results of regular blood glucose tests. You should regularly consult your doctor. This is especially important for children and adolescents, as well as the elderly.
• Your doctor will check your kidney function at least once a year. More frequent checks may be necessary for the elderly or patients with impaired kidney function.

How to take Metformin Vitabalans

Metformin Vitabalans tablets should be taken during or after a meal. This will help avoid gastrointestinal side effects.

Do not crush or chew the tablets. Swallow each tablet with a glass of water.

• If you take one dose a day, take it in the morning (with breakfast).
• If you take two divided doses a day, take them in the morning (with breakfast) and in the evening (with dinner).
• If you take three divided doses a day, take them in the morning (with breakfast), at noon (with lunch), and in the evening (with dinner).

If after some time you feel that the effect of Metformin Vitabalans is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of Metformin Vitabalans than recommended

If you take a higher dose of Metformin Vitabalans than recommended, lactic acidosis may occur. Symptoms of lactic acidosis include vomiting, abdominal pain with muscle cramps, general poor condition with severe fatigue, and breathing difficulties. If such symptoms occur, you should immediately contact your doctor or the nearest hospital, as lactic acidosis can lead to coma.

Missing a dose of Metformin Vitabalans

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

Stopping treatment with Metformin Vitabalans

Your doctor will inform you how long you should take metformin. If you suddenly stop therapy, symptoms may recur. Do not stop taking the medicine without consulting your doctor or pharmacist first.

If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Metformin Vitabalans can cause side effects, although not everybody gets them.

The following side effects may occur:

Metformin Vitabalans may very rarely (may affect up to 1 in 10,000 people) cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, you should stop taking Metformin Vitabalans and immediately contact your doctor or the nearest hospital, as lactic acidosis can lead to coma.

Very common (affects more than 1 in 10 people)

• gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These side effects usually occur at the beginning of treatment with Metformin Vitabalans. You can prevent them by taking the medicine in several doses during the day with a meal or immediately after it. If the symptoms do not disappear, you should stop taking Metformin Vitabalans and consult your doctor.

Common (affects 1 to 10 people in 100)

• taste disorders

Very rare (affects less than 1 in 10,000 people)

• lactic acidosis. This is a very rare but serious complication, especially when the kidneys do not work properly. The symptoms of lactic acidosis are non-specific (see "Warnings and precautions").
• abnormal liver function test results or hepatitis (which can cause fatigue, loss of appetite, weight loss, accompanied by yellowing of the skin and whites of the eyes or without this symptom). If such symptoms occur, you should stop taking the medicine and consult your doctor.
• skin reactions, such as redness, itching, or hives.
• decreased vitamin B12 levels in the blood.

Additional side effects in children and adolescents

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

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist, or nurse. You can report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, PL-02 222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website https://smz.ezdrowie.gov.pl.

You can also report side effects to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metformin Vitabalans

You should keep this medicine out of the sight and reach of children. If Metformin Vitabalans is given to children, parents or caregivers should control the amount of medicine taken by children.

Do not use this medicine after the expiry date stated on the packaging or carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Metformin Vitabalans contains

Metformin Vitabalans 500 mg: Each tablet contains 500 mg of metformin hydrochloride, which corresponds to 390 mg of metformin.

Metformin Vitabalans 1000 mg: Each tablet contains 1000 mg of metformin hydrochloride, which corresponds to 780 mg of metformin.

The active substance of the medicine is metformin.

Other ingredients are: microcrystalline cellulose, povidone (K 29-32), colloidal anhydrous silica, magnesium stearate, polydextrose, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Metformin Vitabalans looks like and contents of the pack

What Metformin Vitabalans looks like:

Metformin Vitabalans 500 mg: White, convex tablet in the shape of a capsule with a dividing line, measuring 7.5 x 18 mm.

Metformin Vitabalans 1000 mg: White, convex tablet in the shape of a capsule with a dividing line, measuring 10 x 21 mm.

The tablet can be divided into two equal doses.

Pack sizes:

30, 60, 100, and 200 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

FINLAND

Tel: +358 (3) 615600

Fax: +358 (3) 6183130

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Metformin Vitabalans (Czech Republic, Denmark, Estonia, Finland, Lithuania, Latvia, Norway, Poland, Slovakia, Slovenia, Sweden, Hungary).

Date of last revision of the leaflet: 2022-10-06