Metformin Vitabalans

Leaflet accompanying the packaging: patient information

Metformin Vitabalans, 500 mg, coated tablets

metformin hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please 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 pack 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 by the pancreas that allows the body to use glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for future use. In diabetic patients, the pancreas does not produce enough insulin or the body is unable to use the insulin produced properly. This leads to an increase in blood glucose levels. Metformin Vitabalans helps lower blood glucose levels to as close to normal as possible.
For adults with overweight, long-term use of Metformin Vitabalans also helps reduce the risk of diabetes complications. 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 exercise alone cannot achieve proper blood glucose control. It is particularly used in patients with overweight.
Adults can take Metformin Vitabalans alone or with other anti-diabetic medicines (oral or insulin).
Children aged 10 years and older 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 severely 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 pre-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 cause 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. These conditions can cause inadequate oxygen supply to tissues, which can increase the risk of lactic acidosis (see "Warnings and precautions" below);
• if you consume large amounts of alcohol.

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

• you need to undergo tests such as radiological examinations (X-ray) or coronary angiography that 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 take another treatment during this time. It is essential to follow your doctor's instructions.

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 cases 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, consult your doctor for more detailed instructions.

You should temporarily stop taking Metformin Vitabalans if you have

a condition that may lead to 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. 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 this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.
You should contact your doctor immediately for further instructions if:

• you have a genetically inherited disease affecting mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.
• you experience any of the following symptoms after starting metformin: seizures, decreased cognitive abilities, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

If you are going to have major surgery, you should not take Metformin Vitabalans during or for some time after the surgery. Your doctor will decide when you should stop and restart Metformin Vitabalans treatment.
Metformin Vitabalans does not cause hypoglycemia (low blood sugar). However, if Metformin Vitabalans is taken with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, or meglitinides), there is a risk of hypoglycemia. If you experience symptoms of hypoglycemia, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, eating or drinking something containing sugar usually helps.
During treatment with Metformin Vitabalans, your doctor will check 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 have a contrast agent containing iodine injected 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 restart Metformin Vitabalans treatment.
Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood glucose checks and kidney function tests or a dose adjustment of Metformin Vitabalans by your doctor. It is especially important to inform your doctor about the following medicines:

• diuretics (increasing 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 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 kidney problems (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other medicines used to treat diabetes.

Taking Metformin Vitabalans with alcohol

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

Pregnancy and breastfeeding

Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant, so that your doctor can change your treatment.
During pregnancy, diabetes should be treated with insulin. Do 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 taken with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, or meglitinides), be extremely careful. Symptoms of hypoglycemia include weakness, dizziness, excessive sweating, rapid heartbeat, vision disturbances, or difficulty concentrating. Do not drive or operate machinery if you experience these symptoms.

3. How to take Metformin Vitabalans

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. Follow your doctor's recommendations regarding diet and regular physical 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 years is only possible on the specific recommendation of 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 kidney problems, your doctor may prescribe a lower dose.

Monitoring

• 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 and for people over 65 years.
• Your doctor will check your kidney function at least once a year. More frequent checks may be necessary for people over 65 years or for patients with kidney problems.

How to take Metformin Vitabalans

Metformin Vitabalans tablets should be taken during or after meals. This will help avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow each tablet with a glass of water.

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

If you feel that the effect of Metformin Vitabalans is too strong or too weak, 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, you may experience lactic acidosis. Symptoms of lactic acidosis include vomiting, abdominal pain with muscle cramps, general feeling of being unwell with severe fatigue, and breathing difficulties. If you experience these symptoms, you need immediate hospital treatment, as lactic acidosis can lead to coma. Contact your doctor or go to the nearest hospital immediately.

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 tell you how long to take metformin. If you suddenly stop treatment, symptoms may recur. Do not stop taking Metformin Vitabalans without consulting your doctor or pharmacist first.
If you have any further questions about taking this medicine, 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 cause (may affect up to 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, stop taking Metformin Vitabalans and contact your doctor or the nearest hospital immediately, 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 meals or immediately after meals. If the symptoms do not disappear, 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 are not working 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, 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 this leaflet, tell your doctor or pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 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

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 the 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Metformin Vitabalans contains

• Each tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
• The active substance is metformin.
• The 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:
White, convex tablet in the shape of a capsule with a dividing line, measuring 7.5 x 18 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

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, Latvia, Norway, Poland, Slovakia, Slovenia, Sweden, Hungary).

Date of last revision of the leaflet: 03/2025