Metformin vitabalans

Package leaflet: Information for the patient

Metformin Vitabalans, 500 mg, film-coated tablets
Metformin Vitabalans, 1000 mg, film-coated tablets
metformini hydrochloridum
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• Consult your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If any of the side effects worsen or if any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

Metformin Vitabalans contains metformin, an active substance used in the treatment of diabetes. It belongs to a group of medicines known as biguanides. Insulin is a hormone produced by the pancreas, which enables the body to take up glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for later use. In patients with diabetes, the pancreas does not produce enough insulin or the body is unable to properly use the insulin it produces. This leads to increased blood glucose levels. Metformin Vitabalans helps reduce blood glucose levels to as close as possible to normal.
In overweight adults, long-term use of Metformin Vitabalans also helps reduce the risk of diabetes-related complications. Treatment with Metformin Vitabalans is associated with both weight maintenance and a slight reduction in body weight.
Metformin Vitabalans is used:
in the treatment of type 2 diabetes, when proper blood glucose levels cannot be achieved through diet and physical exercise alone. It is particularly used in overweight patients.
Adults may take Metformin Vitabalans alone or in combination with other antidiabetic medicines (oral agents or insulin).
Children aged 10 years and older and adolescents may take Metformin Vitabalans alone or together with insulin.

2. Important information before using Metformin Vitabalans

When not to use Metformin Vitabalans

• if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6);
• if the patient has significantly reduced kidney function;
• if the patient has liver disease;
• if the patient has uncontrolled diabetes, for example severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Diabetic ketoacidosis is a condition in which substances called ketones accumulate in the blood and may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odour of the breath.
• if the patient is dehydrated due to prolonged or severe diarrhoea or repeated vomiting. Dehydration may lead to impaired kidney function, which may result in lactic acidosis (see section "Warnings and precautions" below);
• if the patient has a severe infection, for example lung, bronchial or kidney infection. Severe infections may cause impaired kidney function, which may lead to lactic acidosis (see section "Warnings and precautions" below);
• if the patient is being treated for heart failure or has recently had a heart attack, has severe circulatory disorders (stroke) or breathing difficulties. These conditions may cause inadequate oxygen supply to tissues, which may increase the risk of lactic acidosis (see section "Warnings and precautions" below);
• when consuming large amounts of alcohol.

If any of the above situations apply, consult a doctor before starting treatment.
Consult a doctor if:

• the patient needs to undergo diagnostic tests such as radiographic examination (X-ray) or coronary angiography, which require intravascular administration of iodine-containing contrast agents.
• the patient is scheduled for major surgery.

Metformin Vitabalans should be temporarily discontinued for a period before and after the examination or procedure. The doctor will decide whether alternative treatment is necessary during this time. It is important to follow the doctor's instructions.

Warnings and precautions
Risk of lactic acidosis
Metformin Vitabalans may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver dysfunction, and any medical conditions in which part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, seek further instructions from a doctor.
Temporarily discontinue Metformin Vitabalans if the patient develops any illness that may lead to dehydration (significant loss of body water), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient is drinking less fluid than usual. Seek further instructions from a doctor.
Discontinue Metformin Vitabalans immediately and contact a doctor or the nearest hospital if the patient experiences any symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise accompanied by severe fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
If the patient is undergoing major surgery, Metformin Vitabalans must not be used during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart treatment with Metformin Vitabalans.
Metformin Vitabalans does not cause hypoglycaemia (low blood glucose levels). However, if Metformin Vitabalans is used in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylureas, insulin, or meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, blurred vision, or difficulty concentrating, eating or drinking a sugary food or drink usually helps.

During treatment with Metformin Vitabalans, the doctor will monitor kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.

Metformin Vitabalans and other medicines
If an iodine-containing contrast agent is to be injected into the bloodstream, for example for an X-ray or CT scan, the patient must stop taking Metformin Vitabalans before or at the latest at the time of injection. The doctor will decide when the patient should stop and restart treatment with Metformin Vitabalans.
Tell the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or the doctor may need to adjust the dose of Metformin Vitabalans. It is especially important to inform the doctor about the following medicines:

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

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

Pregnancy and breastfeeding
Inform the doctor if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, so that the doctor can adjust the treatment accordingly.
During pregnancy, diabetes should be treated with insulin. Do not use this medicine during breastfeeding or if the patient plans to breastfeed.

Driving and operating machinery
Metformin Vitabalans alone does not cause hypoglycaemia (low blood glucose levels). This means it does not affect the ability to drive or operate machinery.
However, if Metformin Vitabalans is used together with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylureas, insulin, or meglitinides), extra caution is required. Symptoms of hypoglycaemia include weakness, dizziness, excessive sweating, rapid heartbeat, blurred vision, or difficulty concentrating. Do not drive or operate machinery if these symptoms occur.

3. How to use Metformin Vitabalans

This medicine should always be used exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Metformin Vitabalans cannot replace the benefits derived from a healthy lifestyle. You must follow your doctor's advice regarding diet and regularly engage in physical exercise.

Recommended dose
In adults, the usual initial dose is 500 mg of Metformin Vitabalans 2–3 times daily. The maximum daily dose is 1000 mg, divided into three doses.
In children over 10 years of age and adolescents, the usual initial dose is 500 mg of Metformin Vitabalans once daily. Use in children aged 10 to 12 years is possible only on specific recommendation by the doctor, as experience with the use of this medicine in this age group is limited.
If insulin is used concomitantly, your doctor will inform you how to start treatment with Metformin Vitabalans.
If you have impaired kidney function, your doctor may prescribe a lower dose.

Monitoring

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

How to use Metformin Vitabalans
Metformin Vitabalans tablets should be taken during or after a meal. This helps to avoid gastrointestinal side effects.
Do not crush or chew the tablets. Each tablet should be swallowed whole with a glass of water.

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

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

Overdose of Metformin Vitabalans
Taking more Metformin Vitabalans than recommended may lead to lactic acidosis. Symptoms of lactic acidosis include: vomiting, abdominal pain with muscle cramps, general malaise with severe fatigue, and difficulty breathing. If these symptoms occur, immediate hospital treatment is required, as lactic acidosis may lead to coma. You must contact your doctor immediately or go to the nearest hospital.

Missed 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 Metformin Vitabalans
Your doctor will inform you how long you should continue metformin treatment. If you stop treatment suddenly, symptoms may recur. Do not discontinue use of this medicine without first consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult 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:
Metformin Vitabalans may very rarely (may occur in up to 1 patient in 10,000) cause a very serious adverse effect known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, Metformin Vitabalans must be discontinued immediately and the patient should contact a doctor or the nearest hospital without delay, as lactic acidosis may lead to coma.

Very common (occur in more than 1 in 10 patients)

• Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. These adverse effects occur most frequently at the beginning of treatment with Metformin Vitabalans. They can be prevented by taking the medicine in divided doses during the day with meals or immediately after meals. If symptoms do not resolve, treatment with Metformin Vitabalans should be discontinued and a doctor consulted.

Common (occur in 1 to 10 in 100 patients)

• Taste disturbances

Very rare (occur in less than 1 in 10,000 patients)

• Lactic acidosis. This is a very rare but serious complication, particularly when kidneys are not functioning properly. Symptoms of lactic acidosis are non-specific (see section "Warnings and precautions").
• Abnormal liver function test results or hepatitis (which may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin and whites of the eyes). If such symptoms occur, the medicine must be discontinued and a doctor consulted.
• Skin reactions such as redness, itching or urticaria.
• Decreased concentration of vitamin B12 in the blood.

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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 .
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Metformin Vitabalans

Keep this medicine out of sight and reach of children. If Metformin Vitabalans is administered to children, parents or caregivers should monitor the amount of medicine used by children.
Do not use this medicine after the expiry date stated on the container or carton after EXP. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack 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 is metformin.
The other ingredients are: microcrystalline cellulose, povidone (K 29-32), colloidal anhydrous silica,
magnesium stearate, polidextrose, 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 capsule-shaped tablet with a score line, measuring 7.5 x 18 mm.
Metformin Vitabalans 1000 mg: white, convex capsule-shaped tablet with a score 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 Authorisation Holder and Manufacturer
Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
FINLAND
Tel: +358 (3) 615600
Fax: +358 (3) 6183130

This medicinal product is authorised in the European Economic Area countries under the following names:
Metformin Vitabalans (Czech Republic, Denmark, Estonia, Finland, Lithuania, Latvia, Norway, Poland, Slovakia, Slovenia, Sweden, Hungary).