Metformin vitabalans

Package leaflet: Information for the patient

Metformin Vitabalans, 500 mg, coated tablets
metformini hydrochloridum
Please read the entire leaflet carefully before starting to take this 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 similar.
• If any of the side effects worsen, or if you experience any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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, a 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 that 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 use the insulin it produces properly. This leads to an increased concentration of glucose in the blood. Metformin Vitabalans helps reduce blood glucose levels to a value as close as possible to normal.
In overweight adults, long-term treatment with Metformin Vitabalans also helps reduce the risk of diabetes-related complications. Treatment with Metformin Vitabalans is associated with weight maintenance or even 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 by 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. Ketoacidosis is a condition in which substances called ketone bodies 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 can result in lactic acidosis (see section "Warnings and precautions" below);
• if the patient has a severe infection, such as pneumonia, bronchitis or kidney infection. Severe infections may impair kidney function, which can result in 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 lead to inadequate oxygen supply to tissues, increasing the risk of lactic acidosis (see section "Warnings and precautions" below);
• during excessive alcohol consumption.

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

• the patient requires diagnostic tests such as radiological examination (X-ray) or coronary angiography, which involve the administration of iodine-containing contrast agents into the bloodstream.
• the patient is scheduled for major surgery.

Treatment with Metformin Vitabalans should be temporarily discontinued before and after such examinations and before and after surgery. The doctor will decide whether alternative treatment is necessary during this period. 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, particularly 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, consult a doctor for further instructions.
Temporarily discontinue Metformin Vitabalans if the patient develops a medical condition that may lead to dehydration (significant loss of body water), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.
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 profound fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
Contact a doctor immediately for further instructions if:

• the patient has a genetically inherited mitochondrial disorder (cellular energy-producing structures), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• the patient develops any of the following symptoms after starting metformin: seizures, worsening cognitive function, difficulty moving, signs of nerve damage (e.g. pain or numbness), migraine or deafness.

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 to 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 sulfonylureas, insulin, or meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, excessive sweating, rapid heartbeat, blurred vision, or difficulty concentrating, consuming or drinking a sugary food or beverage 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 the patient is to receive an intravenous iodine-containing contrast agent, for example for an X-ray or CT scan, treatment with Metformin Vitabalans must be discontinued before or at the latest at the time of administration. The doctor will decide when to stop and restart treatment with Metformin Vitabalans.
Inform the doctor about all medicines currently taken or recently used, as well as any medicines the patient plans to take. The patient may require more frequent monitoring of blood glucose levels and kidney function, or dose adjustments of Metformin Vitabalans. It is particularly 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 in the treatment of diabetes.

Use of Metformin Vitabalans with alcohol
Avoid excessive alcohol consumption 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 sulfonylureas, 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 taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Metformin Vitabalans cannot replace the benefits of a healthy lifestyle. You should follow your doctor's advice regarding diet and regularly engage in physical exercise.

Recommended dose
For adults, the usual starting dose is 500 mg of Metformin Vitabalans 2–3 times daily. The maximum daily dose is 1000 mg administered in three divided doses.
For children above 10 years of age and adolescents, the usual starting dose is 500 mg of Metformin Vitabalans once daily. Use in children aged 10 to 12 years is possible only on specific medical advice, as experience with the 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 those with impaired kidney function.

How to take Metformin Vitabalans
Metformin Vitabalans tablets should be taken during or after meals. This helps to avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow each tablet 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 breathing difficulties. If these symptoms occur, immediate hospital treatment is required, as lactic acidosis may lead to coma. 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 taking metformin. If you stop treatment suddenly, symptoms may return. Do not discontinue use 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur:
Metformin Vitabalans may very rarely (may occur in up to one patient in 10,000) cause a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, Metformin Vitabalans must be discontinued immediately and medical advice must be sought from a doctor or the nearest hospital because 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 reactions are most common 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, Metformin Vitabalans should be discontinued and medical advice sought.

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 medical advice sought.
• Skin reactions such as redness of the skin, itching, or urticaria.
• Decreased blood levels of vitamin B12.

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions 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 being administered to children, parents or caregivers should monitor the amount of medicine used by the 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 that month.
Medicines must not be disposed of via the sewage system 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

• Each tablet contains 500 mg of metformin hydrochloride, corresponding to 390 mg of metformin.
• The active substance is metformin.
• The other ingredients are: microcrystalline cellulose, povidone (K 29-32), anhydrous colloidal silicon dioxide, magnesium stearate, polidocanol, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Metformin Vitabalans looks like and contents of the pack
What Metformin Vitabalans looks like:
White, capsule-shaped, convex tablet with a division 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 Authorisation Holder and Manufacturer
Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
FINLAND
Tel: +358 (3) 615600
This medicinal product is authorised in the European Economic Area countries under the following names:
Metformin Vitabalans (Czech Republic, Denmark, Estonia, Finland, Latvia, Norway, Poland, Slovakia, Slovenia, Sweden, Hungary).