Metformin hydrochloride biofarm

Package leaflet: Information for the patient

Metformin hydrochloride Biofarm, 850 mg, film-coated tablets
Metformini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Metformin hydrochloride Biofarm is and what it is used for
2. What you need to know before taking Metformin hydrochloride Biofarm
3. How to take Metformin hydrochloride Biofarm
4. Possible side effects
5. How to store Metformin hydrochloride Biofarm
6. Contents of the pack and other information

1. What Metformin hydrochloride Biofarm is and what it is used for

Metformin hydrochloride Biofarm contains metformin, a medicine used in the treatment of diabetes. It belongs to a group of medicines called 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 people with diabetes, the pancreas does not produce enough insulin or the body cannot properly use the insulin it produces. This leads to abnormally high levels of glucose in the blood. Metformin hydrochloride Biofarm helps reduce blood glucose levels to values as close to normal as possible.
In overweight adults, long-term use of Metformin hydrochloride Biofarm also reduces the risk of diabetes-related complications. Treatment with Metformin hydrochloride Biofarm is associated with stable body weight or even moderate weight reduction.
Metformin hydrochloride Biofarm is used to treat patients with type 2 diabetes (also known as "non-insulin-dependent diabetes") in whom adequate control of blood glucose levels cannot be achieved by diet and physical activity alone. It is particularly used in overweight patients.
Adults may take Metformin hydrochloride Biofarm either as monotherapy or in combination with other antidiabetic medicines (oral agents or insulin).
Children aged 10 years and adolescents may take Metformin hydrochloride Biofarm either as monotherapy or in combination with insulin.

2. Important information before using Metformin hydrochloride Biofarm

When not to use Metformin hydrochloride Biofarm:

• if the patient is allergic to metformine or any of the other ingredients of this medicine (listed in section 6),
• in case of liver dysfunction,
• if the patient has significantly reduced kidney function,
• 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 which may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odour of the breath,
• in case of excessive loss of body water (dehydration), e.g. due to prolonged or severe diarrhoea or repeated vomiting. Dehydration may lead to impaired kidney function, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
• in case of severe infection, e.g. pneumonia, bronchitis or kidney infection. Severe infections may lead to impaired kidney function, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
• in case of treatment for acute heart failure or recent myocardial infarction, severe circulatory disorders (e.g. shock) or breathing difficulties. These conditions may cause tissue hypoxia, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
• in case of alcohol abuse.

If any of the above situations apply, the patient should consult a doctor before using this medicine.
It is essential to seek medical advice if:

• a radiological examination or a procedure requiring intravenous injection of an iodine-containing contrast agent is required,
• a major surgical procedure is to be performed.

Metformin hydrochloride Biofarm must be discontinued for a certain period before and after such an examination or surgical procedure. The doctor will decide whether alternative treatment is necessary during this time.
It is important to strictly follow the doctor's instructions.

Warnings and precautions
Risk of lactic acidosis
Metformin hydrochloride Biofarm 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), impaired liver function, and any medical conditions in which a 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, the patient should consult a doctor for further instructions.

The use of Metformin hydrochloride Biofarm should be temporarily discontinued if the patient develops a medical condition that may be associated with 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. The patient should consult a doctor for further instructions.

The use of Metformin hydrochloride Biofarm should be discontinued and the patient should immediately contact a doctor or the nearest hospital if any of the symptoms of lactic acidosis occur, as this condition may lead to coma.
Symptoms of lactic acidosis include:

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

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.

If the patient is to undergo a major surgical procedure, Metformin hydrochloride Biofarm must not be used during the procedure and for a certain time afterwards. The doctor will decide when the patient should stop and resume treatment with Metformin hydrochloride Biofarm.

Metformin hydrochloride Biofarm does not cause hypoglycaemia (low blood glucose levels). However, if Metformin hydrochloride Biofarm is used in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylurea derivatives, insulin, 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 something containing sugar usually helps.

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

Metformin hydrochloride Biofarm and other medicines
If the patient is to receive an intravenous iodine-containing contrast agent, for example during an X-ray examination or computed tomography, the patient must stop taking Metformin hydrochloride Biofarm before or at the latest at the time of injection. The doctor will decide when the patient should stop and resume treatment with Metformin hydrochloride Biofarm.

The patient should inform the doctor about all medicines currently taken or recently taken, as well as any medicines planned for future use. The patient may require more frequent monitoring of blood glucose levels and kidney function, or the doctor may need to adjust the dose of Metformin hydrochloride Biofarm. 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 the blood concentration of Metformin hydrochloride Biofarm, 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.

Metformin hydrochloride Biofarm and alcohol
The patient should avoid consuming excessive amounts of alcohol while taking Metformin hydrochloride Biofarm, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor, as changes in treatment or monitoring of blood glucose levels may be necessary.
This medicine is not recommended for patients who are breastfeeding or planning to breastfeed.

Driving and operating machinery
Metformin hydrochloride Biofarm does not cause hypoglycaemia (low blood glucose levels). This means that it does not affect the patient's ability to drive or operate machinery.
However, particular caution is required if Metformin hydrochloride Biofarm is used together with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycaemia include: weakness, dizziness, increased sweating, rapid heartbeat, blurred vision or difficulty concentrating. If such symptoms occur, the patient should not drive or operate machinery.

3. How to use Metformin hydrochloride Biofarm

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Metformin hydrochloride Biofarm does not replace the benefits of a healthy lifestyle. You should continue to follow your doctor's advice regarding diet and regular physical activity.

Recommended dose
Children aged 10 years and adolescents: treatment usually starts with a dose of 500 mg or 850 mg of Metformin hydrochloride Biofarm once daily. The maximum daily dose is 2000 mg, taken in 2 or 3 divided doses. Treatment of children aged 10 to 12 years should only be used upon specific recommendation by the doctor, as experience with Metformin hydrochloride Biofarm in this age group is limited.
Adults: treatment usually starts with a dose of 500 mg or 850 mg of Metformin hydrochloride Biofarm two or three times daily. The maximum daily dose is 3000 mg, taken in 3 divided doses.
If the patient has impaired kidney function, the doctor may prescribe a lower dose.
If the patient is also using insulin, the doctor will advise on how to start treatment with Metformin hydrochloride Biofarm.

Monitoring of treatment

• Your doctor will order regular blood glucose tests and adjust the dose of Metformin hydrochloride Biofarm according to blood glucose levels. You should attend regular check-ups with your doctor. This is particularly important for children, adolescents, and elderly patients.
• Your doctor will check your kidney function at least once a year. More frequent monitoring may be necessary in elderly patients or if the patient's kidneys are not functioning properly.

How to take Metformin hydrochloride Biofarm
Metformin hydrochloride Biofarm should be taken during or immediately after a meal. This helps to avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet whole with a glass of water.

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

Metformin hydrochloride Biofarm 850 mg tablets have a score line. The score line is not intended for breaking the tablet.
If after some time the patient feels that the effect of Metformin hydrochloride Biofarm is too strong or too weak, they should consult their doctor or pharmacist.

Overdose of Metformin hydrochloride Biofarm
If a dose higher than recommended is taken, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal discomfort) with muscle cramps, general malaise accompanied by severe fatigue and difficulty breathing. Other symptoms include lowered body temperature and slowed heart rate. If any of these symptoms occur, the patient should immediately seek medical help, as lactic acidosis can lead to coma. Metformin hydrochloride Biofarm should be stopped immediately and the patient should contact their doctor or go to the nearest hospital.

Missed dose of Metformin hydrochloride Biofarm
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
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 possible adverse effects are listed below.

Metformin hydrochloride Biofarm may very rarely (may occur in up to 1 in 10,000 patients) cause a very serious adverse effect known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, treatment with Metformin hydrochloride Biofarm must be discontinued and immediate contact must be made with a doctor or the nearest hospital, as lactic acidosis may lead to coma.

Very common adverse effects (may affect more than 1 in 10 people)

• Gastrointestinal disturbances such as nausea, vomiting, diarrhoea, abdominal pain (pain in the abdominal cavity), loss of appetite. These adverse effects most commonly occur at the beginning of treatment with Metformin hydrochloride Biofarm. It may help to divide the daily dose into several smaller doses taken throughout the day and to take Metformin hydrochloride Biofarm with a meal or immediately after a meal. If symptoms do not resolve, Metformin hydrochloride Biofarm should be discontinued and the doctor should be informed.

Common adverse effects (may affect less than 1 in 10 people)

• Taste disturbances.
• Decreased or low blood levels of vitamin B12 (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling sensations (paraesthesiae), or pale or yellowish skin). The doctor may order several tests to determine the cause of symptoms, as some of them may also be caused by diabetes or other health problems unrelated to diabetes.

Very rare adverse effects (may affect less than 1 in 10,000 people)

• Lactic acidosis. This is a very rare but serious complication, particularly occurring when the kidneys are not functioning properly. Symptoms of lactic acidosis are non-specific (see section "Warnings and precautions").
• Abnormal liver function test results or symptoms of hepatitis (with accompanying fatigue, loss of appetite, and weight loss, with or without yellowing of the skin and whites of the eyes). If such symptoms occur, Metformin hydrochloride Biofarm should be discontinued and the doctor should be informed.
• Skin reactions such as redness of the skin (erythema), itching of the skin, or itchy rash (urticaria).

Children and adolescents
Limited data in children and adolescents indicate that the adverse effects experienced are of similar nature and severity to those observed in adults.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. 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, 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 this medicine.

5. How to store Metformin hydrochloride Biofarm

Keep this medicine out of the sight and reach of children.
If Metformin hydrochloride Biofarm is being used by a child, treatment should be supervised by parents or caregivers.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the cardboard box and blister pack following the label "EXP". The expiry date refers to the last day of the stated 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 hydrochloride Biofarm 850 mg contains

• The active substance is metformin hydrochloride. One coated tablet of Metformin hydrochloride Biofarm 850 mg contains 850 mg of metformin hydrochloride, equivalent to 662.9 mg of metformin.
• Other components are: povidone, magnesium stearate, hypromellose, macrogol.

What Metformin hydrochloride Biofarm looks like and contents of the pack
Coated tablet.
Metformin hydrochloride Biofarm 850 mg
Metformin hydrochloride Biofarm 850 mg is white to yellowish, biconvex, oval coated tablets, with an embossed break line between the markings "M" and "B" on one side and an embossed break line on the other side.
Metformin hydrochloride Biofarm 850 mg is available in packs containing 30, 40, 50 or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Tel. +48 61 66 51 500
e-mail: [email protected]
Manufacturer
SAG Manufacturing S.L.U
Crta. N-I, Km 36,
San Agustín de Guadalix,
28750 Madrid
Spain
Galenicum Health, S.L.U.
Sant Gabriel, 50,
Esplugues de Llobregat, 08950
08950 Barcelona
Spain
This medicinal product is authorised in the European Economic Area member states under the following names:
Poland: Metformin hydrochloride Biofarm
Spain: Metformina Biofarm 850 mg comprimidos recubiertos con película EFG