Metformin hidrohloride Biofarm

Package Leaflet: Information for the Patient

Metformin Hydrochloride Biofarm, 1000 mg, Film-Coated Tablets

Metformin Hydrochloride

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

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Metformin Hydrochloride Biofarm and what is it used for
• 2. Important information 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 package and other information

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

Metformin Hydrochloride Biofarm contains metformin, a medicine 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 take up 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 excessive increase in blood glucose levels. Metformin Hydrochloride Biofarm helps to reduce blood glucose levels to values as close to normal as possible.
In adults with overweight, long-term use of Metformin Hydrochloride Biofarm also reduces the risk of complications associated with diabetes. Taking Metformin Hydrochloride Biofarm is associated with maintaining or moderately reducing body weight.
Metformin Hydrochloride Biofarm is used to treat patients with type 2 diabetes (also called "non-insulin-dependent" diabetes), in whom diet and physical exercise alone cannot achieve sufficient blood glucose control. It is particularly used in patients with overweight.
Adults can take Metformin Hydrochloride Biofarm as the only medicine or in combination with other anti-diabetic medicines (oral or insulin).
Children from 10 years of age and adolescents can take Metformin Hydrochloride Biofarm as the only medicine or in combination with insulin.

2. Important information before taking Metformin Hydrochloride Biofarm

When not to take Metformin Hydrochloride Biofarm:

• if the patient is allergic to metformin 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, 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 unusual fruity breath odor,
• in case of excessive fluid loss from the body (dehydration), e.g. due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney dysfunction, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of severe infection, e.g. pneumonia, bronchitis or kidney infection. Severe infections can lead to kidney dysfunction, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of acute heart failure or recent myocardial infarction, severe circulatory disorders (e.g. shock) or breathing difficulties. This can cause tissue hypoxia, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of alcohol abuse.

If any of the above situations occur, the patient should consult a doctor before taking this medicine.
It is necessary to consult a doctor if:

• a radiological examination or a test requiring the injection of a contrast agent containing iodine into the bloodstream is to be performed,
• a major surgical procedure is to be performed.

Metformin Hydrochloride Biofarm must be discontinued for a certain period before and after the examination or surgery. The doctor will decide whether other treatment is necessary during this time.
It is essential to follow the doctor's instructions carefully.

Warnings and Precautions

Risk of Lactic Acidosis

Metformin Hydrochloride Biofarm may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney dysfunction.
The risk of lactic acidosis increases in case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver dysfunction, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g. acute severe heart disease).
If any of the above circumstances apply to the patient, they should consult a doctor for more detailed instructions.

The patient should temporarily discontinue taking Metformin Hydrochloride Biofarm if they experience

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

The patient should discontinue taking Metformin Hydrochloride Biofarm and immediately contact a doctor or the nearest hospital if they experience any of the

symptoms of lactic acidosis, as this condition 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 the patient is to undergo major surgery, they must not take Metformin Hydrochloride Biofarm during and for some time after the surgery. The doctor will decide when the patient should stop and resume taking Metformin Hydrochloride Biofarm.
Metformin Hydrochloride Biofarm does not cause hypoglycemia (low blood sugar). However, if Metformin Hydrochloride Biofarm is taken in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides), there is a risk of hypoglycemia. If symptoms of hypoglycemia occur, such as weakness, dizziness, increased sweating, rapid heart rate, vision disturbances, or difficulty concentrating, eating or drinking a sugary drink usually helps.
During treatment with Metformin Hydrochloride Biofarm, the doctor will monitor the patient's kidney function at least once a year or more frequently if the patient is elderly and/or has impaired kidney function.

Metformin Hydrochloride Biofarm with Other Medicines

If the patient is to be injected with a contrast agent containing iodine into the bloodstream, for example, for an X-ray examination or computed tomography, they must discontinue taking Metformin Hydrochloride Biofarm before or at the latest at the time of such injection. The doctor will decide when the patient should stop and resume taking Metformin Hydrochloride Biofarm.
The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may require more frequent blood glucose monitoring and kidney function tests or dose adjustment of Metformin Hydrochloride Biofarm by the doctor. It is particularly 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 Hydrochloride Biofarm in the blood, 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.

Metformin Hydrochloride Biofarm with 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 "Warnings and precautions").

Pregnancy and Breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult a doctor, as changes in treatment or blood glucose monitoring may be necessary.
This medicine is not recommended for breastfeeding women or those planning to breastfeed.

Driving and Operating Machines

Metformin Hydrochloride Biofarm does not cause hypoglycemia (low blood sugar). This means it does not affect the patient's ability to drive or operate machines.
However, the patient should be careful if they are taking Metformin Hydrochloride Biofarm in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heart rate, vision disturbances, or difficulty concentrating. If such symptoms occur, the patient should not drive or operate machines.

3. How to Take Metformin Hydrochloride Biofarm

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.
Metformin Hydrochloride Biofarm does not replace the benefits of a healthy lifestyle. The patient should continue to follow the doctor's recommendations regarding diet and regular physical activity.

Recommended Dose

Children from 10 years of age and adolescents: usually start treatment with a dose of 500 mg or 850 mg of Metformin Hydrochloride Biofarm once a day. The maximum daily dose is 2000 mg and is taken in 2 or 3 divided doses. Treatment of children from 10 to 12 years of age is only used in case of special recommendation by the doctor, as experience with Metformin Hydrochloride Biofarm in this age group is limited.
Adults: usually start treatment with a dose of 500 mg or 850 mg of Metformin Hydrochloride Biofarm 2 or 3 times a day. The maximum daily dose is 3000 mg and is taken in 3 divided doses.
If the patient has impaired kidney function, the doctor may prescribe a lower dose.
If the patient is also taking insulin, the doctor will inform them how to start taking Metformin Hydrochloride Biofarm.

Treatment Monitoring

• The doctor will prescribe regular blood glucose tests and adjust the dose of Metformin Hydrochloride Biofarm based on blood glucose levels. The patient should regularly visit the doctor for check-ups. This is especially important in case of children and adolescents, as well as elderly patients.
• The doctor will check the patient's kidney function at least once a year. More frequent checks 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 with a meal or immediately after a meal.
This will help avoid gastrointestinal side effects.
The tablets should not be crushed or chewed. The patient should swallow the tablet with a glass of water.

• If the patient takes one dose of the medicine per day, they should take it in the morning (breakfast).
• If the patient takes two doses of the medicine per day, they should take them in the morning (breakfast) and evening (dinner).
• If the patient takes three doses of the medicine per day, they should take them in the morning (breakfast), at noon (lunch), and evening (dinner).

If after some time the patient feels that the effect of Metformin Hydrochloride Biofarm is too strong or too weak, they should consult a doctor or pharmacist.

Taking a Higher Dose of Metformin Hydrochloride Biofarm than Recommended

In case of taking a higher dose of Metformin Hydrochloride Biofarm than recommended, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include:
vomiting, abdominal pain (abdominal cramps), general poor condition with severe fatigue, and breathing difficulties. Other symptoms include decreased 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.
The patient should immediately discontinue taking Metformin Hydrochloride Biofarm and contact a doctor or the nearest hospital.

Missing a Dose of Metformin Hydrochloride Biofarm

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.
In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Metformin Hydrochloride Biofarm can cause side effects, although not everybody gets them.
The side effects that may occur are listed below.
Metformin Hydrochloride Biofarm may very rarely cause (may occur in up to 1 in 10,000 patients) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should discontinue taking Metformin Hydrochloride Biofarm and immediately contact a doctor or the nearest hospital, as lactic acidosis can lead to coma.

Very Common Side Effects (may occur in more than 1 in 10 patients)

• Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, loss of appetite. These side effects usually occur at the beginning of treatment with Metformin Hydrochloride Biofarm. Dividing the daily dose into several smaller doses taken throughout the day and taking Metformin Hydrochloride Biofarm with a meal or immediately after a meal may be helpful. If the symptoms do not disappear, the patient should discontinue Metformin Hydrochloride Biofarm and inform their doctor.

Common Side Effects (may occur in less than 1 in 10 patients)

• Taste disorders.
• Decreased or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, pain and redness of the tongue, numbness or pale or yellowish skin). The doctor may prescribe several tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other unrelated health problems.

and other health problems.

Very Rare Side Effects (may occur in less than 1 in 10,000 patients)

• Lactic acidosis. This is a very rare but serious complication that occurs especially when the kidneys are not functioning properly. Symptoms of lactic acidosis are non-specific (see "Warnings and precautions").
• Abnormal liver function test results or symptoms of hepatitis (with accompanying fatigue, loss of appetite, and weight loss, as well as with or without yellowing of the skin and whites of the eyes). If such symptoms occur, the patient should discontinue Metformin Hydrochloride Biofarm and inform their doctor.

Biofarm and inform their doctor.

• Skin reactions, such as skin redness, itching, or itchy rash (hives).

Children and Adolescents

Limited data in children and adolescents indicate that the side effects have a similar nature and intensity as those observed in adults.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to Store Metformin Hydrochloride Biofarm

The medicine should be stored out of sight and reach of children. If Metformin Hydrochloride Biofarm is used in a child, treatment should be supervised by parents or caregivers.
There are no special recommendations for storing the medicine.
Do not use this medicine after the expiry date stated on the carton and blister after the expiry date (EXP). The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Metformin Hydrochloride Biofarm, 1000 mg contains

• The active substance of the medicine is metformin hydrochloride.

One film-coated tablet of Metformin Hydrochloride Biofarm, 1000 mg contains 1000 mg of metformin hydrochloride, which corresponds to 780 mg of metformin.

• The other ingredients of the medicine are: povidone, magnesium stearate, hypromellose, macrogol.

What Metformin Hydrochloride Biofarm looks like and contents of the package

Film-coated tablet.
Metformin Hydrochloride Biofarm, 1000 mg
Metformin Hydrochloride Biofarm, 1000 mg are white to yellowish, oval, biconvex film-coated tablets with the inscription MC on one side and a break line on the other side. The tablet can be divided into equal doses.
Metformin Hydrochloride Biofarm, 1000 mg is available in packages containing 30, 50, or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Poland: Metformin Hydrochloride Biofarm
Spain: Metformina Biofarm 850 mg comprimidos recubiertos con película EFG

Date of last revision of the package leaflet: