Package leaflet: Information for the patient

Metformin hydrochloride Biofarm, 1000 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, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
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

What Metformin hydrochloride Biofarm is and what it is used for
What you need to know before you take Metformin hydrochloride Biofarm
How to take Metformin hydrochloride Biofarm
Possible side effects
How to store Metformin hydrochloride Biofarm
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 as possible to normal.
In overweight adults, long-term treatment with Metformin hydrochloride Biofarm also reduces the risk of diabetes-related complications. Treatment with Metformin hydrochloride Biofarm is associated with maintenance of body weight or even moderate weight reduction.
Metformin hydrochloride Biofarm is used in the treatment of 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 exercise 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 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, 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 breath,
in case of excessive fluid loss from the body (dehydration), e.g. due to prolonged or severe diarrhoea or repeated vomiting. Dehydration may lead to kidney dysfunction, 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 kidney dysfunction, 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 consult a doctor if:

a radiological examination or a procedure requiring intravenous injection of an iodine-containing contrast agent is necessary,
a major surgical procedure is planned.

Metformin hydrochloride Biofarm must be temporarily discontinued before and after such examination
or surgical procedure. The doctor will decide whether alternative treatment is needed during this period.
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), liver dysfunction, and any medical conditions in which part of the body is inadequately oxygenated (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 fluid loss from the body), such as severe vomiting, diarrhoea, fever, exposure to high temperature, or if the patient drinks 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 scheduled for a major surgical procedure, Metformin hydrochloride Biofarm 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 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 sulfonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating, eating or drinking something containing sugar 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 worsening kidney function.
Metformin hydrochloride Biofarm and other medicines
If an iodine-containing contrast agent is to be injected intravenously, 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 such injection. The doctor will decide when the patient should stop and restart treatment with Metformin hydrochloride Biofarm.
The patient should inform the doctor about all medicines currently taken or taken recently, as well as any medicines planned for future use. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Metformin hydrochloride Biofarm by the doctor. 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 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 breastfeeding women or those 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 sulfonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include: weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances 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 directed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
Metformin hydrochloride Biofarm does not replace the benefits of a healthy lifestyle. You should
continue to follow all 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 initiated on specific
medical advice, 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 you have impaired kidney function, your doctor may prescribe a lower dose.
If you are also using insulin, your doctor will advise you on how to start taking 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 for elderly patients or if your kidneys do not function properly.

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

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

If after some time you feel that the effect of Metformin hydrochloride Biofarm is too strong or too
weak, you should consult your doctor or pharmacist.
Taking more than the recommended dose of Metformin hydrochloride Biofarm
If you take more Metformin hydrochloride Biofarm than prescribed, lactic acidosis may occur.
Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (pain in the
abdominal cavity) 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, you should seek immediate medical attention, as lactic
acidosis can lead to coma. You should stop taking Metformin hydrochloride Biofarm immediately
and contact your doctor or go to the nearest hospital.
Missing a 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 they do not occur in everyone.
The adverse effects that may occur are listed below.
Metformin hydrochloride Biofarm 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, 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 occur in more than 1 in 10 people)

Gastrointestinal disturbances such as nausea, vomiting, diarrhoea, abdominal pain, 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 food or immediately after a meal. If symptoms do not resolve, Metformin hydrochloride Biofarm should be discontinued and the doctor informed.

Common adverse effects (may occur in 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 yellow skin). Your 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 occur in less than 1 in 10,000 people)

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 symptoms of hepatitis (associated with 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 informed.
Skin reactions such as skin redness (erythema), itching or itchy rash (urticaria).

Children and adolescents
Limited data in children and adolescents indicate that the adverse effects observed in these populations are of similar nature 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 or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 the medicine.

5. How to store Metformin hydrochloride Biofarm

Keep the 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 the medicine after the expiry date stated on the cardboard box and blister pack following the "EXP" mark. 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Metformin hydrochloride Biofarm, 1000 mg contains

The active substance is metformin hydrochloride.

One coated tablet of Metformin hydrochloride Biofarm, 1000 mg contains 1000 mg
of metformin hydrochloride, equivalent to 780 mg of metformin.

The other ingredients are: povidone, magnesium stearate, hypromellose, macrogol.

What Metformin hydrochloride Biofarm looks like and contents of the pack
Coated tablet.
Metformin hydrochloride Biofarm, 1000 mg
Metformin hydrochloride Biofarm, 1000 mg is white to yellowish, biconvex, oval coated tablets,
with "MC" embossed on one side and a score line on the other side. The tablet can be divided into
equal doses.
Metformin hydrochloride Biofarm, 1000 mg is available in packs containing 30, 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
Poland
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
Barcelona
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Metformin hydrochloride Biofarm
Spain: Metformina Biofarm 850 mg comprimidos recubiertos con película EFG