Metcrean

Leaflet attached to the packaging: patient information

Metcrean, 500 mg, film-coated tablets

Metcrean, 850 mg, film-coated tablets

Metcrean, 1000 mg, film-coated tablets

Metformin hydrochloride

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• 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.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Metcrean and what is it used for
• 2. Important information before taking Metcrean
• 3. How to take Metcrean
• 4. Possible side effects
• 5. How to store Metcrean
• 6. Contents of the pack and other information

1. What is Metcrean and what is it used for

Metcrean 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 insulin produced. This leads to an excessive increase in blood glucose levels. Metcrean helps reduce blood glucose levels to as close to normal as possible.
In adults with overweight, long-term use of Metcrean reduces the risk of diabetes-related complications. Taking Metcrean is associated with stabilization or a moderate decrease in body weight.
Metcrean is used to treat patients with type 2 diabetes (also known as non-insulin-dependent diabetes), in whom diet and physical exercise alone do not provide adequate control of blood glucose levels. It is particularly used in patients with overweight.
Adults can take Metcrean as the only medicine or with other anti-diabetic medicines (oral or insulin).
Children from 10 years of age and adolescents can take Metcrean as the only medicine or in combination with insulin.

2. Important information before taking Metcrean

When not to take Metcrean:

• if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6),
• in case of liver function disorders,
• if the patient has significantly reduced kidney function,
• if the patient has uncontrolled diabetes, for example, 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 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 function disorders, 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 function disorders, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of treatment for 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 it is necessary to:

• perform a radiological examination or an examination that requires the injection of a contrast agent containing iodine into the bloodstream,
• perform major surgery.

Metcrean must be discontinued for a 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

Metcrean may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney function disorders. The risk of lactic acidosis increases in case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more information below), liver function disorders, 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 stop taking Metcrean if they have 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 stop taking Metcrean and immediately contact a doctor or the nearest hospital if they experience any symptoms of

lactic acidosis,as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell 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 Metcrean during the surgery and for a period after it. The doctor will decide when the patient must stop and resume Metcrean treatment.
Metcrean does not cause hypoglycemia (low blood sugar).
However, if Metcrean is taken 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 heartbeat, vision disturbances, or difficulty concentrating, eating or drinking a sugary drink usually helps.
During treatment with Metcrean, the doctor will check the patient's kidney function at least once a year or more often if the patient is elderly and (or) has impaired kidney function.

Metcrean and 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 stop taking Metcrean before or at the latest at the time of such injection. The doctor will decide when the patient must stop and resume Metcrean treatment.
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 need more frequent blood glucose checks and kidney function tests or a dose adjustment of Metcrean 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 Metcrean 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.

Taking Metcrean with food and drink

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

Pregnancy and breastfeeding

During pregnancy, diabetes treatment requires the use of insulin.
If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should inform their doctor so that the treatment can be changed accordingly.
This medicine is not recommended for breastfeeding women or women planning to breastfeed.

Driving and using machines

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

Metcrean contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

Metcrean contains propylene glycol

Metcrean, 500 mg contains 0.385 mg of propylene glycol in each tablet.
Metcrean, 850 mg contains 0.652 mg of propylene glycol in each tablet.
Metcrean, 1000 mg contains 0.77 mg of propylene glycol in each tablet.

3. How to take Metcrean

Metcrean should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist again.
Treatment with Metcrean does not replace the benefits of a healthy lifestyle.
The patient should continue to follow all the doctor's recommendations regarding diet and exercise.

Recommended dose

Children from 10 years of age and adolescents: usually start treatment with a dose of 500 mg or 850 mg of Metcrean 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 Metcrean in this age group is limited.
Adults: usually start treatment with a dose of 500 mg or 850 mg of Metcrean, two or three 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 Metcrean.

Treatment monitoring

• The doctor will order regular blood glucose tests and adjust the dose of Metcrean according to the glucose levels. The patient should regularly visit their doctor for check-ups. This is especially important in the case of children and adolescents, as well as the elderly.
• The doctor will check the patient's kidney function at least once a year. More frequent checks may be necessary in the elderly or if the patient's kidneys are not functioning properly.

How to take Metcrean

Metcrean 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 tablet should be swallowed with a glass of water.

• If one dose is taken per day, the medicine should be taken in the morning (breakfast).
• If two doses are taken per day, the medicine should be taken in the morning (breakfast) and evening (dinner).
• If three doses are taken per day, the medicine should be taken in the morning (breakfast), at noon (lunch), and evening (dinner).

If after some time the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Metcrean than recommended

In case of taking a higher dose of Metcrean than recommended, lactic acidosis may occur.
Symptoms of lactic acidosis are non-specific and include: vomiting, abdominal pain (abdominal cramps), general feeling of being unwell 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 stop taking Metcrean and contact their doctor or go to the nearest

hospital.

If a dose of Metcrean is missed

The patient should not take a double dose to make up for the missed dose. The next dose should be taken at the usual time.
In case of further questions about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Metcrean 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 stop
taking Metcrean and immediately contact their doctor or the nearest hospital, as lactic acidosis can lead to coma.
Like all medicines, Metcrean can cause side effects, although not everybody gets them.
The side effects that may occur are listed below.

Very common side effects (occurring in more than 1 in 10 patients):

• gastrointestinal disorders such as: nausea, vomiting, diarrhea, abdominal pain (abdominal cramps), loss of appetite. These side effects most often occur at the beginning of treatment with the medicine. It may be helpful to divide the daily dose into several smaller doses and take them during the day, with a meal or immediately after a meal. If the symptoms do not disappear, the patient should stop taking Metcrean and tell their doctor.

Common side effects (occurring in less than 1 in 10 patients):

• taste disorders.

Very rare side effects (occurring in less than 1 in 10,000 patients):

• lactic acidosis. This is a very rare but serious complication, especially when the kidneys are not working properly. Symptoms of lactic acidosis are non-specific (see "Warnings and precautions");
• abnormal liver function test results or symptoms of liver inflammation (with accompanying fatigue, loss of appetite, and weight loss, as well as with or without jaundice of the skin and whites of the eyes). If such symptoms occur, the patient should stop taking Metcrean and tell their doctor;

or without jaundice of the skin and whites of the eyes). If such symptoms occur, the patient should stop taking Metcrean and tell their doctor;

• skin reactions such as: skin redness (rash), itching, or itchy hives (urticaria);
• low levels of vitamin B in the blood.

Children and adolescents

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

Reporting side effects

If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 gather more information on the safety of the medicine.

5. How to store Metcrean

The medicine should be stored out of sight and reach of children. If Metcrean is used in a child, it is recommended that the treatment be supervised by parents or caregivers.
No special storage precautions.
Do not use this medicine after the expiry date stated on the carton and blister after "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 pack and other information

What Metcrean contains

• The active substance of the medicine is metformin hydrochloride. One film-coated tablet of Metcrean, 500 mg contains 500 mg of metformin hydrochloride, which corresponds to 390 mg of metformin. One film-coated tablet of Metcrean, 850 mg contains 850 mg of metformin hydrochloride, which corresponds to 662.9 mg of metformin. One film-coated tablet of Metcrean, 1000 mg contains 1000 mg of metformin hydrochloride, which corresponds to 780 mg of metformin.
• The other ingredients of the medicine are: Tablet core: sodium carboxymethylcellulose (Type A), povidone K-30, corn starch, colloidal silica, anhydrous, magnesium stearate. Coating: hypromellose, titanium dioxide (E171), talc, macrogol 6000, propylene glycol.

What Metcrean looks like and contents of the pack

Metcrean, 500 mg: white, round, biconvex film-coated tablets with the inscription "500" on one side and smooth on the other side.
Metcrean, 850 mg: white, round, biconvex film-coated tablets with the inscription "850" on one side and smooth on the other side.
Metcrean, 1000 mg: white or almost white, oval, biconvex film-coated tablets with the inscription "10" and "00" separated by a notch on one side of the tablet and a dividing line on the other side of the tablet. The tablets can be divided into halves.
PVC/PVDC/Aluminum blisters containing 30, 60, and 90 film-coated tablets, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer/Importer

Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz

Date of last revision of the leaflet: April 2021