Metcrean xr

Package leaflet: Information for the user

Metcrean XR
500 mg, prolonged-release tablets
750 mg, prolonged-release tablets
1000 mg, prolonged-release tablets
Metformini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, 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, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Metcrean XR is and what it is used for

Metcrean XR contains metformin. It belongs to a group of medicines called biguanides, used to treat diabetes.
Metcrean XR is used to treat adult patients with type 2 diabetes (also known as non-insulin-dependent diabetes), particularly in overweight patients.
Insulin is a hormone produced by the pancreas that allows the body to take glucose from the blood and use it for energy or store it for later use. In people with diabetes, the pancreas does not produce enough insulin. Metcrean XR helps lower blood glucose levels to normal values. Treatment with Metcrean XR is associated with maintenance of body weight or moderate weight reduction.
Metcrean XR has been formulated to release slowly from the tablet into the body.

2. Important information before using Metcrean XR

When not to use Metcrean XR:

• if the patient is allergic (hypersensitive) to metformin or any other component of the medicine (see section 6 "What Metcrean XR contains"),
• 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 an unusual fruity odour of the breath.
• if the patient has liver disorders,
• in case of excessive loss of body fluids (dehydration), e.g. due to prolonged or severe diarrhoea or repeated vomiting. Dehydration may lead to kidney dysfunction, which may result in 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 result in 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 result in lactic acidosis (see below "Warnings and precautions"),
• if the patient abuses alcohol,
• if the patient is under 18 years of age.

Warnings and precautions
Risk of lactic acidosis
Metcrean XR may cause a very rare but serious adverse reaction 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 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, consult a doctor for further instructions.
Temporarily discontinue use of Metcrean XR if the patient develops a medical condition that may involve 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 use of Metcrean XR and contact a doctor or nearest hospital immediately 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 severe fatigue,
• difficulty breathing,
• 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 major surgery, Metcrean XR 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 Metcrean XR.
During treatment with Metcrean XR, 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.
The patient may notice tablet remnants in the stool. This is normal for this type of tablet and should not be a cause for concern.
Follow all dietary advice given by the doctor and ensure carbohydrates are consumed regularly throughout the day.
Do not stop using this medicine without consulting the doctor.
Children and adolescents
This medicine should not be used in children and adolescents.
Metcrean XR and other medicines
If the patient is to receive an iodine-containing contrast agent intravenously, for example for an X-ray or CT scan, the patient must stop taking Metcrean XR before or at the latest at the time of injection. The doctor will decide when the patient should stop and restart treatment with Metcrean XR.
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Metcrean XR by the doctor. It is particularly important to inform 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).

Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
If the patient is taking any of the following medicines concurrently, more frequent blood glucose monitoring may be required and the dose of the medicine may need adjustment:

• corticosteroids – medicines used to treat various conditions, such as severe skin inflammation or asthma, e.g. prednisolone, mometasone, beclomethasone,
• sympathomimetic medicines, including epinephrine and dopamine, used to treat myocardial infarction and low blood pressure. Epinephrine is also a component of some local anaesthetics used in dentistry,
• medicines that may alter Metcrean XR blood levels, especially if the patient has impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Taking Metcrean XR with food, drink and alcohol
Take Metcrean XR with a meal or immediately after a meal.
Avoid excessive alcohol consumption while taking Metcrean XR, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Metcrean XR should not be used during pregnancy or breastfeeding.
During pregnancy, diabetes treatment requires insulin therapy.
Driving and using machines
Metcrean XR itself does not cause hypoglycaemia (low blood glucose levels) and therefore does not affect the ability to drive or operate machinery.
However, particular caution is required when driving or operating machinery if Metcrean XR is used concomitantly with other antidiabetic medicines that may cause hypoglycaemia (e.g. sulfonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, excessive sweating, difficulty concentrating, visual disturbances, and rapid heartbeat. If such symptoms occur, do not drive or operate machinery.

3. How to use Metcrean XR

Metcrean XR must always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
The physician may prescribe treatment with Metcrean XR alone or in combination with other oral antidiabetic drugs or insulin.
Treatment usually starts with 1 tablet of Metcrean XR 500 mg once daily with the evening meal. After 10–15 days, the dose is adjusted by the physician based on blood glucose measurements. Gradual dose escalation may improve gastrointestinal tolerance. The maximum daily dose of Metcrean XR is 2000 mg.
If the patient has impaired renal function, the physician may prescribe a lower dose.
Metcrean XR is usually taken once daily with the evening meal.
The physician may recommend taking the medication twice daily.
Tablets should be swallowed whole with a glass of water. The medication should be taken during or immediately after a meal.

Use in children and adolescents
Metcrean XR must not be used in children and adolescents.

Accidental overdose of Metcrean XR
If a larger than recommended dose of Metcrean XR is taken, symptoms of lactic acidosis may occur, such as vomiting, abdominal pain, muscle cramps, general malaise accompanied by severe fatigue, difficulty breathing, lowered body temperature, and slowed heart rate.
The use of Metcrean XR must be discontinued and immediate contact must be made with a physician or the nearest hospital if any symptoms of lactic acidosis occur, as this condition may lead to coma.
Lactic acidosis is a life-threatening condition requiring hospital treatment (see also section 4, "Possible adverse effects").

Missed dose of Metcrean XR
If a dose is missed, it should be taken as soon as remembered. The tablet should be taken with a meal.
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Metcrean XR may cause side effects, although not everybody gets them.

Metcrean XR may very rarely (may occur in up to 1 in 10,000 patients) cause a very serious side effect known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, Metcrean XR treatment must be stopped immediately and the patient should contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Metcrean XR may cause abnormal liver function test results or symptoms of hepatitis (accompanied by fatigue, loss of appetite, weight loss, and with or without yellowing of the skin or eyes). If such symptoms occur, Metcrean XR treatment must be stopped and the patient should contact a doctor immediately.

Very common side effects (occur in more than 1 in 10 people)
Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain, and loss of appetite. These side effects usually occur at the beginning of treatment and resolve spontaneously. It may be helpful to take Metcrean XR with a meal or immediately after a meal.

Common side effects (occur in less than 1 in 10 people)
Taste disturbances.

Very rare side effects (occur in less than 1 in 10,000 people)

• Skin reactions such as redness of the skin (flushing), itching, or itchy rash (urticaria).
• Low blood levels of vitamin B12.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 authorisation holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Metcrean XR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of that month.
No special storage conditions apply for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Metcrean XR contains
The active substance is metformin hydrochloride.
Metcrean XR, 500 mg: each prolonged-release tablet contains 500 mg of metformin hydrochloride, corresponding to 390 mg of metformin.
Metcrean XR, 750 mg: each prolonged-release tablet contains 750 mg of metformin hydrochloride, corresponding to 585 mg of metformin.
Metcrean XR, 1000 mg: each prolonged-release tablet contains 1000 mg of metformin hydrochloride, corresponding to 780 mg of metformin.
The other ingredients are: microcrystalline cellulose, hypromellose (K200 M), povidone (K-90 F), magnesium stearate.

What Metcrean XR looks like and contents of the pack
Metcrean XR, 500 mg: white or almost white capsule-shaped, biconvex tablets with the imprint "500" on one side.
Metcrean XR, 750 mg: white or almost white capsule-shaped, biconvex tablets with the imprint "750" on one side.
Metcrean XR, 1000 mg: white or almost white oval-shaped, biconvex tablets with the imprint "1000" on one side.
Each pack contains 30, 60, or 90 prolonged-release tablets in blisters made of Aluminium/PVC/PVDC, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
Krakowiaków 65 Street
02-255 Warsaw

Manufacturer/Importer
Synoptis Industrial Sp. z o.o.
Rabowicka 15 Street
62-020 Swarzędz