METCREAN 500 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Metcrean XR
   1. Please read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Metcrean XR and what is it used for
4. Important information before taking Metcrean XR
   1. When not to take Metcrean XR:
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. The patient should temporarily stop taking Metcrean XR if they have a condition that may be associated with dehydration
   5. The patient should stop taking Metcrean XR and immediately contact their doctor or the nearest hospital if they experience any symptoms of
   6. Children and adolescents
   7. Metcrean XR and other medicines
   8. Taking Metcrean XR with food, drink, and alcohol
   9. Pregnancy, breastfeeding, and fertility
   10. Driving and using machines
5. How to take Metcrean XR
   1. Use in children and adolescents
   2. Taking a higher dose of Metcrean XR than recommended
   3. The patient should stop taking Metcrean XR and immediately contact their doctor or the nearest hospital if they experience any symptoms of
   4. Missing a dose of Metcrean XR
6. Possible side effects
   1. Very common side effects (occurring in more than 1 in 10 patients)
   2. Common side effects (occurring in less than 1 in 10 patients)
   3. Very rare side effects (occurring in less than 1 in 10,000 patients)
   4. Reporting side effects
7. How to store Metcrean XR
8. Contents of the pack and other information
   1. What Metcrean XR contains
   2. What Metcrean XR looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer/Importer
   6. Date of last revision of the leaflet: 10/2021

Leaflet attached to the packaging: patient information

Metcrean XR

500 mg, prolonged-release tablets
750 mg, prolonged-release tablets
1000 mg, prolonged-release tablets
Metformin hydrochloride

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

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should 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 side effects 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 XR and what is it used for
• 2. Important information 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 is Metcrean XR and what is it used for

Metcrean XR contains metformin. It is a medicine belonging to the group of medicines called biguanides,
intended for the treatment of diabetes.
Metcrean XR is used to treat adult patients with type 2 diabetes (also called non-insulin-dependent diabetes),
especially in patients who are overweight.
Insulin is a hormone produced by the pancreas that allows the body to take glucose from the blood and
use it to produce energy or store it for later use, and in diabetic patients, the pancreas does not produce enough.
Metcrean XR helps to reduce blood glucose levels to normal values. Taking Metcrean XR is associated with
maintaining a stable body weight or moderate weight loss.
Metcrean XR has been developed to release slowly from the tablet into the body.

2. Important information before taking Metcrean XR

When not to take Metcrean XR:

Warnings and precautions

Risk of lactic acidosis

Metcrean XR 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 the 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 insufficiently supplied with oxygen (e.g., acute severe heart disease).
If any of the above circumstances apply to the patient, they should consult their doctor for more detailed instructions.

The patient should temporarily stop taking Metcrean XR 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 their doctor for more detailed instructions.

The patient should stop taking Metcrean XR and immediately contact their 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 malaise 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 XR during the surgery and for some time after it. The doctor will decide when the patient should stop and resume 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 often if the patient is elderly and (or) has worsening kidney function.
The patient may notice tablet residues in their stool. They should not worry, as this is normal for this type of tablet.
The patient should follow all the doctor's dietary recommendations and ensure that carbohydrates are consumed regularly throughout the day.
The patient should not stop taking this medicine without consulting their doctor.

Children and adolescents

This medicine should not be used in children and adolescents.

Metcrean XR and other medicines

If the patient is to be injected with a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they must stop taking Metcrean XR before or at the latest at the time of such injection. The doctor will decide when the patient should stop and resume treatment with Metcrean XR.
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 measurements and kidney function assessments or dose adjustments of Metcrean XR by the doctor. It is especially 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).

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Also, about medicines that are available without a prescription.
If the patient is taking any of the following medicines, they may need to have their blood glucose levels measured more often, and the dose of the medicine they are taking may need to be adjusted:

• corticosteroids - medicines used to treat various diseases, such as severe skin inflammation or asthma), such as prednisolone, mometasone, beclomethasone,
• sympathomimetic medicines, including epinephrine and dopamine, used to treat heart attack and low blood pressure. Epinephrine is also a component of some anesthetics used in dentistry,
• medicines that may change the level of Metcrean XR in the blood, especially if the patient has kidney function disorders (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Taking Metcrean XR with food, drink, and alcohol

Metcrean XR should be taken with a meal or immediately after a meal.
The patient should avoid consuming excessive amounts of alcohol while taking Metcrean XR, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Metcrean XR should not be used during pregnancy and breastfeeding.
During pregnancy, diabetes treatment requires the use of insulin.

Driving and using machines

Metcrean XR itself does not cause hypoglycemia, i.e., low blood glucose levels, so it does not affect the ability to drive and use machines.
However, the patient should be particularly careful when driving and using machines if they are taking Metcrean XR with other anti-diabetic medicines that can cause hypoglycemia (e.g., sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, concentration disorders, vision, rapid heartbeat), If such symptoms occur, the patient should not drive or operate machinery.

3. How to take Metcrean XR

Metcrean XR should always be taken according to the doctor's recommendations. If in doubt, the patient should consult their doctor or pharmacist.
The doctor may recommend taking Metcrean XR alone or in combination with other oral anti-diabetic medicines or insulin.
Treatment usually starts with 1 tablet of Metcrean XR, 500 mg taken once a day with an evening meal. After 10-15 days, the dose is adjusted by the doctor based on blood glucose measurements. Gradual dose increase may improve tolerance to the medicine in the digestive tract. The maximum daily dose of Metcrean XR is 2000 mg.
If the patient has kidney function disorders, the doctor may prescribe a lower dose.
Metcrean XR is usually taken once a day, with an evening meal.
The doctor may recommend taking the medicine twice a day.
The tablets should be swallowed whole, with a glass of water. The medicine should be taken with or immediately after a meal.

Use in children and adolescents

Metcrean XR should not be used in children and adolescents.

Taking a higher dose of Metcrean XR than recommended

In case of taking a higher dose of Metcrean XR than recommended, symptoms of lactic acidosis may occur, such as vomiting, abdominal pain, muscle cramps, general malaise with severe fatigue, breathing difficulties, decreased body temperature, and slowed heart rate.

The patient should stop taking Metcrean XR and immediately contact their doctor or the nearest hospital if they experience any symptoms of

lactic acidosis, as this condition can lead to coma.
Lactic acidosis is a life-threatening condition that requires hospital treatment (see also section 4 "Possible side effects").

Missing a dose of Metcrean XR

The patient should take the missed dose as soon as they remember. The tablet should be taken with a meal.
The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Metcrean XR can cause side effects, although not everybody gets them.
Metcrean XR 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 in a patient, they should stop taking Metcrean XR and immediately contact their doctor or the nearest hospital, as lactic acidosis can lead to coma.
Metcrean XR may cause abnormal liver function test results or symptoms of liver inflammation (with accompanying fatigue, loss of appetite, weight loss, and jaundice or without jaundice of the skin and eyes). If such symptoms occur, the patient should stop taking Metcrean XR and immediately contact their doctor.

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

Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, loss of appetite. These side effects most often occur at the beginning of treatment and resolve on their own. Taking Metcrean XR with a meal or immediately after a meal may be helpful.

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)

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. 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.: 22 49 21 301, fax: 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 the medicine.

5. How to store Metcrean XR

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of that month.
There are no special precautions for storing the medicine.
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 XR contains

The active substance of the medicine is metformin hydrochloride.
Metcrean XR, 500 mg: each prolonged-release tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
Metcrean XR, 750 mg: each prolonged-release tablet contains 750 mg of metformin hydrochloride, equivalent to 585 mg of metformin.
Metcrean XR, 1000 mg: each prolonged-release tablet contains 1000 mg of metformin hydrochloride, equivalent to 780 mg of metformin.
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 inscription "500" on one side.
Metcrean XR, 750 mg: white or almost white, capsule-shaped, biconvex tablets with the inscription "750" on one side.
Metcrean XR, 1000 mg: white or almost white, oval, biconvex tablets with the inscription "1000" on one side.
Each pack contains 30, 60, or 90 prolonged-release tablets in aluminum/PVC/PVDC blisters, 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: 10/2021