Metformin Medreg

Leaflet attached to the packaging: patient information

Metformin Medreg, 500 mg, film-coated tablets

Metformin Medreg, 850 mg, film-coated tablets

Metformin Medreg, 1000 mg, film-coated tablets

Metformin hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Metformin Medreg and what is it used for

Metformin Medreg 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 future 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 increase in blood glucose levels. Metformin Medreg helps to reduce blood glucose levels to as close to normal as possible.
In adults with overweight, long-term use of Metformin Medreg also helps to reduce the risk of complications associated with diabetes. Taking Metformin Medreg is associated with maintaining body weight or modest weight loss.
Metformin Medreg is used to treat patients with type 2 diabetes (also called "non-insulin-dependent diabetes"), when diet and exercise alone are not enough to control blood glucose levels. It is particularly used in patients with overweight.
Adults can take Metformin Medreg as monotherapy or in combination with other anti-diabetic medicines (oral medicines or insulin).
Children aged 10 years and older and adolescents can take Metformin Medreg as monotherapy or in combination with insulin.

2. Important information before taking Metformin Medreg

When not to take Metformin Medreg

• if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6),
• if the patient has liver function disorders,
• if the patient has significantly reduced kidney function,
• if the patient has uncontrolled diabetes, for example with severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid 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 a diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odor from the mouth.
• if the patient has excessive water loss from the body (dehydration), for example due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney function disorders, which can put the patient at risk of lactic acidosis (see "Warnings and precautions").
• if the patient has a severe infection, for example pneumonia, bronchitis or kidney infection. Severe infections can lead to kidney function disorders, which can put the patient at risk of lactic acidosis (see "Warnings and precautions").
• if the patient is being treated for acute heart failure or has recently had a heart attack, has severe circulatory disorders (e.g. shock) or has breathing difficulties. This can lead to tissue hypoxia, which can put the patient at risk of lactic acidosis (see "Warnings and precautions").
• if the patient consumes large amounts of alcohol.

If any of the above situations apply to the patient, they should consult a doctor before taking this medicine.
The patient should consult a doctor if:

• they need to undergo an X-ray examination or computed tomography that requires the injection of a contrast agent containing iodine into the bloodstream,
• they need to undergo a major surgical procedure.

Metformin Medreg must be discontinued for a period before and after the examination or surgical procedure. 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 Medreg 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 also increases in cases of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see more detailed 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 situations apply to the patient, they should consult a doctor for further instructions.

The patient should temporarily discontinue taking Metformin Medreg if they have a condition that may be associated with dehydration

(significant water 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 further instructions.

The patient should discontinue taking Metformin Medreg 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, accompanied by 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 a major surgical procedure, they must discontinue taking Metformin Medreg during and for some time after the procedure. The doctor will decide when the patient should discontinue and resume taking Metformin Medreg.
Metformin Medreg taken alone does not cause hypoglycemia (low blood sugar). However, if Metformin Medreg is taken in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, 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 Medreg, 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 Medreg 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 discontinue taking Metformin Medreg before or at the latest at the time of injection. The doctor will decide when the patient should discontinue and resume taking Metformin Medreg.
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 monitoring of blood glucose levels and kidney function assessments or dose adjustments of Metformin Medreg by the doctor. It is particularly important to inform the doctor about the following medicines:

• diuretics,
• medicines used to treat pain and inflammatory conditions (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 Medreg 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 Medreg and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Metformin Medreg, 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 child, they should consult a doctor, as changes in treatment or monitoring of blood glucose levels may be necessary.
This medicine is not recommended if the patient is breastfeeding or plans to breastfeed their child.

Driving and using machines

Metformin Medreg taken alone does not cause hypoglycemia (low blood sugar). This means that it does not affect the patient's ability to drive or use machines.
However, the patient should be careful if they are taking Metformin Medreg in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, 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 use machines.

Metformin Medreg contains sodium

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

3. How to take Metformin Medreg

This medicine should always be taken according to the doctor's instructions. If the patient has any doubts, they should consult a doctor or pharmacist.
Metformin Medreg does not replace the benefits of a healthy lifestyle.
The patient should continue to follow all the doctor's recommendations regarding diet and regular physical activity.

Recommended dose

Children aged 10 years and older and adolescents usually start treatment with a dose of 500 mg or 850 mg of Metformin Medreg once a day. The maximum daily dose is 2000 mg and is taken in 2 or 3 divided doses.
Treatment of children aged 10 to 12 years is only used in cases where the doctor has given special permission, as experience in this age group is limited.
Adults usually start treatment with a dose of 500 mg or 850 mg of Metformin Medreg, 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 Medreg.

Treatment monitoring

• The doctor will order regular blood glucose tests and adjust the dose of Metformin Medreg based on 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 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 Medreg

Metformin Medreg should be taken with a meal or after a meal. This will help avoid gastrointestinal side effects.
The patient should not crush or chew the tablets. They should swallow the tablet with a glass of water.

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

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

Taking a higher dose of Metformin Medreg than recommended

In the event of taking a higher dose of Metformin Medreg than recommended, lactic acidosis may occur. The symptoms of lactic acidosis are non-specific and include: vomiting, abdominal pain (abdominal cramps) with muscle cramps, general feeling of being unwell, accompanied by severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate.

If the patient experiences any of these symptoms, they should immediately seek medical attention, as lactic acidosis can lead to coma. The patient should immediately discontinue taking Metformin Medreg and contact a doctor or the nearest

hospital.

Missing a dose of Metformin Medreg

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.
If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Metformin Medreg can cause side effects, although not everybody gets them.
The following side effects may occur:
Metformin Medreg may cause a very rare (may affect up to 1 in 10,000 patients), but very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs in the patient, they should discontinue taking Metformin Medreg and immediately contact a doctor or the nearest hospital, as lactic acidosis can lead to coma.
Very common side effects(may affect more than 1 in 10 patients):

• gastrointestinal disorders, such as nausea (nausea), vomiting, diarrhea, abdominal pain (abdominal pain) and loss of appetite. These side effects most often occur at the beginning of treatment with Metformin Medreg. It is helpful to divide the daily dose into several smaller doses taken throughout the day and to take Metformin Medreg with a meal or immediately after a meal. If the symptoms do not disappear, the patient should discontinue taking Metformin Medreg and consult a doctor.

Common side effects(may affect up to 1 in 10 patients):

• taste disorders.
• decreased or low levels of vitamin B in the blood (symptoms may include extreme fatigue, pain and redness of the tongue, numbness or pale or yellowish skin). The doctor may order several tests to determine the cause of the symptoms, as some of them may also be caused by diabetes or other non-diabetes-related health problems.

Very rare side effects(may affect up to 1 in 10,000 patients):

• lactic acidosis. This is a very rare but serious complication that occurs especially when the patient's kidneys are not working properly. The symptoms of lactic acidosis are non-specific (see "Warnings and precautions").
• abnormal liver function test results or hepatitis (hepatitis, with accompanying fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If such symptoms occur, the patient should discontinue taking Metformin Medreg and consult a doctor.
• skin reactions, such as skin redness, itching or itchy rash.

Children and adolescents

Limited data in children and adolescents have shown that side effects have a similar nature and severity to those reported in adults.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 Medreg

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the month stated.
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 packaging and other information

What Metformin Medreg contains:

• The active substance of the medicine is metformin hydrochloride. Metformin Medreg, 500 mg: each film-coated tablet contains 500 mg of metformin hydrochloride (which corresponds to 390 mg of metformin). Metformin Medreg, 850 mg: each film-coated tablet contains 850 mg of metformin hydrochloride (which corresponds to 662.9 mg of metformin). Metformin Medreg, 1000 mg: each film-coated tablet contains 1000 mg of metformin hydrochloride (which corresponds to 780 mg of metformin).
• Other ingredients are: Tablet core: hypromellose 615, sodium carbonate anhydrous, povidone K 25, magnesium stearate. Tablet coating: hypromellose 606, macrogol 6000, titanium dioxide (E 171).

What Metformin Medreg looks like and what the pack contains

Metformin Medreg, 500 mg:
White, round, biconvex film-coated tablet. One side of the tablet has a score line in the shape of the letter V. The diameter of the tablet is approximately 12 mm. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
Metformin Medreg, 850 mg:
White, oval film-coated tablet. Both sides of the tablet have a score line in the shape of the letter V. The dimensions of the tablet are approximately 19 x 8.7 mm. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
Metformin Medreg, 1000 mg:
White, oval film-coated tablet. Score lines are engraved on both sides of the tablet, with one side having a score line in the shape of the letter V. The dimensions of the tablet are approximately 19 x 10 mm. The tablet can be divided into equal doses.
Film-coated tablets are supplied in PVC/Aluminum blisters, in a carton box.
Package sizes: 20, 28, 30, 50, 56, 60, 90, 98, 100, 120 or 180 film-coated tablets.
Not all package sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Importer:

S.C. ZENTIVA S.A.
B-dul Theodor Pallady nr. 50, sector 3
032 266 Bucharest
Romania

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

Czech Republic:
Metformin Medreg
Poland:
Metformin Medreg
Slovakia:
Metformin Medreg 500 mg
Metformin Medreg 850 mg
Metformin Medreg 1 000 mg
Romania:
Metformin Gemax Pharma 500 mg film-coated tablets
Metformin Gemax Pharma 850 mg film-coated tablets
Metformin Gemax Pharma 1000 mg film-coated tablets

Date of last revision of the leaflet: