Metformin medreg

Package leaflet: Information for the user

Metformin Medreg, 500 mg, film-coated tablets
Metformin Medreg, 850 mg, film-coated tablets
Metformin Medreg, 1000 mg, film-coated tablets
Metformini hydrochloridum
Please read this leaflet carefully before taking this medicine, as 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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Metformin Medreg 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 future 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 increased blood glucose levels. Metformin Medreg helps reduce blood glucose levels to values as close to normal as possible.
In overweight adults, long-term use of Metformin Medreg also helps reduce the risk of diabetes-related complications. Treatment with Metformin Medreg is associated with stable body weight or moderate weight reduction.
Metformin Medreg is used in the treatment of patients with type 2 diabetes (also known as "non-insulin-dependent diabetes") when diet and exercise alone are insufficient to control blood glucose levels. It is particularly used in overweight patients.
Adults may take Metformin Medreg as monotherapy or in combination with other antidiabetic medicines (oral agents or insulin).
Children aged 10 years and older and adolescents may use Metformin Medreg as monotherapy or in combination with insulin.

2. Information before using Metformin Medreg

When not to use 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 hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or ketoacidosis. Diabetic 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 excessive loss of body water (dehydration), for example due to prolonged or severe diarrhoea or repeated vomiting. Dehydration may lead to kidney dysfunction, which may put the patient at risk of lactic acidosis (see section "Warnings and precautions").
• if the patient has a severe infection, for example pneumonia, bronchitis or kidney infection. Severe infections may lead to kidney dysfunction, which may put the patient at risk of lactic acidosis (see section "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 difficulty breathing. These conditions may lead to tissue hypoxia, which may 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, the patient should consult a doctor before starting treatment with this medicine.
The patient should consult a doctor if:

• a radiographic or computed tomography (CT) examination requiring intravenous injection of an iodine-containing contrast agent is necessary,
• a major surgical procedure is necessary.

Metformin Medreg must be discontinued for a certain period before and after such examination or surgery. The doctor will decide whether alternative treatment is necessary during this time. It is important to follow the doctor's instructions exactly.

Warnings and precautions

Risk of lactic acidosis
Metformin Medreg 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 is also increased in cases of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for more details), liver function disorders, and any medical conditions in which 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, the patient should consult a doctor for further instructions.

The patient should temporarily stop taking Metformin Medreg if a medical condition occurs that may be associated with 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. The patient should consult a doctor for further instructions.

The patient should stop taking Metformin Medreg and contact a doctor or the nearest hospital immediately if any symptoms of lactic acidosis occur, 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 undergoing a major surgical procedure, the patient must stop taking Metformin Medreg during the procedure and for some time afterwards. The doctor will decide when the patient should stop and resume treatment with Metformin Medreg.

Metformin Medreg alone does not cause hypoglycaemia (low blood glucose levels). However, if Metformin Medreg is used in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, blurred vision or difficulty concentrating, eating or drinking something containing sugar 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 deteriorating kidney function.

Metformin Medreg and other medicines

If the patient is to receive an intravenous iodine-containing contrast agent, for example for a radiographic or CT scan, the patient must stop taking Metformin Medreg before or at the latest at the time of injection. The doctor will decide when the patient should stop and resume treatment with Metformin Medreg.

The patient should 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 Metformin Medreg by the doctor. It is especially important to inform the doctor about the following medicines:

• medicines that increase urine production (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 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 Medreg, 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 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 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 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 planning to breastfeed.

Driving and operating machinery
Metformin Medreg taken alone 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, special caution should be exercised if Metformin Medreg is used together with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include: weakness, dizziness, increased sweating, rapid heartbeat, blurred vision or difficulty concentrating. If such symptoms occur, the patient should not drive or operate machinery.

Metformin Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Metformin Medreg

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Metformin Medreg does not replace the benefits derived from a healthy lifestyle. You should continue to follow all dietary and exercise recommendations provided by your doctor.

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 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 upon specific recommendation by the doctor, as experience in this age group is limited.
Adults usually start treatment with a dose of 500 mg or 850 mg of Metformin Medreg, taken 2 or 3 times daily. The maximum daily dose is 3000 mg, administered in 3 divided doses.
If the patient has impaired kidney function, the doctor may prescribe a lower dose.
If the patient is also using insulin, the doctor will provide instructions on how to start treatment with Metformin Medreg.

Monitoring of treatment

• The doctor will order regular blood glucose tests and adjust the dose of Metformin Medreg according to blood glucose levels. Regular follow-up visits to the doctor are essential. This is particularly important for children, adolescents, and elderly patients.
• The doctor will check kidney function at least once a year. More frequent monitoring may be necessary for 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 immediately after a meal. This helps to avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet whole with a glass of water.

• If the patient takes one dose per day, it should be taken in the morning (with breakfast).
• If the patient takes two doses per day, they should be taken in the morning (with breakfast) and in the evening (with dinner).
• If the patient takes three doses per day, they should be taken in the morning (with breakfast), at midday (with lunch), and in the evening (with dinner).

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

Overdose of Metformin Medreg
If a dose of Metformin Medreg higher than recommended is taken, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal discomfort) 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, the patient should seek immediate medical help, as lactic acidosis may lead to coma. The patient should immediately stop taking Metformin Medreg and contact a doctor or go to the nearest hospital.

Missed dose of Metformin Medreg
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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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 section "Warnings and precautions"). If lactic acidosis occurs in a patient, treatment with Metformin Medreg must be stopped immediately and the patient should contact a doctor or the nearest hospital immediately, because lactic acidosis may lead to coma.

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

• Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. These side effects most commonly 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 or immediately after meals. If symptoms do not resolve, treatment with Metformin Medreg should be discontinued and medical advice sought.

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

• Taste disturbances.
• Reduced or low blood levels of vitamin B_(12) (symptoms may include extreme tiredness, pain and redness of the tongue (glossitis), tingling sensations (paraesthesiae), or pale or yellowish skin). Your doctor may order several tests to determine the cause of the symptoms, as some of them may also be caused by diabetes or other health problems unrelated to diabetes.

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

• Lactic acidosis. This is a very rare but serious complication, particularly when the patient's kidneys are not functioning properly. Symptoms of lactic acidosis are non-specific (see section "Warnings and precautions").
• Abnormal liver function test results or hepatitis (liver inflammation, associated with fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If such symptoms occur, treatment with Metformin Medreg should be stopped and medical advice sought.
• Skin reactions such as redness of the skin (erythema), itching or itchy rash (urticaria).

Children and adolescents
Limited data in children and adolescents have shown that side effects were of similar type and frequency as those reported in adults.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, patients should inform their doctor or pharmacist. Side 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Metformin Medreg

Keep this medicine out of the 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 cardboard packaging and
blister: EXP. 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 Medreg contains:

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

What Metformin Medreg looks like and contents of the pack
Metformin Medreg, 500 mg:
White, round, biconvex film-coated tablet. One side of the tablet is engraved with a V-shaped break line. The tablet diameter is approximately 12 mm. The break line is intended only to facilitate tablet splitting for easier swallowing and does not ensure equal dosing.

Metformin Medreg, 850 mg:
White, oblong film-coated tablet. A V-shaped break line is engraved on both sides of the tablet. The tablet dimensions are approximately 19 x 8.7 mm. The break line is intended only to facilitate tablet splitting for easier swallowing and does not ensure equal dosing.

Metformin Medreg, 1000 mg:
White, oblong film-coated tablet. Break lines are engraved on both sides of the tablet, one being V-shaped. The tablet dimensions are approximately 19 x 10 mm. The tablet can be divided into equal doses.

The film-coated tablets are supplied in PVC/Aluminum blisters, packed in cardboard boxes.
Pack sizes: 20, 28, 30, 50, 56, 60, 90, 98, 100, 120 or 180 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation 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 no. 50, sector 3
032 266 Bucharest
Romania

This medicinal product is authorised in 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 comprimate filmate
Metformin Gemax Pharma 850 mg comprimate filmate
Metformin Gemax Pharma 1000 mg comprimate filmate