Metformin hidrohloride Stada

Leaflet attached to the packaging: information for the user

Metformin hydrochloride STADA, 500 mg, prolonged-release tablets

Metformin hydrochloride STADA, 750 mg, prolonged-release tablets

Metformin hydrochloride STADA, 1000 mg, prolonged-release 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 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 hydrochloride Stada and what is it used for
• 2. Important information before taking Metformin hydrochloride Stada
• 3. How to take Metformin hydrochloride Stada
• 4. Possible side effects
• 5. How to store Metformin hydrochloride Stada
• 6. Contents of the packaging and other information

1. What is Metformin hydrochloride Stada and what is it used for

Metformin hydrochloride Stada contains the active substance metformin hydrochloride, which belongs to a group of medicines called biguanides. Metformin hydrochloride Stada is used to treat patients with type 2 diabetes mellitus (also called non-insulin-dependent diabetes), when diet and exercise alone do not provide adequate control of blood glucose levels. It is particularly used in patients who are overweight. Insulin is a hormone produced by the pancreas that allows the body to take up glucose from the blood. The body uses glucose to produce energy or stores it for later use. In patients with type 2 diabetes, the pancreas does not produce enough insulin or the body is unable to use the insulin produced properly. This leads to an excessive increase in blood glucose levels, which can cause a range of serious and long-term complications. Therefore, it is essential to continue taking the medicine, even if the patient does not experience any obvious symptoms. Metformin hydrochloride Stada increases the body's sensitivity to insulin and helps restore the normal use of glucose by the body. In adults who are overweight, long-term use of Metformin hydrochloride Stada also reduces the risk of complications associated with diabetes. Taking Metformin hydrochloride Stada is associated with maintaining or moderately reducing body weight. The prolonged-release tablets of Metformin hydrochloride Stada are specially designed to release the medicine slowly in the body and therefore differ from many other types of metformin tablets. Adults can take Metformin hydrochloride Stada as the only medicine or in combination with other anti-diabetic medicines (oral or insulin).

2. Important information before taking Metformin hydrochloride Stada

WHEN NOT to take Metformin hydrochloride Stada if:

• the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause a rash, itching, or difficulty breathing
• the patient has liver function disorders
• the patient has significantly reduced kidney function
• the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, 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 can lead to diabetic precoma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odor from the mouth
• the patient has lost excessive amounts of water from the body (dehydration), caused by prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney function disorders, which can increase the risk of lactic acidosis (see below "Warnings and precautions")
• the patient has a severe infection, such as pneumonia, bronchitis, or kidney infection. Severe infections can lead to kidney function disorders, which can increase the risk of lactic acidosis (see below "Warnings and precautions")
• the patient is being treated for acute heart problems, has recently had a heart attack, has severe circulatory problems (such as shock) or breathing difficulties. This can cause tissue hypoxia, which can increase the risk of lactic acidosis (see below "Warnings and precautions")
• the patient consumes large amounts of alcohol

Warnings and precautions

Before starting treatment with Metformin hydrochloride STADA, you should discuss it with your doctor or pharmacist. Risk of lactic acidosis Metformin hydrochloride Stada 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 infection, 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 adequately 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.

You should stop taking Metformin hydrochloride Stada and immediately contact your doctor or the nearest hospital if you experience any of the following symptoms of lactic acidosis

because it 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 heart rate

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.

You should contact your doctor immediately for further instructions if:

• the patient has a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• the patient experiences any of the following symptoms after starting metformin: seizures, impaired cognitive function, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

You should temporarily stop taking Metformin hydrochloride Stada if you have a condition that may lead to dehydration

(excessive water loss from the body),such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. You should consult your doctor for more detailed instructions. You should consider the following:

• If you are to undergo major surgery, you must nottake Metformin hydrochloride Stada during or for some time after the surgery. Your doctor will decide when you should stop and resume treatment with Metformin hydrochloride Stada.
• Metformin hydrochloride Stada, when used alone, does not cause hypoglycemia (low blood sugar). However, if Metformin hydrochloride Stada is used in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia. If hypoglycemia symptoms occur, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, eating or drinking a sugary snack usually helps.
• During treatment with Metformin hydrochloride Stada, your doctor will regularly check your kidney function, at least once a year or more often if you are elderly and/or have impaired kidney function.

It may happen that the tablet coating is visible in the stool. You should not be concerned, as this is normal when taking this type of tablet. Metformin hydrochloride Stada does not replace the benefits of a healthy lifestyle. You should continue to follow your doctor's recommendations regarding diet and regular physical activity. You should not stop taking the medicine without consulting your doctor.

Metformin hydrochloride Stada and other medicines

If you are to receive an intravenous injection of a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, you must stoptaking Metformin hydrochloride Stada before or at the latest at the time of the injection. Your doctor will decide when you should stop and resume treatment with Metformin hydrochloride Stada. You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood sugar checks and kidney function tests or dose adjustments of Metformin hydrochloride Stada by your doctor. It is especially important to inform your doctor about the following medicines:

• diuretics (e.g., furosemide)
• medicines used to treat pain and inflammation (e.g., ibuprofen, celecoxib)
• certain medicines used to treat high blood pressure (e.g., ACE inhibitors, angiotensin II receptor antagonists)
• certain medicines used to treat asthma (e.g., beta-adrenergic receptor agonists, such as salbutamol or terbutaline)
• medicines used to treat heart attack or low blood pressure (e.g., sympathomimetics, including epinephrine and dopamine). Epinephrine is also contained in some dental anesthetics.
• medicines with anti-inflammatory effects (corticosteroids, such as prednisolone, mometasone, beclomethasone)
• medicines that may change the level of Metformin hydrochloride Stada in the blood, especially if you have kidney function disorders (e.g., verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
• other medicines used to treat diabetes.

Metformin hydrochloride Stada and alcohol

You should avoid consuming excessive amounts of alcohol while taking Metformin hydrochloride Stada, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to have a baby, you should consult your doctor, as changes in treatment or blood sugar monitoring may be necessary. This medicine is not recommended for breastfeeding women or those planning to breastfeed.

Driving and using machines

Metformin hydrochloride Stada, when used alone, does not cause hypoglycemia (low blood sugar). This means that it should not affect your ability to drive or use machines. However, you should be careful if you take Metformin hydrochloride Stada with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). Hypoglycemia symptoms include weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating. If you experience such symptoms, you should not drive or use machines.

Metformin hydrochloride Stada contains sodium

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

3. How to take Metformin hydrochloride Stada

Your doctor may prescribe Metformin hydrochloride Stada as the only medicine or in combination with other oral anti-diabetic medicines or insulin. You should always take this medicine exactly as your doctor has told you. If you are unsure, you should consult your doctor or pharmacist.

Recommended dose

The usual starting dose is 500 mg of Metformin hydrochloride Stada per day. After about 2 weeks of treatment with Metformin hydrochloride Stada, your doctor may order a blood sugar test and adjust the dose of the medicine. The maximum daily dose is 2000 mg of Metformin hydrochloride Stada. If you have impaired kidney function, your doctor may prescribe a lower dose. Your doctor will regularly check your blood sugar levels and adjust the dose of Metformin hydrochloride Stada according to the blood sugar levels. You should regularly visit your doctor for check-ups. This is especially important for elderly patients.

Method of administration

The tablets should be taken orally. Usually, you should take the tablets once a day with your evening meal. The tablets should be swallowed whole with a glass of water. The tablets should not be crushed or chewed. The tablets are designed to provide prolonged release of the medicine after administration. This means that the medicine is released slowly into the body, so you only need to take the tablets once a day. In some cases, your doctor may recommend taking the tablets twice a day.

Taking a higher dose of Metformin hydrochloride Stada than recommended

If you take more tablets than recommended, you may experience lactic acidosis. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain with muscle cramps, general feeling of being unwell accompanied by severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and heart rate.

If you experience any of these symptoms, you should immediately stop taking Metformin hydrochloride Stada and contact your doctor or the nearest hospital

because lactic acidosis can lead to coma.

Missing a dose of Metformin hydrochloride Stada

You should take the next dose as soon as possible with a meal. You should not take a double dose to make up for the missed dose. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:

Very rare(may affect up to 1 in 10,000 people)

Metformin hydrochloride Stada may very rarely cause (may affect up to 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, you should stop taking Metformin hydrochloride Stada and immediately contact your doctor or the nearest hospital, as lactic acidosis 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 heart rate

Metformin hydrochloride Stada may very rarely cause (may affect up to 1 in 10,000 people) abnormal liver function test results and hepatitis (which can cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin and whites of the eyes). If you experience such symptoms, you should immediately stop taking Metformin hydrochloride Stada and contact your doctor.

Other possible side effects are listed below by frequency of occurrence:

Very common(may affect more than 1 in 10 people)

• gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, loss of appetite. If you experience these symptoms, you should not stop taking the tablets, as they usually disappear within about 2 weeks. These side effects most commonly occur at the beginning of treatment with Metformin hydrochloride Stada. Taking Metformin hydrochloride Stada with a meal may help. If the symptoms do not disappear, you should stop taking Metformin hydrochloride Stada and tell your doctor.

Common(may affect up to 1 in 10 people)

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

Very rare(may affect up to 1 in 10,000 people)

• skin reactions, such as redness, itching, or itchy rash.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can also report side effects 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metformin hydrochloride Stada

You should keep this medicine out of the sight and reach of children. You should not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month. You should store it below 25°C. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Metformin hydrochloride Stada contains

The active substance of the medicine is metformin hydrochloride. Metformin hydrochloride Stada, 500 mg, prolonged-release tabletsEach prolonged-release tablet contains 500 mg of metformin hydrochloride, which corresponds to 389.938 mg of metformin. Metformin hydrochloride Stada, 750 mg, prolonged-release tabletsEach prolonged-release tablet contains 750 mg of metformin hydrochloride, which corresponds to 584.907 mg of metformin. Metformin hydrochloride Stada, 1000 mg, prolonged-release tabletsEach prolonged-release tablet contains 1000 mg of metformin hydrochloride, which corresponds to 779.876 mg of metformin. The other ingredients of the medicine are: Povidone K-90F, Colloidal anhydrous silica, Carboxymethylcellulose, Hypromellose, Microcrystalline cellulose, Magnesium stearate

What Metformin hydrochloride Stada looks like and contents of the pack

Description Metformin hydrochloride Stada, 500 mg: White to off-white, round, biconvex tablets, with "500" embossed on one side and smooth on the other. The diameter of the tablets is about 12.15 mm. Metformin hydrochloride Stada, 750 mg: White to off-white, biconvex tablets with a capsule shape, with "750" embossed on one side and smooth on the other. The length of the tablets is about 20 mm, and the width is about 9.6 mm. Metformin hydrochloride Stada, 1000 mg: White to off-white, biconvex tablets with a capsule shape, with "1000" embossed on one side and smooth on the other. The length of the tablets is about 22.6 mm, and the width is about 10.6 mm. Contents of the pack Metformin hydrochloride Stada, 500 mg, prolonged-release tabletsThe tablets are available in PVC/PVdC/Aluminum blisters in a carton containing 30, 60, or 100 tablets. Metformin hydrochloride Stada, 750 mg, prolonged-release tabletsThe tablets are available in PVC/PVdC/Aluminum blisters in a carton containing 30, 60, or 100 tablets. Metformin hydrochloride Stada, 1000 mg, prolonged-release tabletsThe tablets are available in PVC/PVdC/Aluminum blisters in a carton containing 30 or 60 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Manufacturer/Importer

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

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

Finland: Metformin STADA 500 mg depottabletti, Metformin STADA 750 mg depottabletti, Metformin STADA 1000 mg depottabletti Germany: Metformin STADA 500 mg Retardtabletten, Metformin STADA 750 mg Retardtabletten, Metformin STADA 1000 mg Retardtabletten Poland: Metformin hydrochloride STADA Czech Republic: Stadamet Prolong Slovakia: STADAMET retard 500 tablety s predĺženým uvoľňovaním, STADAMET retard 750 mg tablety s predĺženým uvoľňovaním, STADAMET retard 1000 mg tablety s predĺženým uvoľňovaním Hungary: Diaform XR 500 mg retard tabletta, Diaform XR 750 mg retard tabletta, Diaform XR 1000 mg retard tabletta, Melliform XR 500 mg retard tabletta, Melliform XR 750 mg retard tabletta, Melliform XR 1000 mg retard tabletta, Diastart XR 500 mg retard tabletta, Diastart XR 750 mg retard tabletta, Diastart XR 1000 mg retard tabletta Italy: METFORMINA EG STADA For more information about this medicine, you should contact the local representative of the marketing authorization holder: STADA Pharm Sp. z o.o., ul. Krakowiaków 44, 02-255 Warsaw, Tel. +48 22 737 79 20

Date of last revision of the leaflet: 03.2025