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

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 (also known as non-insulin-dependent diabetes), when diet and exercise alone do not provide adequate blood sugar control. 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 (sugar) 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 sugar 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 proper use of glucose. In adults with overweight, long-term use of Metformin hydrochloride Stada also reduces the risk of diabetes-related complications. 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

DO NOT 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 diabetic ketoacidosis. Diabetic ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or a characteristic fruity breath odor
• 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, discuss it with your doctor or pharmacist. Risk of lactic acidosis Metformin hydrochloride Stada may rarely cause a 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 sufficiently 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.

Stop taking Metformin hydrochloride Stada and contact your doctor or the nearest hospital immediately if the patient experiences any of the following symptoms of lactic acidosis

as it can lead to coma.Symptoms of lactic acidosis include: vomiting, abdominal pain, muscle cramps, general feeling of being unwell, accompanied by severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and heart rate.

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

Consult 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 encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or inherited diabetes and deafness from their mother (MIDD, maternal inherited diabetes and deafness).
• the patient experiences any of the following symptoms after starting metformin: seizures, decreased cognitive abilities, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

Temporarily stop taking Metformin hydrochloride Stada if the patient experiences 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 the patient drinks less fluid than usual. Consult your doctor for more detailed instructions. Consider the following:

• If the patient is to undergo major surgery, they must nottake Metformin hydrochloride Stada during the surgery and for some time after it. The doctor will decide when the patient should stop and resume treatment with Metformin hydrochloride Stada.
• Metformin hydrochloride Stada, used as the only medicine, 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 sulfonylurea derivatives, 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 drink usually helps.
• During treatment with Metformin hydrochloride Stada, 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 impaired kidney function.

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

Metformin hydrochloride Stada and other medicines

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

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 the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their 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, used as the only medicine, does not cause hypoglycemia (low blood sugar). This means that it should not affect the patient's ability to drive or use machines. However, be cautious if taking Metformin hydrochloride Stada in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides). Hypoglycemia symptoms include weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating. If such symptoms occur, do not drive or operate 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

The doctor may prescribe Metformin hydrochloride Stada as the only medicine or in combination with other oral anti-diabetic medicines or insulin. Always take this medicine exactly as your doctor has told you. If you are not sure, 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 taking Metformin hydrochloride Stada, the 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 the patient has impaired kidney function, the doctor may prescribe a lower dose. The doctor will order regular blood sugar tests and adjust the dose of Metformin hydrochloride Stada based on the blood sugar values. Regular check-ups with the doctor are necessary, especially for elderly patients.

Method of administration

Take the tablets orally. Usually, take the tablets once a day with the evening meal. Swallow the tablets whole with a glass of water. Do not crush or chew the tablets. The tablets are designed to provide prolonged release of the medicine after administration. This means that the medicine is released into the body slowly, so it is only necessary to take the tablets once a day. In some cases, the doctor may recommend taking the tablets twice a day.

Taking a higher dose of Metformin hydrochloride Stada than recommended

If a higher number of tablets than recommended is taken, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal cramps), muscle cramps, general feeling of being unwell, accompanied by severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and heart rate.

If any of these symptoms occur, stop taking Metformin hydrochloride Stada and contact your doctor or the nearest hospital

immediately, as lactic acidosis can lead to coma.

Missing a dose of Metformin hydrochloride Stada

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

4. Possible side effects

Like all medicines, Metformin hydrochloride Stada can cause side effects, although not everybody gets them. The following side effects may occur: Metformin hydrochloride Stada may very rarely cause (may occur in less than 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, stop taking Metformin hydrochloride Stada and contact your doctor or the nearest hospital immediately, 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 occur in less than 1 in 10,000 people) abnormal liver function test results and liver inflammation (which can cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin and whites of the eyes). If such symptoms occur, stop taking Metformin hydrochloride Stada and consult your doctor.

Other possible side effects are listed below, according to their frequency:

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

• gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, loss of appetite. If these symptoms occur, do 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, stop taking Metformin hydrochloride Stada and tell your doctor.

Common(may occur in less than 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 numbness and tingling). The 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 occur in less than 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, tell your 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.: +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metformin hydrochloride Stada

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after "Expiry date" or "EXP". The expiry date refers to the last day of the month stated. Store below 25°C. Medicines should not be disposed of via wastewater or household waste. 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 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 are: Povidone K-90F, Colloidal anhydrous silica, Carboxymethylcellulose, Hypromellose type 100000 cps, 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 approximately 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 approximately 20 mm, and the width is approximately 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 approximately 22.6 mm, and the width is approximately 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 mg tablets with prolonged release, STADAMET retard 750 mg tablets with prolonged release, STADAMET retard 1000 mg tablets with prolonged release 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, 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