Metformin hidrohloride Stada

Leaflet accompanying the packaging: information for the user

Metformin hydrochloride STADA, 500 mg, coated tablets

Metformin hydrochloride STADA, 850 mg, coated tablets

Metformin hydrochloride STADA, 1000 mg, coated tablets

Metformin hydrochloride

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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.
• 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 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 glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for later 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 excessive increase in blood glucose levels. Metformin hydrochloride Stada helps to reduce blood glucose levels to values as close to normal as possible.
In adults with 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 weight or moderate weight loss.
Metformin hydrochloride Stada is used to treat patients with type 2 diabetes (also called "insulin-independent" diabetes), when diet and physical exercise alone cannot achieve proper blood glucose control. It is used especially in patients with overweight.
Adults can take Metformin hydrochloride Stada as the only medicine or in combination with other anti-diabetic medicines (oral medicines or insulin).
Children aged 10 and older and adolescents can take Metformin hydrochloride Stada as the only medicine or in combination with 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)
• if the patient has liver function disorders
• if the patient has significantly reduced kidney function
• if 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 disease in which substances called ketone bodies accumulate in the blood and can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odor from the mouth
• in case of excessive water loss from the body (dehydration) caused by prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney function disorders, which can threaten the occurrence of lactic acidosis (see below "Warnings and precautions")
• in case of severe infection, such as pneumonia, bronchitis or kidney infection. Severe infections can lead to kidney function disorders, which can threaten the occurrence of lactic acidosis (see below "Warnings and precautions")
• if the patient is being treated for acute heart failure, has recently had a heart attack, has severe circulatory disorders (such as shock) or breathing difficulties. This can cause tissue hypoxia, which can threaten the occurrence of lactic acidosis (see below "Warnings and precautions")
• if the patient consumes large amounts of alcohol

If any of the above situations occur, the patient should consult a doctor before taking this medicine.
It is necessary to consult a doctor if it is necessary:

• to perform a radiological examination or an examination that requires the injection of a contrast agent containing iodine into the blood
• to perform a major surgical procedure. The patient must stop taking Metformin hydrochloride Stada for a certain period before and after the examination or surgical procedure. The doctor will decide whether another treatment is necessary during this time. It is important to follow the doctor's instructions carefully.

Warnings and precautions

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 case 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 a doctor for more detailed instructions.

Stop taking Metformin hydrochloride Stada and contact a doctor or the nearest hospital immediately if the patient experiences any of the following

symptoms of lactic acidosis, as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• general malaise with strong fatigue
• breathing difficulties
• decreased body temperature and slowed heart rate

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

Temporarily stop taking Metformin hydrochloride Stada if the patient experiences 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 more detailed instructions.
Consult a doctor immediately for further instructions if:
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 and hearing loss.

Consider the following:

• If the patient is to undergo a major surgical procedure, they must not take Metformin hydrochloride Stada during the procedure and for a certain period after it. The doctor will decide when the patient must 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 symptoms of hypoglycemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances or concentration difficulties, eating or drinking a sugary drink usually helps.
• During treatment with Metformin hydrochloride Stada, the doctor will check the patient's kidney function at least once a year or more often if the patient is elderly and/or has impaired kidney function.

Metformin hydrochloride Stada and other medicines

If the patient is to be injected with a contrast agent containing iodine into the blood, for example for an X-ray examination or computed tomography, they must stop taking Metformin hydrochloride Stada before or at the latest at the time of such injection. The doctor will decide when the patient must stop and resume treatment with Metformin hydrochloride Stada.
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The patient may need more frequent blood glucose checks and kidney function tests or dose adjustments of Metformin hydrochloride Stada by the doctor. It is especially important to inform about the following medicines:

• diuretics
• medicines used to treat pain and inflammation (NSAIDs, COX-2 inhibitors, such as ibuprofen, celecoxib)
• certain medicines used to treat high blood pressure (ACE inhibitors, angiotensin II receptor antagonists)
• beta-adrenergic receptor agonists, such as salbutamol or terbutaline (used to treat asthma)
• corticosteroids (medicines used to treat many diseases, such as severe skin inflammation or asthma)
• medicines that may change the level of Metformin hydrochloride Stada 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 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 she may be pregnant or plans to have a child, she should consult a doctor, as changes in treatment or blood glucose 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 does not affect the patient's ability to drive and use machines.
However, be careful if taking Metformin hydrochloride Stada in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances or concentration difficulties. If such symptoms occur, do not drive or operate machines.

3. How to take Metformin hydrochloride Stada

Always take this medicine exactly as the doctor has told you. If you are not sure, ask your doctor or pharmacist.
Metformin hydrochloride Stada does not replace the benefits of a healthy lifestyle. Continue to follow the doctor's recommendations regarding diet and regular physical activity.

Recommended dose

Children aged 10 and older and adolescents
The usual starting dose is 500 mg or 850 mg of Metformin hydrochloride Stada once a day. The maximum daily dose is 2000 mg and is taken in 2 or 3 divided doses. Treatment in children aged 10 to 12 is only recommended on special recommendation of a doctor, due to limited experience in this age group.
Adults
The usual starting dose is 500 mg or 850 mg of Metformin hydrochloride Stada two or three 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 how to start taking Metformin hydrochloride Stada.
Metformin hydrochloride Stada, 1000 mg, coated tablets
The tablet can be divided into equal doses.

Treatment monitoring

• The doctor will order regular blood glucose tests and adjust the dose of Metformin hydrochloride Stada based on the glucose levels. Regularly visit the doctor for check-ups. This is especially important for children and adolescents and the elderly.
• The doctor will check the patient's kidney function at least once a year. More frequent checks may be necessary for the elderly or if the patient's kidneys are not functioning properly.

Method of administration

Take the tablets orally.
Metformin hydrochloride Stada should be taken during or after a meal. This will help avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet with a glass of water.

• If taking one dose a day, take it in the morning (during breakfast).
• If taking two divided doses a day, take them in the morning (during breakfast) and evening (during dinner).
• If taking three divided doses a day, take them in the morning (during breakfast), at noon (during lunch) and evening (during dinner).

If after some time the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor or pharmacist.

Taking a higher dose of Metformin hydrochloride Stada than recommended

If a higher dose of Metformin hydrochloride Stada is taken than recommended, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include:
vomiting, abdominal pain (abdominal cramps) with muscle cramps, general malaise with strong fatigue and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate. If any of these symptoms occur, the patient should
immediately seek medical attention, as lactic acidosis can lead to coma. Stop taking Metformin hydrochloride Stada
and contact a doctor or the nearest hospital.

Missing a dose of Metformin hydrochloride Stada

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 doubts about taking this medicine, consult a 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:
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 in the patient, stop taking Metformin hydrochloride Stada and contact a doctor or the nearest hospital, as lactic acidosis can lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• general malaise with strong fatigue
• breathing difficulties
• decreased body temperature and slowed heart rate

Other possible side effects are listed below by frequency of occurrence:
Very common(may occur in more than 1 in 10 people)

• gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, loss of appetite. These side effects usually occur at the beginning of treatment with Metformin hydrochloride Stada. Dividing the daily dose into several smaller doses taken throughout the day and taking Metformin hydrochloride Stada with a meal or immediately after a meal may be helpful. If symptoms do not improve, 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, numbness or pale or yellowish skin). 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)

• abnormal liver function test results or symptoms of hepatitis (with accompanying fatigue, loss of appetite, weight loss, and yellowing or non-yellowing of the skin and whites of the eyes). If such symptoms occur, stop taking Metformin hydrochloride Stada and contact a doctor.
• skin reactions, such as skin redness, itching or itchy rash.

Children and adolescents

Limited data from studies in children and adolescents indicate that side effects have a similar nature and severity as in adults.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell a doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 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 packaging after "Expiry date" or "EXP". The expiry date refers to the last day of the month.
Only for bottles: The shelf life after first opening the bottle is 90 days.
No special precautions for storage are necessary.
Medicines should not be disposed of via wastewater or household waste. Ask a 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 hydrochloride Stada contains

Metformin hydrochloride Stada, 500 mg, coated tablets
The active substance is metformin hydrochloride. Each coated tablet contains 500 mg of metformin hydrochloride, which corresponds to 390 mg of metformin. The other ingredients of the medicine are: magnesium stearate, povidone, hypromellose type 2910, titanium dioxide (E 171) and macrogol 3350.
Metformin hydrochloride Stada, 850 mg, coated tablets
The active substance is metformin hydrochloride. Each coated tablet contains 850 mg of metformin hydrochloride, which corresponds to 663 mg of metformin. The other ingredients of the medicine are: magnesium stearate, povidone, hypromellose type 2910, titanium dioxide (E 171) and macrogol 3350.
Metformin hydrochloride Stada, 1000 mg, coated tablets
The active substance is metformin hydrochloride. Each coated tablet contains 1000 mg of metformin hydrochloride, which corresponds to 780 mg of metformin. The other ingredients of the medicine are: magnesium stearate, povidone, hypromellose type 2910, titanium dioxide (E 171) and macrogol 3350.

What Metformin hydrochloride Stada looks like and contents of the pack

Description
Metformin hydrochloride Stada, 500 mg: White to off-white, round, coated tablets with the inscription "001" on one side and "500" on the other. The diameter of the tablets is approximately 11 mm, and the thickness is approximately 6 mm.
Metformin hydrochloride Stada, 850 mg: White to off-white, round, coated tablets with the inscription "002" on one side and "850" on the other. The diameter of the tablets is approximately 13 mm, and the thickness is approximately 7 mm.
Metformin hydrochloride Stada, 1000 mg: White to off-white, oval, biconvex, coated tablets with the inscription "003" on one side and "1000" on the other, with a dividing line on both sides. The tablet can be divided into equal doses. The length of the tablets is approximately 19 mm, and the width is approximately 10 mm.
Contents of the pack
Metformin hydrochloride Stada, 500 mg, coated tablets
PVC/Aluminum blister pack in a cardboard box: 18, 20, 28, 30, 50, 60, 84, 90, 120 and 180 coated tablets.
HDPE bottle with a child-resistant PP closure, white opaque cap, semi-transparent inner seal and a cardboard box, containing 100 coated tablets.
HDPE bottle with a PP screw cap, white opaque cap, semi-transparent inner seal and a cardboard box, containing 500 coated tablets.
Metformin hydrochloride Stada, 850 mg, coated tablets
PVC/Aluminum blister pack in a cardboard box: 18, 30, 40, 50, 56, 60, 90, 100, 120 and 180 coated tablets.
HDPE bottle with a child-resistant PP closure, white opaque cap, semi-transparent inner seal and a cardboard box, containing 100 coated tablets.
HDPE bottle with a PP screw cap, white opaque cap, semi-transparent inner seal and a cardboard box, containing 500 coated tablets.
Metformin hydrochloride Stada, 1000 mg, coated tablets
PVC/Aluminum blister pack in a cardboard box: 18, 30, 50, 60, 90, 120, 180 and 1500 coated tablets.
HDPE bottle with a child-resistant PP closure, white opaque cap, semi-transparent inner seal and a cardboard box, containing 100 coated tablets.
HDPE bottle with a PP screw cap, white opaque cap, semi-transparent inner seal and a cardboard box, containing 500 coated tablets.
Pack sizes of 500 tablets (in HDPE bottles) and 1500 tablets (in blisters) are intended only for hospital use and for dispensing to patients by medical personnel.
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
Centrafarm Services B.V.
Van de Reijtstraat 31 E
4814 NE Breda
Netherlands

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

Belgium:
Metformin EG 500 mg film-coated tablets
Metformin EG 850 mg film-coated tablets
Metformin EG 1000 mg film-coated tablets
Denmark:
Forminet
Finland:
Forminet 500 mg tablets, coated
Forminet 850 mg tablets, coated
Forminet 1000 mg tablets, coated
France:
METFORMINE EG LABO 500 mg, film-coated tablets
METFORMINE EG LABO 850 mg, film-coated tablets
METFORMINE EG LABO 1000 mg, film-coated tablets, divisible
Spain:
Metformina StadaFARMA 850 mg film-coated tablets EFG
Metformina StadaFARMA 1000 mg film-coated tablets EFG
Netherlands:
Metformine CF 1000 mg, film-coated tablets
Iceland:
Forminet 500 mg film-coated tablets
Forminet 850 mg film-coated tablets
Forminet 1000 mg film-coated tablets
Luxembourg:
Metformin EG 500 mg film-coated tablets
Metformin EG 850 mg film-coated tablets
Metformin EG 1000 mg film-coated tablets
Germany:
Metformin AL 500 mg film-coated tablets
Metformin AL 850 mg film-coated tablets
Metformin AL 1000 mg film-coated tablets
Norway:
Forminet
Poland:
Metformin hydrochloride Stada
Portugal:
Metformina Ciclum Farma
Czech Republic: StadaMET NEO
Slovakia:
Metformin Stada 500 mg film-coated tablets
Metformin Stada 850 mg film-coated tablets
Metformin Stada 1000 mg film-coated tablets
Sweden:
Forminet 500 mg film-coated tablets
Forminet 850 mg film-coated tablets
Forminet 1000 mg film-coated tablets
Hungary:
Metformin Stada 1000 mg film-coated tablets
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Phone: +48 22 737 79 20
Date of last revision of the leaflet:03.2025