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

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 necessary.
• In case of 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.
• 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 people with diabetes, the pancreas does not produce enough insulin or the body is not able 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 use 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
• 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 it is necessary to use another treatment 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.

The patient should stop taking Metformin hydrochloride Stada and immediately contact a doctor or the nearest hospital if they experience 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 accompanied by severe fatigue
• breathing difficulties
• decreased body temperature and slowed heart rate

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

The patient should temporarily stop taking Metformin hydrochloride Stada if they experience 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.
The patient should immediately contact a doctor 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.

The patient should be aware of 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 sulfonylureas, 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.
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 blood glucose checks and kidney function assessments 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

The patient 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 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 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 or use machines.
However, the patient should be careful if they take Metformin hydrochloride Stada 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 heartbeat, vision disturbances, or concentration difficulties. If such symptoms occur, the patient should not drive or use machines.

3. How to take Metformin hydrochloride Stada

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult a doctor or pharmacist.
Metformin hydrochloride Stada does not replace the benefits of a healthy lifestyle. The patient should continue to follow the doctor's recommendations regarding diet and regular physical activity.

Recommended dose

Children aged 10 and older and adolescents
The usual initial 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 advice from a doctor, due to limited experience in this age group.
Adults
The usual initial 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 smaller dose.
If the patient is also taking insulin, the doctor will inform them 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 checks and adjust the dose of Metformin hydrochloride Stada based on the glucose levels. The patient should regularly visit the doctor for check-ups. This is especially important for children and adolescents, as well as 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

The tablets should be taken orally.
Metformin hydrochloride Stada should be taken during or after a meal. This will help avoid gastrointestinal side effects.
The tablets should not be crushed or chewed. The tablet should be swallowed with a glass of water.

• In case of taking one dose per day, it should be taken in the morning (during breakfast).
• In case of taking two divided doses per day, they should be taken in the morning (during breakfast) and in the evening (during dinner).
• In case of taking three divided doses per day, they should be taken in the morning (during breakfast), at noon (during lunch), and in the evening (during dinner).

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

Taking a higher dose of Metformin hydrochloride Stada than recommended

In case of taking a higher dose of Metformin hydrochloride Stada 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 accompanied by severe 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.
The patient should stop taking Metformin hydrochloride Stada and contact a doctor or the nearest hospital immediately.

Missing a dose of Metformin hydrochloride Stada

The patient should not take a double dose to make up for a missed dose. The next dose should be taken at the usual time.
In case of any further doubts about taking this medicine, the patient should 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 fewer than 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs in the patient, they should stop taking Metformin hydrochloride Stada and immediately 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 accompanied by severe fatigue
• breathing difficulties
• decreased body temperature and slowed heart rate

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. These side effects most often occur at the beginning of treatment with Metformin hydrochloride Stada. It may be helpful to divide the daily dose into several smaller doses taken throughout the day and take Metformin hydrochloride Stada with a meal or immediately after a meal. If the symptoms do not disappear, the patient should stop taking Metformin hydrochloride Stada and tell their doctor.

Common(may occur in fewer 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 or pale or yellowish skin). The doctor may order some 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 fewer than 1 in 10,000 people)

• abnormal liver function test results or symptoms of hepatitis (accompanied by fatigue, loss of appetite, weight loss, and yellowing of the skin and whites of the eyes). If such symptoms occur, the patient should immediately stop taking Metformin hydrochloride Stada and contact a doctor.
• skin reactions, such as redness of the skin, itching, or an itchy rash (hives).

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, the patient should tell their 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
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

The medicine should be stored out of 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.
There are no special precautions for storing the medicine.
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 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 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 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 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, the patient should 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