Metformin hidrohloride Stada
How to use 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 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 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 up 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 or moderately reducing body weight.
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 particularly used 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 years 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 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:
Warnings and precautions
Risk of lactic acidosis
Metformin hydrochloride Stada may cause a very rare but very severe 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 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 should be aware of the following:
Metformin hydrochloride Stada and other medicines
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:
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
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 are 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 heart rate, vision disturbances, or difficulty concentrating. 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 years 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 years 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 lower dose.
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 their doctor for check-ups. This is especially important for children and adolescents, as well as elderly patients.
- The doctor will check the patient's kidney function at least once a year. More frequent checks may be necessary for elderly patients 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.
Taking a higher dose of Metformin hydrochloride Stada than recommended
immediately stop taking Metformin hydrochloride Stada and contact a doctor or the nearest hospital.
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. Like all medicines, this medicine can cause side effects, although not everybody gets them. Other possible side effects are listed below, according to their frequency: Very common(may occur in more than 1 in 10 people) Common(may occur in fewer than 1 in 10 people) Very rare(may occur in fewer than 1 in 10,000 people) Limited data from studies in children and adolescents indicate that the side effects have a similar nature and severity as in adults.4. Possible side effects
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 severe side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient 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:Children and adolescents
Reporting side effects
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 stated.
Only for bottles: The shelf life after the first opening of 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, film-coated
Forminet 850 mg tablets, film-coated
Forminet 1000 mg tablets, film-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
- Country of registration
- Active substance
- Prescription requiredYes
- ImporterCentrafarm Services B.V. STADA Arzneimittel AG
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
Ask a doctor about Metformin hidrohloride Stada online
Talk to a doctor online
Need help understanding this medicine or your symptoms? Online doctors can answer your questions and offer guidance.
Get updates and exclusive offers
Be the first to know about new services, marketplace updates, and subscriber-only promos.
