Metformin hydrochloride stada: detailed information

Package leaflet: Information for the user

Metformin hydrochloride STADA, 500 mg, film-coated tablets
Metformin hydrochloride STADA, 850 mg, film-coated tablets
Metformin hydrochloride STADA, 1000 mg, film-coated tablets
Metformini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific person only. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

What Metformin hydrochloride STADA is and what it is used for
What you need to know before taking Metformin hydrochloride STADA
How to take Metformin hydrochloride STADA
Possible side effects
How to store Metformin hydrochloride STADA
Contents of the pack and other information

1. What Metformin hydrochloride STADA is and what it is 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 enables the body to take up 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 cannot properly use the insulin it produces. This leads to abnormally high levels of glucose in the blood. Metformin hydrochloride STADA helps lower blood glucose levels to values as close as possible to normal.
In overweight adults, long-term use of Metformin hydrochloride STADA also reduces the risk of diabetes-related complications. Treatment with Metformin hydrochloride STADA is associated with stable body weight or modest weight reduction.
Metformin hydrochloride STADA is used to treat patients with type 2 diabetes (also known as "non-insulin-dependent diabetes") when proper blood glucose control cannot be achieved by diet and physical exercise alone. It is particularly used in patients who are overweight.
Adults may take Metformin hydrochloride STADA as monotherapy or in combination with other antidiabetic medicines (oral medications or insulin).
Children aged 10 years and older and adolescents may take Metformin hydrochloride STADA as monotherapy 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 severely reduced kidney function
if the patient has uncontrolled diabetes, for example severe hyperglycemia (high blood sugar levels), 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 which may lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odor of the breath
in case of excessive fluid loss from the body (dehydration), caused for example by prolonged or severe diarrhea or repeated vomiting episodes. Dehydration may lead to kidney function disorders, which may increase the risk of lactic acidosis (see below "Warnings and precautions")
in case of severe infection, such as infections affecting the lungs, bronchi, or kidneys. Severe infections may lead to kidney function disorders, which may increase the risk of lactic acidosis (see below "Warnings and precautions")
if the patient is being treated for acute heart failure, has recently suffered a myocardial infarction, has severe circulatory disorders (such as shock), or breathing difficulties. These conditions may cause tissue hypoxia, which may increase the risk of lactic acidosis (see below "Warnings and precautions")
if the patient consumes large amounts of alcohol

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

a radiological examination or a procedure requiring intravenous injection of an iodine-containing contrast agent is necessary
a major surgical procedure is planned

The patient must temporarily discontinue treatment with Metformin hydrochloride STADA for a certain period before and after the examination or surgical procedure. The doctor will decide whether alternative treatment is necessary during this time. It is important to strictly follow the doctor's instructions.

Warnings and precautions
Risk of lactic acidosis
Metformin hydrochloride STADA may cause a very rare but serious adverse reaction called lactic acidosis, particularly if the patient has kidney function disorders.
The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver function disorders, and any medical conditions in which a part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, the patient should consult a doctor for further instructions.
The patient must stop taking Metformin hydrochloride STADA and immediately contact a doctor or the nearest hospital if any symptoms of lactic acidosis occur, as this condition may lead to coma.
Symptoms of lactic acidosis include:

vomiting
abdominal pain
muscle cramps
general malaise combined with severe fatigue
difficulty breathing
decreased body temperature and slowed heart rate

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
The patient should temporarily stop taking Metformin hydrochloride STADA if experiencing any medical condition that may lead to dehydration (significant fluid loss from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient is drinking less fluid than usual. The patient should consult a doctor for further instructions.
The patient should immediately contact a doctor to obtain further instructions if:

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

The following points should be considered:

If the patient is scheduled for a major surgical procedure, Metformin hydrochloride STADA must not be taken during the procedure and for a certain period afterward. The doctor will decide when the patient should stop and resume treatment with Metformin hydrochloride STADA.
Metformin hydrochloride STADA, when used alone, does not cause hypoglycemia (low blood glucose levels). However, if Metformin hydrochloride STADA is used in combination with other antidiabetic medicines that may cause hypoglycemia (such as sulfonylureas, insulin, or meglitinides), there is a risk of hypoglycemia. If symptoms of hypoglycemia occur, such as weakness, dizziness, excessive sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, consuming sugar-containing food or drink usually helps.
During treatment with Metformin hydrochloride STADA, the doctor will monitor kidney function at least once a year, or more frequently if the patient is elderly and/or has deteriorating kidney function.

Metformin hydrochloride STADA and other medicines
If the patient receives an iodine-containing contrast agent injected into the bloodstream, for example during an X-ray examination or computed tomography, the patient must stop taking Metformin hydrochloride STADA before or at the latest at the time of such injection. The doctor will decide when the patient should stop and resume treatment with Metformin hydrochloride STADA.
The patient should inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Metformin hydrochloride STADA by the doctor. It is especially important to inform the doctor about the following medicines:

medicines that increase urine production (diuretics)
medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
beta-adrenergic receptor agonists, such as salbutamol or terbutaline (used in asthma treatment)
corticosteroids (medicines used to treat many conditions, such as severe skin inflammation or asthma)
medicines that may alter the blood concentration of Metformin hydrochloride STADA, especially if the patient has impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
other medicines used in diabetes treatment.

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 section "Warnings and precautions").
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, 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 women planning to breastfeed.
Driving and operating machinery
Metformin hydrochloride STADA, when used alone, does not cause hypoglycemia (low blood glucose levels).
This means that it does not affect the patient's ability to drive or operate machinery.
However, particular caution is required if Metformin hydrochloride STADA is used together with other antidiabetic medicines that may cause hypoglycemia (such as sulfonylureas, insulin, or meglitinides). Symptoms of hypoglycemia include weakness, dizziness, excessive sweating, rapid heartbeat, vision disturbances, or difficulty concentrating. If such symptoms occur, the patient should not drive or operate machinery.

3. How to take Metformin hydrochloride STADA

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist.
Metformin hydrochloride STADA does not replace the benefits of a healthy lifestyle. You should continue to follow all your doctor's advice regarding diet and regular
physical activity.
Recommended dose
Children aged 10 years and older and adolescents
The usual starting dose is 500 mg or 850 mg of Metformin hydrochloride STADA once daily. The maximum daily dose is 2000 mg, taken in 2 or
3 divided doses. Treatment in children aged 10 to 12 years is indicated only on special
recommendation of the 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 daily. The maximum daily dose is 3000 mg, taken in
3 divided doses. If the patient has impaired kidney function, the doctor may prescribe
a lower dose.
If the patient is also using insulin, the doctor will advise how to start treatment with
Metformin hydrochloride STADA.
Metformin hydrochloride STADA, 1000 mg, film-coated tablets
The tablet may be divided into equal doses.
Monitoring of treatment

Your doctor will order regular blood glucose tests and adjust the dose of Metformin hydrochloride STADA according to blood glucose levels. You should attend regular check-up visits with your doctor. This is particularly important for children and adolescents, as well as elderly patients.
Your doctor will check your kidney function at least once a year. More frequent monitoring 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 helps to avoid
gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet whole with a glass of water.

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

If after some time the patient feels that the effect of the medicine is too strong or too weak,
they should consult their doctor or pharmacist.
Taking more than the recommended dose of Metformin hydrochloride STADA
If a dose of Metformin hydrochloride STADA higher than recommended is taken, lactic acidosis may
occur. Symptoms of lactic acidosis are non-specific and include:
vomiting, abdominal pain (pain in the abdominal cavity) with muscle cramps, general malaise, accompanied by severe fatigue and difficulty breathing. Other symptoms include decreased body temperature and slowed heart rate. If any of these symptoms occur, the patient should
seek immediate medical help, as lactic acidosis may lead to
coma. The patient must immediately stop taking Metformin hydrochloride STADA
and contact their doctor or go to the nearest hospital.
Missed 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 regarding the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
The following adverse effects may occur:
The medicine Metformin hydrochloride STADA may very rarely (may occur in no more than 1 in 10,000 people) cause a very serious adverse effect known as lactic acidosis (see section "Warnings and precautions"). If a patient develops lactic acidosis, treatment with Metformin hydrochloride STADA must be discontinued immediately and the patient must contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Symptoms of lactic acidosis include:

vomiting
abdominal pain
muscle cramps
general feeling of malaise accompanied by severe fatigue
difficulty breathing
decreased body temperature and slowed heart rate

Other possible adverse effects are listed below, classified according to their frequency of occurrence:
Very common (may affect more than 1 in 10 people)

gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain (pain in the abdominal cavity), loss of appetite. These adverse effects most commonly occur at the beginning of treatment with Metformin hydrochloride STADA. It may help to divide the daily dose into several smaller doses taken throughout the day and to take Metformin hydrochloride STADA with or immediately after meals. If symptoms do not resolve, treatment with Metformin hydrochloride STADA must be discontinued and the doctor must be informed.

Common (may affect up to 1 in 10 people)

taste disturbances
reduced or low levels of vitamin B__ in the blood (symptoms may include extreme fatigue, pain and redness of the tongue (glossitis), tingling sensations (paraesthesiae), or pale or yellowish skin). The doctor may order several tests to determine the cause of symptoms, as some of them may also be caused by diabetes or other health disorders unrelated to diabetes.

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

abnormal liver function test results or symptoms of hepatitis (accompanied by fatigue, loss of appetite, weight loss, and with or without yellowing of the skin and whites of the eyes). If such symptoms occur, treatment with Metformin hydrochloride STADA must be discontinued immediately and the doctor must be contacted.
skin reactions such as skin redness (erythema), itching, or itchy rash (urticaria).

Children and adolescents
Limited data from studies in children and adolescents indicate that adverse effects are of similar nature and severity as in adults.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Metformin hydrochloride STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container following “Expiry” or “EXP”. The expiry date refers to the last day of the stated month.
For bottle only: The shelf life after first opening the bottle is 90 days.
No special storage conditions required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Metformin hydrochloride Stada contains
Metformin hydrochloride Stada, 500 mg, film-coated tablets
The active substance is metformin hydrochloride. Each film-coated tablet contains 500 mg of
metformin hydrochloride, equivalent to 390 mg of metformin. The other ingredients are: magnesium
stearate, povidone, hypromellose type 2910, titanium dioxide (E 171) and macrogol 3350.
Metformin hydrochloride Stada, 850 mg, film-coated tablets
The active substance is metformin hydrochloride. Each film-coated tablet contains 850 mg of
metformin hydrochloride, equivalent to 663 mg of metformin. The other ingredients are: magnesium
stearate, povidone, hypromellose type 2910, titanium dioxide (E 171) and macrogol 3350.
Metformin hydrochloride Stada, 1000 mg, film-coated tablets
The active substance is metformin hydrochloride. Each film-coated tablet contains 1000 mg of
metformin hydrochloride, equivalent to 780 mg of metformin. The other ingredients 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 film-coated tablets
with the imprint “001” on one side and “500” on the other. The diameter of the tablets is approximately
11 mm and the thickness approximately 6 mm.
Metformin hydrochloride Stada, 850 mg: White to off-white, round film-coated tablets
with the imprint “002” on one side and “850” on the other. The diameter of the tablets is approximately
13 mm and the thickness approximately 7 mm.
Metformin hydrochloride Stada, 1000 mg: White to off-white, oval, biconvex film-coated tablets
with the imprint “003” on one side and “1000” on the other, and a division line on both sides. The tablet can be divided into equal doses. The length of the tablets is approximately 19 mm
and the width approximately 10 mm.

Contents of the pack
Metformin hydrochloride Stada, 500 mg, film-coated tablets
PVC/aluminium blister in a cardboard box: 18, 20, 28, 30, 50, 60, 84, 90, 120
and 180 film-coated tablets.
HDPE bottle with child-resistant polypylene (PP) closure, white opaque cap, semi-transparent inner seal and desiccant, in a cardboard box, containing 100 film-coated tablets.
HDPE bottle with polipropylene (PP) screw cap, white opaque cap, semi-transparent inner seal and desiccant, in a cardboard box, containing 500 film-coated tablets.

Metformin hydrochloride Stada, 850 mg, film-coated tablets
PVC/aluminium blister in a cardboard box: 18, 30, 40, 50, 56, 60, 90, 100, 120
and 180 film-coated tablets.
HDPE bottle with child-resistant polypylene (PP) closure, white opaque cap, semi-transparent inner seal and desiccant, in a cardboard box, containing 100 film-coated tablets.
HDPE bottle with polipropylene (PP) screw cap, white opaque cap, semi-transparent inner seal and desiccant, in a cardboard box, containing 500 film-coated tablets.

Metformin hydrochloride Stada, 1000 mg, film-coated tablets
PVC/aluminium blister in a cardboard box: 18, 30, 50, 60, 90, 120, 180 and 1500 film-coated tablets.
HDPE bottle with child-resistant polypylene (PP) closure, white opaque cap, semi-transparent inner seal and desiccant, in a cardboard box, containing 100 film-coated tablets.
HDPE bottle with polipropylene (PP) screw cap, white opaque cap, semi-transparent inner seal and desiccant, in a cardboard box, containing 500 film-coated tablets.

Pack sizes of 500 tablets (in HDPE bottles) and 1500 tablets (in blisters) are intended exclusively for hospital use and for dispensing doses to patients by medical personnel.
Not all pack sizes may be marketed.

Marketing Authorisation 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
The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Metformin EG 500 mg filmomhulde tabletten
Metformin EG 850 mg filmomhulde tabletten
Metformin EG 1000 mg filmomhulde tabletten
Denmark: Forminet
Finland: Forminet 500 mg tabletti, kalvopäällysteinen
Forminet 850 mg tabletti, kalvopäällysteinen
Forminet 1000 mg tabletti, kalvopäällysteinen
France: METFORMINE EG LABO 500 mg, comprimé pelliculé
METFORMINE EG LABO 850 mg, comprimé pelliculé
METFORMINE EG LABO 1000 mg, comprimé pelliculé sécable
Spain: Metformina StadaFARMA 850 mg comprimidos recubiertos con película EFG
Metformina StadaFARMA 1000 mg comprimidos recubiertos con película EFG
The Netherlands: Metformine CF 1000 mg, filmomhulde tabletten
Iceland: Forminet 500 mg filmuhúðaðar töflur
Forminet 850 mg filmuhúðaðar töflur
Forminet 1000 mg filmuhúðaðar töflur
Luxembourg: Metformin EG 500 mg comprimés pelliculés
Metformin EG 850 mg comprimés pelliculés
Metformin EG 1000 mg comprimés pelliculés
Germany: Metformin AL 500 mg Filmtabletten
Metformin AL 850 mg Filmtabletten
Metformin AL 1000 mg Filmtabletten
Norway: Forminet
Poland: Metformin hydrochloride Stada
Portugal: Metformina Ciclum Farma
Czech Republic: StadaMET NEO
Slovakia: Metformin Stada 500 mg filmom obalené tablety
Metformin Stada 850 mg filmom obalené tablety
Metformin Stada 1000 mg filmom obalené tablety
Sweden: Forminet 500 mg filmdragerade tabletter
Forminet 850 mg filmdragerade tabletter
Forminet 1000 mg filmdragerade tabletter
Hungary: Metformin Stada 1000 mg filmtabletta

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warszawa
Tel. +48 22 737 79 20