Metformin hidrohloride Teva

Leaflet attached to the packaging: information for the user

Metformin hydrochloride Teva, 850 mg, film-coated tablets

Metformin hydrochloride

You should carefully read the contents of the leaflet before taking the medicine because it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have 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 Teva and what is it used for
• 2. Important information before taking Metformin hydrochloride Teva
• 3. How to take Metformin hydrochloride Teva
• 4. Possible side effects
• 5. How to store Metformin hydrochloride Teva
• 6. Contents of the pack and other information

1. What is Metformin hydrochloride Teva and what is it used for

Metformin hydrochloride Teva 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 Teva helps to reduce blood glucose levels to values as close to normal as possible.
In adults with overweight, long-term use of Metformin hydrochloride Teva also reduces the risk of diabetes complications. Taking Metformin hydrochloride Teva is associated with maintaining a stable body weight or a moderate weight loss.
Metformin hydrochloride Teva is used to treat patients with type 2 diabetes (also called "non-insulin-dependent" diabetes), in whom diet and physical exercise alone do not provide adequate control of blood glucose levels. It is particularly used in patients with overweight.
Adults can take Metformin hydrochloride Teva as the only medicine or in combination with other anti-diabetic medicines (oral medicines or insulin).
Children from 10 years of age and adolescents can take Metformin hydrochloride Teva as the only medicine or in combination with insulin.

2. Important information before taking Metformin hydrochloride Teva

When not to take Metformin hydrochloride Teva

• if the patient is allergic to metformin or any of the other ingredients of this medicine (see "What Metformin hydrochloride Teva contains" in section 6)
• in case of liver function disorders
• if the patient has significantly reduced kidney function
• if the patient has uncontrolled diabetes, for example with 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 disease in which substances called "ketone bodies" accumulate in the blood and which can lead to a diabetic pre-coma. The 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), for example due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney function disorders, which can threaten the occurrence of lactic acidosis (see "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 "Warnings and precautions")
• in case of treatment of acute heart failure or recently suffered myocardial infarction, severe circulatory disorders (e.g. shock) or breathing difficulties. This may cause tissue hypoxia, which can threaten the occurrence of lactic acidosis (see "Warnings and precautions" below)
• in case of alcohol abuse.

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:

• a radiological examination or an examination requiring the injection of a contrast agent containing iodine into the bloodstream is necessary
• a major surgical procedure is to be performed on the patient.

Metformin hydrochloride Teva must be discontinued for a certain period before and after the examination or surgical procedure. The doctor will decide whether other treatment is necessary during this time. It is important to follow the doctor's instructions.

Warnings and precautions

Risk of lactic acidosis

Metformin hydrochloride Teva 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 increases in case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more 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.

Temporarily discontinue Metformin hydrochloride Teva 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 temperature, or if the patient drinks less fluid than usual. The patient should consult a doctor for more detailed instructions.

Discontinue Metformin hydrochloride Teva 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 feeling of being unwell with severe fatigue
• breathing difficulties
• decreased body temperature and slowed heart rate. Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.

Consult a 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 encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.
• 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, or hearing loss.

If the patient is to undergo a major surgical procedure, they must not take Metformin hydrochloride Teva during the procedure and for a certain period after it. The doctor will decide when the patient must discontinue and resume treatment with Metformin hydrochloride Teva.
Metformin hydrochloride Teva does not cause hypoglycemia (too low blood sugar).
However, if Metformin hydrochloride Teva is taken 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 difficulty concentrating, eating or drinking a sugary drink usually helps.

Metformin hydrochloride Teva with other medicines

If the patient is to be injected with a contrast agent containing iodine into the bloodstream, for example for an X-ray examination or computed tomography, they must discontinue Metformin hydrochloride Teva before or at the latest at the time of such injection. The doctor will decide when the patient must discontinue and resume treatment with Metformin hydrochloride Teva.
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 sugar checks and kidney function tests, or the doctor may need to adjust the dose of Metformin hydrochloride Teva. It is especially important to inform about the following medicines:

• 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-2 adrenergic receptor agonists, such as salbutamol or terbutaline (used to treat asthma)
• corticosteroids (used to treat various diseases, such as severe skin inflammation or asthma)
• medicines that may change the level of Metformin hydrochloride Teva in the blood, especially if the patient has kidney function disorders (such as verapamil, rifampicin, cimetidine, dolutegravir

ranolazine, trimetoprim, vandetanib, isavuconazole, crizotinib, olaparib),

• other medicines used to treat diabetes.

Metformin hydrochloride Teva with alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Metformin hydrochloride Teva, 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 in case any changes are needed in the treatment or monitoring of blood sugar levels.
This medicine is not recommended for breastfeeding women or women planning to breastfeed.

Driving and using machines

Metformin hydrochloride Teva does not cause hypoglycemia (too 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 Teva 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 difficulty concentrating. If such symptoms occur, the patient should not drive or use machines.

3. How to take Metformin hydrochloride Teva

Metformin hydrochloride Teva should always be taken according to the doctor's instructions. If the patient has any doubts, they should consult a doctor or pharmacist.
Metformin hydrochloride Teva 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 from 10 years of age and adolescents: usually start treatment with a dose of 500 mg or 850 mg of Metformin hydrochloride Teva once a day. The maximum daily dose is 2000 mg and is taken in 2 or 3 divided doses. Treatment of children from 10 to 12 years of age is only used in case of special recommendation by the doctor, as experience with Metformin hydrochloride Teva in this age group is limited.
Adults: usually start treatment with a dose of 500 mg or 850 mg of Metformin hydrochloride Teva twice or three times a day. The maximum daily dose is 3000 mg and is taken in 3 divided doses.
If the patient has kidney function disorders, the doctor may prescribe a lower dose.
If the patient is also taking insulin, the doctor will inform them how to start taking Metformin hydrochloride Teva.

Treatment monitoring

• The doctor will order regular blood sugar tests and adjust the dose of Metformin hydrochloride Teva based on the blood sugar values. The patient should regularly visit their 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.

How to take Metformin hydrochloride Teva

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

• If the patient takes one dose a day, it should be taken in the morning (breakfast).
• If the patient takes two doses of the medicine a day, they should be taken in the morning (breakfast) and in the evening (dinner).
• If the patient takes three doses of the medicine a day, they should be taken in the morning (breakfast), at noon (lunch), and in the evening (dinner). If after some time the patient feels that the effect of Metformin hydrochloride Teva is too strong or too weak, they should contact their doctor or pharmacist.

Taking a higher dose of Metformin hydrochloride Teva than recommended

In case of taking a higher dose of Metformin hydrochloride Teva than recommended,
lactic acidosis may occur. The symptoms of lactic acidosis are non-specific and include: vomiting, abdominal pain (abdominal cramps) with muscle cramps, general feeling of being unwell with 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 help, as lactic acidosis can lead to coma.
The patient should immediately discontinue Metformin hydrochloride Teva and contact a doctor or the nearest hospital.

Missing a dose of Metformin hydrochloride Teva

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.
If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Metformin hydrochloride Teva can cause side effects, although not everybody gets them.
The side effects that may occur are presented below.
Metformin hydrochloride Teva may cause a very rare (may occur in up to 1 in 10,000 patients) but very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs in the patient , they should discontinue Metformin hydrochloride Teva and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

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

• Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain (abdominal cramps), and loss of appetite. These side effects most often occur at the beginning of treatment with Metformin hydrochloride Teva. It may be helpful to divide the daily dose into several smaller doses taken throughout the day and take Metformin hydrochloride Teva with a meal or immediately after a meal.
• If the symptoms do not disappear, the patient should discontinue Metformin hydrochloride Teva and contact a doctor.

Common side effects (may occur in less than 1 in 10 people):

• Taste disorders.
• Decreased or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness or tingling, 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 problems.

Reporting of side effects
If side effects occur, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction 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.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Metformin hydrochloride Teva

The medicine should be stored in a place that is out of sight and reach of children.
If Metformin hydrochloride Teva is used in a child, it is recommended that the treatment be supervised by parents or caregivers.
There are no special recommendations for storing the medicine.
Do not use this medicine after the expiry date stated on the carton or blister after "EXP". The expiry date refers to the last day of the month.
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 pack and other information

What Metformin hydrochloride Teva contains

• The active substance of the medicine is metformin hydrochloride. Each film-coated tablet of Metformin hydrochloride Teva, 850 mg contains 850 mg of metformin hydrochloride, which corresponds to 662.9 mg of metformin.
• The other ingredients are: Tablet core: povidence, colloidal silica anhydrous, and magnesium stearate (E470b). Coating: hypromellose (E464), titanium dioxide (E171), and macrogol (E1521).

What Metformin hydrochloride Teva looks like and contents of the pack

Metformin hydrochloride Teva, 850 mg is a white or almost white film-coated tablet of oval shape, marked with the number "93" on one side and the number "49" on the other, with dimensions of approximately 18 mm x 9 mm.
Blisters:
Metformin hydrochloride Teva, 850 mg is available in packs of: 30, 60, 90, 120, and 180 film-coated tablets
Bottle with HPDE cap and desiccant:
Metformin hydrochloride Teva, 850 mg is available in a bottle of 100, 105, 200, 400 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel. (22) 345 93 00

Manufacturer/Importer

Teva Czech Industries s.r.o.
Ostravská 305/29
Opava-Komárov, 747 70
Czech Republic
Teva Gyógyszergyár Zrt.
Pallagi út 13
4042 Debrecen
Hungary
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546, Kraków

Date of last revision of the leaflet: February 2025