Metformin hidrohloride Teva

Package Leaflet: Information for the User

Metformin Hydrochloride Teva, 500 mg, Film-Coated Tablets

Metformin Hydrochloride

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

• You should 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 use glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for future use.
In diabetic patients, the pancreas does not produce enough insulin or the body is unable to use the insulin produced. This leads to an excessive increase in blood glucose levels. Metformin Hydrochloride Teva helps reduce blood glucose levels to as close to normal as possible.
In adults with overweight, long-term use of Metformin Hydrochloride Teva also reduces the risk of complications associated with diabetes. Taking Metformin Hydrochloride Teva is associated with either maintaining body weight or only a modest decrease in body weight.
Metformin Hydrochloride Teva is used to treat patients with type 2 diabetes mellitus (also called non-insulin-dependent diabetes), where diet and exercise alone do not provide adequate control of blood glucose levels. It is especially used in patients with overweight.
Adults can take Metformin Hydrochloride Teva either alone or in combination with other oral antidiabetic medicines or with insulin.
Children from 10 years of age and adolescents can take Metformin Hydrochloride Teva either alone or in combination with insulin.

2. Important information before taking Metformin Hydrochloride Teva

When not to take Metformin Hydrochloride Teva

• if you are allergic to metformin or any of the other ingredients of this medicine (see section 6, "What Metformin Hydrochloride Teva contains");
• in case of liver disease;
• if you have significantly reduced kidney function;
• if you have uncontrolled diabetes, for example with severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid 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 which can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or 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 problems, which can increase the risk 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 problems, which can increase the risk of lactic acidosis (see "Warnings and precautions");
• in case of acute heart failure or recent myocardial infarction, severe circulatory disorders (such as shock) or breathing difficulties. This can cause tissue hypoxia, which can increase the risk of lactic acidosis (see "Warnings and precautions");
• in case of alcohol abuse;

If any of the above conditions apply to you, you should consult your doctor before taking this medicine.
It is essential to consult your doctor if:

• a radiological examination or 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 period before and after the examination or surgery. Your doctor will decide whether other treatment is necessary during this time. It is crucial to follow your 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 you have kidney problems. The risk of lactic acidosis increases in case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more information below), liver disease, and any conditions in which a part of the body is not adequately supplied with oxygen (e.g., acute severe heart disease).
If any of the above conditions apply to you, you should consult your doctor for more detailed instructions.

Temporarily discontinue Metformin Hydrochloride Teva if you have a condition that may lead to dehydration

(significant water loss), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. You should consult your doctor for more detailed instructions.

Stop taking Metformin Hydrochloride Teva and contact your doctor or the nearest hospital immediately if you experience any 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, 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.

Consult your doctor immediately for further instructions if:

• you have a hereditary disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.
• after starting metformin, you experience any of the following symptoms: seizures, worsening of cognitive function, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

If you are to undergo major surgery, you should not take Metformin Hydrochloride Teva during and for some time after the surgery. Your doctor will decide when you should stop and restart treatment with Metformin Hydrochloride Teva.
Metformin Hydrochloride Teva does not cause hypoglycemia (low blood sugar). However, if Metformin Hydrochloride Teva is taken with other antidiabetic 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 difficulty concentrating, eating or drinking something containing sugar usually helps.
During treatment with Metformin Hydrochloride Teva, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have impaired kidney function.

Metformin Hydrochloride Teva with other medicines

If you are to be injected with a contrast agent containing iodine into the bloodstream, for example for an X-ray examination or computed tomography, you must stop taking Metformin Hydrochloride Teva before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart treatment with Metformin Hydrochloride Teva.
Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood glucose checks and kidney function tests or a dose adjustment of Metformin Hydrochloride Teva by your doctor. It is particularly important to inform your doctor 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 you have kidney problems (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other antidiabetic medicines.

Metformin Hydrochloride Teva with alcohol

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 you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice, 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 using machines

Metformin Hydrochloride Teva does not cause hypoglycemia (low blood sugar). This means it does not affect your ability to drive or use machines. However, you should be careful if you are taking Metformin Hydrochloride Teva with other antidiabetic medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating. If such symptoms occur, do not drive or operate machinery.

3. How to take Metformin Hydrochloride Teva

Always take Metformin Hydrochloride Teva exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Metformin Hydrochloride Teva does not replace the benefits of a healthy lifestyle.
You should continue to follow your doctor's advice on diet and regular physical activity.

Recommended dose

Children from 10 years of age and adolescents usually start 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 aged 10 to 12 years is only used in exceptional cases, as experience with Metformin Hydrochloride Teva in this age group is limited.
Adults usually start with a dose of 500 mg or 850 mg of Metformin Hydrochloride Teva 2 or 3 times a day. The maximum daily dose is 3000 mg and is taken in 3 divided doses.
If you have kidney problems, your doctor may prescribe a lower dose.
If you are also taking insulin, your doctor will inform you how to start taking Metformin Hydrochloride Teva.

Monitoring of treatment

• Your doctor will prescribe regular blood glucose tests and adjust the dose of Metformin Hydrochloride Teva according to your blood glucose levels. You should regularly visit your doctor for check-ups. This is especially important for children and adolescents and for people over 65 years of age.
• Your doctor will check your kidney function at least once a year. More frequent checks may be necessary for people over 65 years of age or if your kidneys are not working properly.

How to take Metformin Hydrochloride Teva

Take Metformin Hydrochloride Teva with or after a meal. This will help avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow each tablet with a glass of water.

• If you take one dose a day, take it in the morning (breakfast).
• If you take two doses a day, take them in the morning (breakfast) and evening (dinner).
• If you take three doses a day, take them in the morning (breakfast), at noon (lunch), and evening (dinner). If after some time you feel that the effect of Metformin Hydrochloride Teva is too strong or too weak, contact your doctor or pharmacist.

Taking a higher dose of Metformin Hydrochloride Teva than recommended

If you take a higher dose of Metformin Hydrochloride Teva than recommended, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain with muscle cramps, general feeling of being unwell accompanied by severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate. If you experience any of these symptoms, you should immediately seek medical attention, as lactic acidosis can lead to coma.
Stop taking Metformin Hydrochloride Teva and contact your doctor or the nearest hospital immediately.

Missing a dose of Metformin Hydrochloride Teva

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Metformin Hydrochloride Teva can cause side effects, although not everybody gets them.
The following side effects may occur:

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

• Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, 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 during the day and to take Metformin Hydrochloride Teva with a meal or immediately after a meal. If the symptoms do not disappear, stop taking Metformin Hydrochloride Teva and contact your doctor.

Common side effects (may affect up to 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). Your doctor may prescribe several tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other health problems unrelated to diabetes.

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

• Lactic acidosis. This is a very rare but serious complication that occurs especially when the kidneys are not working properly. Symptoms of lactic acidosis are non-specific (see "Warnings and precautions").
• Abnormal liver function test results or symptoms of liver inflammation (accompanied by fatigue, loss of appetite, and weight loss, with or without yellowing of the skin and whites of the eyes). If such symptoms occur, stop taking Metformin Hydrochloride Teva and tell your doctor.
• Skin reactions, such as redness, itching, or itchy rash (hives).

Children and adolescents

Limited data in children and adolescents indicate that the side effects are similar in nature and severity to those observed in adults.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metformin Hydrochloride Teva

Keep this medicine out of the sight and reach of children.
If Metformin Hydrochloride Teva is used in children, treatment should be supervised by parents or caregivers.
There are no special precautions for storage.
Do not use this medicine after the expiry date which is stated on the carton or blister after "EXP". The expiry date refers to the last day of that month.
Medicines should 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 Teva contains

• The active substance is metformin hydrochloride. Each film-coated tablet of Metformin Hydrochloride Teva, 500 mg, contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
• The other ingredients are: Tablet core: povidone, colloidal anhydrous silica, 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, 500 mg, is a white or almost white, oval, film-coated tablet, marked with "93" on one side and "48" on the other, approximately 15 mm x 8 mm in size.
Blisters:
Metformin Hydrochloride Teva, 500 mg, is available in packs of 30, 60, 90, 120, and 180 film-coated tablets.
Bottle with HPDE cap and desiccant:
Metformin Hydrochloride Teva, 500 mg, is available in bottles of 100, 105, 330, 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