Metformin hydrochloride teva

Package leaflet: Information for the user

Metformin hydrochloride Teva, 500 mg, film-coated tablets
Metformini hydrochloridum
Read the entire leaflet carefully before using this medicine because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

Metformin hydrochloride Teva contains metformin, a medicine used in the treatment of 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 Teva helps reduce blood glucose levels to values as close to normal as possible.
In overweight adults, long-term use of Metformin hydrochloride Teva also reduces the risk of diabetes-related complications. Treatment with Metformin hydrochloride Teva is associated with stable body weight or moderate weight reduction.
Metformin hydrochloride Teva is used to treat patients with type 2 diabetes (also known as "non-insulin-dependent diabetes") in whom adequate control of blood glucose levels cannot be achieved by diet and physical exercise alone. It is particularly used in overweight patients.
Adults may take Metformin hydrochloride Teva as monotherapy or in combination with other antidiabetic medicines (oral medications or insulin).
Children aged 10 years and adolescents may take Metformin hydrochloride Teva as monotherapy 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 hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, 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 odour of the breath
• in case of excessive loss of body fluids (dehydration), for example due to prolonged or severe diarrhoea or repeated vomiting. Dehydration may lead to kidney dysfunction, which may increase the risk of lactic acidosis (see “Warnings and precautions”)
• in case of severe infection, such as pneumonia, bronchitis or kidney infection. Severe infections may lead to kidney dysfunction, which may increase the risk of lactic acidosis (see “Warnings and precautions”)
• in case of treatment for acute heart failure or recent myocardial infarction, severe circulatory disorders (e.g. shock) or breathing difficulties. These conditions may cause tissue hypoxia, which may increase the risk of lactic acidosis (see “Warnings and precautions” below)
• in case of alcohol abuse

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 required,
• the patient is to undergo major surgery.

Metformin hydrochloride Teva must be temporarily discontinued before and after such an examination or
surgical procedure. The doctor will decide whether alternative treatment is necessary during this period. It is important
to strictly follow the doctor’s instructions.

Warnings and precautions

Risk of lactic acidosis
Metformin hydrochloride Teva may cause a very rare but serious adverse effect known as lactic acidosis,
especially if the patient has kidney function impairment.
The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or
alcohol consumption, dehydration (see more detailed information below), liver dysfunction, 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.

Metformin hydrochloride Teva should be temporarily discontinued if the patient develops a medical
condition associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea,
fever, exposure to high temperatures, or if the patient is drinking less fluid than usual. The patient should consult a doctor for further instructions.

Metformin hydrochloride Teva should be discontinued and the patient should immediately contact a
doctor or the nearest hospital if any of the symptoms of lactic acidosis occur, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise associated with profound fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.

Contact a doctor immediately for 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).
• after starting metformin, the patient develops any of the following symptoms: seizures, worsening of cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.

If the patient is to undergo major surgery, Metformin hydrochloride Teva must not be taken during the
procedure and for some time afterwards. The doctor will decide when the patient should stop and resume
treatment with Metformin hydrochloride Teva.

Metformin hydrochloride Teva does not cause hypoglycaemia (low blood glucose levels). However, if
Metformin hydrochloride Teva is used in combination with other antidiabetic medicines that may cause
hypoglycaemia (such as sulfonylurea derivatives, insulin, meglitinides), there is a risk of hypoglycaemia.
If symptoms of hypoglycaemia occur, such as weakness, dizziness, excessive sweating, rapid heartbeat,
blurred vision or difficulty concentrating, it usually helps to eat or drink something containing sugar.

During treatment with Metformin hydrochloride Teva, the doctor will monitor the patient’s kidney
function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney
function.

Metformin hydrochloride Teva and other medicines

If the patient is to receive an intravenous iodine-containing contrast agent, for example for an X-ray or
CT scan, the patient must stop taking Metformin hydrochloride Teva before or at the latest at the time of
administration. The doctor will decide when the patient should stop and resume treatment with Metformin
hydrochloride Teva.

The patient should inform the doctor about all medicines currently used, recently used, or planned to be
used. The patient may require more frequent monitoring of blood glucose levels and kidney function, or
the doctor may need to adjust the dose of Metformin hydrochloride Teva. It is particularly important to
inform the doctor about the following medicines:

• diuretics (medicines that increase urine production),
• 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 in the treatment of asthma),
• corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma),
• medicines that may alter the blood concentration of Metformin hydrochloride Teva, 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 Teva and alcohol
The patient should avoid excessive alcohol consumption while taking Metformin hydrochloride Teva, 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 is planning to become pregnant, she should
consult her doctor to determine whether any changes in treatment or monitoring of blood glucose levels
are necessary. This medicine is not recommended for patients who are breastfeeding or planning to
breastfeed.

Driving and operating machinery
Metformin hydrochloride Teva does not cause hypoglycaemia (low blood glucose levels). This means that
it does not affect the patient’s ability to drive or operate machinery.
However, special caution is required if Metformin hydrochloride Teva is used together with other
antidiabetic medicines that may cause hypoglycaemia (such as sulfonylurea derivatives, insulin,
meglitinides). Symptoms of hypoglycaemia include: weakness, dizziness, excessive sweating, rapid
heartbeat, blurred vision or difficulty concentrating. If such symptoms occur, the patient should not drive
or operate machinery.

3. How to use Metformin hydrochloride Teva

Metformin hydrochloride Teva must always be used exactly as directed by the physician. If in doubt, consult your doctor or pharmacist.
Metformin hydrochloride Teva does not replace the benefits of a healthy lifestyle. You should continue to follow all your doctor's recommendations regarding diet and regular physical activity.

Recommended dose
Children aged 10 years and adolescents usually start treatment with a dose of 500 mg or 850 mg of Metformin hydrochloride Teva once daily. The maximum daily dose is 2000 mg, taken in 2 or 3 divided doses. Treatment of children aged 10 to 12 years should only be initiated on specific medical advice, 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 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 on how to start treatment with Metformin hydrochloride Teva.

Monitoring of treatment

• Your doctor will order regular blood glucose tests and adjust the dose of Metformin hydrochloride Teva according to blood glucose levels. You must attend regular follow-up appointments 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 kidney function is impaired.

How to use Metformin hydrochloride Teva
Metformin hydrochloride Teva should be taken during or after a meal. This helps avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow each tablet whole with a glass of water.

• If taking once daily, take the dose in the morning (with breakfast).
• If taking twice daily, take the doses in the morning (with breakfast) and in the evening (with dinner).
• If taking three times daily, take the doses in the morning (with breakfast), at midday (with lunch), and in the evening (with dinner).
  If after some time the patient feels that the effect of Metformin hydrochloride Teva is too strong or too weak, contact the doctor or pharmacist.

Taking more Metformin hydrochloride Teva than recommended
If a dose of Metformin hydrochloride Teva 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 lowered body temperature and slowed heart rate. If any of these symptoms occur, the patient should seek immediate medical help, as lactic acidosis can lead to coma. Metformin hydrochloride Teva must be stopped immediately and the patient should contact a doctor or go to the nearest hospital.

Missed dose of Metformin hydrochloride Teva
Do not take a double dose to make up for a missed dose. Take the next dose at the usual scheduled time.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Metformin hydrochloride Teva can cause adverse reactions, although not everyone will experience them.
The possible adverse reactions are listed below.
Metformin hydrochloride Teva may cause a very rare (may occur in up to 1 patient in 10,000), but very serious adverse reaction known as lactic acidosis (see section “Warnings and precautions”). If this occurs in a patient**, treatment with Metformin hydrochloride Teva must be discontinued and immediate contact must be made with a doctor or the nearest hospital**, as lactic acidosis may lead to coma.

Very common adverse reactions (may occur in more than 1 in 10 people):

• Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain (stomach pain) and loss of appetite. These adverse reactions most commonly occur at the beginning of treatment with Metformin hydrochloride Teva. It may help to divide the daily dose into several smaller doses taken throughout the day and to take Metformin hydrochloride Teva with a meal or immediately after a meal. If symptoms do not resolve, Metformin hydrochloride Teva should be discontinued and a doctor should be contacted.

Common adverse reactions (may occur in less than 1 in 10 people):

• Taste disturbances.
• Decreased or low blood levels of vitamin B12 (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling sensations (paraesthesiae), or pale or yellowish skin). Your doctor may order several tests to determine the cause of symptoms, as some of them may also be caused by diabetes or other health problems unrelated to diabetes.

Very rare adverse reactions (may occur in less than 1 in 10,000 people):

• Lactic acidosis. This is a very rare but serious complication, particularly occurring when the patient's kidneys are not functioning properly. The symptoms of lactic acidosis are non-specific (see section “Warnings and precautions”).
• Abnormal liver function test results or symptoms of hepatitis (associated with fatigue, loss of appetite and weight loss, with or without yellowing of the skin and whites of the eyes). If such symptoms occur, Metformin hydrochloride Teva should be discontinued and the doctor should be informed.
• Skin reactions such as redness of the skin (erythema), itching of the skin or itchy rash (urticaria).

Children and adolescents
Limited data in children and adolescents indicate that adverse reactions occurring in these populations are of similar nature and frequency as those observed in adults.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Metformin hydrochloride Teva

Keep this medicine out of the sight and reach of children.
If Metformin hydrochloride Teva is being used in a child, treatment should be supervised by parents or caregivers.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton or blister pack following the abbreviation "EXP". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Metformin hydrochloride Teva contains

• The active substance is metformin hydrochloride. Each Metformin hydrochloride Teva 500 mg film-coated tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
• 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-shaped film-coated tablet,
marked with the number "93" on one side and "48" on the other, approximately 15 mm x 8 mm in size.

Blister packs:
Metformin hydrochloride Teva 500 mg is available in packs containing 30, 60, 90, 120, and 180 film-coated tablets.

HDPE bottle with polypropylene cap and desiccant:
Metformin hydrochloride Teva 500 mg is available in bottles containing 100, 105, 330, and 400 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
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.
Mogilska 80
31-546 Kraków
Poland