Metformin hydrochloride teva

Patient Information Leaflet

Metformin hydrochloride Teva, 850 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 you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Metformin hydrochloride Teva is and what it is used for
2. What you need to know 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 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 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 treatment with Metformin hydrochloride Teva also reduces the risk of diabetes-related complications. Treatment with Metformin hydrochloride Teva is associated with stable body weight or modest weight reduction.
Metformin hydrochloride Teva is used to treat patients with type 2 diabetes (also known as "non-insulin-dependent" diabetes) in whom blood glucose control cannot be achieved by diet and exercise alone. It is particularly used in overweight patients.
Adults may take Metformin hydrochloride Teva as the only medicine or in combination with other antidiabetic medicines (oral medications or insulin).
Children aged 10 years and older and adolescents may take Metformin hydrochloride Teva as the only medicine or in combination with insulin.

2. Important information before using Metformin hydrochloride Teva

When not to use 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 water (dehydration), for example due to prolonged or severe diarrhoea or repeated vomiting. Dehydration may lead to kidney function disorders, which may increase the risk of lactic acidosis (see “Warnings and precautions”)
• in case of severe infection, for example pneumonia, bronchitis or kidney infection. Severe infections may lead to kidney function disorders, 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 using this medicine.
The patient should definitely consult a doctor if:

• a radiological examination or a procedure requiring intravenous injection of an iodine-containing contrast agent is necessary,
• the patient requires a major surgical procedure.

Metformin hydrochloride Teva must be temporarily discontinued for a certain period before and after such an 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 Teva may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has kidney function disorders.
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 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 should temporarily stop taking Metformin hydrochloride Teva if experiencing a medical condition associated with dehydration (significant loss of body water), such as severe vomiting, diarrhoea, fever, exposure to high temperature, or if the patient is drinking less fluid than usual. The patient should consult a doctor for further instructions.

The patient should stop taking Metformin hydrochloride Teva 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 feeling of malaise accompanied by severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

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

The patient should contact a doctor immediately for further instructions if:

• the patient has a genetically inherited mitochondrial disorder (energy-producing structures in cells), 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, movement difficulties, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.

If the patient is scheduled for a major surgical procedure, the patient must not take Metformin hydrochloride Teva during and for some time after the procedure. The doctor will decide when the patient should stop and restart 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, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating, eating or drinking a sugary food or drink usually helps.

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 receives an intravenous iodine-containing contrast agent, for example during an X-ray examination or computed tomography, the patient must stop taking Metformin hydrochloride Teva before or at the latest at the time of such injection. The doctor will decide when the patient should stop and restart treatment with Metformin hydrochloride Teva.

The patient should inform the doctor about all medicines currently used, recently used, or planned for use. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Metformin hydrochloride Teva by the doctor. It is especially 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 asthma treatment),
• corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma),
• medicines that may alter the blood levels 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 in the treatment of diabetes.

Metformin hydrochloride Teva and 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, suspects she may be pregnant, or plans to become pregnant, she should talk to her doctor in case 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 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, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating. If such symptoms occur, the patient should not drive or operate machinery.

3. How to take Metformin hydrochloride Teva

Metformin hydrochloride Teva must always be taken exactly as prescribed by your doctor. 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 advice regarding diet and regular physical activity.

Recommended dose
Children aged 10 years and adolescents: treatment usually starts 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: treatment usually starts 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 you have impaired kidney function, your doctor may prescribe a lower dose.
If you are also taking insulin, your doctor will advise you 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 check-ups with your doctor. This is particularly important for children, adolescents, and 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 your kidneys do not function properly.

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

• If taking one dose per day, take it in the morning (with breakfast).
• If taking two doses per day, take them in the morning (with breakfast) and in the evening (with dinner).
• If taking three doses per day, take them in the morning (with breakfast), at midday (with lunch), and in the evening (with 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 more Metformin hydrochloride Teva than prescribed
If you take more Metformin hydrochloride Teva than prescribed, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal discomfort) 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, you must seek immediate medical attention, as lactic acidosis can lead to coma. You must immediately stop taking Metformin hydrochloride Teva and contact your doctor or go to the nearest hospital.

If you forget to take Metformin hydrochloride Teva
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 about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Metformin hydrochloride Teva may cause adverse effects, although they do not
occur in everyone.
The possible adverse effects are listed below.
The medicine Metformin hydrochloride Teva may cause a very rare (may occur in up to 1
patient in 10,000), but very serious adverse effect known as lactic acidosis (see section
"Warnings and precautions"). If it occurs in a patient*, the treatment with Metformin hydrochloride Teva must be discontinued and the patient should immediately contact a doctor or the nearest hospital, as lactic acidosis may lead to coma.
Very common adverse effects (may affect more than 1 in 10 people):

• Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain (pain in the abdominal cavity) and loss of appetite. These adverse effects most commonly 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 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 contacted.

Common adverse effects (may affect 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). The doctor may order several tests to determine the cause of symptoms,
  since some of them may also be caused by diabetes or other health problems unrelated to diabetes.

Very rare adverse effects (may affect 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 (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, Metformin hydrochloride Teva should be discontinued and the doctor informed.
• Skin reactions such as skin redness (erythema), itching of the skin or itchy rash (urticaria).

Children and adolescents
Limited data in children and adolescents indicate that adverse effects occurring in this population are of similar nature and severity as those observed in adults.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store Metformin hydrochloride Teva

Keep the medicine out of the sight and reach of children.
If Metformin hydrochloride Teva is being used by a child, it is recommended that treatment is 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 term "EXP". The expiry date refers to the last day of the stated month.
Medicines must 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 850 mg film-coated tablet contains 850 mg of metformin hydrochloride, equivalent to 662.9 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 850 mg is a white or almost white, oval-shaped film-coated tablet,
marked with the number “93” on one side and the number “49” on the other, approximately 18 mm x 9 mm in size.
Blister packs:
Metformin hydrochloride Teva 850 mg is available in pack sizes of 30, 60, 90, 120 and 180 film-coated tablets.
HDPE bottle with polypropylene cap and desiccant:
Metformin hydrochloride Teva 850 mg is available in bottles containing 100, 105, 200 and 400 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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