Metformax 1000

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Metformax 1000 (Metformin Teva), 1000 mg, coated tablets
Metformini hydrochloridum
Metformax 1000 and Metformin Teva are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as 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 give it to 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Metformax 1000 is and what it is used for
2. Important information before taking Metformax 1000
3. How to take Metformax 1000
4. Possible side effects
5. How to store Metformax 1000
6. Contents of the pack and other information

1. What Metformax 1000 is and what it is used for

What Metformax 1000 is
Metformax 1000 contains the active substance 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 which causes the body to take up glucose (sugar) from the blood.
The body uses glucose to produce energy or stores it for future use.
If you have been diagnosed with diabetes, your pancreas does not produce enough insulin, or your body cannot properly use the insulin it produces. This leads to high levels of glucose in the blood.
Metformax 1000 helps reduce blood glucose levels to values closest to physiological levels.
If you are an adult patient with overweight, long-term use of Metformax 1000 also helps reduce the risk of diabetes-related complications.
Taking metformin is associated with maintenance of body weight or moderate weight reduction.

What Metformax 1000 is used for
Metformax 1000 is used in the treatment of patients with type 2 diabetes (also called "non-insulin-dependent diabetes") when proper control of blood glucose levels has not been achieved by diet and physical exercise alone. It is particularly used in patients with overweight.
Adult patients may take Metformax 1000 alone or in combination with other oral antidiabetic medicines (medicines taken by mouth) or insulin.
Children aged 10 years and older and adolescents may take Metformax 1000 alone or in combination with insulin.

2. Important information before using Metformax 1000

When not to use Metformax 1000

• if the patient has hypersensitivity to metformin or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has liver function disorders
• if the patient has significantly reduced kidney function
• if the patient has uncontrolled diabetes, for example 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 unusual fruity odour of the breath.
• if the patient has lost excessive amounts of body water (dehydration), for example due to prolonged or severe diarrhoea or if the patient has vomited several times in a short period. Dehydration may lead to kidney function disorders, which may increase the risk of lactic acidosis (see "Warnings and precautions", below).
• if the patient has a severe infection, such as lung, respiratory or kidney infections. Severe infections may lead to kidney function disorders, which may increase the risk of lactic acidosis (see "Warnings and precautions", below).
• if the patient is receiving treatment for acute heart failure, has recently had a heart attack or has severe circulatory disorders (e.g. shock) or breathing difficulties. These conditions may lead to tissue hypoxia, which may increase the risk of lactic acidosis (see "Warnings and precautions", below).
• if the patient consumes large amounts of alcohol

If any of the above conditions apply to the patient, contact the doctor before starting treatment with this medicine.
Ensure that the doctor has clarified all doubts:

• if the patient needs to undergo an X-ray examination or computed tomography with intravascular administration of an iodine-containing contrast agent.

If the patient needs to undergo a surgical procedure.
Metformax 1000 must be discontinued for a certain period before and after the examination or surgery. The doctor will recommend alternative treatment if required. It is important to strictly follow the doctor's instructions.

Warnings and precautions
Before starting treatment with Metformax 1000, discuss this with your doctor or pharmacist.

Risk of lactic acidosis
Metformax 1000 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 part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).
If any of the above circumstances apply to the patient, consult the doctor for further instructions.

Temporarily discontinue Metformax 1000 if the patient develops a medical condition associated with dehydration (significant loss of body water), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult the doctor for further instructions.

Discontinue Metformax 1000 immediately and contact the doctor or nearest hospital immediately if the patient experiences any symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:

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

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
If the patient is to undergo major surgery, Metformax 1000 must not be taken during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart treatment with Metformax 1000.

Metformax 1000 alone does not cause hypoglycaemia (low blood glucose levels). However, if Metformax 1000 is taken together with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If the patient experiences symptoms of hypoglycaemia, such as fatigue, dizziness, increased sweating, rapid heartbeat, blurred vision or difficulty concentrating, eating or drinking something containing sugar usually helps.

During treatment with Metformax 1000, 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.

Metformax 1000 and other medicines
If the patient is to receive an intravenous iodine-containing contrast agent, for example during an X-ray examination or computed tomography, the patient must stop taking Metformax 1000 before or at the latest at the time of injection. The doctor will decide when the patient should stop and restart treatment with Metformax 1000.

Inform the doctor or pharmacist about all medicines currently taken 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 the doctor may need to adjust the dose of Metformax 1000. It is especially important to inform 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 infections or asthma),
• medicines that may alter metformin blood levels, 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.

Metformax 1000 and alcohol
Avoid consuming excessive amounts of alcohol while taking Metformax 1000, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

• During pregnancy, diabetes should be treated with insulin. Inform the doctor if the woman suspects she is or may be pregnant, or if she is planning a pregnancy, so that the doctor can initiate appropriate replacement therapy.
• This medicine is not recommended if the patient is breastfeeding or planning to breastfeed.

Driving and operating machinery
Metformax 1000 does not cause hypoglycaemia (low blood glucose levels). This means that the medicine does not affect the ability to drive or operate machinery. However, exercise particular caution when using Metformax 1000 in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include fatigue, dizziness, increased sweating, rapid heartbeat, blurred vision or difficulty concentrating. Do not drive or operate machinery if the patient experiences any of the above symptoms.

3. How to use Metformax 1000

This medicine should always be used as directed by the physician or pharmacist. In case of
doubt, contact your doctor or pharmacist.
Metformax 1000 does not replace the benefits of a healthy lifestyle. You should follow medical
advice regarding diet and regularly perform physical exercise.
Recommended dose
The usual starting dose in children above 10 years of age and adolescents is one tablet of 500 mg or 850 mg of metformin hydrochloride once daily. The maximum daily dose of metformin is 2000 mg, administered in 2 or 3 divided doses. Treatment of children aged 10 to 12 years is recommended only on special medical advice, as therapeutic experience in this age group is limited.
The usual starting dose in adults is one tablet of 500 mg or 850 mg of metformin hydrochloride, taken two or three times daily. The maximum daily dose of metformin is 3000 mg, administered in 3 divided doses.
If the patient has impaired kidney function, the doctor may prescribe a lower dose.
If the patient is also taking insulin, the doctor will inform the patient how to start treatment with Metformax 1000.
Monitoring

• The doctor will recommend regular blood glucose monitoring and will adjust the dose of Metformax 1000 according to the patient's blood glucose levels. The patient should contact the doctor regularly. This is particularly important for children and adolescents, as well as elderly patients.
• The doctor will also check at least once a year how the patient's kidneys are functioning. More frequent monitoring may be necessary if the patient is elderly or if the kidneys are not functioning properly.

How to use Metformax 1000
The tablet should be taken during or after a meal. This helps avoid gastrointestinal side effects. Do not crush or chew the tablets. Swallow each tablet with a glass of water.

• If the patient takes one dose per day, it should be taken in the morning (with breakfast).
• If the patient takes two divided doses, they should be taken in the morning (with breakfast) and in the evening (with dinner).
• If the patient takes three divided doses, they should be taken in the morning (with breakfast), at midday (with lunch), and in the evening (with dinner).

The score line on the tablet is intended only to facilitate breaking the tablet if the patient has difficulty swallowing it whole.
If, after some time of treatment, the patient feels that the effect of Metformax 1000 is too strong or too weak, contact the doctor or pharmacist.
Taking more Metformax 1000 than recommended
If the patient takes more Metformax 1000 than prescribed, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain with muscle cramps, general malaise, severe fatigue, and shortness of breath. Other symptoms include lowered 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 stop taking Metformax 1000 and contact a
doctor or go to the nearest hospital.
Missing a dose of Metformax 1000
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 doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions are very serious and you should contact your doctor immediately if any of these symptoms occur:
Very rare: may affect up to 1 in 10,000 people

• The medicine Metformax 1000 may very rarely cause a very serious adverse reaction known as lactic acidosis, especially if the kidneys are not functioning properly. The symptoms of lactic acidosis are non-specific (see section "Warnings and precautions"). If it occurs in a patient, treatment with Metformax 1000 must be discontinued and immediate contact must be made with a doctor or the nearest hospital, as lactic acidosis may lead to coma.
• Abnormal liver function test results or symptoms of hepatitis (liver inflammation accompanied by fatigue, loss of appetite, and weight loss, with or without yellowing of the skin or whites of the eyes). If such symptoms occur, Metformax 1000 should be discontinued and the doctor informed.

Other adverse reactions:
Very common: may affect more than 1 in 10 people

• Gastrointestinal problems such as nausea, vomiting, diarrhoea, abdominal pain, and loss of appetite. These adverse reactions occur more frequently at the beginning of treatment with Metformax 1000. It may help to take the doses at intervals throughout the day and to take the tablets during or immediately after meals.
  If symptoms persist, Metformax 1000 should be discontinued and a doctor contacted.
  Common: may affect up to 1 in 10 people

• Taste disturbances.

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

• Skin reactions such as redness (erythema), itching of the skin, or itchy rash (urticaria).
• Decreased concentration of vitamin B12 in the blood.

Children and adolescents
Limited data in children and adolescents have shown that adverse reactions were similar in nature and severity to those observed in adult patients.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department for 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Metformax 1000

Keep this medicine out of the sight and reach of children. If Metformax 1000 is being used in a child,
it is recommended that parents or caregivers supervise the treatment.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the
last day of the stated month.
No special storage instructions apply.
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 Metformax 1000 contains

• The active substance is metformin hydrochloride. Each tablet contains 1000 mg of metformin hydrochloride, equivalent to 780 mg of metformin.
• Other ingredients: Core: povidone K 30, colloidal anhydrous silica, magnesium stearate; Coating: hypromellose, macrogol 400 and a colouring agent – titanium dioxide (E 171).

What Metformax 1000 looks like and contents of the pack
White or almost white, oval-shaped tablet, with a dividing line and engraved with the code "9/3" on one side and "72/14" on the other.
Metformax 1000 is available in cardboard boxes containing 60, 90 or 120 tablets.
For further information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Ireland, the country of export:
Teva Pharma B.V.
Swansweg 5
2031GA Haarlem
The Netherlands
Manufacturer:
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Ireland, the country of export: PA 0749/185/003
Parallel Import Licence Number: 71/20
This medicinal product is authorised in the European Economic Area under the following names:
France Metformine TEVA PHARMA 1000 mg, comprimé pélliculé
Czech Republic Metformin Teva
Germany Metformin-ratiopharm 1.000 mg Filmtabletten
Denmark Metformin Teva
Hungary Adimet 1000 mg filmtabletta
Poland Metformax 1000
Portugal Metformina Teva