Metformax 1000

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Metformax 1000 (Metformin Teva), 1000 mg, film-coated tablets

Metformin hydrochloride
Metformax 1000 and Metformin Teva are different trade names for the same medicine.

Before taking the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Metformax 1000 and what is it 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 packaging and other information

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

What is Metformax 1000

Metformax 1000 contains the active substance 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 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 the patient has diabetes, the pancreas does not produce enough insulin or the body is unable to use the insulin produced. This leads to high blood glucose levels. Metformax 1000 helps lower blood glucose levels to near-physiological levels.
If the adult patient is overweight, long-term use of Metformax 1000 also helps reduce the risk of diabetes-related complications.

What is Metformax 1000 used for

Metformax 1000 is used to treat patients with type 2 diabetes (also called "non-insulin-dependent diabetes") when diet and exercise alone have not achieved adequate blood glucose control. It is especially used in patients who are overweight.
Adult patients can take Metformax 1000 alone or in combination with other oral anti-diabetic medicines (medicines taken orally or insulin).
Children aged 10 years and older and adolescents can take Metformax 1000 alone or in combination with insulin.

2. Important information before taking Metformax 1000

When not to take Metformax 1000

• if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6)
• if the patient has liver disease
• if the patient has significantly reduced kidney function
• if the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood glucose), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and can lead to diabetic coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odor from the mouth.
• if the patient has lost too much water from the body (dehydration), e.g. due to prolonged or severe diarrhea or if the patient has vomited several times in a short period. Dehydration can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions" below).
• if the patient has a severe infection, such as pneumonia, respiratory or kidney infection. Severe infections can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions" below).
• if the patient is taking medicines for acute heart failure, has recently had a heart attack or has severe circulatory problems (e.g. shock) or breathing difficulties. This can lead to oxygen deficiency in the tissues, which can 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, they should consult their doctor before starting to take this medicine.
It should be ensured that the doctor has explained all doubts:

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

If the patient is to undergo surgery.
Metformax 1000 should be discontinued for a certain period before the examination or surgery and after they are performed. The doctor will prescribe other treatment if the patient's condition requires it. It is essential to follow the doctor's instructions carefully.

Warnings and precautions

Before taking Metformax 1000, the patient should discuss it with their doctor or pharmacist.

Risk of lactic acidosis

Metformax 1000 may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has 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 sufficiently supplied with oxygen (e.g. acute severe heart disease).
If any of the above circumstances apply to the patient, they should consult their doctor for more detailed instructions.

The patient should temporarily stop taking Metformax 1000 if they have a condition that may be associated with dehydration

(significant loss of water 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 their doctor for more detailed instructions.

The patient should stop taking Metformax 1000 and immediately contact their doctor or the nearest hospital if they experience any symptoms of lactic acidosis

because 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.
If the patient is to undergo major surgery, they should not take Metformax 1000 during and for some time after the surgery. The doctor will decide when the patient should stop and resume treatment with Metformax 1000.
Metformax 1000 itself does not cause hypoglycemia (low blood glucose). However, if Metformax 1000 is taken with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea, insulin, meglitinides), there is a risk of hypoglycemia. If the patient experiences symptoms of hypoglycemia, such as fatigue, dizziness, increased sweating, rapid heart rate, vision disturbances or difficulty concentrating, eating or drinking something containing sugar usually helps.

Metformax 1000 with other medicines

If the patient is to be injected with a contrast agent containing iodine into their bloodstream, e.g. for an X-ray examination or computed tomography, they should stop taking Metformax 1000 before or at the latest at the time of such injection. The doctor will decide when the patient should stop and resume treatment with Metformax 1000.
The patient should tell their doctor or pharmacist 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 glucose tests and kidney function tests or a dose adjustment of Metformax 1000 by the doctor. 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 a range of conditions, such as severe skin infections or asthma),
• medicines that may change the level of metformin in the blood, especially if the patient has kidney problems (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other medicines used to treat diabetes.

Metformax 1000 with alcohol

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

Pregnancy and breastfeeding

• During pregnancy, diabetes should be treated with insulin. The patient should inform their doctor if they are or may be pregnant or plan to become pregnant, so that the doctor can use alternative therapy.
• This medicine is not recommended if the patient is breastfeeding or plans to breastfeed.

Driving and using machines

Metformax 1000 does not cause hypoglycemia (low blood glucose). This means that the medicine will not affect the patient's ability to drive or use machines. However, the patient should be careful when taking Metformax 1000 in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea, insulin, meglitinides). Symptoms of hypoglycemia include fatigue, dizziness, increased sweating, rapid heart rate, vision disturbances or difficulty concentrating. The patient should not drive or use machines if they experience any of these symptoms.

3. How to take Metformax 1000

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Metformax 1000 will not replace the benefits of a healthy lifestyle. The patient should follow the doctor's advice on diet and exercise regularly.

Recommended dose

The usual starting dose for children over 10 years and adolescents is one 500 mg or 850 mg metformin hydrochloride tablet once daily. The maximum dose of metformin is 2000 mg per day, given in 2 or 3 divided doses. Treatment of children aged 10 to 12 years is only recommended after careful consideration by the doctor, as clinical experience in this age group is limited.
The usual starting dose for adults is one 500 mg or 850 mg metformin hydrochloride tablet, 2 or 3 times a day. The maximum dose of metformin is 3000 mg per day, given in 3 divided doses.
If the patient has kidney problems, the doctor may prescribe a lower dose.
If the patient is also taking insulin, the doctor will inform them how to start taking Metformax 1000.

Monitoring

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

How to take Metformax 1000

The patient should take the tablet 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 per day, it should be taken in the morning (breakfast).
• If the patient takes 2 divided doses, they should be taken in the morning (breakfast) and evening (dinner).
• If the patient takes 3 divided doses, they should be taken in the morning (breakfast), at noon (lunch) and evening (dinner).

The dividing line on the tablet is only to facilitate breaking the tablet if the patient has difficulty swallowing it whole.
If, after some time, the patient thinks that the effect of Metformax 1000 is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Metformax 1000 than recommended

If the patient takes more Metformax 1000 than they should, they may experience lactic acidosis. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain with muscle cramps, general feeling of being unwell, severe fatigue, and shortness of breath. 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 stop taking Metformax 1000 and contact their doctor or the nearest hospital immediately.

Missing a dose of Metformax 1000

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.
In case of doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Metformax 1000 can cause side effects, although not everybody gets them.
The following side effects are very serious and the patient should immediately contact their doctorif they experience any of these symptoms:
Very rare: may affect up to 1 in 10,000 people

• Metformax 1000 may very rarely cause a very serious side effect called lactic acidosis, especially if the kidneys are not working properly. Symptoms of lactic acidosis are non-specific (see "Warnings and precautions"). If the patient experiences it, they should stop taking Metformax 1000 and immediately contact their doctor or the nearest hospital, as lactic acidosis can lead to coma.
• Abnormal liver function test results or symptoms of liver inflammation (liver inflammation with accompanying fatigue, loss of appetite, and weight loss, as well as with or without yellowing of the skin and whites of the eyes). If such symptoms occur, the patient should stop taking Metformax 1000 and tell their doctor.

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

• Gastrointestinal problems such as nausea (nausea), vomiting, diarrhea, abdominal pain, and loss of appetite. These side effects are more common at the beginning of treatment with Metformax 1000. It is helpful to take doses at intervals during the day and

if the tablets are taken during or immediately after a meal. If the symptoms do not disappear, the patient should stop taking Metformax 1000 and contact their doctor.
Common: may affect up to 1 in 10 people

• Taste disorders.

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

• Skin reactions such as redness (rash), itching, or itchy rash (hives).
• Decreased vitamin B12 levels in the blood.

Children and adolescents
Limited data in children and adolescents have shown that side effects were similar in nature and severity to those observed in adult patients.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 side effects will help to gather more information on the safety of this medicine.

5. How to store Metformax 1000

The medicine should be stored out of sight and reach of children. If Metformax 1000 is used in a child, the treatment should be supervised by parents or caregivers.
The medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
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 packaging and other information

What Metformax 1000 contains

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

What Metformax 1000 looks like and contents of the pack

White or almost white, oval tablet, with a dividing line, with the inscription "9/3" on one side and "72/14" on the other side.
Metformax 1000 is available in cardboard boxes containing 60, 90, or 120 tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Ireland, the country of export:

Teva Pharma B.V.
Swansweg 5
2031GA Haarlem
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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Ireland, the country of export, authorization number: PA 0749/185/003

Parallel import authorization number: 71/20

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France
Metformine TEVA PHARMA 1000 mg, film-coated tablet
Czech Republic
Metformin Teva
Germany
Metformin-ratiopharm 1.000 mg film-coated tablets
Denmark
Metformin Teva
Hungary
Adimet 1000 mg film-coated tablet
Poland
Metformax 1000
Portugal
Metformina Teva
Date of leaflet approval: 12.05.2022
[Information about the trademark]