Metformax sr 1000

Package leaflet: Information for the patient

Metformax SR 750, 750 mg, prolonged-release tablets
Metformax SR 1000, 1000 mg, prolonged-release 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 a specific individual. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Metformax SR 750 and Metformax SR 1000 are and what they are used for
2. Important information before taking Metformax SR 750 and Metformax SR 1000
3. How to take Metformax SR 750 and Metformax SR 1000
4. Possible side effects
5. How to store Metformax SR 750 and Metformax SR 1000
6. Contents of the pack and other information

1. What Metformax SR 750 and Metformax SR 1000 are and what they are used for

Metformax SR 750 and Metformax SR 1000, prolonged-release tablets, contain metformin hydrochloride as the active substance and belong to a group of medicines called biguanides, used in the treatment of type 2 diabetes (insulin-independent diabetes).
Metformax SR 750 and Metformax SR 1000 are used in the treatment of type 2 diabetes when proper blood glucose (sugar) levels cannot be achieved by diet and physical exercise alone. Insulin is a hormone that allows the body to take up glucose and use it to produce energy or store it for later use. In patients with type 2 diabetes, the pancreas does not produce enough insulin or the body cannot properly use the insulin that is produced. This leads to excessively high blood glucose levels, which may cause a number of serious long-term problems. Therefore, it is important to continue taking the medicine even if there are no obvious symptoms. Metformax SR 750 and Metformax SR 1000 increase the body's sensitivity to insulin and help restore normal glucose utilization.
Taking Metformax SR 750 and Metformax SR 1000 is associated with maintenance of body weight or moderate weight reduction.
Metformax SR 750 and Metformax SR 1000 are prolonged-release tablets specially designed to slowly release the medicine in the body and therefore differ from many other types of tablets containing metformin.

2. Important information before taking Metformax SR 750 and Metformax SR 1000

When not to take Metformax SR 750 and Metformax SR 1000

• if you are allergic to metformin or any of the other ingredients of the medicine (listed in section 6). An allergic reaction may cause rash, itching or shortness of breath.
• if you have liver function disorders,
• if you have significantly reduced kidney function,
• if you have 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 an unusual fruity odour of the breath,
• in case of excessive loss of body fluids (dehydration). Dehydration may lead to kidney function disorders, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
• in case of severe infection, e.g. pneumonia, bronchitis or kidney infection. Severe infections may lead to kidney function disorders, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
• in case of treatment for acute heart failure or recent myocardial infarction, severe circulatory disorders or breathing difficulties. These may cause tissue hypoxia, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
• if you abuse alcohol,
• if you are under 18 years of age.

Warnings and precautions
Before taking Metformax SR 750 and Metformax SR 1000, talk to your doctor.
Risk of lactic acidosis
Metformax SR 750 and Metformax SR 1000 may cause a very rare but serious side effect called lactic acidosis, especially if you have 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 disease states 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 you, consult your doctor for further instructions.
You should temporarily stop taking Metformax SR 750 or Metformax SR 1000 if you develop an illness that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if you are drinking less fluid than usual. Consult your doctor for further instructions.
You should stop taking Metformax SR 750 or Metformax SR 1000 and contact your doctor or nearest hospital immediately if you experience any symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise combined with severe fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate. Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.

Contact your doctor immediately for further instructions if:

• you have 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, you experience any of the following symptoms: seizures, cognitive decline, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.

If you are scheduled for major surgery, you must not take Metformax SR 750 or Metformax SR 1000 during the procedure and for some time afterwards. Your doctor will decide when you should stop and restart treatment with Metformax SR 750 or Metformax SR 1000.
Metformin, when used alone, does not cause hypoglycaemia (low blood glucose levels). However, if it is used in combination with other antidiabetic medicines (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur (such as weakness, dizziness, increased sweating, rapid heartbeat, blurred vision or difficulty concentrating), eat or drink something containing sugar.
While being treated with Metformax SR 750 or Metformax SR 1000, your doctor will monitor your kidney function at least once a year, or more frequently if you are elderly and/or have worsening kidney function.
It is common for the tablet shell to be visible in the stool. Do not be concerned, as this is normal when taking this type of tablet.
Follow your doctor's dietary recommendations and eat carbohydrates regularly throughout the day.
Do not stop taking this medicine without consulting your doctor.

Children and adolescents
Metformax SR 750 and Metformax SR 1000 should not be used in children and adolescents.
It is not known whether this medicine is safe and effective in children and adolescents under 18 years of age.

Metformax SR 750 and Metformax SR 1000 with other medicines
If you are to receive an intravenous iodine-containing contrast agent, for example for an X-ray or CT scan, you must stop taking Metformax SR 750 or Metformax SR 1000 before or at the latest at the time of injection. Your doctor will decide when you should stop and restart treatment with Metformax SR 750 or Metformax SR 1000.
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You may require more frequent monitoring of blood glucose levels and kidney function, or your doctor may need to adjust the dose of Metformax SR 750 or Metformax SR 1000. It is especially important to inform your doctor about the following medicines:

• medicines that increase urine production (diuretics, e.g. furosemide),
• medicines used to treat pain and inflammation [non-steroidal anti-inflammatory drugs (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),
• steroids, such as prednisolone, mometasone, beclomethasone,
• sympathomimetic medicines, including epinephrine and dopamine used in the treatment of heart attacks and low blood pressure. Epinephrine is also a component of some dental anaesthetic medicines.
• medicines that may alter the blood concentration of Metformax SR 750 and Metformax SR 1000, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other medicines used in the treatment of diabetes.

Metformax SR 750 and Metformax SR 1000 with alcohol
Avoid excessive alcohol consumption while taking Metformax SR 750 or Metformax SR 1000, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor in case any changes in treatment or monitoring of blood glucose levels are needed.
Do not take Metformax SR 750 or Metformax SR 1000 if you are breastfeeding.
Before taking this medicine, consult your doctor or pharmacist.

Driving and using machines
Metformax SR 750 or Metformax SR 1000, when used alone as an antidiabetic medicine, does not cause hypoglycaemia (symptoms of low blood sugar or hypoglycaemia, such as fainting, confusion and excessive sweating), and therefore should not affect your ability to drive or operate machinery.
However, if you take Metformax SR 750 or Metformax SR 1000 together with other antidiabetic medicines that may cause low blood sugar, you should exercise particular caution when driving or operating machinery.

Metformax SR 750 and Metformax SR 1000 contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Metformax SR 750 and Metformax SR 1000

Your doctor may prescribe Metformax SR 750 or Metformax SR 1000 as the only antidiabetic medicine or in combination with other oral antidiabetic medicines or insulin.
This medicine should always be taken as directed by your doctor.
If in doubt, consult your doctor or pharmacist.

Recommended dose
Treatment is usually started with one prolonged-release tablet containing 500 mg of metformin taken once daily. After approximately 2 weeks, based on glucose measurements, your doctor may adjust the dose. The maximum daily dose of metformin administered as prolonged-release tablets is 2000 mg.
If you have impaired kidney function, your doctor may prescribe a lower dose.

How to take the tablets
Tablets are usually taken once daily with the evening meal.
In some cases, your doctor may recommend taking the tablets twice daily. Tablets should always be taken with food.
Swallow the tablets whole with a glass of water. Do not chew, break, or crush the tablets.

Taking more Metformax SR 750 or Metformax SR 1000 than prescribed
If you accidentally take extra tablets, do not worry, but if unusual symptoms occur, contact your doctor. If the overdose is significant, lactic acidosis is more likely to 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, you should seek immediate medical help, as lactic acidosis may lead to coma. Immediately discontinue Metformax SR 750 or Metformax SR 1000 and contact your doctor or go to the nearest hospital.

Missed dose of Metformax SR 750 or Metformax SR 1000
If you miss a dose, take it as soon as you remember. Take the tablet with food. Do not take a double dose to make up for a missed dose.

If you have further questions about the use of 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 may occur:
Metformax SR 750 and Metformax SR 1000 may very rarely (may affect up to 1 in 10,000 people) cause a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, treatment with Metformax SR 750 or Metformax SR 1000 must be discontinued immediately and the patient should contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Metformax SR 750 and Metformax SR 1000 may cause abnormalities in liver function tests and hepatitis, which may lead to jaundice (may affect up to 1 in 10,000 people). If yellowing of the eyes and/or skin occurs, the patient should contact a doctor immediately.
Other possible adverse reactions are listed below according to frequency of occurrence as follows:
Very common: may affect more than 1 in 10 people

• Diarrhoea, nausea, vomiting, abdominal pain, loss of appetite. If these symptoms occur, do not stop taking the tablets, as these symptoms usually resolve after approximately 2 weeks. It may help to take the tablets with food or immediately after a meal.

Common: may affect up to 1 in 10 people

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

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

• Skin rash, including redness, itching and urticaria.

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

5. How to store Metformax SR 750 and Metformax SR 1000

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Metformax SR 750 and Metformax SR 1000 contain

• The active substance is metformin hydrochloride. Each prolonged-release tablet contains 750 mg or 1000 mg of metformin hydrochloride, equivalent to 585 mg or 780 mg of metformin, respectively.
• Other components of the medicine are: magnesium stearate, colloidal anhydrous silica, sodium carmellose, and hypromellose.

What Metformax SR 750 and Metformax SR 1000 look like and contents of the pack:
Metformax SR 750 prolonged-release tablets are white or almost white capsule-shaped tablets, 19.6 mm in length, 9.3 mm in width, and 6.9 mm thick, with the engraved mark "SR 750" on one side and smooth on the other side.
Metformax SR 1000 prolonged-release tablets are white or almost white oval tablets, 22.0 mm in length, 10.5 mm in width, and 8.9 mm thick, with the engraved mark "SR 1000" on one side and smooth on the other side.
The tablets are available in blister packs contained in cardboard boxes with 30 or 60 tablets.
Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Manufacturer/Importer
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

| Country of Member State | Name of the medicinal product | |------------------------|-------------------------------| | Czech Republic | Metformin Teva XR | | Hungary | Adimet XR 500 mg retard tabletta
Adimet XR 750 mg retard tabletta
Adimet XR 1000 mg retard tabletta | | Poland | Metformax SR 750
Metformax SR 1000 | | Slovakia | Metformin Teva XR 500 mg
Metformin Teva XR 750 mg
Metformin Teva XR 1000 mg | | United Kingdom (Northern Ireland) | Metformin Teva SR 500 mg, 750 mg & 1000 mg Prolonged-release Tablets |