Metformax sr 500

Package leaflet: Information for the patient

Metformax SR 500, 500 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 only. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Metformax SR 500 is and what it is used for
2. What you need to know before taking Metformax SR 500
3. How to take Metformax SR 500
4. Possible side effects
5. How to store Metformax SR 500
6. Contents of the pack and other information

1. What Metformax SR 500 is and what it is used for

Metformax SR 500 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. Metformax SR 500 helps reduce blood glucose levels to values as close to normal as possible.
In overweight adults, long-term use of Metformax SR 500 also reduces the risk of diabetes-related complications. Treatment with Metformax SR 500 is associated with maintenance of body weight or modest weight reduction.
Metformax SR 500 is used in the treatment of patients with type 2 diabetes (also known as "non-insulin-dependent diabetes") when diet and physical exercise are insufficient to achieve adequate control of blood glucose levels. It is particularly used in overweight patients.
Adults may take Metformax SR 500 as monotherapy or in combination with other antidiabetic medicines (oral agents or insulin).

2. Information before using Metformax SR 500

When not to use Metformax SR 500

• If the patient is allergic to hydrochloride metformin or to 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, 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 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 impaired kidney function, 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 impaired kidney function, 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 (e.g. shock), or breathing difficulties. These conditions may cause tissue hypoxia, which may increase the risk of lactic acidosis (see below "Warnings and precautions").
• If the patient consumes large amounts of alcohol.
• If the patient is under 18 years of age.

If any of the above situations apply, consult a doctor before using this medicine.

Warnings and precautions

Before starting treatment with Metformax SR 500, discuss it with your doctor or pharmacist.

Risk of lactic acidosis

Metformax SR 500 may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more details below), impaired liver function, 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, consult a doctor for further instructions.

Temporarily discontinue use of Metformax SR 500 if the patient develops a medical condition that may lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.

Stop taking Metformax SR 500 and contact a doctor or the 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 associated with 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 scheduled for major surgery, Metformax SR 500 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 SR 500.

Metformax SR 500 does not cause hypoglycaemia (low blood glucose levels). However, if Metformax SR 500 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, consuming food or a sugary drink usually helps.

During treatment with Metformax SR 500, the doctor will monitor kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.

Children and adolescents

Metformax SR 500 should not be used in children and adolescents.

Metformax SR 500 and other medicines

If the patient is to receive an iodine-containing contrast agent injected into the bloodstream, for example during an X-ray or CT scan, the patient must stop taking Metformax SR 500 before or at the latest at the time of injection. The doctor will decide when the patient should stop and restart treatment with Metformax SR 500.

Tell the doctor about all medicines the patient is currently taking or has 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 dose adjustments of Metformax SR 500 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 the treatment of asthma),
• corticosteroids (used to treat various conditions, such as severe skin inflammation 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 to treat diabetes.

Metformax SR 500 and alcohol

• Avoid consuming excessive amounts of alcohol while taking Metformax SR 500, 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 a pregnancy, she should consult her doctor regarding any necessary changes in treatment or blood glucose monitoring.

This medicine is not recommended for patients who are breastfeeding or planning to breastfeed.

Driving and using machines

Metformax SR 500 does not cause hypoglycaemia (low blood glucose levels). This means it does not affect the patient's ability to drive or operate machinery.

However, exercise particular caution if Metformax SR 500 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 Metformax SR 500

This medicine should always be taken exactly as recommended by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist. Metformax SR 500 does not replace the benefits
derived from maintaining a healthy lifestyle. You should continue to follow all your doctor's
recommendations regarding diet and regular physical activity.
Recommended dosage
Information for patients taking Metformax SR 500 alone or in combination with other
oral antidiabetic medicines:
The recommended starting dose is one tablet per day. After 10 to 15 days, the dose should be
adjusted according to blood glucose levels. Your doctor may increase the dose up to a maximum of 2000 mg of metformin hydrochloride per day (four tablets of Metformax SR 500 per day).
Information for patients switching from immediate-release metformin to Metformax SR 500:
The recommended starting dose of Metformax SR 500 should equal the daily dose of metformin previously taken as immediate-release tablets.
Information for patients taking Metformax SR 500 in combination with insulin:
When Metformax SR 500 is used in combination with insulin, the recommended starting dose is
one tablet per day, while the insulin dose is adjusted according to blood glucose levels.
Monitoring of treatment

• Your doctor will order regular blood glucose tests and adjust the dose of Metformax SR 500 according to blood glucose levels. You should attend regular follow-up visits with your doctor. This is particularly important for 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 are not functioning properly.

How to take Metformax SR 500
Metformax SR 500 should be taken during a meal or immediately after an evening meal.
Tablets should be swallowed whole with water. The prolonged-release tablet is a type of tablet that releases the active substance over a longer period than an immediate-release tablet.
Occasionally, the tablet shell may be seen in the stool. This is normal. If you have any further questions, consult your doctor or pharmacist.
Taking more Metformax SR 500 than recommended
If you take more Metformax SR 500 than recommended, 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. Metformax SR 500 should be stopped immediately
and you should contact your doctor or go to the nearest hospital.
Missing a dose of Metformax SR 500
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 concerning the use of this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The following side effect is very serious and if it affects the patient, the patient should
contact a doctor or the nearest hospital immediately:
Very rare (may affect fewer than 1 in 10,000 people)

• Metformax SR 500 may very rarely cause a very serious side effect known as lactic acidosis, especially if the kidneys are not working properly. The symptoms of lactic acidosis are nonspecific (see section “Warnings and precautions”). If lactic acidosis occurs in a patient, Metformax SR 500 should be discontinued immediately and the patient should contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

The following other side effects may occur:
Very common side effects (may affect more than 1 in 10 people)

• Gastrointestinal disorders such as nausea, vomiting, diarrhoea, abdominal pain (pain in the abdominal cavity), loss of appetite. These side effects most commonly occur at the beginning of treatment with Metformax SR 500. It may help to take Metformax SR 500 with a meal or immediately after a meal. If symptoms do not resolve, Metformax SR 500 should be discontinued and the doctor should be informed.

Common side effects (may affect fewer than 1 in 10 people)

• Taste disturbances.
• Decreased or low blood levels of vitamin B(_{12}) (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling sensations (paraesthesia), or pale or yellowish skin). The doctor may order several tests to determine the cause of the symptoms, as some of them may also be caused by diabetes or other health problems unrelated to diabetes.

Very rare side effects (may affect fewer than 1 in 10,000 people)

• Abnormal liver function test results or symptoms of hepatitis (with accompanying fatigue, loss of appetite and weight loss, and with or without yellowing of the skin and whites of the eyes). If such symptoms occur, Metformax SR 500 should be discontinued and the doctor should be informed.
• Skin reactions such as redness of the skin (erythema), itching or itchy rash (urticaria).

Reporting of side effects
If any side effects occur, including any side effects not listed
in this leaflet, they should be reported to a doctor, pharmacist or nurse.
Side effects can be reported directly to the Department of Monitoring of 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 side effects helps to provide more information on the safety of the medicine.

5. How to store Metformax SR 500

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blisters and
outer packaging following “EXP” or “Expiry date”. The expiry date refers to the last day
of the specified month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater 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 500 contains

• The active substance is metformin hydrochloride. Each prolonged-release tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
• Other ingredients are: hypromellose (E454), ethylcellulose, microcrystalline cellulose, and magnesium stearate.

What Metformax SR 500 looks like and contents of the pack:

• Metformax SR 500 is an oval, white or almost white tablet, with the number "93" embossed on one side and "7267" on the other side.
• Tablets are available in packs containing 30, 60, 90, or 120 tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw, Poland
Manufacturer
Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, The Netherlands
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Teva Operations Poland Sp. z o.o., ul. Mogilska 80, 31-546 Kraków, Poland
This medicinal product is authorised in the European Economic Area and in Great Britain (Northern Ireland) under the following names: