Abmetfina xr

Package leaflet: Information for the patient

Abmetfina XR, 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 you personally. 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 Abmetfina XR is and what it is used for
2. What you need to know before taking Abmetfina XR
3. How to take Abmetfina XR
4. Possible side effects
5. How to store Abmetfina XR
6. Contents of the pack and other information

1. What Abmetfina XR is and what it is used for

Abmetfina XR 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, which 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. Abmetfina XR helps reduce blood glucose levels to values as close to normal as possible.
In overweight adults, long-term use of Abmetfina XR also reduces the risk of diabetes-related complications. Treatment with Abmetfina XR is associated with stable body weight or even moderate weight reduction.
Abmetfina XR is used in the treatment of patients with type 2 diabetes (also known as "non-insulin-dependent diabetes"). It is particularly used in patients who are overweight.
Adults may take Abmetfina XR either as monotherapy or in combination with other antidiabetic medicines (oral medications or insulin).
For the prevention of type 2 diabetes in patients with prediabetes.
In polycystic ovary syndrome.

2. Important information before taking Abmetfina XR

When not to take Abmetfina XR:

• if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6),
• in case of liver dysfunction,
• 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 an unusual fruity odour of the breath,
• in case of excessive loss of body fluids (dehydration), e.g. 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"),
• in case of alcohol abuse,
• if the patient is under 18 years of age.

If any of the above conditions apply, the patient should consult a doctor before taking this medicine.
The patient must consult a doctor if:

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

Abmetfina XR must be discontinued for a certain period before and after such examination or surgical procedure. The doctor will decide whether alternative treatment is necessary during this time. It is important to follow the doctor's instructions exactly.

Warnings and precautions

Risk of lactic acidosis
Abmetfina XR may cause a very rare but serious adverse reaction 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 detailed information below), liver dysfunction, 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.

Abmetfina XR should be temporarily discontinued if the patient develops a medical condition
that may be associated with 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. The patient should consult a doctor for further instructions.

Abmetfina XR should be discontinued and the patient should 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 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 to undergo a major surgical procedure, Abmetfina XR 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 Abmetfina XR.

Abmetfina XR does not cause hypoglycaemia (low blood glucose levels).
However, if Abmetfina XR is used in combination with other antidiabetic medicines that may cause hypoglycaemia (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, consuming sugar-containing food or drink usually helps.

During treatment with Abmetfina XR, 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.

The patient should follow the dietary advice provided by the doctor.

It is common for the tablet coating to be visible in the stool. This is normal with this type of tablet and should not be a cause for concern.

Abmetfina XR and other medicines

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

The patient should inform the doctor about all medicines currently taken or recently taken, as well as any medicines planned for future use.

The patient may require more frequent monitoring of blood glucose levels and kidney function, or the doctor may need to adjust the dose of Abmetfina XR.

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 the blood concentration of Abmetfina XR, 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.

Abmetfina XR and alcohol
The patient should avoid consuming excessive amounts of alcohol while taking Abmetfina XR, 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 to become pregnant, she should consult her doctor regarding any necessary changes in treatment or monitoring of blood glucose levels.
This medicine is not recommended for breastfeeding women or women planning to breastfeed.

Driving and operating machinery
Abmetfina XR 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 Abmetfina XR is used concomitantly with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include: weakness, dizziness, increased sweating, rapid heartbeat, blurred vision or difficulty concentrating.
If such symptoms occur, the patient should not drive or operate machinery.

Abmetfina XR contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Abmetfina XR

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Abmetfina XR does not replace the benefits derived from a healthy lifestyle.
You should continue to follow all your doctor's recommendations regarding diet and regular physical activity.

Recommended dose
Children: due to lack of adequate safety data, Abmetfina XR should not be used in children.
Adults: treatment is usually started with 1 tablet of Abmetfina XR 500 mg once daily during the evening meal. After 10–15 days, the dose will be adjusted by the doctor based on blood glucose measurements. After dose adjustment, the doctor may consider switching to Abmetfina XR 1000 mg.
The maximum daily dose is 2000 mg, taken once daily during the evening meal.
For patients already treated with metformin, the initial dose of Abmetfina XR should be equivalent to the daily dose of metformin in immediate-release tablets. When switching from another oral antidiabetic drug to Abmetfina XR 1000 mg, the doctor should discontinue the previously used drug and initiate Abmetfina XR 1000 mg at the dose specified above.
If the patient has impaired kidney function, the doctor may prescribe a lower dose.
For patients treated with metformin at doses exceeding 2000 mg per day in the form of immediate-release tablets, switching to Abmetfina XR is not recommended.
If the patient is also using insulin, the doctor will advise on how to start treatment with Abmetfina XR.

Monotherapy (prediabetes state)
The usual dose is 1000 to 1500 mg of metformin hydrochloride once daily during the evening meal. The doctor will assess whether treatment should be continued based on regular monitoring of blood glucose levels and risk factors.

Polycystic ovary syndrome
The usual dose is 1500 mg of metformin hydrochloride once daily during the evening meal.

Monitoring of treatment

• Your doctor will order regular blood glucose tests and adjust the dose of Abmetfina XR 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 the patient's kidneys are not functioning properly.

How to use Abmetfina XR
Abmetfina XR should be taken with a meal or immediately after a meal. This helps avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet whole with a glass of water.
If at any time the patient feels that the medicine's effect is too strong or too weak, they should consult their doctor or pharmacist.

Taking more Abmetfina XR than recommended
If more Abmetfina XR is taken than prescribed, 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 must seek immediate medical help,
as lactic acidosis can lead to coma. Abmetfina XR must be stopped immediately and the patient should contact their doctor or go to the nearest hospital.

Missed dose of Abmetfina XR
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, this medicine can cause adverse effects, although not everyone will experience them.
The possible adverse effects are listed below.
Abmetfina XR may very rarely cause (may occur in up to 1 in 10,000 people) a very serious adverse effect known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, treatment with Abmetfina XR must be discontinued and immediate contact must be made with 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 disturbances such as nausea, vomiting, diarrhoea, abdominal pain (pain in the abdominal cavity), loss of appetite. These adverse effects most commonly occur at the beginning of Abmetfina XR treatment and in most cases resolve spontaneously. It may be helpful to take Abmetfina XR with a meal or immediately after a meal. If symptoms do not resolve, Abmetfina XR should be discontinued and the doctor informed.

Common adverse effects (may affect less than 1 in 10 people)

• Taste disturbances.
• Reduced or low blood levels of vitamin B (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, as 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 when kidneys are not functioning properly. Symptoms of lactic acidosis – see section "Warnings and precautions".
• Abnormal liver function test results or symptoms of hepatitis (with accompanying fatigue, loss of appetite, weight loss, and with or without yellowing of the skin and whites of the eyes). If such symptoms occur, Abmetfina XR must be discontinued immediately and the doctor informed.
• Skin reactions such as skin redness (erythema), itching, or itchy rash (urticaria).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects 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 Warszawa
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 marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Abmetfina XR

Keep this medicine out of the sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date stated on the carton after the "EXP" mark.
The expiry date refers to the last day of the specified month.
Lot is the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Abmetfina XR contains
The active substance is metformin hydrochloride.
Each Abmetfina XR tablet contains 1000 mg of metformin hydrochloride, equivalent to 780 mg of metformin.
The other ingredients are: calcium hydrogen phosphate anhydrous, povidone (Kollidon 90 F), sodium carboxymethylcellulose, hypromellose 2208 (Benecel K200M Pharm CR), colloidal anhydrous silica, magnesium stearate.

What Abmetfina XR looks like and contents of the pack
White or almost white modified capsule-shaped, uncoated tablets, embossed with the number "14" on one side and "C" on the other side.

Packaging:
PVC/PVDC/Aluminium blisters.
Pack sizes: 3 blisters of 10 tablets (30 tablets) or 6 blisters of 10 tablets (60 tablets) in a cardboard box.

Marketing Authorisation Holder and Importer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Phone number: (22) 811-18-14

For further information about this medicinal product, please contact the Marketing Authorisation Holder.