Abmetfina Xr

Leaflet accompanying the packaging: patient information

Abmetfina XR, 500 mg, prolonged-release tablets

Metformin hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Abmetfina XR contains 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 allows the body to take up glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for later use.
In diabetic patients, the pancreas does not produce enough insulin or the body is unable to use the produced insulin properly. This leads to an excessive increase in blood glucose levels. Abmetfina XR helps to reduce blood glucose levels to as close to normal as possible.
In adults with overweight, long-term use of Abmetfina XR also reduces the risk of diabetes-related complications. Taking Abmetfina XR is associated with maintaining or moderately reducing body weight.
Abmetfina XR is used to treat patients with type 2 diabetes (also called non-insulin-dependent diabetes). It is used especially in patients with overweight.
Adults can take Abmetfina XR as the only medicine or in combination with other anti-diabetic medicines (oral or insulin).
In the prevention of type 2 diabetes in patients with pre-diabetic conditions.
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 function disorders,
• if the patient has significantly reduced kidney function,
• if the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), 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 a diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or a fruity odor from the mouth,
• in case of excessive fluid loss from the body (dehydration), e.g. due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney function disorders, which can threaten the occurrence of lactic acidosis (see "Warnings and precautions" below),
• in case of severe infection, e.g. pneumonia, bronchitis or kidney infection. Severe infections can lead to kidney function disorders, which can threaten the occurrence of lactic acidosis (see "Warnings and precautions" below),
• in case of treatment of acute heart failure or recent myocardial infarction, severe circulatory disorders (e.g. shock) or breathing difficulties. This can cause tissue hypoxia, which can threaten the occurrence of lactic acidosis (see "Warnings and precautions" below),
• in case of alcohol abuse,
• if the patient is under 18 years old.

If any of the above situations occur, the patient should consult a doctor before taking this medicine.
It is necessary to consult a doctor if it is necessary to:

• perform a radiological examination or an examination requiring the injection of a contrast agent containing iodine into the bloodstream,
• perform a major surgical procedure.

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

Warnings and precautions

Risk of lactic acidosis

Abmetfina XR may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney function disorders. The risk of lactic acidosis increases in case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more information below), liver function disorders, 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 a doctor for more detailed instructions.

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

(significant fluid loss from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult a doctor for more detailed instructions.

The patient should stop taking Abmetfina XR and immediately contact a doctor or the nearest hospital if they experience any symptoms of lactic acidosis,

as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general poor condition 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 a major surgical procedure, they must not take Abmetfina XR during the procedure and for a period after it. The doctor will decide when the patient must stop and resume treatment with Abmetfina XR.
Abmetfina XR does not cause hypoglycemia (low blood sugar).
However, if Abmetfina XR is taken in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides), there is a risk of hypoglycemia. If symptoms of hypoglycemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or concentration difficulties, eating or drinking a sugary drink usually helps.
During treatment with Abmetfina XR, the doctor will monitor the patient's kidney function at least once a year or more often if the patient is elderly and/or has impaired kidney function.
The patient should follow the dietary recommendations given by the doctor.
It may happen that the tablet coating is visible in the stool. The patient should not worry, as this is normal when taking this type of tablet.

Abmetfina XR and other medicines

If the patient is to be injected with a contrast agent containing iodine into the bloodstream, for example for an X-ray examination or computed tomography, they must stop taking Abmetfina XR before or at the latest at the time of such injection. The doctor will decide when the patient must stop and resume treatment with Abmetfina XR.
The patient should tell their doctor 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 checks and kidney function tests, 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 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 various diseases, such as severe skin inflammation or asthma),
• medicines that may change the level of Abmetfina XR in the blood, 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.

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 "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult a doctor, as changes in treatment or blood sugar monitoring may be necessary.
This medicine is not recommended for breastfeeding women or those planning to breastfeed.

Driving and using machines

Abmetfina XR does not cause hypoglycemia (low blood sugar). This means it does not affect the patient's ability to drive or use machines.
However, the patient should be careful if they are taking Abmetfina XR in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or concentration difficulties. If such symptoms occur, the patient should not drive or use machines.

Abmetfina XR contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Abmetfina XR

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult a doctor or pharmacist.
Abmetfina XR does not replace the benefits of a healthy lifestyle.
The patient should continue to follow all the doctor's dietary and regular physical activity recommendations.

Recommended dose

Children: due to the lack of appropriate safety data, Abmetfina XR should not be used in children.
Adults: treatment usually starts with one Abmetfina XR 500 mg tablet once a day during the evening meal. After 10-15 days, the dose is adjusted by the doctor based on blood glucose measurements. Gradual dose increase may improve gastrointestinal tolerance.
The doctor may increase the dose to a maximum of 4 tablets per day (2000 mg), taken once a day during the evening meal.
In patients already treated with metformin, the initial dose of Abmetfina XR 500 mg should be equivalent to the daily dose of metformin in the form of immediate-release tablets. When switching from another oral anti-diabetic medicine to Abmetfina XR 500 mg, the doctor should discontinue the previously used medicine and use Abmetfina XR 500 mg in the dose specified above.
If the patient has impaired kidney function, the doctor may prescribe a lower dose.
In patients treated with metformin in a dose above 2000 mg per day in the form of immediate-release tablets, it is not recommended to switch the anti-diabetic treatment to Abmetfina XR.
If the patient is also taking insulin, the doctor will inform them how to start taking Abmetfina XR.
In monotherapy (pre-diabetic condition)
Usually, a dose of 1000 to 1500 mg of metformin hydrochloride is used once a day during the evening meal. The doctor will assess whether treatment should be continued based on regular blood glucose tests and risk factors.
Polycystic ovary syndrome
Usually, a dose of 1500 mg of metformin hydrochloride is used once a day during the evening meal.

Treatment monitoring

• The doctor will order regular blood glucose tests and adjust the dose of Abmetfina XR based on blood glucose values. The patient should regularly visit their doctor for check-ups. This is especially important for elderly patients.
• The doctor will check the patient's kidney function at least once a year. More frequent checks may be necessary for elderly patients or if the patient's kidneys are not functioning properly.

How to take Abmetfina XR

Abmetfina XR should be taken during a meal or immediately after a meal. This will help avoid gastrointestinal side effects.
The patient should not crush or chew the tablets. They should swallow the tablet with a glass of water.
If after some time the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor or pharmacist.

Taking a higher dose of Abmetfina XR than recommended

In case of taking a higher dose of Abmetfina XR than recommended, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal cramps), muscle cramps, general poor condition with severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate.

If the patient experiences any of these symptoms, they should immediately seek medical help, as lactic acidosis can lead to coma. The patient should stop taking Abmetfina XR and contact a doctor or the nearest hospital.

Missing a dose of Abmetfina XR

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.
In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Abmetfina XR can cause side effects, although not everybody gets them.
The side effects that may occur are listed below.
Abmetfina XR may very rarely cause (may occur in up to 1 in 10,000 patients) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should stop taking Abmetfina XR and immediately contact a doctor or the nearest hospital, as lactic acidosis can lead to coma.

Very common side effects (may occur in more than 1 in 10 people)

• Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain (abdominal cramps), loss of appetite. These side effects usually occur at the beginning of treatment with Abmetfina XR and in most cases disappear on their own. Taking Abmetfina XR with a meal or immediately after a meal may be helpful. If the symptoms do not disappear, the patient should stop taking Abmetfina XR and tell their doctor.

Common side effects (may occur in less than 1 in 10 people)

• Taste disorders.
• Decreased or low levels of vitamin B in the blood (symptoms may include extreme fatigue, pain and redness of the tongue, numbness or pale or yellowish skin). The doctor may order some tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other unrelated health problems.

Very rare side effects (may occur in less than 1 in 10,000 people)

• Lactic acidosis. This is a very rare but serious complication, especially if the kidneys are not functioning properly. Symptoms of lactic acidosis - see "Warnings and precautions".
• Abnormal liver function test results or symptoms of hepatitis (with accompanying fatigue, loss of appetite, weight loss, and yellowing or non-yellowing of the skin and whites of the eyes). If such symptoms occur, the patient should immediately stop taking Abmetfina XR and tell their doctor.
• Skin reactions, such as skin redness, itching, or itchy rash.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Abmetfina XR

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the carton after the expiry date: "EXP".
The expiry date refers to the last day of the month.
Lot means batch number.
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 Abmetfina XR contains

The active substance of the medicine is metformin hydrochloride.
Each Abmetfina XR tablet contains 500 mg of metformin hydrochloride, which corresponds to 390 mg of metformin.
The other ingredients are: sodium carmellose, microcrystalline cellulose (Avicel PH-101), hypromellose (Methocel K100M Premium CR), anhydrous colloidal silica, magnesium stearate.

What Abmetfina XR looks like and what the pack contains

White or almost white, round, uncoated tablets with the inscription "16" on one side and "C" on the other.

Packaging:

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

Marketing authorization holder and importer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: (22) 811-18-14
In order to obtain more detailed information about this medicine, the patient should contact the marketing authorization holder.

Date of last revision of the leaflet: