Abmetfina Xr

Package Leaflet: Information for the Patient

Abmetfina XR, 750 mg, Prolonged-Release Tablets

Metformin Hydrochloride

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

• You should 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What Abmetfina XR is and what it is 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 pack and other information

1. What Abmetfina XR is and what it is 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 use glucose (sugar) from the blood for energy or store it for future use.
In people with diabetes, the pancreas does not produce enough insulin or the body is unable to use the insulin it produces properly. This leads to high blood sugar levels. Abmetfina XR helps lower blood sugar levels to as close to normal as possible.
In adults with overweight, long-term use of Abmetfina XR also reduces the risk of complications associated with diabetes. Taking Abmetfina XR is associated with either weight loss or no change in body weight.
Abmetfina XR is used to treat patients with type 2 diabetes (also called non-insulin-dependent diabetes). It is particularly used in patients with overweight.
Adults can take Abmetfina XR either alone or in combination with other anti-diabetic medicines (oral or insulin).

2. Important information before taking Abmetfina XR

When not to take Abmetfina XR:

• if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6),
• if you have liver disease,
• if you have severely reduced kidney function,
• if you have uncontrolled diabetes, for example 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 where substances called ketone bodies build up in the blood and can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or a fruity odor from the mouth,
• in case of excessive loss of body water (dehydration), for example due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of severe infection, for example pneumonia, bronchitis or kidney infection. Severe infections can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of acute heart failure or recent myocardial infarction, severe circulatory disorders (such as shock) or breathing difficulties. This can cause tissue hypoxia, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of alcohol abuse,
• if you are under 18 years old.

If any of the above conditions apply to you, you should consult your doctor before taking this medicine.
It is essential to consult your doctor if it is necessary to:

• perform a radiological examination or an examination that requires 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. Your doctor will decide whether other treatment is necessary during this time. It is essential to follow your 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 you have 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 where a part of the body is not adequately supplied with oxygen (e.g., acute severe heart disease).
If any of the above conditions apply to you, you should consult your doctor for more detailed instructions.

You should temporarily stop taking Abmetfina XR if you have a condition that may lead to dehydration

(excessive loss of body water), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. You should consult your doctor for more detailed instructions.

You should stop taking Abmetfina XR and contact your doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis,

as 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 you are going to have a major surgical procedure, you should not take Abmetfina XR during the procedure and for some time after it. Your doctor will decide when you should stop and restart 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 sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia. If symptoms of hypoglycemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, eating or drinking a sugary drink usually helps.
During treatment with Abmetfina XR, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have impaired kidney function.
You should follow your doctor's dietary recommendations.
It may happen that the tablet coating is visible in the stool. Do not worry, this is normal when taking this type of tablet.

Abmetfina XR with other medicines

If you are going to have a contrast agent containing iodine injected into your bloodstream, for example for an X-ray examination or computed tomography, you should stop taking Abmetfina XR before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart treatment with Abmetfina XR.
You should tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
You may need more frequent blood sugar checks and kidney function tests or a dose adjustment of Abmetfina XR by your doctor.
It is especially important to inform your 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 levels of Abmetfina XR in the blood, especially if you have kidney problems (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other anti-diabetic medicines.

Abmetfina XR with alcohol

You should avoid excessive alcohol consumption while taking Abmetfina XR, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to have a baby, you should consult your doctor before taking this medicine.
This medicine is not recommended for breastfeeding women or women planning to breastfeed.

Driving and using machines

Abmetfina XR does not cause hypoglycemia (low blood sugar). This means it does not affect your ability to drive or use machines.
However, you should be careful if you are taking Abmetfina XR with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating.
If you experience such symptoms, you should not drive or use machines.

Abmetfina XR contains sodium

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

3. How to take Abmetfina XR

You should always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Abmetfina XR does not replace the benefits of a healthy lifestyle.
You should continue to follow your doctor's recommendations regarding diet and regular physical activity.

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 750 mg tablet once daily, taken during the evening meal. After 10-15 days, the dose is adjusted by the doctor based on blood sugar measurements. Gradual dose increase may improve gastrointestinal tolerance.
Your doctor may increase the dose to a maximum of 2 Abmetfina XR 750 mg tablets, taken once daily during the evening meal.
In patients already treated with metformin, the initial dose of Abmetfina XR 750 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 750 mg, the doctor should discontinue the previously used medicine and use Abmetfina XR 750 mg at the dose specified above.
If you have kidney problems, your doctor may prescribe a lower dose.
In patients treated with metformin at a dose above 2000 mg per day in the form of immediate-release tablets, it is not recommended to switch to Abmetfina XR.
If you are also taking insulin, your doctor will tell you how to start taking Abmetfina XR.
In monotherapy (pre-diabetes)
Usually, a dose of 1000 to 1500 mg of metformin hydrochloride is taken once daily during the evening meal. The doctor will assess whether treatment should be continued based on regular blood sugar checks and risk factors.
Polycystic ovary syndrome
Usually, a dose of 1500 mg of metformin hydrochloride is taken once daily during the evening meal.

Monitoring of treatment

• Your doctor will prescribe regular blood sugar checks and adjust the dose of Abmetfina XR according to the blood sugar values. You should regularly visit your doctor for check-ups. This is especially important for elderly people.
• Your doctor will check your kidney function at least once a year. More frequent checks may be necessary for elderly people or if your kidneys are not working properly.

How to take Abmetfina XR

Abmetfina XR should be taken with a meal or immediately after a meal. This will help avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet with a glass of water.
If after some time you feel that the effect of the medicine is too strong or too weak, you should consult your doctor or pharmacist.

Overdose of Abmetfina XR

In case of overdose, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal cramps) with muscle cramps, general feeling of being unwell with severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate.

If you experience any of these symptoms, you should seek medical help immediately, as lactic acidosis can lead to coma. You should stop taking Abmetfina XR and contact your doctor or the nearest hospital.

Missed dose of Abmetfina XR

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Abmetfina XR can cause side effects, although not everybody gets them.
The following side effects may occur with Abmetfina XR:
Abmetfina XR may very rarely cause (may affect up to 1 in 10,000 people) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, you should stop taking Abmetfina XR and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Very common side effects (may affect 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 help. If the symptoms do not disappear, you should stop taking Abmetfina XR and tell your doctor.

Common side effects (may affect up to 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, feeling of tingling, or pale or yellowish skin). Your doctor may prescribe some tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other unrelated health problems.

Rare side effects (may affect up to 1 in 1,000 people)

• Lactic acidosis. This is a very rare but serious complication, especially if the kidneys are not working properly. Symptoms of lactic acidosis - see "Warnings and precautions".
• Abnormal liver function test results or symptoms of liver inflammation (with accompanying fatigue, loss of appetite, weight loss, and jaundice or without jaundice). If such symptoms occur, you should stop taking Abmetfina XR and tell your doctor.
• Skin reactions, such as skin redness, itching, or itchy rash.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the Department of Drug Safety Monitoring, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abmetfina XR

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date which is stated on the carton after "EXP".
The expiry date refers to the last day of that month.
Batch number is the lot number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 750 mg of metformin hydrochloride, which corresponds to 585 mg of metformin.
The other ingredients are: sodium carmellose, microcrystalline cellulose (Avicel PH-101), hypromellose (Methocel K100M Premium CR), colloidal anhydrous silica, magnesium stearate.

What Abmetfina XR looks like and contents of the pack

White or almost white, capsule-shaped, uncoated tablets with the inscription "15" on one side and "C" on the other side.

Packaging:

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

Marketing authorization holder and importer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone: (22) 811-18-14
For more detailed information on this medicine, please contact the marketing authorization holder.

Date of last revision of the leaflet: