Abmetfina xr

Patient Information Leaflet

Abmetfina XR, 750 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, please 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 them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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 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 blood glucose levels. 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 mild 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 overweight patients.
Adults may take Abmetfina XR either alone or in combination with other antidiabetic medicines (oral agents or insulin).
For prevention of type 2 diabetes in patients with prediabetes.
In polycystic ovary syndrome.

2. Important information before using Abmetfina XR

When not to use 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 hyperglycemia (high blood glucose levels), nausea, vomiting, diarrhea, 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 unusual fruity odor of the breath,
• in case of excessive loss of body fluids (dehydration), e.g. due to prolonged or severe diarrhea or repeated vomiting. Dehydration may lead to kidney dysfunction, 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 dysfunction, 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 using 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 surgery.
The doctor will decide whether alternative treatment is necessary during this time. It is important to strictly follow the doctor's instructions.

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 kidney dysfunction. 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, diarrhea, 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 undergoing 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 hypoglycemia (low blood glucose levels).
However, if Abmetfina XR is used in combination with other antidiabetic medicines that may 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, 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 recommendations provided by the doctor.

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

Abmetfina XR with other medicines
If the patient receives an intravenous iodine-containing contrast agent, for example during 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 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 assessments, 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 Abmetfina XR 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.

Abmetfina XR and alcohol
The patient should avoid excessive alcohol consumption 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 hypoglycemia (low blood glucose levels). This means that 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 hypoglycemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycemia 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 it is considered "sodium-free".

3. How to use Abmetfina XR

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Abmetfina XR does not replace the benefits of a healthy lifestyle.
You should continue to follow your doctor's advice 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 750 mg once daily during the evening meal. After 10–15 days, the dose will be adjusted by the doctor based on blood glucose measurements. Gradual dose escalation may improve gastrointestinal tolerance to the medicine.
Your doctor may increase the dose up to a maximum of 2 tablets of Abmetfina XR 750 mg, taken once daily during the evening meal.
For patients already treated with metformin, the starting dose of Abmetfina XR 750 mg should correspond to the daily dose of metformin in immediate-release tablets. When switching from another oral antidiabetic medicine to Abmetfina XR 750 mg, your doctor should discontinue the previously used medicine and initiate Abmetfina XR 750 mg at the dose specified above.
If a patient has impaired kidney function, the doctor may prescribe a lower dose.
Switching antidiabetic treatment to Abmetfina XR is not recommended for patients currently receiving metformin at doses exceeding 2000 mg per day in immediate-release tablets.
If a 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 continue based on regular blood glucose monitoring 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 accordingly. You should attend regular follow-up visits. This is particularly important for elderly patients.
• Your doctor will check kidney function at least once a year. More frequent monitoring may be necessary for elderly patients or if kidney function is impaired.

How to take Abmetfina XR
Abmetfina XR should be taken with food or immediately after a meal. This helps to avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet whole with a glass of water.
If at any time you feel the medicine’s effect is too strong or too weak, consult your doctor or pharmacist.

Taking more Abmetfina XR than prescribed
If you take more Abmetfina XR 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, seek immediate medical help,
as lactic acidosis can lead to coma. You must stop taking Abmetfina XR immediately and contact your doctor or go to the nearest hospital.

If you miss a 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 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 adverse reactions 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 adverse reaction 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 reactions (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 reactions most commonly occur at the beginning of treatment with Abmetfina XR 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 reactions (may affect less than 1 in 10 people)

• Taste disturbances.
• Reduced or low blood vitamin B levels (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling sensations (paraesthesiae), or pale or yellowish skin). Your 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 reactions (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 liver inflammation (hepatitis) (accompanied by 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 stopped immediately and the doctor informed.
• Skin reactions such as skin redness (erythema), itching, or itchy rash (urticaria).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your 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 Warszawa
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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Abmetfina XR

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the carton after the label: "EXP".
The expiry date refers to the last day of the stated month.
Lot is the batch 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 package and other information

What Abmetfina XR contains
The active substance is metformin hydrochloride.
Each Abmetfina XR tablet contains 750 mg of metformin hydrochloride, equivalent to 585 mg of metformin.
Other ingredients: 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, embossed with the number "15" 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
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Telephone number: (22) 811-18-14

For more detailed information about this medicine, please contact the Marketing Authorisation Holder.