Abmetfina xr

Package leaflet: Information for the patient

Abmetfina XR, 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, as 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. Do not pass it on to others. This medicine may harm someone else, 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. 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 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. Abmetfina XR helps reduce blood glucose levels to values as close as possible to normal.
In overweight adults, long-term treatment with Abmetfina XR also reduces the risk of diabetes-related complications. Taking Abmetfina XR is associated with weight maintenance or 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 alone 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 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 function disorders,
• 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 unusual fruity odour of 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 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 situations apply, the patient should consult a doctor before using this medicine.
The patient should definitely 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 strictly follow the doctor's instructions.

Warnings and precautions

Risk of lactic acidosis
Abmetfina XR may cause a very rare but serious adverse effect 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 details below), liver dysfunction, and any medical conditions in which part of the body is inadequately oxygenated (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.

The patient should temporarily stop taking Abmetfina XR if experiencing any illness 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 fluids than usual. The patient should consult a doctor for further instructions.

The patient should stop taking Abmetfina XR and contact a doctor or the nearest hospital immediately 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 profound fatigue,
• breathing difficulties,
• 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 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 sulfonylurea derivatives, insulin, meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances or difficulty concentrating, eating or drinking a sugary food or drink usually helps.

During treatment with Abmetfina XR, the doctor will monitor the patient's 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 cause 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 used 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 dose adjustments of Abmetfina XR 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 asthma treatment),
• 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 in diabetes treatment.

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 blood glucose monitoring.
This medicine is not recommended for breastfeeding women or those 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, particular caution is necessary if Abmetfina XR is used together with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycaemia include: weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances 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, i.e. the medicine is considered "sodium-free".

3. How to use Abmetfina XR

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Abmetfina XR does not replace the benefits of a healthy lifestyle.
You should continue to follow any dietary and regular physical activity advice given by your doctor.
Recommended dose
Children: due to lack of adequate safety data on the use of Abmetfina XR, the medicine should not be used in children.
Adults: treatment is usually started with 1 tablet of Abmetfina XR 500 mg once daily with 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 of the medicine.
The doctor may increase the dose up to a maximum of 4 tablets per day (2000 mg), taken once daily with the evening meal.
For patients already treated with metformin, the starting dose of Abmetfina XR 500 mg should be equivalent to the daily dose of metformin in immediate-release tablets. When switching from another oral antidiabetic medicine to Abmetfina XR 500 mg, the doctor should discontinue the previously used medicine and initiate Abmetfina XR 500 mg at the dose specified above.
If the patient has impaired kidney function, the doctor may prescribe a lower dose.
Switching antidiabetic treatment to Abmetfina XR is not recommended in patients currently receiving metformin in doses exceeding 2000 mg per day as immediate-release tablets.
If the patient is also using insulin, the doctor will advise on how to initiate treatment with Abmetfina XR.
Monotherapy (prediabetic state)
The usual dose is 1000 to 1500 mg of metformin hydrochloride once daily with 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 with the evening meal.
Monitoring of treatment

• The doctor will order regular blood glucose tests and adjust the dose of Abmetfina XR according to blood glucose levels. Regular follow-up visits to the doctor are necessary. This is particularly important for elderly patients.
• The doctor will check kidney function at least once a year. More frequent monitoring may be necessary in 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 to avoid gastrointestinal adverse 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.
Use of a higher than recommended dose of Abmetfina XR
If a higher than recommended dose of Abmetfina XR is taken, 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 attention,
as lactic acidosis may lead to coma. The medicine Abmetfina XR should be discontinued 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 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 medical advice must be sought immediately from 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 disorders 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.
• Decreased 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). 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 acid游戏副本

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 abbreviation: "EXP".
The expiry date refers to the last day of the stated 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 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 500 mg of metformin hydrochloride, equivalent to 390 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, round, uncoated tablets, embossed with the number "16" 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, Poland
Telephone number: (22) 811-18-14
For further information on this medicinal product, please contact the Marketing Authorisation Holder.