Diabufor Xr

Leaflet attached to the packaging: information for the user

Diabufor XR, 500 mg, prolonged-release tablets

Diabufor XR, 750 mg, prolonged-release tablets

Diabufor XR, 1000 mg, prolonged-release tablets

Metformin hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet

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

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

Diabufor XR contains the active substance metformin hydrochloride, which belongs to a group of medicines called biguanides, used to treat type 2 diabetes (non-insulin-dependent).

This medicine is used in combination with diet and physical exercise to reduce the risk of developing type 2 diabetes in adults with overweight, when diet and exercise alone have not been enough to control blood sugar levels for 3 to 6 months.

There is a high risk of developing type 2 diabetes if the person has additional risk factors, such as high blood pressure, age over 40, abnormal lipid levels (fats) in the blood, or gestational diabetes in their medical history.
This medicine is particularly effective if the person is under 45 years old, has a high body mass index, high blood sugar levels after meals, or has developed diabetes during pregnancy.

This medicine is used in patients with type 2 diabetes, when diet and physical exercise alone cannot achieve proper blood sugar control.

Insulin is a hormone that allows the body to take glucose from the blood, which it uses to produce energy or stores for later use.In patients with type 2 diabetes, the pancreas does not produce enough insulin or the body is unable to use the insulin it produces properly. This leads to an excessive increase in blood sugar levels, which can cause a range of serious and long-term complications, which is why it is essential to continue taking the medicine even if there are no obvious symptoms.

How Diabufor XR works

This medicine increases the body's sensitivity to insulin and helps restore the proper use of glucose.
Taking this medicine is associated with maintaining a stable body weight or moderate weight loss.
The prolonged-release tablets of Diabufor XR are specially designed to release the medicine slowly in the body and therefore differ from many other types of metformin tablets.

2. Important information before taking Diabufor XR

When not to take Diabufor XR:

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if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause a rash, itching, or difficulty breathing,
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if the patient has uncontrolled diabetes with severe hyperglycemia (high blood sugar levels), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see below "Risk of lactic acidosis") 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 an unusual fruity odor from the mouth,
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in case of excessive fluid loss from the body (dehydration). Dehydration can lead to kidney function disorders, which can increase the risk of lactic acidosis (see below "Warnings and precautions"),
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in case of severe infection, such as pneumonia or bronchitis or kidney infection. Severe infections can lead to kidney function disorders, which can increase the risk of lactic acidosis (see below "Warnings and precautions"),
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if the patient has significantly reduced kidney function,
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if the patient has been treated for acute heart failure or recently had a heart attack, severe circulatory disorders, or breathing difficulties. This may cause tissue hypoxia, which can increase the risk of lactic acidosis (see below "Warnings and precautions"),
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if the patient has liver function disorders,
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in case of alcohol abuse.

Warnings and precautions

Before starting to take Diabufor XR, you should discuss it with your doctor or pharmacist.
Risk of lactic acidosis
Diabufor 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 also increases in case of uncontrolled diabetes, severe infections, 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 their doctor or pharmacist before taking this medicine.

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

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

The patient should stop taking Diabufor XR and immediately contact their 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 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.
The patient should immediately contact their doctor to receive further instructions if:

• they have a genetically inherited disease affecting mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.
• they have experienced any of the following symptoms after starting metformin: seizures, cognitive impairment, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, and hearing loss.

During treatment with Diabufor XR, the doctor will monitor the patient's kidney and (or) heart function at least once a year or more often if the patient is elderly and (or) has worsening kidney and (or) heart function. In patients over 75 years old, treatment with this medicine should not be initiated to reduce the risk of developing type 2 diabetes.
If the patient is to undergo major surgery, they should not take Diabufor XR during the surgery and for some time after it. The doctor will decide when the patient should stop and resume treatment with Diabufor XR.
It may happen that the tablet coating is visible in the stool. The patient should not be concerned, as this is normal when taking this type of tablet.
The patient should follow the dietary recommendations given by their doctor and ensure they consume carbohydrates regularly throughout the day.
The patient should not stop taking this medicine without consulting their doctor.

Children and adolescents

Diabufor XR should not be given to children and adolescents under 18 years old due to the lack of data that the potential benefits of the medicine outweigh the risks.

Diabufor XR and other medicines

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.
If the patient is to be injected with a contrast agent containing iodine, for example, for an X-ray examination or computed tomography, they should stop taking Diabufor XR before or at the latest at the time of the injection. The doctor will decide when the patient should stop and resume treatment with Diabufor XR.
The patient may need more frequent blood sugar checks and kidney function tests or dose adjustments of Diabufor XR by their doctor. It is especially important to inform about the following medicines:
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medicines containing alcohol, as alcohol may cause lactic acidosis (see section "Warnings and precautions"),
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medicines used to treat pain and inflammation [non-steroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors, such as ibuprofen and celecoxib],
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certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
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diuretics (such as furosemide),
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corticosteroids, such as prednisolone, mometasone, beclomethasone,
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sympathomimetic medicines, including epinephrine and dopamine, used to treat heart attack and low blood pressure. Epinephrine is also a component of some anesthetics used in dentistry,
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medicines that may change the levels of Diabufor XR in the blood, especially if the patient has reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Diabufor XR and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Diabufor XR, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
This medicine should not be taken if the patient is pregnant or breastfeeding.

Driving and using machines

Diabufor XR used as the only anti-diabetic medicine does not cause hypoglycemia (symptoms of low blood sugar, such as fainting, confusion, and increased sweating), so it should not affect the ability to drive and use machines.
However, the patient should remember that this medicine taken with other anti-diabetic medicines may cause hypoglycemia, so they should be extremely careful when driving or operating machines.

3. How to take Diabufor XR

The doctor may prescribe Diabufor XR to be taken alone or in combination with other oral anti-diabetic medicines or insulin.
Diabufor XR should always be taken according to the doctor's recommendations.
In case of doubts, the patient should consult their doctor or pharmacist.
Recommended dose
Treatment usually starts with a dose of 500 mg of Diabufor XR taken once a day. After about 2 weeks of taking the medicine, the doctor may adjust the dose based on blood sugar measurements. The maximum daily dose of Diabufor XR is 2000 mg.
If the patient has reduced kidney function, the doctor may prescribe a lower dose.
The tablets are usually taken once a day with the evening meal.
In some cases, the doctor may recommend taking the tablets twice a day. The tablets should always be taken with a meal.
The tablets should be swallowed whole, washed down with a glass of water, and not chewed.

Taking a higher dose of Diabufor XR than recommended

If the patient has taken extra tablets of Diabufor XR by mistake, they should not be concerned, but if they experience unusual symptoms, they should contact their doctor. In case of significant overdose, lactic acidosis is more likely to occur.
Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain 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 such symptoms occur, immediate hospital treatment is necessary, as lactic acidosis can lead to coma. The patient should stop taking Diabufor XR and immediately contact their doctor or the nearest hospital.

Missing a dose of Diabufor XR

The patient should take the missed dose with any meal as soon as they remember.
They should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Diabufor XR can cause side effects, although not everybody gets them.
Diabufor XR may very rarely cause (less than 1 in 10,000 patients) a very serious side effect called lactic acidosis (see section "Warnings and precautions"). The following symptoms may occur: vomiting, abdominal pain, muscle cramps, general feeling of being unwell with severe fatigue, breathing difficulties, decreased body temperature, and slowed heart rate. In such a case, the patient should stop taking Diabufor XR and immediately contact their doctor or the nearest hospital, as lactic acidosis can lead to coma.
Diabufor XR may cause abnormal liver function test results or hepatitis, which can cause jaundice (may occur less than 1 in 10,000 patients).

If the patient's eyes and (or) skin turn yellow, they should immediately contact their doctor.

Other possible side effects are listed according to their frequency:

Very common (may affect more than 1 in 10 patients):

• diarrhea, nausea, vomiting, abdominal pain, or loss of appetite. If such side effects occur, the patient should not stop taking the tablets, as these symptoms usually disappear within about 2 weeks. Taking the tablets with a meal or immediately after a meal may be helpful

Common (may affect less than 1 in 10 patients):

• taste disorders

Very rare (may affect less than 1 in 10,000 patients):

• decreased vitamin B12 levels in the blood
• skin rashes, including redness of the skin, itching, and hives

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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, more information can be collected on the safety of the medicine.

5. How to store Diabufor XR

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine.
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 pack and other information

What Diabufor XR contains

­ The active substance of Diabufor XR is metformin hydrochloride. Each prolonged-release tablet contains 500 (which corresponds to 389.94 mg of metformin), 750 (which corresponds to 584.91 mg of metformin), or 1000 (which corresponds to 779.88 mg of metformin) milligrams of metformin hydrochloride.
­ The other ingredients are: magnesium stearate, sodium carmellose, hypromellose (100,000 mPas).

What Diabufor XR looks like and contents of the pack

The 500 mg tablets are white or almost white, round, and biconvex.
The 750 mg tablets are white or almost white, oval, and biconvex.
The 1000 mg tablets are white or almost white, oval, and biconvex.
Diabufor XR is packaged in blisters of 10 tablets, and the carton contains 30, 60, or 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw

Importer

Symphar Sp. Z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Estonia:
Diabufor XR
Poland:
Diabufor XR

Date of last revision of the leaflet: