Diabufor Xr

Package Leaflet: 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

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

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Keep this package leaflet, you may need to read it again.
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In case of any doubts, consult a doctor or pharmacist.
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This medicine has been prescribed to you by a doctor. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Contents of the package 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 physical exercise alone have not been sufficient to control blood sugar levels for a period of 3 to 6 months.

There is a high risk of developing type 2 diabetes if the patient has additional risk factors, such as high blood pressure, age over 40, abnormal lipid levels (fats) in the blood, or a history of gestational diabetes.
This medicine is particularly effective if the patient 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 have not been sufficient to achieve normal blood sugar levels.

Insulin is a hormone that allows the body to take up 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 produced properly. This leads to an excessive increase in blood sugar levels, which can cause a range of serious and long-term complications, making it important 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 normal 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 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 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 has 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 treatment with Diabufor XR, discuss it with a 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 a doctor or pharmacist before taking this medicine.

Temporarily discontinue taking Diabufor XR if the patient has a condition that may be associated with dehydration

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

Discontinue taking Diabufor XR and immediately contact a doctor or the nearest hospital if the patient experiences 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.
Consult a doctor immediately for further instructions if:

• the patient has 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.
• the patient has experienced any of the following symptoms after starting metformin: seizures, cognitive impairment, difficulty moving, signs of 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 frequently if the patient is elderly and/or has worsening kidney and/or heart function. In patients over 75 years of age, 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 a certain period after it. The doctor will decide when the patient should stop and restart treatment with Diabufor XR.
It may happen that the tablet coating is visible in the stool. Do not be concerned, as this is normal when taking this type of tablet.
Follow the dietary recommendations given by the doctor and ensure that the patient eats carbohydrates regularly throughout the day.
Do not stop taking this medicine without consulting a doctor.

Children and adolescents

Diabufor XR should not be given to children and adolescents under 18 years of age due to the lack of data on the benefits and risks of the medicine.

Diabufor XR and other medicines

Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If the patient is to receive an iodine-containing contrast agent intravenously, 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 administration. The doctor will decide when the patient should stop and restart treatment with Diabufor XR.
The patient may require more frequent monitoring of blood sugar levels and kidney function or dose adjustment of Diabufor XR by the 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 "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

Avoid excessive alcohol consumption while taking Diabufor XR, as this may increase the risk of lactic acidosis (see "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 a doctor or pharmacist before taking this medicine.
Do not take this medicine if the patient is pregnant or breastfeeding.

Driving and using machines

Diabufor XR, when used as the only antidiabetic medicine, does not cause hypoglycemia (low blood sugar levels, such as fainting, confusion, and increased sweating), and therefore should not affect the ability to drive or operate machines.
However, remember that this medicine taken with other antidiabetic medicines may cause hypoglycemia, so be cautious when driving or operating machines in such cases.

3. How to take Diabufor XR

The doctor may prescribe Diabufor XR to be taken alone or in combination with other oral antidiabetic medicines or insulin.
Always take Diabufor XR exactly as the doctor has told you.
If you are not sure, consult a 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 treatment, 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.
Diabufor XR is 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.
Swallow the tablets whole with a glass of water; do not chew them.

Taking a higher dose of Diabufor XR than recommended

If you have accidentally taken extra tablets, do not worry, but if you experience unusual symptoms, consult a 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. Stop taking Diabufor XR and contact a doctor or the nearest hospital immediately.

Missing a dose of Diabufor XR

Take the missed dose with any meal as soon as you remember. Do 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 "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 cases, stop taking Diabufor XR and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
Diabufor XR may cause abnormal liver function test results or liver inflammation, which may cause jaundice (may occur less than 1 in 10,000 patients).

If the patient's eyes or skin turn yellow, they should contact a doctor immediately.

Other possible side effects are listed according to their frequency:

• diarrhea, nausea, vomiting, abdominal pain, or loss of appetite. If such side effects occur, do 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 help.

Common (may affect up to 1 in 10 patients):

• taste disturbances

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

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

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Diabufor XR

Keep this medicine out of the sight and reach of children.
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.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Diabufor XR contains

­ The active substance is metformin hydrochloride. Each prolonged-release tablet contains 500 mg (equivalent to 389.94 mg of metformin), 750 mg (equivalent to 584.91 mg of metformin), or 1000 mg (equivalent to 779.88 mg of metformin) of metformin hydrochloride.
­ The other ingredients are magnesium stearate, sodium carmellose, hypromellose (100,000 mPa·s).

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 package leaflet: