Diabufor xr
Poland
Table of Contents
Patient Information Leaflet
Diabufor XR, 500 mg, prolonged-release tablets
Diabufor XR, 750 mg, prolonged-release tablets
Diabufor XR, 1000 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.
Please contact your doctor or pharmacist if you have any questions.
This medicine has been prescribed for you personally. Do not share it with others. It may harm
them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, please inform your
doctor or pharmacist. See section 4.
Contents of the leaflet
- What Diabufor XR is and what it is used for
- What you need to know before taking Diabufor XR
- How to take Diabufor XR
- Possible side effects
- How to store Diabufor XR
- Contents of the pack and other information
1. What Diabufor XR is and what it is used for
Diabufor XR contains the active substance metformini hydrochloridum (metformin hydrochloride), which belongs to a group of medicines called biguanides, used in the treatment of type 2 diabetes (non-insulin-dependent diabetes).
This medicine is used together with diet and exercise to reduce the risk of developing type 2 diabetes in overweight adults when diet and exercise alone for a period of 3 to 6 months have not been sufficient to control blood glucose (sugar) levels.
There is a high risk of developing type 2 diabetes if a person has additional risk factors such as high blood pressure, age over 40 years, abnormal blood lipid (fat) levels, or a history of gestational diabetes.
This medicine is particularly effective if the person is under 45 years of age, has significant overweight, high blood glucose levels after meals, or has had diabetes during pregnancy.
This medicine is used in patients with type 2 diabetes when proper blood glucose (sugar) control cannot be achieved by diet and physical exercise alone. Insulin is a hormone that enables the body to take up glucose from the blood, which is then used to produce energy or stored for later use. In patients with type 2 diabetes, the pancreas does not produce enough insulin or the body cannot properly use the insulin it produces. This leads to excessively high blood glucose levels, which may cause a range of serious and long-term complications. Therefore, it is important to continue taking this medicine even if you have no noticeable symptoms.
How Diabufor XR works
This medicine increases the body's sensitivity to insulin and helps restore normal utilization of glucose.
Taking this medicine is associated with maintaining stable body weight or even moderate weight reduction.
Diabufor XR prolonged-release tablets are specially designed to slowly release the medicine in the body and therefore differ from many other types of tablets containing metformin.
2. Important information before using Diabufor XR
When not to use Diabufor XR:
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 rash, itching or
breathlessness,
if the patient has uncontrolled diabetes with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see below "Risk of lactic acidosis") or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and which may lead to a diabetic pre-coma state. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odour of the breath,
in case of excessive loss of body fluids (dehydration). Dehydration may
lead to impaired kidney function, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
in case of severe infection, e.g. affecting the lungs, bronchi or kidneys. Severe infections may lead to impaired kidney function, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
if the patient has significantly reduced kidney function,
if the patient has been treated for acute heart failure or recent myocardial infarction, severe circulatory disorders or breathing difficulties. These conditions may cause tissue hypoxia, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
if the patient has impaired liver function,
in case of alcohol abuse.
Warnings and precautions
Before starting treatment with Diabufor XR, discuss this with your doctor or pharmacist.
Risk of lactic acidosis
Diabufor XR may cause a very rare but serious adverse effect called lactic acidosis, particularly if the patient has impaired kidney function. The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), impaired liver function, 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, consult a doctor or pharmacist before using this medicine.
Temporarily discontinue Diabufor XR if the patient develops a medical condition that may involve dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult your doctor for further instructions.
Stop taking Diabufor XR and contact your doctor or the nearest hospital immediately if the patient experiences any symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:
- vomiting
- abdominal pain
- muscle cramps
- general malaise associated with profound fatigue
- difficulty breathing
- decreased body temperature and slowed heart rate
Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
Contact your doctor immediately for further instructions if:
- the patient has a genetically inherited mitochondrial disorder (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD),
- the patient develops any of the following symptoms after starting metformin: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.
During treatment with Diabufor XR, your doctor will monitor 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. Diabufor XR should not be initiated in patients over 75 years of age for the purpose of reducing the risk of developing type 2 diabetes.
If the patient is to undergo major surgery, Diabufor XR must not be taken during the procedure and for some time afterwards. Your doctor will decide when the patient should stop and resume treatment with Diabufor XR.
Occasionally, the tablet shell may be visible in the stool. This is normal with this type of tablet and should not be a cause for concern.
Follow dietary recommendations provided by your doctor and ensure that the patient consumes carbohydrates regularly throughout the day.
Do not stop taking this medicine without consulting your doctor.
Children and adolescents
Diabufor XR should not be given to children and adolescents under 18 years of age due to lack of data demonstrating that potential benefits outweigh the risks.
Diabufor XR and other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use.
If the patient is to receive an iodine-containing contrast agent intravenously, for example during an X-ray or CT scan, Diabufor XR must be discontinued before or at the latest at the time of administration. Your doctor will decide when the patient should stop and resume treatment with Diabufor XR.
The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Diabufor XR by the doctor. It is particularly important to inform the doctor about the following medicines:
medicines containing alcohol, as alcohol may cause lactic acidosis (see section "Warnings and precautions"),
medicines used to treat pain and inflammation [non-steroidal anti-inflammatory drugs (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),
diuretics (medicines that increase urine production), such as furosemide,
steroids, such as prednisolone, mometasone, beclomethasone,
sympathomimetic medicines, including epinephrine and dopamine, used in the treatment of myocardial infarction and low blood pressure. Epinephrine is also an ingredient in certain dental local anaesthetics,
medicines that may alter the blood concentration of Diabufor XR, 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 section "Warnings and precautions").
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
This medicine should not be used if the patient is pregnant or breastfeeding.
Driving and operating machinery
Diabufor XR, when used alone as an antidiabetic medicine, does not cause hypoglycaemia (symptoms of low blood sugar such as fainting, confusion and excessive sweating), and therefore should not affect the ability to drive or operate machinery.
However, bear in mind that when this medicine is taken with other antidiabetic medicines, hypoglycaemia may occur; therefore, extra caution should be exercised when driving or operating machinery in such cases.
3. How to use Diabufor XR
Your doctor may prescribe Diabufor XR to be used as monotherapy or in combination with other
oral antidiabetic medicines or insulin.
Diabufor XR should always be taken as directed by your doctor.
If in doubt, consult your doctor or pharmacist.
Recommended dose
Treatment is usually started with a dose of 500 mg of Diabufor XR once daily. After approximately
2 weeks of treatment, your doctor may adjust the dose based on blood glucose measurements.
The maximum daily dose of Diabufor XR is 2000 mg.
If you have impaired kidney function, your doctor may prescribe a lower dose.
The tablets are usually taken once daily with the evening meal.
In certain cases, your doctor may recommend taking the tablets twice daily. Tablets should always
be taken with food.
Swallow the tablets whole with a glass of water; do not chew them.
Taking more Diabufor XR than prescribed
If you accidentally take extra tablets, do not panic, but if unusual symptoms occur, contact your
doctor. In cases of significant overdose, lactic acidosis is more likely to occur.
Symptoms of lactic acidosis are nonspecific and include vomiting, abdominal pain with muscle
cramps, general malaise with severe fatigue, and difficulty breathing. Other symptoms include
lowered body temperature and slowed heart rate.
If such symptoms occur, immediate hospital treatment is necessary, as lactic acidosis may lead to
coma. You must immediately stop taking Diabufor XR and contact your doctor without delay or go
to the nearest hospital.
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 a missed dose.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Diabufor XR may very rarely (in fewer than 1 in 10,000 patients) cause a very serious adverse effect known as lactic acidosis (see section "Warnings and precautions"). Symptoms may include: vomiting, abdominal pain, muscle cramps, general feeling of severe malaise with intense fatigue, difficulty breathing, lowered body temperature, and slowed heart rate. In such a case, the use of Diabufor XR must be stopped immediately and medical advice must be sought immediately from a doctor or the nearest hospital, as lactic acidosis can lead to coma.
Diabufor XR may cause abnormal liver function test results or hepatitis, which may lead to jaundice (may occur in fewer than 1 in 10,000 patients).
If yellowing of the eyes and/or skin occurs, contact a doctor immediately.
Other possible adverse effects are listed below according to their frequency of occurrence:
Very common (may affect more than 1 in 10 people):
- diarrhoea, nausea, vomiting, abdominal pain or loss of appetite. If these adverse effects occur, do not stop taking the tablets, as these symptoms usually resolve within about 2 weeks. Taking the tablets with food or immediately after a meal may help
Common (may affect fewer than 1 in 10 people):
- taste disturbances
Very rare (may affect fewer than 1 in 10,000 people):
- decreased blood vitamin B12 levels
- skin rashes including: skin redness, itching and urticaria.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.
5. How to store Diabufor XR
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging after:
EXP. The expiry date refers to the last day of the stated month.
No special storage conditions required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures 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 (corresponding to 389.94 mg of metformin), 750 mg (corresponding to 584.91 mg of metformin), or 1000 mg (corresponding to 779.88 mg of metformin) of metformin hydrochloride.
Other ingredients: magnesium stearate, sodium carmellose, hypromellose (100 000 mPas).
What Diabufor XR looks like and contents of the pack
500 mg tablets are white or almost white, round, biconvex.
750 mg tablets are white or almost white, oblong, biconvex.
1000 mg tablets are white or almost white, oval, biconvex.
Diabufor XR is packed in blisters of 10 tablets. The cardboard box contains 30, 60 or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
Poland
Importer
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
This medicinal product is authorised in the European Economic Area countries under the following names:
Estonia: Diabufor XR
Poland: Diabufor XR