Siofor xr 750 mg

Package leaflet: Information for the patient

Siofor XR 500 mg, 500 mg, prolonged-release tablets
Siofor XR 750 mg, 750 mg, prolonged-release tablets
Siofor XR 1000 mg, 1000 mg, prolonged-release tablets
Metformini hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms appear identical.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents:

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

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

Siofor XR contains the active substance metformini hydrochloridum, which belongs to a group of medicines called biguanides and is used in the treatment of type 2 (non-insulin-dependent) diabetes.
Siofor XR is used to treat patients with type 2 diabetes (also known as "non-insulin-dependent diabetes") in whom diet and physical exercise alone are insufficient to achieve adequate control of blood glucose (sugar) levels. Insulin is a hormone that enables body tissues to take up glucose from the blood to produce energy or store it for later use. In patients with type 2 diabetes, the pancreas does not produce enough insulin or the body does not respond properly to the insulin produced. This leads to an accumulation of glucose in the blood, which may cause a range of serious, long-term complications. Therefore, it is important that the patient continues taking the medicine, even if no visible symptoms are present.
Siofor XR increases the body's sensitivity to insulin and helps restore normal glucose utilization.
Treatment with Siofor XR is associated with both stabilization of body weight and moderate weight reduction.
Siofor XR has been formulated so that the active substance is slowly released in the body, and therefore differs from many other types of tablets containing metformini hydrochloridum.

2. Important information before using Siofor XR

When not to use Siofor XR:

• if the patient is allergic to hydrochloride of metformin or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause rash, itching or shortness of breath,
• 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 the breath,
• in case of excessive loss of body fluids (dehydration), which may occur during prolonged or severe diarrhoea or repeated vomiting. Dehydration may lead to kidney dysfunction, which in turn may increase the risk of lactic acidosis (see below "Warnings and precautions"),
• in case of severe infection, such as affecting the lungs, bronchi or kidneys. 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 or breathing difficulties. This 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.

Warnings and precautions
Before starting treatment with Siofor XR, discuss this with your doctor or pharmacist.
Risk of lactic acidosis
Siofor 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 is also increased 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, consult a doctor for further instructions.
Temporarily discontinue use of Siofor XR if the patient develops a medical condition that may be associated with 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. Consult a doctor for further instructions.
Stop taking Siofor XR and contact your doctor immediately or go to the nearest hospital 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 combined with severe fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring hospital treatment.
Contact your doctor immediately for further instructions if:

• the patient has a genetically inherited disease affecting mitochondria (cellular energy-producing structures), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• after starting metformin treatment, the patient experiences any of the following symptoms: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.

If the patient is scheduled for major surgery, THE PATIENT MUST DISCONTINUE taking Siofor XR during the procedure and for some time afterwards. The doctor will decide when the patient should stop and resume treatment with Siofor XR.
During treatment with Siofor 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.
Undigested tablet residues may appear in the stool. This is normal with this type of tablet and should not be a cause for concern.
Continue to follow the dietary recommendations provided by the doctor and ensure that carbohydrates are consumed regularly throughout the day.
Do not stop taking this medicine without consulting your doctor.
Siofor XR and other medicines:
If the patient is to receive an iodine-containing contrast agent injected into the bloodstream, for example for an X-ray examination or computed tomography, THE PATIENT MUST DISCONTINUE taking Siofor XR before or at the latest at the time of such injection. The doctor will decide when the patient should stop and resume treatment with Siofor XR.
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Siofor XR by the doctor. It is especially important to inform about the following medicines:

• medicines increasing urine production (diuretics (water tablets), such as furosemide),
• 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),
• steroids such as prednisolone, mometasone, beclomethasone,
• sympathomimetic medicines, including epinephrine and dopamine used in the treatment of heart attack and low blood pressure. Epinephrine is also contained in certain dental anaesthetic agents.
• medicines that may alter Siofor XR blood levels, especially if the patient has impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Using Siofor XR with alcohol
Avoid excessive alcohol consumption while taking Siofor XR, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").
Pregnancy, breastfeeding and fertility
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should consult her doctor in case any changes in treatment or monitoring of blood glucose levels are needed.
This medicine is not recommended for patients who are breastfeeding or planning to breastfeed.
Before taking any medicine, consult your doctor or pharmacist.
Driving and operating machinery
Siofor XR, when used as the sole antidiabetic medicine, does not cause hypoglycaemia (symptoms of low blood glucose levels, such as fainting, disorientation and increased sweating). This means it does not affect the patient's ability to drive or operate machinery.
However, bear in mind that Siofor XR taken in combination with other antidiabetic medicines may cause hypoglycaemia. In such cases, special caution should be exercised when driving or operating machinery.
Siofor XR contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Siofor XR

Your doctor may prescribe Siofor XR as the only antidiabetic medicine (monotherapy)
or in combination with other oral antidiabetic medicines or insulin.
This medicine should always be taken as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Recommended dose
The usual starting dose is 500 mg of Siofor XR once daily. After approximately 2 weeks of treatment
with Siofor XR, your doctor will order a blood sugar test and adjust the dose accordingly.
The maximum daily dose is 2000 mg of Siofor XR.
If you have impaired kidney function, your doctor may prescribe a lower dose.
The tablet is usually taken once daily with the evening meal.
In some cases, your doctor may advise taking the tablet twice daily. The tablet should always be taken with a meal.
Swallow the tablet whole with a glass of water. Do not chew.
Taking more Siofor XR than prescribed
Accidentally taking more tablets than recommended should not cause concern,
but if unusual symptoms occur, contact your doctor. In case of significant overdose, 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. Further symptoms include lowered body temperature and slowed heart rate.
If any of these symptoms occur, stop taking Siofor XR immediately and contact your doctor or go to the nearest hospital without delay, because lactic acidosis may lead to coma.
If you forget to take Siofor XR
Take the next dose as soon as possible with a meal. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects may occur:
Siofor XR may very rarely (affecting up to 1 in 10,000 patients) cause a very serious adverse effect known as lactic acidosis (see section “Warnings and precautions”). If this occurs in a patient, treatment with Siofor XR must be discontinued immediately and medical advice must be sought from a doctor or the nearest hospital, as lactic acidosis may lead to coma.
Siofor XR may cause abnormal liver function test results and hepatitis, which may result in jaundice (affecting up to 1 in 10,000 people). If yellowing of the eyes and/or skin occurs, seek immediate medical advice from a doctor.
Other possible adverse effects listed according to the following frequency of occurrence:
Very common (may affect more than 1 in 10 people)

• Diarrhoea, nausea, vomiting, abdominal pain or loss of appetite. If these symptoms occur, do not stop taking the tablets, as these symptoms usually resolve within about 2 weeks. It may help to take Siofor XR with a meal or immediately after a meal.

Common (may affect up to 1 in 10 people)

• Taste disturbances.
• Reduced or low levels of vitamin B in the blood (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 these symptoms, as some of them may also be caused by diabetes or other health problems unrelated to diabetes.

Very rare (may affect up to 1 in 10,000 people)

• Skin rashes, including skin redness, itching, and urticaria.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects 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 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.
By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store Siofor XR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
pack after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicinal product.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Siofor XR contains
The active substance is metformin hydrochloride.
Each prolonged-release tablet of Siofor XR 500 mg contains 500 mg of metformin hydrochloride
(corresponding to 390 mg of metformin).
Each prolonged-release tablet of Siofor XR 750 mg contains 750 mg of metformin hydrochloride
(corresponding to 585 mg of metformin).
Each prolonged-release tablet of Siofor XR 1000 mg contains 1000 mg of metformin hydrochloride
(corresponding to 780 mg of metformin).
The other ingredients are: magnesium stearate, colloidal anhydrous silica, sodium carmellose and
hypromellose.

What Siofor XR looks like and contents of the pack
Siofor XR 500 mg prolonged-release tablets are white or almost white, capsule-shaped, with the
imprint "SR 500" on one side and smooth on the other side. The tablet dimensions are: length 16.5 mm, width 8.2 mm, thickness 6.1 mm.
Siofor XR 750 mg prolonged-release tablets are white or almost white, capsule-shaped, with the
imprint "SR 750" on one side and smooth on the other side. The tablet dimensions are: length 19.6 mm, width 9.3 mm, thickness 6.9 mm.
Siofor XR 1000 mg prolonged-release tablets are white or almost white, oval-shaped, with the
imprint "SR 1000" on one side and smooth on the other side. The tablet dimensions are: length 22 mm, width 10.5 mm, thickness 8.9 mm.
Siofor XR is available in the following pack sizes: 15, 30, 60, 90 or 120 prolonged-release tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
tel. (22) 566 21 00
fax. (22) 566 21 01

This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria: Сиофор SR 500 mg, 750 mg, 1000 mg таблетки с удължено освобождаване
Croatia: Siofor SR 500 mg, 750 mg, 1000 mg tablete s produljenim oslobađanjem
Czech Republic: Siofor Prolong
Estonia: Metforal XR
Germany: Siofor XR 500 mg, 750 mg, 1000 mg Retardtabletten
Hungary: Meforal XR 500 mg, 750 mg, 1000 mg retard tabletta
Latvia: Metforal 500 mg, 750 mg, 1000 mg ilgstošās darbības tabletes
Lithuania: Tivulin 500 mg, 750 mg, 1000 mg pailginto atpalaidavimo tabletės
Poland: Siofor XR 500 mg, 750 mg, 1000 mg
Portugal: Siofor XR 500 mg, 750 mg, 1000 mg comprimidos de libertação prolongada
Romania: Siofor 500 mg, 750 mg, 1000 mg comprimate cu eliberare prelungită
Slovakia: Siofor SR 500 mg, 750 mg, 1000 mg tablety s predĺženým uvoľňovaním
Slovenia: Siofor SR 500 mg, 750 mg, 1000 mg tablete s podaljšanim sproščanjem