Siofor 500

Package leaflet: Information for the patient

SIOFOR 500, 500 mg, film-coated tablets
Metformini hydrochloridum
For use in children over 10 years of age and in adults
Please read this leaflet carefully before taking 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Siofor 500 is and what it is used for
2. Important information before taking Siofor 500
3. How to take Siofor 500
4. Possible side effects
5. How to store Siofor 500
6. Contents of the pack and other information

1. What Siofor 500 is and what it is used for

Siofor 500 contains metformin, an active substance 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. Siofor 500 helps lower blood glucose levels to values as close as possible to normal.
In overweight adults, long-term use of Siofor 500 also reduces the risk of complications associated with type 2 diabetes. Treatment with Siofor 500 is associated with stabilization or moderate reduction in body weight.

For what purpose is Siofor 500 used?
Siofor 500 is a medicine used for:

• the treatment of type 2 diabetes, especially in overweight patients, to achieve proper control of blood glucose levels;
• prevention of type 2 diabetes in patients with prediabetes.

Adults with type 2 diabetes may take Siofor 500 as monotherapy or in combination with other antidiabetic medicines (oral medications or insulin).
Children over 10 years of age and adolescents with type 2 diabetes may take Siofor 500 as monotherapy or in combination with insulin.
While being treated with Siofor 500, patients should follow a diet and engage in physical activity.

2. Information before using Siofor 500

When not to use Siofor 500

• if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6)
• if the patient has significantly reduced kidney function
• in case of liver dysfunction
• 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 an unusual fruity odour of the breath
• in case of excessive loss of body water (dehydration), e.g. due to prolonged or severe diarrhoea or repeated vomiting. 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, such as 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")
• in case of treatment for acute heart failure or recent myocardial infarction, severe circulatory disorders (such as 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.

Warnings and precautions
Before starting treatment with Siofor 500, discuss this with your doctor.
You must consult your doctor if necessary:

• a radiological examination or a procedure requiring intravascular administration of an iodine-containing contrast agent is planned
• a major surgical procedure is planned. If the patient is to undergo surgery, Siofor 500 must not be taken during and for some time after the procedure. The doctor will decide when the patient should stop and restart treatment with Siofor 500. It is important to strictly follow the doctor's instructions.

Risk of lactic acidosis
Siofor 500 may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has impaired kidney function. 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 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 the doctor for further instructions.
The use of Siofor 500 should be temporarily discontinued if the patient develops any medical condition that may be associated with dehydration (significant loss of body water), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult the doctor for further instructions.
Siofor 500 must be discontinued and the patient should immediately contact the doctor or the nearest hospital 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 accompanied by profound fatigue
• difficulty breathing
• decreased body temperature and slowed heart rate

Lactic acid游戏副本 is an acute, life-threatening condition requiring immediate hospital treatment.
Contact the doctor immediately for further instructions if:

• the patient has a genetically inherited mitochondrial disorder (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, signs indicating nerve damage (e.g. pain or numbness), migraine or deafness.

During treatment with Siofor 500, 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.
Siofor 500 alone does not cause hypoglycaemia (low blood glucose levels).
However, there is a risk of hypoglycaemia if Siofor 500 is used in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylurea derivatives, insulin, meglitinides). If symptoms of hypoglycaemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating, eating or drinking something containing sugar usually helps.

Siofor 500 and other medicines
If an iodine-containing contrast agent is to be injected into the bloodstream, for example for an X-ray examination or computed tomography, the patient must stop taking Siofor 500 before or at the latest at the time of such injection. The doctor will decide when the patient should stop and restart treatment with Siofor 500 (see above: "You must consult your doctor if necessary:").
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take together with Siofor 500.
The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Siofor 500 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 the treatment of asthma)
• corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma)
• other medicines used to treat diabetes
• medicines that may alter the blood concentration of Siofor 500, especially if the patient has impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Siofor 500 and alcohol
Avoid consuming excessive amounts of alcohol while taking Siofor 500, as this may increase the risk of lactic acidosis (see section "Warnings and precautions"), particularly in patients with liver dysfunction or in malnourished individuals.
This also applies to medicines containing alcohol.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Pregnancy
During pregnancy, diabetes treatment requires the use of insulin.
Breastfeeding
This medicine is not recommended during breastfeeding.

Driving and using machines
Siofor 500, when used as the sole antidiabetic medicine, does not cause hypoglycaemia (symptoms of low blood glucose levels). This means it does not affect the ability to drive or operate machinery.
However, special caution is required if Siofor 500 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, visual disturbances or difficulty concentrating.
If such symptoms occur, the patient should not drive or operate machinery.

3. How to use Siofor 500

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Siofor 500 does not replace the benefits of a healthy lifestyle. You should continue to follow your doctor's
advice regarding diet and regular physical exercise.

Recommended dose:
For adults, the usual starting dose is 1 Siofor 500 coated tablet two to three times daily (corresponding to
1000 mg or 1500 mg of metformin hydrochloride per day), or 850 mg of metformin hydrochloride two to
three times daily (this dose cannot be achieved when using Siofor 500).
The maximum daily dose is 2 Siofor 500 coated tablets three times daily (corresponding to 3000 mg of
metformin hydrochloride per day).
If you have impaired kidney function, your doctor may prescribe a lower dose.

Use in children and adolescents
In children over 10 years of age and adolescents, the usual starting dose is 1 Siofor 500 coated tablet
once daily (corresponding to 500 mg of metformin hydrochloride per day), or 850 mg of metformin
hydrochloride once daily (this dose cannot be achieved when using Siofor 500).
The maximum daily dose is 2000 mg, administered in 2 or 3 divided doses.
Treatment of children aged over 10 to 12 years is recommended by the doctor only in justified cases,
as experience with the use of this medicine in this age group is limited.
If you are also using insulin, your doctor will advise you on how to start treatment with Siofor 500.

Prediabetes (monotherapy in adults with normal kidney function)
The recommended starting dose for patients with prediabetes is 1 coated tablet (500 mg or 850 mg) once
daily, taken during or after a meal.
The usual dose for patients with prediabetes is 1 coated tablet (500 mg or 850 mg) twice daily, taken
during or after a meal.
Gradual dose escalation may improve gastrointestinal tolerance.
Your doctor will assess whether treatment should be continued based on regular monitoring of blood
glucose levels and risk factors.

Monitoring of treatment

• Your doctor will order regular blood glucose tests and adjust the dose of Siofor 500 according to blood glucose levels. You should attend regular follow-up visits with your doctor. This is particularly important for children, adolescents, and elderly patients.
• Your doctor will check your kidney function at least once a year during treatment with Siofor 500. More frequent monitoring may be necessary for elderly patients or if your kidneys are not functioning properly.

How to take Siofor 500 coated tablets
Take the tablets during or after a meal. This helps avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet whole with a glass of water.

• If taking one dose per day, take it in the morning (with breakfast).
• If taking two divided doses per day, take them in the morning (with breakfast) and in the evening (with dinner).
• If taking three divided doses per day, take them in the morning (with breakfast), at midday (with lunch), and in the evening (with dinner).
  If after some time you feel that the effect of Siofor 500 is too strong or too weak, you should consult your doctor or pharmacist.

Taking more than the recommended dose of Siofor 500
If you take more Siofor 500 than prescribed, lactic acidosis may occur.
Symptoms of lactic acidosis 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 these symptoms occur,
you may require immediate hospital treatment, as lactic acidosis can lead to coma.
Contact your doctor immediately or go to the nearest hospital.

Missing a dose of Siofor 500
Do not take a double dose to make up for a missed dose. Take the next dose according to your scheduled dosing regimen.
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 experiences them.
The following adverse reactions may occur:
Important adverse reactions or symptoms that patients should be aware of, and precautions to be taken if they occur:
Siofor 500 may very rarely (may occur in up to 1 in 10,000 patients) cause a very serious adverse reaction known as lactic acidosis (see section “Warnings and precautions”). If this occurs in a patient, treatment with Siofor 500 must be discontinued immediately and the patient should contact a doctor or the nearest hospital without delay, as lactic acidosis may lead to coma.
Other possible adverse reactions
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), and loss of appetite. These adverse reactions occur most frequently at the beginning of treatment with Siofor 500. It may be helpful to divide the daily dose into several smaller doses taken throughout the day and to take the tablets with meals or immediately after meals. If symptoms do not resolve, Siofor 500 should be discontinued and the doctor should be informed.

Common adverse reactions (may affect less than 1 in 10 people)

• Taste disturbances
• Reduced or low blood levels of vitamin B (symptoms may include extreme fatigue (tiredness), pain and redness of the tongue (glossitis), tingling sensations (paraesthesiae), or pale or yellowish skin). The 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 adverse reactions (may affect less than 1 in 10,000 people)

• Skin reactions such as skin redness (erythema), itching, or itchy rash (urticaria)
• Abnormal liver function test results or hepatitis (liver inflammation, which may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If such symptoms occur, Siofor 500 should be discontinued and the doctor should be informed.

Additional adverse reactions in children and adolescents
Limited data in children and adolescents have shown that adverse reactions were similar in type and severity to those reported in adults.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, patients should inform their doctor, pharmacist, or nurse.
Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Siofor 500

Keep this medicine out of sight and reach of children. If a child is being treated with Siofor 500, parents and caregivers should supervise how this medicine is used.
Do not use this medicine after the expiry date stated on the outer packaging and blister after the abbreviation "EXP". The expiry date refers to the last day of the specified month.
There are no special storage instructions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Siofor 500 contains

• The active substance is metformin hydrochloride.
• One coated tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
• Other components are:
  Tablet core: hypromellose, povidone, magnesium stearate.
  Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E 171).

What Siofor 500 looks like and contents of the pack
White, round, biconvex coated tablets in blisters made of transparent PVC foil and aluminum foil.
Siofor 500 is available in packs containing: 10, 30, 60, 90 or 120 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
BERLIN – CHEMIE AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin, Germany

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.: + 48 22 566 21 00
Fax: + 48 22 566 21 01