Siofor 1000

Leaflet attached to the packaging: patient information

SIOFOR 1000

1000 mg, coated tablets

For use in children over 10 years of age and adults
Metformin hydrochloride

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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 Siofor 1000 and what is it used for
• 2. Important information before taking Siofor 1000
• 3. How to take Siofor 1000
• 4. Possible side effects
• 5. How to store Siofor 1000
• 6.Package contents and other information

1. What is Siofor 1000 and what is it used for

What is Siofor 1000

Siofor 1000 contains metformin, a substance used to treat diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that allows the body to take glucose (sugar) from the blood.
The body uses glucose to produce energy or stores it for later use.
In diabetic patients, the pancreas does not produce enough insulin or the body is unable to use the produced insulin properly. This leads to an excessive increase in blood glucose levels. Siofor 1000 helps lower blood glucose levels to as close to normal as possible.
In adults with overweight, long-term use of Siofor 1000 also reduces the risk of diabetes-related complications. Taking Siofor 1000 is associated with stabilization or moderate weight loss.

What is Siofor 1000 used for

Siofor 1000 is used to treat patients with type 2 diabetes (also known as "insulin-independent" diabetes), in whom diet and physical exercise alone are not enough to achieve sufficient blood glucose control. It is particularly used in patients with overweight.
Adults can take Siofor 1000 as monotherapy or with other anti-diabetic medicines (oral or insulin).
In children over 10 years of age and adolescents, Siofor 1000 may be used as monotherapy or in combination with insulin.

2. Important information before taking Siofor 1000

When not to take Siofor 1000:

• if the patient is allergic to metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if the patient has significantly reduced kidney function,
• if the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, 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 can lead to diabetic pre-coma. Its symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity breath odor,

Warnings and precautions

Before starting Siofor 1000, discuss it with your doctor.

It is necessary to consult a doctor in the following cases:

• if a radiological examination or examination requiring the injection of a contrast agent containing iodine into the blood is necessary,
• if a major surgical procedure is to be performed.

If the patient is to undergo major surgery, they should not take Siofor 1000 during the procedure and for some time after it. The doctor will decide when the patient should stop and resume treatment with Siofor 1000. It is essential to follow the doctor's instructions carefully.

Risk of lactic acidosis

Siofor 1000 may cause a very rare but very severe side effect called lactic acidosis, especially if the patient has kidney dysfunction. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver dysfunction, and any conditions in which some 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 for more detailed instructions.

It is necessary to temporarily stop taking Siofor 1000 if the patient has a condition that may be associated with dehydration

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

It is necessary to stop taking Siofor 1000 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 (abdominal pain),
• muscle cramps,
• general poor condition with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate. Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.

It is necessary to consult a doctor immediately for further instructions if:

• the patient has a genetically inherited disease affecting the 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, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or hearing loss.

During treatment with Siofor 1000, 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 deteriorating kidney function.
Siofor 1000 itself does not cause hypoglycemia (low blood sugar).
However, if Siofor 1000 is used in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia. If symptoms of hypoglycemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, eating or drinking something containing sugar usually helps.

Siofor 1000 and other medicines:

If the patient is to be injected with a contrast agent containing iodine into the bloodstream, for example for an X-ray examination or computed tomography, they must stop taking Siofor 1000 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 1000 (see above: "It is necessary to consult a doctor in the following cases:").
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. The patient may need more frequent blood glucose and kidney function tests or dose adjustments of Siofor 1000 by the doctor. It is particularly important to inform about the following medicines:

• diuretics,
• 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 to treat asthma),
• corticosteroids (used to treat various diseases, such as severe skin inflammation or asthma),
• other anti-diabetic medicines,
• medicines that may change the level of Siofor 1000 in the blood, especially if the patient has kidney dysfunction (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Using Siofor 1000 with alcohol:

It is recommended to avoid consuming excessive amounts of alcohol while taking Siofor 1000, as this may increase the risk of lactic acidosis (see section "Warnings and precautions"), especially in patients with liver failure or malnutrition.
This also applies to medicines containing alcohol.

Pregnancy and breastfeeding:

During pregnancy, diabetes treatment requires the use of insulin.
If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. In this case, the doctor may change the treatment accordingly.
This medicine is not recommended during breastfeeding.

Driving and using machines:

Siofor 1000, used as the only anti-diabetic medicine (monotherapy), does not cause hypoglycemia.
This means it does not affect the ability to drive or use machines.
However, the patient should be particularly careful if they are taking Siofor 1000 in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycemia include: weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating.
If such symptoms occur, the patient should not drive or use machines.

3. How to take Siofor 1000

This medicine should always be taken according to the doctor's instructions. In case of doubts, consult a doctor or pharmacist.
Siofor 1000 does not replace the benefits of a healthy lifestyle. The patient should continue to follow all the doctor's recommendations regarding diet and regular physical exercise.

Recommended dose

In adults, the initial dose is usually half a coated tablet of Siofor 1000 (equivalent to 500 mg of metformin hydrochloride) taken two or three times a day, or 850 mg of metformin hydrochloride taken two or three times a day (this dose is not possible when using Siofor 1000).
The maximum daily dose is one coated tablet of Siofor 1000 taken three times a day.
If the patient has kidney dysfunction, the doctor may prescribe a lower dose.

Use in children and adolescents

In children over 10 years of age and adolescents, the initial dose is usually half a coated tablet of Siofor 1000 (equivalent to 500 mg of metformin hydrochloride) taken once a day, or 850 mg of metformin hydrochloride taken once a day (this dose is not possible when using Siofor 1000).
The maximum daily dose is one coated tablet of Siofor 1000 taken twice a day.
Treatment of children between 10 and 12 years of age is recommended by a doctor only in justified cases, as experience with the use of the medicine in this age group is limited.
If the patient is also taking insulin, the doctor will inform them how to start taking Siofor 1000.

Treatment control

• The doctor will order regular blood glucose tests and adjust the dose of Siofor 1000 according to the blood glucose values. The patient should regularly visit their doctor for check-ups. This is especially important in children and adolescents or the elderly.
• The doctor will check the patient's kidney function at least once a year. More frequent checks may be necessary in the elderly or if the patient's kidneys are not functioning properly.

How to divide Siofor 1000 coated tablets

The tablet can be divided into equal doses. Due to the tablet's design, Siofor 1000 allows for easy and precise division of the coated tablet. The coated tablets can be broken in half with both hands or with the thumb after placing the tablet on a flat surface, with the side containing the break line facing down, and pressing the tablet (see figures 1, 2, 3).

How to take Siofor 1000 coated tablets

The patient should take the tablets during or after a meal. This will help avoid gastrointestinal side effects.
The patient should not crush or chew the tablets. They should swallow the tablet with a glass of water.

• In case of taking one dose per day, it should be taken in the morning (breakfast)
• In case of taking two divided doses per day, they should be taken in the morning (breakfast) and evening (dinner)
• In case of taking three divided doses per day, they should be taken in the morning (breakfast), at noon (lunch), and evening (dinner)

If after some time the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Siofor 1000 than recommended

In case of taking a higher dose of Siofor 1000 than recommended, lactic acidosis may occur.
Symptoms of lactic acidosis include: vomiting, abdominal pain (abdominal pain) with muscle cramps, poor general condition with severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate. If such symptoms occur, the patient may require immediatehospital treatment, as lactic acidosis can lead to coma.
Immediatelycontact a doctor or go to the nearest hospital.

Missing a dose of Siofor 1000

Do not take a double dose to make up for a missed dose. The patient should take the next dose according to the planned dosing schedule.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Siofor 1000 can cause side effects, although not everybody gets them.
The following side effects may occur:
Siofor 1000 may very rarely cause (may occur in up to 1 in 10,000 people) a very severe side effect called lactic acidosis
(see section "Warnings and precautions"). If this occurs in the patient, they should stop taking Siofor 1000 and immediately contact a doctor or the nearest hospital, as lactic acidosis can lead to coma.

Very common side effects (may affect more than 1 in 10 people)

• gastrointestinal disorders, such as: nausea, vomiting, diarrhea, abdominal pain (abdominal pain), loss of appetite. These side effects most often occur at the beginning of Siofor 1000 treatment. It may be helpful to divide the doses throughout the day and take Siofor 1000 with a meal or immediately after a meal. If the symptoms do not disappear, Siofor 1000 should be discontinued and the doctor should be informed.

Common side effects (may affect up to 1 in 10 people)

• taste disorders.
• low or low levels of vitamin B in the blood (symptoms may include extreme fatigue, pain and redness of the tongue, numbness or pale or yellowish skin). The doctor may order several tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other unrelated health problems.

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

• skin reactions, such as: skin redness, itching, or itchy rash (hives),
• abnormal liver function test results or hepatitis (hepatitis, which can cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin and whites of the eyes). If such symptoms occur, the medicine should be discontinued and the doctor should be informed.

Children and adolescents

Limited data on children and adolescents have shown that side effects were similar in type and severity to those reported in adults.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Siofor 1000

The medicine should be stored out of sight and reach of children. If a child is being treated with Siofor 1000, parents and caregivers should supervise how the medicine is taken.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storage.
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. Package contents and other information

What Siofor 1000 contains

The active substance of the medicine is metformin hydrochloride.
Each coated tablet contains 1000 mg of metformin hydrochloride (equivalent to 780 mg of metformin).
The other ingredients are: hypromellose, povidone K 25, magnesium stearate, macrogol 6000, titanium dioxide (E 171).

What Siofor 1000 looks like and what the package contains

Siofor 1000 is a white, biconvex, elongated coated tablet with a break line on one side and a notch on the other.
The tablet can be divided into two equal doses (see section 3 in the instructions for dividing).
The package contains: 30, 60, 90, or 120 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder
Berlin-Chemie AG
Glienicker Weg 125
D-12489 Berlin
Germany
Manufacturer
Berlin-Chemie AG
Glienicker Weg 125
D-12489 Berlin
Germany
Menarini - Von Heyden GmbH
Leipziger Str. 7 - 13
D-01097 Dresden
Germany
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
phone (22) 566 21 00
fax (22) 566 21 01

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

Belgium
Metformax 1000 mg film-coated tablets
Czech Republic
Siofor
Estonia
Metforal 1000 mg
Lithuania
Metforal 1000 mg film-coated tablets
Luxembourg
Metformax 1000 mg coated tablets
Latvia
Metforal 1000
Germany
Siofor 1000
Poland
Siofor 1000
Slovakia
Siofor 1000
Slovenia
Siofor 1000 mg
Hungary
Meforal 1000 mg
Italy
Metforalmille

Date of last revision of the leaflet: 03/2025