Siofor 850

Leaflet attached to the packaging: patient information

SIOFOR 850, 850 mg, coated tablets

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

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 as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Siofor 850 and what is it used for
• 2. Important information before taking Siofor 850
• 3. How to take Siofor 850
• 4. Possible side effects
• 5. How to store Siofor 850
• 6.Package contents and other information

1. What is Siofor 850 and what is it used for

Siofor 850 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 up 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 850 helps lower blood glucose levels to as close to normal as possible.
In adults with overweight, long-term use of Siofor 850 also reduces the risk of complications associated with type 2 diabetes. Taking Siofor 850 is associated with stabilization or moderate weight loss.

What is Siofor 850 used for

Siofor 850 is used to treat:

• type 2 diabetes, especially in patients with overweight, to achieve proper blood glucose control.
• to prevent type 2 diabetes in patients with pre-diabetic conditions.

Adults with type 2 diabetes can take Siofor 850 as monotherapy or with other anti-diabetic medicines (oral medicines or insulin).
Children over 10 years of age and adolescents with type 2 diabetes can take Siofor 850 as monotherapy or in combination with insulin.
During treatment with Siofor 850, you should follow a diet and engage in physical activity.

2. Important information before taking Siofor 850

When not to take Siofor 850:

Warnings and precautions

Before starting treatment with Siofor 850, discuss it with your doctor.

You must consult a doctor if necessary:

• 850. It is crucial to follow the doctor's instructions carefully.

Risk of lactic acidosis

Siofor 850 may cause a very rare but very severe side effect called lactic acidosis, especially if the patient has kidney function disorders. The risk of lactic acidosis increases in case of uncontrolled diabetes, severe infection, 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 for more detailed instructions.

Temporarily discontinue taking Siofor 850 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. You should consult a doctor for more detailed instructions.

Discontinue taking Siofor 850 and contact a doctor or the nearest hospital immediately 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 cramps),
• 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.

Consult a doctor promptly 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 experiences any of the following symptoms after starting metformin: seizures, impaired cognitive abilities, difficulty moving, signs of nerve damage (e.g. pain or numbness), migraine, or hearing loss.

During treatment with Siofor 850, 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 850 itself does not cause hypoglycemia (low blood sugar).
However, there is a risk of hypoglycemia if Siofor 850 is used in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides). 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 850 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 discontinue taking Siofor 850 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 850 (see above: "You must consult a doctor if necessary:").
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take with Siofor 850.
The patient may require more frequent blood glucose monitoring and kidney function tests or dose modification of Siofor 850 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 850 in the blood, especially if the patient has kidney function disorders (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Siofor 850 and alcohol

Avoid consuming excessive amounts of alcohol while taking Siofor 850, as this may increase the risk of lactic acidosis (see section "Warnings and precautions"), especially in patients with liver function disorders or malnutrition.
This also applies to medicines containing alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking 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 850, when used as the only anti-diabetic medicine, does not cause hypoglycemia (symptoms of low blood sugar). This means it does not affect the ability to drive or operate machines.
However, be extremely careful if you are taking Siofor 850 with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycemia include: weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating.
If such symptoms occur, do not drive or operate machines.

3. How to take Siofor 850

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Siofor 850 does not replace the benefits of a healthy lifestyle. You should continue to follow all your doctor's recommendations regarding diet and regular physical exercise.
The recommended dose is:
For adults, the initial dose is usually one 850 mg tablet of Siofor 850 two to three times a day (corresponding to 1700 mg or 2550 mg of metformin hydrochloride per day) or 500 mg of metformin hydrochloride two to three times a day (this dose cannot be achieved with Siofor 850).
The maximum daily dose is 3000 mg in three divided doses.
If the patient has kidney function disorders, the doctor may prescribe a lower dose.

Use in children and adolescents

For children over 10 years of age and adolescents, the initial dose is usually one 850 mg tablet of Siofor 850 once a day (corresponding to 850 mg of metformin hydrochloride per day) or 500 mg of metformin hydrochloride once a day (this dose cannot be achieved with Siofor 850).
The maximum daily dose is 2000 mg, given in 2 or 3 divided doses.
Treatment of children over 10 to 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 how to start taking Siofor 850.

Pre-diabetic state (as monotherapy in adults with normal kidney function)

The recommended initial dose for patients with pre-diabetic state is one 500 mg or 850 mg tablet once a day with food or after food.
The dose usually used for patients with pre-diabetic state is one 500 mg or 850 mg tablet twice a day with food or after food.
Gradual dose increase may improve gastrointestinal tolerance.
The doctor will assess whether treatment should be continued based on regular blood glucose tests and risk factors.

Treatment monitoring

• The doctor will prescribe regular blood glucose tests and adjust the dose of Siofor 850 according to blood glucose levels. You should regularly visit your doctor for check-ups. This is especially important for children and adolescents or the elderly.
• The doctor will check the patient's kidney function at least once a year during treatment with Siofor 850. More frequent checks may be necessary for the elderly or if the patient's kidneys are not functioning properly.

How to take Siofor 850 coated tablets

Take the tablets with or after food. This will help avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet with a glass of water.

• If taking one dose per day, take it in the morning (breakfast)
• If taking two divided doses per day, take them in the morning (breakfast) and evening (dinner)
• If taking three divided doses per day, take them in the morning (breakfast), at noon (lunch), and evening (dinner)

The dividing line on the tablet is only to facilitate breaking it for easier swallowing.
If after some time you feel that the effect of Siofor 850 is too strong or too weak, consult a doctor or pharmacist.

Using a higher dose of Siofor 850 than recommended

If you take a higher dose of Siofor 850 than recommended, lactic acidosis may occur.
Symptoms of lactic acidosis are: vomiting, abdominal pain (abdominal cramps) 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 850

Do not take a double dose to make up for a missed dose. Take the next dose according to the planned dosing schedule.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Siofor 850 can cause side effects, although not everybody gets them.
The following side effects may occur:

Important side effects or symptoms that the patient should know about and precautions to take if they occur:

Siofor 850 may very rarely cause (may occur in up to 1 in 10,000 patients) a very severe side effect called lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, they should stop takingSiofor 850 and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Other possible side effects

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

• gastrointestinal disorders, such as: nausea, vomiting, diarrhea, abdominal pain (abdominal cramps), and loss of appetite. These side effects usually occur at the beginning of treatment with Siofor 850. It may be helpful to divide the doses throughout the day and take the tablets with food or immediately after food. If the symptoms do not disappear, discontinue Siofor 850 and tell your doctor.

Common side effects (may occur in less than 1 in 10 people)

• taste disorders
• decreased or low vitamin B levels 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 occur in less than 1 in 10,000 people)

• skin reactions such as skin redness, itching, or itchy rash
• 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, discontinueSiofor 850 and tell your doctor.

Additional side effects in children and adolescents

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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, you can help provide more information on the safety of this medicine.

5. How to store Siofor 850

Keep this medicine out of the sight and reach of children. If a child is being treated with Siofor 850, parents and caregivers should supervise how the medicine is taken.
Do not use this medicine after the expiry date stated on the outer packaging and blister after the "EXP" abbreviation. 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. Ask your 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 850 contains

• The active substance of the medicine is metformin hydrochloride.
• One coated tablet contains 850 mg of metformin hydrochloride, which corresponds to 662.9 mg of metformin.
• The other ingredients are: Tablet core: hypromellose, povidone, magnesium stearate. Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E 171).

What Siofor 850 looks like and what the package contains

White, elongated coated tablets with a dividing line on both sides in blisters of transparent PVC film and aluminum foil.
Siofor 850 is available in packages containing: 15, 30, 60, 90, or 120 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

BERLIN – CHEMIE AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin, Germany

Manufacturer:

BERLIN – CHEMIE AG
Glienicker Weg 125
12489 Berlin, Germany
Menarini - Von Heyden GmbH
Leipziger Str. 7 – 13
D-01097 Dresden
Germany
To obtain more detailed information about this medicine, please contact the local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: + 48 22 566 21 00
Fax: + 48 22 566 21 01

Date of last revision of the leaflet: 03/2025