Simformin Xr

Leaflet accompanying the packaging: information for the user

Symformin XR, 500 mg, prolonged-release tablets

Symformin XR, 750 mg, prolonged-release tablets

Symformin XR, 1000 mg, prolonged-release tablets

Metformin hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should 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 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 Symformin XR and what is it used for
• 2. Important information before taking Symformin XR
• 3. How to take Symformin XR
• 4. Possible side effects
• 5. How to store Symformin XR
• 6. Contents of the packaging and other information

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

Symformin XR contains metformin, which belongs to a group of medicines called biguanides
and is used to treat diabetes.
Insulin is a hormone produced by the pancreas that allows the body to take glucose (sugar) from the blood and use it for energy or store it for later use.
In diabetic patients, the pancreas does not produce enough insulin or the body is not able to use the produced insulin properly. This leads to an excessive increase in blood glucose levels. Symformin XR helps to reduce blood glucose levels to as close to normal as possible.
In adults with overweight, long-term use of Symformin XR also reduces the risk of diabetes-related complications.
Taking Symformin XR is associated with maintaining a stable body weight or moderate weight loss.
Symformin XR is used to treat patients with type 2 diabetes (also called non-insulin-dependent diabetes). It is especially used in patients with overweight.
Adults can take Symformin XR as the only medicine or in combination with other anti-diabetic medicines (oral medicines or insulin).
In the prevention of type 2 diabetes in patients with a pre-diabetic state.
In polycystic ovary syndrome.
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2. Important information before taking Symformin XR

When not to take Symformin XR:

• if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6);
• if the patient has liver function disorders;
• if the patient has significantly reduced kidney function;
• in case of excessive loss of body water (dehydration), e.g. due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney function disorders, which can threaten the occurrence of lactic acidosis (see below "Warnings and precautions");
• if the patient has a severe infection, e.g. pneumonia (lung infection), bronchitis (infection of the bronchi) or kidney infection. Severe infections can lead to kidney function disorders, which can threaten the occurrence of lactic acidosis (see below "Warnings and precautions");
• if the patient has been treated for acute heart failure or has recently had a heart attack, or has had severe circulatory disorders (e.g. shock) or breathing difficulties. This may have caused tissue hypoxia, which can threaten the occurrence of lactic acidosis (see below: "Warnings and precautions");
• if the patient abuses alcohol;
• if the patient is under 18 years old;
• if the patient has uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a disease in which substances called ketone bodies accumulate in the blood and can lead to a diabetic pre-coma state. Its symptoms include: abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odor from the mouth.

If any of the above situations apply to the patient, they should consult a doctor before taking this medicine.
It is necessary to consult a doctor if it is necessary to:

• perform a radiological examination or an examination that requires the injection of a contrast agent containing iodine into the blood,
• perform a major surgical procedure.

Symformin XR must be discontinued for a period before and after the examination or surgical procedure. The doctor will decide whether other treatment is necessary during this time. It is essential to follow the doctor's instructions carefully.

Warnings and precautions

Before starting to take Symformin XR, the patient should discuss it with their doctor or pharmacist.

Risk of lactic acidosis

Symformin XR 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 detailed information below), liver function disorders, 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.
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The patient should temporarily stop taking Symformin XR if they have

a disease that may be associated with dehydration(significant loss of body water),
such as severe vomiting, diarrhea, fever, exposure to high temperature, or if the patient drinks less fluid than usual. The patient should consult their doctor for more detailed instructions.

The patient should stop taking Symformin XR and immediately contact their doctor or the nearest hospital if they experience any of the

symptoms of lactic acidosis,as this condition can lead to coma.
The symptoms of lactic acidosis include:

• vomiting,
• abdominal pain (pain in the abdominal cavity),
• muscle cramps,
• general malaise with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.
The patient should immediately contact their doctor to receive 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, impaired cognitive function, difficulty moving, signs of nerve damage (e.g. pain or numbness), migraine, or hearing loss.

If the patient is to undergo a major surgical procedure, they must not take Symformin XR during the procedure and for some time after it. The doctor will decide when the patient must stop and resume treatment with Symformin XR.
Symformin XR itself does not cause hypoglycemia (low blood sugar).
However, if Symformin XR is used in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, 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 a sugary drink usually helps.
During treatment with Symformin XR, the doctor will check the patient's kidney function at least once a year or more often if the patient is elderly and/or has impaired kidney function.
The patient should follow the dietary recommendations given by their doctor.
It may happen that remnants of the tablet are visible in the stool. The patient should not worry, as this is normal when taking this type of tablet.

Symformin XR 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 Symformin XR before or at the latest at the time of injection. The doctor will decide when the patient must stop and resume treatment with Symformin XR.
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 checks and kidney function tests, or the doctor may need to adjust the dose of Symformin XR. It is especially important to inform about the following medicines:

• diuretics (increasing 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 to treat asthma);
• corticosteroids (used to treat various diseases, such as severe skin inflammation or asthma);
• medicines that can change the level of Symformin XR in the blood, especially if the patient has impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib);
• other medicines used to treat diabetes.

Taking Symformin XR with alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Symformin XR, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their doctor, as changes in treatment or blood glucose monitoring may be necessary.
This medicine is not recommended for breastfeeding women or those planning to breastfeed.

Driving and using machines

Symformin XR itself does not cause hypoglycemia (symptoms of low blood sugar).
This means that it does not affect the patient's ability to drive or operate machines.
However, the patient should be careful if they are taking Symformin XR 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, the patient should not drive or operate machines.

3. How to take Symformin XR

This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
Symformin XR 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 activity.
The patient should swallow the tablets whole, with a glass of water. The tablets should not be chewed.

Recommended dose

Children: due to the lack of appropriate safety data, Symformin XR should not be used in children.
Adults: treatment usually starts with a dose of 500 mg or 750 mg of Symformin XR once a day during the evening meal.
After 10-15 days, the dose is adjusted by the doctor based on blood glucose measurements. The maximum dose of Symformin XR is 2000 mg per day and is taken once a day during the evening meal. Gradual dose increase may improve gastrointestinal tolerance.
In patients already treated with metformin, the initial dose of Symformin XR should be equivalent to the daily dose of metformin in the form of immediate-release tablets.
In the case of switching from another oral anti-diabetic medicine to Symformin XR, the doctor should discontinue the previously used medicine and use Symformin XR in the dose specified above.
If the patient has impaired kidney function, the doctor may prescribe a lower dose.
In patients treated with metformin in a dose above 2000 mg per day in the form of immediate-release tablets, it is not recommended to switch the anti-diabetic treatment to Symformin XR.
If the patient is also taking insulin, the doctor will inform them how to start taking Symformin XR.
In monotherapy (pre-diabetic state)
Usually, a dose of 1000 to 1500 mg of metformin hydrochloride is used once a day during the evening meal. The doctor will assess whether treatment should be continued based on regular blood glucose tests and risk factors.
Polycystic ovary syndrome
Usually, a dose of 1500 mg of metformin hydrochloride is used once a day during the evening meal.

Treatment monitoring

• The doctor will order regular blood glucose tests and adjust the dose of Symformin XR based on the glucose levels. The patient should regularly visit their doctor for check-ups. This is especially important for elderly patients.
• The doctor will check the patient's kidney function at least once a year. More frequent checks may be necessary for elderly patients or if the patient's kidneys are not functioning properly.

How to take Symformin XR

Symformin XR should be taken with a meal or immediately 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.
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 Symformin XR than recommended

In case of taking a higher dose of Symformin XR than recommended, lactic acidosis may occur. The symptoms of lactic acidosis are non-specific and include: vomiting, abdominal pain (pain in the abdominal cavity) with muscle cramps, general malaise with severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate. If any of these symptoms occur, the patient should immediately seek medical help, as lactic acidosis can lead to coma.

The patient should immediately stop taking Symformin XR and contact their doctor or the nearest hospital.

Missing a dose of Symformin XR

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Symformin XR can cause side effects, although not everybody gets them.
Symformin XR may very rarely (may affect up to 1 in 10,000 people) cause a very severe side effect called lactic acidosis (see "Warnings and precautions"). If this happens to the patient, they should stop takingSymformin XR and immediately contact their doctor or the nearest hospital, as lactic acidosis can lead to coma.
Other possible side effects are listed according to their frequency:

• Very common (may affect more than 1 in 10 people):
• Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain (pain in the abdominal cavity), or loss of appetite. These side effects usually occur at the beginning of treatment with Symformin XR and in most cases disappear on their own. It may be helpful to take Symformin XR with a meal or immediately after a meal. If the symptoms do not disappear, the patient should stop taking Symformin XR and tell their doctor.

Common (may affect up to 1 in 10 people):

• Taste disorders.
• Decreased or low levels of vitamin B in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, or numbness). 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 (may affect up to 1 in 10,000 people):

• Lactic acidosis. This is a very rare but serious complication, especially when the kidneys are not functioning properly. Symptoms of lactic acidosis - see "Warnings and precautions".
• Abnormal liver function test results or hepatitis (with accompanying fatigue, loss of appetite, weight loss, and jaundice or without jaundice of the skin and whites of the eyes). If such symptoms occur, the patient should immediately stop taking Symformin XR and tell their doctor.
• Skin reactions such as skin redness, itching, and itchy rash.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Symformin XR

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The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
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. Contents of the packaging and other information

What Symformin XR contains

• The active substance is metformin hydrochloride. Each prolonged-release tablet contains 500 mg, 750 mg, or 1000 mg of the active substance, metformin hydrochloride.
• The other ingredients are: magnesium stearate, colloidal silica, povidone K30, and hypromellose K100M.

What Symformin XR looks like and contents of the pack

Symformin XR, 500 mg: white or almost white, uncoated, capsule-shaped tablets with dimensions of 16.50 mm x 8.20 mm, with "XR500" embossed on one side and smooth on the other side.
Symformin XR, 750 mg: white or almost white, uncoated, capsule-shaped tablets with dimensions of 19.60 mm x 9.30 mm, with "XR750" embossed on one side and smooth on the other side.
Symformin XR, 1000 mg: white or almost white, uncoated, capsule-shaped tablets with dimensions of 21.10 mm x 10.10 mm, with "XR1000" embossed on one side and smooth on the other side.
Symformin XR, 500 mg and 1000 mg, are available in packs containing 30, 60, 90, or 120 tablets, packaged in blisters.
Symformin XR, 750 mg, is available in packs containing 30 or 60 tablets, packaged in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel.: +48 22 822 93 06
e-mail: biuro@farmakinternational.pl

Manufacturer

Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw

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

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Poland:
Symformin XR
Date of last revision of the leaflet:May 2025
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