Simformin Xr

Leaflet attached to 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.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 unable 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 alone or in combination with other anti-diabetic medicines (oral 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 you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6);
• if you have liver function disorders;
• if you have significantly reduced kidney function;
• in case of excessive water loss from the body (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 you have 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 you have been treated for acute heart failure or have recently had a heart attack, or have 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 you abuse alcohol;
• if you are under 18 years old;
• if you have 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 you, you should consult your doctor before taking this medicine.
It is essential 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,
• to perform major surgery.

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

Warnings and precautions

You should discuss this with your doctor or pharmacist before starting to take Symformin XR.

Risk of lactic acidosis

Symformin XR may cause a very rare but very serious side effect called lactic acidosis, especially if you have 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 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 you, you should consult your doctor for more detailed instructions.
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You should temporarily discontinue taking Symformin XR if you have

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 you drink less fluids than usual. You should consult your doctor for more detailed instructions.

You should discontinue taking Symformin XR and contact your doctor or the nearest hospital immediately if you 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 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.
You should contact your doctor immediately for further instructions if:

• you have 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.
• you have 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 you are to undergo major surgery, you should not take Symformin XR during the surgery and for a period after it. Your doctor will decide when you should stop and resume treatment with Symformin XR.
Symformin XR itself does not cause hypoglycemia (low blood sugar).
However, if Symformin XR is taken 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, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have impaired kidney function.
You should follow your doctor's dietary recommendations.
It may happen that tablet residues are visible in the stool. You should not be concerned, as this is normal when taking this type of tablet.

Symformin XR and other medicines

If you are to be injected with a contrast agent containing iodine into the bloodstream, for example, for an X-ray examination or computed tomography, you should discontinue taking Symformin XR before or at the latest at the time of injection. Your doctor will decide when you should stop and resume treatment with Symformin XR.
You should tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood glucose checks and kidney function tests, or your doctor may need to adjust the dose of Symformin XR. It is especially important to inform your doctor 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 may change the level of Symformin XR in the blood, especially if you have 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

You 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 you are pregnant, think you may be pregnant, or are planning to have a baby, you should consult your 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 your ability to drive or use machines.
However, you should be careful if you are taking Symformin XR in combination 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, you should not drive or use machines.

3. How to take Symformin XR

You should always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, you should ask your doctor or pharmacist.
Symformin XR does not replace the benefits of a healthy lifestyle. You should continue to follow your doctor's recommendations regarding diet and regular physical activity.
You should swallow the tablets whole, with a glass of water. Do not chew the tablets.

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 daily 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 daily 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 you have impaired kidney function, your 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 you are also taking insulin, your doctor will inform you 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 daily 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 daily during the evening meal.

Treatment monitoring

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

How to take Symformin XR

Symformin XR should be taken during a meal or immediately after a meal. This will help avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet with a glass of water.
If after some time you feel that the effect of the medicine is too strong or too weak, you should consult your 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 poor condition with severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate. If you experience any of these symptoms, you should immediately seek medical help, as lactic acidosis can lead to coma.

You should discontinue taking Symformin XR and contact your doctor or the nearest hospital immediately.

Missing a dose of Symformin XR

You should not take a double dose to make up for a missed dose. You should take the next dose at the usual time.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, you should stoptaking Symformin XR and contact your doctor or the nearest hospital immediately, 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. Taking Symformin XR with a meal or immediately after a meal may be helpful. If the symptoms do not disappear, you should discontinue taking Symformin XR and tell your 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). Your doctor may prescribe 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 yellowing or non-yellowing of the skin and whites of the eyes). If such symptoms occur, you should immediately discontinue taking Symformin XR and tell your doctor.
• Skin reactions such as redness of the skin, itching, and itchy rash.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, you can help provide more information on the safety of this 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. You should ask your 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, anhydrous 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: [email protected]

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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