Symformin xr

Package leaflet: 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
Metformini hydrochloridum
Please read the entire leaflet carefully before starting to take the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Symformin XR is and what it is 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 pack and other information

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

Symformin XR contains metformin, which belongs to a group of medicines called biguanides
and is used in the treatment of diabetes.
Insulin is a hormone produced by the pancreas that enables the body to take glucose (sugar)
from the blood and use it for energy or store 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. Symformin XR helps reduce blood glucose levels to values as close to normal as possible.
In overweight adults, long-term use of Symformin XR also reduces the risk of diabetes-related complications.
Taking Symformin XR is associated with maintaining stable body weight or moderate weight reduction.
Symformin XR is used in the treatment of patients with type 2 diabetes (also known as "non-insulin-dependent diabetes"). It is particularly used in patients who are overweight.
Adults may take Symformin XR either as monotherapy or in combination with other antidiabetic medicines (oral medications or insulin).
For the prevention of type 2 diabetes in patients with prediabetes.
In polycystic ovary syndrome.

2. Important information before using Symformin XR

When not to use 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 diarrhoea or repeated vomiting. Dehydration may lead to kidney dysfunction, which may increase the risk of lactic acidosis (see below "Warnings and precautions");
• if the patient has a severe infection, e.g. pneumonia (lung infection), bronchitis (bronchial infection), or kidney infection. Severe infections may lead to kidney dysfunction, which may increase the risk of lactic acidosis (see below "Warnings and precautions");
• if the patient has been treated for acute heart failure or recently suffered a myocardial infarction, or has experienced severe circulatory disorders (e.g. shock) or breathing difficulties. These conditions may cause tissue hypoxia, which may increase the risk of lactic acidosis (see below: "Warnings and precautions");
• if the patient abuses alcohol;
• if the patient is under 18 years of age;
• if the patient has uncontrolled diabetes, for example with 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.

If any of the above situations apply, the patient should consult a doctor before using this medicine.
It is essential to consult a doctor if:

• a radiological examination or a procedure requiring intravenous administration of an iodine-containing contrast agent is necessary,
• a major surgical procedure is planned.

Symformin XR must be discontinued for a certain period before and after such examination or surgery.
The doctor will decide whether alternative treatment is necessary during this time. It is important to strictly follow the doctor's instructions.

Warnings and precautions
Before starting treatment with Symformin XR, discuss it with your doctor or pharmacist.

Risk of lactic acidosis
Symformin XR may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has kidney function disorders. 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 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, medical advice should be sought for further instructions.

Temporarily discontinue use of Symformin XR if the patient develops a medical condition that may lead to dehydration (significant loss of body water), such as severe vomiting, diarrhoea, fever, exposure to high temperature, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.

Stop using Symformin XR and contact a doctor or the nearest hospital immediately if the patient experiences any symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise combined with severe fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.

Seek immediate medical advice if:

• the patient has a genetically inherited mitochondrial disease (cellular energy-producing structures), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• the patient develops any of the following symptoms after starting metformin: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or deafness.

If the patient is undergoing major surgery, Symformin XR must not be used during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart treatment with Symformin XR.

Symformin XR alone does not cause hypoglycaemia (low blood glucose levels). However, if Symformin XR is used in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylureas, insulin, or meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances, or difficulty concentrating, eating or drinking a sugary food or drink usually helps.

During treatment with Symformin XR, the doctor will monitor kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.

Follow the dietary recommendations provided by the doctor.

It is common for tablet residues to be visible in the stool. This is normal with this type of tablet and should not cause concern.

Symformin XR and other medicines
If an iodine-containing contrast agent is administered intravenously, for example for an X-ray examination or CT scan, the patient must stop taking Symformin XR before or at the latest at the time of contrast administration. The doctor will decide when to stop and restart treatment with Symformin XR.

Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to use. The patient may require more frequent monitoring of blood glucose levels and kidney function, or dose adjustments of Symformin XR. It is particularly 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 asthma treatment);
• corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma);
• medicines that may alter the blood concentration of Symformin XR, especially if the patient has impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib);
• other medicines used in diabetes treatment.

Use of Symformin XR with alcohol
Avoid excessive alcohol consumption while taking Symformin XR, as it may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy, breastfeeding and fertility
If the patient is pregnant, suspects she may be pregnant, or is planning a pregnancy, she should consult her doctor regarding any necessary changes in treatment or blood glucose monitoring.

This medicine is not recommended for breastfeeding women or those planning to breastfeed.

Driving and operating machinery
Symformin XR alone does not cause hypoglycaemia (symptoms of low blood sugar). This means it does not affect the patient's ability to drive or operate machinery.

However, special caution is required if Symformin XR is used together with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylureas, insulin, or 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 Symformin XR

This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Symformin XR does not replace the benefits of a healthy lifestyle. You should continue to follow your doctor's advice
on diet and regular physical activity.
Swallow the tablets whole with a glass of water. Do not chew the tablets.
Usual dose
Children: due to lack of adequate safety data, Symformin XR should not be used in children.
Adults: treatment usually starts with a dose of 500 milligrams or 750 milligrams of Symformin XR once daily
during the evening meal.
After 10–15 days, the dose will be adjusted by your doctor based on blood glucose measurements. The maximum dose of
Symformin XR is 2000 milligrams per day, taken once daily during the evening meal. Gradual dose escalation may improve
gastrointestinal tolerance.
For patients already treated with metformin, the initial dose of Symformin XR should be equivalent to the daily dose of
metformin in immediate-release tablets.
When switching from another oral antidiabetic medicine to Symformin XR, your doctor should discontinue the previously
used medicine and initiate Symformin XR at the dose specified above.
If you have impaired kidney function, your doctor may prescribe a lower dose.
Switching antidiabetic treatment to Symformin XR is not recommended for patients currently taking metformin at doses
exceeding 2000 milligrams per day in immediate-release tablets.
If you are also using insulin, your doctor will advise you on how to start treatment with Symformin XR.
Monotherapy (prediabetes state)
The usual dose is 1000 to 1500 mg of metformin hydrochloride once daily during the evening meal. Your doctor will assess
whether treatment should be continued based on regular blood glucose monitoring and risk factors.
Polycystic ovary syndrome
The usual dose is 1500 mg of metformin hydrochloride once daily during the evening meal.
Monitoring of treatment

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

How to use Symformin XR
Symformin XR should be taken during or immediately after a meal. This helps to avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet with a glass of water.
If at any time you feel the medicine's effect is too strong or too weak, you should consult your doctor or pharmacist.
Taking more Symformin XR than you should
If you take more Symformin XR than recommended, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal discomfort) with muscle cramps, general malaise accompanied by severe fatigue and difficulty breathing. Other symptoms include lowered body temperature and slowed heart rate. If any of these symptoms occur, you should seek immediate medical help, as lactic acidosis can lead to coma.
You should stop taking Symformin XR immediately and contact your doctor or go to the nearest hospital.
If you forget to take Symformin XR
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The medicine Symformin XR may very rarely (may affect up to 1 in 10,000 patients) cause a very serious adverse effect called lactic acidosis (see section “Warnings and precautions”). If this occurs in a patient, treatment with Symformin XR 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 effects are listed below according to their frequency of occurrence:

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

• Gastrointestinal disturbances such as nausea, vomiting, diarrhoea, abdominal pain (pain in the abdominal cavity), or loss of appetite. These adverse effects most commonly occur at the beginning of treatment with Symformin XR and in most cases resolve spontaneously. It may be helpful to take Symformin XR with a meal or immediately after a meal. If symptoms do not resolve, Symformin XR should be discontinued and the doctor should be informed.

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

• Taste disturbances.
• Reduced or low levels of vitamin B in the blood (symptoms may include extreme tiredness (fatigue), 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 symptoms, as some of them may also be caused by diabetes or other health problems unrelated to diabetes.

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

• Lactic acidosis. This is a very rare but serious complication, particularly when kidneys are not functioning properly. Symptoms of lactic acidosis – see section “Warnings and precautions”.
• Abnormal liver function test results or hepatitis (associated with fatigue, loss of appetite, weight loss, and with or without yellowing of the skin and whites of the eyes). If such symptoms occur, Symformin XR must be discontinued immediately and the doctor should be informed.
• Skin reactions such as: skin redness (erythema), skin itching, and itchy rash (urticaria).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Symformin XR

Keep this medicine 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 specified month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 milligrams, 750 milligrams, or 1000 milligrams of the active substance, metformin hydrochloride.
• The other ingredients are: magnesium stearate, colloidal anhydrous 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
measuring 16.50 mm x 8.20 mm, embossed with "XR500" on one side and smooth on the other.
Symformin XR 750 mg: white or almost white, uncoated, capsule-shaped tablets
measuring 19.60 mm x 9.30 mm, embossed with "XR750" on one side and smooth on the other.
Symformin XR 1000 mg: white or almost white, uncoated, capsule-shaped tablets
measuring 21.10 mm x 10.10 mm, embossed with "XR1000" on one side and smooth on the other.
Symformin XR 500 mg and 1000 mg are available in packs containing 30, 60, 90, or
120 tablets, packed in blisters.
Symformin XR 750 mg is available in packs containing 30 or 60 tablets,
packed in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the member states of the European Economic Area under the following names:
Poland: Symformin XR