Formetic Sr

Package Leaflet: Information for the Patient

Formetic SR, 750 mg, Prolonged-Release Tablets

Metformin Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Formetic SR and what is it used for
• 2. Important information before taking Formetic SR
• 3. How to take Formetic SR
• 4. Possible side effects
• 5. How to store Formetic SR
• 6. Contents of the pack and other information

1. What is Formetic SR and what is it used for

Formetic SR prolonged-release tablets contain metformin, a medicine 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 future use.
In patients with type 2 diabetes, the pancreas does not produce enough insulin or the body is unable to use the insulin produced. This leads to an excessive increase in blood glucose levels. Formetic SR helps reduce blood glucose levels to as close to normal as possible.
In adults with overweight, long-term use of Formetic SR also reduces the risk of complications associated with diabetes. Taking Formetic SR is associated with either weight loss or no change in body weight.
Formetic SR is used to treat patients with type 2 diabetes (also called non-insulin-dependent diabetes). It is particularly used in patients with overweight.
Adults can take Formetic SR as the only medicine or in combination with other anti-diabetic medicines (oral or insulin).
In the prevention of type 2 diabetes in patients with a pre-diabetic condition.
In polycystic ovary syndrome (PCOS).

2. Important information before taking Formetic SR

When not to take Formetic SR:

• if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6);
• if you have liver disease;
• if you have severely reduced kidney function;
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see below "Risk of lactic acidosis") or diabetic ketoacidosis. Diabetic ketoacidosis is a condition in which substances called ketones accumulate in the blood and can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odor from the mouth.
• if you have excessive loss of body water (dehydration), for example, due to prolonged or severe diarrhea, or repeated vomiting. Dehydration can lead to kidney problems, which can increase the risk of lactic acidosis (see below "Warnings and precautions");
• if you have a severe infection, for example, pneumonia, bronchitis, or pyelonephritis. Severe infections can lead to kidney problems, which can increase the risk of lactic acidosis (see below "Warnings and precautions");
• in case of acute heart failure or recent myocardial infarction, or severe circulatory problems (e.g., shock), or breathing difficulties. This can cause tissue hypoxia, which can increase the risk of lactic acidosis (see below "Warnings and precautions");
• if you abuse alcohol;
• if you are under 18 years old.

If any of the above situations occur, you should consult your doctor before taking this medicine.
It is essential to consult your doctor if it is necessary to:

• perform a radiological examination or other examination requiring the injection of a contrast medium containing iodine into the bloodstream;
• perform major surgery.

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

Warnings and precautions

Before starting treatment with Formetic SR, discuss it with your doctor or pharmacist.

Risk of lactic acidosis

Formetic SR can cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more information below), liver disease, and any conditions in which a part of the body is not adequately supplied with oxygen (e.g., acute severe heart disease).
If any of the above conditions apply to you, you should consult your doctor for more detailed instructions.

You should temporarily stop taking Formetic SR if you have a condition that may lead to dehydration

(significant loss of body water), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. You should consult your doctor for more detailed instructions.

You should stop taking Formetic SR and contact your doctor or the nearest hospital immediately if you experience

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

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell with severe fatigue,
• breathing difficulties,
• decreased body temperature and slower 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 (MIDD);
• you experience any of the following symptoms after starting metformin: seizures, cognitive impairment, 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 Formetic SR during and for some time after the surgery. Your doctor will decide when you should stop and restart treatment with Formetic SR.
Formetic SR itself does not cause hypoglycemia (low blood sugar).
However, if Formetic SR is taken with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia. If you experience symptoms of hypoglycemia, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, eating or drinking something containing sugar usually helps.
During treatment with Formetic SR, 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 is not uncommon for the tablet coating to appear in the stool. Do not be concerned, as this is normal when taking this type of tablet.

Formetic SR with other medicines

If you are to be injected with a contrast medium containing iodine into the bloodstream, for example, for an X-ray examination or computed tomography, you should stop taking Formetic SR before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart treatment with Formetic SR.
Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent monitoring of your blood glucose levels and kidney function or a modification of the Formetic SR dose by your doctor. It is particularly important to inform your doctor 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-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 Formetic SR in the blood, especially if you have kidney problems (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other anti-diabetic medicines.

Formetic SR with alcohol

Avoid excessive alcohol consumption while taking Formetic SR, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice, as changes in treatment or monitoring of blood glucose levels may be necessary.
This medicine is not recommended for breastfeeding women or women planning to breastfeed.

Driving and using machines

Formetic SR, when used alone, does not cause hypoglycemia (low blood sugar). This means it does not affect your ability to drive or use machines.
However, you should be careful when taking Formetic SR 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 you experience such symptoms, do not drive or operate machinery.

Formetic SR contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Formetic SR

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Formetic SR does not replace the benefits of a healthy lifestyle. You should continue to follow your doctor's recommendations regarding diet and regular physical activity.

Recommended dose

Children:
Due to the lack of appropriate safety data, Formetic SR should not be used in children.
Adults:
Treatment usually starts with one 750 mg tablet of Formetic SR once daily, taken during the evening meal.
After 10 to 15 days, the dose is adjusted by the doctor based on blood glucose measurements. Gradually increasing the dose may improve gastrointestinal tolerance.
Your doctor may increase the dose up to a maximum of 2 tablets of 750 mg Formetic SR once daily, taken during the evening meal.
In patients already treated with metformin, the initial dose of Formetic SR 750 mg should be equivalent to the daily dose of metformin in the form of immediate-release tablets.
When switching from another oral anti-diabetic medicine to Formetic SR 750 mg, the doctor should discontinue the previously used medicine and initiate Formetic SR 750 mg at the dose specified above.
If you have impaired kidney function, your doctor may prescribe a lower dose.
Patient's taking insulin should be informed by the doctor how to start taking Formetic SR.
In monotherapy (pre-diabetic state)
The usual dose is 1000 to 1500 mg of metformin hydrochloride once daily, taken during the evening meal. The doctor decides whether to continue treatment based on regular blood glucose tests and risk factors.
In polycystic ovary syndrome
The usual dose is 1500 mg of metformin hydrochloride once daily, taken during the evening meal.
Treatment monitoring

• Your doctor will prescribe regular blood glucose tests and adjust the dose of Formetic SR according to the glucose levels. You should regularly visit your doctor for check-ups. This is especially important for elderly patients.
• Your doctor will check your kidney function at least once a year. More frequent checks may be necessary for elderly patients or if you have impaired kidney function.

How to take Formetic SR
Formetic SR should be taken orally with a meal or immediately after a meal. This will help avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet whole 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 Formetic SR than recommended

If you take more Formetic SR than recommended, you may experience lactic acidosis. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal cramps), general feeling of being unwell with severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slower heart rate . If you experience any of these symptoms, you should seek medical help immediately, as lactic acidosis can lead to coma. You should stop taking Formetic SR and contact your doctor or the nearest hospital immediately.

Missing a dose of Formetic SR

Do not take a double dose to make up for a forgotten dose.
Take the next dose at the usual time.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects that may occur are presented below.
Formetic SR may very rarely cause (may affect up to 1 in 10,000 people) a very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this happens to you, you should stop taking Formetic SR and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
Very common side effects (affecting more than 1 in 10 people):

• gastrointestinal disorders, such as diarrhea, nausea, vomiting, abdominal pain (abdominal cramps), loss of appetite. These side effects most often occur at the beginning of treatment with Formetic SR and usually disappear on their own. Taking Formetic SR with a meal or immediately after a meal may help. If the symptoms do not disappear, you should stop taking Formetic SR and tell your doctor.

Common side effects (affecting less than 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 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.

Rare side effects (affecting less than 1 in 10,000 people):

• lactic acidosis. This is a very rare but serious complication, especially when the kidneys are not working properly. Symptoms of lactic acidosis - see section "Warnings and precautions".
• abnormal liver function test results or symptoms of liver inflammation (with accompanying fatigue, loss of appetite, weight loss, and yellowing of the skin and whites of the eyes). If such symptoms occur, you should stop taking Formetic SR and tell your doctor.
• skin reactions, such as redness, itching, or itchy rash (hives).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Formetic SR

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Formetic SR contains

• The active substance is metformin hydrochloride. Each prolonged-release tablet contains 750 mg of metformin hydrochloride, equivalent to 585 mg of metformin.
• The other ingredients are: povidone; colloidal anhydrous silica; sodium carboxymethylcellulose; hypromellose; microcrystalline cellulose; magnesium stearate.

What Formetic SR looks like and contents of the pack

Formetic SR 750 mg is a white or almost white, biconvex capsule-shaped tablet with "750" embossed on one side and smooth on the other. The tablets are approximately 20.0 mm long and 9.6 mm wide.
The tablets are available in PVC/PVDC/Aluminum blisters in a carton box.
The pack contains 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
phone: +48 22 364 61 01

Importer

PharOS MT Ltd.
HF62X Hal Far Industrial Estate, Birzebbugia
BBG 3000
Malta
Date of last revision of the leaflet:May 2025