Formetic sr

Patient Information Leaflet

Formetic SR, 500 mg, prolonged-release tablets
Metformini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 personally. 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 any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Formetic SR is and what it is used for
2. What you need to know 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 Formetic SR is and what it is used for

Formetic SR prolonged-release tablets contain metformin, a medicine used in the treatment of diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that enables the body to take up glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for later use.
In people with type 2 diabetes, the pancreas does not produce enough insulin or the body cannot use the insulin it produces effectively. This leads to abnormally high levels of glucose in the blood. Formetic SR helps to lower blood glucose levels to values as close to normal as possible.
In overweight adults, long-term use of Formetic SR also reduces the risk of diabetes-related complications. Treatment with Formetic SR is associated with stable body weight or even moderate weight reduction.
Formetic SR 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 Formetic SR either as the only treatment or in combination with other antidiabetic medicines (oral agents or insulin).
For the prevention of type 2 diabetes in patients with prediabetes.
In polycystic ovary syndrome (PCOS).

2. Important information before using Formetic SR

When not to use Formetic SR

• if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6);
• if the patient has impaired liver function;
• if the patient has significantly reduced kidney function;
• if the patient has uncontrolled diabetes, for example severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see below "Risk of lactic acidosis") 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 from the mouth.
• if the patient has excessive loss of body fluids (dehydration), for example due to prolonged or severe diarrhoea, or repeated vomiting. Dehydration may lead to impaired kidney function, which may increase the risk of lactic acidosis (see below section "Warnings and precautions");
• if the patient has a severe infection, for example pneumonia, bronchitis or kidney infection. Severe infections may lead to impaired kidney function, which may increase the risk of lactic acidosis (see below section "Warnings and precautions");
• in case of treatment for acute heart failure or recent myocardial infarction, or 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 section "Warnings and precautions");
• if the patient abuses alcohol;
• if the patient is under 18 years of age.

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

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

Formetic SR must be discontinued for a certain period before and after the examination or surgical procedure.
The doctor will decide whether alternative treatment is necessary during this time. It is important to follow the doctor's instructions exactly.

Warnings and precautions

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

Risk of lactic acidosis

Formetic SR may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), impaired liver function, and any medical conditions in which part of the body is inadequately oxygenated (e.g. acute severe heart disease).

If any of the above conditions apply to the patient, seek further advice from a doctor.

Temporarily discontinue Formetic SR if the patient develops a medical condition that may involve dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.

Stop taking Formetic SR 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 associated with profound fatigue,
• difficulty breathing,
• decreased body temperature and slowed heart rate.

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

Contact a doctor immediately for further instructions if:

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

If the patient is to undergo a major surgical procedure, Formetic SR must not be taken during the procedure and for a certain time afterwards. The doctor will decide when the patient should stop and resume treatment with Formetic SR.

Formetic SR alone does not cause hypoglycaemia (low blood glucose levels).
However, if Formetic SR 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, excessive sweating, rapid heartbeat, blurred vision or difficulty concentrating, eating or drinking a sugary food or drink usually helps.

During treatment with Formetic SR, 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 worsening kidney function.

Follow the dietary recommendations provided by the doctor.

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

Formetic SR and other medicines

If the patient is to receive an intravenous iodine-containing contrast agent, for example for an X-ray or CT scan, the patient must stop taking Formetic SR before or at the latest at the time of injection. The doctor will decide when the patient should stop and resume treatment with Formetic SR.

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

Formetic SR and alcohol

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

Pregnancy and breastfeeding

If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should talk to her doctor, as changes in treatment or monitoring of blood glucose levels may be necessary.

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

Driving and operating machinery

Formetic SR, when used as the sole medication, does not cause hypoglycaemia (low blood sugar levels). This means it does not affect the patient's ability to drive or operate machinery.

However, special caution is required when Formetic SR is used in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include: weakness, dizziness, excessive sweating, rapid heartbeat, visual disturbances or difficulty concentrating. If such symptoms occur, the patient should not drive or operate machinery.

Formetic SR contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Formetic SR

This medicine should always be used exactly as your doctor has told you. If you are unsure, consult
your doctor or pharmacist.
Formetic SR does not replace the benefits of a healthy lifestyle. You should continue to follow all
your doctor's advice regarding diet and regular physical activity.
Recommended dose
Children:
Due to lack of adequate safety data, Formetic SR should not be used in children.
Adults:
The usual starting dose is 1 tablet of Formetic SR 500 mg taken once daily with the evening meal.
After 10 to 15 days, the dose will be adjusted by your doctor based on blood glucose measurements.
Gradual dose escalation may improve gastrointestinal tolerance to the medicine.
Your doctor may increase the dose up to a maximum of 4 tablets daily (2000 mg), taken once daily
with the evening meal.
For patients already treated with metformin, the starting dose of Formetic SR 500 mg should be
equivalent to the daily dose of metformin in immediate-release tablets.
When switching from another oral antidiabetic medicine to Formetic SR 500 mg, your doctor should
discontinue the previously used medicine and initiate Formetic SR 500 mg at the dose specified above.
If you have impaired kidney function, your doctor may prescribe a lower dose.
Switching antidiabetic treatment to Formetic SR is not recommended for patients currently taking
metformin at doses exceeding 2000 mg daily in the form of immediate-release tablets.
If you are also using insulin, your doctor will advise you on how to start treatment with Formetic SR.
In monotherapy (prediabetes state)
The usual dose is 1000 to 1500 mg of metformin hydrochloride once daily with the evening meal.
Your doctor will decide whether treatment should be continued based on regular blood glucose
monitoring and risk factors.
In polycystic ovary syndrome
The usual dose is 1500 mg of metformin hydrochloride once daily with the evening meal.
Treatment monitoring

• Your doctor will order regular blood glucose tests and adjust the dose of Formetic SR according to blood glucose levels. You should attend regular follow-up visits 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 kidney function is impaired.

How to use Formetic SR
Formetic SR should be taken orally during or immediately after a meal. This helps to avoid
gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet whole with a glass of water.
If at any time you feel that the medicine's effect is too strong or too weak, consult your doctor or
pharmacist.
Use of a higher than recommended dose of Formetic SR
If you take more Formetic SR than you should, 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 low body temperature and slower heart rate. If any of these symptoms occur,
seek medical help immediately, as lactic acidosis can lead to coma. Formetic SR should be
stopped immediately and you should contact your doctor or go to the nearest hospital.
Missed dose of Formetic SR
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 side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The side effects that may occur are listed below.
Formetic SR may very rarely cause (in up to 1 patient in 10,000) a very serious side effect known as lactic acidosis (see section “Warnings and precautions”). If this occurs in a patient, treatment with Formetic SR must be discontinued and immediate contact must be made with a doctor or the nearest hospital, as lactic acidosis may lead to coma.

Very common side effects (occur in more than 1 in 10 patients):

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

Common side effects (occur in less than 1 in 10 patients):

• taste disturbances,
• reduced or low blood levels of vitamin B (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 side effects (occur in less than 1 in 10,000 patients):

• lactic acidosis. This is a very rare but serious complication, particularly when the kidneys are not functioning properly. Symptoms of lactic acidosis – see section “Warnings and precautions”.
• abnormal liver function test results or symptoms of liver inflammation (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, Formetic SR must be discontinued immediately and the doctor should be informed.
• skin reactions such as skin redness (erythema), itching, or itchy rash (urticaria).

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Formetic SR

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the outer carton and blister after: EXP. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates 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. Proper disposal helps 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 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
• The other ingredients are: povidone; colloidal silicon dioxide, anhydrous; sodium carboxymethylcellulose; hypromellose; microcrystalline cellulose; magnesium stearate.

What Formetic SR looks like and contents of the pack
Formetic SR 500 mg are white or almost white, round, biconvex tablets, embossed with
"500" on one side and plain on the other. The diameter of the tablets is approximately 12.15 mm.
The tablets are available in PVC/PVDC/Aluminium foil blisters contained in a cardboard box.
Pack sizes contain 28 or 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. +48 22 364 61 01
Importer
PharOS MT Ltd.
HF62X Hal Far Industrial Estate, Birzebbugia
BBG 3000
Malta