Meladine Sr

Leaflet accompanying the packaging: patient information

Meladine SR, 500 mg, prolonged-release tablets

Metformin hydrochloride
This medicine is intended for adult patientsonly.

Read the leaflet carefully before taking the medicine, 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. See section 4.

Table of contents of the leaflet

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

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

Metformin hydrochloride, the active substance of Meladine SR, prolonged-release tablets, belongs to a group of medicines called biguanides, used to treat type 2 diabetes (non-insulin-dependent).
Meladine SR is used in combination with diet and exercise to reduce the risk of developing type 2 diabetes in adults with overweight, when diet and exercise alone have not been enough to control blood sugar levels for 3 to 6 months. There is a high risk of developing type 2 diabetes if the patient has additional risk factors, such as high blood pressure, age over 40, abnormal blood lipid levels, or gestational diabetes.
This medicine is particularly effective if the patient is under 45 years old, has a high degree of overweight, high blood sugar levels after meals, or has developed diabetes during pregnancy.
Meladine SR is used in patients with type 2 diabetes when diet and exercise alone have not been enough to control blood sugar levels. Insulin is a hormone that allows the body to take up glucose from the blood, which it uses to produce energy or stores for later 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 sugar levels, which can cause a range of serious and long-term problems, making it important to continue taking the medicine even if there are no obvious symptoms. Meladine SR increases the body's sensitivity to insulin and helps the body to use glucose properly.
Taking Meladine SR is associated with maintaining a stable body weight or a moderate reduction in body weight. Meladine SR has been specially developed to release the active substance slowly from the tablet into the body, which distinguishes it from many other types of metformin tablets.

2. Important information before taking Meladine SR

When not to take Meladine SR

• if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause a rash, itching, or shortness of breath;
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar levels), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness, or an unusual fruity odor from the mouth,
• in case of excessive fluid loss from the body (dehydration). Dehydration can lead to kidney function disorders, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• if you have liver disease,
• if you have significantly reduced kidney function,
• in case of severe infection, such as pneumonia, bronchitis, or kidney infection. Severe infections can lead to kidney function disorders, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• if you have been treated for acute heart failure or have recently had a heart attack, severe circulatory disorders, or breathing difficulties. This can cause tissue hypoxia, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of alcohol abuse,
• if you are under 18 years old.

Warnings and precautions

Risk of lactic acidosis

Meladine SR may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney function disorders. The risk of lactic acidosis also increases in case of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see more 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.

You should temporarily stop taking Meladine SR if you have

a condition that may be associated with dehydration(excessive fluid loss from the body),
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 Meladine 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 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 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 a major surgical procedure, you should not take Meladine SR during the procedure and for a certain period after it. Your doctor will decide when you should stop and restart treatment with Meladine SR.
During treatment with Meladine SR, your doctor will monitor your kidney function at least once a year or more often if you are elderly and/or have worsening kidney function.
In patients over 75 years old, treatment with Meladine SR should not be initiated to reduce the risk of developing type 2 diabetes.
It may happen that the tablet coating is visible in the stool. Do not be concerned, as this is normal when taking this type of tablet.
You should follow the dietary recommendations given by your doctor and ensure that you eat carbohydrates regularly throughout the day.
You should not stop taking this medicine without consulting your doctor.

Meladine SR and other medicines

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

Meladine SR and alcohol

You should avoid consuming excessive amounts of alcohol while taking Meladine SR, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, you should consult your doctor, as your treatment or blood sugar monitoring may need to be adjusted.
This medicine is not recommended for breastfeeding women or women planning to breastfeed.

Driving and using machines

Meladine SR itself does not cause hypoglycemia (symptoms of low blood sugar levels, such as fainting, disorientation, and increased sweating) and therefore does not affect your ability to drive or use machines.
You should be careful if you are taking Meladine 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, you should not drive or use machines.

Information on excipients

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

3. How to take Meladine SR

Your doctor may recommend taking Meladine SR alone or in combination with other oral anti-diabetic medicines or insulin.
This medicine should always be taken exactly as your doctor has told you.
If you are not sure, you should ask your doctor or pharmacist.
You should swallow the tablets whole with a glass of water. Do not chew the tablets.
Recommended dose
Treatment usually starts with a dose of 500 mg of Meladine SR once a day.
After about two weeks of taking the medicine, your doctor may adjust the dose based on your blood sugar levels. The maximum dose of Meladine SR is 2000 mg per day.
If you have kidney function disorders, your doctor may prescribe a lower dose.
Usually, you should take the tablets once a day with your evening meal.
In some cases, your doctor may recommend taking the tablets twice a day.
You should always take the tablets with a meal.

Taking a higher dose of Meladine SR than recommended

If you accidentally take extra tablets, you should not be concerned, but if you experience unusual symptoms, you should contact your doctor. In case of significant overdose, lactic acidosis is more likely to occur.
Unusual symptoms of lactic acidosis include vomiting, abdominal pain with muscle cramps, general feeling of being unwell with severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate.

If you experience such symptoms, you should stop taking Meladine SR and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma. You should stop taking Meladine SR and seek medical attention immediately.

Missing a dose of Meladine SR

As soon as you remember, you should take the missed dose with any meal.
You should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Meladine SR can cause side effects, although not everybody gets them.
The following side effects may occur:
Meladine SR may very rarely cause (may affect up to 1 in 10,000 people) a very serious side effect called lactic acidosis, especially if your kidneys are not working properly (see "Warnings and precautions"). If this happens to you, you should stop taking Meladine SR and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
Meladine SR may cause abnormal liver function tests and liver inflammation, which can lead to jaundice (may affect up to 1 in 10,000 people), causing fatigue, loss of appetite, weight loss, and yellowing of the skin and whites of the eyes (jaundice). If you experience yellowing of the whites of the eyes and/or skin, you should stop taking Meladine SR and contact your doctor.
Other possible side effects are listed below by frequency:

• Very common (may affect more than 1 in 10 people):
• Gastrointestinal disorders, such as diarrhea, nausea, vomiting, abdominal pain, or loss of appetite. These side effects usually occur at the beginning of treatment with Meladine SR. Taking the tablets with a meal or immediately after a meal may help.

If the symptoms do not go away, you should stop taking Meladine SR 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 inflammation of the tongue, numbness or tingling, or pale or yellowish skin). 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 non-diabetes-related health problems.

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

• skin rashes, including redness of the skin, itching, and hives.

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 Meladine SR

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for this medicine.
Do not use this medicine after the expiry date stated on the blister pack and carton after: EXP.
The expiry date refers to the last day of the month.
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 pack and other information

What Meladine SR contains

Each prolonged-release tablet contains 500 mg of the active substance – metformin hydrochloride.
The other ingredients are: microcrystalline cellulose, hypromellose K 100M, colloidal anhydrous silica, and magnesium stearate.

What Meladine SR looks like and contents of the pack

Meladine SR is a white to almost white, biconvex, uncoated tablet in the shape of a capsule, with dimensions of 19.2 x 9.3 mm, with the inscription "FN1" on one side and smooth on the other.
Meladine SR is packaged in PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters containing 28, 30, 50, 56, 60, 90, or 100 prolonged-release tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer:

Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice

This medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: March 2025