Meladine Sr

Leaflet accompanying the packaging: patient information

Meladine SR, 750 mg, prolonged-release tablets

Meladine SR, 1000 mg, prolonged-release tablets

Metformin hydrochloride
This medicine is intended for adult patients only.

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, tell your doctor. See section 4.

Table of contents of the leaflet

• 1. What is Meladine SR and what is it 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 is Meladine SR and what is it 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 together with diet and physical 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 (glucose) 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 diabetes during pregnancy.
This medicine is particularly effective if the patient is under 45 years old, has a high body mass index, high blood glucose levels after meals, or developed diabetes during pregnancy.
Meladine SR is used in patients with type 2 diabetes when diet and physical exercise alone have not been enough to achieve normal 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 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 high blood sugar levels, which can cause a number of serious and long-term complications, so it is 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 weight loss.

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 liver disease,
• if you have significantly reduced kidney function,
• 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),
• 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(significant fluid 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 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, combined 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 inherited diabetes and deafness from your mother (MIDD).
• you experience any of the following symptoms after starting metformin: seizures, impaired cognitive function, difficulty moving, symptoms indicating nerve damage (e.g., pain or numbness), migraine, or hearing loss.

If you are going to have a major surgical procedure, you should not take Meladine SR during the procedure and for some time after it. Your doctor will decide when you should stop and restart treatment with Meladine SR.
During treatment with Meladine SR, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have deteriorating 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 worry, this is normal when taking this type of tablet.
You should follow the dietary recommendations given by your doctor and make sure you eat carbohydrates regularly throughout the day.
Do not stop taking this medicine without consulting your doctor.

Meladine SR and other medicines

If you are going to have a contrast agent containing iodine injected into your bloodstream, 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.
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 blood glucose checks or kidney function tests, or your doctor may need to adjust the dose of Meladine SR. It is especially important to inform your doctor about the following medicines:

• diuretics, such as furosemide,
• 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),
• corticosteroids, such as prednisolone, mometasone, beclometasone,
• sympathomimetic medicines, including epinephrine and dopamine, used to treat heart attack and low blood pressure. Epinephrine is also a component of some anesthetics used in dentistry.
• medicines that may change the levels 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).

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 plan to have a baby, you should consult your doctor, as your treatment or blood sugar control may need to be changed.
This medicine is not recommended for breastfeeding women or women planning to breastfeed.

Driving and using machines

Meladine SR used alone 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, do not drive or use machines.

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.
Always take this medicine exactly as your doctor has told you.
If you are not sure, 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 glucose measurements. 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.
Always take the tablets with a meal.

Taking a higher dose of Meladine SR than recommended

If you accidentally take extra tablets, do not worry, 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. In case of such symptoms, immediate hospital treatment is necessary, as it may lead to coma. You should stop taking Meladine SR and contact your doctor or the nearest hospital immediately.

Missing a dose of Meladine SR

Take the missed dose as soon as you remember, with a meal. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine 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 (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.
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 improve, 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 redness of the tongue, numbness, 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 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 patient's kidneys are not working properly. The symptoms of lactic acidosis are non-specific (see "Warnings and precautions").
• Abnormal liver function test results or symptoms of hepatitis (with fatigue, loss of appetite, and weight loss, with or without jaundice). If such symptoms occur, you should stop taking Meladine SR and tell your doctor.
• Skin reactions, such as redness, 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 of the 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 will help to gather more information on the safety of this medicine.

5. How to store Meladine SR

Keep this medicine out of the sight and reach of children.
There are no special storage instructions for this medicine.
Do not swallow the desiccant.
Do not take this medicine after the expiry date stated on the label after: EXP. The expiry date refers to the last day of the month stated.
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 Meladine SR contains

Each prolonged-release tablet contains 750 mg or 1000 mg of the active substance – metformin hydrochloride.
The other ingredients are: microcrystalline cellulose, hypromellose, anhydrous colloidal silica, and magnesium stearate.

What Meladine SR looks like and contents of the pack

Meladine SR 750 mg are white to almost white, biconvex, oblong, uncoated tablets, 19.2 mm x 9.3 mm in size, with "FN2" engraved on one side and smooth on the other.
Meladine SR 1000 mg are white to almost white, biconvex, oblong, uncoated tablets, 22.2 mm x 11.0 mm in size, with "FN3" engraved on one side and smooth on the other.
Meladine SR is packaged in HDPE bottles containing 30 prolonged-release tablets.
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
Accord Healthcare B.V.
Winthontlaan 200

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

Date of last revision of the leaflet: March 2025