Meladine sr

Patient Information Leaflet

Meladine SR, 750 mg, prolonged-release tablets
Meladine SR, 1000 mg, prolonged-release tablets
Metformini hydrochloridum
This medicine is intended for adult patients only.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor. See section 4.

Table of Contents

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 in Meladine SR prolonged-release tablets, belongs to a group of medicines called biguanides, used in the treatment of type 2 (non-insulin-dependent) diabetes.

Meladine SR is used in combination with diet and physical exercise to reduce the risk of developing type 2 diabetes in overweight adults when diet and exercise alone over a period of 3 to 6 months have not been sufficient to control blood glucose (sugar) levels. There is a high risk of developing type 2 diabetes if you have additional risk factors such as high blood pressure, age over 40 years, abnormal blood lipid (fat) levels, or a history of gestational diabetes.

This medicine is particularly effective if the patient is under 45 years of age, has significant overweight, high post-meal blood glucose levels, or has had gestational diabetes.

Meladine SR is used in patients with type 2 diabetes when blood glucose (sugar) levels cannot be adequately controlled by diet and physical exercise alone. Insulin is a hormone that enables the body to take up glucose from the blood for energy production or storage for later use. In patients with type 2 diabetes, the pancreas does not produce enough insulin or the body cannot properly use the insulin that is produced. This leads to excessively high blood glucose levels, which may result in a range of serious and long-term complications. Therefore, it is important to continue taking the medicine regularly, even if you do not have any obvious symptoms. Meladine SR increases the body's sensitivity to insulin and helps the body return to proper glucose utilization.

Treatment with Meladine SR is associated with maintenance of stable body weight or moderate weight reduction.

Meladine SR has been specially formulated to release the medicine slowly into the body, which differentiates it from many other types of metformin-containing tablets.

2. Important information before using Meladine SR

When not to use Meladine SR

• if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause rash, itching or shortness of breath;
• if the patient has liver disease;
• 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 "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 a diabetic pre-coma state. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odour of the breath;
• in case of excessive loss of body fluids (dehydration). Dehydration may lead to impaired kidney function, which may increase the risk of lactic acidosis (see section "Warnings and precautions" below);
• in case of severe infection, e.g. pneumonia, bronchitis or kidney infection. Severe infections may lead to impaired kidney function, which may increase the risk of lactic acidosis (see section "Warnings and precautions" below);
• if the patient has been treated for acute heart failure or recent myocardial infarction, severe circulatory disorders or breathing difficulties. These conditions may cause tissue hypoxia, which may increase the risk of lactic acidosis (see section "Warnings and precautions" below);
• in case of alcohol abuse;
• if the patient is under 18 years of age.

Warnings and precautions
Risk of lactic acidosis.
Meladine 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 is also increased 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 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, please consult a doctor for further instructions.
Temporarily discontinue use of Meladine SR if the patient develops a medical condition that may lead to 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.
Discontinue use of Meladine 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 feeling of malaise accompanied by 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 (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).
• the patient develops any of the following symptoms after starting metformin: seizures, worsening cognitive function, difficulty moving, signs indicating nerve damage (e.g. pain or numbness), migraine or deafness.

If the patient is scheduled for major surgery, Meladine SR 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 Meladine SR.
During treatment with Meladine SR, 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.
Meladine SR should not be initiated in patients over 75 years of age to reduce the risk of developing type 2 diabetes.
It is common for the tablet coating to be visible in the stool. This is normal with this type of tablet and should not be a cause for concern.
Follow the dietary advice provided by the doctor and ensure regular intake of carbohydrates throughout the day.
Do not stop using this medicine without consulting a doctor.

Meladine SR and other medicines
If the patient is to receive an iodine-containing contrast agent intravenously, for example for an X-ray examination or computed tomography, treatment with Meladine SR must be discontinued before or at the latest at the time of administration.
The doctor will decide when the patient should stop and restart treatment with Meladine SR.
Inform the doctor about all medicines currently used or recently used, as well as any medicines the patient plans to take. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Meladine SR by the doctor. It is particularly important to inform the doctor about the following medicines:

• diuretics (medicines that increase urine production), 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);
• steroids such as prednisolone, mometasone, beclomethasone;
• sympathomimetic medicines including epinephrine and dopamine, used to treat myocardial infarction and low blood pressure. Epinephrine is also an ingredient in some local anaesthetics used in dentistry;
• medicines that may alter the blood concentration of Meladine SR, especially if the patient has impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Meladine SR and alcohol
Avoid excessive alcohol consumption while taking Meladine 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 consult her doctor regarding any necessary changes in treatment or blood glucose monitoring.
This medicine is not recommended for patients who are breastfeeding or planning to breastfeed.

Driving and operating machinery
Meladine SR, when used as monotherapy, does not cause hypoglycaemia (symptoms of low blood glucose such as fainting, disorientation and excessive sweating), and therefore does not affect the patient's ability to drive or operate machinery.
Exercise particular caution if Meladine SR is used concomitantly with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycaemia include: weakness, dizziness, increased sweating, rapid heartbeat, blurred vision or difficulty concentrating. If such symptoms occur, the patient should not drive or operate machinery.

3. How to take Meladine SR

Your doctor may recommend taking Meladine SR alone or in combination with other oral antidiabetic medicines or insulin.
This medicine should always be taken as prescribed by your doctor.
If in doubt, consult your doctor or pharmacist. Swallow the tablets whole with a glass of water. Do not chew the tablets.
Recommended dosage
Treatment usually starts with a dose of 500 mg of Meladine SR once daily.
After approximately two weeks of treatment, your doctor may adjust the dose based on blood glucose measurements.
The maximum dose of Meladine SR is 2000 mg per day.
If you have kidney function impairment, your doctor may prescribe a lower dose.
The tablets should usually be taken once daily with the evening meal.
In some cases, your doctor may recommend taking the tablets twice daily.
The tablets should always be taken with food.
Taking more Meladine SR than prescribed
If you accidentally take extra tablets, do not worry, but if unusual symptoms occur, 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 malaise with severe fatigue, and difficulty breathing. Other symptoms include lowered body temperature and slowed heart rate. If such symptoms occur, immediate hospital treatment is required, as coma may develop. You must immediately stop taking Meladine SR and contact your doctor or go to the nearest hospital.
Missing a dose of Meladine SR
As soon as you remember, take the missed dose with any meal. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following adverse effects may occur:
Meladine SR may very rarely (may occur in up to 1 in 10,000 patients) cause a very serious adverse effect known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, treatment with Meladine SR must be stopped immediately and medical advice must be sought from a doctor or the nearest hospital, 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 disorders such as diarrhoea, nausea, vomiting, abdominal pain or loss of appetite. These adverse effects most commonly occur at the beginning of treatment with Meladine SR. It may help to take the tablets with food or immediately after a meal. If symptoms do not resolve, Meladine SR should be discontinued and the doctor informed.

Common (may affect less than 1 in 10 people):

• Disturbances of taste
• 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 (may affect less than 1 in 10,000 people):

• Lactic acidosis. This is a very rare but serious complication, occurring particularly when the patient's kidneys are not functioning properly. Symptoms of lactic acidosis are non-specific (see section "Warnings and precautions").
• Abnormal liver function test results or symptoms of hepatitis (associated with fatigue, loss of appetite and weight loss, with or without yellowing of the skin and whites of the eyes). If such symptoms occur, Meladine SR should be discontinued and the doctor informed.
• Skin reactions such as skin redness, itching and 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 Adverse Drug Reactions, 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 Meladine SR

Keep the medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not swallow the desiccant.
Do not use this medicine after the expiry date stated on the bottle label
after: EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer in use. 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, colloidal anhydrous silica,
and magnesium stearate.

What Meladine SR looks like and contents of the pack
Meladine SR 750 mg are white to almost white, biconvex, elongated, uncoated tablets, measuring 19.2 mm x 9.3 mm, with the imprint "FN2" on one side and smooth on the other.
Meladine SR 1000 mg are white to almost white, biconvex, elongated, uncoated tablets, measuring 22.2 mm x 11.0 mm, with the imprint "FN3" on one side and smooth on the other.
Meladine SR is packed in HDPE bottles containing 30 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warszawa
Tel: +48 22 577 28 00

Manufacturer/Importer:
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200

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