Meladine sr

Package leaflet: Information for the patient

Meladine SR, 500 mg, prolonged-release tablets
Metformini hydrochloridum
This medicine is intended for adult patients only.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• 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. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any 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 diabetes (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. The risk of developing type 2 diabetes is high if the patient has 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 marked overweight, high postprandial blood glucose levels, or a history of diabetes during pregnancy.

Meladine SR is used in patients with type 2 diabetes when adequate blood glucose (sugar) control cannot be achieved by diet and physical exercise alone. Insulin is a hormone that enables the body to take up glucose from the blood and use it for energy or store it 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 various serious and long-term complications. Therefore, 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 restore the body's proper use of glucose.

Taking Meladine SR is associated with maintenance of stable body weight or moderate weight reduction. Meladine SR has been specially designed to release the active substance slowly from the tablet into the body, which distinguishes it from many other types of tablets containing metformin.

2. Important information before taking Meladine SR

When not to take 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 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 ketones accumulate in the blood and may lead to a diabetic pre-coma state. Symptoms include: abdominal pain, rapid 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);
• if the patient has liver disease;
• if the patient has significantly reduced kidney function;
• 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 further 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, consult a doctor for further instructions.
Temporarily discontinue Meladine SR if the patient develops any illness 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 Meladine SR immediately and contact a doctor or the nearest hospital without delay 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 being unwell combined 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 disease affecting mitochondria (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 scheduled for a major surgical procedure, Meladine SR must not be taken 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 for the purpose of reducing the risk of developing type 2 diabetes.
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.
Follow the dietary advice provided by the doctor and ensure regular intake of carbohydrates throughout the day.
Do not stop taking this medicine without consulting the doctor.
Meladine 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, treatment with Meladine SR must be stopped 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 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 Meladine 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),
• 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 in the treatment of asthma),
• corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma),
• medicines that may alter Meladine SR blood levels, 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.

Meladine SR and alcohol
Avoid excessive alcohol consumption while taking Meladine SR, as it 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 a pregnancy, 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 alone does not cause hypoglycaemia (symptoms of low blood glucose such as fainting, confusion and excessive sweating) and therefore does not affect the patient's ability to drive or operate machinery.
However, exercise particular caution if Meladine SR is taken together with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylureas, 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.
Information about excipients
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

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.
The tablets should be swallowed 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 impaired kidney function, your doctor may prescribe a lower dose.
The tablets are usually taken once daily with the evening meal.
In some cases, your doctor may recommend taking the tablets twice daily.
Always take the tablets 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 the case of significant overdose, lactic acidosis is more likely to occur.
Unusual symptoms of lactic acidosis include vomiting, abdominal pain with muscle cramps, general 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 necessary,
as coma may develop. You must immediately stop taking Meladine SR and
contact your doctor or go to the nearest hospital.

If you forget to take 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 forgotten dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The following adverse reactions may occur:
Meladine SR may very rarely (may occur in up to 1 patient in 10,000) cause a very serious adverse reaction known as lactic acidosis, especially if the patient's kidneys are not functioning properly (see section "Warnings and precautions"). If lactic acidosis occurs in a patient, treatment with Meladine SR must be discontinued and the patient should immediately contact a doctor or the nearest hospital, as lactic acidosis may lead to coma.
Meladine SR may cause abnormal liver function test results and hepatitis, leading to jaundice (may occur in up to 1 patient in 10,000), which may cause fatigue, loss of appetite, weight loss, and yellowing or lack of yellowing of the skin and whites of the eyes (jaundice). If yellowing of the whites of the eyes and/or skin occurs in a patient, Meladine SR must be discontinued immediately and the patient should contact a doctor.
Other possible adverse reactions 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 reactions most commonly occur at the beginning of treatment with Meladine SR. It may be helpful to take the tablets with food or immediately after a meal. If symptoms persist, Meladine SR should be discontinued and the doctor informed.

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

• Taste disturbances.
• Decreased 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 yellow 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):

• Skin rashes including: skin redness, itching and urticaria.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Meladine SR
Keep the medicine out of sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the blister and carton following 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 required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Meladine SR contains
Each prolonged-release tablet contains 500 mg of the active substance – metformin hydrochloride.
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, capsule-shaped, biconvex, uncoated tablet measuring 19.2 x 9.3 mm, with the imprint “FN1” on one side and smooth on the other.
Meladine SR is packed in PVC/PVDC/Aluminium or OPA/Aluminium/PVC/Aluminium blisters containing 28, 30, 50, 56, 60, 90 or 100 prolonged-release tablets, in a cardboard carton.
Not all pack sizes may be marketed.

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

Manufacturer/Importer:
Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 50
95-200 Pabianice

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