Avamina sr

Patient Information Leaflet

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

Contents of the leaflet

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

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

Avamina SR contains 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, which 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 diabetes, the pancreas does not produce enough insulin or the body cannot properly use the insulin it produces. This leads to abnormally high levels of glucose in the blood. Avamina SR helps reduce blood glucose levels to values as close to normal as possible.
In overweight adults, long-term use of Avamina SR also reduces the risk of diabetes-related complications. Treatment with Avamina SR is associated with weight maintenance or moderate weight reduction.
Avamina 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 Avamina SR either as the only treatment or in combination with other antidiabetic medicines (oral medications or insulin).
For the prevention of type 2 diabetes in patients with prediabetes.
In polycystic ovary syndrome.

2. Important information before using Avamina SR

When not to use Avamina SR

• if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6),
• in case of liver function disorders,
• 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 diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odour of the breath,
• in case of excessive fluid loss from the body (dehydration), e.g. due to prolonged or severe diarrhoea or repeated vomiting. Dehydration may lead to kidney dysfunction, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
• in case of severe infection, e.g. pneumonia, bronchitis or kidney infection. Severe infections may lead to kidney dysfunction, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
• in case of treatment for acute heart failure or recent myocardial infarction, severe circulatory disorders (e.g. shock) or difficulty breathing. These conditions may cause tissue hypoxia, which may increase the risk of lactic acidosis (see below "Warnings and precautions"),
• if the patient abuses alcohol,
• if the patient is under 18 years of age.

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

• when undergoing a radiological examination or a procedure requiring intravenous injection of an iodine-containing contrast agent,
• when undergoing major surgery.

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

Warnings and precautions

Risk of lactic acidosis
Avamina SR may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has kidney dysfunction. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver dysfunction, and any medical conditions in which a part of the body is inadequately oxygenated (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, the patient should consult a doctor for further instructions.

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

Stop taking Avamina SR immediately 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 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 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),
• the patient develops any of the following symptoms after starting metformin: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.

If the patient is to undergo major surgery, Avamina SR must not be taken during and for some time after the procedure. The doctor will decide when the patient should stop and resume treatment with Avamina SR.

Avamina SR does not cause hypoglycaemia (low blood glucose levels).
However, if Avamina SR is used in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylurea derivatives, insulin, meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, excessive sweating, rapid heartbeat, visual disturbances or difficulty concentrating, eating or drinking a sugary food or drink usually helps.

During treatment with Avamina 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 deteriorating kidney function.

The patient should follow the dietary advice given 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.

Avamina SR and other medicines

If the patient is to receive an intravenous iodine-containing contrast agent, for example during an X-ray examination or computed tomography, the patient must stop taking Avamina SR before or at the latest at the time of administration. The doctor will decide when the patient should stop and resume treatment with Avamina SR.

Inform the doctor about all medicines currently taken, recently taken, or planned to be taken. The patient may require more frequent monitoring of blood glucose levels and kidney function, or the doctor may need to adjust the dose of Avamina 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-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 the blood concentration of Avamina 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.

Avamina SR and alcohol
Avoid consuming excessive amounts of alcohol while taking Avamina 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, 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
Avamina SR does not cause hypoglycaemia (low blood glucose levels). This means it has no effect on the patient's ability to drive or operate machinery.
However, particular caution is required if Avamina SR is used together with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylurea derivatives, 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.

Avamina SR contains sodium
Avamina SR contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Avamina SR

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Avamina SR does not replace the benefits of a healthy lifestyle. You should continue to follow your doctor's recommendations regarding diet and regular physical activity.

Recommended dose
Children: Due to lack of adequate safety data, Avamina SR should not be used in children.
Adults: Treatment is usually started with 1 tablet of Avamina SR 500 mg once daily during the evening meal. After 10–15 days, the dose will be adjusted by the doctor based on blood glucose measurements. Gradual dose escalation may improve gastrointestinal tolerance.

The doctor may increase the dose up to a maximum of 4 tablets daily (2000 mg), taken once daily during the evening meal.

For patients already treated with metformin, the starting dose of Avamina SR 500 mg should be equivalent to the daily dose of metformin in immediate-release tablets.

When switching from another oral antidiabetic medicine to Avamina SR 500 mg, the doctor should discontinue the previously used medicine and initiate Avamina SR 500 mg at the dose specified above.

If a patient has impaired kidney function, the doctor may prescribe a lower dose.

Switching antidiabetic treatment to Avamina SR is not recommended in patients treated with more than 2000 mg of metformin daily in immediate-release tablets.

If a patient is also using insulin, the doctor will advise on how to start treatment with Avamina SR.

Monotherapy (prediabetes state)
The usual dose is 1000 to 1500 mg of metformin hydrochloride once daily during the evening meal. The doctor will assess whether treatment should be continued based on regular monitoring of blood glucose levels and risk factors.

Polycystic ovary syndrome
The usual dose is 1500 mg of metformin hydrochloride once daily during the evening meal.

Monitoring of treatment

• The doctor will order regular blood glucose tests and adjust the dose of Avamina SR according to blood glucose levels. Regular follow-up visits to the doctor are essential, particularly in elderly patients.
• The doctor will check kidney function at least once a year. More frequent monitoring may be necessary in elderly patients or in patients with impaired kidney function.

How to use Avamina SR
Avamina SR should be taken 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 the patient feels that the medicine's effect is too strong or too weak, they should consult their doctor or pharmacist.

Use of a higher than recommended dose of Avamina SR
If a higher than recommended dose of Avamina SR is taken, lactic acidosis may occur. Symptoms of lactic acidosis are nonspecific and include vomiting, abdominal pain (abdominal discomfort) with muscle cramps, general malaise accompanied by severe fatigue and difficulty breathing. Other symptoms include lowered body temperature and slowed heart rate. If any of these symptoms occur, the patient should immediately seek medical help, as lactic acidosis may lead to coma. Avamina SR should be stopped immediately and the patient should contact their doctor or go to the nearest hospital.

Missed dose of Avamina 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 doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

Very common adverse reactions (may affect more than 1 in 10 people):

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

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

• 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 adverse reactions (may affect less than 1 in 10,000 people):

• Lactic acidosis. This is a very rare but serious complication, particularly when kidneys are not functioning properly. Symptoms of lactic acidosis – see section "Warnings and precautions".
• Abnormal liver function test results or symptoms of hepatitis (associated with fatigue, loss of appetite, weight loss, and yellowing of the skin and whites of the eyes). If such symptoms occur, Avamina SR must be stopped immediately and the doctor informed.
• Skin reactions such as skin redness (erythema), itchy rash (urticaria).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 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 this medicine.

5. How to store Avamina SR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after:
"EXP". The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must 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 Avamina SR contains

• The active substance is metformin (in the form of hydrochloride). Each prolonged-release tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
• The other ingredients are: sodium carmellose, hypromellose, colloidal anhydrous silica, magnesium stearate.

What Avamina SR looks like and contents of the pack
Avamina SR, 500 mg, prolonged-release tablets are white, round, flat tablets with a diameter of 12 mm, marked with "XR" on one side and unmarked on the other side.
Avamina SR is available in packs containing 30, 60, 90 or 120 prolonged-release tablets in blisters made of PVC/PVDC/Aluminium, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
BIOTON S.A.
02-516 Warsaw
ul. Starościńska 5
tel. 22 721 40 00