Avamina Sr

Leaflet accompanying the packaging: patient information

Avamina SR, 500 mg, prolonged-release tablets

Metformin hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of 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 packaging and other information

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

Avamina SR contains metformin, a medicine used to treat diabetes. It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that allows the body to take glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for later use.
In diabetic patients, the pancreas does not produce enough insulin or the body is unable to use the insulin produced properly. This leads to an excessive increase in blood glucose levels. Avamina SR helps reduce blood glucose levels to as close to normal as possible.
In adults with overweight, long-term use of Avamina SR also reduces the risk of diabetes-related complications. Taking Avamina SR is associated with maintaining or moderately reducing body weight.
Avamina SR is used to treat patients with type 2 diabetes (also known as "non-insulin-dependent"). It is particularly used in patients with overweight.
Adults can take Avamina SR as the only medicine or in combination with other anti-diabetic medicines (oral or insulin).
In the prevention of type 2 diabetes in patients with a pre-diabetic condition.
In polycystic ovary syndrome.

2. Important information before taking Avamina SR

When not to take 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 dysfunction,
• if the patient has significantly reduced kidney function,
• if the patient has uncontrolled diabetes, such as severe hyperglycemia (high blood sugar), 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 coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual fruity breath odor,
• in case of excessive fluid loss from the body (dehydration), e.g. due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney dysfunction, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of severe infection, e.g. pneumonia, bronchitis or kidney infection. Severe infections can lead to kidney dysfunction, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of acute heart failure or recent myocardial infarction, severe circulatory disorders (e.g. shock) or breathing difficulties. This can cause tissue hypoxia, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• if the patient abuses alcohol,
• if the patient is under 18 years old.

If any of the above situations occur, the patient should consult their doctor before taking this medicine.
It is essential to consult a doctor if it is necessary to:

• perform a radiological examination or an examination that requires the injection of a contrast agent containing iodine into the blood,
• perform a major surgical procedure.

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

Warnings and precautions

Risk of lactic acidosis

Avamina SR may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney dysfunction. The risk of lactic acidosis increases in case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more information below), liver dysfunction, 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 the patient, they should consult their doctor for more detailed instructions.

The patient should temporarily stop taking Avamina SR if they have a condition that may be associated with dehydration

(significant fluid loss), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult their doctor for more detailed instructions.

The patient should stop taking Avamina SR and contact their doctor or the nearest hospital immediately if they 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, accompanied by extreme fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.
The patient should contact their doctor immediately for further instructions if:

• they 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.
• they 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 the patient is to undergo a major surgical procedure, they must not take Avamina SR during the procedure and for a period after it. The doctor will decide when the patient must stop and resume treatment with Avamina SR.
Avamina SR does not cause hypoglycemia (low blood sugar).
However, if Avamina SR is taken in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides), there is a risk of hypoglycemia. If symptoms of hypoglycemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, eating or drinking a sugary 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 impaired kidney function.
The patient should follow the dietary recommendations given by their doctor.
It may happen that the tablet coating is visible in the stool. The patient should not be concerned, as this is normal when taking this type of tablet.

Avamina SR and other medicines

If the patient is to be injected with a contrast agent containing iodine into the bloodstream, e.g. for an X-ray examination or computed tomography, they must stop taking Avamina SR before or at the latest at the time of the injection. The doctor will decide when the patient must stop and resume treatment with Avamina SR.
The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may require more frequent monitoring of blood glucose levels and kidney function or modification of the Avamina SR dose by the doctor. It is particularly important to inform the doctor about the following medicines:

• diuretics,
• 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 to treat asthma),
• corticosteroids (used to treat various diseases, such as severe skin inflammation or asthma),
• medicines that may change the level of Avamina SR in the blood, especially if the patient has impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other medicines used to treat diabetes.

Avamina SR and alcohol

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

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor, as changes in treatment or blood glucose monitoring may be necessary.
This medicine is not recommended for breastfeeding women or those planning to breastfeed.

Driving and using machines

Avamina SR does not cause hypoglycemia (low blood sugar). This means it has no effect on the patient's ability to drive or use machines.
However, the patient should be particularly careful if they are taking Avamina SR in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heartbeat, vision 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, which means it is considered "sodium-free".

3. How to take Avamina SR

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Avamina SR does not replace the benefits of a healthy lifestyle. The patient should continue to follow all the doctor's recommendations regarding diet and regular physical activity.

Recommended dose

Children: due to the lack of appropriate safety data, Avamina SR should not be used in children.
Adults: treatment usually starts with 1 tablet of Avamina SR 500 mg, taken once a day during the evening meal. After 10-15 days, the dose is adjusted by the doctor based on blood glucose measurements. Gradual dose increase may improve gastrointestinal tolerance.
The doctor may increase the dose to a maximum of 4 tablets per day (2000 mg), taken once a day during the evening meal.
In patients already treated with metformin, the initial dose of Avamina SR 500 mg should be equivalent to the daily dose of metformin in the form of immediate-release tablets.
In the case of switching from another oral anti-diabetic medicine to Avamina SR 500 mg, the doctor should discontinue the previously used medicine and use Avamina SR 500 mg in the dose specified above.
If the patient has impaired kidney function, the doctor may prescribe a lower dose.
In patients treated with metformin at a dose above 2000 mg per day in the form of immediate-release tablets, it is not recommended to switch to Avamina SR.
If the patient is also taking insulin, the doctor will inform them how to start taking Avamina SR.
In monotherapy (pre-diabetic condition)
Usually, a dose of 1000 to 1500 mg of metformin hydrochloride is used once a day during the evening meal. The doctor will assess whether treatment should be continued based on regular blood glucose testing and risk factors.
Polycystic ovary syndrome
Usually, a dose of 1500 mg of metformin hydrochloride is used once a day during the evening meal.

Treatment monitoring

• The doctor will order regular blood glucose tests and adjust the Avamina SR dose based on blood glucose levels. The patient should regularly visit their doctor for check-ups. This is especially important for elderly patients.
• The doctor will check the patient's kidney function at least once a year. More frequent checks may be necessary for elderly patients or if the patient's kidneys are not functioning properly.

How to take Avamina SR

Avamina SR should be taken with a meal or immediately after a meal. This will help avoid gastrointestinal side effects.
The patient should not crush or chew the tablets. They should swallow the tablet with a glass of water.
If the patient feels that the effect of the medicine is too strong or too weak after some time, they should consult their doctor or pharmacist.

Taking a higher dose of Avamina SR than recommended

In case of taking a higher dose of Avamina SR than recommended, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal cramps), general feeling of being unwell, accompanied by extreme fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate. If any of these symptoms occur, the patient should immediately seek medical attention, as lactic acidosis can lead to coma. The patient should stop taking Avamina SR and contact their doctor or the nearest hospital immediately.

Missing a dose of Avamina SR

The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Avamina SR can cause side effects, although not everybody gets them.
The side effects that may occur are listed below.
Avamina SR may very rarely cause (may occur in up to 1 in 10,000 patients) a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should stop taking Avamina SR and contact their doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.
Very common side effects (may occur in more than 1 in 10 people):

• Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain (abdominal cramps), loss of appetite. These side effects usually occur at the beginning of treatment with Avamina SR and in most cases disappear on their own. Taking Avamina SR with a meal or immediately after a meal may help. If the symptoms do not disappear, the patient should stop taking Avamina SR and tell their doctor.

Common side effects (may occur in less than 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 pale or yellowish skin). The doctor may order some 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 side effects (may occur in less than 1 in 10,000 people)

:

• Lactic acidosis. This is a very rare but serious complication, especially if the kidneys are not functioning properly. Symptoms of lactic acidosis - see "Warnings and precautions".
• Abnormal liver function test results or symptoms of liver inflammation (accompanied by fatigue, loss of appetite, weight loss, and yellowing of the skin and whites of the eyes). If such symptoms occur, the patient should stop taking Avamina SR and tell their doctor immediately.
• Skin reactions, such as skin redness (rash), itching, or urticaria (hives).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. 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:
Aleje Jerozolimskie 181C,
02-222 Warsaw,
phone: 22 49-21-301,
fax: 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 gather more information on the safety of the medicine.

5. How to store Avamina SR

The medicine should be stored 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 month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Avamina SR contains

• The active substance of Avamina SR is metformin (in the form of hydrochloride). Each prolonged-release tablet contains 500 mg of metformin hydrochloride, which corresponds to 390 mg of metformin.
• The other ingredients are: sodium carmellose, hypromellose, anhydrous colloidal 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.
Avamina SR is available in packs containing 30, 60, 90, or 120 prolonged-release tablets in PVC/PVDC/Aluminum blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

BIOTON S.A.
02-516 Warsaw
Starościńska 5 Street
phone: 22 721 40 00
Date of last revision of the leaflet:March 2025