Avamina Sr

Package Leaflet: Information for the Patient

Avamina SR, 1000 mg, prolonged-release tablets

Metformin hydrochloride

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

• Keep this package 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

• 1. What is Avamina SR and what is it 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 is Avamina SR and what is it 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 use glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for future use.
In diabetic patients, the pancreas does not produce enough insulin or the body is unable to use the insulin produced. This leads to an excessive increase in blood glucose levels. Avamina SR helps to 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 complications. Taking Avamina SR is associated with either weight loss or no change in body weight.
Avamina SR is used to treat patients with type 2 diabetes (also called non-insulin-dependent diabetes). It is particularly used in patients with overweight.
Adults can take Avamina SR either alone or in combination with other anti-diabetic medicines (oral or insulin).
In the prevention of type 2 diabetes in patients with pre-diabetic conditions.
In polycystic ovary syndrome.

2. Important information before taking Avamina SR

When not to take Avamina SR

• if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6),
• in case of liver disease,
• if you have significantly reduced kidney function,
• if you have uncontrolled diabetes, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, 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 can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual fruity breath odor,
• in case of excessive loss of body water (dehydration), for example, due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney problems, which can increase the risk of lactic acidosis (see "Warnings and precautions" below),
• in case of severe infection, for example, pneumonia, bronchitis, or kidney infection. Severe infections can lead to kidney problems, 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 you abuse alcohol,
• if you are under 18 years old.

If any of the above conditions apply to you, consult your doctor before taking this medicine.
It is essential to consult your 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 major surgery.

Avamina SR must be discontinued for a period before and after the examination or surgery. Your doctor will decide whether other treatment is necessary during this time. It is crucial to follow your doctor's instructions.

Warnings and precautions

Risk of lactic acidosis

Avamina SR may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis increases in case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more information below), liver disease, and any conditions in which a part of the body is not adequately supplied with oxygen (e.g., acute severe heart disease).
If any of the above conditions apply to you, consult your doctor for more detailed instructions.

You must temporarily stop taking Avamina SR if you have a condition that may lead to dehydration

(significant loss of body water), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink less fluid than usual. Consult your doctor for more detailed instructions.

You must stop taking Avamina 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, 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.
Consult your doctor immediately if:

• you have a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.
• you experience any of the following symptoms after starting metformin: seizures, impaired cognitive function, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, or hearing loss.

If you are going to have major surgery, you should not take Avamina SR during the surgery and for some time after it. Your doctor will decide when you should stop and restart taking Avamina SR.
Avamina SR does not cause hypoglycemia (low blood sugar).
However, if Avamina SR is taken with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia. If you experience symptoms of hypoglycemia, 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, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have impaired kidney function.
Follow your doctor's dietary recommendations.
It is not uncommon for the tablet coating to be visible in the stool. Do not be concerned, as this is normal when taking this type of tablet.

Avamina SR and other medicines

If you are going to have a contrast agent containing iodine injected into your blood, for example, for an X-ray examination or computed tomography, you must stop taking Avamina SR before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart taking Avamina 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 and kidney function tests or a dose adjustment of Avamina SR by your doctor. It is especially important to inform your 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 levels of Avamina SR in the blood, especially if you have kidney problems (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
• other medicines used to treat 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 "Warnings and precautions").

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor, as your treatment or blood glucose monitoring may need to be adjusted.
This medicine is not recommended for breastfeeding women or women planning to breastfeed.

Driving and using machines

Avamina SR does not cause hypoglycemia (low blood sugar). This means it does not affect your ability to drive or use machines.
However, be cautious if you are taking Avamina 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 operate machinery.

Avamina SR contains sodium

Avamina SR contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Avamina SR

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Avamina SR does not replace the benefits of a healthy lifestyle. Continue to follow your doctor's recommendations regarding diet and regular physical activity.

Recommended dose

Children: due to the lack of data on the safety of Avamina SR in children, it should not be used in children.
Adults: treatment usually starts with one 500 mg Avamina SR tablet once daily during the evening meal. After 10-15 days, the dose is adjusted by the doctor based on blood glucose measurements. After the dose is established, the doctor may consider switching to Avamina SR 1000 mg.
The maximum dose of Avamina SR is 2000 mg and is taken once daily during the evening meal.
In patients already treated with metformin, the initial dose of Avamina SR 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 1000 mg, the doctor should discontinue the previously used medicine and use Avamina SR 1000 mg in the dose specified above.
If you have impaired kidney function, your doctor may prescribe a lower dose.
In patients treated with metformin in a dose above 2000 mg per day in the form of immediate-release tablets, it is not recommended to switch to Avamina SR.
If you are also taking insulin, your doctor will inform you how to start taking Avamina SR.
In monotherapy (pre-diabetic state)
Usually, a dose of 1000 to 1500 mg of metformin hydrochloride is used once daily during the evening meal. The doctor will assess whether treatment should be continued based on regular blood glucose tests and risk factors.
Polycystic ovary syndrome
Usually, a dose of 1500 mg of metformin hydrochloride is used once daily during the evening meal.

Treatment monitoring

• Your doctor will order regular blood glucose tests and adjust the dose of Avamina SR based on the glucose levels. You should regularly visit your doctor for check-ups. This is especially important for elderly patients.
• Your doctor will check your kidney function at least once a year. More frequent checks may be necessary for elderly patients or if your kidneys are not working 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.
Do not crush or chew the tablets. Swallow the tablet with a glass of water.
If you feel that the effect of Avamina SR is too strong or too weak, consult your doctor or pharmacist.

Overdose of Avamina SR

In case of overdose of Avamina SR, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal cramps), muscle cramps, general feeling of being unwell, accompanied by extreme fatigue, and breathing difficulties, decreased body temperature, and slowed heart rate. If you experience any of these symptoms, you should immediately seek medical attention, as lactic acidosis can lead to coma. You should stop taking Avamina SR and contact your doctor or 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 questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Avamina SR can cause side effects, although not everybody gets them.
The following side effects may occur with Avamina SR:
Avamina 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, stop taking Avamina SR and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Very common side effects (may affect more than 1 in 10 people):

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

Common side effects (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 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 affect up to 1 in 10,000 people)

:

• Lactic acidosis - this is a very rare but serious complication, especially if the kidneys are not working properly. Symptoms of lactic acidosis - see "Warnings and precautions".
• Abnormal liver function test results and 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, you should stop taking Avamina SR and tell your doctor immediately.
• Skin reactions, such as skin redness, itching, or itchy rash.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. You can also report side effects 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
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Avamina SR

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

• The active substance is metformin (in the form of hydrochloride). Each prolonged-release tablet contains 1000 mg of metformin hydrochloride, which corresponds to 780 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, 1000 mg, prolonged-release tablets are white, slightly convex tablets with dimensions of 22.25 mm x 9 mm, with the inscription "SR2" on one side and no inscription on the other side.
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