Avamina

Package Leaflet: Information for the Patient

AVAMINA, 500 mg, film-coated tablets

AVAMINA, 850 mg, film-coated tablets

AVAMINA, 1000 mg, film-coated tablets

Metformin hydrochloride

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

• 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 experience any side effects, including those not listed in this package leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What Avamina is and what it is used for

Avamina contains metformin, a substance 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 up 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. This leads to an excessive increase in blood glucose levels. Avamina helps to reduce blood glucose levels to near-normal values.
In adults with overweight, long-term use of Avamina also reduces the risk of complications associated with diabetes. Taking Avamina is associated with either weight loss or no change in body weight.
Avamina is used to treat patients with type 2 diabetes mellitus (also called non-insulin-dependent diabetes), in whom diet and exercise alone do not provide adequate control of blood glucose levels. It is particularly used in patients with overweight.
Adults can take Avamina either alone or in combination with other anti-diabetic medicines (oral or insulin).
Children from 10 years of age and adolescents can take Avamina either alone or in combination with insulin.

2. Important information before taking Avamina

When not to take Avamina

• if you are allergic (hypersensitive) to metformin or any of the other ingredients of Avamina (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, which can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or a fruity odor from the mouth.
• in case of excessive water loss from the body (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).
• in case of alcohol abuse.

If any of the above situations occur, you should 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 bloodstream,
• perform major surgery.

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

Warnings and precautions

Risk of lactic acidosis

Avamina 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 circumstances apply to you, you should consult your doctor for more detailed instructions.

Temporarily discontinue taking Avamina if you have

a condition that may lead to dehydration(significant water loss from the body),
such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if you drink
less fluid than usual. You should consult your doctor for more detailed instructions.

Discontinue taking Avamina and contact your doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis

as it can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

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

• you 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.
• you 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 you are to undergo major surgery, you should not take Avamina during and for some time after the surgery. Your doctor will decide when you should stop and restart taking Avamina.
Avamina does not cause hypoglycemia (low blood sugar). However, if Avamina is taken with other anti-diabetic medicines that can cause hypoglycemia, such as sulfonylureas, insulin, and 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.

Avamina with other medicines

If you are to be injected with a contrast agent containing iodine into the bloodstream, for example, for an X-ray examination or computed tomography, you must discontinue taking Avamina before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart taking Avamina.
Tell your doctor about all 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 by your doctor. It is particularly 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 and terbutaline, used to treat asthma,
• corticosteroids used to treat many diseases, such as severe skin inflammation or asthma,
• medicines that may change the level of Avamina 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 with alcohol

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

Pregnancy and breastfeeding

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

Driving and using machines

Avamina does not cause hypoglycemia (low blood sugar). This means it does not affect your ability to drive or use machines.
However, you should be cautious if you take Avamina with other anti-diabetic medicines that can cause hypoglycemia, such as sulfonylureas, insulin, and 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.

3. How to take Avamina

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Avamina 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 from 10 years of age and adolescents usually start treatment with a dose of 500 mg or 850 mg of Avamina once a day. The maximum daily dose is 2000 mg and is taken in 2 or 3 divided doses. Treatment of children from 10 to 12 years of age is only used in exceptional cases, as experience with Avamina in this age group is limited.
Adults usually start treatment with a dose of 500 mg or 850 mg of Avamina 2 or 3 times a day.
The maximum daily dose is 3000 mg taken in 3 divided doses.
Patient with kidney problems
If you have kidney problems, your doctor may prescribe a lower dose.
If you are also taking insulin, your doctor will inform you how to start taking Avamina.

Monitoring of treatment

• Your doctor will prescribe regular blood glucose tests and adjust the dose of Avamina according to your blood glucose levels. You should regularly visit your doctor for check-ups. This is especially important for children and adolescents and for people over 65 years of age.
• your doctor will check your kidney function at least once a year. More frequent checks may be necessary for people over 65 years of age or if your kidneys are not working properly.

How to take Avamina

Avamina should be taken with a meal or just after a meal. This will help avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablets with a glass of water.

• If you take one dose a day, you should take it in the morning (with breakfast).
• if you take two doses a day, you should take them in the morning (with breakfast) and in the evening (with dinner).
• if you take three doses a day, you should take them in the morning (with breakfast), at noon (with lunch), and in the evening (with dinner).

If, after some time, you feel that the effect of Avamina is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of Avamina than recommended

If you take a higher dose of Avamina than recommended, you may experience lactic acidosis. Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain with muscle cramps, general feeling of being unwell with severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate.

If you experience any of these symptoms, you should seek medical help immediately, as lactic acidosis can lead to coma. You should stop taking Avamina and contact your doctor or go to the nearest hospital.

(see "Warnings and precautions").

Missing a dose of Avamina

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Avamina can cause side effects, although not everybody gets them. The following side effects may occur:

Avamina 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, you must stop takingAvamina and contactyour doctor or the nearest hospitalimmediately, as lactic acidosis can lead to coma.

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

• gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain (abdominal pain), and loss of appetite. These side effects usually occur at the beginning of treatment with Avamina. It may be helpful to divide the daily dose into several smaller doses taken throughout the day and to take Avamina with a meal or just after a meal. If the symptoms do not disappear, you should stop taking Avamina 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, or numbness). Your doctor may prescribe some tests to find the cause of the symptoms, as some of them may also be caused by diabetes or other health problems unrelated to diabetes.

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

• Lactic acidosis. This is a very rare but serious complication, especially when the kidneys are not working properly. Symptoms of lactic acidosis are non-specific (see "Warnings and precautions").
• abnormal liver function test results or symptoms of liver inflammation (with fatigue, loss of appetite, and weight loss, as well as with or without yellowing of the skin and whites of the eyes). If such symptoms occur, you should stop taking Avamina and tell your doctor.
• skin reactions, such as redness, itching, or itchy rash (hives).

Children and adolescents

Limited data from studies in children and adolescents indicate that the side effects are similar in nature and severity to those observed in adults.
Reporting of side effects
If you experience any side effects, including those not listed in this package leaflet, please tell your doctor or pharmacist. 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
Al. Jerozolimskie 181C, 02-222 Warsaw;
Phone: +48 22 49 21 301;
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported 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

Keep this medicine out of the sight and reach of children. If Avamina is used in a child, it is recommended that the treatment be supervised by parents or caregivers.
There are no special precautions for storage.
Do not use Avamina after the expiry date stated on the carton or blister after the expiry date (EXP). The expiry date refers to the last day of that month.
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. Other information

What Avamina contains

The active substance of Avamina is metformin in the form of metformin hydrochloride (Metformini hydrochloridum).
Avamina, 500 mg: One film-coated tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
Avamina, 850 mg: One film-coated tablet contains 850 mg of metformin hydrochloride, equivalent to 663 mg of metformin.
Avamina, 1000 mg: One film-coated tablet contains 1000 mg of metformin hydrochloride, equivalent to 780 mg of metformin.
Other ingredients of the medicine are:
Core: povidone K-90, magnesium stearate
Coating: hypromellose 5cP, macrogol 400, and macrogol 6000.

What Avamina looks like and contents of the pack

Film-coated tablet.
Avamina, 500 mg
Film-coated tablets are white, round, biconvex, with the letter "A" engraved on one side and the numbers "60" on the other.
Avamina, 850 mg
Film-coated tablets are white, round, biconvex, with the letter "A" engraved on one side and the numbers "61" on the other.
Avamina, 1000 mg
Film-coated tablets are white, capsule-shaped, biconvex, with a score line on one side and the letter "A" and the numbers "90" on the other side, separated by a score line.
The tablet can be divided into two equal doses.
Avamina is available in blister packs.
Each box contains 30, 60, 90, 120 film-coated tablets in blister packs, each containing 10 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

BIOTON S.A.
ul. Starościńska 5
02-516 Warsaw

Date of last revision of the package leaflet: March 2025