Avamina

Leaflet attached to the packaging: patient information

AVAMINA, 500 mg, film-coated tablets

AVAMINA, 850 mg, film-coated tablets

AVAMINA, 1000 mg, film-coated tablets

Metformin hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to. 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 leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Avamina and what is it 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 is Avamina and what is it 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 future use.
In diabetic patients, the pancreas does not produce enough insulin or the body is not able to use the produced insulin properly. This leads to an excessive increase in blood glucose levels. Avamina helps reduce blood glucose levels to the most 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 maintaining body weight or its moderate reduction.
Avamina is used to treat patients with type 2 diabetes (also called non-insulin-dependent diabetes), in whom diet and physical exercise alone cannot achieve sufficient blood glucose control. It is used especially in patients with overweight.
Adults can take Avamina alone or in combination with other anti-diabetic medicines (oral medicines or insulin).
Children from 10 years of age and adolescents can take Avamina alone or in combination with insulin.

2. Important information before taking Avamina

When not to take Avamina

• if the patient has been diagnosed with hypersensitivity (allergy) to metformin or any of the other ingredients of Avamina (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 ketonuria. Ketonuria is a condition in which substances called ketone bodies accumulate in the blood, which can lead to diabetic precoma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odor from the mouth.
• in case of excessive water loss from the body (dehydration), such as prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney dysfunction, which can threaten the occurrence of lactic acidosis (see "Warnings and precautions" below).
• in case of severe infection, such as pneumonia, bronchitis or kidney infection. Severe infections can lead to kidney dysfunction, which can threaten the occurrence of lactic acidosis (see "Warnings and precautions" below).
• in case of treatment of acute heart failure or recent myocardial infarction, severe circulatory disorders (e.g. shock) or breathing difficulties. This may cause tissue hypoxia, which can threaten the occurrence 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 necessary to consult a doctor if it is necessary to:

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

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

Warnings and precautions

Risk of lactic acidosis

Avamina 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 detailed 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.

Temporarily discontinue taking Avamina if the patient has

a condition that may be associated with dehydration(significant water loss from the body),
such as severe vomiting, diarrhea, fever, exposure to high temperature, or if the patient drinks
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 the patient experiences any symptoms of

lactic acidosis, as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general poor condition 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:

• the patient has 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.
• the patient has experienced any of the following symptoms after starting metformin: seizures, cognitive impairment, difficulty moving, signs of 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 during the procedure and for a period after it. The doctor will decide when the patient must discontinue and resume Avamina treatment.
Avamina does not cause hypoglycemia (low blood sugar). However, if Avamina is taken in combination with other anti-diabetic medicines that can cause hypoglycemia, such as sulfonylureas, insulin, and 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.

Avamina with other medicines

If the patient is to be injected with a contrast agent containing iodine into the bloodstream, for example, for an X-ray examination or computed tomography, they must discontinue taking Avamina before or at the latest at the time of such injection. The doctor will decide when the patient must discontinue and resume Avamina treatment.
You should tell your doctor about all medicines you are currently 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 especially important to inform 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 the patient has kidney dysfunction (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 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 plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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 that it does not affect the patient's ability to drive or use machines.
However, you should be careful if you are taking 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 such symptoms occur, you should not drive or operate machinery.

3. How to take Avamina

This medicine should always be taken 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 used only in case of special recommendation by the doctor, 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 dysfunction
If the patient has kidney dysfunction, the doctor may prescribe a lower dose.
If the patient is also taking insulin, the doctor will inform how to start taking Avamina.

Treatment monitoring

• Your doctor will prescribe regular blood glucose tests and adjust the dose of Avamina based on blood glucose levels. You should regularly visit your doctor for check-ups. This is especially important in the case of children and adolescents, as well as the elderly.
• the doctor will check the patient's kidney function at least once a year. More frequent checks may be necessary in the elderly or if the patient's kidneys are not functioning properly.

How to take Avamina

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

• If one dose is taken per day, it should be taken in the morning (with breakfast).
• if two doses of the medicine are taken per day, they should be taken in the morning (with breakfast) and in the evening (with dinner).
• if three doses are taken per day, they should be taken in the morning (with breakfast), at noon (with lunch), and in the evening (with dinner).

If after some time the patient feels that the effect of Avamina is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Avamina than recommended

In case of taking a higher dose of Avamina than recommended, lactic acidosis may occur. Symptoms of lactic acidosis are non-specific and include: vomiting, abdominal pain with muscle cramps, general poor condition with severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate.

If any of these symptoms occur, the patient should seek medical help immediately, as lactic acidosis can lead to coma. Avamina should be discontinued and the doctor or the nearest hospital should be contacted immediately.

(see "Warnings and precautions").

Missing a dose of Avamina

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 about taking Avamina, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Avamina can cause side effects, although not everybody gets them. The side effects that may occur are presented below.
Avamina 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 in a patient, they should stop takingAvamina and contact their doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Very common side effects (occurring in more than 1 in 10 patients)

• gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain (abdominal pain) and loss of appetite. These side effects most often occur at the beginning of Avamina treatment. It may be helpful to divide the daily dose into several smaller doses taken throughout the day and take Avamina with a meal or immediately after a meal. If the symptoms do not disappear, Avamina should be discontinued and the doctor should be informed.

Common side effects (may occur in less than 1 in 10 patients)

• 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). The doctor may prescribe several 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 (occurring in less than 1 in 10,000 patients)

• 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 accompanying 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, Avamina should be discontinued and the doctor should be informed.
• skin reactions, such as skin redness, itching, or itchy rash.

Children and adolescents

Limited data from studies in children and adolescents indicate that the side effects occurring in this population have a similar nature and severity as the side effects observed in adults.
Reporting side effects
If you experience any side effects, including those not listed in this 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

The medicine should be stored out of 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.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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.
Avamina, 500 mg: One film-coated tablet contains 500 mg of metformin hydrochloride, which corresponds to 390 mg of metformin.
Avamina, 850 mg: One film-coated tablet contains 850 mg of metformin hydrochloride, which corresponds to 663 mg of metformin.
Avamina, 1000 mg: One film-coated tablet contains 1000 mg of metformin hydrochloride, which corresponds 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 what the pack contains

Film-coated tablet.
Avamina, 500 mg
Film-coated tablets are white, round, biconvex, with the letter "A" engraved on one side and the number "60" on the other.
Avamina, 850 mg
Film-coated tablets are white, round, biconvex, with the letter "A" engraved on one side and the number "61" on the other.
Avamina, 1000 mg
Film-coated tablets are white, capsule-shaped, biconvex, with a dividing line on one side and the letter "A" and the number "90" engraved on the other side, separated by a dividing 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, 10 film-coated tablets per pack.
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 leaflet: March 2025