Avamina sr

Package leaflet: information for the patient

Avamina SR, 1000 mg, prolonged-release tablets
Metformini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform 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 package 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 known as biguanides.
Insulin is a hormone produced by the pancreas that 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 as possible to normal.
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 modest 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 sole 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 may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or an unusual fruity odour of the breath,
• in case of excessive loss of body fluids (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 breathing difficulties. 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 conditions apply, the patient should consult a doctor before taking this medicine.
It is essential to consult a doctor if:

• a radiological examination or a procedure requiring intravenous administration of an iodine-containing contrast agent is required,
• a major surgical procedure is planned.

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 involving inadequate tissue oxygenation (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 Avamina SR if the patient develops any illness that may lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.

Stop taking Avamina SR immediately and contact a doctor or the nearest hospital immediately if any symptoms of lactic acidosis occur, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise associated with 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 mitochondrial disorder (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD),
• after starting metformin, the patient develops any of the following symptoms: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.

If the patient is scheduled for a major surgical procedure, Avamina SR must not be taken during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart 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 sulfonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, blurred vision 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 worsening kidney function.

Follow the dietary recommendations provided 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 or CT scan, 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 restart treatment with Avamina SR.

Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take. The patient may require more frequent monitoring of blood glucose levels and kidney function, or dose adjustments of Avamina SR by the doctor. 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 Avamina SR blood levels, 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
Avoid excessive alcohol consumption 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 regarding any necessary changes in treatment or monitoring of blood glucose levels.
This medicine is not recommended for patients who are breastfeeding or planning to breastfeed.

Driving and operating machinery
Avamina SR does not cause hypoglycaemia (low blood glucose levels). This means it does not affect the patient's ability to drive or operate machinery.
However, extra caution is required if Avamina SR is used together with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include: weakness, dizziness, increased sweating, rapid heartbeat, blurred vision 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, meaning the medicine is considered "sodium-free".

3. How to use Avamina SR

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Avamina SR does not replace the benefits derived from a healthy lifestyle. You should
continue to follow all dietary and regular physical activity recommendations provided by your doctor.
Recommended dose
Children: Due to lack of adequate safety data, Avamina SR should not be used in children.
Adults: Treatment is usually initiated 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 physician based on blood
glucose measurements. After dose stabilization, the physician may consider switching to Avamina SR 1000 mg.
The maximum dose of Avamina SR is 2000 mg, taken once daily with the evening meal.
For patients already treated with metformin, the starting dose of Avamina SR should be
equivalent to the daily dose of metformin in immediate-release tablets.
When switching from another oral antidiabetic medicine to Avamina SR 1000 mg, the physician
should discontinue the previously used medicine and initiate Avamina SR 1000 mg at the dose
specified above.
If the patient has impaired kidney function, the physician may prescribe a lower dose.
Switching antidiabetic treatment to Avamina SR is not recommended for patients treated with
metformin at doses exceeding 2000 mg per day in the form of immediate-release tablets.
If the patient is also using insulin, the physician will advise on how to initiate treatment with
Avamina SR.
Monotherapy (prediabetic state)
The usual dose is 1000 to 1500 mg of metformin hydrochloride once daily with the evening meal.
The physician will evaluate whether treatment should be continued based on regular blood glucose
monitoring and risk factors.
Polycystic ovary syndrome
The usual dose is 1500 mg of metformin hydrochloride once daily with the evening meal.
Monitoring of treatment

• The physician will order regular blood glucose tests and adjust the dose of Avamina SR according to blood glucose levels. Regular follow-up visits to the physician are necessary. This is particularly important for elderly patients.
• The physician will check kidney function at least once a year. More frequent monitoring may be required for elderly patients or if the patient's kidneys are not functioning properly.

How to use Avamina SR
Avamina SR should be taken during or immediately after a meal. This helps avoid
gastrointestinal adverse 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 dose of Avamina SR than recommended is taken, lactic acidosis may occur.
Symptoms of lactic acidosis are nonspecific and include vomiting, abdominal pain (abdominal
cavity pain) with muscle cramps, general malaise accompanied by severe fatigue and difficulty
breathing, lowered body temperature, and slowed heart rate. If any of these symptoms occur, the
patient should seek immediate medical help, as lactic acidosis may lead to coma. Avamina SR
should be discontinued 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 questions about 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 experiences them.
The possible adverse reactions are listed below.
Avamina SR may very rarely (may occur in up to 1 in 10,000 patients) cause 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 diarrhoea, nausea, vomiting, abdominal pain (pain in the abdominal cavity), loss of appetite. These adverse reactions most commonly occur at the beginning of treatment with Avamina SR and in most cases resolve spontaneously. It may be helpful to take Avamina SR with food or immediately after a meal. If symptoms do not resolve, Avamina SR should be discontinued and the doctor informed.

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

• Taste disturbances.
• Decreased 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 and 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 discontinued immediately and the doctor informed.
• Skin reactions such as skin redness (erythema), itching, or itchy rash (urticaria).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 stated on the carton after:
"EXP". The expiry date refers to the last day of the specified 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. Such measures 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, equivalent to 780 mg of metformin.
• The other ingredients are: croscarmellose sodium, 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 of size 22.25 mm x 9 mm, marked with "SR2" 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
Starościńska Street 5
tel. 22 721 40 00