Metformin Galena

Package Leaflet: Information for the Patient

METFORMIN GALENA

850 mg, tablets
Metformin hydrochloride

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

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Metformin Galena and what is it used for

Metformin Galena contains the active substance metformin hydrochloride, which belongs to a group of antidiabetic medicines called biguanides.
Indications for use
Treatment of type 2 diabetes (non-insulin-dependent), especially in overweight patients, when diet and exercise alone have not been able to control blood sugar levels.
Metformin Galena can be used alone or in combination with other oral antidiabetic medicines or insulin.

2. Important information before taking Metformin Galena

When not to take Metformin Galena

• -if the patient is allergic to metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• -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 pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odor from the mouth.
• -in pre-coma state in diabetes;
• -in case of dehydration (e.g. due to chronic or severe, recurring diarrhea, recurring vomiting);
• -with liver function disorders;
• -during severe infection (e.g. respiratory, urinary tract);
• -in case of necessity to perform a radiological examination with intravascular administration of a contrast agent containing iodine;
• -if the patient has heart disease, circulatory or respiratory problems;
• -after a recent myocardial infarction;
• -in case of shock;
• -in case of alcohol abuse or acute alcohol poisoning;
• -during pregnancy or breastfeeding.

Warnings and precautions

Before starting to take Metformin Galena, the patient should discuss it with their doctor or pharmacist.

Risk of lactic acidosis

Metformin Galena may cause a very rare but very serious side effect called lactic acidosis, especially if the patient has 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 function disorders, 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 Metformin Galena if they have

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 fluids than usual. The patient should consult their doctor for more detailed instructions.

The patient should stop taking Metformin Galena and immediately contact their doctor or the nearest hospital 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 along with severe fatigue,
• breathing difficulties,
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment.
Special caution should be exercised in situations where kidney function may be impaired, e.g. at the beginning of treatment with blood pressure-lowering drugs, diuretics, and non-steroidal anti-inflammatory drugs.
During treatment with Metformin Galena, the patient should continue to follow the dietary recommendations given by their doctor. During treatment, the patient should have regular blood tests to assess changes in blood sugar levels.
In case of any infectious diseases, e.g. flu, respiratory or urinary tract infections, the patient should inform their doctor.
If the patient needs to undergo a radiological examination with intravascular administration of a contrast agent containing iodine, they must inform their doctor about taking Metformin Galena, as the medicine should be discontinued before the examination or during the examination. The doctor will decide when the patient should stop and resume treatment with Metformin Galena.
If the patient is to undergo major surgery, they should not take Metformin Galena during the surgery and for some time after it. The doctor will decide when the patient should stop and resume treatment with Metformin Galena.
Treatment with Metformin Galena alone does not cause excessive lowering of blood sugar (hypoglycemia). However, when taking Metformin Galena in combination with other oral antidiabetic medicines, hypoglycemia may occur (see "Driving and using machines").
During treatment with Metformin Galena, the doctor will monitor the patient's kidney function at least once a year or more often if the patient is elderly and/or has deteriorating kidney function.
In case of any of the above situations and in case of doubts about taking the medicine, the patient should consult their doctor.

Children

Metformin Galena is not recommended for use in children.

Metformin Galena and other medicines

The patient should tell their doctor about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
The patient may need more frequent monitoring of blood sugar levels and kidney function, or the doctor may need to adjust the dose of Metformin Galena.
It is especially 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).

During treatment with Metformin Galena, due to the risk of lactic acidosis, the patient should avoid medicines containing alcohol.
If the patient is to be given a contrast agent containing iodine intravascularly, e.g. for an X-ray examination or computed tomography, they must stop taking Metformin Galena before or at the latest at the time of such administration. The doctor will decide when the patient should stop and resume treatment with Metformin Galena.

Metformin Galena with food, drink, and alcohol

During treatment with this medicine, the patient should avoid consuming excessive amounts of alcohol, as alcohol may increase the risk of lactic acidosis (see "Warnings and precautions").
It is recommended to take the medicine during or immediately after a meal, as this will help avoid unwanted gastrointestinal symptoms.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.
Pregnancy
During pregnancy, diabetes should be treated with insulin. If a woman becomes pregnant during treatment with Metformin Galena, she should consult her doctor, who will make the necessary changes to the treatment.
Breastfeeding
Metformin Galena should not be taken during breastfeeding.

Driving and using machines

Metformin Galena does not cause hypoglycemia and therefore does not affect the ability to drive or use machines. However, Metformin Galena taken with other antidiabetic medicines (sulfonylureas, insulin, repaglinide, or other medicines that lower blood sugar) may cause hypoglycemia and impair physical and mental performance. Symptoms of hypoglycemia include: fainting, confusion, excessive sweating, rapid heartbeat, pain, and dizziness or vision disturbances.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Metformin Galena

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor.
The patient should continue to follow the dietary recommendations given by their doctor.
The doctor will start treatment with a low dose of Metformin Galena and gradually increase the dose, depending on the treatment results observed based on blood sugar levels. The patient should regularly visit their doctor for check-ups.

Recommended dose

Adults
Metformin Galena taken alone or in combination with other oral antidiabetic medicines
The initial dose is usually 850 mg of metformin hydrochloride (1 tablet) 2 to 3 times a day.
After 10-15 days, the doctor will adjust the dose based on blood sugar levels. The maximum daily dose is 3 g of metformin hydrochloride.
The doctor will check the patient's kidney function at least once a year. More frequent checks of kidney function are necessary for patients with kidney problems and elderly patients.
Metformin Galena taken in combination with insulin
If the patient is also taking insulin, the doctor will inform them how to start taking Metformin Galena. The initial dose is usually 850 mg of metformin hydrochloride (1 tablet) 2 to 3 times a day. The dose of insulin is adjusted by the doctor based on blood sugar levels.
Elderly patients
Due to the risk of kidney problems in elderly patients, the dose of metformin hydrochloride will be adjusted by the doctor based on kidney function parameters. During treatment, regular monitoring of kidney function is necessary.
Children
Metformin Galena is not recommended for use in children.

Method of administration

Oral administration.
The tablets should be taken during a meal or immediately after a meal. The tablets should not be crushed or chewed before swallowing. The tablets should be swallowed whole.
If, after some time, the medicine seems to be working too weakly or too strongly, the patient should tell their doctor or pharmacist.

Taking a higher dose of Metformin Galena than recommended

In case of taking more tablets of Metformin Galena than recommended, the patient should immediately consult their doctor or go to the hospital. Overdose of the medicine may cause lactic acidosis, which is life-threatening and requires hospital treatment.

Missing a dose of Metformin Galena

The patient should not take a double dose to make up for a missed dose. The patient should take the next dose of the medicine at the usual time.

Stopping treatment with Metformin Galena

Usually, there are no side effects associated with stopping the medicine, but if diabetes is not treated further, complications may arise from lack of treatment.
In case of any further doubts about taking this medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Metformin Galena can cause side effects, although not everybody gets them.
Metformin Galena 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 the patient, they should stop taking
Metformin Galena and immediately contact their doctor or the nearest hospital, as lactic acidosis can lead to coma.
The frequency of possible side effects listed below is defined as follows:

• very common (affects more than 1 in 10 people),
• common (affects 1 to 10 people in 100),
• uncommon (affects 1 to 10 people in 1,000),
• rare (affects 1 to 10 people in 10,000),
• very rare (affects less than 1 in 10,000 people),
• not known (frequency cannot be estimated from the available data).

Very common:
Gastrointestinal disorders, such as: nausea, vomiting, diarrhea, abdominal pain, and loss of appetite.
These side effects usually occur at the beginning of treatment and in most cases disappear on their own. To prevent them, it is recommended to take the medicine in 2 or 3 doses a day during or immediately after a meal. If these symptoms persist, the patient should stop taking the medicine and consult their doctor.
Common:
Taste disorders.
Very rare:
Skin reactions, such as: redness (skin flushing), itching, or urticaria (itchy rash on the skin).
Decreased absorption of vitamin B12 and decreased levels of vitamin B12 in the blood.
Isolated cases:
Abnormal liver function test results or transient liver inflammation after stopping Metformin Galena.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Poland
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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Metformin Galena

There are no special precautions for storage.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
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 pack and other information

What Metformin Galena contains

• -the active substance is metformin hydrochloride 850 mg, which corresponds to 662.9 mg of metformin;
• -the other ingredients are: sodium carboxymethyl starch (type A), corn starch, povidone K30, colloidal anhydrous silica, magnesium stearate.

What Metformin Galena looks like and what the pack contains

Metformin Galena is available in the form of tablets. The tablet is white, odorless, round, and biconvex.
Available packaging: 30 tablets.
PVC/PVDC/Al blisters in a cardboard box.

Marketing authorization holder and manufacturer

Pharmaceutical Cooperative "GALENA"
Krucza Street 62
53-411 Wrocław
Poland

Date of last revision of the leaflet: