Etform 500

Leaflet attached to the packaging: patient information

Etform 500, 500 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.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed to a specific person. It should not be given to others.
The medicine may harm another person, even if their disease symptoms are the same.
If the patient experiences any side effects, including any possible 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 Etform 500 and what is it used for
• 2. Important information before taking Etform 500
• 3. How to take Etform 500
• 4. Possible side effects
• 5. How to store Etform 500
• 6. Package contents and other information

1. What is Etform 500 and what is it used for

Etform 500 contains metformin, a medicine from the biguanide group, used to treat diabetes.
Insulin is a hormone produced in the pancreas that makes the body absorb glucose (sugar) from the blood. Glucose is the body's energy material or is stored for later use.
In people with diabetes, the pancreas does not produce enough insulin or the body is not able to use the produced insulin properly. This leads to an increase in blood glucose levels. Etform 500 helps reduce blood glucose levels to values as close to normal as possible.
In adults with overweight, long-term use of Etform 500 also helps reduce the risk of complications associated with diabetes. Taking Etform 500 is associated with either maintaining a stable body weight or slightly reducing it.
Etform 500 is used to treat people with type 2 diabetes (so-called "insulin-independent diabetes"), in whom it is not possible to properly control blood glucose levels with diet and physical exercise alone. In type 2 diabetes, insulin production and (or) its action decrease gradually.
Etform 500 is particularly used in patients with overweight.
Adultscan take Etform 500 as the only medicine or together with other anti-diabetic medicines (oral or with insulin).
Childrenaged 10 years and older and adolescents can take Etform 500 as the only medicine or together with insulin.

2. Important information before taking Etform 500

When not to take Etform 500

if the patient is allergicto metformin 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, e.g. with severe hyperglycemia (high blood glucose), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see below "Risk of lactic acidosis") or diabetic ketoacidosis. Diabetic ketoacidosis is a disease in which substances called ketone bodies accumulate in the blood and can lead to diabetic pre-coma. Symptoms include: stomach pain, rapid and deep breathing, drowsiness or unusual fruity breath odor.
if the patient has liver function disorders;
if the patient regularly consumes large amounts of alcohol;
if the patient has lost too much water from the body (is dehydrated), e.g. due to

• prolonged or severe diarrhea, or
• repeated vomiting Dehydration can cause kidney function disorders with a risk of developing lactic acidosis (see "Warnings and precautions"). if the patient is being treated for acute heart failureor has recently had a heart attack, has severe circulation disorders (such as shock) or breathing difficulties. They can lead to tissue hypoxia with a risk of developing lactic acidosis (see "Warnings and precautions"). if the patient has a severe infection, affecting, for example, lung, respiratory tract, or kidney function. Severe infections can lead to kidney function disorders with a risk of developing lactic acidosis (see "Warnings and precautions").

If any of the above situations apply to the patient, they should tell their doctor before starting to take the medicine.
You should consult a doctor if:
the patient is to undergo an examination, such as an X-ray or CT scan, that requires the administration of contrast agents containing iodine,
the patient is to undergo a major surgical procedure.
If the patient is to undergo a major surgical procedure, they should not take Etform 500 during the procedure and for some time after it. The doctor will decide when the patient should stop and when to resume taking Etform 500.

Warnings and precautions

Risk of lactic acidosis

Etform 500 may rarely cause a very rare but very serious side effect called lactic acidosis, especially if the patient has kidney function disorders. The risk of lactic acidosis increases in the case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (more detailed 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 immediately contact their doctor for further instructions if:
they have a genetically inherited disease affecting 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 (MIDD).
after starting to take metformin, the patient experiences any of the following symptoms: seizures, impaired cognitive abilities, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or hearing loss.

The patient should temporarily stop taking Etform 500 if they experience a condition that may be associated with dehydration

(significant loss of water from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult their doctor for more detailed instructions.

The patient should stop taking Etform 500 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 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.
Etform 500 does not cause hypoglycemia (low blood glucose). However, if Etform 500 is taken with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides), there is a risk of hypoglycemia. If symptoms of hypoglycemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or concentration difficulties, eating or drinking something containing sugar usually helps.
If the patient is to undergo a major surgical procedure, they should not take Etform 500 during the procedure and for some time after it. The doctor will decide when the patient should stop and when to resume taking Etform 500.
Before taking Etform 500, the patient should discuss with their doctor if they experience any of the following situations:
the patient has symptoms of low blood sugar, such as:

• weakness
• dizziness
• increased sweating
• rapid heartbeat
• vision disturbances
• concentration difficulties If such symptoms occur, the patient should eat or drink something containing sugar. Etform 500 itself, unlike other anti-diabetic medicines, cannot cause excessive lowering of blood sugar. ObesityThe patient should follow a calorie-controlled diet. use of other medicinesSee "Etform 500 and other medicines".

While taking Etform 500, the doctor will check the patient's kidney function at least once a year, or more often if the patient is elderly and (or) their kidney function is deteriorating.

Children under 10 years of age

It is not recommendedto use Etform 500 in this age group.

Etform 500 and other medicines

If the patient is to be injected with a contrast agent containing iodine, for example, for an X-ray examination or CT scan, they must stop taking Etform 500 before or at the latest at the time of the injection. The doctor will decide when the patient should stop and when to resume taking Etform 500.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may need more frequent blood glucose checks and kidney function assessments, or the doctor may need to adjust the dose of Etform 500. It is especially important to inform about the use of:
medicines containing alcohol
corticosteroids, medicines that prevent the rejection of a transplanted organ, reduce inflammation (e.g. of the skin), or are used to treat asthma
bronchodilators, such as salbutamol, fenoterol, and terbutaline
medicines that increase urine production (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)
medicines that may change the amount of Etform 500 in the blood, especially in patients with kidney function disorders (i.e. verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
medicines that lower blood sugar, such as insulin or oral hypoglycemic agents. Taking these medicines with Etform 500 may cause excessive lowering of blood sugar. See "Warnings and precautions".

Etform 500 and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Etform 500, as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy and breastfeeding

If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their doctor, as changes in treatment or blood glucose monitoring may be necessary.
This medicine is not recommended for breastfeeding women or those planning to breastfeed.

Driving and using machines

Etform 500 taken alone does not cause hypoglycemia (low blood glucose), so it does not affect the ability to drive or use machines. However, the patient should be cautious if they are also taking other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or concentration difficulties. If the patient experiences such symptoms, they should not drive or use machines.

3. How to take Etform 500

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. If the patient has kidney function disorders, the doctor may prescribe a lower dose of the medicine.
If the patient is also taking insulin, the doctor will inform them how to start taking Etform 500.

• 500.

Etform 500 does not replace the benefits of a healthy lifestyle. The patient should follow the diet and exercise regimen recommended by their doctor.
* There are also 850 mg and 1000 mg tablets of the active substance (metformin hydrochloride) available on the market, which can be used to individually adjust the dose of the medicine.

Adults

Recommended initial dose: 1 tablet of Etform 500 taken 2 or 3 times a day.
After about 2 weeks of taking Etform 500, the doctor may check the patient's blood glucose levels and adjust the dose.
Maximum dose: 6 tablets of Etform 500* per day in three divided doses.

Children aged 10 years and older

Usual initial dose: 1 tablet of Etform 500 or 850 mg* of metformin hydrochloride per day.
After about 2 weeks of taking Etform 500 in children, the doctor may check the patient's blood glucose levels and adjust the dose.
Maximum dose: 4 tablets of Etform 500* per day in 2 or 3 divided doses.

Patients aged 65 years and older

Due to the frequent kidney function disorders in this age group, the doctor will determine the dose of Etform 500 based on the function of this organ (see also "Warnings and precautions" in section 2).

Method of administration

The tablets should be swallowed with a glass of water during or after a meal. This will help avoid gastrointestinal side effects.
The tablets should not be crushed or chewed. The patient should swallow the tablet with a glass of water.

• If the patient takes one dose per day, they should take the medicine in the morning (breakfast).
• If the patient takes two doses of the medicine per day, they should take it in the morning (breakfast) and in the evening (dinner).
• If the patient takes three doses of the medicine per day, they should take it in the morning (breakfast), at noon (lunch), and in the evening (dinner).

If after some time the patient feels that the effect of Etform 500 is too strong or too weak, they should consult their doctor or pharmacist.

Monitoring of treatment

The doctor will regularly order blood glucose tests and adjust the dose of Etform 500 according to the results. The patient should regularly visit their doctor for check-ups.
This is especially important in the case of children and adolescents, as well as elderly patients.
The doctor will also check the patient's kidney function at least once a year. More frequent checks may be necessary in elderly patients or those with impaired kidney function.

Duration of treatment

The duration of treatment is determined by the doctor.

Taking a higher dose of Etform 500 than recommended

In case of taking a higher dose of Etform 500 than recommended, lactic acidosis may occur.
Symptoms of lactic acidosis are non-specific and include: vomiting, abdominal pain (abdominal cramps), general poor condition with severe fatigue, and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate.

If the patient experiences any of these symptoms, they should immediately seek medical attention, as lactic acidosis can lead to coma. The patient should stop taking Etform 500 and immediately contact their doctor or the nearest hospital.

Hospital.

Missing a dose of Etform 500

If the patient forgets to take a dose, they should skip it and take the next dose at the recommended time.
The patient should not take a double dose to make up for the missed dose. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

Stopping treatment with Etform 500

Stopping treatment with Etform 500 without consulting a doctor may cause uncontrolled increase in blood glucose levels, which in turn may increase the risk of long-term complications affecting, for example, the eyes, kidneys, and blood vessels.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Etform 500 can cause side effects, although not everybody gets them.
Etform 500 may very rarely cause a very serious side effect called lactic acidosis (may occur in less than 1 in 10,000 patients). If this occurs in the patient, they should stop takingEtform 500 and immediately contacttheir doctor or the nearest hospital, as lactic acidosis can lead to coma.
Other possible side effects
Very common(may occur in more than 1 in 10 people)
nausea
vomiting
diarrhea
abdominal pain
loss of appetite
These symptoms usually occur at the beginning of treatment. It may be helpful to divide the daily dose into several smaller doses taken throughout the day and to take Etform 500 with a meal or immediately after a meal. If the symptoms do not resolve, the patient should stop taking Etform 500 and tell their doctor.
Common(may occur in less than 1 in 10 people)
taste disorders
decreased or low levels of vitamin B12 in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, numbness, or pale or yellowish skin). The doctor may order several 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.
Very rare(may occur in less than 1 in 10,000 people)
lactic acidosis. This is a very rare but serious complication, especially when the kidneys do not work properly.
Symptoms of lactic acidosis are non-specific (see "Warnings and precautions").
redness of the skin
itching
pruritic rash
abnormal liver function test results or hepatitis, which may cause:

• fatigue
• loss of appetite
• weight loss with or without jaundice of the skin and eyes

If the patient experiences such symptoms, they should stop taking Etform 500 and consult their doctor immediately.

Children and adolescents

Limited data in children and adolescents indicate that the side effects occurring in this age group have a similar nature and severity to the side effects observed in adults.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. 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
tel.: + 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, it is possible to gather more information on the safety of the medicine.

5. How to store Etform 500

The medicine should be stored out of sight and reach of children. If Etform 500 is used in children, parents or caregivers should supervise the taking of the medicine.
The medicine should not be used after the expiry date stated on the carton, blister, or bottle after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storage.
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. Package contents and other information

What Etform 500 contains

The active substanceis metformin hydrochloride.
Each film-coated tablet contains 500 mg of metformin hydrochloride, which corresponds to 390 mg of metformin base.
The other ingredients are: povidone K 90, magnesium stearate, hypromellose, macrogol 4000, titanium dioxide (E171).

What Etform 500 looks like and what the package contains

White, round, biconvex film-coated tablets with the symbol "M 500" embossed on one side and smooth on the other, with dimensions of 11 mm x 6 mm.
The medicine is available in HDPE containers with an LDPE or PP cap and a desiccant, containing 30 or 60 film-coated tablets, and in PVC/aluminum blisters containing 30, 60, 90, or 120 film-coated tablets.
The desiccant should be kept in the container.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1256-Ljubljana, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Podlipie 16
95-010 Stryków

To obtain more detailed information about the medicine and its names in other Member States of the European Economic Area, the patient should contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:03/2025
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