Etform 500

Package leaflet: Information for the patient

Etform 500, 500 mg, coated tablets
Metformini hydrochloridum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.
Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others.
The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any possible adverse reactions not listed
in this leaflet, inform your doctor or pharmacist.
See section 4.
Table of contents:

1. What Etform 500 is and what it is used for
2. What you need to know before taking Etform 500
3. How to take Etform 500
4. Possible side effects
5. How to store Etform 500
6. Contents of the pack and other information

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

Etform 500 contains metformin, a medicine belonging to the group of drugs known as biguanides, used in the treatment of diabetes.
Insulin is a hormone produced by the pancreas, which causes the body to take up glucose (sugar) from the blood.
Glucose serves as the body's energy source or is stored 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 increased glucose levels in the blood. Etform 500 helps reduce blood glucose levels to values as close as possible to normal.
In overweight adults, long-term use of Etform 500 also helps reduce the risk of diabetes-related complications.
Treatment with Etform 500 is associated either with stable body weight or with slight weight reduction.
Etform 500 is used in the treatment of people with type 2 diabetes (so-called "insulin-independent diabetes"),
in whom blood glucose levels cannot be adequately controlled by diet and physical exercise alone.
In type 2 diabetes, insulin production and (or) its action gradually decreases.
Etform 500 is particularly used in patients who are overweight.
Adults may take Etform 500 as the only antidiabetic medicine or in combination with other antidiabetic medicines (oral or insulin).
Children aged at least 10 years and adolescents may take Etform 500 as monotherapy or in combination with insulin.

2. Information before using Etform 500

When not to use Etform 500
if the patient is allergic to metformin or to 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, for example with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and which may lead to diabetic pre-coma. Symptoms include: stomach pain, rapid and deep breathing, drowsiness or unusual fruity odour of the breath.
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), for example due to

• prolonged or severe diarrhoea, or
• repeated vomiting. Dehydration may cause kidney function disorders with risk of developing lactic acidosis (see “Warnings and precautions”). if the patient is being treated for acute heart failure or has recently had a myocardial infarction, has serious circulatory disorders (such as shock) or breathing difficulties. These conditions may lead to tissue hypoxia with risk of developing lactic acidosis (see “Warnings and precautions”). if the patient has a severe infection affecting, for example, lung function, respiratory tract or kidneys. Severe infections may lead to kidney function disorders with risk of developing lactic acidosis (see “Warnings and precautions”).

If any of the above situations apply to the patient, tell the doctor before starting treatment with this medicine.
Consult a doctor if:
the patient needs to undergo a diagnostic test such as X-ray or scintigraphy, requiring intravenous administration of iodine-containing contrast agents,
the patient is scheduled for a major surgical procedure.
If the patient is undergoing a major surgical procedure, Etform 500 must not be taken during and for some time after the procedure. 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 cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has impaired kidney function. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (more details below), liver function disorders, and any disease states in which a part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, consult the doctor for further instructions.
Contact the doctor immediately for further guidance if:
the patient has 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 metformin treatment, the patient develops any of the following symptoms: seizures, worsening of cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.
The patient should temporarily stop taking Etform 500 if experiencing any illness that may lead to dehydration (significant loss of water from the body), such as severe vomiting, diarrhoea, fever, exposure to high temperature, or if the patient drinks less fluid than usual. Consult the doctor for further instructions.
The patient must stop taking Etform 500 and contact the doctor or 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 accompanied by profound fatigue
• difficulty breathing
• decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
Etform 500 does not cause hypoglycaemia (low blood glucose levels). However, if Etform 500 is used in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylurea derivatives, insulin, meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, excessive sweating, rapid heartbeat, blurred vision or difficulty concentrating, eating or drinking something containing sugar usually helps.
If the patient is undergoing a major surgical procedure, Etform 500 must not be taken during and for some time after the procedure. The doctor will decide when the patient should stop and when to resume taking Etform 500.
Before using Etform 500, discuss with the doctor if any of the following situations apply:
the patient has symptoms of low blood sugar levels, such as:

• weakness
• dizziness
• excessive sweating
• rapid heartbeat
• blurred vision
• difficulty concentrating. If such symptoms occur, eat or drink something containing sugar. Etform 500 itself, unlike other antidiabetic medicines, does not cause excessive lowering of blood sugar levels. Obesity Follow a calorie-controlled diet. Use of other medicines See “Etform 500 and other medicines”.

While taking Etform 500, the doctor will monitor the patient’s kidney function at least once a year, or more frequently if the patient is elderly and/or kidney function is deteriorating.
Children under 10 years of age
Etform 500 is not recommended for use in this age group.
Etform 500 and other medicines
If the patient is to receive an intravenous iodine-containing contrast agent, for example for an X-ray or CT scan, the patient must stop taking Etform 500 before or at the latest at the time of injection. The doctor will decide when the patient should stop and resume treatment with Etform 500.
Tell the doctor or pharmacist about all medicines the patient is currently taking or has 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 Etform 500 by the doctor. It is especially important to inform about the use of:
medicines containing alcohol
glucocorticoids, medicines preventing organ transplant rejection, reducing inflammation (e.g. of the skin) or used in asthma treatment
bronchodilators, such as salbutamol, fenoterol and terbutaline
medicines increasing 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 alter the levels of Etform 500 in the blood, especially in patients with impaired kidney function (e.g. verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
medicines that lower blood glucose levels, such as insulin or oral antidiabetic agents.
Taking these medicines together with Etform 500 may cause excessive lowering of blood glucose levels. See “Warnings and precautions”.
Etform 500 and alcohol
Avoid excessive alcohol consumption while taking Etform 500, 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 have a baby, she should talk to the doctor, as changes in treatment or monitoring of blood glucose levels may be necessary.
This medicine is not recommended for breastfeeding women or women planning to breastfeed.
Driving and operating machinery
Etform 500 alone does not cause hypoglycaemia (low blood glucose levels) and therefore does not affect the ability to drive or operate machinery. However, caution is required if, in addition to Etform 500, the patient is also taking other antidiabetic medicines that may cause hypoglycaemia (such as sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycaemia include, among others, weakness, dizziness, excessive sweating, rapid heartbeat, blurred vision or difficulty concentrating. If such symptoms occur, the patient should not drive or operate machinery.

3. How to use Etform 500

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist. If the patient has impaired kidney function, the doctor
may prescribe a lower dose of the medicine.
If the patient is also using insulin, the doctor will advise on how to start taking Etform 500.
Etform 500 does not replace the benefits of a healthy lifestyle. You should follow the diet and
exercise regimen recommended by your doctor.

* Tablets containing 850 mg and 1000 mg of the active substance (metformin hydrochloride) are also available on the market, allowing individual dose adjustment.

Adults
Recommended starting dose: 1 tablet of Etform 500 taken 2 or 3 times daily.
After approximately 2 weeks of treatment with Etform 500, the doctor may measure the patient's blood glucose level and adjust the dose accordingly.
Maximum dose: 6 Etform 500 tablets* daily, divided into three doses.

Children aged 10 years and older
Typical starting dose: 1 tablet of Etform 500 or 850 mg* of metformin hydrochloride daily.
After approximately 2 weeks of treatment with Etform 500 in a child, the doctor may measure the patient's blood glucose level and adjust the dose accordingly.
Maximum dose: 4 Etform 500 tablets* daily, divided into 2 or 3 doses.

Patients aged 65 years and older
Due to the frequent occurrence of impaired kidney function in this patient group, the doctor will determine the dose of Etform 500 based on kidney function (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 helps to avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow the tablet whole with a glass of water.

• If taking one dose per day, take the medicine in the morning (with breakfast).
• If taking two doses per day, take the medicine in the morning (with breakfast) and in the evening (with dinner).
• If taking three doses per day, take the medicine in the morning (with breakfast), at midday (with lunch), and in the evening (with 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 measurements and adjust the dose of Etform 500 according to the results obtained. Regular follow-up visits to the doctor are essential.
This is particularly important for children, adolescents, and elderly patients.
The doctor will also check kidney function at least once a year. More frequent monitoring may be necessary for elderly patients or those with impaired kidney function.

Duration of treatment
The duration of treatment will be determined by the doctor.

Taking more than the recommended dose of Etform 500
If a dose of Etform 500 higher than recommended is taken, lactic acidosis may occur.
Symptoms of lactic acidosis are non-specific and include vomiting, abdominal pain (abdominal discomfort) with muscle cramps, general malaise accompanied by severe fatigue and difficulty breathing. Other symptoms include lowered body temperature and slowed heart rate.
If any of these symptoms occur, the patient should seek immediate medical help, as lactic acidosis can lead to coma. The patient should stop taking Etform 500 immediately and contact their doctor without delay or go to the nearest hospital.

Missed dose of Etform 500
If the patient forgets to take a dose, they should skip the missed dose and take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose. If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

Stopping Etform 500
Stopping treatment with Etform 500 without consulting your doctor may result in uncontrolled increase in blood glucose levels, thereby increasing the risk of long-term complications affecting, for example, the eyes, kidneys, and blood vessels.
If you have any further doubts 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 they do not occur in everyone.
Etform 500 may very rarely cause a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If this occurs in a patient, treatment with Etform 500 must be discontinued immediately and the patient should contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

Other possible adverse reactions:
Very common (may affect more than 1 in 10 people):

• nausea
• vomiting
• diarrhoea
• abdominal pain
• loss of appetite

These symptoms occur mainly 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 food or immediately after a meal. If symptoms do not resolve, Etform 500 should be discontinued and the doctor informed.

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

• taste disturbances
• reduced or low blood vitamin B12 levels (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 these symptoms, as some of them may also be caused by diabetes or other health problems unrelated to diabetes.

Very rare (may affect less than 1 in 10,000 people):

• lactic acidosis. This is a very rare but serious complication, particularly when the kidneys are not functioning properly.
  Symptoms of lactic acidosis are non-specific (see section "Warnings and precautions").
• skin redness
• itching
• itchy rash
• abnormal liver function tests or hepatitis, which may cause:
  • feeling of fatigue
  • loss of appetite
  • weight loss accompanied (or not) by yellowing of the skin and whites of the eyes

If any of these symptoms occur, Etform 500 should be discontinued and a doctor should be consulted immediately.

Children and adolescents
Limited data in children and adolescents indicate that adverse reactions observed in these populations are of similar nature and severity to those observed in adults.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
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 Etform 500

Keep this medicine out of the sight and reach of children. If Etform 500 is being used by a child, parents or caregivers should supervise the administration of the medicine.
Do not use this medicine after the expiry date stated on the cardboard packaging, blister pack, or bottle after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Etform 500 contains
The active substance is metformin hydrochloride.
Each coated tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of
metformin base.
The other ingredients are: povidone K 90, magnesium stearate, hypromellose, polyethylene glycol 4000, titanium dioxide (E171).

What Etform 500 looks like and contents of the pack
White, round, biconvex coated tablets with the imprint "M 500" on one side and smooth on the other side, measuring 11 mm x 6 mm.
The medicine is available in HDPE containers with LDPE or PP caps and a desiccant, containing 30 or 60 coated tablets, as well as in PVC/aluminum foil blisters containing 30, 60, 90 or 120 coated tablets.
The desiccant should be kept in the container.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturers
Lek Pharmaceuticals d.d.
Verovškova 57
1256-Ljubljana, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Podlipie 16
95-010 Stryków, Poland
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia

For further information about the medicine and its names in other European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
tel. 22 209 70 00