Patient Information Leaflet

Etform, 1000 mg, film-coated tablets
Metformini hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
Keep this leaflet for future reference.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others.
This medicine may harm another person, even if their symptoms are the same.
If you experience any side effects, including any possible side effects not listed in this leaflet,
inform your doctor or pharmacist. See section 4.
Contents of the leaflet:

What Etform is and what it is used for
Important information before taking Etform
How to take Etform
Possible side effects
How to store Etform
Contents of the pack and other information

1. What Etform is and what it is used for

Etform 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 that enables the body to absorb 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 elevated blood glucose levels. Metformin helps reduce blood glucose levels to values as close as possible to normal.
In overweight adults, long-term use of Etform also helps reduce the risk of diabetes-related complications. Treatment with Etform is associated either with stable body weight or with a slight reduction in body weight.
Etform is used to treat patients with type 2 diabetes (also known as insulin-independent diabetes) when diet and physical exercise alone are insufficient to achieve adequate control of blood glucose levels. The medicine is particularly used in patients who are overweight.

Adults may take Etform either as the sole therapy or in combination with other antidiabetic medicines (oral agents or insulin).
Children aged 10 years and older and adolescents may take Etform either as monotherapy or in combination with insulin.

2. Important information before using Etform

When not to use Etform
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 liver dysfunction.
if the patient has uncontrolled diabetes, e.g. with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden weight loss, or 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 an unusual fruity odour of the breath.
if the patient has lost too much water from the body (dehydration), e.g. due to persistent or severe diarrhoea or prolonged vomiting. Dehydration may cause kidney dysfunction with a risk of developing lactic acidosis (see below "Warnings and precautions").
if the patient has a serious infection, e.g. affecting the lungs or respiratory tract or kidneys. Serious infections may cause kidney dysfunction with a risk of developing lactic acidosis (see below "Warnings and precautions").
if the patient is being treated for acute heart failure or has recently suffered a heart attack, has severe circulatory disorders (e.g. shock) or breathing difficulties. In such cases, oxygen delivery to tissues may be impaired, which may lead to the development of lactic acidosis (see below "Warnings and precautions").
if the patient drinks large amounts of alcohol.
If any of the above situations apply to the patient, inform the doctor before starting treatment with this medicine.

Consult your doctor if:
the patient is scheduled for an imaging procedure (such as X-ray or CT scan)
using intravenously administered iodine-containing contrast agents
the patient is scheduled for a major surgical procedure
Etform must be discontinued for a certain period before and after the examination or surgery. The doctor will decide whether other medications are required during this period. It is important to strictly follow the doctor's instructions.

Warnings and precautions
Risk of lactic acidosis
Etform may cause a very rare but serious adverse effect called lactic acid游戏副本

3. How to take Etform

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Etform does not replace the benefits of a healthy lifestyle. You should follow the diet and exercise
regimen recommended by your doctor.

Recommended dose:
Children aged 10 years and older, and adolescents
The usual starting dose is 500 mg or 850 mg of metformin hydrochloride* once daily. The maximum
daily dose is 2000 mg, given in 2 or 3 divided doses. Use in children aged 10 to 12 years is only
recommended at the explicit instruction of a doctor, as experience in this age group is limited.
Adults
The usual starting dose is 500 mg or 850 mg of metformin hydrochloride* 2 or 3 times daily.
The maximum daily dose is 3000 mg in 3 divided doses.
* Tablets containing 500 mg and 850 mg of the active substance (metformin hydrochloride) are also
available, allowing individual dose adjustment.
If the patient is also taking insulin, the doctor will determine the appropriate starting dose of
Etform.
In patients with impaired kidney function, the doctor may prescribe a lower dose of the medicine.

Monitoring of treatment

Your doctor will regularly order blood glucose tests and adjust the dose of Etform accordingly. You should attend regular follow-up visits. This is particularly important for children, adolescents, and elderly patients.
Your doctor will also check your kidney function at least once a year. More frequent monitoring may be necessary for elderly patients or those with impaired kidney function.

How to take Etform
The medicine should be taken during or after a meal, as this helps to minimize gastrointestinal side
effects. Do not crush or chew the tablets. Swallow them whole with a glass of water.

If the patient takes one daily dose, it should be taken in the morning (during or after breakfast).
If the patient takes two divided doses daily, one should be taken in the morning (during or after breakfast) and one in the evening (during or after dinner).
If the patient takes three divided doses daily, one should be taken in the morning (during or after breakfast), one at midday (during or after lunch), and one in the evening (during or after dinner).

The break line on the tablet is intended only to facilitate breaking the tablet if the patient has
difficulty swallowing the whole tablet.
If, after some time on treatment, the patient feels that the effect of Etform is too strong or too weak,
they should consult their doctor or pharmacist.

Taking more Etform than prescribed
Taking too much Etform may cause lactic acidosis. Symptoms are nonspecific and may include
vomiting, abdominal pain with muscle cramps, general malaise with severe fatigue and difficulty
breathing. Further symptoms include low body temperature and slowed heart rate. The appearance
of such symptoms may require immediate hospital treatment, as lactic acidosis can lead to coma.
Etform 1000 should be stopped immediately and medical advice should be sought urgently from a
doctor or the nearest hospital.
Missing a dose of Etform
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 any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below may occur.
Etform 1000 may very rarely (in less than 1 in 10,000 people) cause a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If a patient develops lactic acidosis, treatment with Etform must be discontinued and medical advice must be sought immediately from 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 disturbances such as nausea, vomiting, diarrhoea, abdominal pain, and loss of appetite. These symptoms usually occur at the beginning of Etform treatment. Taking the tablet during or immediately after a meal, in divided doses throughout the day, may help reduce these symptoms. If symptoms persist, treatment with Etform should be discontinued and a doctor should be consulted.

Common adverse reactions (may affect less than 1 in 10 people):
altered taste
reduced or low blood levels of vitamin B12 (symptoms may include extreme tiredness (fatigue), pain and redness of the tongue (glossitis), tingling sensations (paraesthesia), or pale or yellowish skin). Your 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 adverse reactions (may affect less than 1 in 10,000 people):
lactic acidosis, a very rare but serious complication, especially in patients with impaired kidney function. Symptoms of lactic acidosis are non-specific (see "Warnings and precautions")
abnormal liver function test results or hepatitis (which may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin and whites of the eyes)
If any of these symptoms occur, Etform should be discontinued and a doctor should be consulted.
skin reactions such as skin redness (erythema), itching, or itchy rash (urticaria)

Children and adolescents
Limited data in children and adolescents indicate that the nature and severity of adverse reactions were similar to those reported in adults.

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

Keep the medicine out of sight and reach of children. If the medicine is used in children,
parents and caregivers should supervise its administration.
There are no special storage requirements.
Do not use this medicine after the expiry date stated on the cardboard box, container, or blister
pack after EXP. The expiry date refers to the last day of the stated month.
The batch number on the packaging is marked as "Lot".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What the medicine Etform contains
The active substance is metformin hydrochloride.
Each coated tablet contains 1000 mg of metformin hydrochloride, equivalent to 780 mg of
metformin.
The other ingredients are: povidone K 90, magnesium stearate, hypromellose, macrogol 4000, titanium
dioxide (E171).
What Etform looks like and contents of the pack
White, oval coated tablets with a score line and embossed mark "M 1G" on one side and smooth on the other side. Approximate dimensions: 19 mm x 10 mm.
PVC/aluminium blisters contain 30, 60, 90 or 120 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Lek S.A.
ul. Podlipie 16
95-010 Stryków, Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
For further information about this medicine and its names in other European Economic Area countries,
please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. 22 209 70 00