Etform

Package Leaflet: Information for the Patient

Etform, 1000 mg, Film-Coated Tablets

Metformin Hydrochloride

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

Keep this leaflet, as you may need to read it again.
In case of any doubts, 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 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 and what is it used for
• 2. Important information before taking Etform
• 3. How to take Etform
• 4. Possible side effects
• 5. How to store Etform
• 6. Contents of the pack and other information

1. What is Etform and what is it used for

Etform contains metformin, a medicine from the biguanide group, used to treat diabetes.
Insulin is a hormone produced by the pancreas that makes the body absorb glucose (sugar) from the blood. Glucose is 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 use the produced insulin properly. This leads to an increase in blood glucose levels. Metformin helps reduce blood glucose levels to as close to normal as possible.
In adults with overweight, long-term use of Etform also helps reduce the risk of diabetes complications. Taking Etform is associated with either maintaining a stable body weight or a slight weight loss.
Etform is used to treat patients with type 2 diabetes (also called non-insulin-dependent diabetes), when diet and physical exercise alone do not provide adequate blood glucose control. The medicine is particularly used in patients with overweight.

• Adults can take Etform alone or in combination with other diabetes medicines (oral or insulin).
• Children aged 10 and above and adolescents can take Etform alone or in combination with insulin.

2. Important information before taking Etform

When not to take Etform

if the patient is allergicto metformin or any of the other ingredients of this medicine (listed in section 6).
if the patient has severely reduced kidney function.
if the patient has liver function disorders.
if the patient has uncontrolled diabetes, e.g. with severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, or lactic acidosis (see below "Risk of lactic acidosis") 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 stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity odor from the mouth.
if the patient has lost too much waterfrom the body (dehydration), e.g. due to persistent or severe diarrhea or prolonged vomiting. Dehydration can cause kidney function disorders with a risk of lactic acidosis (see below "Warnings and precautions").
if the patient has a severe infection, e.g. an infection of the lungs or urinary tract. Severe infections can cause kidney function disorders with a risk of lactic acidosis (see below "Warnings and precautions").
if the patient is being treated for acute heart failure or has recently had a heart attack, has severe circulatory problems (e.g. shock), or breathing difficulties. In such cases, oxygen supply to the tissues may be impaired, which can lead to lactic acidosis (see below "Warnings and precautions").
if the patient drinks a lot of alcohol.
If any of these situations apply to the patient, they should tell their doctor before taking Etform.

Consult a doctor if:

the patient is to undergo an imaging test (such as an X-ray or CT scan) using intravenously administered iodine-containing contrast agents
the patient is to undergo major surgery
It is necessary to stop taking Etform for a while before and after the test or surgery. The doctor will decide whether the patient needs to take other medicines during this period. It is essential to follow the doctor's instructions.

Warnings and precautions

Risk of lactic acidosis

Etform can cause a very rare but very serious side effect called lactic acidosis, especially in patients with kidney function disorders. The risk of lactic acidosis also increases in case of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (see below), liver function disorders, and any conditions in which a part of the body is not adequately supplied with oxygen (e.g. acute severe heart disease).
If any of these situations 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 the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalomyopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.
if the patient experiences any of the following symptoms after starting metformin: seizures, impaired cognitive abilities, difficulty moving, signs of nerve damage (e.g. pain or numbness), migraine, or hearing loss.

The patient should temporarily stop taking Etform in situations that may involve

dehydration(significant water loss from the body), such as severe vomiting, diarrhea, fever, exposure to high temperatures, or reduced fluid intake. The patient should consult their doctor for more detailed instructions.

The patient should stop taking Etform and immediately contact their doctor or the nearest hospital if they experience

any symptoms of lactic acidosis, as this condition can lead to coma.
The symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• general feeling of being unwell with severe fatigue
• breathing difficulties
• low body temperature and slow heart rate.

Lactic acidosis is a life-threatening condition that requires hospital treatment.
If the patient is to undergo major surgery, they should not take Etform during and for some time after the surgery. The doctor will decide when to stop and restart taking Etform.
During Etform treatment, the doctor will check the patient's kidney function at least once a year or more frequently if the patient is elderly and/or has impaired kidney function.
Etform 1000 taken alone does not cause hypoglycemia (low blood sugar). However, taking Etform with other diabetes medicines that can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides) increases the risk of hypoglycemia. If the patient experiences symptoms of hypoglycemia, such as weakness, dizziness, excessive sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, it is usually helpful to eat or drink something containing sugar.

Etform and other medicines

If the patient is to receive an iodine-containing contrast agent intravenously, e.g. for an X-ray or CT scan, they must stop taking Etform before or at the latest at the time of administration. The doctor will decide when the patient should stop and restart taking Etform.
The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. More frequent blood glucose and kidney function tests or Etform dose adjustments may be necessary. It is particularly important to inform about the use of:
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)
beta-2-agonists, such as salbutamol or terbutaline (medicines used to treat asthma)
corticosteroids(medicines used to treat various diseases, such as severe skin inflammation or asthma)
medicinesthat may change the amount of Etform in the blood, especially in patients with kidney function disorders (e.g. verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
other diabetes medicines

Etform and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Etform, 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 baby, they should consult their doctor, as changes in treatment or blood glucose monitoring may be necessary. If the patient is breastfeeding or plans to breastfeed, the use of this medicine is not recommended.

Driving and using machines

Etform taken alone does not cause hypoglycemia, so it does not affect the ability to drive or use machines.
However, the patient should be cautious if they are also taking other diabetes medicinesthat can cause hypoglycemia (such as sulfonylurea derivatives, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, excessive sweating, rapid heartbeat, vision disturbances, or difficulty concentrating. If the patient experiences such symptoms, they should not drive or use machines.

3. How to take Etform

Take this medicine always as directed by your doctor. In case of doubt, consult your doctor or pharmacist.
Etform does not replace the benefits of a healthy lifestyle. The patient should follow the diet and exercise regimen recommended by their doctor.
The recommended dose is:

Children aged 10 and above and adolescents

The usual starting dose is 500 mg or 850 mg of metformin hydrochloride once a day. The maximum daily dose is 2000 mg in 2 or 3 divided doses. The use of Etform in children aged 10 to 12 is only recommended if prescribed by 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 a day.
The maximum daily dose is 3000 mg in 3 divided doses.
* Also available are tablets containing 500 mg and 850 mg of the active substance (metformin hydrochloride), allowing for individual dose adjustment of the medicine.
If the patient is also taking insulin, the doctor will determine the starting dose of Etform.
In patients with kidney function disorders, the doctor may use a lower dose of Etform.

Monitoring treatment

• The doctor will regularly order blood glucose tests and adjust the Etform dose according to the results. The patient should regularly visit their doctor for check-ups. This is especially important in 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.

How to take Etform

Take the medicine with a meal or after a meal, as this will help avoid gastrointestinal upset. Do not crush or chew the tablets. Swallow them whole with a glass of water.

• If the patient takes one dose a day, they should take it in the morning (with breakfast or after breakfast).
• If the patient takes two divided doses a day, they should take one in the morning (with breakfast or after breakfast) and one in the evening (with dinner or after dinner).
• If the patient takes three divided doses a day, they should take one in the morning (with breakfast or after breakfast), one at noon (with lunch or after lunch), and one in the evening (with dinner or after dinner).

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

Taking a higher dose of Etform than recommended

After taking too much Etform, the patient may experience lactic acidosis. The symptoms are non-specific, e.g. vomiting, abdominal pain with muscle cramps, general feeling of being unwell with severe fatigue, and breathing difficulties. Further symptoms include low body temperature and slow heart rate. The occurrence of such symptoms may require immediate hospital treatment, as lactic acidosis can lead to coma.
Stop taking Etform 1000 and immediately contact 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.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Etform can cause side effects, although not everybody gets them.
The following side effects may occur.
Etform 1000 can very rarely (in less than 1 in 10,000 people) cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, stop taking Etform and immediately contact a doctor or the nearest hospital, as lactic acidosis can lead to coma.
Very commonside effects (may affect more than 1 in 10 people):
gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, and loss of appetite. These symptoms usually occur at the beginning of Etform treatment. Taking the tablet with a meal or after a meal can help alleviate these symptoms. If the symptoms persist, stop taking Etform and consult a doctor.
Commonside effects (may affect less than 1 in 10 people):
change in taste
decreased or low vitamin B12 levels in the blood (symptoms may include extreme fatigue, pain, and redness of the tongue, or numbness). 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 unrelated health problems.
Very rareside effects (may affect less than 1 in 10,000 people):
lactic acidosis, a very rare but serious complication, especially in patients with kidney function disorders. The 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, yellowing of the skin and whites of the eyes, or without yellowing)
If such symptoms occur, stop taking Etformand consult a doctor.
skin reactions, such as redness, itching, or itchy rash (hives)

Children and adolescents

Limited data from children and adolescents indicate that the nature and severity of side effects were similar to those reported in adults.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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:
Aleje 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Etform

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

6. Contents of the pack and other information

What Etform contains

The active substanceis metformin hydrochloride.
Each film-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, film-coated tablets with a score line and engraved with the symbol "M 1G" on one side and smooth on the other. Approximate dimensions: 19 mm x 10 mm.
PVC/Aluminum blisters containing 30, 60, 90, or 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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
Lek S.A.
ul. Podlipie 16
95-010 Stryków
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

For more information about this medicine and its names in other EU countries, please 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
Sandoz logo