ETFORM 850 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Etform 850, 850 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Etform 850 and what is it used for
4. Important information before taking Etform 850
   1. When not to take Etform 850
   2. Warnings and precautions
   3. Risk of lactic acidosis
   4. The patient should temporarily stop taking Etform 850 if they experience a condition that may lead to dehydration
   5. The patient should stop taking Etform 850 and immediately contact their doctor or the nearest hospital if they experience any symptoms of lactic acidosis
   6. Children under 10 years of age
   7. Etform 850 and other medicines
   8. Etform 850 and alcohol
   9. Pregnancy and breastfeeding
   10. Driving and using machines
5. How to take Etform 850
   1. Adults
   2. Children aged 10 years and older
   3. Patient over 65 years of age
   4. Method of administration
   5. Monitoring of treatment
   6. Duration of treatment
   7. Taking a higher dose of Etform 850 than recommended
   8. 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 850 and immediately contact their doctor or the nearest
   9. Missing a dose of Etform 850
   10. Stopping treatment with Etform 850
6. Possible side effects
   1. Children and adolescents
   2. Reporting side effects
7. How to store Etform 850
8. Contents of the pack and other information
   1. What Etform 850 contains
   2. What Etform 850 looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. To obtain more detailed information on this medicine and its names in other EU member states, please contact:

Leaflet accompanying the packaging: patient information

Etform 850, 850 mg, film-coated tablets

Metformin hydrochloride

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

Keep this leaflet, 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 850 and what is it used for
• 2. Important information before taking Etform 850
• 3. How to take Etform 850
• 4. Possible side effects
• 5. How to store Etform 850
• 6. Contents of the pack and other information

1. What is Etform 850 and what is it used for

Etform 850 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 source or is stored for later use.
In people with diabetes, the pancreas does not produce enough insulin or the body is unable to use the produced insulin properly. This leads to an increase in blood glucose levels. Etform 850 helps reduce blood glucose levels to values as close to normal as possible.
In adults with overweight, long-term use of Etform 850 also helps reduce the risk of diabetes-related complications. Taking Etform 850 is associated with either maintaining a stable body weight or a slight reduction in body weight.
Etform 850 is used to treat patients 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 decrease.
Etform 850 is particularly used in patients with overweight.
Adultscan take Etform 850 alone or in combination with other anti-diabetic medicines (oral or with insulin).
Childrenaged 10 years and older and adolescents can take Etform 850 alone or in combination with insulin.

2. Important information before taking Etform 850

When not to take Etform 850

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 sugar), nausea, vomiting, diarrhea, sudden weight loss, 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 a diabetic pre-coma. Symptoms include: stomach pain, rapid and deep breathing, drowsiness or an unusual fruity odor from the mouth.
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 circulatory disorders (such as shock) or breathing difficulties. These conditions can lead to tissue hypoxia with a risk of developing lactic acidosis (see "Warnings and precautions"). if the patient has a severe infection affecting the lungs, airways, or kidneys. Severe infections can lead to kidney function disorders with a risk of developing lactic acidosis (see "Warnings and precautions").

If any of these situations apply to the patient, they should tell their doctor before starting to take the medicine.
Patients should consult their doctor if:
they are to undergo an examination, such as an X-ray or CT scan, that requires the injection of contrast agents containing iodine into the bloodstream,
they are to undergo major surgery.
If the patient is to undergo major surgery, they should not take Etform 850 during and for some time after the surgery. The doctor will decide when the patient should stop and resume taking Etform 850.

Warnings and precautions

Risk of lactic acidosis

Etform 850 may rarely cause a very serious side effect called lactic acidosis, especially if the patient has kidney function disorders. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting, or alcohol consumption, dehydration (more information 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 conditions apply to the patient, they should consult their doctor for more detailed instructions.
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 inherited diabetes and deafness from their mother (MIDD, maternal inherited diabetes and deafness).
after starting metformin, the patient experiences any of the following symptoms: seizures, impaired cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine, or hearing loss.

The patient should temporarily stop taking Etform 850 if they experience a condition that may lead to 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 850 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, accompanied by severe fatigue
• breathing difficulties
• decreased body temperature and slowed heart rate.

Lactic acidosis is a life-threatening condition that requires immediate hospital treatment. Etform 850 does not cause hypoglycemia (low blood sugar). However, if Etform 850 is taken with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia. If symptoms of hypoglycemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, eating or drinking something containing sugar usually helps. If the patient is to undergo major surgery, they should not take Etform 850 during and for some time after the surgery. The doctor will decide when the patient should stop and resume taking Etform 850.
Before taking Etform 850, the patient should discuss with their doctor if they experience any of the following situations:
the patient has symptoms of low blood sugarsuch as:

• weakness
• dizziness
• increased sweating
• rapid heartbeat
• vision disturbances
• difficulty concentrating If such symptoms occur, the patient should eat or drink something containing sugar. Etform 850 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 850 and other medicines".

During treatment with Etform 850, the doctor will check the patient's kidney function at least once a yearor more often if the patient is elderly and/or has kidney function disorders.

Children under 10 years of age

It is not recommendedto use Etform 850 in this age group.

Etform 850 and other medicines

If the patient is to be injected with a contrast agent containing iodine into the bloodstream, e.g. for an X-ray or CT scan, they should stop taking Etform 850 before or at the latest at the time of the injection. The doctor will decide when the patient should stop and resume taking Etform 850.
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 sugar checks and kidney function assessments or dose adjustments of Etform 850 by their doctor. It is especially important to inform about the use of:
medicines containing alcohol
corticosteroids, medicines to prevent transplant rejection, anti-inflammatory medicines (e.g. for skin conditions) or medicines 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 850 in the blood, especially in patients with kidney function disorders (e.g. 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 850 may cause excessive lowering of blood sugar. See "Warnings and precautions".

Etform 850 and alcohol

The patient should avoid consuming excessive amounts of alcohol while taking Etform 850, 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 sugar monitoring may be necessary.
This medicine is not recommended for breastfeeding women or women planning to breastfeed.

Driving and using machines

Etform 850 taken alone does not cause hypoglycemia (low blood sugar), and therefore 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 sulfonylureas, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased 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 850

This medicine should always be taken exactly as prescribed 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 Etform 850.
If the patient is also taking insulin, the doctor will inform them how to start taking Etform 850.

Etform 850 does not replace the benefits of a healthy lifestyle. The patient should follow the diet and exercise regimen recommended by their doctor.
* Etform 850 tablets with 500 mg and 1000 mg of the active substance (metformin hydrochloride) are also available on the market, allowing for individual dose adjustment.

Adults

Usual dose: 1 tablet of Etform 850 taken 2 or 3 times a day.
After about 2 weeks of treatment with Etform 850, the doctor may check the patient's blood sugar levels and adjust the dose.
Maximum dose: 3000 mg of metformin hydrochloride per day in three divided doses.

Children aged 10 years and older

Usual initial dose: 500 mg of metformin hydrochloride or 1 tablet of Etform 850 mg per day.
After about 2 weeks of treatment with Etform 850 in children, the doctor may check the patient's blood sugar levels and adjust the dose.
Maximum dose: 2000 mg of metformin hydrochloride per day in 2 or 3 divided doses.

Patient over 65 years of age

Due to the frequent kidney function disorders in this age group, the doctor will determine the dose of Etform 850 based on the patient's kidney function (see also "Warnings and precautions" in section 2).

Method of administration

Tablets should be swallowed with a glass of water during or after a meal.
The score line on the tablet is only to facilitate breaking the tablet and not to divide it into equal doses.
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 per day, they should take the medicine in the morning (breakfast) and evening (dinner).
• If the patient takes three doses per day, they should take the medicine in the morning (breakfast), at noon (lunch), and evening (dinner).

If the patient feels that the effect of Etform 850 is too strong or too weak, they should consult their doctor or pharmacist.

Monitoring of treatment

The doctor will regularly prescribe blood sugar tests and adjust the dose of Etform 850 according to the results. The patient should regularly visit their doctor for check-ups.
This is especially important for 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 for elderly patients or those with kidney function disorders.

Duration of treatment

The duration of treatment is determined by the doctor.

Taking a higher dose of Etform 850 than recommended

In case of taking a higher dose of Etform 850 than recommended, lactic acidosis may occur.
Symptoms of lactic acidosis are non-specific and include: vomiting, abdominal pain (abdominal cramps), general feeling of being unwell, accompanied by 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 850 and immediately contact their doctor or the nearest

hospital.

Missing a dose of Etform 850

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 the use of this medicine, the patient should consult their doctor or pharmacist.

Stopping treatment with Etform 850

Stopping treatment with Etform 850 without consulting a doctor may cause uncontrolled increase in blood sugar levels, which can increase the risk of long-term complications affecting the eyes, kidneys, and blood vessels.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Etform 850 can cause side effects, although not everybody gets them.
Etform 850 may very rarely cause a very serious side effect called lactic acidosis (may occur in less than 1 in 10,000 patients). If this happens to the patient, they should stoptaking Etform 850 and immediately contact their doctor or the nearesthospital, 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 850 with a meal or immediately after a meal. If the symptoms do not disappear, the patient should stop taking Etform 850 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 prescribe 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.
• skin redness
• itching
• pruritic rash
• abnormal liver function test results or hepatitis, which may cause:

If the patient experiences any of these symptoms, they should stop taking Etform 850 and consult their doctor immediately.

Children and adolescents

Limited data in children and adolescents indicate that the side effects have a similar nature and severity as those observed 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, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Etform 850

The medicine should be stored out of sight and reach of children. If Etform 850 is used in children, parents or caregivers should supervise the administration of the medicine.
Do not use this medicine 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. Contents of the pack and other information

What Etform 850 contains

Active substanceis metformin hydrochloride.
Each film-coated tablet contains 850 mg of metformin hydrochloride, which corresponds to 662.9 mg of metformin.
Other ingredients are: povidone K 90, magnesium stearate, hypromellose, macrogol 4000, titanium dioxide (E171).

What Etform 850 looks like and contents of the pack

White, oval, film-coated tablets with a score line on one side and the symbol "M 850" embossed on the other side, measuring 19 mm x 6.5 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 on this medicine and its names in other EU member states, 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
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