Etform Sr

Package Leaflet: Information for the Patient

Etform SR, 500 mg, prolonged-release tablets

Etform SR, 750 mg, prolonged-release tablets

Etform SR, 1000 mg, prolonged-release tablets

Metformin hydrochloride

Read the package 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 SR and what is it used for
• 2. Important information before taking Etform SR
• 3. How to take Etform SR
• 4. Possible side effects
• 5. How to store Etform SR
• 6. Contents of the pack and other information

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

Etform SR in the form of prolonged-release tablets contains the active substance metformin hydrochloride and belongs to the group of medicines called biguanides, used to treat type 2 diabetes (non-insulin-dependent).
Etform SR is used to treat adults with type 2 diabetes when diet and physical exercise alone are not enough to control blood sugar levels, especially in patients who are overweight.
Etform SR can be used alone or in combination with other medicines used to treat diabetes (oral medicines or insulin).
Etform SR is also used to prevent type 2 diabetes in patients with a pre-diabetic condition.
Insulin is a hormone that allows the body's tissues to absorb glucose from the blood and use it for energy or store it for later use.
In people with type 2 diabetes, the pancreas does not produce enough insulin or the body does not respond properly to the insulin produced. This leads to a buildup of glucose in the blood, which can cause a range of serious, long-term problems, so it is essential to continue taking the medicine, even if the patient does not experience any obvious symptoms.
Etform SR increases the body's sensitivity to insulin and helps restore the normal use of glucose by the body.
Taking Etform SR is associated with either maintaining a stable body weight or a slight reduction in weight.
The prolonged-release tablets of Etform SR are specially designed to release the medicine slowly in the body, so they differ from many other types of metformin-containing tablets.

2. Important information before taking Etform SR

When not to take Etform SR

Warnings and precautions

Before starting to take Etform SR, the patient should discuss it with their doctor or pharmacist.

Risk of lactic acidosis

Etform SR may cause a very rare but very serious side effect called lactic acidosis, especially in patients with kidney function disorders. The risk of developing lactic acidosis also increases in case of uncontrolled diabetes, severe infections, prolonged fasting, or alcohol consumption, dehydration (more information below), liver problems, 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 these situations apply to the patient, they should consult their doctor for more detailed instructions.
The patient should contact their doctor immediately for further instructions if:
they have a genetically inherited disease affecting the 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.
after starting metformin, the patient experiences any of the following symptoms: seizures, cognitive impairment, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

The patient should stop taking Etform SR for a short period in situations that may involve

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

The patient should stop taking Etform SR 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
• stomach 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 a major surgical procedure, they must stop taking Etform SR during and for some time after the procedure. The doctor will decide when to stop and when to resume Etform SR treatment.
During Etform SR treatment, the doctor will monitor the patient's kidney function at least once a year or more frequently if the patient is elderly and (or) has worsening kidney function.
If the patient takes Etform SR in combination with other diabetes medicines (oral medicines or insulin), they should be careful about symptoms of hypoglycemia (such as fainting, confusion, and increased sweating).
In patients over 75 years old, Etform SR treatment should not be started to reduce the risk of developing type 2 diabetes.
Tablet residues may be visible in the stool. The patient should not be concerned, as this is normal when taking this type of tablet.
The patient should continue to follow any dietary advice given by their doctor and ensure they eat carbohydrates regularly throughout the day.
The patient should not stop taking Etform SR without consulting their doctor.

Etform SR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
If the patient is to be injected with a contrast agent containing iodine, e.g., for an X-ray examination or computed tomography, they must stop taking Etform SR before or at the latest during the injection. The doctor will decide when the patient must stop and when to resume Etform SR treatment.
More frequent monitoring of blood sugar levels and kidney function may be necessary, and the doctor may adjust the dose of Etform SR. It is particularly important to inform about the use of:
diuretics (such as furosemide)
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)
corticosteroids, such as prednisolone, mometasone, beclomethasone
sympathomimetics, including epinephrine and dopamine, used to treat heart attack and low blood pressure. Epinephrine is also a component of some dental anesthetics.
medicines that may change the amount of Etform SR in the blood, especially in patients with reduced kidney function (e.g., verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib),
other medicines used to treat diabetes.

Etform SR and alcohol

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
If the patient is breastfeeding or plans to breastfeed, they should not take Etform SR.

Driving and using machines

Etform SR used alone does not cause hypoglycemia (symptoms of low blood sugar, such as fainting, confusion, and increased sweating), so it should not affect the ability to drive or use machines.
However, the patient should be careful if they are also taking other diabetes medicines that can cause hypoglycemia. If the patient experiences such symptoms, they should not drive or use machines.

3. How to take Etform SR

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor may prescribe Etform SR to be taken alone or in combination with other oral diabetes medicines or insulin.
Recommended dose

Treatment of diabetes with metformin alone or in combination with other medicines

Treatment usually starts with 500 mg of Etform SR per day. After about 2 weeks of taking Etform SR, the doctor may check the blood sugar level and adjust the dose.
The maximum daily dose of Etform SR is 2000 mg.
If the patient has reduced kidney function, the doctor may prescribe a lower dose.

Treatment of pre-diabetic condition with metformin alone

Usually, 1000 mg to 1500 mg of Etform SR is taken once a day.
The doctor will assess whether regular treatment is needed.
Tablets are usually taken once a day, with the evening meal.
In some cases, the doctor may recommend taking tablets twice a day. Tablets should always be taken with a meal.
Tablets should be swallowed whole, with a glass of water, and not chewed.

Use in children and adolescents

Etform SR should not be used in children and adolescents.

Taking a higher dose of Etform SR than recommended

If the patient accidentally takes extra tablets, they should not be concerned, but if unusual symptoms occur, they should tell their doctor. In case of a large overdose, there is a higher risk of developing lactic acidosis. The symptoms of lactic acidosis are non-specific, e.g., vomiting, stomach pain with muscle cramps, general feeling of being unwell with severe fatigue, and breathing difficulties. Later symptoms include low body temperature and slow heart rate. If any of these symptoms occur, the patient should immediately seek medical help, as lactic acidosis can lead to coma. The patient should stop taking Etform SR and immediately consult their doctor or go to the nearest hospital.

Missing a dose of Etform SR

The next dose should be taken as soon as possible with a meal. The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Etform SR can cause side effects, although not everybody gets them.
The following side effects may occur:
Etform SR may very rarely (less than 1 in 10,000 people) cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this occurs, the patient should stop taking Etform SR and immediately contact their doctor or the nearest hospital, as lactic acidosis can lead to coma.
Etform SR may cause abnormal liver function test results and hepatitis, which can lead to jaundice (very rare, may occur less than 1 in 10,000 people). If the patient experiences yellowing of the eyes and (or) skin, they should immediately consult their doctor.
Other possible side effects are listed below by frequency:

Very common (may affect more than 1 in 10 people):
diarrhea, nausea, vomiting, stomach pain, or loss of appetite. If these symptoms occur, the patient should not stop taking the tablets, as they usually disappear after about 2 weeks. It is helpful to take the tablet with a meal or immediately after it.
Common (may affect less than 1 in 10 people):
change in taste
Very rare (may affect less than 1 in 10,000 people):
reduced vitamin B levels in the blood
skin rashes, including redness, itching, and hives.

Reporting side effects

If the patient experiences any side effects, including any 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +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 SR

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicinal product.
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 SR contains

The active substance is metformin hydrochloride Metformin hydrochloride
Etform SR, 500 mg
Each tablet contains 500 mg of metformin hydrochloride, equivalent to 390 mg of metformin.
Etform SR, 750 mg
Each tablet contains 750 mg of metformin hydrochloride, equivalent to 585 mg of metformin.
Etform SR, 1000 mg
Each tablet contains 1000 mg of metformin hydrochloride, equivalent to 780 mg of metformin.
Other ingredients are:
Core:stearic acid, shellac, povidone K 30, colloidal silica, anhydrous, magnesium stearate.
Coating:hypromellose, hydroxypropylcellulose, titanium dioxide (E 171), propylene glycol, macrogol 6000, talc.

What Etform SR looks like and contents of the pack

Etform SR, 500 mg
Almost white, oval, biconvex, film-coated tablets, smooth on both sides.
Approximate dimensions: 15 mm x 8.5 mm.
Etform SR, 750 mg
Almost white, biconvex, film-coated tablets in the shape of a capsule, smooth on both sides. Approximate dimensions: 19.1 mm x 9.3 mm.
Etform SR, 1000 mg
Almost white, oval, biconvex, film-coated tablets with a dividing line on one side and smooth on the other side. Approximate dimensions: 20.4 mm x 9.7 mm.
PVC/PVDC/Aluminum blisters
Pack sizes: 30, 60, or 120 tablets in a blister.

Marketing authorization holder and importer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Importer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Sachsen-Anhalt, Barleben
Germany
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana, Slovenia

For more information about this medicine, please contact:

Sandoz Polska Sp. z o.o.
Domaniewska 50 C
02-672 Warsaw
phone: 22 209 70 00

This medicinal product is authorized in the Member States of the EEA under the following names:

Poland
Etform SR
Bulgaria
Meglucon XR 500 mg prolonged release tablet
Meglucon XR 750 mg prolonged release tablet
Meglucon XR 1000 mg prolonged release tablet
Date of last revision of the leaflet:05/2025
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