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
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 share it with others.
The medicine may harm another person, even if their symptoms are similar.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet,
inform your doctor or pharmacist.
See section 4.
Table of contents of the leaflet:

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

Etform SR prolonged-release tablets contain the active substance metformin hydrochloride and belong to a group of medicines called biguanides, used in the treatment of type 2 (non-insulin-dependent) diabetes.
Etform SR is used in the treatment of adult patients with type 2 diabetes when diet and physical exercise alone are insufficient to achieve adequate control of blood glucose (sugar) levels, particularly in patients who are overweight.
Etform SR may be used as monotherapy or in combination with other antidiabetic medicines (oral antidiabetic agents or insulin).
Etform SR is also used for the prevention of type 2 diabetes in patients with prediabetes.
Insulin is a hormone that enables body tissues to take up 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 accumulation of glucose in the blood, which may cause a number of serious, long-term complications. Therefore, it is important for the patient to continue taking the medicine regularly, even if no obvious symptoms are present.
Etform SR increases the body's sensitivity to insulin and helps restore the normal way the body uses glucose.
Treatment with Etform SR is associated either with stable body weight or with slight weight reduction.
The prolonged-release tablets of Etform SR are specially designed to release the medicine slowly in the body and therefore differ from many other types of tablets containing metformin.

2. Information before using Etform SR

When not to use Etform SR

• if the patient is allergic to metformin or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause rash, itching or shortness of breath.
• if the patient has liver function disorders.
• if the patient has significantly reduced kidney function.
• 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. Diabetic ketoacidosis is a condition in which substances called "ketone bodies" accumulate in the blood and may lead to a diabetic pre-coma state. Symptoms include abdominal pain, rapid deep breathing, drowsiness or unusual fruity odour of breath.
• if the patient has lost too much body fluid (dehydration). Dehydration may cause kidney problems, increasing the risk of developing lactic acidosis (see below "Warnings and precautions").
• if the patient has a severe infection, e.g. affecting the lungs, bronchi or kidneys. Severe infections may impair kidney function and increase the risk of lactic acidosis (see below "Warnings and precautions").
• if the patient has been treated for acute heart failure or recently suffered a myocardial infarction, or has severe circulatory disorders or breathing difficulties. These conditions may lead to inadequate oxygen supply to tissues, increasing the risk of lactic acidosis (see below "Warnings and precautions").
• if the patient drinks large amounts of alcohol.
• if the patient is under 18 years of age.

Warnings and precautions
Before starting treatment with Etform SR, discuss this with your doctor or pharmacist.
Risk of lactic acidosis
Etform SR may cause a very rare but serious adverse effect called lactic acidosis, especially in patients with impaired kidney function. The risk of lactic acidosis is also increased in cases of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (further details below), liver problems, and any medical conditions in which part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).
If any of the above situations apply to the patient, consult a doctor for further instructions.
Contact a doctor immediately for further guidance if:
the patient has a genetically inherited disorder affecting mitochondria (cellular structures producing energy), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
after starting metformin, the patient develops any of the following symptoms: seizures, worsening cognitive function, movement difficulties, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.
Etform SR should be temporarily discontinued in situations that may lead to dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, exposure to high temperatures, or reduced fluid intake. Consult a doctor for further instructions.
Stop taking Etform SR immediately and contact a doctor or the nearest hospital if the patient experiences any symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• abdominal pain
• muscle cramps
• general malaise accompanied by severe fatigue
• difficulty breathing
• low body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring hospital treatment.
If the patient is scheduled for major surgery, Etform SR must be discontinued before and for some time after the procedure. The doctor will decide when to stop and when to resume treatment with Etform SR.
During treatment with Etform SR, the doctor will monitor kidney function at least once a year, or more frequently if the patient is elderly and/or has deteriorating kidney function.
If the patient takes Etform SR in combination with other antidiabetic medicines (oral agents or insulin), be alert for symptoms of hypoglycaemia (such as fainting, confusion and excessive sweating).
Etform SR should not be initiated in patients over 75 years of age for the purpose of reducing the risk of type 2 diabetes.
Tablet residues may be visible in the stool. This is normal for this type of tablet and should not be a cause for concern.
Continue to follow all dietary recommendations given by the doctor and ensure regular intake of carbohydrates throughout the day.
Do not discontinue treatment without consulting your doctor.
Etform SR and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
If the patient is to receive an iodine-containing contrast agent intravenously, for example during an X-ray or CT scan, Etform SR must be discontinued before or at the latest at the time of injection. The doctor will decide when to stop and when to resume taking Etform SR.
More frequent monitoring of blood glucose levels and kidney function may be necessary, or the doctor may adjust the dose of Etform SR. It is especially important to inform about the use of:
diuretics (medicines that increase urine production), 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)
steroids, such as prednisolone, mometasone, beclomethasone
sympathomimetics, including epinephrine and dopamine, used in the treatment of myocardial infarction and low blood pressure. Epinephrine is also an ingredient in some dental anaesthetics.
medicines that may alter the blood levels of Etform SR, especially in patients with reduced kidney function (e.g. verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
other medicines used in the treatment of diabetes.
Etform SR and alcohol
Avoid excessive alcohol consumption while taking Etform SR, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant or plans to become pregnant, she should consult her doctor before using this medicine.
If the patient is breastfeeding or intends to breastfeed, she should not take Etform SR.
Driving and operating machinery
Etform SR, when used as monotherapy, does not cause hypoglycaemia (symptoms of low blood sugar such as fainting, confusion and excessive sweating), and therefore should not affect the ability to drive or operate machinery.
However, caution is advised if, in addition to Etform SR, the patient is also taking other antidiabetic medicines that may cause hypoglycaemia. If such symptoms occur, the patient should not drive or operate machinery.

3. How to take Etform SR

This medicine should always be taken according to your doctor's instructions. If you have any doubts,
you should consult your doctor or pharmacist.
Your doctor may prescribe Etform SR to be taken as monotherapy or in combination with other
oral antidiabetic medicines or insulin.
Recommended dose
Treatment of diabetes with metformin as monotherapy or in combination with other medicines
Treatment usually starts with 500 mg of Etform SR once daily. After approximately 2 weeks of
taking Etform SR, your doctor may check your blood sugar levels and adjust the dose accordingly.
The maximum daily dose of Etform SR is 2000 mg.
If you have reduced kidney function, your doctor may prescribe a lower dose.
Treatment of prediabetes with metformin as monotherapy
The usual dose is 1000 mg to 1500 mg of Etform SR once daily.
Your doctor will assess whether ongoing treatment is necessary.
Tablets are usually taken once daily with the evening meal.
In some cases, your doctor may recommend taking the tablets twice daily. Tablets should always be taken with food.
The tablets must be swallowed whole with a glass of water and must not be chewed.
Use in children and adolescents
Etform SR must not be used in children and adolescents.
Accidental overdose of Etform SR
If additional tablets are taken by mistake, do not panic, but inform your doctor if any unusual symptoms occur. In the case of a large overdose, there is an increased risk of lactic acidosis. Symptoms of lactic acidosis are nonspecific, such as vomiting, abdominal pain with muscle cramps, general malaise with severe fatigue, and difficulty breathing. Later symptoms include lowered body temperature and slowed heart rate. If any of these symptoms occur, seek immediate medical attention, as lactic acidosis may lead to coma. You must immediately stop taking Etform SR and contact your doctor or go to the nearest hospital without delay.
Missed dose of Etform SR
Take the next dose as soon as possible with food. Do not take a double dose to make up for the missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects may occur:
Etform SR may very rarely (less frequently than in 1 out of 10,000 people) cause a very serious adverse effect known as lactic acidosis (see "Warnings and precautions"). If this occurs in a patient, administration of Etform SR must be stopped immediately and medical advice must be sought immediately from a doctor or the nearest hospital, because lactic acidosis may lead to coma.
Etform SR may cause abnormal liver function test results and hepatitis, which may lead to jaundice (very rarely, may occur less frequently than in 1 out of 10,000 people). If yellowing of the eyes and/or skin occurs in a patient, medical advice should be sought immediately.
Other possible adverse effects are listed below by frequency of occurrence:
Very common (may affect more than 1 in 10 people):
diarrhoea, nausea, vomiting, abdominal pain or loss of appetite. If these symptoms occur, do not stop taking the tablets, as they usually resolve after about 2 weeks. It is helpful to take the tablet during or immediately after a meal.
Common (may affect less than 1 in 10 people):
taste disturbances
Very rare (may affect less than 1 in 10,000 people):
reduced blood levels of vitamin B
skin rashes, including redness, itching and urticaria.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Etform SR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box or
blister pack after EXP. The expiry date refers to the last day of the stated month.
No special storage precautions apply for this medicinal product.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
Such measures help protect the environment.

6. Contents of the pack and other information

What Etform SR contains
The active substance is metformin hydrochloride Metformini hydrochloridum
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.
The other ingredients are:
Tablet core: stearic acid, shellac, povidone K 30, colloidal anhydrous silica, 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 coated tablets, smooth on both sides.
Approximate dimensions: 15 mm x 8.5 mm.
Etform SR, 750 mg
Almost white, biconvex, capsule-shaped coated tablets, smooth on both sides.
Approximate dimensions: 19.1 mm x 9.3 mm.
Etform SR, 1000 mg
Almost white, oval, biconvex coated tablets with a dividing line on one side and smooth on the other side.
Approximate dimensions: 20.4 mm x 9.7 mm.
Packs: PVC/PVDC/Aluminium blisters.
Pack sizes: 30, 60 or 120 tablets in a blister pack.

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

For further information about this medicinal product, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Tel. 22 209 70 00

This medicinal product is registered in the EEA countries 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