Entecavir Fomed

Leaflet included in the packaging: information for the user

Entecavir Fomed, 0.5 mg, coated tablets

Entecavir

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

You should keep this leaflet, so that you can read it again if necessary.

In case of any doubts, you should consult a doctor or pharmacist.

This medicine has been prescribed to you personally. 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 undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Entecavir Fomed and what is it used for
• 2. Important information before taking Entecavir Fomed
• 3. How to take Entecavir Fomed
• 4. Possible side effects
• 5. How to store Entecavir Fomed
• 6. Contents of the packaging and other information

1. What is Entecavir Fomed and what is it used for

Entecavir Fomed in tablet form is an antiviral medicine used in adults to treat chronic (long-term) viral hepatitis B

(HBV).Entecavir Fomed can be used in patients with damaged liver function, but still functioning properly (with compensated liver function) and in patients whose liver does not function properly (with decompensated liver function).

Entecavir Fomed in tablet form is also used to treat chronic

(long-term) HBV infection in children and adolescents from 2 years to less than 18 years.Entecavir Fomed can be used in children whose liver is damaged but still functions properly (with compensated liver function).
Hepatitis B virus infection can lead to liver damage. Entecavir Fomed reduces the amount of virus in the body and improves liver function.

2. Important information before taking Entecavir Fomed

When not to take Entecavir Fomed

If the patient is allergic (hypersensitive)to entecavir or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Entecavir Fomed, you should discuss it with your doctor or pharmacist.

If the patient has had any kidney disease,they should inform their doctor. This is important because Entecavir Fomed is excreted from the body by the kidneys and it may be necessary to reduce the dose of the medicine or change the dosing schedule.

Do not stop taking Entecavir Fomed without consulting

your doctor,as this may have a negative impact on the course of hepatitis. After stopping Entecavir Fomed, the doctor will monitor the patient's condition for several months and perform blood tests.

You should discuss with your doctor whether your liver is functioning properly, and if not, what the potential impact of its condition on the treatment with Entecavir Fomed may be.

If the patient is also infected with HIV(human immunodeficiency virus), they should inform their doctor. The patient should not take Entecavir Fomed to treat hepatitis B, if they are not receiving HIV treatment, as this may reduce the effectiveness of future HIV treatment. Entecavir Fomed does not treat HIV infection.

Taking Entecavir Fomed does not prevent infection of other people with hepatitis B virus

(HBV)through sexual contact or bodily fluids (including infected blood). Therefore, it is also important to take appropriate precautions to prevent the infection of other people with HBV. A vaccine is available to protect people at risk of HBV infection.

Entecavir Fomed belongs to a group of medicines that can cause lactic acidosis

(an excess of lactic acid in the blood) and liver enlargement. Symptoms such as nausea, vomiting, and abdominal pain may indicate the development of lactic acidosis. This is a rare but serious side effect, sometimes fatal. Lactic acidosis occurs more frequently in women, especially those who are significantly overweight. During treatment with Entecavir Fomed, the doctor will regularly monitor the patient's condition.

If the patient has been previously treated for chronic hepatitis B,

they should inform their doctor.

Children and adolescents

Entecavir Fomed should not be used in children under 2 years of age or weighing less than 10 kg.

Entecavir Fomed and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Taking Entecavir Fomed with food and drink

In most cases, Entecavir Fomed can be taken with or without food. However, if the patient has previously taken medicines containing lamivudine as an active substance, the following recommendations should be considered. If the treatment has been changed to Entecavir Fomed due to the ineffectiveness of lamivudine, Entecavir Fomed should be taken once a day, on an empty stomach. If the liver disease is very advanced, the doctor will also recommend taking Entecavir Fomed on an empty stomach. This means taking the medicine at least 2 hours after a meal and at least 2 hours before the next meal.
Children and adolescents (from 2 to less than 18 years) can take Entecavir Fomed regardless of meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or plans to have a child, they should consult their doctor. So far, it has not been shown that taking Entecavir Fomed during pregnancy is safe. Entecavir Fomed should not be taken during pregnancy, unless it is specifically recommended by the doctor. It is important for women of childbearing age taking Entecavir Fomed to use effective contraception to avoid becoming pregnant.
During treatment with Entecavir Fomed, the patient should not breastfeed. If the patient is breastfeeding, they should inform their doctor. It is not known whether entecavir, the active substance of Entecavir Fomed, passes into human milk.

Driving and using machines

Dizziness, fatigue, and drowsiness are common side effects that may affect the ability to drive and operate machinery. In case of any doubts, the patient should consult their doctor.

Entecavir Fomed contains lactose

This medicine contains lactose. Before taking this medicinal product, the patient should contact their doctor if they have previously been diagnosed with intolerance to some sugars.

3. How to take Entecavir Fomed

Not every patient needs to take the same dose of Entecavir Fomed.

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose for adultsis 0.5 mg or 1 mg once a day (orally).

The dose of the medicine depends on:

previous treatment of HBV infection and the medicines used;

the presence of kidney function disorders; in this case, the doctor may prescribe a lower dose of the medicine or recommend taking the medicine less frequently than once a day;

the patient's liver condition.
For children and adolescents(from 2 to less than 18 years), the doctor will determine the appropriate dose based on the child's body weight.
Children weighing at least 32.6 kg can take a 0.5 mg tablet or entecavir in the form of an oral solution. For patients weighing from 10 kg to 32.5 kg, entecavir in the form of an oral solution is recommended. All doses are taken once a day (orally). There are no recommendations for entecavir in children under 2 years of age or weighing less than 10 kg.
The doctor will determine the appropriate dose based on the child's body weight.
The recommendation for the correct dose is the responsibility of the doctor. The patient should always take the dose recommended by the doctor to ensure the full effectiveness of the medicine and to limit the development of resistance to treatment. Entecavir Fomed should be taken for as long as the doctor recommends. The doctor will inform the patient about the end of treatment.
Some patients may need to take Entecavir Fomed on an empty stomach (see Entecavir Fomed with food and drink, section 2). If the doctor recommends taking Entecavir Fomed on an empty stomach, it means taking the medicine at least 2 hours after a meal and at least 2 hours before the next meal.

Taking a higher dose of Entecavir Fomed than recommended

The patient should immediately contact their doctor.

Missing a dose of Entecavir Fomed

It is important not to miss any dose of the medicine. If the patient misses a dose of Entecavir Fomed, they should take it as soon as possible, and then take the next dose at the usual time. If it is almost time for the next dose, the patient should not take the missed dose. They should wait and take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Do not stop taking Entecavir Fomed without consulting your doctor

After stopping Entecavir Fomed, some people may experience severe symptoms of hepatitis. The patient should immediately inform their doctor about any changes in symptoms that occur after stopping treatment.
In case of any further doubts related to the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Entecavir Fomed can cause side effects, although not everybody gets them.
Patients treated with entecavir have reported the following side effects:
common (at least 1 in 100 patients): headache, insomnia, fatigue (very severe exhaustion), dizziness, drowsiness, vomiting, diarrhea, nausea, dyspepsia (indigestion), and increased liver enzyme activity in the blood;
uncommon (at least 1 in 1000 patients): rash or hair loss;
rare (at least 1 in 10,000 patients): severe allergic reactions.
If the patient experiences any side effects, including any side effects not mentioned in this leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not mentioned in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail:
ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Entecavir Fomed

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
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 packaging and other information

What Entecavir Fomed contains

The active substance of the medicine is entecavir. Each coated tablet contains 0.5 mg of entecavir (as entecavir monohydrate).

The other ingredients are: lactose monohydrate, microcrystalline cellulose, crospovidone type B, hypromellose 6 mPa·s, magnesium stearate.
The coating Opadry white 13B58802 contains: hypromellose 6 mPa·s, titanium dioxide (E171), macrogol 400, polysorbate 80.

What Entecavir Fomed looks like and contents of the pack

White, triangular-shaped coated tablets with dimensions 8.7 x 8.4 mm, with the inscription "A" on one side and "88" on the other side.
The medicine is packaged in blisters (OPA/Aluminium/PVC/Aluminium) containing 30 or 90 coated tablets, in a carton.
Not all pack sizes may be marketed.

Marketing authorization holder:

FOMED PHARMACEUTICALS SL
Gabriel Garcia Marquez 4, las Rozas
Madrid, Spain

Importer:

Pharmacare Premium Ltd.
HHF003 Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Wessling Hungary Kömyezetvédelmi
Fóti út 56
1047 Budapest
Hungary

Date of last revision of the leaflet: 24 July 2019