Package leaflet: Information for the patient

Entecavir Ranbaxy, 0.5 mg, film-coated tablets
Entecavir Ranbaxy, 1 mg, film-coated tablets
Entecavirum
Please read this leaflet carefully before taking this medicine because it contains important
information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Entecavir Ranbaxy is and what it is used for
Important information before taking Entecavir Ranbaxy
How to take Entecavir Ranbaxy
Possible side effects
How to store Entecavir Ranbaxy
Contents of the pack and other information

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

Entecavir Ranbaxy in tablet form is an antiviral medicine used to treat chronic (long-term)
hepatitis B virus (HBV) infection in adults. Entecavir Ranbaxy can be used in patients with liver damage but whose liver still functions properly (compensated liver function) as well as in patients whose liver is damaged and does not function properly (decompensated liver function).
Entecavir Ranbaxy in tablet form is also used to treat chronic (long-term) HBV infection in
children and adolescents aged 2 to 18 years. Entecavir Ranbaxy can be used in children whose liver is damaged but still functions properly (compensated liver function).
Hepatitis B virus infection can lead to liver damage. Entecavir Ranbaxy reduces the amount of virus in the body and improves liver function.

2. Information before using Entecavir Ranbaxy

When not to use Entecavir Ranbaxy:

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

Warnings and precautions
Before starting treatment with Entecavir Ranbaxy, please discuss this with your doctor or
pharmacist.

If the patient has any kidney disease, inform the doctor. This is important because Entecavir Ranbaxy is eliminated from the body through the kidneys, and it may be necessary to reduce the dose or adjust the dosing schedule.
Do not stop taking Entecavir Ranbaxy without consulting your doctor, as this may negatively affect the course of hepatitis. After stopping Entecavir Ranbaxy, the doctor will monitor the patient's condition and perform blood tests for several months.
Discuss with the doctor whether the liver is functioning properly and, if not, what potential impact this may have on treatment with Entecavir Ranbaxy.
If the patient is also infected with HIV (human immunodeficiency virus), inform the doctor. The patient should not take Entecavir Ranbaxy to treat hepatitis B virus (HBV) infection unless also receiving anti-HIV medications, as this could reduce the effectiveness of future HIV treatment. Entecavir Ranbaxy does not treat HIV infection.
Taking Entecavir Ranbaxy does not prevent spreading the hepatitis B virus (HBV) to others through sexual contact or bodily fluids (including infected blood). Therefore, it is important to take appropriate precautions to prevent transmission of HBV to others. A vaccine is available to protect individuals at risk of HBV infection.
Entecavir Ranbaxy belongs to a group of medicines that can cause lactic acidosis (excess lactic acid in the blood) and hepatomegaly (enlarged liver). Symptoms such as nausea, vomiting, and abdominal pain may indicate the development of lactic acidosis. This is a rare but serious adverse effect, which can occasionally be fatal. Lactic acidosis occurs more frequently in women, especially those who are significantly overweight. While taking Entecavir Ranbaxy, the doctor will regularly monitor the patient's condition.
If the patient has previously been treated for chronic hepatitis B, inform the doctor.

Children and adolescents
Entecavir Ranbaxy should not be used in children under 2 years of age or with body weight
less than 10 kg.
Entecavir Ranbaxy and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Entecavir Ranbaxy with food and drink
In most cases, Entecavir Ranbaxy can be taken with or without food.
However, if the patient previously took medicines containing lamivudine as the active substance, the following recommendations should be considered. If treatment has been switched to Entecavir Ranbaxy due to lamivudine treatment failure, Entecavir Ranbaxy should be taken once daily on an empty stomach. If liver disease is very advanced, the doctor may also recommend taking Entecavir Ranbaxy 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 (aged 2 to less than 18 years) may take Entecavir Ranbaxy regardless of meals.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or planning to become pregnant, she should inform her doctor. It has not been established that using Entecavir Ranbaxy during pregnancy is safe. Entecavir Ranbaxy should not be used during pregnancy unless specifically recommended by a doctor.
It is important that women of childbearing potential using Entecavir Ranbaxy use effective contraception to avoid becoming pregnant.
Do not breastfeed while taking Entecavir Ranbaxy. If the patient is breastfeeding, she should inform her doctor. It is not known whether entecavir, the active substance in Entecavir Ranbaxy, passes into human breast milk.
Driving and operating machinery
Dizziness, fatigue, and somnolence are commonly reported adverse effects that may impair the ability to drive or operate machinery. If in doubt, consult your doctor.
Entecavir Ranbaxy contains lactose
This medicine contains lactose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Entecavir Ranbaxy
Not all patients require the same dose of Entecavir Ranbaxy.
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose in adults is 0.5 mg or 1 mg once daily (orally).
The dose depends on:

prior treatment for HBV infection and medicines used;
presence of kidney function impairment; in such cases, the doctor may prescribe a lower dose or recommend less frequent dosing than once daily;
the patient's liver condition.

In children and adolescents (aged 2 to less than 18 years), the doctor will determine the appropriate dose based on the child's body weight.
Oral solution of entecavir is recommended for patients with body weight between 10 kg and 32.5 kg.
Children with body weight of at least 32.6 kg may take the oral solution or 0.5 mg tablets. The medicine is taken orally once daily. The use of entecavir has not been established in children under 2 years of age or with body weight less than 10 kg.
The appropriate dose should be determined by the doctor. Always take the dose prescribed by the doctor to ensure full therapeutic effectiveness and to minimize the development of treatment resistance. Entecavir Ranbaxy should be taken for as long as directed by the doctor. The doctor will inform the patient when to stop treatment.
Some patients must take this medicine on an empty stomach (see Entecavir Ranbaxy with food and drink in section 2). If the doctor advises taking tablets 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.
Taking more Entecavir Ranbaxy than prescribed
Contact your doctor immediately.
Missing a dose of Entecavir Ranbaxy
It is important not to miss any dose. If a dose is missed, take it as soon as possible, then continue with the next dose at the usual time. If it is almost time for the next dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a missed dose.
Do not stop treatment with Entecavir Ranbaxy without medical advice
After stopping this medicine, some patients may experience severe worsening of hepatitis. After stopping treatment, inform your doctor immediately about any changes in symptoms.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Patients treated with entecavir have reported the following adverse reactions:
Entecavir Ranbaxy may cause rare but serious adverse reactions called
lactic acidosis (excess lactic acid in the blood) and enlargement of the liver (see
section 2 in Warnings and precautions).

Adults
Common (affects at least 1 in 100 people):

headache;
insomnia, drowsiness;
feeling of fatigue (very strong exhaustion);
dizziness;
vomiting, diarrhoea, nausea, dyspepsia (indigestion);
increased liver enzyme activity in blood.

Uncommon (affects at least 1 in 1,000 people):

rash;
hair loss.

Rare (affects at least 1 in 10,000 people):

severe allergic reactions.

Children and adolescents
Adverse reactions observed in children and adolescents are similar to those occurring in
adults as described above, with the following difference:
Very common (affects at least 1 in 10 people): low neutrophil granulocyte count (a
type of white blood cells important in fighting infections).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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.: 22 49 21 301; fax: 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Entecavir Ranbaxy

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle label, or blister pack after: Expiry date. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Bottle: shelf life after first opening the bottle: 30 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Entecavir Ranbaxy contains

The active substance is entecavir (in the form of monohydrate entecavir). Each tablet contains 0.5 mg or 1 mg of entecavir (as entecavir monohydrate).
Other ingredients are: tablet core: lactose monohydrate, povidone K30, crospovidone type B, microcrystalline cellulose PH 102, magnesium stearate; coating Opadry 13B58802 White (Entecavir Ranbaxy, 0.5 mg): hypromellose 2910, 6 cP, titanium dioxide (E 171), macrogol 400, polysorbate 80; coating Opadry 13B84610 Pink (Entecavir Ranbaxy, 1 mg): hypromellose 2910, 6 cP, titanium dioxide (E 171), macrogol 400, polysorbate 80, iron oxide red (E 172).

What Entecavir Ranbaxy looks like and contents of the pack
Entecavir Ranbaxy, 0.5 mg are white to off-white, triangular film-coated tablets measuring 8.60 x 8.30 mm, with the imprint 'RL1' on one side and smooth on the other side.
Entecavir Ranbaxy, 1 mg are pale pink to pink, triangular film-coated tablets measuring 10.90 x 10.60 mm, with the imprint 'RL2' on one side and smooth on the other side.
Available pack sizes: HDPE bottle, blisters in packs of 30 or 90 film-coated tablets or single-dose blisters in packs of 30 x 1 or 90 x 1 film-coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw
Poland

Manufacturer/Importer
S.C. Terapia S.A.
Str. Fabricii nr. 124
400632 Cluj-Napoca, Jud. Cluj
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands
Alkaloida Chemical Company Zrt.
Kabay János u. 29
4440 Tiszavasvári
Hungary