Entecavir Ranbaxi

Package Leaflet: Information for the Patient

Entecavir Ranbaxy, 0.5 mg, Film-Coated Tablets

Entecavir Ranbaxy, 1 mg, Film-Coated Tablets

Entecavir

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Entecavir Ranbaxy in tablet form is an antiviral medicine used to treat chronic (long-term) hepatitis B virus (HBV) infection in adults.

HBV) in adults.Entecavir Ranbaxy can be used in people with damaged liver function but still functioning properly (with compensated liver function) and in people with damaged liver function that is not functioning properly (with decompensated liver function).

Entecavir Ranbaxy in tablet form is also used to treat chronic

(long-term) HBV infection in children and adolescents from 2 to 18 years of age.Entecavir Ranbaxy 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 Ranbaxy reduces the amount of virus in the body and improves liver function.

2. Important information before taking Entecavir Ranbaxy

When not to take Entecavir Ranbaxy:

Warnings and precautions

Before starting treatment with Entecavir Ranbaxy, discuss this with your doctor or pharmacist.

• If you have ever had kidney disease,tell your doctor. This is important because Entecavir Ranbaxy is excreted from the body by the kidneys and may need to have the dose reduced or the dosing schedule changed.
• Do not stop taking Entecavir Ranbaxy without consulting your doctor,as this may affect the course of hepatitis B. After stopping Entecavir Ranbaxy, your doctor will monitor your condition and perform blood tests for several months.
• Discuss with your doctor whether your liver is functioning properly, and if not, what potential impact this may have on the treatment with Entecavir Ranbaxy.
• If you are also infected with HIV(human immunodeficiency virus), tell your doctor. You should not take Entecavir Ranbaxy to treat hepatitis B virus infection if you are not receiving HIV treatment, as this may reduce the future effectiveness of HIV treatment. Entecavir Ranbaxy does not treat HIV infection.
• Taking Entecavir Ranbaxy does not prevent the infection of other people with hepatitis B virus (HBV)through sexual contact or bodily fluids (including infected blood). Therefore, it is essential to take appropriate precautions to prevent the infection of HBV in other people. A vaccine is available to protect people at risk of HBV infection.
• Entecavir Ranbaxy belongs to a group of medicines that can cause lactic acidosis(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. While taking Entecavir Ranbaxy, your doctor will regularly monitor your condition.
• If you have been previously treated for chronic hepatitis B,tell your doctor.

Children and adolescents

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

Entecavir Ranbaxy and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Entecavir Ranbaxy with food and drink

In most cases, Entecavir Ranbaxy can be taken with or without food.
If you have previously taken medicines containing lamivudine as the active substance, consider the following recommendations. If treatment has been changed to Entecavir Ranbaxy due to lamivudine treatment failure, take Entecavir Ranbaxy once daily on an empty stomach. If liver disease is very advanced, your doctor will 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 (from 2 to less than 18 years of age) can take Entecavir Ranbaxy with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or planning to become pregnant, tell your doctor. The use of Entecavir Ranbaxy during pregnancy is not recommended unless clearly necessary.
Women of childbearing potential using Entecavir Ranbaxy should use effective contraception to avoid becoming pregnant.
Do not breastfeed during treatment with Entecavir Ranbaxy. If you are breastfeeding, tell your doctor. It is not known whether entecavir, the active substance of Entecavir Ranbaxy, passes into human breast milk.

Driving and using machines

Dizziness, fatigue, and somnolence are common side effects that may affect your ability to drive or use machines. If you are unsure, consult your doctor.

Entecavir Ranbaxy contains lactose

This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Entecavir Ranbaxy

Not all patients need to take the same dose of Entecavir Ranbaxy.

Entecavir Ranbaxy.

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
The recommended dose for adultsis 0.5 mg or 1 mg once daily (orally).

The dose of Entecavir Ranbaxy depends on:

• previous treatment for HBV infection and the medicines used;
• the presence of kidney function disorders; in this case, your doctor may prescribe a lower dose or recommend taking the medicine less frequently than once daily;
• the patient's liver condition.

For children and adolescents(from 2 to less than 18 years of age), your doctor will determine the appropriate dose based on the child's body weight.
Entecavir oral solution is recommended for patients with a body weight of 10 kg to 32.5 kg.
Children with a body weight of at least 32.6 kg can take the oral solution or 0.5 mg tablets. The medicine is taken orally, once daily. There are no recommendations for the use of entecavir in children under 2 years of age or weighing less than 10 kg.
The recommendation for the dose is the responsibility of the doctor. Always take the dose recommended by your doctor to ensure the full effectiveness of the treatment and to limit the development of resistance to the treatment. Entecavir Ranbaxy should be taken for as long as your doctor recommends. Your doctor will inform you about the end of treatment.
Some patients may need to take this medicine on an empty stomach (see Entecavir Ranbaxy with food and drink in section 2). If your doctor recommends taking the 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 than the recommended dose of Entecavir Ranbaxy

Contact your doctor immediately.

Missing a dose of Entecavir Ranbaxy

It is important not to miss any dose. If you miss a dose, take it as soon as possible, and then take the next tablets at the usual time. If it is almost time for the next dose, do not take the missed tablets. Wait and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Do not stop taking Entecavir Ranbaxy without consulting your doctor

After stopping Entecavir Ranbaxy, some patients may experience severe hepatitis symptoms. After stopping treatment, immediately inform your doctor of any changes in symptoms.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Entecavir Ranbaxy can cause side effects, although not everybody gets them.
Patients treated with entecavir have reported the following side effects:

Entecavir Ranbaxy may cause a rare but serious side effect called

lactic acidosis(excess of lactic acid in the blood) and liver enlargement (see section 2, Warnings and precautions).

Adults

Common (at least 1 in 100 patients):

• headache;
• insomnia, somnolence;
• fatigue (very severe exhaustion);
• dizziness;
• vomiting, diarrhea, nausea, dyspepsia (indigestion);
• increased liver enzyme activity in the blood.

Uncommon (at least 1 in 1,000 patients):

• rash;
• hair loss.

Rare (at least 1 in 10,000 patients):

• severe allergic reactions.

Children and adolescents

Side effects observed in children and adolescents are similar to those in adults and are described above, with the following difference:
Very common (at least 1 in 10 patients): low neutrophil count (a type of white blood cell important in fighting infections).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Entecavir Ranbaxy

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, label, or blister after: Expiry date. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Bottle: shelf-life after first opening of 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 required. This will help protect the environment.

6. Contents of the pack and other information

What Entecavir Ranbaxy contains

• The active substance is entecavir (as entecavir monohydrate). Each tablet contains 0.5 mg or 1 mg of entecavir (as entecavir monohydrate).
• The 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, 8.60 x 8.30 mm in size, with ‘RL1’ embossed on one side and plain on the other.
Entecavir Ranbaxy, 1 mg, are pale pink to pink, triangular, film-coated tablets, 10.90 x 10.60 mm in size, with ‘RL2’ embossed on one side and plain on the other.
The pack sizes are: 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 authorization holder and manufacturer

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw

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
Netherlands
Alkaloida Chemical Company Zrt.
Kabay János u. 29
4440 Tiszavasvári
Hungary
Date of last revision of the leaflet: 28.06.2023