Entecavir Aurovitas

Package Leaflet: Information for the User

Entecavir Aurovitas, 0.5 mg, film-coated tablets

Entecavir Aurovitas, 1 mg, film-coated tablets

Entecavir

Read all of 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, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

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

(HBV).Entecavir Aurovitas can be used in patients with liver damage, but still functioning properly (with compensated liver disease) and in patients with liver damage that is not functioning properly (with decompensated liver disease).

Entecavir Aurovitas is also used to treat chronic HBV infection in children and adolescents from 2 years to less than 18 years of age.

Entecavir Aurovitas can be used in children with liver damage that is still functioning properly (with compensated liver disease).
Hepatitis B virus infection can lead to liver damage. Entecavir Aurovitas reduces the amount of virus in the body and improves liver function.

2. Before you take Entecavir Aurovitas

Do not take Entecavir Aurovitas

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

Warnings and precautions

Before taking Entecavir Aurovitas, talk to your doctor or pharmacist.

• If you have ever had any kidney problems, tell your doctor. This is important because Entecavir Aurovitas is removed from the body by the kidneys and may need a dose adjustment or a change in dosing schedule.
• Do not stop taking Entecavir Aurovitas without talking to your doctor, as this may worsen your hepatitis. After stopping Entecavir Aurovitas, your doctor will monitor your condition and perform blood tests for several months.
• Discuss with your doctor whether your liver is working properly, and if not, what the potential impact could be on your treatment with Entecavir Aurovitas.
• If you are also infected with HIV (human immunodeficiency virus), tell your doctor. You should not take Entecavir Aurovitas to treat your hepatitis B virus infection if you are not also taking medicines to treat your HIV infection, as this may reduce the future effectiveness of HIV treatment. Entecavir Aurovitas does not treat HIV infection.
• Taking Entecavir Aurovitas does not prevent the spread of hepatitis B virus to other peoplethrough sexual contact or body fluids (including blood). Therefore, it is important to take appropriate precautions to prevent the spread of hepatitis B virus to others. A vaccine is available to protect those at risk of hepatitis B virus infection.
• Entecavir Aurovitas belongs to a group of medicines that can cause lactic acidosis (a build-up of lactic acid in the blood)and an enlarged liver. Symptoms such as nausea, vomiting, and abdominal pain might indicate the development of lactic acidosis. This is a rare but serious side effect, sometimes fatal. Lactic acidosis occurs more often in women, especially if they are significantly overweight. While taking Entecavir Aurovitas, your doctor will monitor your condition.
• If you have been treated before for chronic hepatitis B, tell your doctor.

Children and adolescents

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

Entecavir Aurovitas with other medicines

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

Taking Entecavir Aurovitas with food and drink

In most cases, Entecavir Aurovitas can be taken with or without food. However, if you have previously taken medicines containing lamivudine, consider the following recommendations. If your treatment is switched to Entecavir Aurovitas because lamivudine is no longer effective, take Entecavir Aurovitas once daily on an empty stomach. If your liver disease is very advanced, your doctor may also recommend taking Entecavir Aurovitas 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.

Entecavir Aurovitas 0.5 mg:

Children and adolescents (from 2 to less than 18 years of age) can take Entecavir Aurovitas without regard to food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice. Up to now, it has not been proven that taking Entecavir Aurovitas during pregnancy is safe. You should not take Entecavir Aurovitas during pregnancy unless clearly necessary. It is important that women of childbearing age using Entecavir Aurovitas use effective contraception to prevent pregnancy. Do not breast-feed during treatment with Entecavir Aurovitas. If you are breast-feeding, tell your doctor. It is not known whether entecavir, the active ingredient in Entecavir Aurovitas, 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 operate machines. If you are affected, do not drive or operate machines. Consult your doctor if you are unsure.
Entecavir Aurovitas contains lactose.If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Entecavir Aurovitas

The same dose of Entecavir Aurovitas is not suitable for all patients.

Entecavir Aurovitas.

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The recommended dose for adultsis 0.5 mg or 1 mg once daily (by mouth).

The dose depends on:

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

Entecavir Aurovitas 0.5 mg:

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 weight. Children weighing at least 32.6 kg can take a 0.5 mg tablet or entecavir oral solution. For patients weighing from 10 kg to 32.5 kg, entecavir oral solution is recommended. All doses are taken once daily (by mouth). There are no recommendations for Entecavir Aurovitas in children under 2 years of age or weighing less than 10 kg.
Your doctor will determine the appropriate dose based on the child's weight.

Entecavir Aurovitas 1 mg:

For children and adolescents (from 2 to less than 18 years of age), 0.5 mg tablets of Entecavir Aurovitas or entecavir oral solution are available.
Your doctor will determine the appropriate dose based on the child's weight.
The recommendation for the correct dose is the responsibility of your doctor. You should always take the dose recommended by your doctor to ensure the full effectiveness of the medicine and to reduce the development of resistance to treatment. You should take Entecavir Aurovitas for as long as your doctor recommends. Your doctor will inform you when to stop the treatment.
Some patients may need to take Entecavir Aurovitas on an empty stomach (see Entecavir Aurovitas with food and drink in section 2). If your doctor recommends that you take Entecavir Aurovitas 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.

If you take more Entecavir Aurovitas than you should

Contact your doctor immediately.

If you forget to take Entecavir Aurovitas

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

Do not stop taking Entecavir Aurovitas without talking to your doctor

After stopping Entecavir Aurovitas, some people have had severe hepatitis. You should immediately tell your doctor about any changes in your symptoms after stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Entecavir Aurovitas can cause side effects, although not everybody gets them.
Patient taking Entecavir Aurovitas have reported the following side effects:

Adults:

• common (at least 1 in 100 patients): headache, insomnia, fatigue, dizziness, somnolence, vomiting, diarrhea, nausea, dyspepsia, and increased liver enzymes in the blood;
• uncommon (at least 1 in 1,000 patients): rash or hair loss;
• rare (at least 1 in 10,000 patients): severe allergic reactions.

Children and adolescents

Side effects in children and adolescents are similar to those in adults and include:
Very common (at least 1 in 10 patients): low neutrophil count (a type of white blood cell important for fighting infections).
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the contact details. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Entecavir Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, carton, blister, and bottle after EXP. The expiry date refers to the last day of that month.
Blisters:Store in a temperature below 30°C.
Bottles:No special storage precautions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Entecavir Aurovitas contains

The active substance is entecavir.
Each film-coated tablet contains 0.5 mg of entecavir (as entecavir monohydrate).
Each film-coated tablet contains 1 mg of entecavir (as entecavir monohydrate).
The other ingredients are:
Lactose monohydrate, microcrystalline cellulose 101, microcrystalline cellulose 102, crospovidone (type A), magnesium stearate.
Tablet coating:Hypromellose 2910 (6cp), macrogol 400, titanium dioxide (E 171).

What Entecavir Aurovitas looks like and contents of the pack

Film-coated tablet.
Entecavir Aurovitas, 0.5 mg, film-coated tablets:
White, triangular (8.4 mm in size), biconvex, film-coated tablets, with "ET" engraved on one side and "0 5" on the other side.
Entecavir Aurovitas, 1 mg, film-coated tablets:
White, round (8.2 mm in diameter), biconvex, film-coated tablets, with "ET" engraved on one side and "1" on the other side.
PVC/PVDC/Aluminum blisters: 30 and 90 film-coated tablets.
HDPE bottles with PP caps: 30, 100, and 250 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
Polska

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Arrow Génériques
26 avenue Tony Garnier
69007 Lyon
France
Generis Farmacêutica, S.A.
Rua João de Deus n.˚ 19, Venda Nova
2700-487 Amadora
Portugal

Date of last revision of the leaflet: 03/2023