Entecavir aurovitas
Poland
Table of Contents
Package leaflet: Information for the user
Entecavir Aurovitas, 0.5 mg, film-coated tablets
Entecavir Aurovitas, 1 mg, film-coated tablets
Entecavirum
Please 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 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.
Contents of the leaflet:
- What Entecavir Aurovitas is and what it is used for
- What you need to know before taking Entecavir Aurovitas
- How to take Entecavir Aurovitas
- Possible side effects
- How to store Entecavir Aurovitas
- Contents of the pack and other information
1. What Entecavir Aurovitas is and what it is used for
Entecavir Aurovitas in tablet form is an antiviral medicine used in adults to treat chronic
(long-term) hepatitis B virus (HBV) infection. Entecavir Aurovitas can be used in patients with
liver damage but whose liver still functions properly (with compensated liver function) and in
patients whose liver does not function properly (with decompensated liver function).
Entecavir Aurovitas in tablet form is also used to treat chronic (long-term) HBV infection in
children and adolescents aged from 2 years to less than 18 years. Entecavir Aurovitas can be used
in children whose liver is damaged but still functions properly (with compensated liver function).
Hepatitis B virus infection may lead to liver damage. Entecavir Aurovitas reduces the number of
viruses in the body and improves liver function.
2. What you need to know before taking 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
Talk to your doctor or pharmacist before taking Entecavir Aurovitas:
- If you have had any kidney disease, tell your doctor. This is important because Entecavir Aurovitas is eliminated from the body through the kidneys, and your dose may need to be reduced or the dosing schedule changed.
- Do not stop taking Entecavir Aurovitas without consulting your doctor, as this may negatively affect the course of 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 functioning properly, and if not, what impact this may have 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 hepatitis B if you are not receiving anti-HIV medications, as this may reduce the effectiveness of future HIV treatment. Entecavir Aurovitas does not treat HIV infection.
- Taking Entecavir Aurovitas does not prevent spreading hepatitis B virus (HBV) to others through sexual contact or body fluids (including infected blood). Therefore, it is important to take appropriate precautions to prevent spreading HBV to others. A vaccine is available to protect people at risk of HBV infection.
- Entecavir Aurovitas belongs to a group of medicines that may cause lactic acidosis (excess lactic acid in the blood) and liver enlargement. Symptoms such as nausea, vomiting, and abdominal pain may indicate lactic acidosis. This is a rare but serious side effect, which may sometimes be fatal. Lactic acidosis occurs more frequently in women, particularly those who are significantly overweight. Your doctor will monitor your condition regularly during treatment with Entecavir Aurovitas.
- If you have previously been treated for chronic hepatitis B, inform 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 and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Entecavir Aurovitas with food and drink
In most cases, Entecavir Aurovitas can be taken with or without food. However, if you previously took medicines containing lamivudine as the active substance, consider the following recommendations. If treatment has been switched to Entecavir Aurovitas due to lamivudine treatment failure, Entecavir Aurovitas should be taken once daily on an empty stomach. If liver disease is very advanced, your doctor will 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 (aged 2 to less than 18 years) may take Entecavir Aurovitas regardless of meals.
Pregnancy, breastfeeding, and fertility
If you are pregnant or planning to become pregnant, consult your doctor. It has not yet been established that using Entecavir Aurovitas during pregnancy is safe. Entecavir Aurovitas should not be used during pregnancy unless specifically recommended by your doctor. It is important that women of childbearing potential using Entecavir Aurovitas use effective contraception to avoid becoming pregnant.
Do not breastfeed while taking Entecavir Aurovitas. If you are breastfeeding, inform your doctor. It is not known whether entecavir, the active substance in Entecavir Aurovitas, passes into human milk.
Driving and using machines
Dizziness, fatigue, and somnolence are common side effects that may impair the ability to drive or operate machinery. If in doubt, consult your doctor.
Entecavir Aurovitas contains lactose. If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
3. How to take Entecavir Aurovitas
Not all patients require the same dose of Entecavir Aurovitas.
Always take this medicine exactly as your doctor has told you. 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 of the medicine depends on:
- Previous treatment for HBV infection and medicines used;
- Presence of kidney function disorders; in such cases, your doctor may prescribe a lower dose or recommend taking the medicine less frequently than once daily;
- The patient's liver condition.
Entecavir Aurovitas 0.5 mg:
In children and adolescents (aged 2 to less than 18 years), your doctor will determine the appropriate dose based on the child's body weight. Children weighing at least 32.6 kg may take the 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 (orally). Recommendations for Entecavir Aurovitas have not been established 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 body weight.
Entecavir Aurovitas 1 mg:
In children and adolescents (aged 2 to less than 18 years), Entecavir Aurovitas 0.5 mg tablets or entecavir oral solution may be available. Your doctor will determine the appropriate dose based on the child's body weight.
The correct dose is determined by your doctor. Always follow the prescribed dose to ensure full effectiveness of the medicine and to minimize the development of treatment resistance. Entecavir Aurovitas should be taken for as long as your doctor recommends. Your doctor will inform you when to stop treatment.
Some patients must take Entecavir Aurovitas on an empty stomach (see Entecavir Aurovitas with food and drink in section 2). If your doctor advises taking Entecavir Aurovitas on an empty stomach, this means at least 2 hours after a meal and at least 2 hours before the next meal.
Taking more Entecavir Aurovitas than recommended
Seek immediate medical advice.
If you miss a dose of Entecavir Aurovitas
It is important not to miss any dose. If you miss a dose of Entecavir Aurovitas, 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 missed dose.
Do not stop treatment with Entecavir Aurovitas without medical advice
After stopping Entecavir Aurovitas, some people may experience severe symptoms of hepatitis. Inform your doctor immediately about any changes in symptoms occurring after stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Patients treated with Entecavir Aurovitas have reported the following adverse events:
Adults:
- Common (affects at least 1 in 100 patients): headache, insomnia, feeling of fatigue (very strong exhaustion), dizziness, somnolence, vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased liver enzyme activity in blood;
- Uncommon (affects at least 1 in 1,000 patients): rash or hair loss;
- Rare (affects at least 1 in 10,000 patients): severe allergic reactions.
Children and adolescents
Adverse effects occurring in children and adolescents are similar to those occurring in adults and described above, with the following difference:
Very common (affects at least 1 in 10 patients): low neutrophil granulocyte count (one type of white blood cells important in fighting infections).
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your 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 may also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Entecavir Aurovitas
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton, blister pack, or bottle after: EXP. The expiry date refers to the last day of the stated month.
Blister packs: Store below 30°C.
Bottles: No special requirements for storage of the medicine.
Medicines must 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 coated tablet contains 0.5 mg entecavir (as entecavir monohydrate).
Each coated tablet contains 1 mg entecavir (as entecavir monohydrate).
The other ingredients are:
Monohydrate lactose, microcrystalline cellulose 101, microcrystalline cellulose 102, crospovidone
(type A), magnesium stearate.
Tablet coating: Hypromellose 2910 (6 cP), polyethylene glycol 400, titanium dioxide (E 171).
What Entecavir Aurovitas looks like and contents of the pack
Coated tablet.
Entecavir Aurovitas, 0.5 mg, coated tablets:
White, triangular-shaped (8.4 mm in size), biconvex, coated tablets, embossed with "ET" on one side and "0 5" on the other side.
Entecavir Aurovitas, 1 mg, coated tablets:
White, round (8.2 mm in diameter), biconvex coated tablets, embossed with "ET" on one side and "1" on the other side.
PVC/PVDC/Aluminium blisters: 30 and 90 coated tablets.
HDPE bottles with PP closure: 30, 100 and 250 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
Poland
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.º 19, Venda Nova
2700-487 Amadora
Portugal