ENTECAVIR DOC GENERICI

Package leaflet: Information for the patient

ENTECAVIR DOC 0.5 mg film-coated tablets, 1 mg film-coated tablets

Equivalent medicine
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ENTECAVIR DOC is and what it is used for
2. What you need to know before taking ENTECAVIR DOC
3. How to take ENTECAVIR DOC
4. Possible side effects
5. How to store ENTECAVIR DOC
6. Contents of the pack and other information

1. What ENTECAVIR DOC is and what it is used for

ENTECAVIR DOC tablets are an antiviral medicine, used in adults for the treatment of chronic (long-term)
hepatitis B virus infection. ENTECAVIR DOC can be used in patients whose liver is damaged but still functions properly (compensated liver disease) and in patients whose liver is damaged and does not function properly (decompensated liver disease).
ENTECAVIR DOC tablets are also used for the treatment of chronic (long-term) hepatitis B virus infection
in children and adolescents from 2 to 18 years of age. ENTECAVIR DOC can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Hepatitis B virus infection can cause liver damage. ENTECAVIR DOC reduces the amount of virus in the body and improves liver condition.

2. What you need to know before taking ENTECAVIR DOC

Do not take ENTECAVIR DOC

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

Warnings and precautions
Talk to your doctor or pharmacist before taking ENTECAVIR DOC

• if you have had kidney problems – inform your doctor. This is important because ENTECAVIR DOC is eliminated from the body through the kidneys, and you may require a dose adjustment or different dosing schedule.
• do not stop taking ENTECAVIR DOC without medical advice, as hepatitis may worsen after stopping treatment. If treatment with ENTECAVIR DOC is discontinued, your doctor will continue to monitor you and perform blood tests for several months.
• discuss with your doctor whether your liver is functioning properly, and, if not, how this may affect your treatment with ENTECAVIR DOC.
• if you are also infected with HIV (human immunodeficiency virus), inform your doctor. You must not take ENTECAVIR DOC to treat hepatitis B infection unless you are already receiving medications for HIV, as the effectiveness of future HIV treatment may be reduced. ENTECAVIR DOC will not control your HIV infection.
• taking ENTECAVIR DOC will not prevent you from transmitting the hepatitis B virus (HBV) to others through sexual contact or bodily fluids (including blood contamination). Therefore, it is important to take precautions to avoid spreading the hepatitis B virus (HBV) to others. A vaccine is available to protect individuals at risk of contracting hepatitis B virus (HBV) infection.
• ENTECAVIR DOC belongs to a class of medicines that can cause lactic acidosis (excess lactic acid in the blood) and enlargement of the liver. Symptoms such as nausea, vomiting, and stomach pain may indicate the development of lactic acidosis. This rare but serious side effect has occasionally been fatal. Lactic acidosis occurs more frequently in women, especially those who are significantly overweight. Your doctor will monitor you regularly during treatment with ENTECAVIR DOC.
• if you have previously received treatment for chronic hepatitis B, inform your doctor.

Children and adolescents
ENTECAVIR DOC must not be given to children under 2 years of age or weighing less than 10 kg.
Other medicines and ENTECAVIR DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
ENTECAVIR DOC with food and drink
In most cases, you may take ENTECAVIR DOC with or without food. However, if you have previously been treated with a medicine containing the active substance lamivudine, the following considerations apply. If you have switched to ENTECAVIR DOC because lamivudine treatment was not successful, you must take ENTECAVIR DOC once daily on an empty stomach. If your liver disease is very advanced, your doctor will instruct you to take ENTECAVIR DOC on an empty stomach. An empty stomach means at least 2 hours after a meal and at least 2 hours before the next meal.
Children and adolescents (from 2 to 18 years of age) may take ENTECAVIR DOC with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It has not been established that ENTECAVIR DOC is safe to use during pregnancy. Unless specifically indicated by your doctor, ENTECAVIR DOC must not be used during pregnancy. It is important that women of childbearing potential use an effective method of contraception during treatment with ENTECAVIR DOC to avoid pregnancy.
You must not breastfeed during treatment with ENTECAVIR DOC. Inform your doctor if you are breastfeeding. It is not known whether entecavir, the active substance in ENTECAVIR DOC, is excreted in human breast milk.
Driving and using machines
Dizziness, fatigue, and somnolence are common side effects that may impair your ability to drive or operate machinery. Consult your doctor for any clarification.
ENTECAVIR DOC contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take ENTECAVIR DOC

Not all patients need to take the same dose of ENTECAVIR DOC.
Always take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
For adults, the recommended dose is 0.5 mg or 1 mg, taken once daily by mouth (orally).
Your dose will depend on:

• whether you have previously received treatment for hepatitis B virus (HBV) infection, and which medicine you were treated with;
• whether you have kidney problems. Your doctor may prescribe you a lower dose or advise you to take it less than once daily;
• the condition of your liver.

Use in children and adolescents
For 0.5 mg tablets
For children and adolescents (from 2 to 18 years of age), your child’s doctor will determine the appropriate dose based on
your child’s body weight. Children weighing at least 32.6 kg may take the 0.5 mg tablets, or an oral solution of entecavir may
be available. For patients weighing between 10 and 32.5 kg, an oral solution of entecavir is recommended. Each dose will be
administered once daily by mouth (orally).
There are no recommendations for ENTECAVIR DOC in children under 2 years of age or with body weight
below 10 kg.
Your child’s doctor will determine the correct dose based on your child’s body weight.
For 1 mg tablets
For children and adolescents (from 2 to 18 years of age), ENTECAVIR DOC 0.5 mg tablets or an oral solution of entecavir are
available.
Your child’s doctor will determine the appropriate dose based on your child’s body weight.
Your doctor will inform you of the correct dosage. To ensure the medicine is fully effective and to reduce the
risk of developing resistance to therapy, always take the dose recommended by your doctor. Take ENTECAVIR
DOC for the entire duration prescribed by your doctor. Your doctor will advise you whether and when to stop treatment.
Some patients must take ENTECAVIR DOC on an empty stomach (see ENTECAVIR DOC with food and
drinks in section 2). If your doctor has instructed you to take ENTECAVIR DOC on an empty stomach, this means
at least 2 hours after a meal and at least 2 hours before the next meal.

If you take more ENTECAVIR DOC than you should
Contact your doctor immediately.

If you forget to take ENTECAVIR DOC
It is important not to miss any doses. If you forget a dose of ENTECAVIR DOC, take it as soon as possible, then take the next dose at the scheduled time. If it is almost time for the next dose, do not take the missed dose. Wait and take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

Do not stop treatment with ENTECAVIR DOC without consulting your doctor
Many people experience very severe hepatitis symptoms when they stop taking ENTECAVIR DOC. Inform your doctor immediately if you notice any changes in your symptoms after stopping treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The following side effects have been reported in patients treated with ENTECAVIR DOC:
Adults

• Common (affects at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (excessive tiredness), dizziness, somnolence (drowsiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased liver enzyme levels in the blood.
• Uncommon (affects at least 1 in 1,000 patients): rash (skin rash), hair loss.
• Rare (affects at least 1 in 10,000 patients): severe allergic reaction.

Children and adolescents
Side effects observed in children and adolescents are similar to those observed in adults as described above, with the following difference:
Very common (affects at least 1 in 10 patients): low levels of neutrophils (a type of white blood cell important in fighting infections).
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ENTECAVIR DOC

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 carton or blister after “Exp”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ENTECAVIR DOC contains

• The active substance is entecavir. Each film-coated tablet contains 0.5 mg or 1 mg of entecavir (as monohydrate).
• The other components are: Tablet core: lactose monohydrate, microcrystalline cellulose (E460), hydroxypropylcellulose (E463), crospovidone type A (E1202), and magnesium stearate (E470b). Tablet coating: hypromellose (E464), macrogol 400 (E1521), titanium dioxide (E171), and, only for the 1 mg tablets, red iron oxide (E172).

Description of the appearance of ENTECAVIR DOC and package contents
0.5 mg tablets: The film-coated tablets (tablets) are white to almost white, triangular in shape, marked with "0.5" on one side and smooth on the other.
1 mg tablets: The film-coated tablets (tablets) are pink, triangular in shape, marked with "1" on one side and smooth on the other.
ENTECAVIR DOC is available in packages containing 30x1 film-coated tablets (in unit dose divisible blisters).
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – Italy.

Manufacturer
Remedica Ltd - Aharnon Street, Limassol Industrial Estate, Limassol, 3056 – Cyprus.

This medicinal product is authorized in the European Economic Area countries under the following names
Italy: ENTECAVIR DOC