Patient leaflet - Entecavir Accord
1. What Entecavir Accord is and what it is used for
Entecavir Accord tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus (HBV) infection in adults. Entecavir Accord can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease).
Entecavir Accord tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years. Entecavir Accord can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Infection by the hepatitis B virus can lead to damage to the liver. Entecavir Accord reduces the amount of virus in your body, and improves the condition of the liver.
2. What you need to know before you take Entecavir Accord
Do not take Entecavir Accord
-
■ if you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine (listed in section 6).
Warning and precautions
Talk to your doctor or pharmacist before taking Entecavir Accord
-
■ if you have ever had problems with your kidneys , tell your doctor. This is important because Entecavir Accord is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.
-
■ do not stop taking Entecavir Accord without your doctor’s advice since your hepatitis may worsen after stopping treatment. When your treatment with Entecavir Accord is stopped, your doctor will continue to monitor you and take blood tests for several months.
-
■ discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Entecavir Accord treatment may be.
-
■ if you are also infected with HIV (human immunodeficiency virus) be sure to tell your doctor. You should not take Entecavir Accord to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced. Entecavir Accord will not control your HIV infection.
-
■ taking Entecavir Accord will not stop you from infecting other people with hepatitis B virus (HBV) through sexual contact or body fluids (including blood contamination). So, it is important to take appropriate precautions to prevent others from becoming infected with HBV. A vaccine is available to protect those at risk from becoming infected with HBV.
-
■ Entecavir Accord belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver. Symptoms such as nausea, vomiting and stomach pain might indicate the development of lactic acidosis. This rare but serious side effect has occasionally been fatal. Lactic acidosis occurs more often in women, particularly if they are very overweight. Your doctor will monitor you regularly while you are receiving Entecavir Accord.
-
■ if you have previously received treatment for chronic hepatitis B , please inform your doctor.
Children and adolescents
Entecavir Accord should not be used for children below 2 years of age or weighing less than 10 kg.
Other medicines and Entecavir Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Entecavir Accord with food and drink
In most cases you may take Entecavir Accord with or without food. However, if you have had a previous treatment with a medicine containing the active substance lamivudine you should consider the following. If you were switched over to Entecavir Accord because the treatment with lamivudine was not successful, you should take Entecavir Accord on an empty stomach once daily. If your liver disease is very advanced, your doctor will also instruct you to take Entecavir Accord on an empty stomach. Empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.
Children and adolescents (from 2 to less than 18 years of age) can take Entecavir Accord with or without food.
Pregnancy, breast-feeding and fertility
Tell your doctor if you are pregnant or planning to become pregnant. It has not been demonstrated that Entecavir Accord is safe to use during pregnancy. Entecavir Accord must not be used during pregnancy unless specifically directed by your doctor. It is important that women of childbearing age receiving treatment with Entecavir Accord use an effective method of contraception to avoid becoming pregnant.
You should not breast-feed during treatment with Entecavir Accord. Tell your doctor if you are breastfeeding. It is not known whether entecavir, the active ingredient in Entecavir Accord, is excreted in human breast milk.
Driving and using machines
Dizziness, tiredness (fatigue) and sleepiness (somnolence) are common side effects which may impair your ability to drive and use machines. If you have any concerns consult your doctor.
Entecavir Accord contains soy polysaccharides
This medicinal product contains soy polysaccharides. If you are allergic to soya, do not use this medicinal product.
3. How to take Entecavir Accord
Not all patients need to take the same dose of Entecavir Accord.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
For adults the recommended dose is either 0.5 mg or 1 mg once daily orally (by mouth).
Your dose will depend on:
-
■ whether you have been treated for HBV infection before, and what medicine you received.
-
■ whether you have kidney problems. Your doctor may prescribe a lower dose for you or instruct
you to take it less often than once a day.
-
■ the condition of your liver.
For children and adolescents (from 2 to less than 18 years of age), Entecavir Accord 0.5 mg tablets are available or an entecavir oral solution may be available.
Your child's doctor will decide the right dose based on your child's weight. Children weighing at least 32.6 kg may take the 0.5 mg tablet or an entecavir oral solution may be available. For patients weighing from 10 kg to 32.5 kg, an entecavir oral solution is recommended. All dosing will be taken once daily orally (by mouth). There are no recommendations for entecavir in children less than 2 years of age or weighing less than 10 kg.
Your doctor will advise you on the dose that is right for you. Always take the dose recommended by your doctor to ensure that your medicine is fully effective and to reduce the development of resistance to treatment. Take Entecavir Accord as long as your doctor has told you. Your doctor will tell you if and when you should stop the treatment.
Some patients must take Entecavir Accord on an empty stomach (see Entecavir Accord with food and drink in Section 2 ). If your doctor instructs you to take Entecavir Accord on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.
Entecavir Accord is only available as 0.5 and 1 mg film-coated tablets. For patients who are not able to swallow tablets or for whom a dose reduction is recommended, other entecavir-containing products with more suitable formulations may be available.
If you take more Entecavir Accord than you should
Contact your doctor at once.
If you forget to take Entecavir Accord
It is important that you do not miss any doses. If you miss a dose of Entecavir Accord, take it as soon as possible, and then take your next scheduled dose at its regular time. If it is almost time for your 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 forgotten dose.
Do not stop Entecavir Accord without your doctor’s advice
Some people get very serious hepatitis symptoms when they stop taking Entecavir Accord. Tell your doctor immediately about any changes in symptoms that you notice after stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Patients treated with Entecavir Accord have reported the following side effects:
Adults:
- common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased blood levels of liver enzymes.
- uncommon (at least 1 in 1,000 patients): rash, hair loss.
- rare (at least 1 in 10,000 patients): severe allergic reaction.
5. How to store Entecavir Accord
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 bottle, blister or carton after EXP.
That expiry date refers to the last day of that month.
After opening the bottle use within 90 days.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Entecavir Accord contains
The active substance is entecavir.
Entecavir Accord 0.5 mg film-coated tablets
Each tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir.
Entecavir Accord 1 mg film-coated tablets
Each tablet contains entecavir monohydrate equivalent to 1 mg entecavir.
The other ingredients are:
Tablet core: Calcium carbonate, starch, pregelatinized, carmellose sodium, soy polysaccharides, citric acid monohydrate, sodium stearyl fumarate.
Tablet coating:
Entecavir Accord 0.5 mg film-coated tablets
Hypromellose, titanium dioxide (E171), macrogol, polysorbate 80
Entecavir Accord 1 mg film-coated tablets
Hypromellose, titanium dioxide (E171), macrogol, iron oxide red (E172)
What Entecavir Accord looks like and contents of the pack
Entecavir Accord 0.5 mg film-coated tablets: White to off white, triangle shaped, biconvex film-coated tablets debossed with ‘J' on one side and ‘110’ on other side.
Entecavir Accord 1 mg film-coated tablets: Pink, triangle shaped, biconvex film-coated tablets debossed with ‚J‘ on one side and ‚111‘ on other side.
Entecavir Accord are supplied in cartons containing 30 × 1 or 90 × 1 film-coated tablet (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6a planta,
08039 Barcelona,
Spain
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95–200 Pabianice, Poland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Accord Healthcare Limited, UK
Tel: 0044 208 863 1427
This leaflet was last revised in { MM/YYYY}
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
41