0.5 mg and 1 mg film-coated tablets
entecavir
1. What Entecavir Accord is and what it is used for
Accord tablets Entecavir is anti-virus for the treatment of chronic (long-term) infection with hepatitis B virus (HBV) in adults. Entecavir Accord can be used by people whose liver is damaged but still functioning properly (compensated liver disease) and by 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 between 2 and 18 years of age. Entecavir Accord can be used by children whose liver is damaged but still functioning properly (compensated liver disease).
Infection with the hepatitis B virus can lead to liver damage. Entecavir Accord reduces the amount of virus in your body and improves the condition of the liver.
What you need to know before using Entecavir Accord
Do not use 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).
Warnings and cautions
Talk to your doctor or pharmacist before taking Entecavir Accord
- If you have ever had kidney problems, tell your doctor. This is important because Entecavir Accord is excreted from the 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, as your hepatitis B infection may worsen after stopping treatment. When your Entecavir Accord treatment is stopped, your doctor will monitor your treatment and take blood samples for several months.
- Discuss with your doctor if your liver is working properly, and if not, what effect this may have on your Entecavir Accord treatment.
- if you also have HIV (human immunodeficiency virus) do not forget to tell your doctor. You should not take Entecavir Accord to treat your hepatitis B infection if you are not taking medicines for HIV at the same time, as the effect of future HIV treatment may be reduced. Entecavir Accord will not control your HIV – infection under control.
- Using Entecavir Accord does not prevent you from infecting other people with the hepatitis B virus through sexual intercourse or body fluids (including blood infections). Thus, it is important to take precautions to prevent others from becoming infected with the hepatitis B virus. Some vaccines protect people who are at risk of contracting the hepatitis B virus.
- Entecavir Accord belongs to a group of medicines that can cause lactic acidosis (too much lactic acid in the blood) and liver enlargement. Symptoms such as nausea, vomiting, and abdominal pain may indicate the development of lactic acidosis. This rare but serious side effect has in some cases be fatal. Lactic acidosis is more common in women, especially if they are very overweight. Your doctor will perform regular check-ups while you are taking Entecavir Accord.
- Tell your doctor if you have previously been treated for chronic hepatitis B.
Children and young people
Entecavir Accord should not be used in children under 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 can take Entecavir Accord with or without food. However, if you have previously been treated with a medicine containing the active substance lamivudine, you should consider the following. If you have switched to Entecavir Accord treatment because the lamivudine treatment has not had sufficient effect, Entecavir Accord should be taken once daily on an empty stomach. If your liver disease is very advanced, your doctor will also instruct you to take Entecavir Accord on an empty stomach. Fasting means at least 2 hours after one meal and at least 2 hours before your next meal.
Children and adolescents (from 2 to younger than 18 years) can take Entecavir Accord with or without food.
Pregnancy, breastfeeding, and fertility
Tell your doctor if you are pregnant or planning to become pregnant. It has not been shown that it is safe to use Entecavir Accord during pregnancy. Entecavir Accord should not be used during pregnancy unless clearly instructed to do so by your doctor. Women of childbearing potential receiving treatment with Entecavir Accord must use an effective method of contraception to avoid becoming pregnant.
Breast-feeding mothers should not breast-feed during treatment with Entecavir Accord. Tell your doctor if you are breast-feeding. It is unknown whether entecavir, the active substance in Entecavir Accord, is excreted in human milk.
Driving and using machines
Dizziness, tiredness, and drowsiness are common side effects that can impair your ability to drive and use machines. If you have any further questions on the use of this product, ask your doctor.
Entecavir Accord contains soy polysaccharides
This medicine contains soy polysaccharides.
If you are allergic to soy, do not use this medicine.
3. How to use 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. Ask your doctor or pharmacist if you are unsure.
For adults, the recommended dose is either 0.5 mg or 1 mg once daily taken orally (by mouth).
Your dosage depends on:
- if you have been treated for hepatitis B infection before and what medicine you were given.
- if you have kidney problems. Your doctor may prescribe a lower dose or instruct you to take dose one less often than once a day.
- the condition of your liver.
Use for children and adolescents
For children and adolescents (from 2 to less than 18 years of age), Entecavir Accord 0.5 mg tablets or an oral solution may be available. The child’s doctor determines the correct dosage based on the child’s weight. Children weighing at least 32.6 kg may take the 0.5 mg tablet or an oral solution may be available. For patients weighing between 10 and 32.5 kg, an oral solution of entecavir is recommended.
All doses are taken orally (orally) once daily. There are no recommendations for entecavir for children under 2 years of age or weighing less than 10 kg.
Your doctor will prescribe a dose that is right for you. For the medicine to have full effect and to reduce the risk of developing resistance to the treatment, you should always take the dose recommended by your doctor. Take Entecavir Accord for as long as your doctor tells you to. Your doctor will tell you if and when to stop treatment.
Some patients need to 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, fasting means at least 2 hours after a meal and at least two hours before the next meal.
Entecavir Accord is only available as 0.5 and 1 mg film-coated tablets.
For patients who are unable to swallow tablets or for whom a reduced dose is recommended, other entecavir medicines with more suitable dosage forms may be available.
If you use more Entecavir Accord then you should
Contact your doctor immediately.
If you forget to use Entecavir Accord
You mustn’t forget to take your medicine. If you forget to take a dose of Entecavir Accord, take it as soon as you can, and then take the next dose as usual at the time of taking it. Do not take the missed dose if it is only a short time before you take your next dose. Then wait and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.
Do not stop taking Entecavir Accord without your doctor’s instructions
Some people get very severe hepatitis symptoms when they stop taking Entecavir Accord. Talk to your doctor immediately if you notice any changes in symptoms when you stop 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, 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, fatigue, dizziness, drowsiness, vomiting, diarrhea, nausea, dyspepsia (problems with digestion that cause discomfort in the stomach and intestines after meals), and elevated levels of liver enzymes 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 young people
The side effects experienced by children and adolescents are similar to those described above for adults with the following difference:
Very common (at least 1 in 10 patients): low levels of neutrophils (a type of white blood cell that is important in defending against infections ).
If you get any side effects, talk to your doctor or pharmacist.
This also applies to any side effects not mentioned in this information.
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 can, blister, or carton after EXP. The expiration date is the last day of the specified month.
Use the jar within 90 days of opening.
No special storage instructions.
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 to protect the environment.
6. Contents of the packaging and other information
Content declaration
- 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, pregelatinized starch, carmellose sodium, soy polysaccharides, citric acid monohydrate, sodium stearyl fumarate.
Tablet cover:Entecavir Accord 0.5 mg film-coated tabletsHypromellose, titanium dioxide (E171), macrogol, polysorbate 80.
Entecavir Accord 1 mg film-coated tabletsHypromellose, titanium dioxide (E171), macrogol, red iron oxide (E172).
What the medicine looks like and the contents of the pack
Entecavir Accord 0.5 mg film-coated tablets: White to off-white, triangular, biconvex film-coated tablets debossed with “J” on one side and “110” on the other side.
Entecavir Accord 1 mg film-coated tablets: Pink, triangular, biconvex film-coated tablets debossed with “J” on one side and “111” on the other side.
Entecavir Accord is supplied in cartons of 30 x 1 or 90 x 1 film-coated tablets (in unit dose blisters) and cans containing 30 film-coated tablets.
Not all pack sizes may be marketed in your country.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s / n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer:
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF
UK
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Accord Healthcare Polska Sp.z oo
ul. Lutomierska 50
95-200 Pabianice
Poland
Contact the representative of the marketing authorization holder to find out more about this medicine:
Accord Healthcare Limited, United Kingdom
Tel: 0044 208 863 1427