Entecavir Milpharm 0.5mg film-coated Tablets

• 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.

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

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

Talk to your doctor or pharmacist before taking Entecavir.

• If you have ever had problems with your kidneys, tell your doctor. This is important because Entecavir is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.
• Do not stop taking Entecavir without your doctor’s advice since your hepatitis may worsen after stopping treatment. When your treatment with Entecavir 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 treatment may be.
• If you are also infected with HIV (human immunodeficiency virus) be sure to tell your doctor. You should not take Entecavir 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 will not control your HIV infection.
• Taking Entecavir 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 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.
• If you have previously received treatment for chronic hepatitis B, please inform your doctor.

Entecavir should not be used for children below 2 years of age or weighing less than 10 kg.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In most cases you may take Entecavir 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 because the treatment with lamivudine was not successful, you should take Entecavir on an empty stomach once daily. If your liver disease is very advanced, your doctor will also instruct you to take Entecavir on an empty stomach. Empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.

0.5 mg:

Children and adolescents (from 2 to less than 18 years of age) can take entecavir with or without food.

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 before taking this medicine. It has not been demonstrated that Entecavir is safe to use during pregnancy.

Entecavir must not be used during pregnancy unless specifically directed by your doctor. It is important that women of childbearing age receiving treatment with Entecavir use an effective method of contraception to avoid becoming pregnant.

You should not breast-feed during treatment with Entecavir. Tell your doctor if you are breast-feeding. It is not known whether entecavir, the active ingredient in Entecavir tablets, is excreted in human breast milk.

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 contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

• 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.

0.5 mg:

For children and adolescents (from 2 to less than 18 years of age), 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 child’s doctor will decide the right dose based on your child’s weight.

1 mg:

For children and adolescents (from 2 to less than 18 years of age), Entecavir 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.

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 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 on an empty stomach (see Entecavir with food and drink in Section 2). If your doctor instructs you to take Entecavir on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.

Contact your doctor at once.

It is important that you do not miss any doses. If you miss a dose of Entecavir, 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.

Some people get very serious hepatitis symptoms when they stop taking Entecavir. Tell your doctor immediately about any changes in symptoms that you notice after stopping treatment.

• 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.

The side effects experienced in children and adolescents are similar to those experienced in adults as described above with the following difference:

Very common (at least 1 in 10 patients): low levels of neutrophils (one type of white blood cells, which are important in fighting infection).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is entecavir.
  Each film-coated tablet contains 0.5 mg entecavir (as monohydrate).
  Each film-coated tablet contains 1 mg entecavir (as monohydrate).
• The other ingredients are
  Tablet Core: Lactose monohydrate, cellulose, microcrystalline (E460), crospovidone(E1202), magnesium stearate.
  Tablet coating: Hypromellose (E464), macrogol 400, titanium dioxide (E 171).

Film coated tablet.

Entecavir 0.5 mg film-coated tablets

White triangular shaped, biconvex, film-coated tablets, debossed with ‘ET’ on one side and ‘0 5’ on the other side.

Entecavir 1 mg film-coated tablets

White round shaped, biconvex, film-coated tablets, debossed with ‘ET’ on one side and ‘1’ on the other side.

Entecavir film-coated tablets are available in blister packs and HDPE bottle packs with polypropylene closure.

Pack sizes:

Blister packs: 30 and 90 film-coated tablets

HDPE packs: 30, 100 and 250 film-coated tablets.

Not all pack sizes may be marketed.

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