Entecavir 0.5 mg film-coated tablets Entecavir 1 mg film-coated tablets – patient leaflet, side effects, dosage

1. What Entecavir is and what it is used for

The name of your medicine is Entecavir film-coated tablets called Entecavir throughout this leaflet.

Entecavir tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus (HBV) infection in adults. Entecavir 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 tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years. Entecavir 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 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

Do not take Entecavir:

• 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:

• 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.

Children and adolescents

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

Other medicines and Entecavir

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines bought without a prescription, including herbal medicines.

Entecavir with food and drink

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.

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

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or planning to become pregnant. 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, 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 contains lactose

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

3. How to take Entecavir

Not all patients need to take the same dose of Entecavir.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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.

Use in 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. The Entecavir oral solution is recommended for patients weighing from 10 kg to 32.5 kg. Children weighing at least 32.6 kg may take the oral solution or the 0.5 mg tablet. 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 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. The score line is not intended for breaking the tablet

If you take more Entecavir than you should

Contact your doctor at once.

If you forget to take Entecavir

It is important that you do not miss any doses. If you forget a dose, take it as soon as you remember it, and then take your next scheduled dose at its regular time. However, if it is nearly time for the next dose, skip the missed dose. Wait and take the next dose at the regular time.

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0.5mg/1mg

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New product introduction.

Entecavir 0.5mg & 1mg Film-Coated Tablets

Do not take a double dose to make up for a forgotten dose

If you stop taking Entecavir

Do not stop Entecavir without your doctor’s advice. 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.

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 have reported the following side effects:

Adults

Common (may affect up to 1 in 10 people)

• Headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion) and increased blood levels of liver enzymes.

Uncommon (may affect up to 1 in 100 people)

• Rash, hair loss

Rare (may affect up to 1 in 1,000 people)

• Severe allergic reaction

Children and adolescents

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 people):

• low levels of neutrophils (a type of white blood cell, 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Entecavir

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 blister and carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C. Store in the original package.

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 contains

The active substance is entecavir. Each film-coated tablet contains entecavir monohydrate corresponding to 0.5 mg or 1 mg entecavir.

The other ingredients are microcrystalline cellulose, lactose monohydrate, starch maize pregelatinised, crospovidone, magnesium stearate. The film-coating contains titanium dioxide (E171), hypromellose, macrogol 400, and polysorbate. Entecavir also contains red iron oxide (E172)

What Entecavir looks like and contents of the pack

Entecavir 0.5 mg film-coated tablets are white oval shaped tablet with scoreline on both sides with a length of 10.1 mm and thickness of 3.7 mm.

Entecavir 1 mg film-coated tablets are pink oval shaped tablet with scoreline on both sides with a length 12.8 mm and thickness of 4.8 mm.

These are packed in blisters containing 30 or 90 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

STADA,

Linthwaite,

Huddersfield,

HD7 5QH,

UK

Manufacturer

Medis International a.s.,

Production plant Bolatice,

Bolatice,

Czech Republic

Other formats

To request a copy of this leaflet in braille, large print or audio please call 01484 848164.

This leaflet was last revised in August 2021

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