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Entac Tablets


Therapeutic Classes

Indicative Actions

ENTAC® Tablets

entecavir (as monohydrate) tablets


Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before taking Entac. This leaflet answers some common questions about Entac.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Entac against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Entac is used for

Entac contains entecavir (as monohydrate) and belongs to a group of medicines called antiviral medicines.

Entac is used to treat adults infected with hepatitis B virus.

How Entac Works

Infection by the hepatitis B virus can lead to damage to the liver. Entac reduces the amount of virus in your body, and has been shown to improve the condition of the liver.

It is not known how safe Entac is when taken for long periods.

Your doctor may have prescribed Entac for another reason. Ask your doctor if you have any questions about why Entac has been prescribed for you.

Entac is not addictive. This medicine is available only with a doctor's prescription.

Entac is not recommended for use in children under 16 years, as there have been no studies of its effects in children.

Before you take Entac

It is important that you check the information below before you take Entac.

When you must not take Entac

You must not take Entac if you have a history of severe allergic reactions to Entac or to any of the ingredients listed at the end of this leaflet. Symptoms of a severe allergic reaction may include; chills, fever, fast heart beat, wheezing or coughing, difficulty breathing, dizziness, flushing, sweating and swelling of the face, tongue or other parts of the body.

Do not use Entac after the expiry date printed on the back of the pack. If this medicine is taken after the expiry date has passed, it may not work as well.

Do not take Entac if the packaging is torn or shows signs of tampering.

Before you start to take Entac

It is important to remain under the care of your doctor during Entac therapy and after stopping Entac. You should report any new symptoms, medications or any other aspects affecting your health to your doctor.

Your hepatitis B virus infection may get worse if you stop taking Entac. If your doctor advises you to stop Entac, they will monitor your health and perform regular blood tests to monitor your liver.

Tell your doctor if you:

  1. have allergies to:
  • any other medicines you have been given or purchased
  • substances such as foods, preservatives or dyes;
    Symptoms of a severe allergic reaction may include; chills, fever, fast heart beat, wheezing or coughing, difficulty breathing, dizziness, flushing, sweating and swelling of the face, tongue or other parts of the body.
  1. are pregnant or intend to become pregnant.

Experience is limited with the use of Entac in pregnant women. Therefore, it should not be used during pregnancy unless it is clearly needed. If there is an urgent need to consider Entac during pregnancy, your doctor will discuss with you the benefits and risks of taking it. If you take Entac while you are pregnant, talk to your doctor about how you can take part in the Entac Pregnancy Registry. The purpose of the pregnancy registry is to collect information about the health of you and your baby.

  1. are breast feeding or planning to breast-feed.

It is not known whether Entac passes into breast milk. Therefore to avoid possible side effects in the nursing infant, mothers should stop breastfeeding if they are taking Entac;

  1. currently experience or have experienced any medical conditions especially any problems with your kidneys.
  2. have HIV and you are not currently on HIV treatment.

Entac is not recommended in patients who have both HIV and Hepatitis B and who are not currently receiving anti-HIV treatment. Entac may affect your HIV virus which could impact on future treatment options for HIV.

  1. are lactose intolerant. Entac tablets contain lactose monohydrate.

If you have not told your doctor about any of the above, tell them before you use Entac.

Taking other medicines

Tell your doctor if you are taking other medicines, including vitamin supplements, herbal preparations or any medicines you buy with or without a prescription from your pharmacy, supermarket or health food shop.

Your doctor and pharmacist may have more information on medicines to be careful with, or to avoid while taking Entac.

How to take Entac

Entac should be given only when prescribed by your doctor. Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

How much to take

The usual dose of Entac is 0.5 mg (one white tablet) or 1 mg (one pink tablet) once a day.

If you have a medical problem with your kidneys your doctor may need to change how often you take your Entac tablets. Your doctor will tell you what dose to take and how often you should take your Entac tablets.

Please talk to your doctor or pharmacist for more information.

How to take it

Swallow the tablet whole with a glass of water. The dose of Entac should be taken on an empty stomach.

When to take Entac

Entac may be taken at any time of day provided it is taken on an empty stomach. Empty stomach means at least 2 hours before or 2 hours after a meal.

Talk to your doctor or pharmacist to work out when it is best for you to take your dose of Entac.

How long to take it

Entac helps control your condition but does not cure it. Therefore you must take Entac every day as directed by your doctor. Continue taking Entac for as long as your doctor tells you to.

Your doctor has prescribed Entac to prevent hepatitis B virus from further damaging your liver.

Entac is a very important treatment that can improve the inflammation and scar tissue caused by the hepatitis B virus in your liver and may reduce the chance of developing cirrhosis, liver failure and liver cancer.

It is extremely important that you do not stop taking Entac without discussing it with your doctor. If Entac is suddenly stopped, the hepatitis B virus can become very active again and lead to sudden development of severe liver failure. There is a high risk of dying if liver failure develops and liver transplantation may be necessary to save your life.

It is important to take Entac every day or as directed by your doctor, to not miss medicine doses, and to make sure you have enough supply until you next see your doctor.

Do not stop taking Entac or change the dose unless asked to do so by your doctor, even if you feel better, as it can be very dangerous.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.

Otherwise take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting an unwanted side effect. If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints and inform your doctor that you have missed a dose. It is very important not to miss your doses of Entac.

If you take too much (overdose)

Immediately call your doctor or the Poisons Information Centre on 131126 in Australia or 0800 764 766 in New Zealand, or go to the Accident and Emergency Centre at your nearest hospital if you or anyone else takes too much Entac. Do this even if there are no signs of discomfort or poisoning.

While you are using Entac

Things you must do

  • If you become pregnant while taking Entac, tell your doctor immediately.
  • If you are about to start taking any new medicines, tell your doctor and pharmacist that you are taking Entac. Entac may interfere with the medicine you are taking.
  • If you are about to have any medical tests, tell your doctor that you are taking Entac. Entac may interfere with the results of these tests.
  • If you plan to have surgery, tell your doctor or dentist that you are taking Entac.

Things you must not do

  • Do not give Entac to anyone else, even if they have the same condition as you.
  • Do not use Entac to treat any other complaints unless your doctor tells you to.
  • Do not stop taking Entac or lower the dosage without checking with your doctor. Your hepatitis may worsen after stopping treatment.

Things to be careful of

  • Be careful driving or operating machinery until you know how Entac affects you.
    Some patients taking Entac have experienced dizziness. It is not known if this was caused by Entac. Make sure you know how you react to Entac before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy.
  • Make sure that you visit your doctor regularly throughout your entire course of treatment with Entac.
    When your treatment with Entac is stopped, your doctor will continue to monitor you and take blood tests for several months.
  • There is no evidence that Entac reduces the risk of infecting others with hepatitis B through sexual contact or body fluids (including blood contamination).
    Therefore it is important to take appropriate precautions to prevent others being infected with hepatitis B. Talk to your doctor about safe sexual practices that protect your partner. Never share needles. Do not share personal items that can have blood or bodily fluids on them, like toothbrushes and razor blades. A vaccine is available to protect those at risk of becoming infected with hepatitis B.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Entac. Entac helps most people with hepatitis B infection but it may have unwanted side effects in some people. Ask your doctor or pharmacist to answer any questions you may have.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. Some very important side effects are listed below.

Tell your doctor immediately, or go to accident and emergency at your nearest hospital if you notice any of the following signs of a sudden life-threatening allergic reaction:

chills, fever, fast heart beat, wheezing or coughing, difficulty breathing, dizziness, flushing, sweating and swelling of the face, tongue or other parts of the body.

Some people who have taken Entac or medicines like Entac have developed a serious condition called lactic acidosis. Lactic acidosis is a serious medical emergency that can cause death. Lactic acidosis must be treated in the hospital. Reports of lactic acidosis with Entac generally involved patients who were seriously ill due to their liver disease or other medical condition.

Call your healthcare provider right away if you get any of the following signs or symptoms of lactic acidosis:

Feeling very weak or tired, unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, feeling cold (especially in your arms and legs), feeling dizzy or light-headed, fast or irregular heartbeat.

Some people who have taken medicines like Entac have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Hepatomegaly with steatosis is a serious medical emergency that can cause death.

Call your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

Your skin or the white part of your eyes turns yellow (jaundice), urine turns dark, bowel movements (stools) turn light in colour, you don't feel like eating food for several days or longer, nausea, lower stomach pain.

You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight, or have been taking medicines, like Entac, for a long time.

The most common side-effects are diarrhoea, indigestion, tiredness and headache.

This is not a complete list of side effects, other side effects not listed above may also occur in some patients.

Tell your doctor if you notice anything that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them or only some of them.

After using Entac

Storage

Store Entac tablets in a cool dry place where the temperature stays below 30°C.

Keep your tablets in the blister pack until it is time to take one. If you take the tablets out of the pack they may not keep as well.

Do not store Entac or any other medicine in the bathroom or near the kitchen sink. Do not leave it in the car. Heat and dampness can destroy some medicines.

Do not keep Entac tablets where children can reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Entac, or the tablets have passed their expiry date, ask your pharmacist what to do with what is left over.

Product description

What it looks like

Entac tablets come in two types:

  • Entac 0.5 mg tablet – white to off-white, triangular shaped, biconvex, film coated tablets with 'E' on one side and plain on other
  • Entac 1 mg tablet – pink coloured, triangular shaped, biconvex, film coated tablets with 'E' on one side and '1' on the other

Ingredients

Each tablet contains:

Active ingredients:

  • Entac 0.5 mg tablet – 0.5 mg of entecavir (as monohydrate) per tablet
  • Entac 1 mg tablet – 1 mg of entecavir (as monohydrate) per tablet

Other ingredients:

Lactose monohydrate, microcrystalline cellulose, crospovidone, hyprolose, and magnesium stearate. The 0.5 mg tablet coating contains Opadry complete film coating system 04F58804 white and the 1 mg tablet coating contains Opadry complete film coating system 03B14899 pink.

Registration Numbers

Entac 0.5 mg – 10’s and 30's – AUST R 267116

Entac 1 mg – 10’s and 30's – AUST R 267113

Sponsored by

Cipla Australia Pty Ltd
Level 1, 132- 136 Albert Road
South Melbourne, VIC 3205

Date of Preparation: July 2016

This information in no way replaces the advice of your doctor or pharmacist.

Published by MIMS August 2017