What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/17/1227/008.


Entecavir Mylan 0.5 & 1 mg film-coated tablets

Package leaflet: Information for the user

Entecavir Mylan 0.5 mg film-coated tablets

Entecavir Mylan 1 mg film-coated tablets

entecavir

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • 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.

What is in this leaflet

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

1. What Entecavir Mylan is and what it is used for

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

Do not take Entecavir Mylan

  • 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 Mylan

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

Children and adolescents

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

Other medicines and Entecavir Mylan

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

Entecavir Mylan with food and drink

In most cases you may take Entecavir Mylan 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 Mylan because the treatment with lamivudine was not successful, you should take Entecavir Mylan on an empty stomach once daily. If your liver disease is very advanced, your doctor will also instruct you to take Entecavir Mylan 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 Mylan 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 is safe to use during pregnancy. Entecavir Mylan must not be used during pregnancy unless specifically directed by your doctor. It is important that women of childbearing age receiving treatment with Entecavir Mylan use an effective method of contraception to avoid becoming pregnant.

You should not breast-feed during treatment with Entecavir Mylan. Tell your doctor if you are breastfeeding. It is not known whether entecavir, the active ingredient in Entecavir Mylan, 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 Mylan 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 Mylan

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

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), 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 doses should 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.

For children and adolescents (from 2 to less than 18 years of age), Entecavir Mylan 0.5 mg Film-coated Tablets are available or an 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 Mylan 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 Mylan on an empty stomach (see Entecavir Mylan with food and drink in Section 2). If your doctor instructs you to take Entecavir Mylan on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.

If you take more Entecavir Mylan than you should

Contact your doctor at once.

If you forget to take Entecavir Mylan

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

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.

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 the 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 Mylan

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. The expiry date refers to the last day of that month.

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 Mylan contains

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

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

The other ingredients are:

Tablet core: microcrystalline cellulose, crospovidone, lactose monohydrate (see section 2, “Entacavir Mylan contains lactose”), magnesium stearate

Tablet coating: titanium dioxide (E171), hypromellose, macrogol 400, polysorbate 80.

What Entecavir Mylan looks like and contents of the pack

0.5 mg: the film-coated tablets (tablets) are white, film-coated, round, biconvex, beveled edge tablet debossed with “M” on one side and “EA” on the other side.

1 mg: the film-coated tablets (tablets) are white, film-coated, round, biconvex, beveled edge tablet debossed with “M” on one side and “EB” on the other side.

Entecavir Mylan 0.5 mg film-coated tablets Entecavir Mylan 1 mg film-coated tablets are supplied in blisters packs containing 30 tablets, perforated blister packs containing 30 x 1 or 90 x 1 tablets, and in bottles containing 30 or 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan S.A.S.
117 Allée des Parcs
69800 Saint Priest
France

Manufacturer

McDermott Laboratories Limited t/a Gerard Laboratories
Unit 35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
Mylan Hungary Kft.
Mylan utca 1
Komárom
2900
Hungary

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Generics [UK] Ltd
Tel: +44 1707 853000

This leaflet was last revised in September 2017

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.