0.5 mg and 1 mg film-coated tablets 
entecavir

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Entecavir Mylan is and what it is used for 
2. What you need to know before you use Entecavir Mylan 
3. How to use Entecavir Mylan 
4. Possible side effects 
5. How to store Entecavir Mylan 
6. Contents of the packaging and other information 

What Entecavir Mylan is and what it is used for

Entecavir Mylan tablets are anti-virus for the treatment of chronic (long-term) infection with hepatitis B virus (HBV) in adults. Entecavir Mylan 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 Mylan tablets are also used to treat chronic (long-term) HBV infections in children and adolescents between 2 and 18 years of age. Entecavir Mylan 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 Mylan reduces the amount of virus in your body and improves the condition of the liver.

What you need to know before you use Entecavir Mylan

Do not take Entecavir Mylan 

  • if you are allergic 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 Mylan

  • If you have ever had kidney problems, tell your doctor. This is important because Entecavir Mylan is excreted from the 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, as your hepatitis B infection may get worse after stopping treatment. When your Entecavir Mylan treatment is stopped, your doctor will follow up on 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 Mylan treatment.
  • if you also have HIV (human immunodeficiency virus) do not forget to tell your doctor. You should not take Entecavir Mylan to treat your hepatitis B infectionunless you are taking HIV at the same time, as the effect of future HIV treatment may be reduced. Entecavir Mylan will not control your HIV – infection under control.
  • Using Entecavir Mylan does not prevent you from infecting other people with the hepatitis B virus through sexual intercourse or body fluids (including blood transfusions). 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 Mylan 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 Mylan.
  • Tell your doctor if you have previously received treatment for chronic hepatitis B.

Children and young people

Entecavir Mylanska is not for use by children under 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 can take Entecavir Mylan 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 Mylan treatment because the treatment with lamivudine has not had sufficient effect, Entecavir Mylan 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 Mylan 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 Mylan 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 Mylan during pregnancy. Entecavir Mylan should not be used during pregnancy unless clearly instructed to do so by your doctor. Women of childbearing potential receiving treatment with Entecavir Mylan must use an effective method of contraception to avoid becoming pregnant.

Breast-feeding mothers should not breast-feed during treatment with Entecavir Mylan. Tell your doctor if you are breast-feeding. It is unknown whether entecavir, the active substance in Entecavir Mylan, 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 Mylan contains lactose

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

How to use 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. If you are not sure, talk to your doctor or pharmacist.

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 then prescribe a lower dose or instruct you to take a dose at longer intervals than once a day.
  • the condition of your liver.

For children and young people 

For children and adolescents (from 2 to younger than 18 years), 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 of entecavir may be available. An oral solution is recommended for patients weighing from 10 kg to 32.5 kg. 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. Your doctor will tell you if and when to stop 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, fasting means at least 2 hours after a meal and at least two hours before the next meal.

If you take more Entecavir Mylan then you should

Contact your doctor immediately.

If you forget to take Entecavir Mylan

You mustn’t forget to take your medicine. If you forget to take a dose of Entecavir Mylan, take it as soon as you can, and then take the next dose as usual at the time you should take 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 Mylan without your doctor’s instructions

Some people get very severe hepatitis symptoms when they stop taking Entecavir Mylan. 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 have reported the following side effects:

Adults

  • Common (at least 1 in 100 patients): headache, insomnia, extreme fatigue, dizziness, drowsiness, vomiting, diarrhea, nausea, indigestion ( dyspepsia ), 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 reaction.

Children and young people

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 the defense of infections ).

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 can, blister, or carton after EXP. The expiration date is the last day of the specified month.

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

0.5 mg film-coated tablets

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

1 mg film-coated tablets

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

Other ingredients are:

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

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

What the medicine looks like and the contents of the pack

0.5 mg film-coated tablets

The film-coated tablets (tablets) are white, film-coated, round, biconvex, oblique tablets debossed with “M” on one side and “EA” on the other.

1 mg film-coated tablets

The film-coated tablets (tablets) are white, film-coated, round, biconvex, oblique tablets debossed with “M” on one side and “EB” on the other.

Entecavir Mylan film-coated tablets are available in blister packs containing 30 tablets, perforated blister packs containing 30 x 1 or 90 x 1 tablet, and cans containing 30 or 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan SAS

Allée des Parcs

69800 Saint Priest

France

Manufacturer

McDermott Laboratories Limited to Gerard Laboratories 
Unit 35/36 Baldoyle Industrial Estate, 
Grange Road, Dublin 13 
Ireland

Mylan Hungary Kft. 
Mylan utca 1, 
Komárom – 2900 
Hungary

Mylan Germany GmbH

Branch drop Bad Homburg vd Hoehe, Benzstrasse 1

Bad Homburg vd Hoehe

Hessen, 61352,

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienMylan bvba / sprlTel: + 32 (0) 2 658 61 00 LithuaniaMylan Healthcare UAB Tel: +370 5 205 1288
BulgariaМайлан ЕООДTel: +359 2 44 55 400 Luxembourg / LuxemburgMylan bvba / sprlTel: + 32 (0) 2 658 61 00(Belgium / Belgium)
Czech RepublicMylan Healthcare CZTel: + 420 222 004 400 HungaryMylan EPD KftTel: + 36 1 465 2100
DenmarkMylan Denmark ApSTel: + 45 28 11 69 32 MaltaVJ Salomone Pharma LtdTel: + 356 21 22 01 74
GermanyMylan Healthcare GmbHTel: + 49 800 0700 800 The NetherlandsMylan BVTel: +31 (0) 20 426 3300
EestiBGP Products Switzerland GmbH Eesti subsidiary Tel: + 372 6363 052 NorwayMylan Healthcare Norge ASTel: + 47 66 75 33 00
Greece Generics Pharma Hellas ΕΠΕ :Ηλ: +30 210 993 6410 AustriaArcana Arzneimittel GmbHTel: +43 1 416 2418
SpainMylan Pharmaceuticals, SLTel: + 34 900 102 712 PolandMylan Healthcare Sp. ZooTel: + 48 22 546 64 00
FranceMylan SASTel: +33 4 37 25 75 00 PortugalMylan, Lda.Tel: + 351 21 412 72 56
CroatiaMylan Hrvatska dooTel: +385 1 23 50 599 RomaniaBGP Products SRLTel: +40 372 579 000
IrelandMylan LimitedTel: +353 (0) 87 1694982 SloveniaMylan Healthcare dooTel: + 386 1 23 63 180
IcelandIcepharma hfTel: + 354 540 8000 Slovak RepublicMylan sroTel: +421 2 32 199 100
ItalyMylan SpATel: + 39 02 612 46921 Finland / FinlandMylan Finland OYPuh / Tel: +358 20 720 9555
LatviaMylan Healthcare SIA Tel: +371 676 055 80 United KingdomGenerics [UK] LtdTel: +44 1707 853000

Muhammad Nadeem

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