Patient leaflet - Entecavir Mylan
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
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■ 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
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■ 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.
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■ 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.
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■ discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Entecavir Mylan treatment may be.
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■ 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.
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■ 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.
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■ 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.
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■ 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. Ifyou 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. Ifyou 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 medicine.
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:
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■ whether you have been treated for HBV infection before, and what medicine you received.
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■ 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.
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■ 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:
Adults
- 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.
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 patients): low levels of neutrophils (one type of white blood cells, which are important in fighting infection).
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 [to be completed nationally]. 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
0.5 mg film-coated tablets
The active substance is entecavir. Each film-coated tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir.
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1 mg film-coated tablets
What Entecavir Mylan looks like and contents of the pack
0.5 mg film-coated tablets
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.
Entecavir Mylan film-coated tablets are supplied in blisters packs containing 30 tablets, perforated blister packs containing 30 × 1 or 90 × 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,
Komarom – 2900
Hungary
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| België/Belgique/Belgien Mylan bvba/sprl Tél/Tel: + 32 (0)2 658 61 00 Eíxiiapiisi MaüaaH EOOfl Tea.: +359 2 44 55 400 Česká republika Mylan Healthcare CZ s.r.o. Tel: +420 222 004 400 Danmark Mylan Denmark ApS Tel: + 45 28 11 69 32 | Lietuva Mylan Healthcare UAB Tel: +370 5 205 1288 Luxembourg/Luxemburg Mylan bvba/sprl Tel: + 32 (0)2 658 61 00 (Belgique/Belgien) Magyarorszag Mylan EPD Kft Tel: + 36 1 465 2100 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74 |
| Deutschland Mylan Healthcare GmbH Tel: + 49 800 0700 800 | Nederland Mylan BV Tel: + 31 (0)20 426 3300 |
| Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 052 | Norge Mylan Healthcare Norge AS Tel: + 47 66 75 33 00 |
| EZZàôa Generics Pharma Hellas EnE TnÀ: +30 210 993 6410 | Österreich Arcana Arzneimittel GmbH Tel: +43 1 416 2418 |
| España Mylan Pharmaceuticals, S.L Tel: + 34 900 102 712 | Polska Mylan Healthcare Sp. z.o.o. Tel: + 48 22 546 64 00 |
| France Mylan S.A.S Tel: +33 4 37 25 75 00 | Portugal Mylan, Lda. Tel: + 351 21 412 72 56 |
| Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599 | Romania BGP Products SRL Tel: + 40 372 579 000 |
| Ireland Mylan Ireland Limited Tel: +353 (0) 87 1694982 | Slovenija Mylan Healthcare d.o.o. Tel: + 386 1 23 63 180 |
| Ísland Icepharma hf Tel: + 354 540 8000 | Slovenská republika Mylan s.r.o. Tel: +421 2 32 199 100 |
| Italia Mylan Italia S.r.l Tel: + 39 02 612 46921 | Suomi/Finland Mylan Finland OY Puh/Tel: + 358 20 720 9555 |
| Kùnpoç Varnavas Hadjipanayis Ltd TnÀ: + 357 2220 7700 | Sverige Mylan AB Tel: + 46 855 522 750 |
| Latvija Mylan Healthcare SIA Tel: +371 676 055 80 | United Kingdom Generics [UK] Ltd Tel: +44 1707 853000 |
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:.
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