Entecavir Viatris – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Entecavir Viatris, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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 pharmacis t. 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.
ℹ️ 1. What Entecavir Viatris is and what it is used for
Entecavir Viatris tablets are anti-viral medicines, used to tre at chronic (long term) hepatitis B virus (HBV) infection in adults. Entecavir Viatris can be used in people whose liver is damaged but still functions properl y (compensated liver disease) and in peo ple whose liver is damaged and does not function properly (decomp ensated liver disease).
Entecavir Viatris tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years. Entecavir Viatris can be used in children whose liver is damaged but still functio ns properly (compensated live r disease).
Infection by the hepa titis B virus can lead to damage to the li ver. Entecavir Viatris reduces the amount of virus in your body, and impro ves the condition of the liver.
⚠️ 2. What you need to know befo re you take Entecavir Viatris
Do not take Entecavir Viatris
if you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine (listed in s ection 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Entecavir Viatr is if you have ever had prob lems with your kidneys , tell your doctor. This is important because Entecavir Viatris is eliminated from your body through the kidn eys and your dose or dosing schedule may need to be adjusted. do not stop taking Entecavir Viat ris without your doctor’s advi ce since your hepatitis may worsen after stopping treatment . When your treatment with Entec avir Viatris is stopped, your doctor will continue t o monitor you and take blood tests for se veral months. discuss with your doctor whether your liver functions properly and, if not, wha t the possible effects on your Entecavir Viatris treatment may be. if you are also infected with HIV (human immunodeficiency virus ) be sure to tell your doctor.
You should not take Entecavir Viatris to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of fut ure HIV treatment may be reduced. Entecavir Viatris will no t control your HIV infection. taking Entecavir Viatris will not stop you from infecting other people with hepatitis B virus (HBV) through sexual contact or body fluids (including blood contami nation). So, it is important to take appropriate precautions to prevent others fro m becoming infected with HBV.
A vaccine is available to protect those at risk from becoming i nfected with HBV. Entecavir Viatris belongs to a class of medicines that can caus e lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver. Sympto ms 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. You r doctor will monitor you regularly while y ou are receivin g Entecavir Viatris. if you have previously received treatment for chronic hepatitis B, please inform your doctor.
Children and adolescents
Entecavir Viatris should not be used for children below 2 years of age or weighing less than 10 kg.
Other medicines and Entecavir Viatris Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Entecavir Viatris with food and drink In most cases you may take Entecavir Viatris with or without fo od. However, if you have had a previous treatment with a medicine containing the active substa nce lamivudine you should consider the following. If you were switched over to Entecavir Viatris b ecause the treatment with lamivudine was not successful, you should t ake Entecavir Via tris on an emp ty stomach once da ily. If your liver disease is very advanc ed, your doctor will also instruct you to take Entecavir Viatris 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 Viatris with or without food.
Pregnancy, breast-feeding and fertility
Tell your doctor if you are pregnant or planning to become preg nant. It has not been demonstrated that entecavir is safe to use during pregnancy. Entecavir Viatris mu st not be used during pregnancy unless specifically directed by your doctor. It is important that wome n of childbearing age receiving treatment with Entecavir Viatris use an eff ective method of con traception to avoid becoming pregnant.
You should not breast-feed during treatment with Entecavir Viat ris. Tell your doc tor if you are breastfeeding. It is not known w hether entecavir, the active su bstance in Entecavir Viatris, is excreted in human breast milk.
Driving and using machines
Dizziness, tiredness (f atigue) and sleepiness (somnolence) are common side effects which may impair your ability to drive and use mach ines. If you hav e any concern s consult your doctor.
Entecavir Viatris contains lactose
This medicine contains lactose. If you have been told by your d octor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
💊 3. How to take Entecavir Viatris
Not all patients need to take the same dose of Entecavir Viatri s.
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 orall y (by mouth).
Your dose will depend on: whether you have been treated for HBV infection before, and wha t medicine you received. whether you have kidney problems. Your doctor may prescribe a l ower 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 wil l decide the right dose based on your child’s w eight. Children weighing at l east 32.6 kg may take the 0.5 mg tablet or an entecavir oral solution ma y be available. For patients we ighing from 10 kg to 32.5 kg, an entecavir oral solution is recommended. All doses should be tak en once daily orally (by mouth). There are no recommendations for entecavir in children less than 2 ye ars of age or weighing less than 10 kg.
For children and adolescents (from 2 to less than 18 years of age), Entecavir Viatris 0.5 m g Film- coated Tablets are available or a n oral solution may be availab le. Your child’s doc tor will decide the right dose based on your child’s weight.
Your doctor will advise you on th e dose that is right for you.
Always take the dose recommended by your doctor to ensure that your medicine is f ully effective and to reduce the development of resistance to treatment. Take Ente cavir Viatris 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 Viatris on an empty stomach ( see Entecavir Viatris with food and drink in Section 2 ). If your doctor instructs you t o take Entecavir Viatris on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hour s before your next meal.
If you take more Entecavir Viatris than you should
Contact your doctor at once.
If you forget to take Entecavir Viatris
It is important that you do not miss any doses. If you miss a d ose of Entecavir Viatris, take it as soon as possible, and then take your next scheduled dose at its regu lar 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 Viatris without your doctor’s advice Some people get very s erious hepatitis sympt oms 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, altho ugh not everybody gets them.
Patients treated with entecavir ha ve reported the following sid e effects:
48 Adults Common (at least 1 in 100 patient s): headache, insomnia (inabil ity to sleep), fatigue (extreme tiredness), dizziness, somnolenc e (sleepiness), vomiting, diarr hoea, 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 patie nts): severe alle rgic reaction.
Children and adolescents
The side effects experienced in children and adolescents are si milar to those experienced in adults as described above with the following d ifference:
Very common (at least 1 in 10 pa tients): low levels of neutroph ils (one type of wh ite 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 di rectly via the nationa l reporting system listed in Appendix V . By reporting side effects you can help provide more informati on on the safety of this medicine.
🌡️ 5. How to store Entecavir Viatris
Keep this medicine out of the sight and reach of children. Do not use this medicine after t he 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 medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household was te. Ask your pharmacist how to throw away medicines y ou no longer use. The se measures will hel p protect the environment.
📦 6. Contents of the pack and other information
What Entecavir Via tris contains
Entecavir Viatris 0.5 mg film-coated tablets The active substance is entecavir. Each film-coated tablet cont ains entecavir monohydrate equivalent to 0.5 mg entecavir.
Entecavir Viatris1 mg film-coated tablets The active substance is entecavir. Each film-coated tablet cont ains entecavir monohydrate equivalent to 1 mg entecavir.
The other ingredients are:
Tablet core: microcrys talline cellulose, crospovidone, lactose monohydrate (see section 2, “Entacavir
Viatris contains lactose”), magnesium stearate
Tablet coating: titanium dioxide (E171), hyprome llose, macrogol 400, polysorbate 80.
What Entecavir Viatr is looks like and contents of the pack
Entecavir Viatris 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.
49 Entecavir Viatris 1 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 “EB” on the other side.
Entecavir Viatris film-coated ta blets are supplied in blisters packs containing 30 tablets, perforated blister packs containing 30 x 1 or 90 x 1 tablets, and in bottl es containing 30 or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN Ireland
Manufacturer
McDermott Laboratories Limited t/a Gerard Laboratories Unit 35/36 Baldoyle I ndustrial Estate, Grange Road, Dublin 13 Ireland Mylan Hungary Kft.
Mylan utca 1, Komárom – 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 m edicine, please contact the loc al representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Viatris Tél/Tel: + 32 (0)2 658 61 00 Lietuva Viatris UAB Tel: +370 5 205 1288 България Майлан ЕООД Teл.: +359 2 44 55 400 Luxembourg/Luxemburg Viatris Tél/Tel: + 32 (0 )2 658 61 00 (Belgique/Belgien) Česká republika Viatris CZ s.r.o.
Tel: + 420 222 004 400 Magyarország Viatris Healthcare Kft.
Tel.: + 36 1 465 2100 Danmark Viatris ApS Tlf: +45 28 11 69 32 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74 50 Deutschland Viatris Healthcare GmbH Tel: +49 800 0700 800 Nederland Mylan BV Tel: +31 (0)20 426 3300 Eesti Viatris OÜ Tel: + 372 6363 052 Norge Viatris AS Tlf: + 47 66 75 33 00 Ελλάδα Viatris Hellas Ltd Τηλ: +30 2100 100 02 Österreich Arcana Arzneimittel GmbH Tel: +43 1 416 2418 España Viatris Pharmaceuticals, S.L. Tel: + 34 900 102 712 Polska Viatris Healthcare Sp. z o.o. Tel: + 48 22 546 64 00 France Viatris Santé Tél: +33 4 37 25 75 00 Portugal Mylan, Lda.
Tel: + 351 214 127 200 Hrvatska Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599 România BGP Products SRL Tel: +40 372 579 000 Ireland Mylan Ireland Limited Tel: +353 1 8711600 Slovenija Viatris d.o.o.
Tel: + 386 1 23 63 180 Ísland Icepharma hf.
Sími: +354 540 8000 Slovenská republika Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100 Italia Viatris Italia S.r.l.
Tel: + 39 (0) 2 612 46921 Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9555 Κύπρος GPA Pharmaceuticals Ltd Τηλ: +357 22863100 Sverige Viatris AB Tel: +46 (0)8 630 19 00 Latvija Viatris SIA Tel: +371 676 055 80 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711600
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the Europ ean Medicines Agency web site: http://www.ema.europa.eu .
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Entecavir Viatris (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/17/1227).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.