Patient leaflet - ENTECAVIR ACCORD 0.5 MG FILM-COATED TABLETS
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Package leaflet: Information for the user
Entecavlr Accord 0.5 mg film-coated tablets
Entecavlr Accord 1 mg film-coated tablets
entecavlr
Raad all of this leaflet canfuly before you atari taking thle medicine because It contain* Important Intonnation for you.
- Keep this leaflet You may need to read It again.
- If you have any nattier questions, ask your doctor or pharmacist
- Thia medicine has been prescribed for you only. Do not pass It on tn others. It may harm them, even If their signs of Illness are the sama as yours.
- If you get any side effects, talk tn you doctor or pharmacist. This Includes any posstola side effects not listed In this leaflet. See section 4.
What I* In this leaflet
1. What Entecavt Accord Is and what It Is used for
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2. What you need to knew before you take Entecavk Accord
3. How to take Entecavlr Accord
4. Possible side effects
5. How to store Entecavlr Accord
6. Contents of the pack and other Information
1. what entecavlr accord is and what it is used for
Entecavlr Accord labiate are anti-vtal medicine*, used to treat chronic (long term) hepatttl* B virua (HBV) Infection In adults. EntecavirAccord can be used In people whose liver Is damaged but still functions property (compensated liver disease) and ta people whose liver Is damaged and does not function properly (decompensated liver disease).
Entecavlr Accord tablet* are also used to treat chronic (long term) HBV Infection In children and adolescent* aged 2 year* to les* than 18 year*. EntecavirAccord can be used ta children whose liver Is damaged but still fteictians property (compensated liver disease).
Infection by the hepatitis B virus can lead to damage to the liver. EntecavirAccord reduces the amount of vtais In your body, and Improves the condition of the liver.
2. what you need to know before you take entecaviraccord
Do not taka Entecavlr Accord
- If you are alarglc (hyparsanalttva) to entecavlr or any of the other tagrerflents of this medicine (listed In section 6).
Wamtag and precaution*
Talk to your doctor or pharmacist before taktag EntecavirAccord
- If you have ever had problem* with your kidneys, tell your doctor. This la Important because EntecavirAccord Is ekntaated from you body through the klrtaeys and your dose or dosing schedule may need tn be adjusted.
- do not stop taking Entecavlr Accord without your doctor's advice since your hepatitis may worsen after stopptag treatment. When your treatment with EntecavirAccord Is stopped, your doctor will continue to monitor you and take blood teste for several months.
- discus* with your doctor whether your liver functions property and. If not, what the passible effects on your Entecavi Accord treatment may be.
- If you are also Infected with HIV (human Immunodeficiency vtais) be sure to tell you doctor. You shotad not take EntecavirAccord to treat your hepatitis B tafection unless you are taktag medicines for HIV at the same time, as the effectiveness of futias HIV treatment may be reduced. EntecavirAccord will not control you HIV iifection.
- taking EntecavirAccord wfl not stop you from Infecting other people with hepattti* B virus (HBV) through semal contact or body fluids (taclutBig Hood contamination). So, It Is Important to take appropriate precautions to prevent others from becoming tafected with HBV. A vaccine Is available to protect those at risk from becomtog Infected with HBV.
- Entecavlr Accord belongs to a class of medicine* diet can cause lactic acidosis (excess of lactic add to your blood) and enlargement of the liver. Symptoms such as nausea, vomiting and stomach pain might tadlcata the development of lactic acidosis. This rare but serious side effect has occasionally been fetal. Lactic acidosis occurs more often In women, particularly If they are vary overweight Your doctor will monitor you regularly while you are receiving EntecavirAccord.
- If you have previously received treatment far chronic hepatitis B, please Inform your doctor.
Children and adolescent*
Entecavi Accord should not be used for children below 2 years of age or welghiig less than 10 kg.
Other medicine* and Entecavlr Accord
Tel you doctor or pharmacist If you are taktag, have recently taken or might take any other medicines.
Entecavlr Accord with food and drink
In most cases you may take Entecavi Accord wtth or without food. However, If you have had a previous treatment wtth a medicine containing the active substance lamlvudlne you should consider the folkwring. If you were switched over to Entecavlr Accord because the treatment wtth lamlvudlne was not successful, you should take EntecavirAccord on an empty stomach once dally. If you liver disease Is very advanced, you doctor will also Instruct you to take Entecavi Accord on an empty stomach. Empty stomach means at least 2 hours altera meal and at least 2 houa before your next meal.
Chldren and adolescents (from 2 to less than 18 years of age) can take EntecavirAccord with or without food.
Pregnancy, breast-feeding and fertility
Tel you doctor If you are pregnant or ptennlng to become pregnant It has not been demonstrated that EntecavirAccord Is safe to use diking pregnancy. Entecavi Accord must mt ba used during pregnancy unless specifically cfeected by you doctor. It Is Important that women of childbearing age receiving treatment wtth EntecavirAccord use an effective method of contraception to avoid becomtog pregnant
You shotad not breast-feed during treatment wtth Entecavi Accord. Tell your doctor If you are breast- feerfetg. It Is not known whether entecavlr, the active toyedlent In EntecavirAccord, Is excreted In human breast milk.
Driving and using machine*
Dizziness, tiredness (fatigue) and sleepiness (somnolence) are common side effects which may Impair your ability to drive and use machines. If yreu have any concerns constat you doctor.
Entecavlr Accord contains soy polysaccharides
This medicinal product contains soy polysaccharides. If you are allergic to soya, do not use this medicinal product
3. how to take entecavlr accord
Not all patient* need to take the same dose at EntecavirAccord.
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 doae Is either 0.5 mg or 1 mg once dally orally (by mouth).
Your does will depend on:
- whether you have been treated far HBV Infection before, and what medkfoe you received.
- whether you have kidney problems. Your doctor may prescribe a lower doae far you or Instruct you to tala It less often than once a day.
- the conation of your liver.
For children and adolescent* (from 2 to leas than 18 years of age), EntecavirAccord 0.5 mg tablets are available or an entecavlr oral solution may be available.
Your Ohio's doctor will deckle the right dose based on your child's wrel^ff. Chilian weighing at least 32.6 kg may take the 0.5 mg tablet or an entecavlr oral solution may be available. For patients weighing from 10 kg to 32.5 kg, an entecavlr oral solution Is recommended. All dosing wfl be taken once deiy orally (by mouth). There are no recommendations for entoeavir in children les* than 2 years of age or weighing less then 10 kg.
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 foly effective end to reduce the development of resistance to treatment. Take EntecavirAccord as long as your doctor has told you. Your doctor wfl toll you if and when you should stop the treatment
Some patents must take EntecavirAccord on an empty stomach (see Entecavlr Accord wtth food and drink in Section 2). If your doctor instruct* you to take EntecavirAccord on an empty stomach, empty stomach mean* at least 2 hour* after a meal and at least 2 hour* before your next meal.
EntecavirAccord is only available a* 0.5 and 1 mg film-coated tablets. For patients who are not able to swafcrw tablets or for whom a does reduction is recommended, other entecavir-corrtainang products with more statable formulation* may be avaiaUe.
If you taka more Entecavlr Accord than you should Contact your doctor at once.
If you forget to take Entecavlr Accord
It is important that you do not mis* any doses. If you miss a dose of EntecavirAccord, tako it as soon as possible, and then take you next scheduled dose at its regular tine. If it is almost tine for you next dose, do not take the missed dose. Wait and take the next dose at the regtaartime. Do not take a double dose to make up for a forgotten dose.
Do not stop Entecavi Accord without you- doctor3* advice
Some people get very serious hepatitis symptoms when they stop taking EntecavirAccord. Tell your doctor Immediately about any changes In symptoms that you notice after stopptag
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. possible side effects
Like ai medicines, this medicine can cause side effects, although not everybody gets them.
Patients treated with Entecavlr Accord have reported the following side effects:
Adults:
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■ common (at least 1 to 100 patients): headache, Insomnia (Inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleeptoess), vomlttog, diarrhoea, nausea, dyspepsia (Indgestlon), and Increased blood levels of liver enzymes.
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■ uncommon (at least 1 In 1,000 patients): rash, hair loss.
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■ rare (at least 1 In 10,000 patents): severe allege reaction.
Children and edolescaots
The side effects experienced In chllrken and adolescents are similar to those experienced In adults as desorbed above with the following difference:
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■ Very common (at least 11n 10 patients): low levels of neutrophils (one type of white blood cells, which are Important to lighting Infection).
If you get any side effects, talc to your doctor or pharmacist This Includes any possible side effects not listed In this leaflet
Reporting of aide offsets
If you get any side effects, talc to your doctor or pharmacist or. This Includes any passible side effects not listed In this leaflet By raporttog side effects you can help provide more Information on the safety of this medicine.
For United Kingdom- You can also report side effects rfcectiy via Yellow Card Scheme, Website: or search for MHRA Yellow Card In the Google Play or Apple AppStore
For Ireland- You can also report side effects directly via
HPRA Pharmacovtgllance
Website:
For Malta- You can also report side effects dkeeby via ADR Reporting, Website:
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5. how to store entecavlr accord
Koop this medicine out of the sight end reedi of chddren.
Do not use this mecSdne after the expiry date which is staled on the bottle, blister or carton after EXP. That expiry date refers to the last day of that month.
After opentog the bottle use within SO days.
This medidnal 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
Entwavfr Awwrd 0.5 mg fllm-wated tablpte
Each tablet contatos entecavlr monchydrate equivalent to 0.5 mg entecavlr.
Entwavfr Awwrd 1 mg fllm-g?ated labiate
Each tablet contatos entecavlr monchydrate equivalent to 1 mg entecavlr.
The other Ingredients ere:
Tablet core: Calcium carbonate, starch, pregelaflnlzed, carmeilosa sodium, soy polysaccharides, citric acid monohydrate, sorkum stearyt fumarate.
Tablet coating:
Entecavk Award 0,6 mg Ulm-waled tablata
Hypromelose, titanium dioxide (E171), macrogd, polysorbate 60
Entecavk Award 1 mg film-coated labiate
Hypromelose, titanium dioxide (E171), macrogol, kon oxide red (E172)
What Entecavk Accord looks like and contorts of the pack
Entecavk Accord 0.6 mg film-coated tablets: White to off white, triangle shaped, biconvex Bn-coated tablets debossed with ‘J on one side and ‚110‘ on other side.
Entecavk Accord 1 mg film-coated tablets: Pink, triangle shaped, biconvex tilm-coatad tablets debossed with ‚J on one side and '111‘ on other side.
Entecavk Accord are supplied to cartons containing 30 × 1 or 90 × 1 film-coated tablet (In unit-dose blisters) and In bottles contalntog 30 film-coated tablets.
Not all pack sizes may be marketed In your country.
Marketing Authorisation Haidar Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n, Edlffd Eat 6* planta, 08039 Barcelona, Spain
Manufacturer
Pharmadox Healthcare Ltd.
KW20A Kordln Industrial Park
Paola, PLA 3000 Malta
For any Information about this merkdne, please contact the local rapresentattve of the Marketing Authorisation Holder.
Accord Healthcare S.L.U. Tel: +34 93 301 00 64
This leaflet was last revised to 01/2021.
Other sources of Information
□staled Information on this medicine Is available on the European Medktoes Agency web site: .
The active substance Is entecavlr.
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