Edurant
rilpivirine
rilpivirine
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 EDURANT is and what it is used for
What you need to know before you take EDURANT
How to take EDURANT
Possible side effects
How to store EDURANT
Contents of the pack and other information
EDURANT contains rilpivirine that is used for the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). EDURANT works by reducing the amount of HIV in your body.
12 years of age and older who are infected with HIV and who have never been treated before with HIV medicines.
Your doctor will discuss with you which combination of medicines is best for you.
carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and prevent seizures)
rifampicin, rifapentine (medicines to treat some bacterial infections such as tuberculosis)
omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, (proton pump inhibitors that are medicines to prevent and treat stomach ulcers, heartburn or acid reflux disease)
dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and
allergic reactions) when taken by mouth or injected, except as a single dose treatment
products that contain St John’s wort (Hypericum perforatum) (a herbal product used for depression).
If you are taking any of the above, ask your doctor about alternatives.
Talk to your doctor or pharmacist before taking EDURANT.
EDURANT is not a cure for HIV infection. It is part of a treatment reducing the amount of virus in the blood. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your physician the precautions needed to avoid infecting other people.
EDURANT has only been used in a limited number of patients of 65 years or older. If you belong to this age group, please discuss the use of EDURANT with your doctor.
Make sure that you check the following points and tell your doctor if any of these apply to you.
Tell your doctor if you have or have had problems with your liver, including
hepatitis B and/or C, and/or problems with your kidneys. Your doctor may evaluate how severe your liver or kidney disease is before deciding if you can take EDURANT.
Tell your doctor immediately if you notice any symptoms of infections (for example, fever,
chills, sweats). In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Tell your doctor if you are taking any medicines that may cause a life-threatening irregular heartbeat (Torsade de Pointes).
EDURANT is not for use in children less than 12 years of age, because it has not been sufficiently studied in these patients.
You must take EDURANT together with other HIV medicines. Your doctor will advise on which HIV medicines can be combined with EDURANT and together you will decide which combination fits your needs best. Follow your doctor’s instruction carefully.
Some medicines may affect the levels of EDURANT in the blood when they are taken at the same time as EDURANT.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
rifabutin (a medicine to treat some bacterial infections). If you take this medicine while taking EDURANT, please carefully read how to take EDURANT in section 3 “Instructions for proper
use in adults and adolescents (12 to less than 18 years of age)”.
clarithromycin, erythromycin (antibiotics)
cimetidine, famotidine, nizatidine, ranitidine (H2-receptor antagonists used to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux). If you take these medicines,
please carefully read how to take them in section 3 “Instructions for proper use in adults and adolescents (12 to less than 18 years of age)”.
antacids (used to treat diseases related to the acid in the stomach; for example,
aluminium/magnesium hydroxide, calcium carbonate). If you take these medicines, please carefully read how to take them in section 3 “Instructions for proper use in adults and adolescents (12 to less than 18 years of age)”.
methadone (used to treat narcotic withdrawal and dependence)
dabigatran etexilate (anticoagulant).
Tell your doctor immediately if you are pregnant or if you plan to become pregnant. Pregnant women should discuss the use of EDURANT with their doctor.
HIV infected mothers must not breastfeed, as there is a possibility of infecting the baby with HIV via
breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Some patients may experience tiredness, dizziness or drowsiness during treatment with EDURANT. Do not drive or operate machinery if you feel tired, dizzy or drowsy while taking EDURANT.
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of EDURANT is one tablet once a day.
EDURANT must be taken with a meal. A meal is important to get the right levels of active substance in your body. A nutritional drink (e.g. protein-rich) alone does not replace a meal.
There are four situations that require special attention:
before or at least 4 hours after EDURANT (see section 2 “Other medicines and EDURANT”).
If you take an H2-receptor antagonist (medicines used to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux (such as cimetidine, famotidine, nizatidine or
ranitidine). Take the H2-receptor antagonist at least 12 hours before or at least 4 hours after EDURANT (see section 2 “Other medicines and EDURANT”). H2-receptor antagonists should not be taken in a twice a day regimen. Talk to your doctor about an alternative regimen.
Didanosine should be administered on an empty stomach at least two hours before or at least four hours after EDURANT (which must be taken with a meal).
The bottle comes with a child resistant cap. It can be opened by pushing the screw cap down while turning it anti-clockwise.
Contact your doctor or pharmacist immediately. In case of overdose, you may have a headache, nausea, dizziness, and/or abnormal dreams.
If you notice within 12 hours of the time you usually take EDURANT, you must take the tablet as soon as possible. The EDURANT tablet must be taken with a meal. Then take the next dose as usual.
If you notice after 12 hours, then skip that dose and take the next doses as usual.
Do not take a double dose to make up for a forgotten dose.
If you vomit less than 4 hours after taking EDURANT, take another tablet with a meal. If you vomit more than 4 hours after taking EDURANT you do not need to take another tablet until your next regularly scheduled tablet.
Contact your doctor if uncertain about what to do if you miss a dose or vomit.
HIV treatment does not cure HIV infection! Do not stop using EDURANT without talking to your doctor first. Even if you feel better, do not stop taking EDURANT or your other HIV medicines.
Doing so could increase the risk of the virus developing resistance. Talk to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Very common:
headache
nausea
difficulty falling asleep (insomnia)
dizziness
changes in one of your routine liver tests (transaminase)
increase in cholesterol and/or pancreatic amylase in your blood
Common:
abnormal dreams
rash
stomach pain
depression
tiredness
vomiting
drowsiness
decreased appetite
sleep disorders
stomach discomfort
depressed mood
dry mouth
low white blood cell and/or platelet count, decrease in haemoglobin in your blood, increase in triglycerides, lipase and/or bilirubin in your blood
Uncommon:
signs or symptoms of inflammation or infection, for example fever, chills, sweats (immune reactivation syndrome)
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 thenationalreportingsystem listedinAppendixV. By reporting side effects you can help provide more information on the safety of this medicine.
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 carton and on the bottle after EXP. The expiry date refers to the last day of that month.
Store in the original bottle in order to protect from light.
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.
The active substance is rilpivirine in the form of rilpivirine hydrochloride. Each tablet of EDURANT contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
The other ingredients of the film-coated tablet core are lactose monohydrate, croscarmellose sodium, povidone K30, polysorbate 20, silicified microcrystalline cellulose and magnesium stearate. The film-coating contains lactose monohydrate, hypromellose 2910 6 mPa.s, titanium
dioxide E171, macrogol 3000 and triacetin.
White to off-white, film-coated, round, biconvex tablet, with “TMC” on one side and “25” on the other side.
A bottle with child resistant closure containing 30 film-coated tablets.
B-2340 Beerse Belgium
Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 88
„Джонсън & Джонсън България” ЕООД Тел.: +359 2 489 94 00
Janssen-Cilag NV Tél/Tel: +32 14 64 94 11
Janssen-Cilag A/S Tlf: +45 4594 8282
AM MANGION LTD. Tel: +356 2397 6000
Janssen-Cilag GmbH Tel: +49 2137 955 955
Janssen-Cilag B.V. Tel: +31 76 711 1111
UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7410
Janssen-Cilag AS Tlf: +47 24 12 65 00
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Tηλ: +30 210 80 90 000
Janssen-Cilag Pharma GmbH Tel: +43 1 610 300
Janssen-Cilag, S.A. Tel: +34 91 722 81 00
Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 00
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
Janssen-Cilag Farmacêutica, Lda. Tel: +351 214 368 600
Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 700
Johnson & Johnson România SRL Tel: +40 21 207 1800
Janssen Sciences Ireland UC Tel: +353 1 800 709 122
Johnson & Johnson d.o.o. Tel: +386 1 401 18 00
Janssen_safety_slo@its.jnj.com
Janssen-Cilag AB c/o Vistor hf
Sími: +354 535 7000
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
Βαρνάβας Χατζηπαναγής Λτδ Τηλ: +357 22 207 700
Janssen-Cilag AB Tfn: +46 8 626 50 00
UAB "JOHNSON & JOHNSON" filiāle Latvijā Tel: +371 678 93561
Janssen Sciences Ireland UC Tel: +44 1 494 567 444