25 mg film-coated tablets
rilpivirine
1. What EDURANT is and what it is used for
EDURANT contains rilpivirine used for the treatment of infection with human immunodeficiency virus ( HIV ). 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.
EDURANT is used in combination with other HIV medicines to treat adolescents and adults aged 12 years and older who are infected with HIV and who have not been previously treated with HIV medicines.
Your doctor will discuss with you which drug combination is best for you.
2. What you need to know before taking EDURANT
Do not take EDURANT
if you are allergic to rilpivirine or any of the other ingredients of this medicine (listed in section 6).
Do not use EDURANT in combination with any of the following medicines as they may affect the way EDURANT or the other medicine works:
- carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines used to treat epilepsy and prevent seizures)
- rifampicin, rifapentine (medicines to treat certain bacterial infections such as tuberculosis )
- omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole ( proton pump inhibitors which are medicines that prevent and treat stomach ulcers , heartburn or reflux disease )
- dexamethasone (a corticosteroid used in many different conditions such as inflammation and allergic reactions) when taken orally or injected, except when given as a single dose.
- preparations containing St. John’s wort ( Hypericum perforatum ) (an herbal medicine used for mild depression and mild anxiety).
If you take any of the above, talk to your doctor about any options.
Warnings and cautions
Talk to your doctor or pharmacist before taking EDURANT.
EDURANT is not a cure for HIV – infection . It is part of a treatment that reduces the amount of virus in the blood. You can still transmit HIV infection when you take this medicine, even though the risk of effective antiviral therapy is reduced . Discuss with your doctor the necessary steps to avoid infecting others.
EDURANT has only been used in a limited number of patients aged 65 years or older. If you belong to this age group, discuss the use of EDURANT with your doctor.
Tell your doctor about your situation
Carefully check the following points and tell your doctor if any of them apply to you.
- Tell your doctor if you have or have had problems with your liver , e.g. hepatitisB and / or C, and / or kidney problems . Your doctor can assess the severity of your liver or kidney disease before deciding if you can take EDURANT.
- Tell your doctor immediately if you notice symptoms of infection (eg fever, chills and sweating). In some patients with advanced HIV – infection and earlier opportunistic infection , signs and symptoms of inflammation from previous infections you may occur shortly after HIV -behandlingen started. It is believed that these symptoms are due to an improvement in the body’s immune response, which allows the body to fight infections that may have been present without giving clear symptoms.
- In addition to opportunistic infection, you can autoimmune disorders (condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines to treat your HIV – infection . Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands or feet and moves to the torso, palpitations, tremors or hyperactivity, inform your doctor immediately for the necessary treatment.
- Tell your doctor if you are taking any medicines that may cause a life-threatening irregular heartbeat ( Torsade de Pointes ).
Children
EDURANT should not be used in children under 12 years of age as it has not been adequately studied in these patients.
Other medicines and EDURANT
You must take EDURANT with other HIV medicines. Your doctor will tell you which HIV drugs can be combined with EDURANT and you will decide together which combination best suits your needs. Follow your doctor’s instructions carefully.
Some medicines can affect the levels of EDURANT in the blood when 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.
It is recommended that EDURANT not be combined with other non- nucleosidereverse transcriptase inhibitors (NNRTIs) such as delavirdine, efavirenz, etravirine and nevirapine.
The effects of EDURANT or other medicines may be affected if you take EDURANT with any of the following medicines. Tell your doctor if you are taking:
- rifabutin (a medicine used to treat certain bacterial infections). If you are taking this medicine while taking EDURANT Read carefully in section 3 “Instructions for proper use in adults and adolescents (12 to under 18 years of age”) how to take EDURANT
- clarithromycin, erythromycin ( antibiotics )
- cimetidine, famotidine, nizatidine, ranitidine (H 2 -receptor antagonists used to treat stomach or intestinal ulcers or used to relieve heartburn due to acid flux). If you are taking these medicines, carefully read how to take them in section 3 “Instructions for proper use in adults and adolescents (12 to under 18 years of age)”
- antacids (used to treat diseases due to the acid in the stomach, eg aluminum / magnesium hydroxide, calcium carbonate ). If you are taking these medicines, carefully read how to take them in section 3 “Instructions for proper use in adults and adolescents (12 to under 18 years of age)”
- methadone (used to treat opiate addiction)
- dabigatran etexilate ( anticoagulants ).
Pregnancy and breastfeeding
Tell your doctor immediately if you are pregnant or planning to become pregnant. Pregnant women should discuss the use of EDURANT with their doctor.
HIV- infected mothers should not breast-feed, as there is a risk of infecting the baby with HIV through breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Some patients may experience fatigue, dizziness or drowsiness during treatment with EDURANT. Do not drive or use machines if you feel tired, dizzy or sleepy while taking EDURANT.
EDURANT 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.
EDURANT contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
3. How to take EDURANT
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Instructions for proper use in adults and adolescents ( 12 to under 18 years)
The recommended dose of EDURANT is one tablet once a day.
EDURANT must be taken with a meal. It is important to have a meal to get the right levels of the active substance in the body. Only a nutritional drink (eg a protein-rich drink) does not replace a meal.
There are four situations that require special attention:
- If you are taking rifabutin (a medicine used to treat certain bacterial infections), take two tablets of EDURANT once a day. When you stop taking rifabutin, take one EDURANT tablet once a day. If you are not sure, talk to your doctor or pharmacist.
- If you are taking antacids (a medicine used to treat diseases that are due to stomach acid, eg aluminum / magnesium hydroxide, calcium carbonate ). Take antacids either at least 2 hours before or at least 4 hours after EDURANT (see section 2 ” Other medicines and EDURANT “).
- If you are taking an H 2 -receptor antagonist (medicines used to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux (eg cimetidine, famotidine, nizatidine or ranitidine) Take the H 2 -receptor antagonist at least 12 hours before or at least 4 hours after EDURANT (see section 2 ” Other medicines and EDURANT “) H 2 receptor antagonists should not be taken twice daily Talk to your doctor about an alternative schedule.
- If you are taking didanosine (a medicine to treat HIV – infection ), no dose adjustment. Didanosine should be taken on an empty stomach at least two hours before or at least four hours after EDURANT (which must be taken with a meal).
Remove the child-resistant coverShow larger
| The jar has a child-resistant lid. It is opened by pushing the screw cap down while turning it counterclockwise. |
If you take more EDURANT than you should
Contact a doctor or pharmacist immediately. In case of an overdose, you may experience headaches, nausea, dizziness and / or abnormal dreams.
If you forget to take EDURANT
If you notice it within 12 hours after the time you usually take EDURANT , 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 it after more than 12 hours , skip the one dose and take the next dose 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 a new tablet with a meal. If you vomit more than 4 hours after taking EDURANT, you do not need to take a new tablet until your next tablet according to the usual schedule.
Contact your doctor if you are not sure what to do if you miss a dose or vomit.
Do not stop taking EDURANT
HIV treatment does not cure HIV infection! Do not stop taking EDURANT without talking to your doctor first. Even if you feel better, do not stop taking EDURANT or your other HIV medicines. Doing so increases the risk of the virus developing resistance . Talk to a doctor first.
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.
Very common:
- headache
- nausea
- difficulty falling asleep (insomnia)
- dizziness
- changes to one of your routine liver tests ( transaminases )
- elevated cholesterol and / or pancreatic amylase in the blood
Usual:
- abnormal dreams
- rash
- abdominal pain
- Depression
- fatigue
- vomiting
- somnolence
- decreased appetite
- sleep disorders
- feeling of discomfort in the stomach
- lowered mood
- dry mouth
- low white blood cell and / or platelet count , decreased hemoglobin in the blood, increase in triglycerides , lipase and / or bilirubin in the blood
Uncommon:
- signs or symptoms of inflammation or infection , such as fever, chills, sweating (immune reactivation syndrome)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
5. How to store EDURANT
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 jar after EXP. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light.
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
- The active substance is rilpivirine in the form of rilpivirine hydrochloride. One EDURANT tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
- The other ingredients in 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.
What the medicine looks like and contents of the pack
White to off-white, film-coated, round, biconvex tablet marked “TMC” on one side and “25” on the other side.
A jar with a child-resistant lid contains 30 film-coated tablets.
Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B 2340 Beerse
Belgium
Manufacturer
Janssen-Cilag SpA.
Via C. Janssen
Borgo San Michele
04100 Latina
Italy
Contact the representative of the marketing authorization holder to find out more about this medicine:
Sweden
Janssen ‑ Cilag AB
Tel: +46 8 626 50 00
jacse@its.jnj.com