EDURANT 25 mg FILM-COATED TABLETS

2. What you need to know before you take EDURANT

Do not take EDURANTif you are allergic to rilpivirine or any of the other ingredients of this medicine (listed in section 6).

Do not take EDURANT with any of the following medicinesas they may affect how EDURANT or the other medicine works:

• carbamazepine, oxcarbazepine, phenobarbital, and phenytoin (medicines 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 that are used to prevent and treat stomach ulcers, heartburn, or acid reflux disease)

• dexamethasone (a corticosteroid used to treat various disorders, such as inflammation and allergic reactions) when taken by mouth or injected, except when a single dose is taken

• products containing St. John's Wort or Hypericum (Hypericum perforatum) (a medicinal plant used for depression)

If you are taking any of these medicines, consult your doctor for possible alternatives.

Warnings and precautions

Consult your doctor or pharmacist before starting EDURANT.

EDURANT does not cure HIV infection. It is part of a treatment that reduces the amount of virus in the blood. While taking this medicine, you can still transmit HIV to others, although effective antiviral treatment reduces the risk. Consult your doctor about the precautions needed 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, consult your doctor about using EDURANT.

Tell your doctor about your situation

Check the following points and tell your doctor if you are in any of these situations.

• Tell your doctor if you have or have had liver disease, including hepatitis B and/or C, and/or kidney disease. Your doctor will assess the severity of your liver or kidney disease before deciding if you can take EDURANT.

• Tell your doctor immediately if you notice any symptoms of infection(e.g., fever, chills, sweats). Some patients with advanced HIV infection and a history of opportunistic infections may develop signs and symptoms of inflammation due to previous infections soon after starting HIV treatment. These symptoms are thought to be due to the improvement of the body's immune response, which enables it to fight off infections that may not have caused symptoms before.
• In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you have started taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving up towards the trunk of the body, palpitations, tremors, or hyperactivity, tell your doctor immediately to receive the necessary treatment.

• Tell your doctor if you are taking any medicine that may cause an abnormal heart rhythm (Torsade de Pointes).

Children

EDURANT should not be used in children under 12 years of age, as it has not been studied in these patients.

Using EDURANT with other medicines

You must take EDURANT with other anti-HIV medicines. Your doctor will recommend which anti-HIV medicines can be combined with EDURANT and together decide which combination best suits your needs. Follow your doctor's instructions carefully.

Some medicines may affect the blood levels of EDURANT 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.

Do not combine EDURANT withother non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as delavirdine, efavirenz, etravirine, and nevirapine.

The effects of EDURANT or other medicines may be affectedif 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 how to take EDURANT in section 3 "Instructions for correct use in adults and adolescents (12 to 18 years of age)".
• clarithromycin, erythromycin (antibiotics)
• cimetidine, famotidine, nizatidine, ranitidine (H2 receptor antagonists used to treat stomach ulcers or intestines or to relieve heartburn due to acid reflux). If you are taking these medicines, read carefully how to take them in section 3 "Instructions for correct use in adults and adolescents (12 to 18 years of age)".

• antacids (used to treat acid-related diseases of the stomach; e.g., aluminum/magnesium hydroxide, calcium carbonate). If you are taking these medicines, read carefully how to take them in section 3 "Instructions for correct use in adults and adolescents (12 to 18 years of age)".
• methadone (used to treat narcotic withdrawal and dependence)
• dabigatran etexilate (an anticoagulant)

Pregnancy and breastfeeding

If you are pregnant or planning to become pregnant, inform your doctor immediately.

Pregnant women should discuss the use of EDURANT with their doctor.

Mothers infected with HIV should not breastfeed their babies, as there is a risk of transmitting the HIV infection through breast milk.

Consult your doctor or pharmacist 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 fatigue, dizziness, or drowsiness while taking EDURANT.

EDURANT contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take EDURANT

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Instructions for correct use in adults and adolescents (12 to 18 years of age)The recommended dose of EDURANT is one tablet once a day.

EDURANT must be taken with a meal. It is important to take it with food to achieve the correct levels of the active substance in your body. A nutritional drink (even if high in protein) alone does not replace a meal.

There are four situations that require special attention:

1. If you are taking rifabutin(a medicine used to treat certain bacterial infections), take two EDURANT tablets once a day. When you stop taking rifabutin, take one EDURANT tablet once a day. If in doubt, ask your doctor or pharmacist.
2. If you are taking an antacid(a medicine for the treatment of acid-related diseases of the stomach, such as aluminum/magnesium hydroxide or calcium carbonate). Take the antacid at least 2 hours before or at least 4 hours after EDURANT (see section 2 "Using EDURANT with other medicines").

1. If you are taking an H2 receptor antagonist(medicines used to treat stomach ulcers or intestines or to relieve heartburn due to acid reflux; e.g., 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 "Using EDURANT with other medicines"). H2 receptor antagonists should not be taken in twice-daily dosing regimens. Ask your doctor if there is any other treatment.

1. If you are taking didanosine(a medicine for the treatment of HIV infection), no dose adjustment is required. Didanosine should be taken on an empty stomach at least 2 hours before or at least 4 hours after EDURANT (which should be taken with a meal).

Opening the child-resistant cap

The bottle has a child-resistant cap. It can be opened by pushing the cap and turning it at the same time in the opposite direction to the arrows.

If you take more EDURANT than you should

Tell your doctor or pharmacist immediately. In case of overdose, you may have a headache, nausea, dizziness, and/or abnormal dreams.

If you forget to take EDURANT

If you realize within 12 hours of the usual time you take EDURANT, take the tablet as soon as possible. The EDURANT tablet should be taken with a meal. Then take the next dose as usual. If you realize after 12 hours, do not take that dose and continue with the next doses as usual.

Do not take a double dose to make up for forgotten doses.

If you vomit and it has been less than 4 hours since taking EDURANT, take another tablet with food. If you vomit and it has been more than 4 hours after taking EDURANT, it is not necessary to take another tablet until the next scheduled dose.

Contact your doctor if you have any doubts about what to do if you forget a dose or vomit.

Do not stop taking EDURANT

HIV treatment does not cure HIV infection!Do not stop taking EDURANT or your other anti-HIV medicines without first discussing this with your doctor. Even if you feel better, do not stop taking EDURANT or your other anti-HIV medicines. If you do, you may increase the risk of developing resistance to the virus. Consult your doctor first.

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.

Very common:

• headache
• nausea

• difficulty sleeping (insomnia)
• dizziness
• abnormal results in one of the usual liver tests (transaminases)
• increased cholesterol and/or pancreatic amylase in your blood

Common:

• abnormal dreams
• skin rash (exanthema)

• stomach pain
• depression

• fatigue
• vomiting
• drowsiness

• loss of appetite
• sleep disorders

• stomach discomfort
• depressed mood
• dry mouth

• low white blood cell count and/or platelets, decreased hemoglobin in your blood, increased triglycerides, lipase, and/or bilirubin in your blood

Uncommon:

• signs or symptoms of inflammation or infection, for example, fever, chills, sweats (immune reconstitution syndrome)

Reporting of side effects

If you experience 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 the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 bottle after "EXP". The expiry date refers to the last day of the month shown.

Store in the original bottle to protect from 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 protect the environment.

6. Package Contents and Additional Information

Composition of EDURANT

• The active ingredient is rilpivirine in the form of rilpivirine hydrochloride. Each EDURANT tablet contains rilpivirine hydrochloride equivalent to 25 mg of rilpivirine.
• The other components of the film-coated tablet core are lactose monohydrate, sodium croscarmellose, povidone K30, polysorbate 20, silicified microcrystalline cellulose, and magnesium stearate. The tablet coating contains lactose monohydrate, hypromellose 2910 6 mPa.s, titanium dioxide E171, macrogol 3000, and triacetin.

Appearance and Package Contents

White to off-white, round, biconvex, film-coated tablet engraved with "TMC" on one side and "25" on the other.

Child-resistant bottle with 30 film-coated tablets.

Marketing Authorization Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen-Cilag SpA

Via C. Janssen

Borgo San Michele

04100 Latina

Italy

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet: {MM/YYYY}.

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.