Edurant 25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

EDURANT 25 mg film-coated tablets

rilpivirine

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What EDURANT is and what it is used for

2. What you need to know before taking EDURANT

3. How to take EDURANT

4. Possible side effects

5. How to store EDURANT

6. Contents of the pack and other information

1. What EDURANT is and what it is used for

EDURANT contains rilpivirine, which is used to treat Human Immunodeficiency Virus (HIV) infection. It belongs to a group of anti-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 anti-HIV medicines to treat HIV-infected adults and adolescents aged 12 years and older who have not previously received anti-HIV treatment.

Your doctor will explain the most appropriate combination of medicines for you.

2. What you need to know before taking EDURANT

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

Do not take EDURANT in combination with any of the following medicines, as they may affect how EDURANT or other medicines work:

• carbamazepine, oxcarbazepine, phenobarbital, and phenytoin (medicines used to treat epilepsy and prevent seizures)

• rifampicin, rifapentine (medicines used to treat certain bacterial infections such as tuberculosis)

• omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors, which are medicines 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 orally or by injection, except for a single dose

• products containing St. John’s wort (Hypericum perforatum) (a herbal remedy used for depression).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting EDURANT.

EDURANT does not cure HIV infection. It is part of a treatment regimen that reduces the amount of virus in the blood. While taking this medicine, you may still transmit HIV to others, although effective antiviral treatment reduces this risk. Consult your doctor about which precautions are necessary to avoid infecting others.

EDURANT has been used in only a limited number of patients aged 65 years or older. If you belong to this age group, consult your doctor about the use of EDURANT.

Inform your doctor about your condition

Check the following points and inform your doctor if any of these situations apply to you.

• Inform 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 whether you can take EDURANT.

• Inform your doctor immediately if you notice any signs of infection (e.g., fever, chills, sweating). Some patients with advanced HIV infection and a history of opportunistic infections may experience signs and symptoms of inflammation due to previous infections shortly after starting anti-HIV treatment. These symptoms are believed to result from the improvement of the body's immune response, enabling it to fight infections that may have been present but not causing obvious symptoms.

• In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you have started taking medicines for your HIV infection. Autoimmune disorders may appear 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 toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

• Inform your doctor if you are taking any medicine that may cause a potentially life-threatening irregular heartbeat (Torsade de Pointes).

Children

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

Taking EDURANT with other medicines

You must take EDURANT together with other anti-HIV medicines. Your doctor will recommend which anti-HIV drugs can be combined with EDURANT, and together you will decide which combination best meets 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 need to take any other medicine.

Combining EDURANT with other non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as delavirdine, efavirenz, etravirine, and nevirapine is not recommended.

The effects of EDURANT or other medicines may be affected if you take EDURANT together with any of the following medicines. Inform your doctor if you take:

• rifabutin (a medicine used to treat certain bacterial infections). If you are taking this medicine while on EDURANT, read carefully how to take EDURANT in section 3 “Correct use instructions for adults and adolescents (12 to 18 years of age)”.

• clarithromycin, erythromycin (antibiotics)

• cimetidine, famotidine, nizatidine, ranitidine (H2-receptor antagonists used to treat stomach or intestinal ulcers or to relieve heartburn due to acid reflux). If you are taking these medicines, read carefully how to use EDURANT in section 3 “Correct use instructions for adults and adolescents (12 to 18 years of age)”.

• antacids (used to treat acid-related stomach conditions; e.g., aluminium/magnesium hydroxide, calcium carbonate). If you are taking these medicines, read carefully how to use EDURANT in section 3 “Correct use instructions for adults and adolescents (12 to 18 years of age)”.

• methadone (used for treatment of narcotic withdrawal and dependence)

• dabigatran etexilate (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 must not breastfeed, as there is a risk that the child may become infected with HIV through breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Some patients may experience fatigue, dizziness, or somnolence during treatment with EDURANT. Do not drive or operate machinery if you feel fatigued, dizzy, or sleepy while taking EDURANT.

EDURANT contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take EDURANT

Follow exactly the dosing instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Correct dosing instructions in adults and adolescents (aged 12 to 18 years)
The recommended dose of EDURANT is one tablet once daily.

EDURANT must be taken with a meal. It is important to take it with food to achieve adequate concentrations 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 requiring special attention:

1. If you are taking rifabutin (a medicine used to treat certain bacterial infections), take two EDURANT tablets once daily. When you stop taking rifabutin, take one EDURANT tablet once daily. If in doubt, ask your doctor or pharmacist.
2. If you are taking an antacid (a medicine used to treat acid-related stomach conditions, such as aluminium/magnesium hydroxide or calcium carbonate), take the antacid at least 2 hours before or at least 4 hours after EDURANT (see section 2 “Taking EDURANT with other medicines”).
3. If you are taking an H2-receptor antagonist (medicines used to treat stomach or intestinal ulcers or to relieve heartburn due to acid reflux; for example, 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 “Taking EDURANT with other medicines”). H2-receptor antagonists should not be taken in regimens administered twice daily. Ask your doctor if there is an alternative treatment.
4. If you are taking didanosine (a medicine used to treat 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 must be taken with a meal).

Opening the child-resistant cap

The bottle has a child-resistant cap. To open, press down on the cap while turning it counterclockwise.

If you take more EDURANT than you should

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

If you forget to take EDURANT

If you remember within 12 hours of your usual dosing time, take the tablet as soon as possible. The EDURANT tablet must be taken with a meal. Then take your next dose at the usual time. If you remember more than 12 hours after your usual dosing time, do not take the missed dose; simply take your next dose at the regular time.

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

If you vomit and less than 4 hours have passed since taking EDURANT, take another tablet with food. If you vomit more than 4 hours after taking EDURANT, you do not need to take another tablet until your next scheduled dose.

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

Do not stop treatment with EDURANT

HIV treatment does not cure HIV infection! Do not stop treatment with EDURANT without first consulting your doctor. Even if you feel well, do not stop taking EDURANT or any other anti-HIV medicines. Doing so may increase the risk of the virus developing resistance. Consult your doctor first.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common:

• headache
• nausea
• difficulty sleeping (insomnia)
• dizziness
• abnormalities in one of the standard liver function tests (transaminases)
• increase in cholesterol and/or pancreatic amylase in your blood

Common:

• abnormal dreams
• skin rash (exanthema)
• stomach pain
• depression
• tiredness
• vomiting
• drowsiness
• loss of appetite
• sleep disturbances
• stomach discomfort
• depressed mood
• dry mouth
• low count of white blood cells and/or platelets, decrease in hemoglobin in your blood, increase in triglycerides, lipase, and/or bilirubin in your blood

Uncommon:

• signs or symptoms of inflammation or infection, such as fever, chills, sweating (immune reconstitution syndrome).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the carton and on the bottle after "EXP". The expiry date is the last day of the month indicated.

Store in the original container to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of EDURANT

• The active substance 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 core of the film-coated tablet are monohydrate lactose, sodium croscarmellose, povidone K30, polysorbate 20, microcrystalline cellulose silicified and magnesium stearate. The tablet coating contains monohydrate lactose, hypromellose 2910 6 mPa.s, titanium dioxide E171, macrogol 3000 and triacetin.

Appearance of the product and contents of the pack

Film-coated tablet, white to off-white, round, biconvex, engraved with the inscription “TMC” on one side and “25” on the other.

Child-resistant bottle containing 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: {MM/YYYY}.

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