Product Information for the User

EDURANT 25 mg Film-Coated Tablets

rilpivirina

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. How to Take EDURANT
2. Possible Adverse Effects

1. Storage of EDURANT
2. Contents of the Package and Additional Information

EDURANT contains rilpivirina, which is used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of HIV medications known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). EDURANT acts by reducing the amount of HIV in the body.

EDURANT is used in combination with other HIV medicationsto treat adults andadolescents 12 years of age and older who are infected with HIV and have never received treatment with HIV medications.

Your doctor will explain the most suitable combination of medications for you.

Do not take EDURANTif you are allergic to rilpivirina or any of the other components of thismedication (listed in section 6).

Do not take EDURANT in combination with any of the following medicationssince theymay affect the way EDURANT or other medications work:

• carbamazepine, oxcarbazepine, phenobarbital, and phenytoin (medications for treating epilepsy and preventing seizures)
• rifampicin, rifapentine (medications for treating certain bacterial infections such as tuberculosis)
• omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole (proton pump inhibitors used to prevent and treat stomach ulcers, heartburn, or acid reflux disease)

• dexamethasone (a corticosteroid used to treat various conditions, such as inflammation and allergic reactions) when taken orally or by injection, except in a single dose

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 medication, you may still transmit HIV to others, although effective antiviral treatment reduces the risk. Consult your doctor about necessary precautions to avoid infecting others.

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

Inform your doctor about your situation

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

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

• Inform your doctor immediately if you observe anysymptoms of infection(such as 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 HIV treatment. It is believed that these symptoms are due to the improvement of the body's immune response, allowing it to fight off infections that may not have shown obvious symptoms.
• Additionally, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may appear after you have started taking medications for HIV treatment. Autoimmune disorders can appear many months after starting treatment. If you observe any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and ascending to the body trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

• Inform your doctor if you are taking any medication that may cause a potentially fatal irregular heartbeat (Torsade de Pointes).

Children

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

Use of EDURANT with other medications

You must take EDURANT along with other HIV medications. Your doctor will recommend HIV medications that can be combined with EDURANT and together decide which combination best meets your needs. Follow your doctor's instructions carefully.

Some medications may affect the blood concentrations of EDURANT when taken at the same time as EDURANT.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

The effects of EDURANT or other medications may be affectedif you take

EDURANT along with any of the following medications. Inform your doctor if you take:

• rifabutin (a medication used to treat some bacterial infections). If you are taking this medication while taking EDURANT, read carefully how to take EDURANT in section 3 “Correct use instructions for adults and adolescents (12 years to 18 years)”.
• clarithromycin, erythromycin (antibiotics)
• cimetidine, famotidine, nizatidine, ranitidine (H2 receptor antagonists used to treat stomach ulcers or intestinal ulcers or to relieve heartburn due to acid reflux). If you are taking these medications, read carefully the usage instructions in section 3 “Correct use instructions for adults and adolescents (12 years to 18 years)”.

• antacids (used to treat conditions related to stomach acid; for example, aluminum/magnesium hydroxide, calcium carbonate). If you are taking these medications, read carefully the usage instructions in section 3 “Correct use instructions for adults and adolescents (12 years to 18 years)”.
• methadone (used for the treatment of withdrawal and narcotic dependence)
• dabigatran etexilate (an anticoagulant).

Pregnancy and breastfeeding

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

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

Mothers infected with HIV should not continue breastfeeding, as there is a possibility that the child may contract HIV through breast milk.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

Some patients may experience fatigue, dizziness, or drowsiness during EDURANT treatment. Do not drive or operate 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 certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Correct use instructions for adults and adolescents (12 years to 18 years old)The recommended dose of EDURANT is one tablet once a day.

EDURANTmust be taken with a meal. It is essential to take it with food to achieve the correct concentrations of the active ingredient in your body. A nutritional beverage (although rich in proteins) by itself does not substitute a meal.

There are four situations that require special attention:

1. If you take rifabutina(a medication used to treat some bacterial infections),take two EDURANT tablets once a day. When you stop taking rifabutina, take one EDURANT tablet once a day. In case of doubt, ask your doctor or pharmacist.
2. If you take an antacid(a medication for the treatment of diseases related tostomach acid, 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 “EDURANT use with other medications”).

1. If you take an H2 receptor antagonist2(medications used to treat stomach ulcers or intestine or to relieve stomach burning 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 “EDURANT use with other medications”). H2 receptor antagonists should not be taken in twice-daily dosing regimens. Ask your doctor if there is any other treatment.

1. If you take didanosine(a medication for the treatment of HIV infection), no dose adjustment is required. Didanosine must be administered with an empty stomach at least two hours before or at least four hours after EDURANT (which should be taken with a meal).

Removing the child-resistant cap

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

If you take more EDURANT than you should

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

If you forget to take EDURANT

If you realizewithin 12 hours of the usual time for taking 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 realizeafter 12 hours, do not take that dose and continue with the next ones as usual.

Do not take a double dose to compensate for the missed doses.

If you vomit and less than 4 hours have passed since taking EDURANT, take another tablet with food. If you vomit and more than 4 hours have passed since 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 miss a dose or vomit.

Do not interrupt EDURANT treatment

HIV treatment does not cure HIV infection! Do not interrupt EDURANT treatment without consulting your doctor first. Although you may feel better, do not stop taking EDURANT or other HIV medications. If you do, you may increase the risk of the virus becoming resistant. Consult your doctor first.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very frequent:

• Headache
• Nausea

• Difficulty falling asleep (insomnia)
• Dizziness
• Abnormal results in one of the usual liver function tests (transaminases)
• Increased cholesterol and/or pancreatic amylase in your blood

Frequent:

• 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 platelet count, decreased hemoglobin in your blood, increased triglycerides, lipase, and/or bilirubin in your blood

Rare:

• Signs or symptoms of inflammation or infection, for example fever, chills, sweating (immune reconstitution syndrome).

Reporting 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 prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the bottle after “CAD”. The expiration date is the last day of the month indicated.

Store in the original bottle to protect it from light.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

EDURANT Composition

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

Appearance of the product and contents of the pack

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

Child-resistant bottle containing 30 film-coated tablets.

Marketing Authorisation Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Responsible for Manufacturing

Janssen-Cilag SpA

Via C. Janssen

Borgo San Michele

04100 Latina

Italy

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of this leaflet: {MM/AAAA}.

For more detailed information about this medicinal product, please consult the website of the European Medicines Agency:http://www.ema.europa.eu/.