Package Leaflet: Information for the User

INTELENCE 200 mg tablets

etavirine

Read this 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 give it to others even if they have similar symptoms to yours, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

INTELENCE contains the active ingredient etravirina. INTELENCE belongs to a group of medications against HIV called non-nucleoside reverse transcriptase inhibitors (NNRTIs).

INTELENCE is a medication used in the treatment of Human Immunodeficiency Virus (HIV) infection. INTELENCE acts by reducing the amount of HIV in the body. This way, your immune system will improve and the risk of developing diseases related to HIV infection will decrease.

INTELENCE is used in combination with other HIV medications to treat adults and children 6 years of age and older who are infected with HIV and have already used other HIV medications.

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

Do not take INTELENCE

• if you are allergic to etravirina or any of the other components of this medication (listed in section 6)
• if you are taking elbasvir/grazoprevir (a medication for treating hepatitis C infection)

Warnings and precautions

Consult your doctor or pharmacist before starting to take INTELENCE.

INTELENCE 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 be able to transmit HIV to others, although effective antiviral treatment reduces the risk. Consult your doctor about the precautions you need to take to avoid infecting others.

Older patients

INTELENCE has only been used in a limited number of patients aged 65 years or older.

Discuss the use of INTELENCE with your doctor if you belong to this age group.

Weight and increase in lipid and glucose levels in the blood

During HIV treatment, there may be an increase in weight and levels of glucose and lipids in the blood. This may be partly related to recovery of health and lifestyle, and in the case of lipids in the blood, sometimes to HIV medications themselves. Your doctor will monitor these changes.

Bone problems

Some patients taking combined antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by loss of blood supply to the bone). The duration of combined antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, increased body mass index, among others, may be one of the many risk factors for developing this disease. Signs of osteonecrosis include joint stiffness, pain, and discomfort (especially in the hip, knee, and shoulder) and difficulty moving. If you notice any of these symptoms, please consult your doctor.

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 experience askin rash.A skin rash usually appears shortly after starting HIV treatment with INTELENCE and usually disappears within one or two weeks, although the medication is continued. Occasionally during INTELENCE treatment, you may experience a hypersensitivity reaction (allergic reaction including rash and fever but also facial, tongue, or throat swelling, difficulty breathing or swallowing) that may be life-threatening. Please contact your doctor immediately if you experience a hypersensitivity reaction. Your doctor will advise you on how to treat the symptoms and will indicate whether you should discontinue INTELENCE treatment. If you have discontinued treatment due to a hypersensitivity reaction, do not restart INTELENCE treatment.
• Inform your doctor if you have or have hadliver problems, including hepatitis B and/or C. Your doctor may evaluate the severity of your liver disorder before deciding whether you can use INTELENCE.
• Inform your doctor immediately if you observe anysymptoms of infections. In some patients with advanced HIV infection and a history of opportunistic infections, signs and symptoms of inflammation due to previous infections may appear shortly after starting HIV treatment. It is believed that these symptoms are due to the improvement of the body's immune response, which allows 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 may 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.

Children and adolescents

Do not give this medication to children under 6 years of age and weighing less than 16 kg, as the potential benefit or risk has not yet been established.

INTELENCE with other medications

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

Most of the time, INTELENCE can be combined with HIV medications from another group. However, there are some combinations that are not recommended. In other cases, it may be necessary to increase monitoring and/or modify the medication dose. That's why you should always inform your doctor if you are taking other HIV medications. Also, be sure to read the leaflets that accompany these medications carefully. Follow your doctor's instructions carefully about the medications that can be combined.

Do not recommend combining INTELENCE with any of the following medications:

• tipranavir/ritonavir, efavirenz, nevirapina, rilpivirina, indinavir, nelfinavir, atazanavir/cobicistat, darunavir/cobicistat (HIV medication)
• carbamazepina, fenobarbital, fenitoína (medications to prevent seizures)
• rifampicina because it is contraindicated with protease inhibitors and rifapentina (medications to treat certain infections, such as tuberculosis)
• products containing St. John's Wort (Hypericum perforatum) (a herbal product used to treat depression)
• daclatasvir, simeprevir (medications to treat hepatitis C infection).

If you are taking any of the products listed, consult your doctor.

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

INTELENCE with any of the following medications. You may need to change the dose of some medications, as their therapeutic effect or adverse effects may be affected when combined with INTELENCE. Inform your doctor if you are taking:

• dolutegravir, maraviroc, amprenavir/ritonavir, and fosamprenavir/ritonavir (HIV medications)
• amiodarona, bepridilo, digoxina, disopiramida, flecainida, lidocaína, mexiletina, propafenona, and
• quinidina (medications to treat certain heart disorders, e.g., arrhythmias)
• warfarina (a medication to reduce blood coagulation). Your doctor will perform blood tests
• fluconazol, itraconazol, ketoconazol, posaconazol, voriconazol (medications to treat fungal infections)
• claritromicina, rifabutina (antibiotics)
• artemeter/lumefantrina (a medication to treat malaria)
• diazepam (a medication to treat sleep problems and/or anxiety)
• dexametasona (a corticosteroid used to treat various disorders, such as
• inflammation and allergic reactions)
• boceprevir (a medication to treat hepatitis C infection)
• atorvastatina, fluvastatina, lovastatina, rosuvastatina, simvastatina (medications to reduce cholesterol)
• ciclosporina, sirolimus, tacrolimus (immunosuppressants - medications that reduce the activity of your immune system)
• sildenafilo, vardenafilo, tadalafilo (medications to treat erectile dysfunction and/or pulmonary arterial hypertension)

• clopidogrel (a medication to prevent blood clot formation).

Pregnancy and breastfeeding

If you are pregnant, inform your doctor immediately. Pregnant women should not take INTELENCE, unless your doctor specifically advises you to do so.

Infected mothers should not breastfeed their children, as there is a possibility that the child may contract HIV infection.

Driving and operating machinery

Do not operate machinery or drive if you experience drowsiness or dizziness after taking your 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.

Use in adults

The recommended dose of INTELENCE is one tablet twice a day.

Take one tablet of 200 mg of INTELENCE in the morning after a meal.

Take one tablet of 200 mg of INTELENCE in the evening after a meal.

Use in children and adolescents from 6 years of age and with a weight of at least 16 kg

Your doctor will indicate the correct dose based on the child's weight.

Your doctor will inform you exactly how much INTELENCE the child should take.

Instructions for taking INTELENCE for all patients

It is essential to take INTELENCE after meals. If you take INTELENCE on an empty stomach, only half of the INTELENCE amount is absorbed. Follow your doctor's instructions on the type of food you should take with INTELENCE.

Swallow the INTELENCE tablets whole with a glass of water. Do not chew the tablets.

• If you cannot swallow the INTELENCE tablets whole, you can do the following:
• Place the tablets in 5 ml (1 teaspoon) of water, or at least a sufficient amount of liquid to cover the medication,
• Shake well until the water has a milky appearance,
• If desired, you can add more water or juice (do not place the tablets directly in juice),
• Drink it immediately,
• Wash the glass several times with water, juice, or milk and drink all the contents each time to ensure that the entire dose is taken.
• Do not use hot water (40°C or more) or carbonated beverages when taking the INTELENCE tablets.

Child-resistant cap removal

If you take more INTELENCE than you should

Inform your doctor or pharmacist immediately. The most common adverse effects of INTELENCE are skin rash, diarrhea, nausea, and headache (see section “4. Possible adverse effects”).

If you forgot to take INTELENCE

If you realizewithin 6 hours of the usual INTELENCE taking time,take the tablet as soon as possible. Take the tablet always after a meal.

Then take the next dose as usual. If you realizeafter 6 hours,omit that dose and take the next one at the usual time. Do not take a double dose to compensate for the missed doses.

If you vomit within less than 4 hours after taking INTELENCE, take another tablet after a meal. If you vomit more than 4 hours after taking INTELENCE, it is not necessary to take another tablet until the next scheduled dose.

Consult your doctor if you have doubts about what to do if you miss a dose or vomit.

Do not stop taking INTELENCE without first talking to your doctor

The HIV treatment may increase your sense of well-being. Although you feel better, do not stop taking INTELENCE or the 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 medicines, this medicine can cause side effects, although not everyone will experience them.

The frequency of side effects associated with INTELENCE is shown below.

Very common side effects (may affect more than 1 in 10 people)

• skin rash. The rash is usually mild to moderate. In rare cases, a severe type of rash has been reported that can be life-threatening. Therefore, it is essential to contact your doctor immediately if you experience a rash.

Your doctor will instruct you on how to act on your symptoms and whether you should stop taking INTELENCE;

• headache;
• diarrhea, nausea.

Common side effects (may affect up to 1 in 10 people)

• allergic reactions (hypersensitivity);
• diabetes, reduced appetite;
• anxiety, drowsiness, insomnia, sleep disorders;
• tingling or pain in hands or feet, numbness, loss of skin sensitivity, memory loss, fatigue;
• blurred vision;
• renal insufficiency, high blood pressure, heart attack, shortness of breath during exercise;
• vomiting, heartburn, abdominal pain, abdominal distension, stomach inflammation, flatulence, constipation, mouth inflammation; dry mouth;
• night sweats, itching, dry skin;
• changes in some blood cell or biochemical values that can be observed in blood and/or urine test results. Your doctor will explain them to you. For example, low red blood cell count.

Uncommon side effects (may affect up to 1 in 100 people)

• decrease in white blood cell count;
• infection symptoms (e.g., enlarged lymph nodes and fever);
• abnormal dreams, confusion, disorientation, nervousness, nightmares;
• drowsiness, tremor, fainting, seizures, attention disorders;
• dizziness, slowness;
• angina, irregular heart rhythm;
• difficulty breathing;
• hiccups, pancreatitis, vomiting blood;
• liver problems such as hepatitis, liver enlargement;
• excessive sweating, facial and/or throat swelling;
• breast enlargement in men.

Rare side effects (may affect up to 1 in 1,000 people)

• stroke.

Side effects of unknown frequency (frequency cannot be estimated from available data)

• severe allergic reactions characterized by rash accompanied by fever and organ inflammation, such as hepatitis.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not use after 6 weeks from the first opening of the bottle.

INTELENCE tablets must be stored in the original bottle and keep the bottle perfectly closed to protect it from moisture. The bottle contains 3 sachets (desiccants) to keep the tablets dry. These sachets must be kept in the bottle at all times and must not be ingested.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and the medications that you no longer need. In this way, you will help protect the environment.

Composition of INTELENCE

• The active ingredient is etravirina. Each INTELENCE tablet contains 100 mg of etravirina.
• The other components are hypromellosemicrocrystalline silicified cellulose, microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose and magnesium stearate.

Appearance of the product and contents of the pack

This medicinal product is presented in the form of a white to off-white, biconvex, oblong tablet with the indication “T200” engraved on one side.

Plastic bottle with 60 tablets and 3 sachets to keep the tablets dry.

Marketing Authorisation Holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Responsible for manufacturing

Janssen-Cilag SpA, Via C. Janssen, 04100 Borgo San Michele, Latina, Italy

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:{MM/AAAA}

The detailed information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.