INTELENCE 200 mg TABLETS

2. What you need to know before you take INTELENCE

Do not take INTELENCE

• if you are allergic to etravirine or any of the other ingredients of this medicine (listed in section 6)
• if you are taking elbasvir/grazoprevir (a medicine to treat hepatitis C infection).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking INTELENCE.

INTELENCE does not cure HIV infection. It is one of a number of medicines that you will need to take to control your infection. While taking this medicine, you may still pass HIV to other people (e.g. by blood, sex, or from mother to child). You should take precautions to avoid passing the disease on. Discuss this with your doctor.

Elderly patients

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

If you belong to this age group, discuss the use of INTELENCE with your doctor.

Weight and increased lipid and glucose levels in the blood

During HIV treatment, weight and levels of glucose and lipids in the blood may increase. This may be due in part to recovery from your illness and to lifestyle changes, and in the case of blood lipids, to the HIV medicines themselves. Your doctor will monitor these changes.

Bone problems

Some patients taking combination antiretroviral therapy (ART) may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of ART, use of corticosteroids, alcohol consumption, severe immunosuppression, increased body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, pain, and difficulty walking. If you notice any of these symptoms, please contact your doctor.

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 a rash.When a rash occurs, it usually appears shortly after starting HIV treatment with INTELENCE and usually disappears within one or two weeks, although you continue to take the medicine. Occasionally during treatment with INTELENCE, you may experience a hypersensitivity reaction (an allergic reaction that includes rash and fever but also swelling of the face, tongue, or throat, difficulty breathing or swallowing) that can 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 indicate whether you should stop treatment with INTELENCE. If you have stopped treatment due to a hypersensitivity reaction, do not start taking INTELENCE again.
• Tell your doctor if you have or have had liver problems, including hepatitis B and/or C. Your doctor may assess the severity of your liver disorder before deciding whether you can use INTELENCE.
• Tell your doctor immediately if you notice any symptoms of infection. 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. These symptoms are believed to be due to the improvement in the body's immune response, which enables it to fight infections that may have been present without obvious symptoms.
• In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you start taking medicines to treat your HIV infection. Autoimmune disorders can 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 towards the trunk of the body, palpitations, tremors, or hyperactivity, tell your doctor immediately to receive the necessary treatment.

Children and adolescents

Do not give this medicine to children under 6 years of age and weighing less than 16 kg, as the potential benefits and risks have not been established yet.

Taking INTELENCE with other medicines

INTELENCE may interact with other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In most cases, INTELENCE can be combined with HIV medicines that belong to another group. However, there are some combinations that are not recommended. In other cases, it may be necessary to increase monitoring and/or adjust the dose of the medicine. Therefore, you should always tell your doctor if you are taking other HIV medicines. It is also important that you carefully read the package leaflets that come with these medicines. Follow your doctor's instructions carefully regarding which medicines can be combined.

Do not combine INTELENCE with any of the following medicines:

• tipranavir/ritonavir, efavirenz, nevirapine, rilpivirine, indinavir, nelfinavir, atazanavir/cobicistat, darunavir/cobicistat (HIV medicines)
• carbamazepine, phenobarbital, phenytoin (medicines to prevent seizures)
• rifampicin, as it is contraindicated with boosted protease inhibitors and rifapentine (medicines to treat certain infections, such as tuberculosis)
• products containing St. John's Wort (Hypericum perforatum) (a herbal product used for depression)
• daclatasvir, simeprevir (medicines to treat hepatitis C infection).

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

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

INTELENCE with any of the following medicines. It may be necessary to change the dose of some medicines, as their therapeutic effect or side effects may be affected when combined with INTELENCE. Tell your doctor if you are taking:

• dolutegravir, maraviroc, amprenavir/ritonavir, and fosamprenavir/ritonavir (HIV medicines)
• amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, and quinidine (medicines to treat certain heart conditions, e.g., irregular heartbeat)
• warfarin (a medicine to reduce blood clotting). Your doctor will perform blood tests
• fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole (medicines to treat fungal infections)
• clarithromycin, rifabutin (antibiotics)
• artemeter/lumefantrine (a medicine to treat malaria)
• diazepam (a medicine to treat sleep problems and/or anxiety)
• dexamethasone (a corticosteroid used to treat various conditions, such as inflammation and allergic reactions)
• boceprevir (a medicine to treat hepatitis C infection)
• atorvastatin, fluvastatin, lovastatin, rosuvastatin, simvastatin (medicines that lower cholesterol)
• ciclosporin, sirolimus, tacrolimus (immunosuppressants - medicines that reduce the activity of your immune system)
• sildenafil, vardenafil, tadalafil (medicines to treat erectile dysfunction and/or pulmonary arterial hypertension)

• clopidogrel (a medicine to prevent blood clots).

Pregnancy and breastfeeding

If you are pregnant, inform your doctor immediately. Pregnant women should not take INTELENCE unless specifically advised by their doctor.

Mothers infected with HIV should not breastfeed their child, as there is a risk of passing on the HIV infection.

Driving and using machines

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

3. How to take INTELENCE

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

Use in adults

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

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

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

Use in children and adolescents from 6 years of age and weighing at least 16 kg

Your doctor will tell you 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 important to take INTELENCE after meals. If you take INTELENCE on an empty stomach, only half of the amount of INTELENCE is absorbed. Follow your doctor's instructions about the type of meal you should take with INTELENCE.

Swallow the INTELENCE tablet(s) whole with a glass of water. Do not chew the tablet(s).

• If you cannot swallow the INTELENCE tablet(s) whole, you can do the following:
• place the tablet(s) in 5 ml (1 teaspoon) of water, or at least enough liquid to cover the medicine,
• shake well until the water has a milky appearance,
• if desired, you can add more water or orange juice or milk (do not put the tablets directly in orange juice or milk),
• drink it immediately,
• rinse the glass several times with water, orange juice, or milk and drink the entire contents each time to ensure you take the full dose.
• Do not use hot water (40°C or more) or carbonated drinks when taking the INTELENCE tablet(s).

Opening the child-resistant cap

If you take more INTELENCE than you should

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

If you forget to take INTELENCE

If you realize within 6 hours of the usual time you take INTELENCE, take the tablet as soon as possible. Always take the tablet after a meal.

Then take your next dose as you normally would. If you realize after 6 hours, skip that dose and take the next one at the usual time. Do not take a double dose to make up for forgotten doses.

If you vomit within 4 hours of taking INTELENCE, take another tablet after a meal. If you vomit more than 4 hours after taking INTELENCE, you do not need to take another tablet until your 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 INTELENCE without talking to your doctor

HIV treatment can improve your condition. Although you feel better, do not stop taking INTELENCE or your other HIV medicines. If you do, you may increase the risk of the virus becoming resistant. 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.

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 rash that can be life-threatening has been reported. Therefore, it is essential that you contact your doctor immediately if you develop a rash.

Your doctor will advise you on how to treat 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, decreased appetite;
• anxiety, drowsiness, insomnia, sleep disorders;
• tingling or pain in hands or feet, numbness, loss of skin sensitivity, memory loss, fatigue;
• blurred vision;
• kidney failure, high blood pressure, heart attack, difficulty breathing during exercise;
• vomiting, heartburn, abdominal pain, abdominal distension, stomach inflammation, flatulence, constipation, mouth inflammation; dry mouth;
• night sweats, itching, dry skin;
• changes in some of your blood cell or blood chemistry test results that can be seen in your blood or urine test results. Your doctor will explain these 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., swollen lymph nodes and fever);
• abnormal dreams, confusion, disorientation, nervousness, nightmares;
• lethargy, tremors, fainting, seizures, attention disorders;
• dizziness, slowness;
• angina, irregular heartbeat;
• difficulty breathing;
• retching, pancreatitis, vomiting blood;
• liver problems such as hepatitis, liver enlargement;
• excessive sweating, swelling of the face and/or throat;
• breast enlargement in men.

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

• stroke.

Side effects with frequency not known (frequency cannot be estimated from the available data)

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

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. Storing INTELENCE

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.

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

INTELENCE tablets should be kept in the original bottle and the bottle should be kept tightly closed to protect from moisture. The bottle contains 3 sachets (desiccants) to keep the tablets dry. These sachets should always remain in the bottle and should not be swallowed.

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. Packaging Contents and Additional Information

Composition of INTELENCE

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

Appearance and Packaging of the Product

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

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

Marketing Authorization Holder

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

Manufacturer

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

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

Date of the last revision of this prospectus:{MM/AAAA}

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