INTELENCE 100mg tablets

INTELENCE is a medicine used for the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). INTELENCE works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.

INTELENCE is used in combination with other anti-HIV medicines to treat adults who are infected by HIV and who have used other anti-HIV medicines before.

Your doctor will discuss with you which combination of medicines is best for you.

Do not take INTELENCE

• if you are allergic (hypersensitive) to etravirine or any of the other ingredients of INTELENCE. These other ingredients are listed in section 6.

Take special care with INTELENCE

INTELENCE is not a cure for HIV infection. It is part of a treatment reducing the amount of virusin the blood. INTELENCE does not reduce the risk of passing HIV to others through sexual contact or contamination with blood. Therefore, you must continue to use appropriate precautions (a condom or other barrier method) to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions or blood.

People taking INTELENCE may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor.

INTELENCE is not for use in children or adolescents, because it has not been sufficiently studied in patients under 18years of age.

INTELENCE has only been used in a limited number of patients of 65years or older. If you belong to this age group, please discuss the use of INTELENCE with your doctor.

Tell your doctor about your situation

Make sure that you check the following points and tell your doctor if any of these apply to you.

• Tell your doctor if you develop a rash. If a rash occurs, it usually appears soon after anti-HIV treatment with INTELENCE is started and often disappears within 1to 2weeks, even with continued use of the medicine. Occasionally, during INTELENCE treatment, you can experience hypersensitivity reaction (allergic reaction including rash and fever but also swelling of the face, tongue or throat, difficulty in breathing or swallowing) which could be potentially life-threatening. Please contact your doctor immediately if you get a hypersensitivity reaction. Your doctor will advise you how to deal with your symptoms and whether INTELENCE must be stopped. If you have stopped treatment due to a hypersensitivity reaction, you should not re-start therapy with INTELENCE.
• Tell your doctor if you have or have had problems with your liver, including hepatitis B and/or C. Your doctor may evaluate how severe your liver disease is before deciding if you can take INTELENCE.
• Tell your doctor if you notice changes in body shape or fat. A gain, loss or redistribution of body fat may occur if you take a combination of anti-HIV medicines.
• Tell your doctor immediately if you notice any symptoms of infections. In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body?s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.

Taking other medicines

INTELENCE might interact with other medicines. Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In most cases, INTELENCE can be combined with anti-HIV medicines belonging to another class.However some combinations are not recommended. In other cases, increased monitoring and/or a change in the dose of the medicine may be needed. Therefore always tell your doctor which other anti-HIV medicines you take. Furthermore, itis important that you carefully read the package leaflets that are provided with these medicines. Follow your doctor?s instruction carefully on which medicines can be combined.

It isnot recommendedto combine INTELENCE with any of the following medicines:

• tipranavir/ritonavir (anti-HIV medicine)
• carbamazepine, phenobarbital, phenytoin (medicines to prevent seizures)
• rifampicin, because it is contraindicated with boosted protease inhibitors, and rifapentine (medicines to treat some infections such as tuberculosis)
• products that contain StJohn?swort ( Hypericum perforatum) (a herbal product used for depression).

If you are taking any of these, ask your doctor for advice.

The effects of INTELENCE or other medicines might be influencedif you take INTELENCE together with any of the following medicines. Tell your doctor if you take:

• amiodarone, bepridil, digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone and quinidine (medicines to treat certain heart disorders, e.g., abnormal heart beat)
• warfarin (a medicine used to reduce clotting of the blood). Your doctor will have to check your blood
• fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole (medicines to treat fungal infections)
• clarithromycin, rifabutin (antibiotics)
• diazepam (medicines to treat trouble with sleeping and/or anxiety)
• dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions)
• atorvastatin, fluvastatin, lovastatin, rosuvastatin, simvastatin (cholesterol-lowering medicines)
• cyclosporine, sirolimus, tacrolimus (immunosuppressants)
• sildenafil, vardenafil, tadalafil (medicines to treat erectile dysfunction).

Taking INTELENCE with food and drink

It is important that you take INTELENCE following a meal. If you take it on an empty stomach, only half the amount of INTELENCE is absorbed. For further information see section 3 ?HOW TO TAKE INTELENCE?.

Pregnancy and breast-feeding

Tell your doctor immediately if you are pregnant. Pregnant women should not take INTELENCE unless specifically directed by the doctor.
HIV infected mothers must not breast-feed, as there is a possibility of infecting the baby with HIV.

Driving and using machines

No studies on the effects of INTELENCE on the ability to drive and use machines have been performed. However, do not drive or operate machines if you feel sleepy or dizzy after taking your medicines.

Important information about some of the ingredients of INTELENCE

INTELENCE tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars (lactose), contact your doctor before taking this medicine.

Bone problems

Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Always take INTELENCE exactly as your doctor has told you. You should check with your doctor if you are not sure.

Instructions for proper use

The usual dose of INTELENCE is two tablets twice a day.
In the morning, take two 100milligram INTELENCE tablets, following a meal.
In the evening, take two 100milligram INTELENCE tablets, following a meal.
It is important that you take INTELENCE following a meal. If you take INTELENCE on an empty stomach, only half the amount of INTELENCE is absorbed. Swallow the tablets whole with a glass of water. Do not chew the tablets. If you are unable to swallow the INTELENCE tablets whole, you may place the tablets in a glass of water. Stir well until the water looks milky, then drink it immediately. Rinse the glass with water several times, and completely swallowthe rinse each time to make sure you take the entire dose.

Removing the child resistant cap

The plastic bottle comes with a child resistant cap and should be opened as followsPush the plastic screw cap down while turning it counter clockwise.Remove the unscrewed cap

If you take more INTELENCE than you should

Contact your doctor or pharmacist immediately.

If you forget to take INTELENCE

If you notice within 6hours of the time you usually take INTELENCE,you must take the tablets as soon as possible. Always take the tablets following a meal. Then take the next dose as usual. If you notice after 6hours, then skip the intake and take the next doses as usual. Do not take a double dose to make up for a forgotten dose.

Do not stop using INTELENCE without talking to your doctor first

HIV therapy may increase your sense of well-being. Even if you feel better, do not stop taking INTELENCE or your other anti-HIV medicines. Doing so could increase the risk of the virus developing resistance. Talk to your doctor first.

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

Like any medicine, INTELENCE can cause side effects, although not everybody gets them.The frequency of possible side effects listed below is defined using the following convention:

• very common: affects more than 1user in 10
• common: affects 1to 10users in 100
• uncommon: affects 1to 10users in 1,000
• rare: affects 1to 10users in 10,000
• very rare: affects less than 1user in 10,000
• not known: frequency cannot be estimated from the available data.

Very common side effects

• skin rash. The rash is usually mild to moderate. In rare instances, very serious rash has been reported which can be potentially life-threatening.It istherefore important to contact your doctor immediately if you develop a rash. Your doctor will advise you how to deal with your symptoms and whether INTELENCE must be stopped.

Common side effects

• changes in some values of your blood cells or chemistry. These can be seen in the results from blood tests. Your doctor will explain these to you. Examples are: low red blood cell count, lowblood platelet count, high or abnormal blood fat levels, high cholesterol levels, high sugar levels
• headache, tingling or pain in hands or feet, numbness, tiredness, sleeplessness, anxiety
• diarrhoea, nausea, vomiting, heartburn, abdominal pain, inflammation of the stomach, flatulence
• kidney failure, high blood pressure, heart attack, diabetes
• accumulation of fat, night sweats.

Uncommon side effects

• angina, irregular heart rhythm
• loss of skin sensibility, drowsiness, trembling, fainting, sleepiness, loss of memory, seizures, stroke, disturbance in attention
• blurred vision, dizziness, sluggishness
• difficulty breathing
• dry mouth,mouth inflammation, retching, constipation, distension of the abdomen, inflammation of the pancreas, vomiting blood, decrease of appetite
• excessive sweating, itching, dry skin, swelling of the face and/or throat
• allergic reactions (hypersensitivity), symptoms of infection (for example enlarged lymph nodes and fever)
• liver problems such as hepatitis
• swelling of breasts in men
• sleep disorders, abnormal dreams, confusion, disorientation, nervousness
• body changes associated with fat redistribution.

Not known

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight of children.

Do not use INTELENCE 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 that month.

INTELENCE tablets should be stored in the original bottle. Keep the bottle tightly closed in order to protect from moisture.The bottle contains 3little pouches (desiccants) to keep the tablets dry. These pouches should stay in the bottle all the time and are not to be eaten.
Medicinesshould not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What INTELENCE contains

• The active substance isetravirine. Each tablet of INTELENCE contains 100mg of etravirine.
• The other ingredients are hypromellose, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate and lactose monohydrate.

What INTELENCE looks like and contents of the pack

White to off-white, oval tablet, with ?T125? on one side and ?100? on the other side.A plastic bottle containing 120tablets and 3pouches to keep the tablets dry.

Marketing Authorisation Holder

Janssen-CilagInternationalNV,Turnhoutseweg30, B-2340 Beerse, Belgium

Manufacturer

Janssen-CilagSpA, Via C. Janssen, 04010Borgo San Michele, Latina, Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgienTIBOTEC, een divisie van, une division de, eine Division der JANSSEN-CILAG NVSARoderveldlaan 1B-2600 BerchemTélTel 32 3 280 54 11LuxembourgLuxemburgTIBOTEC, une division de, eine Division der JANSSEN-CILAG NVSARoderveldlaan 1B-2600 BerchemBelgiqueBelgienTélTel 32 3 280 54 1

MagyarországTIBOTEC, a JANSSEN-CILAG Kft. divíziójaH-2045 Törökbálint, Tó ParkTel 36 23 513 800 TIBOTEC, Johnson Johnson, d.o.o... 4 , 4 1715. 359 2 489 94 0

eská republikaTIBOTEC, divize JANSSEN-CILAG s.r.o.Karla Englie 320106CZ-150 00 Praha 5 - SmíchovTel 420 227 012 222 MaltaAM MANGION LTD.Mangion Building, Triq dida fi Triq VallettaMT-al-Luqa LQA 6000Tel 356 2397 600

DanmarkTIBOTEC, en division af JANSSEN-CILAG ASHammerbakken 19DK-3460 BirkerødTlf 45 45 94 82 82NederlandTIBOTEC, een divisie van JANSSEN-CILAG B.V.Postbus 90240NL-5000 LT TilburgTel 31 13 583 73 7

DeutschlandJANSSEN-CILAG GmbHJohnson Johnson Platz 1D-41470 NeussTel 49 2137 955-955 NorgeTIBOTEC, en divisjon av JANSSEN-CILAG ASDrammensveien 288N-0283 OsloTlf 47 24 12 65 0

EestiTIBOTEC, JANSSEN-CILAG Polska Sp. z o.o.Eesti filiaalLõõtsa 2EE-11415 TallinnTel 372 617 7410 ÖsterreichTIBOTEC, eine Division von JANSSEN-CILAG Pharma GmbHPfarrgasse 75A-1232 WienTel 43 1 610 30

TIBOTEC, JANSSEN-CILAG .... 56GR-151 21 , T 30 210 80 90 000 PolskaTIBOTEC, oddzia JANSSEN-CILAG Polska Sp. z o.o.ul. Iecka 24PL-02-135 WarszawaTel 48 22 237 60 0

EspañaJANSSEN-CILAG, S.A. división TIBOTECPaseo de las Doce Estrellas, 5-7Campo de las NacionesE-28042 MadridTel 34 91 722 81 00PortugalTIBOTEC, uma divisão da JANSSEN-CILAG FARMACÊUTICA, LDA.Estrada Consiglieri Pedroso, 69 AQueluz de BaixoPT-2734-503 BarcarenaTel 351 21 43 68 83

FranceTIBOTEC, une division de JANSSEN-CILAG1, rue Camille Desmoulins, TSA 91003F-92787 Issy Les Moulineaux, Cedex 9Tél 0 800 25 50 75 33 1 55 00 44 44RomâniaTIBOTEC, subsidiar a Janssen-Cilag, Johnson Johnson d.o.o.Strada Tipografilor nr. 11-15, Cldirea S-Park,corp A2, etaj 5013714 BucuretiTel 40 21 2 071 80

IrelandTIBOTEC, a division of JANSSEN-CILAG Ltd.50-100 Holmers Farm WayHigh WycombeBuckinghamshire HP12 4EG - UKTel 44 1494 567 444 SlovenijaTIBOTEC za Janssen-Cilag, del JohnsonJohnson d.o.o.martinska cesta 53SI-1000 LjubljanaTel 386 1 401 18 3

Slovenská republikaTIBOTEC, divízia Johnson Johnson s.r.o.Plynárenská 7BSK-824 78 BratislavaTel 421 233 552 600ÍslandTIBOTEC, deild hjá JANSSEN-CILAGco Vistor hf.Hörgatún 2IS-210 GarðabærSími 354 535 700

ItaliaTIBOTEC, una divisione di JANSSEN-CILAG SpAVia M.Buonarroti, 23I-20093 Cologno Monzese MITel 39 02 2510 1 SuomiFinlandTIBOTECJANSSEN-CILAG OYVaisalantieVaisalavägen 2FI-02130 EspooEsboPuhTel 358 207 531 30

,7 CY-1060 357 22 755 214SverigeTIBOTEC, en division inom JANSSEN-CILAG ABBox 7073S-192 07 SollentunaTel 46 8 626 50 0

LatvijaTIBOTEC, JANSSEN-CILAG Polska Sp. z o.o. filile LatvijMatrou iela 15LV-1048, RgaTel 371 678 93561 United KingdomTIBOTEC, a division of JANSSEN-CILAG Ltd.50-100 Holmers Farm WayHigh WycombeBuckinghamshire HP12 4EG - UKTel 44 1494 567 44

Lietuva

UAB ?Johnson & Johnson?
Gele-inio Vilko g. 18A
LT-08104 Vilnius
Tel: +370 5 278 68 88

This leaflet was last approved in {MM/YYYY}.

This medicine has been given ?conditional approval?.
This means that there is more evidence to come about this medicine.
The European Medicines Agency will review new information on the medicine every year and this leaflet will be updated as necessary.