Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - intelence

Document Subject

Generated Narrative: MedicinalProductDefinition mp5e413a0f6e2a52f2ac02e5e2b260ebdf

identifier: http://ema.europa.eu/identifier/25 mg: EU/1/08/468/003

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: INTELENCE 25 mg tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-5e413a0f6e2a52f2ac02e5e2b260ebdf

identifier: http://ema.europa.eu/identifier/25 mg: EU/1/08/468/003

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - intelence

Attesters

What is in this leaflet

1. What INTELENCE is and what it is used for
2. What you need to know before you take INTELENCE
3. How to take INTELENCE
4. Possible side effects
5. How to store INTELENCE
6. Contents of the pack and other information

INTELENCE contains the active substance etravirine. INTELENCE belongs to a group of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). INTELENCE is a medicine used for the treatment of Human Immunodeficiency Virus (HIV) infection. 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 and children 2 years of age and older 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 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 taking INTELENCE. INTELENCE is not a cure for HIV infection. It is part of a treatment reducing the amount of virus in the blood. Elderly INTELENCE has only been used in a limited number of patients of 65 years or older. If you belong to this age group, please discuss the use of INTELENCE with your doctor. Weight and increased blood lipids and glucose During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes. 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. 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 1 to 2 weeks, even with continued use of the medicine. Rarely, during INTELENCE treatment, you can experience severe skin rash with blisters or peeling skin, particularly around the mouth or eyes or 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 experience these symptoms. 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 restart 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 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.

In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment. Children and adolescents Do not give this medicine to children less than 2 years of age and weighing less than 10 kg because the potential benefits and risks have not been established. Other medicines and INTELENCE INTELENCE might 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 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, it is 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 is not recommended to combine INTELENCE with any of the following medicines:

tipranavir/ritonavir, efavirenz, nevirapine, rilpivirine, indinavir, atazanavir/cobicistat, darunavir/cobicistat (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 St John s wort (Hypericum perforatum) (a herbal product used for depression)

daclatasvir (a medicine to treat hepatitis C infection). If you are taking any of these, ask your doctor for advice. The effects of INTELENCE or other medicines might be influenced if you take INTELENCE together with any of the following medicines. The dosages of some medicines might need to be changed since their therapeutic effect or side effects may be influenced when combined with INTELENCE. Tell your doctor if you take:

dolutegravir, maraviroc, amprevanir/ritonavir and fosamprenavir/ritonavir (anti-HIV medicine)

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)

artemether/lumefantrine (a medicine to treat malaria)

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 medicines used to dampen down 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 breast-feeding Tell your doctor immediately if you are pregnant. Pregnant women should not take INTELENCE unless specifically directed by the doctor. Because of the potential for side effects in breast-fed infants, it is recommended that women not breast-feed if they are receiving INTELENCE. Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk. If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible. Driving and using machines Do not drive or operate machines if you feel sleepy or dizzy after taking your medicines. INTELENCE contains lactose 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. INTELENCE contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium free .

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Use in adults Other form(s) of this medicine may be more suitable for adults. The recommended dose of INTELENCE is 200 mg twice a day. In the morning, take two 100 milligram INTELENCE tablets, following a meal. In the evening, take two 100 milligram INTELENCE tablets, following a meal. Use in children and adolescents 2 years of age and older and weighing at least 10 kg The doctor will work out the right dose based on the weight of the child. The doctor will inform you exactly how much INTELENCE the child should take. Instructions for taking INTELENCE for all patients 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. Follow your doctor s advice on the type of meal you should be taking with INTELENCE. Swallow the INTELENCE tablet(s) whole with a glass of water. Do not chew the tablet(s). The tablet can be divided into two equal doses. If you are unable to swallow the INTELENCE tablet(s) whole, you may do the following:

place the tablet(s) in 5 ml (1 teaspoon) of water, or at least enough liquid to cover the medicine,

stir well for about 1 minute until the water looks milky,

if desired, add up to 30 ml (2 tablespoons) more of water or alternatively orange juice or milk (do not place the tablets directly in orange juice or milk),

drink it immediately,

rinse the glass several times with water, orange juice, or milk and completely swallow the rinse each time to make sure you take the entire dose. If you mix INTELENCE tablet(s) with a liquid, take this first, before other liquid anti-HIV medicines that you need to take at the same time. Contact your doctor if you are not able to swallow the entire dose when mixed with a liquid. If your child needs to take INTELENCE tablet(s) mixed with a liquid, it is very important that he/she takes the entire dose so that the right amount of medicine enters into the body. If the full dose is not taken, the risk of the virus developing resistance is higher. Contact your doctor if your child is not able to swallow the entire dose when mixed with a liquid, as they may consider giving another medicine to treat your child. Do not use warm (40 C and above) or carbonated beverages when taking INTELENCE tablet(s). Removing the child resistant cap The plastic bottle comes with a child resistant cap and should be opened as follows:

Push 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. The most frequent side effects of INTELENCE are rash, diarrhoea, nausea, and headache (see section 4. Possible side effects ). If you forget to take INTELENCE If you notice within 6 hours of the time you usually take INTELENCE, you must take the tablet(s) as soon as possible. Always take the tablet(s) following a meal. Then take the next dose as usual. If you notice after 6 hours, then skip the intake and take the next doses as usual. Do not take a double dose to make up for a forgotten dose. If you vomit less than 4 hours after taking INTELENCE, take another dose following a meal. If you vomit more than 4 hours after taking INTELENCE, then you do not need to take another dose until your regularly scheduled dose. Contact your doctor if you are uncertain about what to do if you miss a dose or vomit. Do not stop taking 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 medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency rate of the side effects associated with INTELENCE is given below. Very common side effects (may affect more than 1 in 10 people)

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 is therefore 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;

headache;

diarrhoea, nausea. Common side effects (may affect up to 1 in 10 people)

allergic reactions (hypersensitivity);

diabetes, decrease of appetite;

anxiety, sleepiness, sleeplessness, sleep disorders;

tingling or pain in hands or feet, numbness, loss of skin sensibility, loss of memory tiredness;

blurred vision;

kidney failure, high blood pressure, heart attack, shortness of breath when exercising;

vomiting, heartburn, abdominal pain, distension of the abdomen, inflammation of the stomach, flatulence, constipation, mouth inflammation, dry mouth;

night sweats, itching, dry skin;

Change in some values of your blood cells or chemistry. These can be seen in the results of blood and/or urine tests. Your doctor will explain these to you. Examples are: low red blood cells. Uncommon side effects (may affect up to 1 in 100 people)

decreased number of white blood cells;

symptoms of infection (for example enlarged lymph nodes and fever);

abnormal dreams, confusion, disorientation, nervousness, nightmares;

drowsiness, trembling, fainting, seizures, disturbance in attention;

dizziness, sluggishness;

angina, irregular heart rhythm;

difficulty breathing;

retching, inflammation of the pancreas, vomiting blood;

liver problems such as hepatitis, enlarged liver;

excessive sweating, swelling of the face and/or throat;

swelling of breasts in men. Rare side effects (may affect up to 1 in 1,000 people)

stroke;

severe skin rash with blisters or peeling skin, particularly around the mouth or eyes; this may occur in children and adolescents more frequently than in adults. Very rare side effects (may affect up to 1 in 10,000 people)

severe hypersensitivity reactions characterised by rash accompanied by fever and organ inflammation such as hepatitis. Reporting of side effects If you get 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.

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 that month. Do not use after 8 weeks of first opening the bottle. INTELENCE tablets should be stored in the original bottle and keep the bottle tightly closed in order to protect from moisture. The bottle contains 2 little pouches (desiccants) to keep the tablets dry. These pouches should stay in the bottle all the time and are not to be eaten. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What INTELENCE contains

The active substance is etravirine. Each tablet of INTELENCE contains 25 mg of etravirine.

The other ingredients are hypromellose, microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, magnesium stearate and lactose (as monohydrate). What INTELENCE looks like and contents of the pack This medicinal product is presented as white to off-white, oval, scored tablet, with TMC on one side. The tablet can be divided into two equal doses. A plastic bottle containing 120 tablets and 2 pouches to keep the tablets dry. Marketing Authorisation Holder Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium Manufacturer Janssen-Cilag SpA, Via C. Janssen, 04100 Borgo San Michele, Latina, Italy For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Janssen-Cilag NV Tel/T l: +32 14 64 94 janssen@jacbe.jnj.com Lietuva UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 lt@its.jnj.com

&
.: +359 2 489 94 jjsafety@its.jnj.com Luxembourg/Luxemburg Janssen-Cilag NV T l/Tel: +32 14 64 94 janssen@jacbe.jnj.com esk republika Janssen-Cilag s.r.o. Tel: +420 227 012 Magyarorsz g Janssen-Cilag Kft. Tel.: +36 1 884 2janssenhu@its.jnj.com Danmark Janssen-Cilag A/S Tlf: +45 4594 8jacdk@its.jnj.com Malta AM MANGION LTD. Tel: +356 2397 6Deutschland Janssen-Cilag GmbH Tel: +49 2137 955 jancil@its.jnj.com Nederland Janssen-Cilag B.V. Tel: +31 76 711 1janssen@jacnl.jnj.com Eesti UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7ee@its.jnj.com Norge Janssen-Cilag AS Tlf: +47 24 12 65 jacno@its.jnj.com

Janssen-Cilag . . . . T : +30 210 80 90 sterreich Janssen-Cilag Pharma GmbH Tel: +43 1 610 Espa a Janssen-Cilag, S.A. Tel: +34 91 722 81 contacto@its.jnj.com Polska Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 France Janssen-Cilag T l: 0 800 25 50 75 / +33 1 55 00 40 medisource@its.jnj.com Portugal Janssen-Cilag Farmac utica, Lda. Tel: +351 214 368 Hrvatska Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 jjsafety@JNJCR.JNJ.com Rom nia Johnson & Johnson Rom nia SRL Tel: +40 21 207 1Ireland Janssen Sciences Ireland UC Tel: +353 1 800 709 Slovenija Johnson & Johnson d.o.o. Tel: +386 1 401 18 Janssen_safety_slo@its.jnj.com sland Janssen-Cilag AB c/o Vistor hf. S mi: +354 535 7janssen@vistor.is Slovensk republika Johnson & Johnson s.r.o. Tel: +421 232 408 Italia Janssen-Cilag SpA Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com Suomi/Finland Janssen-Cilag Oy Puh/Tel: +358 207 531 jacfi@its.jnj.com

: +357 22 207 Sverige Janssen-Cilag AB Tfn: +46 8 626 50 jacse@its.jnj.com Latvija UAB "JOHNSON & JOHNSON" fili le Latvij Tel: +371 678 93lv@its.jnj.com United Kingdom (Northern Ireland) Janssen Sciences Ireland UC Tel: +44 1 494 567 This leaflet was last revised in {MM/YYYY}. Detailed information on this medicine is available on the European Medicines Agency web site: