Document Content
identifier: http://ema.europa.eu/identifier/EU/1/06/380/006
status: Final
type: Package Leaflet
category: Raw
date: 2022-02-16 13:28:17+0000
author: Organization ACME industry
title: TEST PURPOSES ONLY - prezista
Attesters
| - | Mode | Time |
| * | Official | 2022-02-16 13:28:17+0000 |
B. Package Leaflet
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Package leaflet: Information for the user
What is in this leaflet
What is in this leaflet
- What PREZISTA is and what it is used for
- What you need to know before you take PREZISTA
- How to take PREZISTA
- Possible side effects
- How to store PREZISTA
- Contents of the pack and other information
1. What prezista is and what it is used for
What is PREZISTA? PREZISTA contains the active substance darunavir. PREZISTA is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. PREZISTA 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. What it is used for? PREZISTA is used to treat HIV infected adults as well as HIV infected children of 3 years of age and above, and at least 15 kilogram body weight (see How to take PREZISTA). PREZISTA must be taken in combination with a low dose of cobicistat or ritonavir and other anti-HIV medicines. Your doctor will discuss with you which combination of medicines is best for you.
2. What you need to know before you take prezista
Do not take PREZISTA
if you are allergic to darunavir or any of the other ingredients of this medicine (listed in section 6) or to cobicistat or ritonavir.
if you have severe liver problems. Ask your doctor if you are unsure about the severity of your liver disease. Some additional tests might be necessary. Tell your doctor about all medicines you take including medicines taken orally, inhaled, injected or applied to the skin. Do not combine PREZISTA with any of the following medicines If you are taking any of these, ask your doctor about switching to another medicine. Medicine Purpose of the medicine Avanafil to treat erectile dysfunction Astemizole or terfenadine to treat allergy symptoms Triazolam and oral (taken by mouth) midazolam to help you sleep and/or relieve anxiety Cisapride to treat some stomach conditions Colchicine (if you have kidney and/or liver problems) to treat gout or familial Mediterranean fever Lurasidone, pimozide, quetiapine or sertindole to treat psychiatric conditions Ergot alkaloids like ergotamine, dihydroergotamine, ergometrine and methylergonovine to treat migraine headaches Amiodarone, bepridil, dronedarone, ivabradine, quinidine, ranolazine to treat certain heart disorders e.g. abnormal heart beat Lovastatin, simvastatin and lomitapide to lower cholesterol levels Rifampicin to treat some infections such as tuberculosis The combination product lopinavir/ritonavir this anti-HIV medicine belongs to the same class as PREZISTA Elbasvir/grazoprevir to treat hepatitis C infection Alfuzosin to treat enlarged prostate Sildenafil to treat high blood pressure in the pulmonary circulation Ticagrelor to help stop the clumping of platelets in the treatment of patients with a history of a heart attack Naloxegol to treat opioid induced constipation Dapoxetine to treat premature ejaculation Domperidone to treat nausea and vomiting Do not combine PREZISTA with products that contain St John s Wort (Hypericum perforatum). Warnings and precautions Talk to your doctor, pharmacist or nurse before taking PREZISTA. PREZISTA is not a cure for HIV infection. People taking PREZISTA may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor. People taking PREZISTA may develop a skin rash. Infrequently a rash may become severe or potentially life-threatening. Please contact your doctor whenever you develop a rash. In patients taking PREZISTA and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately. Tell your doctor about your situation BEFORE and DURING your treatment Make sure that you check the following points and tell your doctor if any of these apply to you.
Tell your doctor if you have had problems with your liver before, including hepatitis B or C infection. Your doctor may evaluate how severe your liver disease is before deciding if you can take PREZISTA.
Tell your doctor if you have diabetes. PREZISTA might increase sugar levels in the blood.
Tell your doctor immediately if you notice any symptoms of infection (for example enlarged lymph nodes and fever). 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.
Tell your doctor if you have haemophilia. PREZISTA might increase the risk of bleeding.
Tell your doctor if you are allergic to sulphonamides (e.g. used to treat certain infections).
Tell your doctor if you notice any musculoskeletal 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. Elderly PREZISTA has only been used in limited numbers of patients 65 years or older. If you belong to this age group, please discuss with your doctor if you can use PREZISTA. Children PREZISTA is not for use in children younger than 3 years of age or weighing less than 15 kilograms. Other medicines and PREZISTA Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. There are some medicines that you must not combine with PREZISTA. These are mentioned above under the heading Do not combine PREZISTA with any of the following medicines: In most cases, PREZISTA can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)]. PREZISTA with cobicistat or ritonavir has not been tested with all PIs (protease inhibitors) and must not be used with other HIV PIs. In some cases dosage of other medicines might need to be changed. Therefore always tell your doctor if you take other anti-HIV medicines and follow your doctor s instruction carefully on which medicines can be combined. The effects of PREZISTA might be reduced if you take any of the following products. Tell your doctor if you take:
Phenobarbital, phenytoin (to prevent seizures)
Dexamethasone (corticosteroid)
Efavirenz (HIV infection)
Rifapentine, rifabutin (medicines to treat some infections such as tuberculosis)
Saquinavir (HIV infection). The effects of other medicines might be influenced if you take PREZISTA and your doctor might want to do some additional blood tests. Tell your doctor if you take:
Amlodipine, diltiazem, disopyramide, carvedilol, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nifedipine, nicardipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.
Apixaban, dabigatran etexilate, edoxaban, rivaroxaban, warfarin, clopidogrel (to reduce clotting of the blood) as their therapeutic effect or side effects may be altered.
Oestrogen-based hormonal contraceptives and hormonal replacement therapy. PREZISTA might reduce its effectiveness. When used for birth control, alternative methods of non-hormonal contraception are recommended.
Ethinylestradiol/drospirenone. PREZISTA might increase the risk for elevated potassium levels by drospirenone.
Atorvastatin, pravastatin, rosuvastatin (to lower cholesterol levels). The risk of muscle damage might be increased. Your doctor will evaluate which cholesterol lowering regimen is best for your specific situation.
Clarithromycin (antibiotic)
Ciclosporin, everolimus, tacrolimus, sirolimus (for dampening down your immune system) as the therapeutic effect or side effects of these medicines might be increased.
Buprenorphine/naloxone (medicines to treat opioid dependence)
Salmeterol (medicine to treat asthma)
Artemether/lumefantrine (a combination medicine to treat malaria)
Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (to treat cancer)
Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension)
Glecaprevir/pibrentasvir (to treat hepatitis C infection)
Fentanyl, oxycodone, tramadol (to treat pain)
Fesoterodine, solifenacin (to treat urologic disorders). Your doctor might want to do some additional blood tests and the dosage of other medicines might need to be changed since either their own or PREZISTA s therapeutic effect or side effects may be influenced when combined. Tell your doctor if you take:
Dabigatran etexilate, edoxaban, warfarin (to reduce clotting of the blood)
Alfentanil (injectable strong and short-acting painkiller that is used for surgical procedures)
Digoxin (to treat certain heart disorders)
Clarithromycin (antibiotic)
Itraconazole, isavuconazole, fluconazole, posaconazole, clotrimazole (to treat fungal infections). Voriconazole should only be taken after medical evaluation.
Rifabutin (against bacterial infections)
Sildenafil, vardenafil, tadalafil (for erectile dysfunction or high blood pressure in the pulmonary circulation)
Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety)
Maraviroc (to treat HIV infection)
Methadone (to treat opiate dependence)
Carbamazepine, clonazepam (to prevent seizures or to treat certain types of nerve pain)
Colchicine (to treat gout or familial Mediterranean fever)
Bosentan (to treat high blood pressure in the pulmonary circulation)
Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam when used as injection, zolpidem (sedative agents)
Perphenazine, risperidone, thioridazine (to treat psychiatric conditions)
Metformin (to treat type 2 diabetes). This is not a complete list of medicines. Tell your healthcare provider about all medicines that you are taking. PREZISTA with food and drink See section 3 How to take PREZISTA. Pregnancy and breast-feeding Tell your doctor immediately if you are pregnant or planning to become pregnant. Pregnant women should not take PREZISTA with ritonavir unless specifically directed by the doctor. Pregnant women should not take PREZISTA with cobicistat. Because of the potential for side effects in breast-fed infants, women should not breast-feed if they are receiving PREZISTA. 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 operate machines or drive if you feel dizzy after taking PREZISTA. PREZISTA oral suspension contains sodium methyl parahydroxybenzoate. This ingredient may cause allergic reactions (sometimes delayed). PREZISTA contains sodium This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially sodium-free .
3. How to take prezista
The child must take PREZISTA always together with cobicistat or ritonavir. PREZISTA cannot work properly without cobicistat or ritonavir.
The child must take the appropriate doses of PREZISTA and ritonavir two times per day or once a day or PREZISTA and cobicistat once a day. If prescribed PREZISTA twice daily the child must take one dose in the morning, and one dose in the evening. Your child s doctor will determine the appropriate dosing regimen for your child.
The child must take PREZISTA with food. PREZISTA cannot work properly without food. The type of food is not important. Dose for adults who have not taken antiretroviral medicines before (your doctor will determine this) The usual dose of PREZISTA is 800 milligram once daily. You must take PREZISTA every day and always in combination with 150 milligram of cobicistat or 100 milligram of ritonavir and with food. PREZISTA cannot work properly without cobicistat or ritonavir and food. You must eat a meal or a snack within 30 minutes prior to taking your PREZISTA and cobicistat or ritonavir. The type of food is not important. Even if you feel better, do not stop taking PREZISTA and cobicistat or ritonavir without talking to your doctor. Dose for adults who have taken antiretroviral medicines before (your doctor will determine this) The dose is either:
600 milligram PREZISTA together with 100 milligram ritonavir twice daily. OR
800 milligram PREZISTA together with 150 milligram cobicistat or 100 milligram ritonavir once daily. Please discuss with your doctor which dose is right for you. Instructions for adults
Take PREZISTA always together with cobicistat or ritonavir. PREZISTA cannot work properly without cobicistat or ritonavir.
Take PREZISTA with food. PREZISTA cannot work properly without food. The type of food is not important. Instructions for use Use the dosing pipette supplied with the pack to measure your dose accurately:
- Shake the bottle well before each use.
- Open the bottle of PREZISTA oral suspension by pushing downward on the cap and twisting it counter-clockwise.
- Insert the supplied oral dosing pipette all the way into the bottle.
- Pull the plunger until the top of the barrel meets the line that matches the dose prescribed by your healthcare provider.
- Take the dose of PREZISTA. Place the tip of the oral dosing pipette in the mouth. Press on the plunger of the pipette towards the mouth, then swallow.
- Close the bottle with the cap after use, and store PREZISTA oral suspension as directed in section 5 below.
- Remove the plunger from the barrel of the pipette, rinse both with water and allow to air dry after each use.
- Put the oral dosing pipette back together after air drying and store with the PREZISTA bottle. Do not use the dosing pipette for any other medicines. If you take more PREZISTA than you should Contact your doctor, pharmacist or nurse immediately. If you forget to take PREZISTA If you take PREZISTA two times a day and if you notice within 6 hours, you must take the oral suspension immediately. Always take with ritonavir and food. 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 take PREZISTA once a day and if you notice within 12 hours, you must take the oral suspension immediately. Always take with cobicistat or ritonavir and food. If you notice after 12 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 after taking PREZISTA and cobicistat or ritonavir If you vomit within 4 hours of taking the medicine, another dose of PREZISTA and cobicistat or ritonavir should be taken with food as soon as possible. If you vomit more than 4 hours after taking the medicine, then you do not need to take another dose of PREZISTA and cobicistat or ritonavir until the next regularly scheduled time. Contact your doctor if you are uncertain about what to do if you miss a dose or vomit. Do not stop taking PREZISTA without talking to your doctor first Anti-HIV medicines may make you feel better. Even when you feel better, do not stop taking PREZISTA. Talk to your doctor first. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
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. Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you develop any of the following side effects Liver problems that may occasionally be severe have been reported. Your doctor should do blood tests before you start PREZISTA. If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or pain and discomfort on your right side below your ribs. Skin rash (more often when used in combination with raltegravir), itching. The rash is usually mild to moderate. A skin rash might also be a symptom of a rare severe situation. It is important to talk to your doctor if you develop a rash. Your doctor will advise you how to deal with your symptoms or whether PREZISTA must be stopped. Other severe side effects were diabetes (common) and inflammation of the pancreas (uncommon). Very common side effects (may affect more than 1 in 10 people)
diarrhoea. Common side effects (may affect up to 1 in 10 people)
vomiting, nausea, abdominal pain or distension, dyspepsia, flatulence
headache, tiredness, dizziness, drowsiness, numbness, tingling or pain in hands or feet, loss of strength, difficulty falling asleep. Uncommon side effects (may affect up to 1 in 100 people)
chest pain, changes in electrocardiogram, rapid heart beating
decreased or abnormal skin sensibility, pins and needles, attention disturbance, loss of memory, problems with your balance
difficulty breathing, cough, nosebleed, throat irritation
inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching
kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of urine, sometimes at night
urticaria, severe swelling of the skin and other tissues (most often the lips or the eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, colouration of nails
muscle pain, muscle cramps or weakness, pain in extremity, osteoporosis
slowing down of the thyroid gland function. This can be seen in a blood test.
high blood pressure, flushing
red or dry eyes
fever, swelling of lower limbs due to fluids, malaise, irritability, pain
symptoms of infection, herpes simplex
erectile dysfunction, enlargement of breasts
sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive Rare side effects (may affect up to 1 in 1,000 people)
a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung]
heart attack, slow heart beating, palpitations
visual disturbance
chills, feeling abnormal
a feeling of confusion or disorientation, altered mood, restlessness
fainting, epileptic fits, changes or loss of taste
mouth sores, vomiting blood, inflammation of the lips, dry lips, coated tongue
running nose
skin lesions, dry skin
stiffness of muscles or joints, joint pain with or without inflammation
changes 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: increase in some white blood cells
darunavir crystals in the kidney causing kidney disease. Some side effects are typical for anti-HIV medicines in the same family as PREZISTA. These are:
muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have been serious. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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. How to store prezista
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 store above 30 C. Do not refrigerate or freeze. Avoid exposure to excessive heat. Store in the original container. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What PREZISTA contains
The active substance is darunavir. Each milliliter contains 100 milligram of darunavir (as ethanolate).
The other ingredients are hydroxypropyl cellulose, microcrystalline cellulose and carmellose sodium, citric acid monohydrate, sucralose, strawberry cream flavour, masking flavour, sodium methyl parahydroxybenzoate (E219), hydrochloric acid (for pH adjustment), purified water. What PREZISTA looks like and contents of the pack White to off-white opaque oral suspension. Provided in a 200 ml amber glass bottle with polypropylene child resistant closure and a 6 ml low density polyethylene (LDPE) oral dosing pipette with 0.2 ml gradations. The bottle neck is filled with a low density polyethylene (LDPE) insert that accommodates the dosing pipette. Do not use the oral dosing pipette for any other medicines. PREZISTA is also available as 75 milligram, 150 milligram, 400 milligram, 600 milligram and 800 milligram film-coated tablets. Marketing Authorisation Holder Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium Manufacturer Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium 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:
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The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
