Crixivan
indinavir
indinavir
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What CRIXIVAN is and what it is used for
What you need to know before you take CRIXIVAN
How to take CRIXIVAN
Possible side effects
How to store CRIXIVAN
Contents of the pack and other information
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CRIXIVAN contains a substance called indinavir. It belongs to a group of medicines called ‘protease inhibitors’.
CRIXIVAN is used to treat Human Immunodeficiency Virus (HIV) in adults. CRIXIVAN is used at the same time as other HIV treatments (antiretroviral medicines). This is called combination antiretroviral therapy.
An example of another medicine that might be given to you, at the same time as CRIXIVAN, is ritonavir.
CRIXIVAN treats HIV and helps to lower the number of HIV particles in your blood.
CRIXIVAN helps to:
lower the risk that you get illnesses related to HIV
lower the amount of HIV in your body (your ‘viral load’)
raise your CD4 (T) cell count. CD4 cells are an important part of your immune system. The main role of the immune system is to protect you from infections.
CRIXIVAN may not do these things in all patients. Your doctor will monitor how this medicine works for you.
if you are allergic to indinavir or any of the other ingredients of this medicine (listed in Section 6).
if you are taking any of the following medicines:
rifampicin - an antibiotic used to treat infections
cisapride - used for gut problems
amiodarone - used for heart rhythm problems
pimozide - used for some mental health problems
lovastatin or simvastatin - used to lower cholesterol
St. John's wort (Hypericum perforatum) - a herbal medicine used for depression
ergot tartramine (with or without caffeine) - used for migraines
astemizole or terfenadine - antihistamines used for hay fever and other allergies
quetiapine – used for some mental illnesses such as schizophrenia, bipolar
disorder and major depressive disorder
alprazolam, triazolam and midazolam (by mouth) - used to make you calmer or help you sleep.
Do not take CRIXIVAN if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist or nurse before taking CRIXIVAN.
In addition, when CRIXIVAN is given at the same time as the medicine ritonavir:
if you have liver problems
if you are taking any of the following medicines:
fusidic acid - an antibiotic used to treat infections
piroxicam - used for arthritis
alfuzosin - used for prostate problems
bepridil - used for chest pain (angina)
clozapine - used for some mental health problems
pethidine or propoxyphene - used for pain
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estazolam or flurazepam - used to help you sleep
clorazepate or diazepam - used to make you calmer
encainide, flecanide, propafenone, or quinidine - used for uneven heartbeat
problems.
Do not take either CRIXIVAN or ritonavir if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist or nurse before taking CRIXIVAN.
Talk to your doctor, pharmacist or nurse before taking CRIXIVAN if you have had or develop any of the following:
drink alcohol
have a high body mass index
have an immune system that is very weak
have been taking corticosteroids at the same time as CRIXIVAN
take combination antiretroviral therapy for a long time.
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If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking CRIXIVAN.
CRIXIVAN is not recommended in children under the age of 18 years.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
CRIXIVAN can affect the way some other medicines work. Also some other medicines can affect the way CRIXIVAN works.
Ritonavir is used for increasing the blood levels of CRIXIVAN or, less frequently and then at higher doses, for HIV treatment. Talk to your doctor if you are going to take both CRIXIVAN and ritonavir. Also look at the Package Leaflet for ritonavir.
Please see ‘Do not take CRIXIVAN’ and ‘Do not take either CRIXIVAN or ritonavir’ above under Section 2 for an important list of medicines that you must not combine with CRIXIVAN. Do not take CRIXIVAN if you are taking or have recently taken any of these medicines. If you are not sure, talk to your doctor, pharmacist or nurse before taking CRIXIVAN.
theophylline - used for asthma
warfarin - used to thin the blood
morphine, fentanyl - used for pain
buspirone - used to make you calmer
fluconazole - used for fungal infections
venlafaxine, trazodone - used for depression
tacrolimus, ciclosporin - used mainly after organ transplantation
delavirdine, efavirenz, nevirapine - used for HIV
amprenavir, saquinavir, atazanavir - used for HIV
sildenafil, vardenafil, tadalafil - used for impotence
dexamethasone - used to stop swelling (inflammation)
itraconazole, ketoconazole - used to treat fungal infections
atorvastatin, rosuvastatin, pravastatin, fluvastatin - used to lower cholesterol
fexofenadine, loratidine - antihistamines used for hay fever and other allergic conditions
oral contraceptive medicines (‘The Pill’) containing norethindrone or ethinyl estradiol
phenobarbital, phenytoin, carbamazepine, divalproex, lamotrigine - medicines used to treat fits (epilepsy)
midazolam (by injection) - used for acute fits (seizures) and to send patients to sleep before some medical procedures
amlodipine, felodipine, nifedipine, nicardipine, digoxin, diltiazem - used for high blood pressure and some heart problems.
quetiapine – used for some mental illnesses such as schizophrenia, bipolar disorder and major depressive disorder
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking CRIXIVAN.
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See Section 3 below for information on how to take CRIXIVAN. It is however especially important that you:
do not take CRIXIVAN with food that is high in calories, fat and protein. This is because these foods stop your body being able to take in as much CRIXIVAN and it will not work as well.
If you are pregnant, think you may be pregnant or are planning to have a baby, only take CRIXIVAN if your doctor decides it is clearly necessary. It is not known whether CRIXIVAN is harmful to an unborn baby when taken by a pregnant woman.
It is recommended that women with HIV do not breast-feed. This is to stop HIV being passed on to their baby.
Dizziness and blurred vision have been reported during treatment with CRIXIVAN. If this happens, do not drive or operate machines.
CRIXIVAN is not a cure for HIV. You may still get infections or other illnesses related to HIV. So you still need to keep seeing your doctor while you are taking CRIXIVAN.
HIV is spread by blood or sexual contact with a person with HIV. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your physician the precautions needed to avoid infecting other people.
This medicine contains lactose (type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
The recommended dose of CRIXIVAN is:
Four 200 mg capsules (800 mg) - taken three times a day (every 8 hours).
This means you will take a total of twelve 200 mg capsules (2400 mg) each day.
You usually take less CRIXIVAN if you are also taking ritonavir. The recommended doses are:
CRIXIVAN - two 200 mg capsules (400 mg) - taken twice a day.
This means you will take a total of four 200 mg capsules (800 mg) each day.
ritonavir - 100 mg - taken twice a day.
Take this medicine by mouth.
Swallow the capsules whole with a drink of water, skimmed or low fat milk, juice, tea or coffee.
Do not crush or chew the capsules.
It is important for adults to drink at least 1.5 litres of liquid each day while taking CRIXIVAN. This will help lower the risk of you getting kidney stones.
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Do not take CRIXIVAN with food that is high in calories, fat and protein. This is because these stop your body being able to take in as much CRIXIVAN and it will not work as well.
Take 1 hour before or 2 hours after a meal.
If you cannot take it without food then take CRIXIVAN with a low-fat light meal. This could be dry toast with jam or cornflakes with skimmed or low-fat milk and sugar.
If you are also taking ritonavir, then you can take CRIXIVAN at any time of the day with or without food.
If you take more CRIXIVAN than you should, talk to your doctor as soon as possible. The following effects may happen:
nausea
vomiting
diarrhoea
back pain
blood in your urine.
Do not take a double dose to make up for a forgotten dose. If you have missed a dose, do not take it later in the day. Simply continue to follow your usual schedule.
It is important that you take CRIXIVAN exactly as your doctor tells you to - he or she will tell you how long you should take your medicine.
Do not stop taking CRIXIVAN without talking to your doctor.
This is because reducing or missing doses will make it more likely that HIV will become resistant to CRIXIVAN.
If this happens, your treatment will stop working.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
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. The following side effects have been reported by patients taking CRIXIVAN:
allergic reactions - signs include itchy skin, redness of the skin, ‘wheals’ or ‘hives’, swelling of the face, lips, tongue or throat and difficulty breathing. It is not known how often this may happen (cannot be estimated from the available data), but the reaction can sometimes be severe and include shock
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headache
rash or dry skin
nausea
vomiting
altered taste sensations
indigestion or diarrhoea
stomach pain or swelling
feeling dizzy, weak or tired.
passing gas
itching
dry mouth
acid reflux
muscle pain
pain on urination
difficulty getting to sleep
feeling numb or unusual feeling of the skin.
hair loss
inflamed pancreas
severe skin reactions
darkening skin colour
having a numb mouth
low red blood cell count
ingrown toenails with or without infection
liver problems such as inflammation or liver failure
kidney problems such as kidney infection, worsening or loss of kidney function
pain and difficulty moving shoulder.
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.
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 bottle or carton after ‘EXP’. The expiry date refers to the last day of that month.
Store CRIXIVAN in the original bottle and keep the bottle tightly closed to protect it from moisture. The bottle contains desiccant canisters that should remain in the bottle.
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 to protect the environment.
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The active substance is indinavir. Each hard capsule contains indinavir sulphate corresponding to 200 mg of indinavir.
The other ingredients are anhydrous lactose, magnesium stearate, gelatin and titanium dioxide (E 171).
The capsules are printed with printing ink containing indigo carmine (E 132).
CRIXIVAN 200 mg hard capsules are supplied in HDPE bottles with a polypropylene cap and a foil seal containing 180, 270 or 360 capsules. Not all pack sizes may be marketed.
The capsules are semi-translucent white and coded ‘CRIXIVAN 200 mg’ on them in blue.
Marketing Authorisation Holder: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Manufacturer: Merck Sharp & Dohme B.V., Waarderweg 39, Postbus 581, 2003 PC Haarlem The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UAB Merck Sharp & Dohme Tel.: +370 5 278 02 47
Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3737
Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111
MSD Pharma Hungary Kft. Tel.: +361 888 53 00
MSD Danmark ApS Tlf: +45 4482 4000
Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558)
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
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Merck Sharp & Dohme BV
Tel: 0800 9999000 (+31 23 5153153)
Merck Sharp & Dohme OÜ Tel.: +372 6144 200
MSD (Norge) AS Tlf: +47 32 20 73 00
msdnorge@ msd.no
MSD Α.Φ.Β.Ε.Ε.
Τηλ: +30 210 98 97 300
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00
MSD Polska Sp. z o.o. Tel.: +48 22 549 51 00
MSD France
Tél: + 33 (0) 1 80 46 40 40
Merck Sharp & Dohme, Lda Tel: +351 21 4465700
Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333
Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 00
Merck Sharp & Dohme Ireland (Human Health) Limited
Tel: +353 (0)1 2998700
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: + 386 1 5204 201
Vistor hf.
Sími: +354 535 7000
Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010
MSD Italia S.r.l.
Tel: +39 06 361911
medicalinformation.it@merck.com
MSD Finland Oy
Puh/Tel: +358 (0) 9 804 650
Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+357 22866700)
Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488
SIA Merck Sharp & Dohme Latvija Tel: +371 67364224
Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272
medicalinformationuk@merck.com
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This leaflet is available in all EU/EEA languages on the European Medicines Agency website.