Crixivan

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  • Crixivan
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Staðsetning

  • Fáanlegt í:
  • Crixivan
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Antivirals for systemic use,
  • Lækningarsvæði:
  • HIV Infections
  • Ábendingar:
  • Crixivan is indicated in combination with antiretroviral nucleoside analogues for the treatment of HIV-1 infected adults.,
  • Vörulýsing:
  • Revision: 39

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/000128
  • Leyfisdagur:
  • 03-10-1996
  • EMEA númer:
  • EMEA/H/C/000128
  • Síðasta uppfærsla:
  • 26-03-2019

Opinber matsskýrsla

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

EMA/721612/2016

EMEA/H/C/000128

EPAR summary for the public

Crixivan

indinavir

This is a summary of the European public assessment report (EPAR) for Crixivan. It explains how the

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Crixivan.

For practical information about using Crixivan, patients should read the package leaflet or contact their

doctor or pharmacist.

What is Crixivan and what is it used for?

Crixivan is an antiviral medicine for treating adults infected with human immunodeficiency virus type 1

(HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).

Crixivan is used in combination with other antiviral medicines and contains the active substance

indinavir.

How is Crixivan used?

Crixivan is available as capsules (200 and 400 mg) and is taken by mouth one hour before or two

hours after a meal with water or a light low-fat meal. The standard dose is 800 mg every eight hours,

but Crixivan can also be taken at a dose of 400 mg twice a day if each dose is taken with 100 mg

ritonavir (another antiviral medicine). To avoid the risk of developing kidney stones, patients should

drink plenty of liquids (at least 1.5 litres every day for adults).

Crixivan should only be prescribed by doctors with experience in treating HIV and can only be obtained

by prescription.

Crixivan

Page 2/3

How does Crixivan work?

The active substance in Crixivan, indinavir, is a protease inhibitor. It blocks an enzyme called protease,

which is involved in the reproduction of HIV. By blocking this enzyme, indinavir stops the virus from

reproducing normally and thereby slows down the spread of infection.

Crixivan does not cure HIV infection or AIDS, but it can hold off damage to the immune system and

the development of infections and diseases associated with AIDS.

Ritonavir, another protease inhibitor, is sometimes used with Crixivan as a ‘booster’. It slows down the

rate at which indinavir is broken down, helping to increase levels of indinavir in the blood.

What benefits of Crixivan have been shown in studies?

Studies have shown that Crixivan in combination with other antiviral medicines is effective at reducing

the level of HIV in the blood (viral load). In one study, 90% of those taking Crixivan in combination

with zidovudine and lamivudine had viral loads below 500 copies/ml after 24 weeks of treatment,

compared with 43% of those taking Crixivan alone and none (0%) of those taking zidovudine and

lamivudine without Crixivan.

What are the risks associated with Crixivan?

The most common side effects with Crixivan (seen in more than 1 patient in 10) are increases in size

of red blood cells, decreases in neutrophils (a type of white blood cell), headache, dizziness, nausea

(feeling sick), vomiting, diarrhoea, heartburn, instances of high blood bilirubin levels that do not cause

any symptoms, increased levels of liver enzymes (alanine and aspartate transaminases), rash, dry

skin, blood in the urine, protein in the urine, crystals in the urine, weakness or tiredness, an altered

sense of taste and abdominal pain (stomach ache). For the full list of side effects reported with

Crixivan, see the package leaflet.

Crixivan must not be taken with certain other medicines because of the possibility of harmful

interactions. For the full list of restrictions, see the package leaflet.

Why is Crixivan been approved?

The CHMP decided that Crixivan’s benefits are greater than its risks and recommended that it be given

marketing authorisation.

What measures are being taken to ensure the safe and effective use of

Crixivan?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Crixivan have been included in the summary of product characteristics and the

package leaflet.

Other information about Crixivan

The European Commission granted a marketing authorisation valid throughout the European Union

for Crixivan on 4 October 1996.

The full EPAR for Crixivan can be found on the Agency’s website:

ema.europa.eu/Find medicine/Human

medicines/European Public Assessment Reports. For more information about treatment with Crixivan,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Crixivan

Page 3/3

This summary was last updated in 11-2016.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the user

CRIXIVAN 200 mg hard capsules

indinavir

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

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 is in this leaflet

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

1.

What CRIXIVAN is and what it is used for

What CRIXIVAN is

CRIXIVAN contains a substance called indinavir. It belongs to a group of medicines called ‘protease

inhibitors’.

What CRIXIVAN is used for

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.

How CRIXIVAN works

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.

2.

What you need to know before you take CRIXIVAN

Do not take CRIXIVAN:

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:

Do not take either CRIXIVAN or 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

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.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking CRIXIVAN if you have had or develop any of

the following:

allergies

kidney problems (including inflammation of the kidneys, kidney stones, or back pain with or

without blood in your urine)

‘haemophilia’ – CRIXIVAN may make you more likely to bleed. If you notice bleeding or if you

feel weak, talk to your doctor straight away.

liver problems – people with ‘chronic hepatitis B or C’ or ‘cirrhosis’ who are treated with

‘antiretroviral’ medicines are more likely to have serious and potentially fatal liver side effects

with this medicine. You may need to have blood tests to check how your liver is working.

severe pain, tenderness or weakness in your muscles – this is more likely to happen if you are

taking cholesterol-lowering medicines called ‘statins’ (such as simvastatin). On rare occasions the

muscle problems can be serious (rhabdomyolysis). Inform your doctor as soon as possible if you

develop severe muscle pain or weakness.

signs of infection – this may be a previous infection which comes back soon after anti-HIV

treatment is started. This may be because the body is able to start fighting infections again. This

happens in some people with advanced HIV infection (AIDS) and who have had HIV related

infections before. If you notice any symptoms of infection, please inform your doctor

immediately.

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.

bone problems – signs include stiff joints, aches and pains, especially the hip and difficulty

moving. If you notice any of these signs, talk to your doctor. Such problems might be due to a

bone disease called ‘osteonecrosis’ (loss of blood supply to the bone causing bone death), which

can occur months to years after starting HIV therapy. The risk of you having bone problems is

higher if you:

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.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before

taking CRIXIVAN.

Children and adolescents

CRIXIVAN is not recommended in children under the age of 18 years.

Other medicines and CRIXIVAN

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

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.

In addition, talk to your doctor, pharmacist or nurse before taking CRIXIVAN if you are

taking any of the following medicines since your doctor may want to adjust the dose of your

medicines:

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.

CRIXIVAN with food and drink

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.

Pregnancy and breast-feeding

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.

Driving and using machines

Dizziness and blurred vision have been reported during treatment with CRIXIVAN. If this happens,

do not drive or operate machines.

Other things you should know

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.

CRIXIVAN contains lactose

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.

3.

How to take CRIXIVAN

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.

How much to take

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.

Taking this medicine

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.

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.

When to take

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

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.

If you forget to take CRIXIVAN

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.

If you stop taking CRIXIVAN

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.

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.

The following side effects have been reported by patients taking CRIXIVAN:

See your doctor straight away if you notice any of the following serious side effects - you may

need urgent medical treatment:

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

There are also other side effects that you may get while taking this medicine such as increased

bleeding in haemophiliacs, muscle problems, signs of infection, and bone problems. Please see

‘Warnings and precautions’ in Section 2 above.

Additional side effects include:

Very common (affects more than 1 in 10 people):

headache

rash or dry skin

nausea

vomiting

altered taste sensations

indigestion or diarrhoea

stomach pain or swelling

feeling dizzy, weak or tired.

Common (affects less than 1 in 10 people):

passing gas

itching

dry mouth

acid reflux

muscle pain

pain on urination

difficulty getting to sleep

feeling numb or unusual feeling of the skin.

The following side effects have also been reported since the medicine has been used. How

often they happen is not known:

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.

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 CRIXIVAN

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.

6.

Contents of the pack and other information

What CRIXIVAN contains

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).

What CRIXIVAN looks like and contents of the pack

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 and Manufacturer

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:

Belgique/België/Belgien

MSD Belgium BVBA/SPRL

Tél/Tel: +32(0)27766211

dpoc_belux@merck.com

Lietuva

UAB Merck Sharp & Dohme

Tel.: +370 5 278 02 47

msd_lietuva@merck.com

България

Мерк Шарп и Доум България ЕООД

Тел.: +359 2 819 3737

info-msdbg@merck.com

Luxembourg/Luxemburg

MSD Belgium BVBA/SPRL

Tél/Tel: +32(0)27766211

dpoc_belux@merck.com

Česká republika

Merck Sharp & Dohme s.r.o.

Tel.: +420 233 010 111

dpoc_czechslovak@merck.com

Magyarország

MSD Pharma Hungary Kft.

Tel.: +361 888 53 00

hungary_msd@merck.com

Danmark

MSD Danmark ApS

Tlf: +45 4482 4000

dkmail@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited

Tel: 8007 4433 (+356 99917558)

malta_info@merck.com

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)

e-mail@msd.de

Nederland

Merck Sharp & Dohme BV

Tel: 0800 9999000 (+31 23 5153153)

medicalinfo.nl@merck.com

Eesti

Merck Sharp & Dohme OÜ

Tel.: +372 6144 200

msdeesti@merck.com

Norge

MSD (Norge) AS

Tlf: +47 32 20 73 00

msdnorge@ msd.no

Ελλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300

dpoc_greece@merck.com

Österreich

Merck Sharp & Dohme Ges.m.b.H.

Tel: +43 (0) 1 26 044

msd-medizin@merck.com

España

Merck Sharp & Dohme de España, S.A.

Tel: +34 91 321 06 00

msd_info@merck.com

Polska

MSD Polska Sp. z o.o.

Tel.: +48 22 549 51 00

msdpolska@merck.com

France

MSD France

Tél: + 33 (0) 1 80 46 40 40

Portugal

Merck Sharp & Dohme, Lda

Tel: +351 21 4465700

clic@merck.com

Hrvatska

Merck Sharp & Dohme d.o.o.

Tel: + 385 1 6611 333

croatia_info@merck.com

România

Merck Sharp & Dohme Romania S.R.L.

Tel: +40 21 529 29 00

msdromania@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health)

Limited

Tel: +353 (0)1 2998700

medinfo_ireland@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila

d.o.o.

Tel: + 386 1 5204 201

msd_slovenia@merck.com

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Merck Sharp & Dohme, s. r. o.

Tel.: +421 2 58282010

dpoc_czechslovak@merck.com

Ιtalia

MSD Italia S.r.l.

Tel: +39 06 361911

medicalinformation.it@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0) 9 804 650

info@msd.fi

Κύπρος

Merck Sharp & Dohme Cyprus Limited

Τηλ: 800 00 673 (+357 22866700)

cyprus_info@merck.com

Sverige

Merck Sharp & Dohme (Sweden) AB

Tel: +46 77 5700488

medicinskinfo@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija

Tel: +371 67364224

msd_lv@merck.com.

United Kingdom

Merck Sharp & Dohme Limited

Tel: +44 (0) 1992 467272

medicalinformationuk@merck.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

Package leaflet: Information for the user

CRIXIVAN 400 mg hard capsules

indinavir

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

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 is in this leaflet

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

1.

What CRIXIVAN is and what it is used for

What CRIXIVAN is

CRIXIVAN contains a substance called indinavir. It belongs to a group of medicines called ‘protease

inhibitors’.

What CRIXIVAN is used for

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.

How CRIXIVAN works

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.

2.

What you need to know before you take CRIXIVAN

Do not take CRIXIVAN:

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:

Do not take either CRIXIVAN or 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

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.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking CRIXIVAN if you have had or develop any of

the following:

allergies

kidney problems (including inflammation of the kidneys, kidney stones, or back pain with or

without blood in your urine)

‘haemophilia’ – CRIXIVAN may make you more likely to bleed. If you notice bleeding or if you

feel weak, talk to your doctor straight away.

liver problems – people with ‘chronic hepatitis B or C’ or ‘cirrhosis’ who are treated with

‘antiretroviral’ medicines are more likely to have serious and potentially fatal liver side effects

with this medicine. You may need to have blood tests to check how your liver is working.

severe pain, tenderness or weakness in your muscles – this is more likely to happen if you are

taking cholesterol-lowering medicines called ‘statins’ (such as simvastatin). On rare occasions the

muscle problems can be serious (rhabdomyolysis). Inform your doctor as soon as possible if you

develop severe muscle pain or weakness.

signs of infection – this may be a previous infection which comes back soon after anti-HIV

treatment is started. This may be because the body is able to start fighting infections again. This

happens in some people with advanced HIV infection (AIDS) and who have had HIV related

infections before. If you notice any symptoms of infection, please inform your doctor

immediately.

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.

bone problems – signs include stiff joints, aches and pains, especially of the hip and difficulty

moving. If you notice any of these signs, talk to your doctor. Such problems might be due to a

bone disease called ‘osteonecrosis’ (loss of blood supply to the bone causing bone death), which

can occur months to years after starting HIV therapy. The risk of you having bone problems is

higher if you:

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.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before

taking CRIXIVAN.

Children and adolescents

CRIXIVAN is not recommended in children under the age of 18 years.

Other medicines and CRIXIVAN

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

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.

In addition, talk to your doctor, pharmacist or nurse before taking CRIXIVAN if you are

taking any of the following medicines since your doctor may want to adjust the dose of your

medicines:

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.

CRIXIVAN with food and drink

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.

Pregnancy and breast-feeding

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.

Driving and using machines

Dizziness and blurred vision have been reported during treatment with CRIXIVAN. If this happens,

do not drive or operate machines.

Other things you should know

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.

CRIXIVAN contains lactose

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.

3.

How to take CRIXIVAN

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.

How much to take

The recommended dose of CRIXIVAN is:

Two 400 mg capsules (800 mg) - taken three times a day (every 8 hours).

This means you will take a total of six 400 mg capsules (2400 mg) each day.

You usually take less CRIXIVAN if you are also taking ritonavir. The recommended doses are:

CRIXIVAN – one 400 mg capsules (400 mg) - taken twice a day.

This means you will take a total of two 400 mg capsules (800 mg) each day.

ritonavir - 100 mg - taken twice a day.

Taking this medicine

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.

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.

When to take

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

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.

If you forget to take CRIXIVAN

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.

If you stop taking CRIXIVAN

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 thismedicine, 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.

The following side effects have been reported by patients taking CRIXIVAN:

See your doctor straight away if you notice any of the following serious side effects - you may

need urgent medical treatment:

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

There are also other side effects that you may get while taking this medicine such as increased

bleeding in haemophiliacs, muscle problems, signs of infection, and bone problems. Please see

‘Warnings and precautions’ in Section 2 above.

Additional side effects include:

Very common (affects more than 1 in 10 people):

headache

rash or dry skin

nausea

vomiting

altered taste sensations

indigestion or diarrhoea

stomach pain or swelling

feeling dizzy, weak or tired.

Common (affects less than 1 in 10 people):

passing gas

itching

dry mouth

acid reflux

muscle pain

pain on urination

difficulty getting to sleep

feeling numb or unusual feeling of the skin.

The following side effects have also been reported since the medicine has been used. How

often they happen is not known:

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.

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 CRIXIVAN

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.

6.

Contents of the pack and other information

What CRIXIVAN contains

The active substance is indinavir. Each hard capsule contains indinavir sulphate corresponding

to 400 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 titanium dioxide (E 171), indigo carmine

(E 132) and iron oxide (E 172).

What CRIXIVAN looks like and contents of the pack

CRIXIVAN 400 mg hard capsules are supplied in HDPE bottles with a polypropylene cap and a foil

seal containing 90 or 180 capsules. Not all pack sizes may be marketed.

The capsules are semi-translucent white and coded ‘CRIXIVAN 400 mg’ on them in green.

Marketing Authorisation Holder and Manufacturer

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:

Belgique/België/Belgien

MSD Belgium BVBA/SPRL

Tél/Tel: +32(0)27766211

dpoc_belux@merck.com

Lietuva

UAB Merck Sharp & Dohme

Tel.: +370 5 278 02 47

msd_lietuva@merck.com

България

Мерк Шарп и Доум България ЕООД

Тел.: +359 2 819 3737

info-msdbg@merck.com

Luxembourg/Luxemburg

MSD Belgium BVBA/SPRL

Tél/Tel: +32(0)27766211

dpoc_belux@merck.com

Česká republika

Merck Sharp & Dohme s.r.o.

Tel.: +420 233 010 111

dpoc_czechslovak@merck.com

Magyarország

MSD Pharma Hungary Kft.

Tel.: +361 888 53 00

hungary_msd@merck.com

Danmark

MSD Danmark ApS

Tlf: +45 4482 4000

dkmail@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited

Tel: 8007 4433 (+356 99917558)

malta_info@merck.com

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)

e-mail@msd.de

Nederland

Merck Sharp & Dohme BV

Tel: 0800 9999000 (+31 23 5153153)

medicalinfo.nl@merck.com

Eesti

Merck Sharp & Dohme OÜ

Tel.: +372 6144 200

msdeesti@merck.com

Norge

MSD (Norge) AS

Tlf: +47 32 20 73 00

msdnorge@ msd.no

Ελλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300

dpoc_greece@merck.com

Österreich

Merck Sharp & Dohme Ges.m.b.H.

Tel: +43 (0) 1 26 044

msd-medizin@merck.com

España

Merck Sharp & Dohme de España, S.A.

Tel: +34 91 321 06 00

msd_info@merck.com

Polska

MSD Polska Sp. z o.o.

Tel.: +48 22 549 51 00

msdpolska@merck.com

France

MSD France

Tél: + 33 (0) 1 80 46 40 40

Portugal

Merck Sharp & Dohme, Lda

Tel: +351 21 4465700

clic@merck.com

Hrvatska

Merck Sharp & Dohme d.o.o.

Tel: + 385 1 6611 333

croatia_info@merck.com

România

Merck Sharp & Dohme Romania S.R.L.

Tel: +40 21 529 29 00

msdromania@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health)

Limited

Tel: +353 (0)1 2998700

medinfo_ireland@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila

d.o.o.

Tel: + 386 1 5204 201

msd_slovenia@merck.com

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Merck Sharp & Dohme, s. r. o.

Tel.: +421 2 58282010

dpoc_czechslovak@merck.com

Ιtalia

MSD Italia S.r.l.

Tel: +39 06 361911

medicalinformation.it@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0) 9 804 650

info@msd.fi

Κύπρος

Merck Sharp & Dohme Cyprus Limited

Τηλ: 800 00 673 (+357 22866700)

cyprus_info@merck.com

Sverige

Merck Sharp & Dohme (Sweden) AB

Tel: +46 77 5700488

medicinskinfo@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija

Tel: +371 67364224

msd_lv@merck.com.

United Kingdom

Merck Sharp & Dohme Limited

Tel: +44 (0) 1992 467272

medicalinformationuk@merck.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.