200 mg hard capsules 
indinavir

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What CRIXIVAN is and what it is used for 
2. What you need to know before taking CRIXIVAN 
3. How to take CRIXIVAN 
4. Possible side effects 
5. How to store CRIXIVAN 
6. Contents of the packaging 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 for treating the human immunodeficiency virus ( HIV ) in adults. CRIXIVAN is used with other HIV therapies (antiretroviral medicines). This is called combination antiretroviral therapy.

  • An example of another medicine that you can take while taking CRIXIVAN is ritonavir.

How CRIXIVAN works

CRIXIVAN treats HIV and helps reduce the number of HIV particles in the blood.

CRIXIVAN helps to:

  • reduce the risk of getting HIV- related diseases
  • reduce the amount of HIV in the body (your “viral load”)
  • increase the number of CD4 (T -) cells. CD4 cells are an important part of your immune system. The main function of the immune system is to protect you from infection.

CRIXIVAN may not have these effects in all patients. Your doctor will check how this medicine works for you.

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 you
    • cisapride – used for intestinal problems
    • amiodarone – used for heart rhythm problems
    • pimozide – used for certain mental health problems
    • lovastatin or simvastatin – used to lower cholesterol levels
    • St. John’s wort ( Hypericum perforatum ) – herbal medicine used in depression
    • ergotamine tartrate (with or without caffeine) is used for migraines
    • astemizole or terfenadine – antihistamine s used in hay fever and other allergies
    • quetiapine – used in certain mental illnesses such as schizophrenia, bipolar disorder, and major depression
    • alprazolam, triazolam, and midazolam (taken by mouth) – used as sedatives and for insomnia.

Do not take CRIXIVAN if any of the above applies to you. If you are unsure, talk to a doctor,

your pharmacist or nurse before taking CRIXIVAN.

CRIXIVAN can be given at the same time as the drug ritonavir: Do not take CRIXIVAN or ritonavir:

  • if you have liver problems
  • if you are taking any of the following medicines:
    • fusidic – an antibiotic used to treat infections you
    • piroxicam – used in arthritis
    • alfuzosin – used for prostate problems
    • bepridil – used for chest pain (angina)
    • clozapine – used for certain mental health problems
    • pethidine or propoxyphene – used for pain
    • estazolam or flurazepam – used for insomnia
    • clorazepate or diazepam – used as sedatives
    • encainide, flecainide, propafenone, or quinidine – used for problems with irregular heartbeats.

Do not take 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 cautions

Talk to your doctor, pharmacist, or nurse before taking CRIXIVAN if you have previously had or are developing any of the following:

  • allergy is
  • kidney problems (including kidney inflammation, kidney stones, or back pain with or without blood in the urine)
  • hemophilia – CRIXIVAN may make you bleed easier. If you notice bleeding or if you feel weak, talk to a doctor immediately.
  • Liver problems – people with chronic hepatitis B or C or cirrhosis, who are being treated with antiretroviral medicines, are more likely to get serious and potentially life-threatening liver side effects with this medicine. You may need to take blood samples to check how your liver is working.
  • severe muscle pain, muscle soreness or muscle weakness – the risk of this increases if you take cholesterol-lowering medicines called statins (such as simvastatin ). In rare cases, muscle problems can be severe ( rhabdomyolysis ). Tell your doctor as soon as possible if you develop severe muscle pain or muscle weakness.
  • signs of infection – this may be a previous infection that comes back shortly after starting treatment for HIV. This may be because the body has regained the ability to fight infection. This occurs in some people with advanced HIV – infection ( AIDS) and a history of HIV -related infection. If you notice any symptoms of infection, tell your doctor immediately.
  • autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines to treat your HIV – infection. Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, inform your doctor immediately for the necessary treatment.
  • Problems with bone tissue – signs include stiff joints, aches, and pains, especially in the hip, as well as problems with mobility. If you notice any of these signs, talk to your doctor. These problems can be due to a bone disease called osteonecrosis(lost blood supply to bone tissue that can cause tissue death in the bone), and which can occur months or years after starting HIV treatment. The risk of you getting problems with bone tissue is greater if you:
    • drinking alcohol
    • has a high BMI (body mass index)
    • has a very weak immune system
    • have taken corticosteroids with CRIXIVAN
    • receive combination antiretroviral therapy for a long time.

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

Children and young people

CRIXIVAN is not recommended for use in children below 18 years of age.

Other medicines and CRIXIVAN

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, including herbal remedies.

CRIXIVAN may affect the way other medicines work. Some other medicines may also affect the way CRIXIVAN works.

Ritonavir

Ritonavir is used to increase blood levels of CRIXIVAN or, more rarely, to treat HIV and then at higher doses. Talk to your doctor if you are going to take both CRIXIVAN and ritonavir. See also ritonavir package leaflet.

Please see the section above “Do not take CRIXIVAN” and “Do not take CRIXIVAN or ritonavir” 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.

Also talk to your doctor, pharmacist, or nurse before taking CRIXIVAN if you are taking any of the following medicines as your doctor may want to adjust the dose of one of your medicines:

  • theophylline – used in asthma
  • warfarin – a blood thinner
  • morphine, fentanyl – used for pain
  • buspirone – used as a sedative
  • fluconazole – used in fungal infections
  • venlafaxine, trazodone – used in depression
  • tacrolimus, ciclosporin – used mainly after organ transplantation
  • delavirdine, efavirenz, nevirapine – used in HIV
  • amprenavir, saquinavir, atazanavir – used for HIV
  • sildenafil, vardenafil, tadalafil – used for impotence
  • dexamethasone – used to prevent swelling ( inflammation )
  • itraconazole, ketoconazole – used in the treatment of fungal infections
  • atorvastatin, rosuvastatin, pravastatin, fluvastatin – used to lower cholesterol
  • fexofenadine, loratadine – antihistamines used in hay fever or other allergic conditions
  • birth control pills containing norethindrone or Ethinyl estradiol
  • phenobarbital, phenytoin, carbamazepine, Divalproex, lamotrigine are used in the treatment of seizures ( epilepsy )
  • midazolam (as an injection ) – used in acute seizures and to put patients to sleep before certain medical procedures
  • amlodipine, felodipine, nifedipine, nicardipine, digoxin, diltiazem are used for high blood pressure and some heart problems.
  • quetiapine – used in certain mental illnesses such as schizophrenia, bipolar disorder, and major depression.

If any of the above applies 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 especially important that you:

  • Do not take CRIXIVAN with foods rich in calories, fat, and protein. This is because this type of food reduces the body’s ability to absorb CRIXIVAN, which will then not have as good an effect.

Pregnancy and breastfeeding

  • If you are pregnant, think you may be pregnant, or are planning to have a baby, take CRIXIVAN only if your doctor tells you that there is a clear need. It is unknown whether CRIXIVAN is harmful to the fetus when used by a pregnant woman.
  • It is recommended that women with HIV do not breast-feed. This is to prevent the transmission of HIV to the infant.

Driving and using machines

Dizziness and blurred vision have been reported during treatment with CRIXIVAN. If this happens, avoid driving or using machines.

Other things you should know

CRIXIVAN is not a cure for HIV. You can still get an infection or other diseases related to HIV. You still need to see your doctor while taking CRIXIVAN.

HIV is spread through blood or sexual contact with a person who has HIV. You can still transmit HIV infection when you take this medicine, even though the risk of effective antiviral therapy is reduced. Discuss with your doctor the necessary steps to avoid infecting others.

CRIXIVAN contains lactose

This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take CRIXIVAN

Always take this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

How much to take

The recommended dose of one of CRIXIVAN is:

  • Four 200 mg capsules (800 mg) – taken three times a day (every 8 hours). This means that you will take a total of twelve 200 mg capsules (2400 mg) each day.

You are usually taking 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 that you will take a total of four 200 mg capsules (800 mg) each day.
  • ritonavir 100 mg twice daily.

Taking this medicine

  • Take this medicine by mouth.
  • Swallow the capsule whole with water, skimmed milk or skimmed milk, juice, tea, or coffee.
  • The capsule should not be crushed or chewed.
  • Adults need to drink at least 1.5 liters of fluid every day while taking CRIXIVAN. This helps reduce the risk of you getting kidney stones.
  • Do not take CRIXIVAN with foods rich in calories, fat, and protein. This is because this type of food reduces the body’s ability to absorb CRIXIVAN, which will then not have as good an effect.

When to take this medicine

  • Take the medicine 1 hour before or 2 hours after a meal.
  • If you can not take CRIXIVAN without food, then take it with a low-fat meal.
  • If you are also taking ritonavir, 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 if you have taken more CRIXIVAN than you should. The following effects may occur:

  • nausea
  • vomiting
  • diarrhea
  • back pain
  • blood in the urine.

If you forget to take CRIXIVAN

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, do not take it later in the day. Simply continue to follow the usual schedule.

If you stop taking CRIXIVAN

You must take CRIXIVAN exactly as your doctor has told you – he or she will tell you how long to take your medicine.

  • Do not stop taking CRIXIVAN without talking to a doctor.
  • This is because reducing or missing a dose increase the risk of HIV – the virus et becoming resistant to CRIXIVAN.
  • If this happens, your treatment will stop working.

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

4. Possible side effects

During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Seek medical attention immediately if you notice any of the following serious side effects – you may need immediate medical attention:

  • allergic reactions – signs of this can be itchy skin, reddening of the skin, hives or hives, swelling of the face, lips, tongue, or throat, and difficulty breathing. It is not known how often this can happen (cannot be calculated 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 hemophilia, muscle problems, signs of infection, and problems with bone tissue. Please see “Warnings and Cautions” section 2 above.

Other side effects include:

Very common (may affect more than 1 user in 10):

  • headache
  • skin rash or dry skin
  • nausea
  • vomiting
  • taste changes
  • indigestion or diarrhea
  • abdominal pain or swelling
  • dizziness, weakness, or fatigue.

Common (may affect up to 1 in 10 people):

  • gases
  • itching
  • dry mouth
  • acid reflux
  • muscle pain
  • pain when urinating
  • difficulty falling asleep
  • numbness or unusual feeling in the skin.

The following side effects have also been reported with the use of the drug. It is not known how often they occur:

  • hair loss
  • inflammation of the pancreas
  • severe skin reactions
  • darker skin tone
  • numbness in the 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, deterioration, or loss of kidney function
  • pain and difficulty moving the shoulder.

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 can or carton after EXP. The expiration date is the last day of the specified month.

Store CRIXIVAN in the original package. Close the jar tightly, moisture sensitive. The jar contains a desiccant that should remain in the jar.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is indinavir. Each hard capsule contains indinavir sulfate equivalent to 200 mg indinavir.
  • The other ingredients are anhydrous lactose, magnesium stearate, gelatin, and titanium dioxide (E171).
  • The capsules are marked with ink containing indigo carmine (E132).

What the medicine looks like and the contents of the pack

CRIXIVAN 200 mg hard capsules are supplied in HDPE cans, with a polypropylene cap and foil seal, containing 180, 270, or 360 capsules. Not all pack sizes may be marketed.

The capsules are translucent, white, and marked “CRIXIVAN TM 200 mg” with blue text.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN Haarlem, The Netherlands

Manufacturer: Merck Sharp & Dohme BV, Waarderweg 39, PO Box 581, 2003 PC Haarlem Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine.

Belgique / België / BelgienMSD Belgium BVBA / SPRLTel: +32 (0) 27766211dpoc_belux@merck.com LithuaniaUAB Merck Sharp & DohmeTel .: +370 5 278 02 47msd_lietuva@merck.com
BulgariaMark Harp and Doom Bulgaria BulgariaTel: +359 2 819 3737info-msdbg@merck.com Luxembourg / LuxemburgMSD Belgium BVBA / SPRLTel: +32 (0) 27766211dpoc_belux@merck.com
Czech RepublicMerck Sharp & Dohme sroTel .: +420 233 010 111dpoc_czechslovak@merck.com
HungaryMSD Pharma Hungary Kft.Tel .: +361 888 53 00hungary_msd@merck.com
DenmarkMSD Danmark ApSTel: +45 4482 4000dkmail@merck.com

MaltaMerck Sharp & Dohme Cyprus LimitedTel: 8007 4433 (+356 99917558)malta_info@merck.com
GermanyMSD SHARP & DOHME GMBHTel: 0800 673 673 673 (+49 (0) 89 4561 2612)e-mail@msd.de The NetherlandsMerck Sharp & Dohme BVTel: 0800 9999000 (+31 23 5153153)medicalinfo.nl@merck.com
EestiMerck Sharp & Dohme OÜTel .: +372 6144 200msdeesti@merck.com
NorwayMSD (Norway) ASTel: +47 32 20 73 00msdnorge @ msd.no
GreeceMSD Α.Φ.Β.Ε.Ε.:Ηλ: +30 210 98 97 300dpoc_greece@merck.com
AustriaMerck Sharp & Dohme Ges.mbHTel: +43 (0) 1 26 044msd-medizin@merck.com
SpainMerck Sharp & Dohme de España, SATel: +34 91 321 06 00msd_info@merck.com PolandMSD Polska Sp. z ooTel .: +48 22 549 51 00msdpolska@merck.com
FranceMSD FranceTel: +33 (0) 1 80 46 40 40

PortugalMerck Sharp & Dohme, LdaTel: +351 21 4465700clic@merck.com
CroatiaMerck Sharp & Dohme dooTel: + 385 1 6611 333croatia_info@merck.com
RomaniaMerck Sharp & Dohme Romania SRLTel: +40 21 529 29 00msdromania@merck.com
IrelandMerck Sharp & Dohme Ireland ( HumanHealth) LimitedTel: +353 (0) 1 2998700medinfo_ireland@merck.com SloveniaMerck Sharp & Dohme, an innovative freelance dooTel: + 386 1 5204 201msd_slovenia@merck.com
IcelandVistor hf.Phone: +354 535 7000
Slovak RepublicMerck Sharp & Dohme, sroTel .: +421 2 58282010dpoc_czechslovak@merck.com
ItalyMSD Italia SrlTel: +39 06 361911medicalinformation.it@merck.com Finland / FinlandMSD Finland OyPuh / Tel: +358 (0) 9 804 650info@msd.fi
ΚύπροςMerck Sharp & Dohme Cyprus Limited:Ηλ: 800 00 673 (+357 22866700)cyprus_info@merck.com
LatviaSIA Merck Sharp & Dohme LatvijaTel: +371 67364224msd_lv@merck.com. United KingdomMerck Sharp & Dohme LimitedTel: +44 (0) 1992 467272medicalinformationuk@merck.com

Muhammad Nadeem

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