Do not take CRIXIVAN
- if you are allergic (hypersensitive) to indinavir or any of the other ingredients of CRIXIVAN. Signs and symptoms of an allergic reaction may include: itchy skin, redness of the skin, wheals or hives, swelling of the face, lips, tongue and/or throat, or difficulty breathing.
Do not take CRIXIVAN with or without ritonavir
- if you take products containing rifampicin, amiodarone, terfenadine, astemizole, cisapride, alprazolam, triazolam, oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety), pimozide ergot derivatives such as ergot tartramine and ergot tartramine with caffeine, St. John's wort ( Hypericum perforatum), simvastatin or lovastatin.
In addition, do not take CRIXIVAN with ritonavir
- if you take products containing alfuzosin, meperidine, piroxicam, propoxyphene, bepridil, encainide, flecanide, propafenone, quinidine, fusidic acid, clozapine, clorazepate, diazepam, estazolam, and flurazepam.
- if you have decompensated liver disease.
When CRIXIVAN is used with ritonavir, please tell your doctor and refer to the package leaflet for ritonavir for more information.
Take special care with CRIXIVAN
You should know that CRIXIVAN is not a cure for HIV infection and that you may continue to develop infections or other illnesses associated with HIV disease. You should, therefore, remain under the care of your doctor while taking CRIXIVAN.
HIV infection is a disease spread by contact with blood or sexual contact with an infected individual. Treatment with CRIXIVAN has not been shown to reduce the risk of transmission of HIV to others through sexual contact or blood contamination.
Please speak with your doctor if you have a history of liver disease. Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk for severe and potentially fatal liver adverse events and may require blood tests for control of liver function.
Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat.
Bone problems
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.
In some patients with advanced HIV infection (AIDS) 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. If you notice any symptoms of infection, please inform your doctor immediately.
Tell your doctor
- about any past or present medical problems, including liver disease due to cirrhosis;
- if you have kidney problems (including back pain with or without blood in your urine);
- if you have allergies;
- if you have high cholesterol and if you are taking cholesterol?lowering medicines called ?statins?;
- if you have diabetes;
- if you have haemophilia;
- if you are intolerant to lactose because each hard capsule contains 74.8 mg lactose (anhydrous).
Children
CRIXIVAN can be taken by children 4 years of age and older who are able to swallow hard capsules.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
There are some medicines that should not be taken with CRIXIVAN with or without ritonavir (see Do not take CRIXIVAN) or that require dosage changes of that medicine or CRIXIVAN (e.g., itraconazole, ketoconazole, cyclosporine, nevirapine, delavirdine and efavirenz).
Consult your doctor before taking certain cholesterol?lowering medicines (e.g., atorvastatin, rosuvastatin, pravastatin, fluvastatin), antifungals (e.g., fluconazole), anticonvulsants (e.g., phenobarbital, phenytoin, carbamazepine), steroids (e.g., dexamethasone), protease inhibitors (e.g., amprenavir, saquinavir, atazanavir), medicines for impotence (e.g., sildenafil), blood thinners (e.g., warfarin), calcium channel blockers (e.g., amlodipine, felodipine?class of medicinal products used for the treatment of hypertension and some specific heart disorders), sedative agents (e.g. midazolam administered by injection), antidepressants (e.g., venlafaxine), oral contraceptives (e.g. "the Pill"), medicines for asthma (e.g., theophylline) or any other medicines.
CRIXIVAN may be taken with a number of medicines that are commonly used in HIV infection (zidovudine, didanosine, lamivudine, stavudine, quinidine, cimetidine, clarithromycin, isoniazid, fluconazole, trimethoprim/sulfamethoxazole, methadone).
Some medications may interact with CRIXIVAN taken in combination with ritonavir. Please consult with your physician regarding taking medications with CRIXIVAN and ritonavir.
Taking CRIXIVAN with food and drink
CRIXIVAN should be taken without food but with water. If co-administered with ritonavir, CRIXIVAN may be administered with or without food.
If water is not preferred, CRIXIVAN can be taken with skimmed or low?fat milk, juice, coffee, or tea. If CRIXIVAN cannot be taken without food, a low?fat light meal, such as dry toast with jam or fruit conserve, juice and coffee with skimmed or low?fat milk and sugar, or a light meal such as corn flakes with skimmed or low?fat milk and sugar is acceptable.
Taking CRIXIVAN with a meal that is high in calories, fat, and protein reduces your body?s ability to absorb the medicine and in turn reduces its effectiveness.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or intend to become pregnant.
If you are pregnant, you should take CRIXIVAN only if your doctor decides it is clearly needed. It is not known whether CRIXIVAN is harmful to an unborn baby when taken by a pregnant woman. Tell your doctor if you are breast?feeding.
It is recommended that HIV-infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Driving and using machines
There is no specific information to suggest that CRIXIVAN affects your ability to drive and use machinery. However, dizziness and blurred vision have been reported during treatment with CRIXIVAN. Do not drive or operate machines if you experience these symptoms.
Important information about some of the ingredients of CRIXIVAN
This medicinal product contains 299.2 mg of lactose in each 800-mg dose (maximum single dose). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
