Do not take Invirase
- if you are allergic (hypersensitive) to saquinavir, ritonavir or any of the other ingredients (see section ?Important information about an ingredient of Invirase? and section ?What Invirase contains?).
- if you were born with or have
- any condition with certain abnormal electrocardiogram (ECG, electrical recording of the heart) changes,
- a salt imbalance in the blood, especially low concentrations of potassium in the blood (hypokalaemia) which are currently not corrected by treatment,
- a very slow heart rate (bradycardia),
- a weak heart (heart failure), or
- a history of abnormal heart rhythms (arrhythmias) - if you are taking other medicines that result in certain abnormal ECG changes:
- certain HIV antiviral agents (e.g. atazanavir, lopinavir),
- certain heart medicines (amiodarone, bepridil, dofetilide, flecainide, hydroquinidine, ibutilide, lidocaine, propafenone, quinidine, sotalol),
- medicines to treat depression (amitryptiline, imipramine, trazodone),
- medicines used to treat severe mental disorders (e.g. clozapine, haloperidol, mesoridazine, phenothiazines, sertindole, sultopride, thioridazine, ziprasidone),
- certain anti-infectives (e.g. clarithromycin, erythromycin, halofantrine, pentamidine, sparfloxacin)
- certain narcotic analgesics (e.g. methadone),
- medicines used to treat erectile dysfunction (sildenafil, vardenafil, tadalafil),
- some other medicines (alfentanyl, cisapride, dapsone, diphemanil, disopyramide, fentanyl, mizolastine, quinine, vincamine) - if you have liver disease with severe disease symptoms (e.g. jaundice or hepatitis with liquid accumulation in the belly, mental confusion and/or bleeding from veins of the oesophagus). - if you are currently taking any of the following medicines:
- terfenadine and astemizole (commonly used to treat allergy symptoms),
- pimozide (for psychiatric problems),
- ergot alkaloids (used to treat migraine attacks),
- triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or relieve anxiety),
- rifampicin (used to prevent or treat tuberculosis),
- simvastatin and lovastatin (used to lower blood cholesterol).
Take special care with Invirase
You should know that Invirase/ritonavir 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 Invirase/ritonavir.
Treatment with Invirase/ritonavir has not been shown to reduce the risk of transmission of HIV to others through sexual contacts or contamination with blood. Therefore, you must continue to take appropriate precautions to avoid giving the virus to others.
At present, there is only limited information on the use of Invirase/ritonavir in children under the age of 16 years and in adults over 60 years.
Abnormal heart rhythms (arrhythmias):
Invirase can change your heart?s ECG, especially if you are female or elderly. If you are taking any medicine that decreases your blood potassium levels talk to your doctor before taking Invirase. Contact your doctor immediately, if you experience palpitations or an irregular heartbeat during treatment. He/she may wish to perform an ECG to measure your heart rhythm.
Consult your doctor if you have a history of kidney disease.
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.
There are certain conditions, which you may have, or have had, which require special care before or while taking Invirase/ritonavir. Therefore, before using this medicine, you should have told your doctor if you suffer from diabetes mellitus, diarrhoea, or if you have allergies (see section 4) or if you have an intolerance to some sugars (see section ?Important information about an ingredient of Invirase?).
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 (see section 4).
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 (see section 4).
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.
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.
Invirase/ritonavir may be taken with a number of other medications that are commonly used in HIV infection.
There are some medications that must not be taken with Invirase/ritonavir (see section "Do not take
Invirase") or that require dosage reduction of that medicine or Invirase or ritonavir. Ask your doctor or pharmacist for more information about taking Invirase/ritonavir with other medicines.
Medicines that can interact with saquinavir andor ritonavir include other HIV antiviral agents e.g. nelfinavir, indinavir, nevirapine, delavirdine, efavirenz, some medicines affecting the immune system e.g. ciclosporin, sirolimus rapamycin, tacrolimus, various steroids e.g. dexamethasone, ethinyl estradiol, fluticasone, certain heart medicines e.g. calcium channel blockers, quinidine, digoxin, medicines used to lower blood cholesterol e.g. statins, antifungals ketoconazole, itraconazole, anticonvulsants e.g. phenobarbital, phenytoin, carbamazepine, sedative agents e.g. midazolam administered by injection, certain antibiotics e.g. quinupristindalfopristin, rifabutin, medicines to treat depression e.g. nefazodone, tricyclic antidepressants, medicines for anticoagulation warfarin, herbal preparations containing St. Johns wort or garlic capsules, some medicines that treat diseases related to the acid in the stomach e.g. omeprazole or other proton pump inhibitors
Therefore you should not take Invirase/ritonavir with other medicines without your doctor?s consent.
If you are taking an oral contraceptive to prevent pregnancy, you should use an additional or different type of contraception since ritonavir may reduce the effectiveness of oral contraceptives.
Taking Invirase with food and drinkInvirase must be taken together with ritonavir and with or after food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Inform your doctor if you are pregnant or planning to become pregnant. This medicine should be taken during pregnancy only after consultation with your doctor.
You should not breast-feed your baby if you are taking Invirase/ritonavir.
Driving and using machines
Invirase has not been tested for its effect on your ability to drive a car or operate machinery. However, dizziness and fatigue have been reported during treatment with Invirase. Do not drive or operate machines if you experience these symptoms.
Important information about an ingredient of Invirase
Each capsule contains lactose (anhydrous) 63.3 mg. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.