Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 10/2011
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is
important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,
patients should understand their medication and cooperate with the treatment.
Brand name:INVIRASE Capsule 200mg
Active ingredient:Saquinavir mesilate
Dosage form:green/pale brown capsule (major axis: approx. 21.0mm)
Print on wrapping:
Effects of this medicine
The medicine discourages reproduction of infectious viruses by inhibiting the function of HIV protease (enzyme which
synthesizes protein). It is usually used to treat HIV infection in combination with ritonavir and other anti-HIV drugs.
Before using this medicine, be sure to tell your doctor and pharmacist
・If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
If you are a patient with hepatic function disorder, QT prolonged, hypokalemia, hypomagnesemia, AV block
complete without using pacemaker, hemophilia, bleeding tendency or renal function disorder.
・If you are pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal
effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
・Your dosing schedule prescribed by your doctor is<<
to be written by a healthcare professional>>
・General dosage regimen: For adults, take 5 capsules (1000mg of saquinavir) in combination with 100mg of ritonavir
twice a day. They should be taken within 2 hours after meal concurrently. Strictly follow the instructions of your
doctor/pharmacist.
・Each meal influences the absorption of the medicine. Eat meals on a regular schedule as much as possible, and make
sure to take the medicine within 2 hours after meal.
・The medicine may lose effectiveness if you miss a dose. So it is important not to miss a dose. If you miss a dose by
any chance and realize it, eat something and then take the missed dose as soon as possible. If it is almost time for
the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to
make up for the missed dose.
・If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.
・Do not stop taking the medicine without the instructions of your doctor.
Precautions while taking this medicine
・Avoid taking hypericum perforatum (Saint John's wort)-containing food or garlic-constituent containing
product(food,supplement,etc.), since they affect the medicine.
・Grape fruit juice may cause the medicine to act excessively. Do not take the medicine with it.
・Anti-HIV drugs may change distribution of fat in the body, which may lead to an increase of your waistline or loss of
flesh on your face or limbs.
・After starting taking anti-HIV drug, your immunity will be improved, which may produce/worsen inflammatory
reaction (such as fever and diarrhea) against opportunistic infection and so on.
Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: hepatic
(function) disorder, anemia, diarrhea, nausea, fatigue, vomiting, abdominal pain, flatulence, etc.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated
in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor
immediately.
・suicide attempt [suicide attempt]
・confused/disturbed consciousness, impaired mind [confusion]
・convulsion [convulsion ]
・unable to perform intended/complicated movements [coordination disturbance]
・severe stomachache/abdominal pain, back pain, nausea, vomiting [pancreatitis]
・severe lower abdominal pain, feeling sick at the stomach, vomiting, failure of passing stool [intestinal tract
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obstruction]
・enlarged feeling of abdomen [ascites]
・yellowness in the skin and/or the white of the eye, brown urine, rash, fever, lassitude, loss of appetite, nausea,
vomiting, itch [severe hepatic function disorder , jaundice, hepatitis]
・enlarged feeling of abdomen, palpitation/shortness of breath when going upstairs or uphill, headache, shortness of
breath, ear ringing, dizziness, lassitude [portal hypertension]
・excess intake of water, thirst, increased urinary volume, lassitude, weight loss, feeling of weariness [hyperglycemia,
diabetes]
・dizziness, palpitation, ear ringing, nose/gum bleeding, bleeding tendency, blue spot, shortness of breath
[pancytopenia]
・lightheadedness, dizziness on standing up, easy fatigability, top-heavy feeling, dizziness, lassitude,
palpitation/shortness of breath when moving, yellowness in the skin and/or the white of the eye, brown urine
[hemolytic anemia]
・sore throat, fever [leukopenia, neutropenia]
・blue spot, gum bleeding, bleeding tendency [thrombocytopenia]
・skin, lips and nails turning bluish purple, swelling, fever, swollen legs [thrombophlebitis]
・bleeding [bleeding]
・lassitude, breathlessness, coldness of the limbs, facial pallor [peripheral vasoconstriction]
・shortness of breath, dizziness, fever, lassitude, bleeding tendency [acute myelogenous leukemia]
・high fever, pain in the genitalia, severe stomatitis, lip/intraoral sore, fever, red rash with dropsical swelling in the
center, red rash, inflamed eye and eyelid, loss of appetite, lassitude, conjunctival sore [mucocutaneous ocular
syndrome (Stevens-Johnson syndrome)]
・severe low-back/back pain, bloody urine [nephrolithiasis]
・falling upper eyelid, double vision, loss of strength, heavy feeling in the eyelids, muscle fatigue [asthenia]
・joint pain/enlargement [polyarthritis]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your
doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
・Keep out of the reach of children. Store at room temperature (1-30℃), away from light and moisture.
・Discard the remainder. Do not store them. Ask the pharmacist how to discard.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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