Drug Information Sheet ("Kusuri-no-Shiori")
620003516
Revised: 10/2011
Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries
other than Japan.
In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit
(effects) it will do. The patient's cooperation is indispensable here.
Brand name： INVIRASE Capsule 200mg
Active ingredient： Saquinavir mesilate
Dosage form： green/pale brown capsule (major axis: approx. 21.0mm)
Printings 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, tell your doctor/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 using any other prescription or nonprescription (OTC) medicine. (It is important to reduce
the risk of drug interactions.)
Dosage regimen (proper use of this medicine)
・ Your dosage regimen is:≪
:order of your doctor≫
・ 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.
・ Missed dose: 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.
・ Overdose: If you took too much of the medicine (more than ordered), check with your
doctor/pharmacist.
・ Others: Do not stop taking the medicine without the instructions of your doctor.
Precautions while using 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.
Continued on next page.
Side effects of 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.
Symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur,
stop taking your medicine and check with 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 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］
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any
worrisome symptom.
Storage 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 doctor use only: Day
Month
Year
For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert
information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices
Agency.
Drug Information Sheet ("Kusuri-no-Shiori")
620004347
Revised: 10/2011
Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries
other than Japan.
In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit
(effects) it will do. The patient's cooperation is indispensable here.
Brand name： INVIRASE Tablet 500mg
Active ingredient： Saquinavir mesilate
Dosage form： pale to dusty orange, or faintly reddish-yellow tablet (major axis:
approx. 19.0mm, minor axis: approx. 8.9mm, thickness: approx.
7.2mm)
Printings 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, tell your doctor/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 using any other prescription or nonprescription (OTC) medicine. (It is important to reduce
the risk of drug interactions.)
Dosage regimen (proper use of this medicine)
・ Your dosage regimen is:≪
:order of your doctor≫
・ General dosage regimen: For adults, take 2 tablets (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.
・ Missed dose: 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.
・ Overdose: If you took too much of the medicine (more than ordered), check with your
doctor/pharmacist.
・ Others: Do not stop taking the medicine without the instructions of your doctor.
Precautions while using 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.
Continued on next page.
Side effects of 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.
Symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur,
stop taking your medicine and check with 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 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］
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any
worrisome symptom.
Storage and other information
・ Keep out of the reach of children. Store at room temperature (1-30℃), away from direct sunlight and
moisture.
・ Discard the remainder. Do not store them. Ask the pharmacist how to discard.
For doctor use only: Day
Month
Year
For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert
information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices
Agency.