ACTOS OD Tablets£¨Pioglitazone hydrochloride£©
Brand name : ACTOS OD Tablets 15
¡¡Active ingredient: Pioglitazone hydrochloride
¡¡Dosage form: yellowish white tablets, φ7.1 mm, thickness 2.8 mm
¡¡Print on wrapping: (Face) 376, ¥¢¥¯¥È¥¹OD15, (Back) ¥¢¥¯¥È¥¹OD15
Effects of this medicine
This medicine improves hyperglycemia by enhancing the action of insulin.
Usually, used for treatment of type II diabetes mellitus.
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 have a heart disease or a history of heart disease, ketosis, diabetic coma or precoma, insulin-dependent diabetes mellitus, hepatic disorder, renal disorder, or severe infection; are in a pre- or post-operative state; have an injury, pituitary abnormality, adrenal disorder, inadequate food intake, or debility; are doing strenuous physical exercise, or a heavy drinker; or have a bladder cancer or a history of bladder cancer, or diabetic retinopathy.
•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 0.5 to 1 tablets (15 to 30 mg of pioglitazone) at a time, once a day, before or after breakfast. The dosage should be adjusted according to your gender, age and symptoms, but 1.5 tablets (45 mg) a day is the upper limit of dosage.
When given concomitantly with an insulin preparation, for adults, take 0.5 tablets (15 mg of pioglitazone) at a time, once a day, before or after breakfast. The dosage should be adjusted according to your gender, age and symptoms, but 1 tablet (30 mg) a day is the upper limit of dosage.
Strictly follow the instructions of your doctor/pharmacist.
•This medicine may be moistened with saliva on the tongue, then lightly squashed with the tongue, and swallowed with saliva. It may also be taken with water like usual drugs.
•If you missed a dose, take the missed dose as soon as possible if prior to noon. As hypoglycemia may occur, do not take the medicine after severe exercise or on an empty stomach. 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
•Strictly adhere to dietary instructions given and to kinesitherapy prescribed.
•Much caution should be exercised as hypoglycemia may occur.
•When hypoglycemia symptoms occur, take an adequate amount of sugar (e.g., sugar, glucose, soft drinks). If you are taking the medicine concomitantly with an α-glucosidase inhibitor (drugs which delay absorption of sugar such as voglibose and acarbose), ingest glucose in case of any hypoglycemic symptoms.
•Although this drug has not been concluded to cause bladder cancer, there has been a report overseas stating that a potential risk for bladder cancer increases with increasing duration of this drug medication. Therefore, patients receiving this drug are followed by periodic urinary tests, etc. If hematuria, frequent urination, painful micturition, etc. appear, check with your doctor.
Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: anemia, increased blood pressure, palpitation, pressurized feeling in the chest, hot flush, rash, itching, nausea, vomiting, abdominal discomfort, heart burn, abdominal pain, enlarged feeling of abdomen, diarrhea, constipation, excessive appetite, loss of appetite, dizziness, light-headedness, headache, sleepiness, malaise, lassitude, numbness, weight increase, aggravation of diabetic retinopathy, shortness of breath, 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.
•swelling, rapid weight increase, shortness of breath, palpitation [heart failure]
•swelling, rapid weight increase [edema]
•loss of appetite, yellowing of the skin or whites of the eyes [liver disorder, jaundice]
•cold sweat, feeling hungry, trembling of hands/feet [hypoglycemia]
•lassitude, muscle pain, brown urine [rhabdomyolysis]
•pain in the pit of stomach, nausea, black stool [relapse of gastric ulcer]
•fever, cough, breathing difficulty [interstitial pneumonia]
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 away from direct sunlight, heat and humidity.
•Discard the remainder. Do not store them.
Takeda Chemical Industries, Ltd.Internal
Revised: 7/2011
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.