Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**DOSAGE AND ADMINISTRATION** - Angina pectoris, variant angina pectoris The usual adult dosage for oral use is 30 mg of diltiazem hydrochloride three times a day (90 mg/day). The dosage may be increased to 60 mg three times a day (180 mg/day), if necessary. - Essential hypertension (mild to moderate) The usual adult dosage for oral use is 30 to 60 mg of diltiazem hydrochloride three times a day (90 – 180 mg/day). The dosage may be adjusted depending on the patient’s age and symptoms.
ORAL
Medical Information
**INDICATIONS** - Angina pectoris, variant angina pectoris - Essential hypertension (mild to moderate)
**CONTRAINDICATIONS (HERBESSER and HERBESSER 60 are contraindicated in the following patients.)** 1. Patients with severe congestive heart failure. \[The symptoms of heart failure may be exacerbated.\] 2. Patients with 2nd- or 3rd-degree atrioventricular block or sick sinus syndrome (continuous sinus bradycardia (less than 50 beats/minute), sinus arrest, sinoatrial block, etc.) \[Excessive inhibition of sinus rhythm and cardiac conduction may occur.\] 3. Patients with a history of hypersensitivity to any of the ingredients in the drug. 4. Pregnant women or women who may possibly be pregnant, etc. \[See PRECAUTIONS – Use during Pregnancy, Delivery or Lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.\] 5. Patients receiving ivabradine hydrochloride. \[See “Drug Interactions” section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.\]
C08DB01
diltiazem
Manufacturer Information
MITSUBISHI TANABE PHARMA SINGAPORE PTE. LTD.
PT Mitsubishi Tanabe Pharma Indonesia
Active Ingredients
Documents
Package Inserts
Herbesser Tablet 30mg and 60mg_PI.pdf
Approved: April 11, 2023