Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CAPSULE
**DOSAGE AND ADMINISTRATION** - Essential hypertension (mild to moderate) Usually, for adults, I00 mg to 200 mg of diltiazem hydrochloride is orally administered once daily. The dosage may be adjusted according to the patient’s age and symptoms. - Angina pectoris, variant angina pectoris Usually, for adults, 100 mg of Diltiazem hydrochloride is orally administered once daily. If the effect is insufficient, the dosage may be increased to 200 mg once daily.
ORAL
Medical Information
**INDICATIONS** - Essential hypertension (mild to moderate) - Angina pectoris, variant angina pectoris
**CONTRAINDICATIONS (HERBESSER R is contraindicated in the following patients.)** 1. Patients with severe congestive heart cardiac failure \[Symptoms of cardiac failure may be aggravated\]. 2. Patients with second or third degree atrioventricular block or sick sinus syndrome (persistent sinus bradycardia) (less than 50 beats/ minute), sinus arrest, sinoatrial block, etc.) \[Depression of cardiac stimulation and cardiac conduction may occur excessively\]. 3. Patients with a history of hypersensitivity to any of the ingredients of this product. 4. Pregnant women or women who may possibly be pregnant \[See “Use during pregnancy, Delivery or lactation” section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\]. 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
Mitsubishi Tanabe Pharma Factory Ltd.
Active Ingredients
Documents
Package Inserts
Herbesser R100 and R200mg Capsule PI.pdf
Approved: April 11, 2023