Sanwashoyaku.co.jp

Standard Commodity Classification No. of Japan This product is easy to take, fine granules made from the extract of “ogonto”listed in“SHOKANRON”. Storage・Caution Keep a container tightly closed in a dry area away from Date of listing in the NHI reimbursement price October 1986 Expiration date Use before the expiration date indicated on the label or the outer package. CONTRAINDICATIONS ( Ogonto is contraindicated in (1) When this product is used, the patient’s“SHO”(con- stitution/symptoms) should be taken into account. The patient’s progress should be carefully monitored, and if no improvement in symptoms/findings is obse- [1-3: These diseases or symptoms may be aggravated.] rved, continuous treatment should be avoided. (2) Since this product contains Glycyrrhiza, careful atte- ntion should be paid to the serum potassium level,bl- 7.5g/day of SANWA Ogonto extract fine granules contains ood pressure,etc., and if any abnormality is observed, 4.0g of a dried extract of the following mixed crude drugs. (3) When this product is coadministered with other Ka- mpo-preparations(Japanese traditional herbal medi- cines),etc.,attention should be paid to the duplicatio- SHO：The term“SHO”refers to a particular pathological status of a patient evaluated by the Kampo diagnosis,a- nd is patterned according to the patient’s constitution,s- ymptoms, etc. Kampo-preparations(Japanese tradition- al herbal medicines) should be used after confirmation that it is suitable for the identified“SHO”of the patient. Precautions for coadministration ( Ogonto should be ad- Ogonto is fine granules, yellow-brown color, it has charac- ministered with care when coadministered with the fol- teristic smell, and it tastes sweet and bitter. Ogonto is indicated for the relief of intestinal catarrh, dy- ur as a result of hy- potassium excreti- The usual adult dose is 7.5g/day orally in 3 divided doses before or between meals. The dosage may be adjusted ac- cording to the patient’s age and symptoms. This product has not been investigated(drug use investiga- tions, etc.)to determine the incidence of adverse reactions. Therefore, the incidence of adverse reactions is not known. (1) Clinically significant adverse reactions 1) Pseudoaldosteronism: Pseudoaldosteronism such as hypokalemia, increased blood pressure, retention of sodium/body fluid, edema, increased body weight,etc. may occur. The patient should be carefully monitore- d (measurement of serum potassium level, etc.), and if any abnormality is observed, administration shoul d be discontinued and appropriate measures such as administration of potassium preparations should be 2) Myopathy: Myopathy may occur as a result of hypo- kalemia. The patient should be carefully monitored, and if any abnormality such as weakness, convulsio- n/paralysis of limbs, etc. are observed, administrati- on should be discontinued and appropriate measure- s such as administration of potassium preparations Because elderly patients often have reduced physiological function, careful supervision and measures such as reduc- 5. Use during Pregnancy, Delivery or Lactation The safety of this product in pregnant women has not be- en established. Therefore, the product should be used in pregnant women, women who may possibly be pregnant only if the expected therapeutic benefits outweigh the p- ossible risks associated with treatment. 6. Pediatric Use The safety of this product in children has not been estab- lished. [Insufficient clinical data.] PACKAGING Bottles of 500g 2.5g×300 packets Manufactured and Distributed by: 6-1, Hiraide-Kogyo-Danchi, Utsunomiya-city, Tochigi 321-0905, Japan

Source: http://www.sanwashoyaku.co.jp/products/upload_docs/EPIPDougontou1.pdf