Acofide Special Precautions

Important precautions: This product is an acetylcholinesterase inhibitor which enhances the effects of acetylcholine; therefore, attention shall be paid to this fact.
If symptoms improved continuously, discontinuation of treatment with this product shall be considered to avoid using the product aimlessly over a long period of time (Continuous usage of the medicine should not exceed six months).
[See Pharmacology: Pharmacodynamics: Clinical Studies: Phase III study and Long-term administration study under Actions.]
Precaution concerning indication: Efficacy has not been demonstrated against pain and burning sensation in the epigastric region associated with functional dyspepsia.
Structural diseases, including malignant diseases such as gastric cancer, shall be excluded by the upper gastrointestinal tract endoscopy or other examination.
Precaution concerning dosage and administration: If symptoms have not improved after 1 month of treatment, discontinuation of the treatment shall be considered.
If symptoms persist, upper gastrointestinal tract endoscopy shall be considered, along with other tests as needed, taking into account possible structural disease.
Precautions concerning the dispensing of the drug: For drugs that are dispensed in a press-through package (blister), patients shall be instructed to remove the drug from the blister prior to use. If a blister sheet is swallowed accidentally, the sharp edge of the sheet may be stuck in the esophageal mucosa and cause perforation, resulting in serious complications, such as mediastinitis.
Other precautions: In a 24-month carcinogenicity study in rats, endometrial adenocarcinoma was observed in 5/50, 8/50, and 5/50 subjects in the 200, 600 and 2,000 mg/kg/day groups, respectively, demonstrating a significant increase in the 600 mg/kg/day group (approx. 100 times the clinical dose in dose equivalent). Conversely, no genotoxicity or estrogenic effect was observed in the use of this product.
In addition, no effects of this products were observed at doses of up to 2,000 mg/kg/day (approx. 330 times the clinical dose in dose equivalent) in a 24-month carcinogenicity study in mice and at 2,000 mg/kg/day in a two-phase uterine carcinogenesis study in genetically modified animals.
Effects on ability to drive and use machine: Acofide has no influence on the ability to drive and use machines.
Use in Children: No clinical studies have been conducted in pediatric patients.
Use in the Elderly: In the event of any abnormality, appropriate actions shall be taken (e.g., treatment interruption). Physiological functions (e.g., renal function and hepatic function) have generally been decreased in elderly patients.