For Healthcare Professionals Only
About Fexuclue®
40mg Tablet | 10mg Tablet
Fexuclue® 40mg
Approved Indication:
Treatment of Erosive Esophagitis (EE)
Treatment of Erosive Esophagitis (EE)
Is administered to adults as follows:
Orally once a day. In the case of persistent symptoms, an additional 4 weeks of treatment can be administered.
Orally once a day. In the case of persistent symptoms, an additional 4 weeks of treatment can be administered.
Fexuclue® 10mg
Approved Indication:
Improvement of Gastric Mucosal Lesions in Acute or Chronic Gastritis
Improvement of Gastric Mucosal Lesions in Acute or Chronic Gastritis
Is administered to adults as follows:
Orally twice a day for 2 weeks.
Orally twice a day for 2 weeks.
PRECAUTIONS FOR USE
CONTRAINDICATIONS
1.
Patients who have a history of hypersensitivity to the Product or its components
2.
Patients taking a drug containing atazanavir, nelfinavir, or rilpivirine (refer to ‘5. Interactions’)
3.
Pregnant and lactating women (refer to ‘6. Administration to Pregnant and Lactating Women’)
4.
Patients who have congenital conditions for lactose such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, as this medicine contains lactose
THE FOLLOWING PATIENTS SHOULD BE ADMINISTERED WITH CARE:
1.
Patients with hepatic impairment (no experience of use)
2.
Patients with renal impairment (no experience of use)
3.
Elderly (refer to ‘8. Geriatric Use’)
4.
Patients who have a history of hypersensitivity or allergy to Yellow 4 Tartrazine
CLINICAL STUDY
A total of two clinical trials were conducted in patients with erosive esophagitis (EE). Of the subjects who participated in the clinical trials, 183 received 40 mg of the Product. Adverse events reported in clinical trials are as follow. Adverse events (1% or more) and adverse drug reactions (*) commonly reported in the Product administration group are shown in the following Table 1.
Table 1. Adverse events reported by 1% or more in clinical trials
System Organ Class (SOC) | Adverse Event |
Gastrointestinal disorders | Dyspepsia , diarrhea, nausea*, abdominal discomfort*, chronic gastritis, gastritis, erosive gastritis |
Skin and subcutaneous tissue disorders | Erythema*, pruritus* |
Nervous system disorders | Headache* |
Musculoskeletal and connective tissue disorders | Back pain |
Other adverse events reported in clinical trials with an incidence of less than 1% after administration of the Product are listed according to the major system organ class as follows.
•
Gastrointestinal disorders: Hiatal hernia, Brunner’s gland hyperplasia
•
Infections and infestations: Bronchitis, herpes simplex, influenza, periodontitis, pharyngitis, vaginal infection
•
Skin and subcutaneous tissue disorders: Dermatitis contact, swelling face*
•
General disorders and administration site conditions: Chest discomfort, feeling abnormal*, edema, pain, pyrexia
•
Nervous system disorders: Dizziness, dysgeusia*
•
Musculoskeletal and connective tissue disorders: Myalgia*, musculoskeletal pain, neck pain
•
Eye disorders: Cataract, conjunctival haemorrhage*, retinal tear
•
Ear and labyrinth disorders: Ear discomfort*
•
Respiratory, thoracic and mediastinal disorders: Rhinorrhoea
•
Metabolic and nutritional disorders: Hypertriglyceridemia