Racetril Cap.

Rx

Indications

• Symptomatic treatment of acute diarrhoea in adults.
• If causal treatment is possible, racecadotril can be administered as a complementary treatment.

Dosage

• One capsule initially regardless of the time of day. Then, one capsule three times daily preferably before the main meals.
• Treatment should be continued until two normal stools are recorded.
• Treatment should not exceed 7 days.
• Long-term treatment with racecadotril is not recommended.
• Other pharmaceutical forms of racecadotril are suitable for use in infants and children.
• Dosage adjustment is not necessary in the elderly.

Usage

• Racetril Cap. is administered via the oral route.

• Hypersensitivity to racecadotril or to any of the excipients in the formulation.
• Patients who experienced angioedema while under treatment with ACE inhibitors (e.g. captopril, enalapril, lisinopril, perindopril, ramipril).

• Inform your physician or pharmacist immediately of any adverse reactions when using Racetril Cap., most common is headache.

• The administration of racecadotril does not modify the usual rehydration regimens.
• The presence of bloody or purulent stools and fever may indicate the presence of invasive bacteria as a reason for diarrhoea, or the presence of other severe disease.
• Also, racecadotril has not been tested in antibiotic-associated diarrhoea, therefore, racecadotril should not be administered under these conditions.
• Chronic diarrhoea has not been sufficiently studied with this medicinal product.
• There are limited data in patients with renal or hepatic impairment. These patients should be treated with caution.
• There is a possible reduced availability in patients with prolonged vomiting.
• Racetril Cap. contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Occurrence of skin reactions has been reported with the use of the product. These are in most cases mild and do not require treatment but in some cases they can be severe, even life-threatening. Association with racecadotril cannot be fully excluded. When experiencing severe skin reactions, the treatment has to be stopped immediately.
• Hypersensitivity/angioneurotic oedema have been reported in patients with racecadotril. This may occur at any time during therapy. Angioedema of the face, extremities, lips, mucous membranes may occur. Where there is angioedema associated with upper airway obstruction, such as tongue, glottis and/or larynx, emergency therapy should be administered promptly. Racecadotril should be discontinued and the patient should be under close medical supervision with appropriate monitoring initiated and continued until complete and sustained resolution of symptoms has occurred. Patients with a history of angioedema unrelated to racecadotril therapy may be at increased risk of angioedema. Concomitant use of racecadotril and ACE inhibitors may increase the risk of angioedema. Hence, a careful benefit-risk assessment is needed before initiating treatment with racecadotril in patients on ACE inhibitors.
• Racecadotril should not be administered to pregnant and breastfeeding women.
• Racecadotril has no or negligible influence on the ability to drive and use machines.