Cilnistella 5

Rx

Indications

• For the treatment of hypertension.

Dosage

• Usually, for adults, 5 to 10 mg is administered as cilnidipine for orally once a day.
• The dosage may be adjusted according to the patient’s age and symptoms.
• The dose can be increased up to 20 mg once a day, if a sufficient response does not appear.
• For adults with severe hypertension, cilnidipine should be administered 10 to 20 mg once a day.

Administration

• Administered orally, after breakfast.

• Patients with hypersensitivity to cilnidipine or to any of the excipients,
• Pregnant women or women having possibilities of being pregnant.

Clinically significant adverse reactions:

• Liver dysfunction and jaundice (frequency unknown).
• Thrombocytopenia (incidence: < 0.1%).

Other adverse reactions that may occur:

• Dizziness,
• Flushing,
• Headache,
• Hypotension,
• Tachycardia,
• Gastrointestinal dysfunction,
• Angina,
• Anemia,
• Rash,
• Liver and kidney dysfunction,
• Tremor.

• Careful administration in patients with serious hepatic dysfunction, patients with a history of serious adverse reactions to be calcium antagonists, elderly patients.
• If the discontinuation of cilnidipine is necessary, the dosage should be gradually decreased under close observation.
• If cilnidipine is withdrawn from a daily dose of 5 mg, appropriate measures, such as replacement with other antihypertensive agents, should be taken.
• Patients not to discontinue this drug without physician’s instructions.
• Use in the elderly: Cilnidipine should be administered carefully under close observation of the patient’s condition, taking such measures as starting with a lower dose (e.g. 5 mg). Use in the elderly is generally acknowledged that the excessive hypotensive action should be avoided in the elderly.
• Pediatric use: The safety of cilnidipine in pediatric patients has not been established.
• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take Cilnistella 5.
• Cilnidipine should not be administered to pregnant women or women having possibilities of being pregnant.
• It is advisable to avoid the administration of cilnidipine to nursing mothers.
• The symptoms, such as dizziness may occur because of the hypotensive action from this drug. Give warning against engaging in hazardous activities requiring alertness, such as working at a height, operating machinery or driving motor vehicles.