País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
DILTIAZEM HYDROCHLORIDE
Sanofi-Aventis Ireland Limited
120 Milligram
Tablets
2010-02-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tildiem Retard 120 mg Prolonged Release Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 120 mg diltiazem hydrochloride as the active ingredient. For excipients see 6.1 3 PHARMACEUTICAL FORM Prolonged release tablet. Off-white biconvex tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mild to moderate hypertension and angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tildiem Retard tablets should be swallowed with a little water and not chewed. Patients should be advised that the tablet membrane may pass through the gastrointestinal tract unchanged. Adults: Angina and hypertension: The usual starting dose is one tablet (90mg or 120mg) twice daily. Patient responses may vary and dosage requirements can differ significantly between individual patients. Higher divided doses up to 480mg/day have been used with benefit in some angina patients especially in unstable angina. Doses of 360mg/day may be required to provide adequate BP control in hypertensive patients. Elderly and patients with impaired hepatic or renal function: Heart rate should be monitored in these patients and if it falls below 40 beats per minute the dose should not be increased.Tildiem Retard 120mg Prolonged Release tablets should be used with caution in patients with renal or hepatic impairment (see section 4.4 Special Warnings and Precautions for Use) Angina: The recommended starting dose is one Tildiem 60mg tablet twice daily. This dose may be increased to one 90mg or 120mg Tildiem Retard tablet twice daily. Hypertension: The starting dose should be one 120mg Tildiem Retard tablet daily. Dose adjustment to one 90mg or one 120mg Tildiem Retard tablet twice daily may be required. Children: Safety and efficac Leia o documento completo