TILDIEM 60MG PROLONGED RELEASE TABLETS
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
29-04-2024
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Ingredient activ:
DILTIAZEM HYDROCHLORIDE
Disponibil de la:
Sanofi-Aventis Ireland Limited
Dozare:
60 Milligram
Forma farmaceutică:
Tablet Prolonged Release
Data de autorizare:
2010-02-12
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tildiem 60 mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60 mg diltiazem hydrochloride.
Excipients: Each tablet contains 125.5mg lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged released tablet.
Off-white biconvex tablets, engraved ‘Tildiem 60’ on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Angina pectoris and hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS: The usual dose is one tablet (60mg) three times daily. However, patient responses may vary and dosage
requirements can differ significantly between individual patients. If necessary the dosage may be increased to
360mg/day. Higher doses up to 480mg/day have been used with benefit in some patients especially in unstable angina.
There is no evidence of any decrease in efficacy at these high doses.
ELDERLY AND PATIENTS WITH IMPAIRED HEPATIC OR RENAL FUNCTION: The recommended starting dose is one tablet (60mg)
twice daily. The heart rate should be measured regularly in these groups of patients and the dose should not be
increased if the heart rate falls below 40 beats per minute.
Tildiem 60mg Prolonged Release Tablets should be used with caution in patients with renal or hepatic impairment (see
section 4.4 Special Warnings and Special Precautions For Use)
CHILDREN: Safety and efficacy in children have not been established. Therefore diltiazem is not recommended for use
in children.
4.3 CONTRAINDICATIONS
Pregnancy, women of childbearing potential _(see section 4.6 Pregnancy and Lactation)_.Sick sinus syndrome except in
the presence of a functioning ventricular pacemaker
Second or third degree AV block except in the presence of a f
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