Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Felodipine
Sandoz Ltd
C08CA02
Felodipine
10mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060200
PARMID XL 10 MG PROLONGED RELEASE TABLETS Summary of Product Characteristics Updated 28-May-2015 | Sandoz Limited 1. Name of the medicinal product Parmid XL 10 mg Prolonged Release Tablets 2. Qualitative and quantitative composition Each prolonged release tablet contains 10mg of felodipine. Excipient(s) with known effect: lactose monohydrate (92.50 mg/tablet) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Prolonged release tablets Round, pale red to grey-red, biconvex film-coated tablet with embossment F10 4. Clinical particulars 4.1 Therapeutic indications Hypertension Stable angina pectoris 4.2 Posology and method of administration Posology _Hypertension_ The dose should be adjusted individually. Treatment can be started with 5 mg once daily. Depending on the patient's response, the dosage can, where applicable, be decreased to 2.5 mg or increased to 10 mg daily. If necessary another antihypertensive agent may be added. The standard maintenance dose is 5 mg once daily. For a dose of 2.5 mg a medicinal product with an appropriate strength should be used. _Angina pectoris_ The dose should be adjusted individually. Treatment should be initiated with 5 mg once daily and, if needed, increased to 10 mg once daily. _Elderly population_ Initial treatment with lowest available dose should be considered. _Renal impairment_ Dose adjustment is not needed in patients with impaired renal function. _Hepatic impairment_ Patients with impaired hepatic function may have elevated plasma concentrations of felodipine and may respond to lower doses (see section 4.4) For a dose of 2.5 mg a medicinal product with an appropriate strength has to be used. _Paediatric population_ There is limited clinical trial experience of the use of felodipine in hypertensive paediatric patients (see sections 5.1 and 5.2). Method of administration The tablets should be taken in the morning and be swallowed with water. In order to keep the prolonged- release properties, the tablets must not be divided, crushed or chewed. Th Baca dokumen lengkap