- Approval Id
- 5e32a47a6995443b
- Drug Name
- PLENDIL TABLET 5 MG
- Product Name
- PLENDIL TABLET 5 MG
- Approval Number
- SIN08781P
- Approval Date
- 1996-07-03
- Registrant
- ZUELLIG PHARMA PTE. LTD.
- Licence Holder
- ZUELLIG PHARMA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, EXTENDED RELEASE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><strong>Adults</strong></p>
<p><u><em><strong>Hypertension</strong></em></u></p>
<p>The dose should be adjusted individually.</p>
<p>Treatment should be started with 5 mg once daily. In elderly patients a starting dose of 2.5 mg once daily should be considered.</p>
<p>If necessary, the dose can be increased in 2.5 or 5 mg/day increments. The usual maintenance dose is 5 mg to 10 mg daily. Doses higher than 20 mg daily of Plendil are not recommended.</p>
<p><em><u><strong>Stable angina pectoris</strong></u></em></p>
<p>Treatment should be started with 5 mg once daily and if needed be increased to 10 mg once daily.</p>
<p><strong>Administration</strong></p>
<p>PLENDIL tablets should be swallowed whole and taken with water and must not be divided, crushed or chewed.</p>
<p><strong>Paediatric patients</strong></p>
<p>Felodipine should, due to limited clinical trial experience, not be used in paediatric patients.</p>
<p><strong>Elderly patients</strong></p>
<p>The dose should be adjusted individually, taking patient age into consideration (see PRECAUTIONS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). An initial dose of 2.5 mg once daily should be considered.</p>
<p><strong>Patients with hepatic impairment</strong></p>
<p>The dose of felodipine should be reduced in patients with severely impaired liver function.</p>
<p><strong>Patients with renal impairment</strong></p>
<p>Impaired renal function does not influence felodipine peak plasma concentrations or AUC, and a dosage reduction is not necessary for patients with renal impairment.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Hypertension. Stable angina pectoris.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul>
<li>Pregnancy, including the early stages. Women who are likely to become pregnant should not be treated with felodipine.</li>
<li>Known hypersensitivity to felodipine or any other component of the product (see “Description” section – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Uncompensated heart failure.</li>
<li>Acute myocardial infarction.</li>
<li>Unstable angina pectoris.</li>
<li>Haemodynamically significant cardiac valvular obstruction.</li>
<li>Dynamic cardiac outflow obstruction.</li>
</ul>
- Atc Code
- C08CA02
- Atc Item Name
- felodipine
- Pharma Manufacturer Name
- ASTRAZENECA SINGAPORE PTE LTD
