PLENDIL Prolonged-release tablet Ref.[6817] Active ingredients: Felodipine

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.

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).

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. The tablets can be administered without food or following a light meal not rich in fat or carbohydrate.

Symptoms

Overdosage may cause excessive peripheral vasodilatation with marked hypotension and sometimes bradycardia.

Management

If justified: activated charcoal, gastric lavage if performed within one hour after ingestion.

If severe hypotension occurs, symptomatic treatment should be instituted.

The patient should be placed supine with the legs elevated. In case of accompanying bradycardia, atropine 0.5-1 mg should be administered intravenously. If this is not sufficient, plasma volume should be increased by infusion of e.g., glucose, saline, or dextran. Sympathomimetic medicinal products with predominant effect on the α1-adrenoceptor may be given if the above-mentioned measures are insufficient.

Prolonged-release tablets 2.5 mg (blister): 2 years.

Prolonged-release tablets 2.5 mg (bottle): 3 years.

This medicinal product does not require any special storage conditions.

High-density polyethylene bottle with a standard cap of polypropylene.

PVC/PVDC/Aluminium blister.

Blister pack:

20 tablets (blister pack)
28 tablets (calendar blister pack)
30 tablets (blister pack)
50 tablets (unit-dose pack)
98 tablets (calendar blister pack)
100 tablets (blister pack)

Plastic bottle:

30 tablets (bottle)
100 tablets (bottle)
500 tablets (bottle for dose dispensing)

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.