Plendil 5mg Prolonged-release Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FELODIPINE

Available from:

AstraZeneca AB SE-151 85, Södertälje, Sweden

ATC code:

C08CA02

INN (International Name):

FELODIPINE 5 mg

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

FELODIPINE 5 mg

Prescription type:

POM

Therapeutic area:

CALCIUM CHANNEL BLOCKERS

Authorization status:

Withdrawn

Authorization date:

2006-03-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PLENDIL
2.5 MG PROLONGED
-
RELEASE TABLETS
PLENDIL
5 MG PROLONGED
-
RELEASE TABLETS
PLENDIL
10 MG PROLONGED
-
RELEASE TABLETS
felodipine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor. This includes any
possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Plendil is and what it is used for
2.
What you need to know before you take Plendil
3.
How to take Plendil
4.
Possible side effects
5.
How to store Plendil
6.
Contents of the pack and other information
1.
WHAT PLENDIL IS AND WHAT IT IS USED FOR
Plendil contains the active substance felodipine. This belongs to a
group of medicines called
calcium antagonists. It lowers blood pressure by dilating small blood
vessels. It does not
negatively affect the heart function.
Plendil is used in the treatment of high blood pressure (hypertension)
and heart and chest pain
brought on by for example exercise and stress (angina pectoris).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PLENDIL
DO NOT TAKE PLENDIL
•
if you are pregnant. You should tell your doctor as soon as possible
if you become
pregnant while using this medicine.
•
if you are allergic to felodipine or any of the other ingredients of
this medicine (listed in
section 6).
•
if you suffer from uncompensated heart failure.
•
if you have acute myocardial infarction (heart attack).
•
if you have chest pain of recent onset, or angina pectoris that is
lasting for more than 15
minutes or longer or is more severe than usual.
•
if you have disease of a heart valve or heart muscle, until you have
talked to your doctor.
WARNINGS AND PRECAUTIONS
Pl

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Plendil 5 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg felodipine.
Excipients with known effect:
Each tablet contains 28 mg lactose and 5 mg macrogolglycerol
hydroxystearate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
The tablet is pink, circular, biconvex, engraved A/Fm on one side and
5 on the other side, with a
diameter of 9 mm.
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.
_ _
_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).
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.
4.3
CONTRAINDICATIONS
•
Pregnancy
•
Hypersensitivity to felodipine or any of the excipients listed in
section 6.1
•
Dec