Cardioplen XL 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Felodipine

Available from:

Chiesi Ltd

ATC code:

C08CA02

INN (International Name):

Felodipine

Dosage:

10mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060200; GTIN: 5028613002698

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CARDIOPLEN
®
XL 2.5 MG, 5 MG & 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 or pharmacist.
- 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 or pharmacist. This
includes any
possible side effects not listed in this leafet. See section 4.
WHAT IS IN THIS LEAFLET:
1. WHAT CARDIOPLEN IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARDIOPLEN
3. HOW TO TAKE CARDIOPLEN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CARDIOPLEN
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT CARDIOPLEN IS AND WHAT IT IS USED FOR
Cardioplen XL Prolonged Release Tablets contain felodipine which
belongs to a group of
medicines called calcium-channel blockers that act on the
cardiovascular system (the
heart and blood vessels). Cardioplen has been prescribed by your
doctor to treat your
high blood pressure or to reduce the frequency of your anginal
attacks. They are called
prolonged release tablets because they are manufactured in a way that
allows the
felodipine to be released and slowly absorbed by your body over a
period of several
hours.
In high blood pressure, felodipine works by widening the blood
vessels. This creates less
resistance to the blood flow, and results in lower blood pressure,
which in turn reduces
the strain on your heart.
In angina, felodipine works by opening up the arteries supplying the
heart muscle and
this allows more blood and oxygen to reach the muscle, decreasing the
chances of angina
(chest pains) occurring when extra strain is placed upon the heart.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARDIOPLEN
DO NOT TAKE CARDIOPLEN:
•
if you are allergic to felodipine, other calcium-

Summary of Product characteristics

OBJECT 1
CARDIOPLEN XL 10MG PROLONGED RELEASE TABLETS
Summary of Product Characteristics Updated 16-May-2017 | Chiesi
Limited
1. Name of the medicinal product
Cardioplen XL 10 mg Prolonged Release Tablets
2. Qualitative and quantitative composition
Cardioplen XL 10mg Prolonged Release Tablets contain 10mg of
felodipine.
Cardioplen XL 10mg Prolonged Release Tablets contain 21.45mg of
lactose monohydrate/prolonged
release tablet.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Reddish brown, round, biconvex, film coated prolonged-release tablets
with imprint 10.
4. Clinical particulars
4.1 Therapeutic indications
In the management of hypertension and prophylaxis of chronic stable
angina pectoris.
4.2 Posology and method of administration
For oral administration
Hypertension:
_Adults (including older people): _The dose should be adjusted to the
individual requirements of the patient.
The recommended starting dose is 5mg once daily. If necessary the dose
may be further increased or
another antihypertensive agent added. The usual maintenance dose is
5-10mg once daily. Doses higher
than 20mg daily are not usually needed. For dose titration purposes a
2.5mg tablet is available. In older
patients an initial treatment with 2.5mg daily should be considered.
Angina pectoris:
_Adults: _The dose should be adjusted individually. Treatment should
be started with 5 mg once daily and if
needed be increased to 10mg once daily.
Elderly population: Initial treatment with lowest available dose
should be considered.
_Administration: _The tablets should regularly be taken in the morning
without food or with a light meal.
Cardioplen XL 10mg Prolonged Release Tablets must not be chewed or
crushed. They should be
swallowed whole with half a glass of water.
_Paediatric Population: _The safety and efficacy of Cardioplen XL 10
mg Prolonged Release Tablets in
children has not been established.
Cardioplen XL 10mg Prolonged Release Tablets can be used in
combination with β-blockers, ACE
inhibitors or diuretics. The eff