Cardene 30mg capsules

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Nicardipine hydrochloride

Verfügbar ab:

Laboratoire X.O

ATC-Code:

C08CA04

INN (Internationale Bezeichnung):

Nicardipine hydrochloride

Dosierung:

30mg

Darreichungsform:

Oral capsule

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 02060200; GTIN: 5013346070021

Gebrauchsinformation

WHAT IS IN THIS LEAFLET:
1. What Cardene is and what it is used for
2.
What you need to know before you take Cardene
3. How to take Cardene
4.
Possible side effects
5.
How to store Cardene
6. Contents of the pack and other information
The name of your medicine is Cardene 20mg/30mg
capsules. However, it will be referred to as Cardene
capsules throughout the remainder of the leaflet.
1. WHAT CARDENE IS AND WHAT IT IS USED FOR
WHAT ARE CARDENE CAPSULES
Cardene
capsules
contain
the
active
ingredient
nicardipine hydrochloride which belongs to the class
of drugs called calcium channel blockers. These cause
relaxation of the smooth muscle of the blood vessels
causing these vessels to widen or dilate.
WHAT CARDENE CAPSULES ARE USED FOR
Your
medicine
is
used
for
the
treatment
of
mild
to
moderate high blood pressure (hypertension) and to
help prevent attacks of chest pain diagnosed by your
doctor as chronic stable angina. Chronic stable angina
is a pattern of attacks of chest pain that are predictable
and reproducible under certain conditions such as after
exercise, stress or in cold weather. They are short in
duration and can be relieved by rest or certain drugs.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARDENE
DO NOT TAKE CARDENE
•
if
you
are
ALLERGIC
to
NICARDIPINE,
OTHER
DIHYDROPYRIDINES, or ANY OF THE OTHER INGREDIENTS
OF THIS MEDICINE (listed in section 6)
•
if you have had a RECENT HEART ATTACK (ie. within the
last month)
•
if you suffer from a condition called SEVERE AORTIC
STENOSIS which is narrowing of your aortic heart valve
•
if your CHEST PAIN IS DIAGNOSED BY YOUR DOCTOR
AS UNSTABLE ANGINA (for example, if the pattern of
attacks of chest pain changes and occurs without
exertion, you should contact your doctor immediately)
•
if you need IMMEDIATE RELIEF OF CHEST PAIN IN A
SUDDEN
OR
ACUTE
ANGINA
ATTACK
(this
situation
should be treated with a different class of medicine)
•
TO TRY TO PREVENT THE OCCURRENCE OF FUTURE HEART
ATTACKS (if you have already had at least one heart
attack)
•
if
you
are
PREGN

Fachinformation

OBJECT 1
CARDENE 20MG
Summary of Product Characteristics Updated 27-Apr-2017 | Astellas
Pharma Ltd
1. Name of the medicinal product
Cardene 20 mg
Cardene 30 mg
2. Qualitative and quantitative composition
Each Cardene 20 mg hard capsule contains nicardipine hydrochloride 20
mg
Each Cardene 30 mg hard capsule contains nicardipine hydrochloride 30
mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Cardene 20 mg: Hard capsule with an opaque blue cap and opaque white
body, marked in red ink with the
strength and company logo.
Cardene 30 mg: Hard capsule with an opaque blue cap and opaque pale
blue body, marked in red ink with
the strength and company logo.
4. Clinical particulars
4.1 Therapeutic indications
Cardene is indicated in adults for the prophylaxis of patients with
chronic stable angina. For the treatment
of hypertension considered to be mild to moderate in severity.
4.2 Posology and method of administration
Posology
_Prophylaxis of chronic stable angina:_
Starting dose: 20 mg every 8 hours titrating upwards as required.
Usual effective dose: 30 mg every 8 hours (range of total dose 60 mg -
120 mg per day).
Allow at least 3 days before increasing the dose of Cardene to ensure
steady state plasma levels have been
achieved.
_Hypertension:_
Starting dose: 20 mg every 8 hours titrating upwards as required.
Usual effective dose: 30 mg every 8 hours (range of total dose 60 mg -
120 mg per day).
_Use in elderly_
Starting dose is 20 mg 3 times a day. Titrate upwards with care as
nicardipine may lower systolic pressure
more than diastolic pressure in these patients.
_Paediatric population_
The safety and efficacy in low birth weight infants, newborns, nursing
infants, infants, and children has
not been established. Cardene is not recommended in patients under the
age of 18.
Method of administration
Cardene capsules are for oral administration.
The capsules should be taken with a little water and swallowed whole.
4.3 Contraindications
Pregnancy and lactation.
Hypersensitivity to the active subs