Coracten SR 10mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nifedipine

Available from:

Teofarma S.r.l.

ATC code:

C08CA05

INN (International Name):

Nifedipine

Dosage:

10mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060200; GTIN: 5015313009720

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CORACTEN SR CAPSULES 10 MG AND CORACTEN SR CAPSULES 20 MG
NIFEDIPINE
READ ALL 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 leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Coracten SR is and what it is used for
2. What you need to know before you take Coracten SR
3. How to take Coracten SR
4. Possible side effects
5. How to store Coracten SR
6. Contents of the pack and other information
1.
WHAT CORACTEN SR IS AND WHAT IT IS USED FOR
Coracten SR contains nifedipine, which belongs to a group of medicines
called calcium-channel
blockers.
Used to treat:
•
high blood pressure in adults
To prevent:
•
chronic stable angina pectoris (heart/chest pain) in adults.
For high blood pressure: Coracten SR works by relaxing and expanding
the blood vessels. This makes
the blood flow more easily and lowers blood pressure. Lower blood
pressure reduces the strain on
your heart.
For angina: Coracten SR works by relaxing and expanding the arteries
supplying the heart. This allows
more blood and oxygen to reach the heart and decreases the strain on
it. Your angina attacks will be
less severe and less frequent if there is less strain on the heart.
PLEASE NOTE:
These capsules are sustained-release capsules which release the active
ingredient
slowly over 12 hours. Do not use to treat attacks of angina or heart
attacks when they happen. See
your doctor if you are unsure why you have been prescribed these
capsules.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CORACTEN SR
DO NOT TAKE CORACTEN SR:
•
if you are allergic to nifedipine or a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Coracten SR capsules 10 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg nifedipine.
Excipients with known effect: sucrose and lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Modified-release capsule, hard
Opaque brownish-pink cap and opaque grey body, printed in white with
‘Coracten’ on the
body and ‘10 mg’ on the cap, containing yellow spherical granules.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Coracten SR capsules are indicated in adults for the prophylaxis of
chronic stable angina
pectoris and the treatment of hypertension.
They are also indicated for the treatment of Prinzmetal (variant)
angina when diagnosed by a
cardiologist.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose of Coracten SR capsules is 10mg every 12
hours swallowed
with water with subsequent titration of dosage according to response.
The dose may be
adjusted to 40mg every 12 hours.
Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may
result in the
recommendation to adapt the nifedipine dose or not to use nifedipine
at all (see section 4.5).
_Duration of treatment_
Treatment may be continued indefinitely.
_Elderly (_
≥
_ 65 years)_
The pharmacokinetics of nifedipine are altered in the elderly so that
lower maintenance doses
of nifedipine may be required.
_Hepatic impairment _
Caution should be exercised in treating patients with hepatic
impairment. In these patients the
use of one 10mg Coracten SR capsule every 12 hours, together with
careful monitoring, is
suggested when commencing therapy.
_Renal impairment _
Dosage adjustments are not usually required in patients with renal
impairment (see section
5.2).
_Paediatric population _
The safety and efficacy of Coracten SR capsules in children below 18
years of age has not
been established. Currently available data for the use of nifedipine
in hypertension are
described in section 5.1.
Method of a