Adipine XL 30mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nifedipine

Available from:

Chiesi Ltd

ATC code:

C08CA05

INN (International Name):

Nifedipine

Dosage:

30mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 02060200; GTIN: 5028613001905

Patient Information leaflet

0108006100/01
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADIPINE
®
XL 30 MG & 60 MG
PROLONGED RELEASE TABLETS
Nifedipine
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 leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. WHAT ADIPINE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADIPINE
3. HOW TO TAKE ADIPINE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ADIPINE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT ADIPINE IS AND WHAT IT IS USED FOR
Adipine XL Prolonged Release Tablets contain nifedipine which belongs
to a group of
medicines called calcium- channel blockers that act on the
cardiovascular system (the
heart and blood vessels). Adipine XL is used to treat high blood
pressure or angina
(chest pain). They are called prolonged release tablets because they
are manufactured
in a way that allows the nifedipine to be released and slowly absorbed
by your body
over a period of several hours.
For high blood pressure: Adipine XL 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: Adipine XL 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADIPINE
DO NOT TAKE ADIPINE:
• if you are allergic to nifedipine, other calcium-channel blockers
(e.g verapamil, diltiazem
or fel

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Adipine XL 30 mg Tablets
Adipine XL 60 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Adipine XL 30mg Tablets
Each tablet contains 30mg of nifedipine
Adipine XL 60mg Tablets
Each tablet contains 60mg of nifedipine
3
PHARMACEUTICAL FORM
Adipine XL 30mg Tablets
Prolonged release tablet
Each pale red tablet is round and biconvex and embossed with "30" on
one side.
Adipine XL 60mg Tablets
Prolonged release tablet
Each pale red tablet is round and biconvex and embossed with "60" on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The tablets are indicated for :
- the treatment of all grades of hypertension
- the prophylaxis of chronic stable angina pectoris, either as
monotherapy or in
combination with a beta-blocker
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
In mild to moderate hypertension, the recommended initial dose is one
20 mg tablet
once-daily. In severe hypertension, the recommended initial dose is
one 30 mg tablet
once-daily.
If
necessary,
the
dosage
can
be
increased
according
to
individual
requirements up to a maximum of 90 mg once-daily.
For the prophylaxis of angina pectoris, the recommended initial dose
is one 30 mg
tablet once-daily. The dosage can be increased according to individual
requirements
up to a maximum of 90 mg once-daily.
Prophylactic antianginal efficacy is maintained when patients are
switched from other
calcium antagonists such as diltiazem or verapamil to Adipine XL.
Patients switched
from other calcium antagonists should initiate therapy at the
recommended initial dose
of 30 mg Adipine XL once-daily. Subsequent titration to a higher dose
may be
initiated as warranted clinically.
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.
_ _
_Additional information on special populations _
_Paediatric population _
Th