Adalat LA 60 mg Prolonged-Release Tablet

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Nifedipine

Boleh didapati daripada:

LTT Pharma Limited

Kod ATC:

C08CA; C08CA05

INN (Nama Antarabangsa):

Nifedipine

Dos:

60 milligram(s)

Borang farmaseutikal:

Prolonged-release tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Dihydropyridine derivatives; nifedipine

Status kebenaran:

Authorised

Tarikh kebenaran:

2010-11-26

Risalah maklumat

(nifedipine)
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
*
Keep this leaflet. You may need to read it again.
*
If you have more questions, ask your doctor or pharmacist.
*
This medicine has been prescribed for you. Do not pass it on to
others. It
may harm them, even if their symptoms are the same as yours.
*
If any of the side effects get serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
What Adalat LA is
Before you take Adalat LA
How to take Adalat LA
Possible side effects
How to store Adalat LA
Further information
WHAT ADALAT LA IS
Adalat LA contains nifedipine, which belongs to a group of medicines
called _calcium antagonists_.
ADALAT LA IS USED TO TREAT HIGH BLOOD PRESSURE OR ANGINA (_chest
pain_).
For high blood pressure: Adalat LA 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: Adalat LA 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.
BEFORE YOU TAKE ADALAT LA
DO NOT TAKE ADALAT LA:
*
IF YOU HAVE HAD A HEART ATTACK within the last month.
*
IF YOU GET A SUDDEN ANGINA ATTACK. Adalat LA will not help relieve
symptoms of angina quickly.
*
IF YOU HAVE UNSTABLE ANGINA
*
IF YOU ARE ALLERGIC to the active ingredient (nifedipine), to any
other similar
medicines (known as _dihydropyridines_) or to any of the other
ingredients.
The ingredients of Adalat LA are listed in section 6.
*
IF YOU ARE TAKING RIFAMPICIN, an antibiotic.
*
IF YOU HAVE A LIVER DISEASE THAT prevents your liver from working
properly.
*
IF YOU HAVE INFLAMMATION OF THE BOWEL OR INTESTINES, such as Crohn’s
disease.
*
IF YOU HAVE AN OBSTRUCTION OR NARROWING IN YOUR INTESTINES, or have
had th

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adalat LA 60 mg Prolonged-Release Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 60 mg nifedipine.
Excipient(s) with known effect:
Each tablet contains Sodium.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release film-coated tablet.
_Product imported from the UK and Spain:_
Pink, circular convex tablets with "Adalat 60" marked on one side and
a laser hole on the other side.
4 CLINICAL PARTICULARS
As per PA1410/025/007
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/025/007
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Propylene glycol
Cellulose acetate
Hypromellose
Hydroxypropylcellulose
Polyethylene oxide
Macrogol
Magnesium stearate
Titanium dioxide (E171)
Iron oxide (E172)
Sodium chloride (salt)
_Product imported from the UK also contains:_
Shellac
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Store in the original container in order to protect from light and
moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips of 2 x 14 tablets. Blister pa