Adalat Retard 20 mg Prolonged-Release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nifedipine

Available from:

LTT Pharma Limited

ATC code:

C08CA; C08CA05

INN (International Name):

Nifedipine

Dosage:

20 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Dihydropyridine derivatives; nifedipine

Authorization status:

Authorised

Authorization date:

2010-11-12

Patient Information leaflet

PACKAGE LEAFLET - INFORMATION FOR THE USER
ADALAT RETARD 20MG PROLONGED-RELEASE TABLETS
(nifedipine)
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 gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
What Adalat Retard is
Before you take Adalat Retard
How you take Adalat Retard
Possible side effects
How to store Adalat Retard
Further information
WHAT ADALAT RETARD IS
Adalat Retard contains nifedipine, which belongs to a group of
medicines
called _calcium antagonists_.
ADALAT RETARD IS USED TO TREAT HIGH BLOOD PRESSURE OR ANGINA
_(chest pain)._
For high blood pressure: Adalat Retard work 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 Retard 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 RETARD
DO NOT TAKE ADALAT RETARD:
*
IF YOU HAVE HAD A HEART ATTACK within the last month.
*
IF YOU GET A SUDDEN ANGINA ATTACK. Adalat Retard 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 Retard are listed in section 6.
*
IF YOU ARE TAKING RIFAMPICIN, an antibiotic.
*
IF YOU HAVE BEEN TOLD THAT YOU HAVE A NARROWING OF THE AORTIC HEART
VALVE (stenosis).
*
IF YOU HAVE EVER HAD A COLLAPSE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adalat Retard 20 mg Prolonged-Release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated, prolonged-release tablet contains 20 mg nifedipine.
Excipients: Lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated, prolonged-release tablets
_Product imported from Spain:_
Grey-pink, circular, film-coated, prolonged-release tablets marked
‘A20’ on one side with the Bayer Cross on the
reverse.
4 CLINICAL PARTICULARS
As per PA1410/025/004
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/025/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Maize starch
Lactose
Polysorbate 80
Magnesium stearate
Hypromellose
Macrogol 4000
Titanium dioxide (E 171)
Red iron oxide (E 172)
6.2 INCOMPATIBILITIES
Not applicable.
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.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original container in order to protect from light.
Keep container in the outer carton.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister strips of tablets in a cardboard outer container, in packs of
60 tablets.
Pack size: 60 Tablets
6.6 SPECIAL PR