Adalat Retard 20 mg Prolonged-Release Tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Nifedipine

Prieinama:

Imbat Limited

ATC kodas:

C08CA; C08CA05

INN (Tarptautinis Pavadinimas):

Nifedipine

Dozė:

20 milligram(s)

Vaisto forma:

Prolonged-release tablet

Recepto tipas:

Product subject to prescription which may be renewed (B)

Gydymo sritis:

Dihydropyridine derivatives; nifedipine

Autorizacija statusas:

Authorised

Leidimo data:

2008-03-07

Pakuotės lapelis

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADALAT
® RETARD 20MG
PROLONGED-RELEASE TABLETS
(nifedipine)
Your medicine is available using the name Adalat Retard
20mg Prolonged-Release Tablets but will be referred to as
Adalat Retard throughout this 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 gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET
1.
What Adalat Retard is
2.
Before you take Adalat Retard
3.
How you take Adalat Retard
4.
Possible side effects
5.
How to store Adalat Retard
6.
Contents of the pack and other information
1.
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 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 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.
2.
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 ingr

Prekės savybės

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 20mg nifedipine.
Excipient: Lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated, prolonged-release tablet.
_Product imported from Spain:_
Grey-pink circular tablets marked with ‘A20’ on one side and a
‘Bayer cross’ on the reverse.
_Product imported from Germany:_
Grey-pink, circular tablets marked with '1U'
on one side and a '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
Polysorbate 80
Hypromellose
Lactose monohydrate
Maize starch
Macrogol 4000
Magnesium stearate
Titanium dioxide (E171)
Red iron oxide (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Germany
Do not store above 25°C.
Store in the original package.
Spain
Store in the original package in order to protect from light.