Adalat Retard 20 mg Prolonged-Release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Nifedipine

Available from:

PCO Manufacturing Ltd.

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:

1987-08-12

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 onto 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.
FURTHER 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 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.
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
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 (_s

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 20mg nifedipine.
Excipient: Lactose monohydrate
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
o
Film-coated, prolonged-release tablets
_Product imported from the UK:_
o
Pink-grey circular tablets impressed with ‘I U’ on one face and
the Bayer cross on the reverse.
_Product imported from Spain:_
o
Pink-grey circular tablets with ‘A 20’ embossed on one face and
the Bayer cross on the reverse.
4 CLINICAL PARTICULARS
As per PA 1410/025/004
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/025/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose (E460)
Polysorbate 80
Hypromellose
Lactose
Maize starch
Macrogol
Magnesium stearate
Titanium dioxide (E171)
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
Do not store above 25
o
C.
Store in the original container.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 56 or 60 tablets co