Adalat LA 20 mg Prolonged-Release Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
05-11-2020
Summary of Product characteristics
(SPC)
05-11-2020
Active ingredient:
Nifedipine
Available from:
Bayer 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:
Marketed
Authorization date:
1999-03-04
Patient Information leaflet
20083
PACKAGE LEAFLET - INFORMATION
FOR THE USER
ADALAT® LA 20 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 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 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 ADALAT LA IS AND WHAT
IT IS USED FOR
2 WHAT YOU NEED TO KNOW
BEFORE YOU TAKE ADALAT LA
3 HOW TO TAKE ADALAT LA
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE ADALAT LA
6 CONTENTS OF THE PACK AND
OTHER INFORMATION
1 WHAT ADALAT LA IS AND WHAT
IT IS USED FOR
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.
2 WHAT YOU NEED TO KNOW
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
nifedipine, to any other similar
medicines (known as
_dihydropyridines) _
or any of the
other ingredients of this medicine
(listed in section 6).
•
IF YOU ARE TAKING RIFAMPICIN,
an antibiotic.
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
04 November 2020
CRN009Z6W
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adalat LA 20 mg Prolonged-Release Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 20 mg nifedipine.
Excipients with known effect
Each tablet contains 8.3 mg sodium. Please see section 4.4 for further
information.
3 PHARMACEUTICAL FORM
Prolonged-release film-coated tablet.
Pink, circular convex tablets with Adalat 20 marked on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of mild to moderate hypertension.
For the management of chronic stable angina pectoris either as
monotherapy or in combination with a beta-blocker.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
As far as possible the treatment must be tailored to the needs of the
individual.
Depending on the clinical picture in each case, the basic dose must be
introduced gradually.
Unless otherwise prescribed, the following dosage guidelines apply for
adults:
For CORONARY HEART DISEASE: CHRONICSTABLE ANGINA PECTORIS(angina of
effort)1 Adalat LA 20 mg tablet once daily
(1 x 20 mg/day)
For HYPERTENSION:1 Adalat LA 20 mg tablet once daily (1 x 20 mg/day)
In general therapy should be initiated with
30 mg once daily.
Where registered a starting dose of 20 mg once daily may be considered
when medically indicated. Interim doses i.e. 40 mg, 50
mg etc. can be applied by combinations of i.e. 20 mg + 20 mg or 20 mg
+ 30 mg tablets.
Depending on the severity of the disease and the patient's response
the dose can be increased in stages up to 90 mg once
daily.
Coadministration 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 "Interaction with other
medicinal products other forms of interaction")_.
_ _
_Duration of Treatment_
The attending doctor will determine the duration of use.
_ADDITIONAL INFORMATION ON SPECIAL POPULATIONS_
_Paediatric populations_
The safety and efficac
Read the complete document
