Adalat LA 30 Prolonged Release Tablets

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

NIFEDIPINE

Disponible desde:

Bayer PLC

Código ATC:

C08CA05

Designación común internacional (DCI):

NIFEDIPINE

formulario farmacéutico:

PROLONGED-RELEASE TABLET

Composición:

NIFEDIPINE 30 mg

tipo de receta:

POM

Área terapéutica:

CALCIUM CHANNEL BLOCKERS

Estado de Autorización:

Authorised

Fecha de autorización:

2006-11-23

Información para el usuario

PMR 85987992 (H3/01-C/MU-0201710563) Pantone: Black, Orange 021
Page 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
0
ADALAT
® LA 30 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 any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their signs
of illness 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, any other similar medicines
(known as_ dihydropyridines_) or any of the other ingredients of
this medicine (list

Ficha técnica

V 028_0
1
1.3.1
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Adalat LA 30 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 30 mg nifedipine.
Each tablet contains a 10% overage of nifedipine to deliver the label
claim.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
Pink, round, convex prolonged-release tablet with a laser hole on one
side and marked with Adalat
30.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of all grades of hypertension.
For the prophylaxis of chronic stable angina pectoris either as
monotherapy or in combination with
a beta-blocker.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
_ _
In mild to moderate hypertension, the recommended initial dose is one
20 mg tablet once-daily. In
severe hypertension, the recommended initial dose is one 30 mg tablet
once-daily. If necessary,
the dosage can be increased according to individual requirements up to
a maximum of 90 mg
once-daily.
For the prophylaxis of angina pectoris, the recommended initial dose
is one 30 mg tablet once-
daily. The dosage can be increased according to individual
requirements up to a maximum of
90 mg once-daily.
Patients in whom hypertension or anginal symptoms are controlled on
Adalat capsules or Adalat
retard may be safely switched to Adalat LA. Prophylactic anti-anginal
efficacy is maintained when
patients are switched from other calcium antagonists such as diltiazem
or verapamil to Adalat LA.
Patients switched from other calcium antagonists should initiate
therapy at the recommended initial
dose of 30 mg Adalat LA once-daily. Subsequent titration to a higher
dose may be initiated as
warranted clinically.
Co-administration 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 section 4.5).
_Duration of treatment_
_ _
Treatment may be continued indefinitely.
_Additional inform