Adalat LA 30 mg Prolonged-Release Tablet

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Nifedipine

Disponível em:

IMED Healthcare Ltd.

Código ATC:

C08CA; C08CA05

DCI (Denominação Comum Internacional):

Nifedipine

Dosagem:

30 milligram(s)

Forma farmacêutica:

Prolonged-release tablet

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

Dihydropyridine derivatives; nifedipine

Status de autorização:

Authorised

Data de autorização:

2012-04-05

Folheto informativo - Bula

PACKAGE LEAFLET - INFORMATION FOR THE USER
ADALAT® LA 30 MG 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
1 WHAT ADALAT LA IS
2 BEFORE YOU TAKE ADALAT LA
3 HOW YOU TAKE ADALAT LA
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE ADALAT LA
6 FURTHER INFORMATION
1 WHAT ADALAT LA IS
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 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 the active ingredient (nifedipine), to any
other
similar medicines (known as _dihydropyridines) _or to any of the other
ingredients. The ingredients of Adalat LA are listed in section 6.
• IF YOU ARE TAKING RIFAMPICIN, an antibiotic.
• IF YOU HAVE A LIVER DISEASE that prevents your liver from working
properly.
• IF YOU HAVE INFLAMMATION OF THE BOWEL OR INTESTINES, such as
Crohn’s

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adalat LA 30 mg Prolonged-Release Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 30 mg nifedipine.
Each tablet contains 9.4mg sodium.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release film-coated tablet.
_Product imported from the UK:_
Pink, round tablets with a laser hole on one side and marked ‘Adalat
30’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of all grades of 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
METHOD OF ADMINISTRATION
ORAL USE
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:
o
For CORONARY HEART DISEASE:
CHRONIC STABLE ANGINA PECTORIS (angina of effort)
1 Adalat LA 30 mg tablet once daily (1 x 30 mg/day)
o
For HYPERTENSION:
1 Adalat LA 30 mg tablet once daily (1 x 30 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
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