ADALAT RETARD 10 MG PROLONGED-RELEASE TABLETS.
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
27-08-2016
Summary of Product characteristics
(SPC)
11-08-2017
Active ingredient:
NIFEDIPINE
Available from:
Bayer Limited
ATC code:
C08CA05
INN (International Name):
NIFEDIPINE
Dosage:
10 mg Milligram
Pharmaceutical form:
Tablet Prolonged Release
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
nifedipine
Authorization status:
Not Marketed
Authorization date:
1987-11-06
Patient Information leaflet
PACKAGE LEAFLET - INFORMATION
FOR THE USER
ADALAT® RETARD 10MG
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 RETARD 10 MG IS
2 BEFORE YOU TAKE ADALAT
RETARD 10 MG
3 HOW YOU TAKE ADALAT RETARD
10 MG
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE ADALAT RETARD
10 MG
6 FURTHER INFORMATION
1 WHAT ADALAT RETARD 10 MG IS
Adalat Retard 10 mg contains
nifedipine, which belongs to a
group of medicines called
_calcium antagonists. _
ADALAT RETARD 10 MG IS USED TO
TREAT HIGH BLOOD PRESSURE OR
ANGINA (_chest pain_).
For high blood pressure: Adalat
Retard 10 mg 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 10 mg
work 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 10 MG
DO NOT TAKE ADALAT RETARD 10
MG:
• 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 10
mg are listed in section 6.
• IF YOU ARE TAKING RIFAMPICIN,
an antibiotic.
• IF YOU HAVE BEEN TOLD THAT Y
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adalat Retard 10 mg Prolonged-Release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated, prolonged-release tablet contains 10 mg nifedipine.
Excipients: Lactose monohydrate 10.00 mg per tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated, prolonged-release tablets.
Grey-pink, circular tablets marked with A10 on one side and a Bayer
cross on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the management of chronic stable angina pectoris and the treatment
of mild to moderate hypertension.
Adalat retard 10 mg is intended primarily for the treatment of milder
forms of cardiovascular diseases and in general, for
those patients who, irrespective of the severity of their disease,
respond particularly intensely to nifedipine.
In addition
Adalat retard 10 mg permits a gradual start to treatment and very
finely adjusted dosage.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
ORAL USE
DOSAGE REGIMEN
As far as possible the treatment must be tailored to the needs of the
individual according to the severity of the disease and
the patient's response.
Depending on the clinical picture in each case, the basic dose must be
introduced gradually
Adalat
retard
10 mg is
particularly suitable
for
dose
titration.
Dose
titration is
particularly recommended for
hypertensives with severe cerebrovascular disease and for patients,
who because of low body weight or multiple therapies
with other antihypertensive drugs, are likely to have an excessive
reaction to nifedipine. In addition, patients in whom side
effects in response to the nifedipine treatment make a finer dose
adjustment desirable should be individually stabilized
with Adalat retard 10 mg.
Unless otherwise prescribed, the following dosage guidelines apply for
adults:
IN CORONARY HEART DISEASE:
CHRONIC STABLE ANGINA PECTORIS
1 Adalat retard 10 MG tablet twice daily
(angina of effort)
(2 x 10 mg/day)
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