ADALAT 10 MG SOFT CAPSULES

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

NIFEDIPINE

थमां उपलब्ध:

Bayer Limited

ए.टी.सी कोड:

C08CA05

INN (इंटरनेशनल नाम):

NIFEDIPINE

डोज़:

10 Milligram

फार्मास्यूटिकल फॉर्म:

Capsules, Soft

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

चिकित्सीय क्षेत्र:

nifedipine

प्राधिकरण का दर्जा:

Not Marketed

प्राधिकरण की तारीख:

1977-05-25

सूचना पत्रक

PACKAGE LEAFLET - INFORMATION
FOR THE USER
ADALAT® 10MG
soft capsules
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 CAPSULES ARE
2 BEFORE YOU TAKE ADALAT
CAPSULES
3 HOW YOU TAKE ADALAT
CAPSULES
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE ADALAT CAPSULES
6 FURTHER INFORMATION
1 WHAT ADALAT CAPSULES ARE
Adalat capsules contain
nifedipine, which belongs to a
group of medicines called
_calcium antagonists. _
ADALAT CAPSULES ARE USED TO
TREAT HIGH BLOOD PRESSURE,
ANGINA (_chest pain_) OR A
CONDITION CALLED _RAYNAUD’S _
_SYNDROME _which causes
discolouration (often whitening)
of the fingers and toes.
For high blood pressure: Adalat
capsules 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 capsules 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.
Adalat capsules can increase the
risk of serious heart problems in
patients with high blood pressure
or angina. Because of this, Adalat
capsules are only used in these
patients if no other treatments are
appropriate.
For Raynaud’s syndrome: Adalat
capsules work by relaxing and
expanding the blood vessels in
the fingers and toes. This helps
ensure a good blood supply.
2 BEFORE YOU TAKE ADALAT
CAPSULES
DO NOT TAKE ADALAT CAPSULES:
• IF YOU HAVE HAD A HEART ATTACK
within the last month.
• IF YOU GET

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adalat 10 mg soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg nifedipine.
Excipients: Sunset yellow (E110) 0.27 mg per capsule
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft.
Orange, gelatin ovoid capsules containing a yellow viscous liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the management of chronic stable angina pectoris, the treatment of
Raynaud’s syndrome and essential
hypertension.
For patients suffering from essential hypertension or chronic stable
angina pectoris, and treated with fast release
forms of nifedipine (Adalat 5 mg and 10 mg capsules), a dose dependent
increase in the risk of cardiovascular
complications (e.g., myocardial infarction) and mortality may occur.
Due to this, Adalat 5 mg and 10 mg capsules should only be used for
treatment of patients with essential
hypertension or chronic stable angina pectoris if no other treatment
is appropriate.
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
Dose titration is 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 5
mg capsule.
Unless otherwise prescribed, the following dosage guidelines are
recommended for adults:
IN CORONARY HEART DISEASE:
CHRONIC STABLE ANGINA PECTORIS
1 ADALAT 5 MG capsule 3 times daily
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