Nyefax Retard

Страна: Нова Зеландія

мова: англійська

Джерело: Medsafe (Medicines Safety Authority)

Активний інгредієнт:

Nifedipine 20mg;  

Доступна з:

Douglas Pharmaceuticals Limited

ІПН (Міжнародна Ім'я):

Nifedipine 20 mg

Дозування:

20 mg

Фармацевтична форма:

Modified release tablet

Склад:

Active: Nifedipine 20mg   Excipient: Iron oxide black Iron oxide red Lactose monohydrate Macrogol 4000 Magnesium stearate Methylcellulose Microcrystalline cellulose Polysorbate 80 Pregelatinised maize starch Purified water Titanium dioxide

Одиниць в упаковці:

Blister pack, 30 tablets

Клас:

Prescription

Тип рецепту:

Prescription

Виробник:

Siegfried Ltd

Огляд продуктів:

Package - Contents - Shelf Life: Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light and moisture

Дата Авторизація:

1986-02-20

інформаційний буклет

CONSUMER MEDICINE INFORMATION
1
NYEFAX RETARD™
_nifedipine _
20 mg tablets
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING NYEFAX RETARD
This leaflet answers some common questions
about NYEFAX RETARD. It does not contain all
the available information. It does not take the
place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your
doctor has weighed the risks of you taking
NYEFAX RETARD against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY
NEED TO READ IT AGAIN.
WHAT NYEFEX RETARD™ IS USED
FOR
NYEFAX RETARD is used for the treatment of
coronary heart disease, angina pectoris - exercise
induced chest pain, hypertension - high blood
pressure.
NYEFAX RETARD contains nifedipine, which
belongs to a group of medicines called calcium
antagonist. For angina, NYEFAX RETARD works by
relaxing and expanding the arteries supplying the
heart which allows more blood and oxygen to
reach the heart and this decreasing the strain on
it. For high blood pressure, NYEFAX RETARD
works by relaxing and expanding the blood
vessels which makes the blood flow more easily
and lowers blood pressure.
NYEFAX RETARD does not change the amount of
calcium in your blood or bones.
Your doctor may have prescribed NYEFAX
RETARD for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY NYEFAX RETARD HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with a doctor's
prescription.
BEFORE YOU TAKE NYEFAX
RETARD™
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE NYEFAX RETARD IF YOU HAVE AN
ALLERGY TO:
•
nifedipine
•
other calcium channel blockers
•
any of the ingredients listed at the end
of this leaflet
Some of the symptoms of an allergic reaction
may include:
•
difficulty in breathing or wheezing
•
shortness of breath
•
swelling of the face, tongue, lips, or
other parts of the body
•
hives on the skin, rash, or itching
DO NOT

Характеристики продукта

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Nyefax® Retard modified-release tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 20 mg nifedipine.
EXCIPIENT(S) WITH KNOWN EFFECT
Contains lactose monohydrate. For the full list of excipients, see
section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release tablets.
Pale pink, biconvex, film-coated tablet of 7 mm diameter.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
•
Treatment of coronary heart disease
•
Chronic stable angina pectoris (angina of effort)
•
Treatment of hypertension
4.2.
DOSE AND METHOD OF ADMINISTRATION
DOSE
RECOMMENDED USUAL DOSE
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. In
patients with impaired liver function careful monitoring and, in
severe cases, a dose reduction
may be necessary.
_ADULTS _
Unless otherwise prescribed, the following dosage guidelines apply for
adults:
2 | P a g e
IN CORONARY HEART DISEASE
Chronic stable angina pectoris (angina of effort) 1 Nyefax Retard
tablet twice daily
(2 x 20 mg/day)
If higher dosages are necessary, the dose can be increased in stages
up to a maximum of 60 mg
daily.
IN HYPERTENSION 1 Nyefax Retard tablet twice daily (2 x 20 mg/day)
If higher dosages are necessary, the dose can be increased in stages
up to a maximum of 60 mg
daily.
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 (refer to section
4.5).
DURATION OF TREATMENT
The attending doctor will determine the duration of use.
Because Nyefax Retard has a pronounced anti-ischaemic and
anti-hypertensive action, it should
be discontinued gradually, particularly when high doses are used.
_SPECIAL POPULATION _
Use in elderly
The pharmacokinetics of nifedipine are altered in the elderly so that
lower main