Accolate 20mg

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

ZAFIRLUKAST

Предлага се от:

AstraZeneca UK Limited 600, Capability Green, Luton LU1 3LU, United Kingdom

АТС код:

R03DC01

INN (Международно Name):

ZAFIRLUKAST 20 mg

Лекарствена форма:

TABLET

Композиция:

ZAFIRLUKAST 20 mg

Вид предписание :

POM

Терапевтична област:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Статус Оторизация:

Withdrawn

Дата Оторизация:

2005-09-27

Листовка

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 Accolate is and what it is
used for
2. What you need to know before
you take Accolate
3. How to take Accolate
4. Possible side effects
5. How to store Accolate
6. Contents of the pack and other
information
1. WHAT ACCOLATE IS AND WHAT IT IS
USED FOR
Accolate contains a medicine called
zafirlukast. This belongs to a group
of medicines called ‘leukotriene
antagonists’. This means that it
reduces the effects of ‘leukotrienes’.
These are natural substances in the
lung that cause asthma.
•
Accolate is used to control the
symptoms of your asthma.
•
It is also used to prevent your
asthma from getting worse.
Do not take Accolate to treat sudden
(acute) asthma attacks. Your doctor
will provide you with other inhalers to
treat sudden attacks.
2. BEFORE YOU TAKE ACCOLATE
DO NOT TAKE ACCOLATE IF:
•
You are allergic (hypersensitive)
to zafirlukast or any of the other
ingredients of this medicine (listed
in Section 6).
•
You have a chronic liver condition.
Do not take Accolate if any of the
above applies to you. If you are not
sure, talk to your doctor or pharmacist
before taking Accolate.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist
before taking Accolate if:
•
You have had problems with your
liver that were caused by taking
Accolate.
If you are not sure if this applies to
you, talk to your doctor or pharmacist
before taking Accolate.
If you go into hospital let the medical
staff know that you are taking
Accolate.
CHILDRE

Данни за продукта

MT SmPC Accolate 20 mg RSP 15 0041(based on RSP 14 0065) 08/07/15 ND
Page 1 of 12
1.
NAME OF THE MEDICINAL PRODUCT
Accolate 20 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of zafirlukast
EXCIPIENT WITH KNOWN EFFECT:
Each tablet contains 45 mg lactose monohydrate (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
White, round, biconvex, film-coated tablets intagliated with 'Accolate
20' on one
side and plain on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Accolate is indicated in adults and children aged 12 years and over
for the
prophylaxis and chronic treatment of asthma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Accolate is taken to prevent asthma attacks and should therefore be
taken
continuously.
POSOLOGY::
Therapy should be initiated at 20 mg twice daily. The usual
maintenance dosage is
20 mg twice daily. Increasing the dose, titrating to a maximum of 40
mg twice
daily, may provide additional benefit. This dose should not be
exceeded because
higher doses may be associated with hepatotoxicity.
As food may reduce the bioavailability of zafirlukast, Accolate should
not be taken
with meals. Each tablet should be swallowed whole with a drink of
water.
SPECIAL POPULATIONS:
ELDERLY:
MT SmPC Accolate 20 mg RSP 15 0041(based on RSP 14 0065) 08/07/15 ND
Page 2 of 12
The clearance of zafirlukast is reduced in elderly patients (>65 years
old), such that
C
max
and AUC are approximately twice those of younger adults. However,
accumulation of Accolate is not evident in elderly patients. In
clinical trials, elderly
patients receiving a dose of 20 mg twice daily were not associated
with an increase
in the overall incidence of adverse events or withdrawals because of
adverse events.
Therapy may be initiated at 20 mg twice daily and adjusted according
to clinical
response.
PATIENTS WITH RENAL IMPAIRMENT:
Experience is limited in patients with mild to severe renal
impairment, so clear d