Accolate 20mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Zafirlukast

Предлага се от:

AstraZeneca UK Ltd

АТС код:

R03DC01

INN (Международно Name):

Zafirlukast

дозиране:

20mg

Лекарствена форма:

Oral tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 03030200; GTIN: 5000455006454

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
ACCOLATE 20MG TABLETS / ZAFIRLUKAST 20MG TABLETS
(zafirlukast)
This product is available as any of the above names but will be
referred to as Accolate
throughout the remainder of this leaflet.
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 medicines to treat sudden attacks.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACCOLATE
DO NOT TAKE ACCOLATE:
•
If you are allergic to zafirlukast or any of the other ingredients of
this medicine (listed in
Section 6).
•
If you have ever had problems with your liver.
•
If you have had problems with your liver that were caused by taking
Accolate.
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 this medicine.
WARNINGS AND PR

Данни за продукта

OBJECT 1
ACCOLATE 20MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 31-Mar-2016 | AstraZeneca
UK Limited
1. Name of the medicinal product
Accolate™ 20 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 20 mg 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 treatment of asthma.
4.2 Posology and method of administration
Accolate should be taken continuously.
POSOLOGY:
The dosage is one 20 mg tablet twice daily. This dosage should not be
exceeded. Higher doses may be
associated with elevations of one or more liver enzymes consistent
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:
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 dose recommendations
cannot be given. Therefore, Accolate should be used with caution in
these patients (see section 5.2).
PAEDIATRIC POPULATION:
The safety and efficacy of Accolate in children under 12 years has not
been