Tilade 2mg/dose inhaler CFC free

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Nedocromil sodium

から入手可能:

Sanofi

ATCコード:

R03BC03

INN（国際名）:

Nedocromil sodium

投薬量:

2mg/1dose

医薬品形態:

Pressurised inhalation

投与経路:

Inhalation

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 03030100; GTIN: 5000283651772

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE
USER
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE
●
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.
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. See section 4.
IN THIS LEAFLET:
1.
What Tilade is and what it is used for
2.
Before you use Tilade
3.
How to use Tilade
4.
Possible side effects
5.
How to store Tilade
6.
Further information
1.WHAT TILADE IS AND WHAT IT IS
USED FOR
Tilade CFC-Free Inhaler (called Tilade
throughout this leaflet) contains a medicine
called nedocromil sodium. Tilade is used to
treat asthma.
●
It works by helping to stop tissues from
swelling
●
This helps stop the narrowing of the
airways that happens in asthma
Tilade is used to prevent asthma attacks and
may be called a ‘preventer’.
●
Tilade will not help an asthma attack that
has already started
●
You will need to use a different inhaler,
called a ‘reliever’, for these attacks (see
Section 3)
2.BEFORE YOU USE TILADE
DO NOT USE THIS MEDICINE AND TELL
YOUR DOCTOR IF:
✖
You are allergic (hypersensitive) to
nedocromil sodium or any of the other
ingredients of Tilade (listed in Section 6).
Signs of an allergic reaction to Tilade
include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat
or tongue
Do not take this medicine if the above applies
to you. If you are not sure, talk to your
doctor or pharmacist before using Tilade.
TAKE SPECIAL CARE WITH TILADE
CHECK WITH YOUR DOCTOR OR
PHARMACIST BEFORE TAKING YOUR
MEDICINE IF:
▲
You are using any other inhalers
If you are not sure if the above applies to you,
talk to your doctor or pharmacist before
using Tilade
USI

製品の特徴

OBJECT 1
TILADE CFC-FREE INHALER
Summary of Product Characteristics Updated 15-May-2014 | SANOFI
1. Name of the medicinal product
Tilade CFC-Free Inhaler 2mg per actuation pressurised inhalation
suspension
2. Qualitative and quantitative composition
One metered dose (ex-valve) contains 2 mg nedocromil sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pressurised inhalation suspension.
Tilade CFC-Free Inhaler/Syncroner/Fisonair contains a new propellant,
HFA-227, and does not contain
any chlorofluorocarbons (CFCs).
4. Clinical particulars
4.1 Therapeutic indications
Tilade CFC-Free is recommended for the treatment of bronchial asthma
where regular preventative anti-
inflammatory therapy is indicated and, in particular, in patients
whose asthma is not adequately controlled
by bronchodilators alone. Tilade CFC-Free may be given in addition to
all existing therapies and in many
cases will provide added therapeutic benefit.
4.2 Posology and method of administration
Posology
For inhalation use.
_ADULTS, INCLUDING THE ELDERLY AND CHILDREN OVER 6 YEARS OF AGE._
The initial dose is 4 mg (2 actuations) four times daily. Once control
of symptoms has been achieved it
may be possible to reduce the dose to a maintenance dose of 4mg (2
actuations) twice daily.
Tilade CFC-Free is intended for regular daily use and should not be
used for the relief of symptoms in an
acute attack.
Tilade CFC-Free is not recommended for use in children 6 years of age
and younger.
_CONCOMITANT BRONCHODILATOR THERAPY_
Where a concomitant inhaled bronchodilator is prescribed it is
recommended that this be administered
prior to Tilade CFC-Free.
_CONCOMITANT STEROID THERAPY_
In patients currently treated with steroids, the addition of Tilade
CFC-Free to the regimen may make it
possible to reduce the maintenance dose of steroids, or discontinue
steroid therapy completely. The
patient must be carefully supervised while the steroid dose is
reduced; a rate of 10% weekly is suggested.
If a reduction of a steroid dose has been p