Formoterol Easyhaler 12microgramsdose dry powder inhaler

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Formoterol fumarate dihydrate

Tersedia dari:

Orion Pharma (UK

Kode ATC:

R03AC13

INN (Nama Internasional):

Formoterol fumarate dihydrate

Dosis:

12microgram/1dose

Bentuk farmasi:

Inhalation powder

Rute administrasi :

Inhalation

Kelas:

No Controlled Drug Status

Jenis Resep:

VMP not recommended to prescribe - patient training required

Ringkasan produk:

BNF: 03010101; GTIN: 6432100009647

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FORMOTEROL EASYHALER 12 MICROGRAMS/DOSE
INHALATION POWDER
formoterol fumarate dihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Formoterol Easyhaler is and what it is used for
2.
What you need to know before you use Formoterol Easyhaler
3.
How to use Formoterol Easyhaler
4.
Possible side effects
5.
How to store Formoterol Easyhaler
6.
Contents of the pack and other information
1.
WHAT FORMOTEROL EASYHALER IS AND WHAT IT IS USED FOR
WHAT IS FORMOTEROL EASYHALER?
FORMOTEROL EASYHALER
is an asthma medication that opens up the airways thus preventing and
treating
breathing symptoms such as wheezing, shortness of breath and coughing.
The active ingredient is formoterol. Formoterol powder is packed in an
inhaler called Easyhaler. You inhale
the powder into your lungs through the mouthpiece of the inhaler.
WHAT IS FORMOTEROL EASYHALER USED FOR?
It is used:
•
together with inhaled corticosteroids to treat and prevent asthma
symptoms
•
to treat
and prevent
symptoms of chronic obstructive pulmonary disease (COPD)
The effect of formoterol begins within 1
−
3 minutes and lasts for approximately 12 hours.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FORMOTEROL EASYHALER
DO NOT USE FORMOTEROL EASYHALER
•
if you are allergic to formoterol or the other ingredient of this
medicine (listed in section 6), which is
lactose (which contains small amounts of milk protein)
Not to be given to children under the age of 6.
WARNINGS AND PRECAUTIONS
Talk

Karakteristik produk

OBJECT 1
FORMOTEROL EASYHALER 12 MICROGRAMS PER DOSE
INHALATION POWDER
Summary of Product Characteristics Updated 21-Jul-2015 | Orion Pharma
(UK) Limited
1. Name of the medicinal product
Formoterol Easyhaler
®
12 micrograms/dose inhalation powder
2. Qualitative and quantitative composition
One metered dose contains 12 micrograms of formoterol fumarate
dihydrate.
With the Easyhaler device the delivered dose (ex-actuator) contains
the same quantity of active substance
as the metered dose (ex-reservoir).
Excipient with known effect: Lactose monohydrate
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Inhalation powder.
White to yellowish white powder.
4. Clinical particulars
4.1 Therapeutic indications
Formoterol Easyhaler 12 micrograms/dose inhalation powder is indicated
for use in the treatment of
asthma in patients treated with inhaled corticosteroids and who also
require a long-acting beta2-agonist in
accordance with current treatment guidelines.
Formoterol Easyhaler 12 micrograms/dose inhalation powder is indicated
also for the relief of reversible
airways obstruction in patients with chronic obstructive pulmonary
disease (COPD) and requiring long-
term bronchodilator therapy.
4.2 Posology and method of administration
Posology
ADULTS (INCLUDING OLDER PEOPLE) AND ADOLESCENTS (ABOVE 12 YEARS)
Asthma
Regular maintenance therapy:
1 inhalation (12 micrograms) to be inhaled twice daily. For more
severe disease this dose regimen can be
increased to 2 inhalations (24 micrograms) to be inhaled twice daily.
The maximum daily dose is 4 inhalations (2 inhalations inhaled twice
daily).
Chronic Obstructive Pulmonary Disease
Regular maintenance therapy:
1 inhalation (12 micrograms) to be inhaled twice daily.
The maximum daily dose is 2 inhalations (1 inhalation inhaled twice
daily).
_Paediatric population_
CHILDREN 6 to 12 YEARS
Asthma
Regular maintenance therapy:
1 inhalation (12 micrograms) to be inhaled twice daily. The maximum
daily dose is 24 micrograms.
Chronic Obstructive Pulmonary Disease
Not