Flixotide Evohaler 125 micrograms, per metered dose, Pressurised Inhalation, Suspension

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

FLUTICASONE PROPIONATE

Dostupné z:

LTT Pharma Limited

ATC kód:

R03BA; R03BA05

INN (Medzinárodný Name):

FLUTICASONE PROPIONATE

Dávkovanie:

125 Mcg/Dose

Forma lieku:

Pressurised inhalation, suspension

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Glucocorticoids; fluticasone

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2015-02-20

Príbalový leták

•
the way steroids are produced by your body
may be affected when using Flixotide (adrenal
suppression). This is more likely to happen if
you use high doses for a long period of time
(e.g. 400 micrograms daily in children). This can
cause:
- young people to grow more slowly.
- something called ‘Cushing’s syndrome’. This
happens when you have too much steroid in
your body and it can cause thinning of your
bones and eye problems (such as cataracts
and glaucoma which is high pressure in the
eye).
Your doctor will help stop this happening by
making sure you use the lowest dose of steroid
which controls your symptoms.
FREQUENCY NOT KNOWN, BUT MAY ALSO OCCUR
•
depression or aggression. These effects are
more likely to occur in children.
•
nosebleeds
•
blurred vision (that may be due to cataract or
glaucoma).
TALK TO YOUR DOCTOR AS SOON AS POSSIBLE IF:
•
after 7 days of using Flixotide your shortness of
breath or wheezing does not get better, or gets
worse.
•
you or your child is on high doses of inhaled
steroid and become unwell with vague
symptoms such as tummy ache, sickness,
diarrhoea, headache or drowsiness. This can
happen during an infection such as a viral
infection or stomach upset. It is important that
your steroid is not stopped suddenly as this
could make your asthma worse and could also
cause problems with the body’s hormones.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via HPRA
Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: [phone];
Fax: [phone].
Website: www.hpra.ie; E-mail: [e-mail].
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE FLIXOTIDE
•
Keep this medicine out of the sight and reach of
children.
•
Clean you inhaler on a weekly basis and if it
becomes blocked as described under ‘Cleaning
your Evohaler’,
•
Do not u

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flixotide Evohaler 125 micrograms, per metered dose, Pressurised
Inhalation, Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 125 micrograms of fluticasone propionate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised Inhalation, Suspension (Pressurised inhalation)
_Product imported from Greece._
Pressurised inhalation suspension supplied in an aluminium can with
metering valve and an orange (120 dose) actuator.
4 CLINICAL PARTICULARS
As per PA1077/044/014
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/044/014
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Norflurane (HFA 134a)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the device and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
Do not refrigerate or freeze.
Store in the original package.
Avoid storage in direct sunlight or heat.
Do not expose to temperatures higher than 50°C. Do not pierce, break
or burn the canister even when apparently empty.
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Replace the mouthpiece cover firmly and snap it into position.
As with most inhaled medications in pressuri