Seretide 500 Diskus 50 microgram/500 microgram/dose inhalation powder, pre-dispensed

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE

Διαθέσιμο από:

LTT Pharma Limited

Φαρμακολογική κατηγορία (ATC):

R03AK; R03AK06

INN (Διεθνής Όνομα):

SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE

Δοσολογία:

50/500 microgram(s)

Φαρμακοτεχνική μορφή:

Powder for Inhalation

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salmeterol and fluticasone

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-01-23

Φύλλο οδηγιών χρήσης

•
Feeling shaky (tremor) and fast or uneven
heart beat (palpitations) - these are usually
harmless and get less as treatment continues
.
•
Chest pain
•
Feeling worried (this effect mainly occurs in
children).
•
Disturbed sleep
•
Allergic skin rash
RARE (AFFECTS LESS THAN 1 PERSON IN 1000)
•
BREATHING DIFFICULTIES OR WHEEZING THAT GET
WORSE STRAIGHT AFTER TAKING SERETIDE. If this
happens STOP USING YOUR SERETIDE INHALER.
Use your fast-acting ‘reliever’ inhaler to
help your breathing and TELL YOUR DOCTOR
STRAIGHT AWAY.
•
Seretide may affect the normal production of
steroid hormones in the body, particularly if you
have taken high doses for long periods of time.
The effects include:
- Slowing of growth in children and adolescents,
- Thinning of the bones
- Glaucoma
- Weight gain
- Rounded (moon shaped) face (Cushing’s
Syndrome)
Your doctor will check you regularly for any of
these side effects and make sure you are taking
the lowest dose of Seretide to control your
asthma.
•
Behavioural changes, such as being unusually
active and irritable (these effects mainly occur in
children).
•
Uneven heart beat or heart gives an extra beat
(arrhythmias). Tell your doctor, but do not stop
taking Seretide unless the doctor tells you to
stop.
•
A fungal infection in the oesophagus (gullet),
which might cause difficulties in swallowing.
FREQUENCY NOT KNOWN, BUT MAY ALSO OCCUR:
•
Depression or aggression. These effects are
more likely to occur in children.
•
Blurred vision.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or
pharmacist. 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: +353 1
6764971; 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 SERETIDE
•
KEEP THIS MEDICINE OUT OF THE SIGHT AND
REACH OF CHILDREN

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Seretide 500 Diskus 50 microgram/500 microgram/dose inhalation powder,
pre-dispensed
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of 47 micrograms of salmeterol (as
salmeterol xinafoate) and 460 micrograms of fluticasone propionate.
This corresponds to a pre-dispensed dose of 50
micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms
fluticasone propionate.
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
_Product imported from Hungary._
Moulded plastic device containing a foil strip with 60 regularly
placed blisters.
4 CLINICAL PARTICULARS
As per PA1077/046/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/046/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container 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.
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6.5 NATURE AND CONTENTS OF CONTAINER
The inhalation powder is contained in blisters