Zoreeda 25 microgram/125 microgram per actuation pressurised inhalation, suspension
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
10-10-2019
Summary of Product characteristics
(SPC)
20-11-2021
Active ingredient:
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Available from:
Cipla Europe NV
ATC code:
R03AK; R03AK06
INN (International Name):
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Dosage:
25/125 microgram(s)
Pharmaceutical form:
Pressurised inhalation, suspension
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salmeterol and fluticasone
Authorization status:
Not marketed
Authorization date:
2017-03-10
Patient Information leaflet
1
0006a
30‐01‐17 Updated at Nat phase
PACKAGE LEAFLET: INFORMATION FOR THE USER
salmeterol/fluticasone propionate
READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
KEEP THIS LEAFLET. YOU MAY NEED IT TO READ IT AGAIN. • IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR
PHARMACIST. • THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU PERSONALLY AND YOU
SHOULD NOT PASS IT ON TO OTHERS.
IT MAY HARM THEM, EVEN IF THEIR SYMPTOMS 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 Zoreeda is and what it is used for
2. What you need to know before you use Zoreeda
3. How to use Zoreeda
4. Possible side effects
5. How to store Zoreeda
6. Contents of the pack and other information
1.
WHAT ZOREEDA IS AND WHAT IT IS USED FOR
Zoreeda contains two medicines, salmeterol and fluticasone propionate:
• Salmeterol is a long-acting bronchodilator. Bronchodilators help
the airways in the lungs to stay
open. This makes it easier for air to get in and out. The effects last
for at least 12 hours.
• Fluticasone propionate is a corticosteroid which reduces swelling
and irritation in the lungs.
The doctor has prescribed this medicine to help prevent breathing
problems such as asthma.
You must use Zoreeda every day as directed by your doctor. This will
make sure that it works
properly in controlling your asthma.
ZOREEDA HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON.
HOWEVER, ZOREEDA SHOULD NOT
BE USED TO RELIEVE A SUDDEN ATTACK OF BREATHLESSNESS OR WHEEZING. IF
THIS HAPPENS YOU NEED TO USE
A FAST-ACTING ‘RELIEVER’ (‘RESCUE’) INHALER, SUCH AS
SALBUTAMOL. YOU SHOULD ALWAYS HAVE YOUR FAST-
ACTING ‘RESCUE’ INHALER WITH YOU. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ZOREEDA
DO NOT TAKE ZOREEDA:
If you are allergic (hypersensitive) to salmeterol, fluticasone
propionate or to the other ingredient
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
19 November 2021
CRN00C6J0
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zoreeda 25 microgram/125 microgram per actuation pressurised
inhalation, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex valve) contains:
25 micrograms of salmeterol (as salmeterol xinafoate) and 125
micrograms of fluticasone propionate. This is equivalent to a
delivered dose (exactuator) of 21 micrograms of salmeterol and 110
micrograms of fluticasone propionate.
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
The canister contains a white to off-white suspension.
The canisters are fitted into white plastic actuators incorporating an
atomising orifice and fitted with pink (25 microgram/125
microgram) dust-caps.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ZOREEDA ISINDICATEDFOR USE INADULTSWITH ASTHMA 18 YEARS OFAGE AND
OLDER ONLY.
Zoreeda is indicated in the regular treatment of patients with
moderate to severe asthma where use of a combination product
(long-acting β
2
agonist and inhaled corticosteroid) is appropriate:
- patients not adequately controlled on a lower strength
corticosteroid and 'as needed' inhaled short-acting β
2
agonist.
or
- patients already adequately controlled on an inhaled corticosteroid
in a mid or high strength and a long-acting β
2
agonist.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Zoreeda is indicated in adults 18 years of age and older only.
Zoreeda is not indicated for use in children, 12 years of age or
younger, or adolescents, 13 to 17 years of age.
Posology
Route of administration: Inhalation use.
Patients should be made aware that Zoreeda must be used daily for
optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of Zoreeda they are receiving remains optimal and is
only changed on medical advice. The dose should be titrated to the
lowest dose at which effective control of symptoms i
Read the complete document
