Sereflo 25 microgram/250 microgram per actuation pressurised inhalation, suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Available from:

Fannin (UK) Ltd

ATC code:

R03AK; R03AK06

INN (International Name):

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Dosage:

25/250 microgram(s)/dose

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:

Marketed

Authorization date:

2017-03-10

Patient Information leaflet

485 mm
65 mm
30 mm
BRAND NAME Panel
2D
Code
65 mm
30 mm
BRAND NAME Panel
2D
Code
240 mm
Colours
CUSTOMER: Cipla
DESIGNER: AWG (SCY)
PRODUCT: Sereflo 25/125mcg and 25/250 mcg HFA Inhaler
ITEM CODE: CP.SER.JNT.IN.CP.IE.V1P1
PROOF NO AND DATE: 6 31/01/2017
ARTWORK FOR SUBMISSION
Supersedes: n/a
DIMENSIONS: 240mm x 485mm
Pantone
280 C
Front
PACKAGE LEAFLET: INFORMATION FOR THE USER SEREFLO 25MICROGRAM/125MICROGRAM PER ACTUATION PRESSURISED
INHALATION, SUSPENSION
SEREFLO 25MICROGRAM/250MICROGRAM PER ACTUATION PRESSURISED INHALATION,
SUSPENSION
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 Sereflo is and what it is used for
2. What you need to know before you use Sereflo
3. How to use Sereflo
4. Possible side effects
5. How to store Sereflo
6. Contents of the pack and other information
WHAT SEREFLO IS AND WHAT IT IS USED FOR
Sereflo 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 Sereflo every day as directed by your doctor.
This will make
sure that it works properly in controlling your asthma.
SEREFLO HELPS TO STOP BREATHLESSNESS AND WHEEZ

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sereflo 25 microgram/250 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 250
micrograms of fluticasone propionate. This is equivalent
to a delivered dose (ex actuator) of 21 micrograms of salmeterol and
220 micrograms of fluticasone propionate.
For a 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 rubine red dust-
caps.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SEREFLO IS INDICATED FOR USE IN ADULTS WITH ASTHMA 18 YEARS OF AGE AND
OLDER ONLY.
Sereflo is indicated in the regular treatment of patients with
moderate to severe asthma where use of a combination
product (long-acting
agonist and inhaled corticosteroid) is appropriate:
- patients not adequately controlled on a lower strength
corticosteroid combination product or
- patients already adequately controlled on an inhaled corticosteroid
in a mid or high strength and a long-acting
agonist.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Sereflo is indicated in adults 18 years of age and older only.
Sereflo 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 Sereflo must be used daily for
optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of Sereflo 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 is maintained.
NOTE: Sereflo is only available in two strengths, it is not available
in a lower strength product containing salmeterol 2