FLUTICASONE SALMETEROL CIPHALER 500/50 fluticasone propionate 500 microgram / salmeterol (as xinfoate) 50 microgram powder for inhalation blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

salmeterol xinafoate, Quantity: 0.0725 mg (Equivalent: salmeterol, Qty 0.05 mg); fluticasone propionate, Quantity: 0.5 mg

Available from:

Cipla Australia Pty Ltd

Pharmaceutical form:

Inhalation, powder for

Composition:

Excipient Ingredients: lactose monohydrate

Administration route:

Inhalation

Units in package:

60s

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the regular treatment of asthma, where the use of a combination product is appropriate. This may include: ?Patients on effective maintenance doses of long-acting beta-2 agonists and inhaled corticosteroids ?Patients who are symptomatic on current inhaled corticosteroid therapy,For the symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. FLUTICASONE SALMETEROL CIPHALER 500/50 is not indicated for the initiation of bronchodilator therapy in COPD.

Product summary:

Visual Identification: White to off white powder filled in a strip of 60 blisters; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-09-29

Patient Information leaflet

FLUTICASONE SALMETEROL CIPHALER 500/50
1
FLUTICASONE SALMETEROL CIPHALER 500/50
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING FLUTICASONE SALMETEROL CIPHALER 500/50?
FLUTICASONE SALMETEROL CIPHALER 500/50 contains the active ingredients
fluticasone propionate and salmeterol (as
xinafoate). FLUTICASONE SALMETEROL CIPHALER 500/50 is used to help
with asthma and chronic obstructive pulmonary
disease (COPD) in people who need regular treatment.
For more information, see Section 1. Why am I using FLUTICASONE
SALMETEROL CIPHALER 500/50? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FLUTICASONE SALMETEROL CIPHALER
500/50?
Do not use if you have ever had an allergic reaction to any medicine
containing fluticasone propionate or salmeterol (as
xinafoate) or lactose monohydrate or any of the ingredients listed at
the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
FLUTICASONE SALMETEROL CIPHALER 500/50? in the
full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with FLUTICASONE SALMETEROL CIPHALER
500/50 and affect how it works. A list of these
medicines is in Section 3. What if I am taking other medicines? in the
full CMI.
4.
HOW DO I USE FLUTICASONE SALMETEROL CIPHALER 500/50?
•
Follow dosage directions given to you by your doctor or pharmacist and
continue taking it for as long as your doctor tells you.
•
FLUTICASONE SALMETEROL CIPHALER 500/50 should be inhaled into your
lungs through the mouth, through the inhaler.
More instructions can be found in Section 4. How do I use FLUTICASONE
SALMETEROL CIPHALER 500/50? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING FLUTICASONE SALMETEROL CIPHALER 500/50?
THINGS YOU
SHOULD DO

Remind any doctor, dentist or

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
FLUTICASONE SALMETEROL CIPHALER 500/50
(FLUTICASONE PROPIONATE/SALMETEROL XINAFOATE) DOSE INHALATION POWDER,
PRE-DISPENSED
1.
NAME OF THE MEDICINE
Fluticasone propionate/salmeterol xinafoate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each a foil strip contains regularly placed blisters each containing
500 micrograms of fluticasone
propionate and 50 micrograms of salmeterol (as xinafoate).
Excipients with known effect
Each blister of FLUTICASONE SALMETEROL CIPHALER 500/50 contains 11.92
mg of lactose
monohydrate.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
FLUTICASONE SALMETEROL CIPHALER 500/50 is a white to off white powder
filled in a strip
of 60 blisters.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the regular treatment of asthma, where the use of a combination
product is appropriate. This may
include:
•
Patients on effective maintenance doses of long-acting beta-2 agonists
and inhaled corticosteroids
•
Patients who are symptomatic on current inhaled corticosteroid therapy
For the symptomatic treatment of patients with severe COPD (FEV
1
<50% predicted normal) and a
history of repeated exacerbations who have significant symptoms
despite regular beta-2 agonist
bronchodilator therapy. FLUTICASONE SALMETEROL CIPHALER 500/50 is not
indicated for the
initiation of bronchodilator therapy in COPD.
4.2
DOSE AND METHOD OF ADMINISTRATION
FLUTICASONE SALMETEROL CIPHALER 500/50 must be used regularly for
optimum benefit,
even when asymptomatic.
Patients should be regularly assessed by a doctor, so the dose of
FLUTICASONE SALMETEROL
CIPHALER 500/50 they are receiving remains optimal. Strength of dose
should only be increased or
decreased on medical advice.
The inhaler releases a powder that is inhaled into the lungs. The
device is opened by sliding the lever.
The mouthpiece is then placed in the mouth and the lips closed around
it. The dose can then be inhaled
and the device closed. A dose counte