Fluticasone+Salmeterol Cipla 125/25 fluticasone propionate/salmeterol (as xinafoate) 125/25 microgram inhalation pressurised aerosol can metered dose

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

salmeterol xinafoate, Quantity: 36.32 microgram/actuation (Equivalent: salmeterol, Qty 25 microgram/actuation); fluticasone propionate, Quantity: 125 microgram/actuation

Available from:

Cipla Australia Pty Ltd

INN (International Name):

fluticasone propionate,Salmeterol xinafoate

Pharmaceutical form:

Inhalation, pressurised

Composition:

Excipient Ingredients: norflurane

Administration route:

Inhalation

Units in package:

120 metered doses

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 less than 50 precent predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. Fluticasone propionate/salmeterol (125 microgram/25 microgram and 250 microgram/25 microgram) is not indicated for the initiation of bronchodilator therapy in COPD.

Product summary:

Visual Identification: A rigid, aluminium container fitted with a metered dose valve, containing a white homogeneous suspension, fitted to a plastic actuator with a white coloured body and pink coloured cap, with a dose indicator.; Container Type: Aerosol Can - Metered Dose; Container Material: 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:

Licence status A

Authorization date:

2016-12-15

Patient Information leaflet

FLUTICASONE + SALMETEROL CIPLA 125/25
FLUTICASONE + SALMETEROL CIPLA 250/25
_125/25 MICROGRAM AND 250/25 MICROGRAM MDI _
_Fluticasone propionate/Salmeterol (as xinafoate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start
using Fluticasone + Salmeterol Cipla.
This leaflet answers some common questions
about Fluticasone + Salmeterol Cipla. It does
not contain all the available information. It does
not take the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your
doctor has weighed the risks of you taking
Fluticasone + Salmeterol Cipla against the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FLUTICASONE + SALMETEROL CIPLA
IS USED FOR
Fluticasone + Salmeterol Cipla is available as a
Metered Dose Inhaler (MDI).

Fluticasone + Salmeterol Cipla
125/25 (125 microgram fluticasone
propionate and 25 microgram
salmeterol), or

Fluticasone + Salmeterol Cipla
250/25 (250 microgram fluticasone
propionate and 25 microgram
salmeterol).
Fluticasone + Salmeterol Cipla is used to help
with asthma and chronic obstructive pulmonary
disease (COPD) in people who need regular
treatment.
Asthma is a condition affecting the lungs.
Symptoms of asthma include shortness of breath,
wheezing, chest tightness and cough. Two main
causes of asthma symptoms are
bronchoconstriction (tightening of the muscle
surrounding the airways) and inflammation
(swelling and irritation of the airways).
Chronic obstructive pulmonary disease (COPD) is
a long-term condition affecting the lungs,
resulting
from chronic bronchitis or emphysema.
Symptoms
of COPD include shortness of breath, cough, chest
discomfort and coughing up phlegm. The COPD
symptoms are mainly due to bronchoconstriction
(tightening of the muscle surrounding the airways)
and inflammation (swelling and irritation of the
airways).
Fluticasone + Sal

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION –
FLUTICASONE + SALMETEROL CIPLA 125/25 (FLUTICASONE PROPIONATE/
SALMETEROL (AS XINAFOATE))
FLUTICASONE + SALMETEROL CIPLA 250/25 (FLUTICASONE PROPIONATE/
SALMETEROL (AS XINAFOATE))
1
NAME OF THE MEDICINE
Fluticasone propionate/ Salmeterol xinafoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single actuation of Fluticasone + Salmeterol Cipla pressurised
metered dose inhalation
contains, 125 micrograms or 250 micrograms of fluticasone propionate
(delivered from the
valve) and 25 micrograms of salmeterol (as salmeterol xinafoate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Pressurised Inhalation
Fluticasone + Salmeterol Cipla 125/25 are a rigid, aluminium,
container fitted with a metered
dose valve, containing a white homogeneous suspension, fitted to a
plastic actuator with a white
coloured body and pink coloured cap, with a dose indicator.
Fluticasone + Salmeterol Cipla 250/25 are a rigid, aluminium,
container fitted with a metered
dose valve, containing a white homogeneous suspension, fitted to a
plastic actuator with a white
coloured body and rubin red coloured cap, with a dose indicator.
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 the following:

Patients on effective maintenance doses of long-acting beta-2 agonists
and inhaled
corticosteroids

Patients who are symptomatic on current inhaled corticosteroid therapy
Fluticasone propionate 125 microgram/actuation + salmeterol 25
microgram/actuation
pressurised inhalation, 120 actuations
NOTE:

This product is not indicated for initiation of treatment in asthma

This product is not PBS-subsidised for the treatment of chronic
obstructive pulmonary
disorder (COPD)

The Patient must not be on a concomitant single agent
long-acting-beta-2-agonist (LABA)

A LABA includes olodaterol, indacaterol, salmeterol, formoterol or
vilanterol

Adherence to curr