Seretide Diskus 50 microgram/250 microgram/ dose inhalation powder, pre-dispensed

Country: Malta

Language: English

Source: Medicines Authority

Available from:

NeoFarma Pharmaceuticals Limited 42-46, Mill Street, Qormi, QRM 3105, Malta

ATC code:

R03AK06

INN (International Name):

SALMETEROL XINAFOATE 50 µg FLUTICASONE PROPIONATE 250 µg

Pharmaceutical form:

INHALATION POWDER, PRE-DISPENSED

Composition:

SALMETEROL XINAFOATE 50 µg FLUTICASONE PROPIONATE 250 µg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Product summary:

Licence number in the source country: Latvia - 00-0934

Authorization status:

Authorised

Authorization date:

2024-01-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SERETIDE DISKUS 50 MICROGRAM/250 MICROGRAM/ DOSE
INHALATION POWDER, PRE-DISPENSED
salmeterol/fluticasone propionate
Read all of this leaflet carefully before you start taking this
medicine because it contains
important information for you.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others.
It may harm them, even if their signs of illness 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 Seretide is and what it is used for
2.
What you need to know before you use Seretide
3.
How to use Seretide
4.
Possible side effects
5.
How to store Seretide
6.
Contents of the pack and other information
1.
WHAT SERETIDE IS AND WHAT IT IS USED FOR
Seretide 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
•
Chronic Obstructive Pulmonary Disease (COPD). Seretide Diskus, at a
dose
of 50/500 micrograms, reduces the number of flare ups of COPD
symptoms.
You must use Seretide every day as directed by your doctor. This will
make sure that it
works properly in controlling your asthma or COPD.
Seretide helps to stop breathlessness and wheeziness coming on.
However Seretide
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' in

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Seretide Diskus 50 microgram/250 microgram/ dose inhalation powder,
pre-dispensed.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains 50 micrograms

(g) of salmeterol (
_Salmeterolum_
) as salmeterol xynafoate and 250 of
fluticasone
_ propionate_
.
Excipients with known effect:
Each delivered dose contains up to 12.5 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
Moulded plastic device containing a foil strip with 28 or 60 regularly
placed blisters.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ASTHMA _
Seretide is indicated in the regular treatment of asthma where use of
a combination product (long-
acting

2
agonist and inhaled corticosteroid) is appropriate:
-
patients not adequately controlled with inhaled corticosteroids and
‘as needed’ inhaled
short-acting

2
agonist
or
-
patients already adequately controlled on both inhaled corticosteroid
and long-acting

2
agonist.
Note: Seretide 50 microgram /100 microgram strength is not appropriate
in adults and children with
severe asthma.
_CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) _
Seretide is indicated for the symptomatic treatment of patients with
COPD, with a FEV
1
<60%
predicted normal (pre-bronchodilator) and a history of repeated
exacerbations, who have significant
symptoms despite regular bronchodilator therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
Route of administration: Inhalation use.
Patients should be made aware that Seretide Diskus must be used daily
for optimum benefit, even
when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of Seretide they are
receiving remains optimal and is only changed on medical advice.
Patients should be given the strength of Seretide containing the
appropriate fluticasone propionate
dosage for the severity of their disease. If an individual patient
should require dosages ou