Seretide 500 Accuhaler

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluticasone propionate; Salmeterol xinafoate

Available from:

CST Pharma Ltd

ATC code:

R03AK06

INN (International Name):

Fluticasone propionate; Salmeterol xinafoate

Dosage:

500microgram/1dose ; 50microgram/1dose

Pharmaceutical form:

Inhalation powder

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 03020000; GTIN: 5055946801186

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SERETIDE
® 500 ACCUHALER
®
(SALMETEROL XINAFOATE/ FLUTICASONE PROPIONATE)
The name of your medicine is Seretide 500 Accuhaler but will
be referred to Seretide throughout this leaflet.
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
symptoms and 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 Accuhaler, 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

Summary of Product characteristics

PRODUCT SUMMARY
1.
Trade Name of the Medicinal Product
Not applicable.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Not applicable.
3.
PHARMACEUTICAL FORM
Not applicable.
CLINICAL PARTICULARS
4.1.
Therapeutic Indications
Not applicable.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Not applicable.
4.3.
CONTRA-INDICATIONS
Not applicable.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not applicable.
4.5.
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
Not applicable.
4.6.
PREGNANCY AND LACTATION
Not applicable.
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable.
4.8.
UNDESIRABLE EFFECTS
Not applicable.
4.9.
OVERDOSE
Not applicable.
PHARMACOLOGICAL PROPERTIES
5.1.
Pharmacodynamic Properties
Not applicable.
5.2.
PHARMACOKINETIC PROPERTIES
Not applicable.
5.3.
PRECLINICAL SAFETY DATA
Not applicable.
PHARMACEUTICAL PARTICULARS
6.1.
List of Excipients
Not applicable.
6.2.
INCOMPATIBILITIES
Not applicable.
6.3.
SHELF LIFE
Not applicable.
6.4.
SPECIAL PRECAUTIONS FOR STORAGE
Not applicable.
6.5.
NATURE AND CONTENTS OF CONTAINER
Not applicable.
6.6.
INSTRUCTION FOR USE/HANDLING
Not applicable.
ADMINISTRATIVE DATA
7.
Marketing Authorisation Holder
Not applicable.
8.
MARKETING AUTHORIZATION NUMBER
Not applicable.
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Not applicable.
10.
DATE OF (PARTIAL) REVISION OF THE TEXT
Not applicable.