Seretide 250 Accuhaler

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Fluticasone propionate; Salmeterol xinafoate

Tilgængelig fra:

CST Pharma Ltd

ATC-kode:

R03AK06

INN (International Name):

Fluticasone propionate; Salmeterol xinafoate

Dosering:

250microgram/1dose ; 50microgram/1dose

Lægemiddelform:

Inhalation powder

Indgivelsesvej:

Inhalation

Klasse:

No Controlled Drug Status

Recept type:

Caution - AMP level prescribing advised

Produkt oversigt:

BNF: 03020000; GTIN: 5055946801162

Indlægsseddel

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SERETIDE™ 250 ACCUHALER™
(salmeterol xinafoate / fluticasone propionate)
Seretide Accuhaler is available in different strengths. Seretide 250
Accuhaler will be referred to
as Seretide Accuhaler 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 ACCUHALER IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SERETIDE ACCUHALER
3.
HOW TO USE SERETIDE ACCUHALER
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SERETIDE ACCUHALER
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT SERETIDE ACCUHALER IS AND WHAT IT IS USED FOR
Seretide Accuhaler 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 Accuhaler every day as directed by your doctor.
This will make sure that
it works properly in controlling your asthma or COPD.
SERETIDE ACCUHALER HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING
ON. HOWEVER
SERETIDE ACCUHALER S

Produktets egenskaber

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
As per UK PL no 00057/0277
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
As per UK PL no 00057/0277
4.3.
CONTRA-INDICATIONS
As per UK PL no 00057/0277
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As per UK PL no 00057/0277
4.5.
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
As per UK PL no 00057/0277
4.6.
PREGNANCY AND LACTATION
As per UK PL no 00057/0277
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
As per UK PL no 00057/0277
4.8.
UNDESIRABLE EFFECTS
As per UK PL no 00057/0277
4.9.
OVERDOSE
As per UK PL no 00057/0277
PHARMACOLOGICAL PROPERTIES
5.1.
Pharmacodynamic Properties
As per UK PL no 00057/0277
5.2.
PHARMACOKINETIC PROPERTIES
As per UK PL no 00057/0277
5.3.
PRECLINICAL SAFETY DATA
None stated.
PHARMACEUTICAL PARTICULARS
6.1.
List of Excipients
As per ECMA no 026821013 issued by Italy
6.2.
INCOMPATIBILITIES
As per UK PL no 00057/0277
6.3.
SHELF LIFE
36 Months (unopened)
6.4.
SPECIAL PRECAUTIONS FOR STORAGE
Store below 30°C.
6.5.
NATURE AND CONTENTS OF CONTAINER
Blister strips in cardboard carton
Pack size : 30
6.6.
INSTRUCTION FOR USE/HANDLING
None stated.
ADMINISTRATIVE DATA
7.
Marketing Authorisation Holder
Waymade Plc
Miles Gray Road
Basildon
Essex SSl4 3FR
8.
MARKETING AUTHORIZATION NUMBER
PLPI 06464/0315
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
None stated.
10.
DATE OF (PARTIAL) REVISION OF THE TEXT
None stated.