Duohal 25 mikrogram/250 mikrogram/dos Inhalationsspray, suspension

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

flutikasonpropionat; salmeterolxinafoat

Available from:

Cipla Europe NV

ATC code:

R03AK06

INN (International Name):

fluticasone propionate; salmeterol

Dosage:

25 mikrogram/250 mikrogram/dos

Pharmaceutical form:

Inhalationsspray, suspension

Composition:

salmeterolxinafoat 36,32 mikrog Aktiv substans; flutikasonpropionat 250 mikrog Aktiv substans

Prescription type:

Receptbelagt

Product summary:

Förpacknings: Spraybehållare, 10 x 120 doser (sjukhusförpackning); Spraybehållare, 2 x 120 doser; Spraybehållare, 3 x 120 doser; Spraybehållare, 120 doser

Authorization status:

Godkänd

Authorization date:

2016-12-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DUOHAL 25 MICROGRAMS /125 MICROGRAMS /DOSE PRESSURISED INHALATION,
SUSPENSION
DUOHAL 25 MICROGRAMS /250 MICROGRAMS /DOSE PRESSURISED INHALATION,
SUSPENSION
Salmeterol/fluticasone propionate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
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 or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Duohal is and what it is used for
2.
What you need to know before you use Duohal
3.
How to use Duohal
4.
Possible side effects
5.
How to store Duohal
6.
Contents of the pack and other information
1.
WHAT DUOHAL
IS AND WHAT IT IS USED FOR
Duohal 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.
You must use Duohal every day as directed by your doctor. This will
make sure that it works properly in
controlling your asthma.
Duohal helps to stop breathlessness and wheeziness coming on. However
Duohal should not be used to
relieve a sudden attack of breathlessness or wheezing. If that happens
you need to use a fast acting ‘reliever’
(rescue) inhaler, such as salbutamol.
You should always have your fast-acting ‘rescue’ inhaler with you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DUOHAL
DO NOT TAKE DUOHAL:
If you

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Duohal 25 micrograms/125 micrograms /dose pressurised inhalation,
suspension
Duohal 25 micrograms/250 micrograms /dose pressurised inhalation,
suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of Duohal provides:
25 micrograms of salmeterol (as salmeterol xinafoate) and 125 or 250
micrograms of fluticasone
propionate (delivered from the valve). This is equivalent to 21
micrograms of salmeterol and 110
or 220 micrograms of fluticasone propionate delivered from the
actuator (delivered dose).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
The canister contains a white homogeneous suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Duohal is indicated in the regular treatment of asthma where use of a
combination product (long-
acting β
2
agonist and inhaled corticosteroid) is appropriate:
-
patients not adequately controlled with inhaled corticosteroids and
'as needed' inhaled short
acting β
2
agonist
or
-
patients already adequately controlled on both inhaled corticosteroids
and long-acting β
2
agonist.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Duohal is for inhalation use only.
Patients should be made aware that Duohal must be used daily for
optimum benefit, even when
asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of Duohal they are
receiving remains optimal and is only changed on medical advice.
THE DOSE SHOULD BE TITRATED
TO THE LOWEST DOSE AT WHICH EFFECTIVE CONTROL OF SYMPTOMS IS
MAINTAINED.
Where the control of symptoms is maintained with the lowest strength
of Duohal (25/125
microgram), the next step could include a swap to a different inhaled
salmeterol fluticasone
product available in a lower strength (25/50 micrograms).
As an alternative, patients requiring a long-acting β
2
agonist could be titrated to
salmeterol/fluticasone propionate given once daily if, in the opinion
of the prescriber,