Sereflo 25 microgram/125 microgram per actuation pressurised inhalation, suspension

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

제공처:

Fannin Limited

ATC 코드:

R03AK; R03AK06

INN (국제 이름):

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

복용량:

25 / 125 microgram(s)/dose

약제 형태:

Pressurised inhalation, suspension

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salmeterol and fluticasone

승인 상태:

Marketed

승인 날짜:

2017-03-10

환자 정보 전단

1
0008a
PACKAGE LEAFLET: INFORMATION FOR THE USER
salmeterol/fluticasone propionate
READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
KEEP THIS LEAFLET. YOU MAY NEED IT TO READ IT AGAIN.
•
IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR
PHARMACIST.
•
THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU PERSONALLY AND YOU SHOULD
NOT PASS IT ON TO OTHERS.
IT MAY HARM THEM, EVEN IF THEIR SYMPTOMS 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.
Sereflo 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 Sereflo every day as directed by your doctor. This will
make sure that it works
properly in controlling your asthma.
SEREFLO HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON.
HOWEVER, SEREFLO 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’ INHALER WITH YOU.
DO NOT TAKE SEREFLO:
If you are allergic (hypersensitive) to salmeterol, fluticasone
propionate or to the other ingredient
norflurane (HFA134a).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE USING SEREFLO IF YOU HAVE:
•
Heart disease, including an irregular or fast heart beat
•
Overactive thyroid gland
•
High blood pressure
•
Diabetes mellitus (Sereflo may increase your blood sugar)
SEREFLO 25MICROGRAM/125 MICROGRAM PER ACTUATION PRESSURISED
INHALATION, SUSPENS

제품 특성 요약

Health Products Regulatory Authority
24 October 2019
CRN0091GM
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sereflo 25 microgram/125 microgram per actuation pressurised
inhalation, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex valve) contains:
25 micrograms of salmeterol (as salmeterol xinafoate) and 125
micrograms of fluticasone propionate. This is equivalent to a
delivered dose (ex actuator) of 21 micrograms of salmeterol and 110
micrograms of fluticasone propionate.
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
The canister contains a white to off-white suspension.
The canisters are fitted into white plastic actuators incorporating an
atomising orifice and fitted with pink dust-caps.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SEREFLO IS INDICATED FOR USE IN ADULTS WITH ASTHMA 18 YEARS OF AGE AND
OLDER ONLY.
Sereflo is indicated in the regular treatment of patients with
moderate to severe asthma where use of a combination product
(long-acting β
2
agonist and inhaled corticosteroid) is appropriate:

patients not adequately controlled on a lower strength corticosteroid
combination product
or

patients already adequately controlled on an inhaled corticosteroidin
a mid or high strength and a long-acting β
2
agonist.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Sereflo is indicated in adults 18 years of age and older only.
Sereflo is not indicated for use in children, 12 years of age or
younger, or adolescents, 13 to 17 years of age.
Posology
Route of administration: Inhalation use.
Patients should be made aware that Sereflo must be used daily for
optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of Sereflo 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.
NOTE: Sereflo is only available in two