Fluticasone Elpen 250 mikrogram/dos Inhalationspulver, avdelad dos

Valsts: Zviedrija

Valoda: zviedru

Klimata pārmaiņas: Läkemedelsverket (Medical Products Agency)

Aktīvā sastāvdaļa:

flutikasonpropionat

Pieejams no:

Elpen Pharmaceutical Co. Inc

ATĶ kods:

R03BA05

SNN (starptautisko nepatentēto nosaukumu):

fluticasone propionate

Deva:

250 mikrogram/dos

Zāļu forma:

Inhalationspulver, avdelad dos

Kompozīcija:

flutikasonpropionat 250 mikrog Aktiv substans; laktosmonohydrat Hjälpämne

Receptes veids:

Receptbelagt

Produktu pārskats:

Förpacknings: Inhalatorer, 120 (2 x 60) doser (2 st Elpenhaler); Inhalator, 30 doser (1 st Elpenhaler); Inhalator, 60 doser (1 st Elpenhaler)

Autorizācija statuss:

Godkänd

Autorizācija datums:

2019-03-28

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUTICASONE ELPEN 250 MICROGRAM/DOSE INHALATION POWDER, PRE-DISPENSED
FLUTICASONE ELPEN 500 MICROGRAM/DOSE INHALATION POWDER, PRE-DISPENSED
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you use
3.
How to use
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
is a cortisone preparation that counteracts
inflammation and allergy directly
in the lungs. Reducing inflammation can prevent asthma attacks.
is used as a regular treatment for asthma and COPD
(Chronic Obstructive
Pulmonary Disease) together with a long-acting bronchodilator. The
full effect is first observed
after several days of regular treatment. does not
provide rapid relief in the event
of acute asthma attacks. If such event occur, a quick and short-acting
bronchodilator medicine
should be used. If the treatment does not give the desired effect,
consult a doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
DO NOT USE
-
if you are allergic to fluticasone propionate or any of the other
ingredients in this medicine
(specified in section 6). Lactose monohydrate may contain
lactoprotein.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before using .
is not intended

Produkta apraksts

1.
ΝΑΜΕ OF THE MEDICINAL PRODUCT
Fluticasone Elpen 250 microgram per dose inhalation powder,
pre-dispensed
Fluticasone Elpen 500 microgram per dose inhalation powder,
pre-dispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 250 microgram contains 250 microgram of
fluticasone propionate.
Each dose of 500 microgram contains 500 microgram of
fluticasone propionate
Excipient with known effect:
Each dose of 250 microgram & 500 microgram contains
approximately 14 mg of
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
White powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bronchial asthma
_IN ADULTS_
.
For the treatment of severe chronic obstructive pulmonary disease,
COPD (FEV1 <50% the predicted
normal value) in combination with long-acting bronchodilators in
patients with a history of recurrent
exacerbations
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
is intended for oral inhalation only.
Patients should be made aware that treatment with is
prophylactic and that it must be
used daily for optimum therapeutic effect, even in the absence of
symptoms.
If the patient experiences that the treatment with a short-acting
bronchodilator becomes less effective
or that more inhalations than usual are needed, he should seek medical
attention.
The dose should be titrated until effective control of symptoms is
achieved, or reduced to the lowest
effective dose according to individual response.
_Asthma_
Dosage is individual.
_Adults 250 or 500 microgram twice daily._
Prescribers should be awareasthma that fluticasone propionate is as
effective as other inhaled steroids
at approximately half the daily dose expressed in micrograms, e.g. 100
micrograms fluticasone
propionate corresponds to approximately 200 micrograms beclomethasone
dipropionate (inhalation
spray with freons) or budesonide.
A temporary dose increase may become necessary (in adults, up to 2,000
micrograms