Mesaflu Forspiro 50 mikrogram/250 mikrogram/dos Inhalationspulver, avdelad dos

Страна: Швеція

мова: шведська

Джерело: Läkemedelsverket (Medical Products Agency)

Активний інгредієнт:

flutikasonpropionat; salmeterol

Доступна з:

Sandoz A/S

Код атс:

R03AK06

ІПН (Міжнародна Ім'я):

fluticasone propionate; salmeterol

Дозування:

50 mikrogram/250 mikrogram/dos

Фармацевтична форма:

Inhalationspulver, avdelad dos

Склад:

laktitolmonohydrat Hjälpämne; salmeterol 0,05 mg Aktiv substans; flutikasonpropionat 0,25 mg Aktiv substans

Тип рецепту:

Receptbelagt

Огляд продуктів:

Förpacknings: Inhalator, 1 x 60 doser; Inhalator, 10 x 60 doser; Inhalator, 6 x 60 doser; Inhalator, 5 x 60 doser; Inhalator, 4 x 60 doser; Inhalator, 3 x 60 doser; Inhalator, 2 x 60 doser

Статус Авторизація:

Avregistrerad

Дата Авторизація:

2015-11-19

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
Mesaflu Forspiro, 50 microgram/250 microgram/dose, inhalation powder,
predispensed
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 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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Mesaflu Forspiro is and what it is used for
2. What you need to know before you use Mesaflu Forspiro
3. How to use Mesaflu Forspiro
4. Possible side effects
5. How to store Mesaflu Forspiro
6. Contents of the pack and other information
1.
WHAT MESAFLU FORSPIRO IS AND WHAT IT IS USED FOR
Mesaflu Forspiro is used to treat:

asthma
This medicine contains two active substances.

Salmeterol: a long-acting substance that widens the airways

Fluticasone: a corticosteroid which reduces swelling and inflammation
in the lungs
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MESAFLU FORSPIRO
DO NOT USE MESAFLU FORSPIRO

if you are
ALLERGIC
to salmeterol, fluticasone or to the other ingredient of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Mesaflu Forspiro if you
have:

heart disease, including an irregular or fast heartbeat

overactive thyroid gland

high blood pressure

diabetes mellitus (Mesaflu Forspiro may increase your blood sugar)

low potassium in your blood

tuberculosis (TB) now or in the past or other lung infections
Contact your doctor if you experience blurred vision or other visual
disturbances.
Mesaflu Forspiro prevents the onset of breathlessness and wheezing.
Please note that it does
not work whe

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mesaflu Forspiro, 50 microgram/250 microgram/dose, inhalation powder,
pre-dispensed
Mesaflu Forspiro, 50 microgram/500 microgram/dose, inhalation powder,
predispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of Mesaflu Forspiro provides:
For 50 microgram/250 microgram/dose, inhalation powder, pre-dispensed:
50 micrograms of salmeterol (as salmeterol xinafoate) and 250
micrograms of fluticasone propionate.
Corresponding with a delivered dose of:
45 micrograms of salmeterol (as salmeterol xinafoate) and 233
micrograms of fluticasone propionate
Excipient with known effect: lactose monohydrate: 12.20 mg per metered
dose
Each metered dose of Mesaflu Forspiro provides:
For 50 microgram/500 microgram/dose, inhalation powder, predispensed:
50 micrograms of salmeterol (as salmeterol xinafoate) and 500
micrograms of fluticasone propionate.
Corresponding with a delivered dose of:
45 micrograms of salmeterol (as salmeterol xinafoate) and 465
micrograms of fluticasone propionate
Excipient with known effect: lactose monohydrate: 11.95 mg per metered
dose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
White, homogenous powder.
The pre-dispensed powder, contained in blister, is delivered by a
purple plastic dry-powder inhalation
device.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ASTHMA_
Mesaflu Forspiro 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 corticosteroid
and long-acting β
2
agonist.
_CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_
Mesaflu Forspiro is indicated for the symptomatic treatment of
patients with COPD, with a FEV
1
<60% predicted normal (pre-bronchodilator) and a history of