FENOROL 12mcg Inhalation Powder Hard Capsules

Pays: Malaisie

Langue: anglais

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingrédients actifs:

FORMOTEROL FUMARATE

Disponible depuis:

EURODRUG LABORATORIES (M) SDN BHD

DCI (Dénomination commune internationale):

FORMOTEROL FUMARATE

Unités en paquet:

60capsule Capsules

Fabriqué par:

Laboratorios Liconsa

Notice patient

FENOROL 12MCG INHALATION
POWDER HARD CAPSULES
_Formoterol Fumarate Dihydrate 12mcg _
_Consumer Medication Information Leaflet (RiMUP _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
WHAT FENOROL IS USED FOR
2.
HOW FENOROL WORKS
3.
BEFORE YOU USE FENOROL
4.
HOW TO USE FENOROL
5.
WHILE YOU ARE USING IT
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
FENOROL
8.
FURTHER INFORMATION
medical conditions such as:
•
Allergic or sensitive to or have had a
reaction to any of the ingredients in
the medicine
•
Have certain types of heart problems
•
Have thyrotoxicosis
•
Have diabetes
•
Have an aneurysm
•
Have phaeochromocytoma
•
Have high blood pressure
•
Have liver problems
4. HOW TO USE FENOROL
HOW MUCH TO USE
Always take this medicine exactly as
your doctor has told you. Check with
your doctor or pharmacist if you are not
sure.
ASTHMA
In asthma, Fenorol can be used once or
twice daily (‘regular dosage’), and as
•
Have kidney problems
‘relief medication’ to relieve acute
broncho-obstructive symptoms.
1.
WHAT FENOROL IS USED FOR
Fenorol is used to treat asthma in people
who are already taking inhaled steroids
but still have symptoms such as
wheezing and breathlessness. Taking
Fenorol regularly together with inhaled
steroids will help to prevent breathing
problems.
Fenorol is also used to treat breathing
problems in patients with chronic
obstructive pulmonary disease (COPD).
2.
HOW FENOROL WORKS
Fenorol contains Formoterol Fumarate
Dihydrate, which is a bronchodilator.
Formoterol Fumarate Dihydrate works
in the air passages of the lungs. It helps
to keep the airways open, making it
easier to breathe.
3.
BEFORE YOU USE FENOROL
WHEN YOU MUST NOT USE IT
If you Allergic or sensitive to or have
had a reaction to any of the ingredients
in the medicine.
Do not use this medicine in children
under 6 years of age.
BEFORE YOU START TO USE IT
Talk to your doctor or, pharmacist or
nurse before using Fenorol.
Your doctor will supervise your
treatment more closely if you have
If you have ever had any of these
conditions, tell your

Résumé des caractéristiques du produit

FRONT SIDE / ANVERSO
140 x 540 1 mm
0234
100%
Dimensions:
Scale:
Material
type:
Leaflet
Drawing #:
Date:
Version:
B
xxxx
09.05.19
-
LF FENOROL FORMO 12MCG X60 EXELTIS MY
Laetus #:
Folded:
YES
NO
Substitutes
mat. #:
Material #/
Product :
LICONSA
LEON FARMA
X
Launch:
Internal change:
Customer change:
X
Pantones:
1 fold in horizontal to 140 x 270mm
3 folds in horizontal to 140 x 34mm
die cut
black
0000
Signature:
Date:
With the signed proof of this file you commit to have had reviewed and
agreed with the following points as part of your
review:
- Keyline used.
- Free varnish areas.
- Colors.
- Text.
- Prefixes order for variable info (If the order is changed you
commint to clearly comunicate this change to
Chemo's artworks department, otherwise Chemo will not be responsible).
- Any other info included in the file.
DRAWED BY:
APPROVED BY CUSTOMER (Regulatory Affair or Quality Assurance)
Pharma Code
Read Directions
XXXX
PHARMA CODE
PHARMA CODE
CONTRAINDICATIONS
Hypersensitivity to the active
substance(s) or to any of the excipients
PRECAUTIONS
Asthma related death
Formoterol fumarate dihydrate, the active
ingredient of Fenorol, belongs to the class
of long acting beta2adrenergic agonists
(LABAs). In a study with salmeterol, a
different long acting beta2agonist, a
higher rate of death due to asthma was
observed in the patients treated with
salmeterol (13/13,176) than in the
placebo group (3/13,179). No study
adequate to determine whether the rate of
asthma related death is increased with
Fenorol has been conducted.
_IN THE TREATMENT OF ASTHMA_
Fenorol should not be used (and is not
sufficient) as the first treatment for
asthma.
When treating patients with asthma, use
Fenorol only as an add on to an inhaled
corticosteroid (ICS) for patients who are
not adequately controlled on an ICS
alone or whose disease severity clearly
warrants initiation of treatment with both
an ICS and a LABA.
Children up to the age of 6 years should
not be treated with Fenorol as sufficient
experience is not
available for this group.
For childre