MIFLONIDE POWDER FOR INHALATION 400 MCGCAPSULE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BUDESONIDE

Available from:

NOVARTIS ISRAEL LTD

ATC code:

R03BA02

Pharmaceutical form:

CAPSULES

Composition:

BUDESONIDE 400 MCG

Administration route:

INHALATION

Prescription type:

Required

Manufactured by:

PHARMACHEMIE B.V., THE NETHERLANDS

Therapeutic group:

BUDESONIDE

Therapeutic area:

BUDESONIDE

Therapeutic indications:

Maintenance treatment of bronchial asthma.

Authorization date:

2012-01-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s prescription only
MIFLONIDE
®
MIFLONIDE
®
POWDER FOR INHALATION
POWDER FOR INHALATION
200 MCG/CAPSULE
400 MCG/CAPSULE
CAPSULES
CAPSULES
THE ACTIVE INGREDIENT:
THE ACTIVE INGREDIENT:
Each capsule contains:
Each capsule contains:
Budesonide 200 mcg
Budesonide 400 mcg
Each 200 mcg capsule contains 230 mcg budesonide and releases 200 mcg
budesonide
when used with an Aerolizer inhaler.
Each 400 mcg capsule contains 460 mcg budesonide and releases 400 mcg
budesonide
when used with an Aerolizer inhaler.
INACTIVE INGREDIENTS:
See section 2 “Important information about some of the ingredients
of the medicine”
and section 6 “Further information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions, refer to
the doctor or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to others. It
may harm them even if it seems to you that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Maintenance treatment for pulmonary asthma.
THERAPEUTIC GROUP:
Glucocorticoids.
The medicine Miflonide is provided as a capsule. The capsule is to be
put in an inhaler
called Aerolizer. The inhaler opens the capsule and releases a dry
powder that is
delivered to the lungs by breathing in.
Miflonide contains an active ingredient called budesonide; this
substance belongs to a
group of medicines called corticosteroids )glucocorticoids(.
The medicine Miflonide is used to prevent asthma attacks and ease
breathing problems
in adults and children from age 6 and above. Use it regularly every
day, even if you feel
better, as this medicine will help to prevent future breathing
problems.
Do not use Miflonide to treat a sudden asthma attack. Use a different
inhaler to treat
these asthma attacks, such as albuterol or salbutamol.
Asthma is caused by inflammati

Summary of Product characteristics

MIF API MAR14 CL V7 COR CPO CL REF CDS 040713
די לע רשואו קדבנ ונכותו תואירבה דרשמ
י"ע עבקנ הז ןולע טמרופ
ו
ב
ץרמ
2014
.
MIFLONIDE

(BUDESONIDE)
200 or 400 microgram inhalation powder, hard capsules
PRESCRIBING INFORMATION
Trade name
Miflonide
®
Powder for Inhalation 200 mcg/capsule
Miflonide
®
Powder for Inhalation 400 mcg/capsule
1
DESCRIPTION AND COMPOSITION
Powder for inhalation in capsules to be used in combination with the
Aerolizer
®
.
Each capsule contains the equivalent of either 200 micrograms or 400
micrograms of
budesonide.
PHARMACEUTICAL FORM(S)
Inhalation powder, hard capsule_. _
The 200 microgram capsule has a pink opaque cap and a colourless
transparent body, printed

/
BUDE 200.
The 400 microgram capsule has a pink opaque cap and a colourless
transparent body, printed
with

/
BUDE 400.
ACTIVE SUBSTANCE
Budesonide
EXCIPIENTS
Lactose monohydrate (which contains milk proteins):
Each Capsule of Miflonide
®
Powder for Inhalation 200 mcg/capsule contains 24.77mg lactose
monohydtare.
Each Capsule of Miflonide
®
Powder for Inhalation 400 mcg/capsule contains 24.54mg lactose
monohydtare.
Page 2
MIF API MAR14 CL V7 COR CPO CL REF CDS 040713
2
INDICATIONS
Maintenance treatment of bronchial asthma.
3
DOSAGE AND ADMINISTRATION
DOSAGE
The dosage should be adjusted individually to the lowest dose required
for maintenance
therapy. Budesonide should be taken regularly every day. The dose
should be retitrated
individually when transferring a patient from one inhalation device to
another,. In order to
reduce the risk of candida infection it is recommended to rinse the
mouth well with water and
subsequently spit out the rinsing water after each administration (see
section 6 Warnings and
precautions and section 7 Adverse drug reactions). Rinsing the mouth
may also help to
prevent throat irritation and reduce the risk of systemic effects.
The lowest dosage in a single capsule is 200 micrograms. If a single
dose of less than 200
micrograms is required, t