Zenhale Pressurized Inhalation Suspension 50/5mcg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FORMOTEROL FUMARATE; MOMETASONE FUROATE

Boleh didapati daripada:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

FORMOTEROL FUMARATE; MOMETASONE FUROATE

Unit dalam pakej:

1units Units

Dikeluarkan oleh:

3M Health Care Limited.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
ZENHALE
®
Mometasone Furoate/Formoterol Fumarate Dihydrate (50/5mcg, 100/5mcg,
200/5mcg)
1
WHAT IS IN THIS LEAFLET
1.
What ZENHALE is used for
2.
How ZENHALE works
3.
Before you use ZENHALE
4.
How to use ZENHALE
5.
While you are using ZENHALE
6.
Side effects
7.
Storage and Disposal of ZENHALE
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ZENHALE IS USED FOR
Your doctor has prescribed ZENHALE
to help control asthma.
ZENHALE is used twice a day to help
people 12 years of age or older who
need treatment for asthma and the
doctor recommends a combination
product.
ZENHALE is not a rescue medication.
Your doctor should prescribe a rescue
medication for you. Use the rescue
medication if you have sudden asthma
symptoms.
ZENHALE is for patients with asthma
that:

was not well controlled with other
asthma controlling medications or

is severe enough that the doctor
recommends starting asthma treatment
with two asthma medications
This medicine is for YOU. Only a doctor
can prescribe it for you. Never give it to
someone else. It may harm them, even if
their symptoms are the same as yours.
HOW ZENHALE WORKS
ZENHALE contains two medicines,
mometasone furoate and formoterol
fumarate dihydrate:

Mometasone furoate is a
corticosteroid. Corticosteroids are used
to prevent asthma attacks because they
have an anti-inflammatory effect
(reduce swelling and irritation in the
walls of the small air passages of the
lungs), easing breathing problems.

Formoterol fumarate dihydrate is a
long-acting bronchodilator.
Bronchodilators help the airways in the
lungs to stay open. It makes breathing
easier by relaxing muscle spasms in the
air passages of the lungs. The effects
last for 12 hours.
BEFORE YOU USE ZENHALE
SERIOUS WARNINGS FOR ASTHMA
PATIENTS
Formoterol, one of the medicines in
ZENHALE, may increase the risk of
asthma-related death. It may increase
the risk of asthma-related
hospitalization in paediatrics and
adolescent pat

Ciri produk

ZENHALE ® LPC -MK0887A -AO -062014 a
PRESSURIZED INHALATI ON SUSPENSION
50/5 mcg , 100/5 mcg , 200/5mcg
mometasone furoate / formoterol fumarate dihydrat e
HEALTH PROFESSIONAL INFORMATION
Route of
Administration
Dosage Form /
Strength
Nonmedicinal Ingredients
oral Pressurized Inhalation
Suspension /
50, 100 or 200 mcg
mometasone furoate &
5 mcg formoterol
fumarate dihydrate per
actuation
Ethanol, HFA ( propellant), oleic acid
INDICATIONS AND CLINICAL USE
ZENHALE (mometasone furoate / formoterol fumarate dihydrate pressurized inhalation
suspension ), is indicated for the treatment of asthma, in patients 12 years of age and older with
reversible obstruc tive airway disease.
ZENHALE is not indicated for patients whose asthma can be managed by occasional use of a
rapid onset, short duration, inhaled beta 2-agonist, or for patients whose asthma can be
successfully managed by inhaled corticosteroids along wit h occasional use of a rapid onset,
short duration, inhaled beta 2-agonist.
Long -acting beta 2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients
in ZENHALE may increase the risk of asthma -related death. Available data from contro lled
clinical trials suggest that LABA increase the risk of asthma -related hospitalization in pediatric
and adolescent patients (see WARNINGS AND PRECAUTIONS). Therefore, when treating
patients with asthma, physicians should only prescribe ZENHALE for pati ents not adequately