Atimos Modulite 12micrograms/dose inhaler

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Formoterol fumarate dihydrate

Available from:

Chiesi Ltd

ATC code:

R03AC13

INN (International Name):

Formoterol fumarate dihydrate

Dosage:

12microgram/1dose

Pharmaceutical form:

Pressurised inhalation

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03010101; GTIN: 5028613002759

Patient Information leaflet

87H03.08/01
Note per il fornitore: Microforatura lungo la piega centrale a
discrezione del fornitore / PIEGA CON CODICI A
BARRE A VISTA
PAG. 1/2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATIMOS
®
MODULITE
®
12 MICROGRAMS/ACTUATION PRESSURISED INHALATION SOLUTION
Formoterol fumarate dihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them even if
their
symptoms are the same as yours.
-
I
f any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET:
1.
WHAT ATIMOS MODULITE IS AND WHAT IT IS USED FOR
2.
BEFORE YOU USE ATIMOS MODULITE
3.
HOW TO USE ATIMOS MODULITE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ATIMOS MODULITE
6.
FURTHER INFORMATION
1. WHAT ATIMOS MODULITE IS AND WHAT IT IS USED FOR
Atimos Modulite is an inhalation medicine delivering its active
ingredient directly into your lungs where it is
needed. It is used to treat the symptoms of wheezing and
breathlessness in patients with moderate to severe
asthma. Its active ingredient, formoterol fumarate, belongs to a group
of medicines called bronchodilators: they
make breathing easier by relaxing muscle spasms in the air passages of
the lungs. Regular use of Atimos
Modulite together with steroids (either by inhaler or by mouth), will
help to prevent breathing problems over the
long term.
Atimos Modulite can also be used for the relief of symptoms such as
cough, wheezing and shortness of breath in
patients with chronic obstructive pulmonary disease (COPD) who require
long-term regular bronchodilator
therapy.
2. BEFORE YOU USE ATIMOS MODULITE
DO NOT USE ATIMOS MODULITE:
•
if you are allergic to formoterol or to any of the ingredients of
Atimos Modulite.
•
TO TREAT A SUDDEN ATTACK OF BREATHLESSNESS. It will not help. Use a
relie

Summary of Product characteristics

OBJECT 1
ATIMOS MODULITE 12 MICROGRAMS INHALER
Summary of Product Characteristics Updated 21-Oct-2015 | Chiesi
Limited
1. Name of the medicinal product
Atimos Modulite 12 micrograms/actuation pressurised inhalation
solution
2. Qualitative and quantitative composition
Each metered dose contains 12 micrograms of formoterol fumarate
dihydrate. This corresponds to a
delivered dose of 10.1 micrograms.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Pressurised inhalation solution
4. Clinical particulars
4.1 Therapeutic indications
For the long-term symptomatic treatment of persistent, moderate to
severe asthma in patients requiring
regular bronchodilator therapy in combination with long-term
anti-inflammatory therapy (inhaled and / or
oral glucocorticoids).
Glucocorticoid therapy should be continued on a regular basis.
Atimos is indicated for the relief of broncho-obstructive symptoms in
patients with chronic obstructive
pulmonary disease (COPD).
4.2 Posology and method of administration
The dosage depends on the type and severity of disease.
The following dosages are recommended for adults, including elderly
patients, and adolescents aged 12
years and above:
Asthma
Adults and adolescents aged 12 years and above
Usually one actuation in the morning and evening (24 micrograms of
formoterol fumarate dihydrate per
day). In severe cases, up to a maximum of two actuations in the
morning and evening (48 micrograms of
formoterol fumarate dihydrate per day).
The maximum daily dose is 4 actuations (48 micrograms of formoterol
fumarate dihydrate).
Children younger than 12 years of age:
The safety and efficacy of Atimos Modulite in children younger than 12
years of age has not been
established yet, therefore Atimos Modulite should not be used in
children.
Chronic Obstructive Pulmonary Disease (COPD)
Adults (aged 18 years and above)
The usual dose is one actuation twice daily (one in the morning and
one in the evening, 24 micrograms
formoterol fumarate dihydrate per day).
The daily dose for regular use shoul