FLUTIFORM 1255

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FLUTICASONE PROPIONATE; FORMOTEROL FUMARATE DIHYDRATE

Available from:

RAFA LABORATORIES LTD

ATC code:

R01AD08

Pharmaceutical form:

PRESSURISED SUSPENTION FOR INHALATION

Composition:

FLUTICASONE PROPIONATE 0.125 MG/DOSE; FORMOTEROL FUMARATE DIHYDRATE 0.005 MG/DOSE

Administration route:

INHALATION

Prescription type:

Required

Manufactured by:

RECIPHARM HC LIMITED, UK

Therapeutic group:

FLUTICASONE

Therapeutic area:

FLUTICASONE

Therapeutic indications:

The regular treatment of asthma where use of a combination product (an inhaled corticosteroid and a long -acting β2 agonist) is appropriate:• For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short -acting β2 agonist.• For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist.Flutiform 125mcg/5mcg inhaler is indicated in adults and adolescents aged 12 years and above.

Authorization date:

2018-07-31

Patient Information leaflet

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
FLUTIFORM 50/5
FLUTIFORM 125/5
FLUTIFORM 250/10
SUSPENSION FOR INHALATION
ACTIVE INGREDIENTS:
Each FLUTIFORM 50/5 inhaler actuation contains:
Fluticasone propionate 50 mcg and formoterol fumarate dihydrate 5 mcg.
Each FLUTIFORM 125/5 inhaler actuation contains:
Fluticasone propionate 125 mcg and formoterol fumarate dihydrate 5
mcg.
Each FLUTIFORM 250/10 inhaler actuation contains:
Fluticasone propionate 250 mcg and formoterol fumarate dihydrate 10
mcg.
For the list of additional ingredients, see section 6.
See also 'Important information about some of the medicine's
ingredients' in section 2.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further questions, please
refer to your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them,
even if it seems to you that their illness is similar to yours.
The use of Flutiform 50/5 is not intended for children under 5 years
of age.
The use of Flutiform 125/5 is not intended for children under 12 years
of age.
The use of Flutiform 250/10 is not intended for children and
adolescents under 18 years of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for treatment of asthma patients, in cases
suited for combined treatment of
corticosteroids and long-acting beta agonists by inhalation.
Fluticasone propionate helps to reduce swelling and inflammation in
the lungs.
Formoterol fumarate dihydrate is a long-acting bronchodilator which
helps the airways in your lungs
stay open, making it easier for you to breathe.
THERAPEUTIC GROUPS:
Fluticasone propionate: corticosteroids.
Formoterol fumarate dihydrate: beta agonist (long-acting).
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
You are sensitive (allergic) to the active ingredients or to any of
the ot

Summary of Product characteristics

DL-Flutiform-SPC-18- April 2023-02
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
FLUTIFORM 50 /5
FLUTIFORM 125 /5
FLUTIFORM 250 /10
PRESSURISED SUSPENSION FOR INHALATION
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex-valve) contains:
•
50 micrograms of fluticasone propionate and 5 micrograms of formoterol
fumarate dihydrate.
This is equivalent to a delivered dose (ex-actuator) of approximately
46 micrograms of
fluticasone propionate and 4.5 micrograms of formoterol fumarate
dihydrate.
•
125 micrograms of fluticasone propionate and 5 micrograms of
formoterol fumarate dihydrate.
This is equivalent to a delivered dose (ex-actuator) of approximately
115 micrograms of
fluticasone propionate and 4.5 micrograms of formoterol fumarate
dihydrate.
•
250 micrograms of fluticasone propionate and 10 micrograms of
formoterol fumarate dihydrate.
This is equivalent to a delivered dose (ex-actuator) of approximately
230 micrograms of
fluticasone propionate and 9.0 micrograms of formoterol fumarate
dihydrate.
Excipient with known effect
Each actuation contains 1 mg ethanol.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pressurised inhalation, suspension
The canister contains white to off white liquid suspension. The
canister is in a white actuator with a
grey integrated dose indicator and a light grey mouthpiece cover.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The regular treatment of asthma where use of a combination product (an
inhaled corticosteroid and a
long – acting β2 agonist) is appropriate:
•
For patients not adequately controlled with inhaled corticosteroids
and ‘as required’ inhaled
short -acting β2 agonist.
Or
•
For patients already adequately controlled on both an inhaled
corticosteroid and a long-acting β2
agonist.
2
_FLUTIFORM _50/5
inhaler is indicated in adults, adolescents and children aged 5 years
and above.
_FLUTIFORM _125/5
inhaler is indicated in adults and adolescents aged 12 years and
above.
_FLUTIFORM _250/10
inhal