Flutiform 50 microgram/5 microgram per metered dose pressurised inhalation, suspension.

Flutiform 125 microgram/5 microgram per metered dose pressurised inhalation, suspension.

Flutiform 250 microgram/10 microgram per metered dose pressurised inhalation, suspension.

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 microgram of fluticasone propionate/4.5 microgram 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 microgram of fluticasone propionate/4.5 microgram 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 microgram of fluticasone propionate/9.0 microgram of formoterol fumarate dihydrate.

For a full list of excipients, see section 6.1.

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.

This fixed-dose combination of fluticasone propionate and formoterol fumarate (Flutiform inhaler) is indicated in the regular treatment of asthma where the 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.

Flutiform 50 microgram/5 microgram inhaler is indicated in adults and adolescents aged 12 years and above.

Flutiform 125 microgram/5 microgram inhaler is indicated in adults and adolescents aged 12 years and above.

Flutiform 250 microgram/ 10 microgram inhaler is indicated in adults only.

Posology

For inhalation use.

Patients will need to be trained on the use of the inhaler and their asthma should be regularly reassessed by a doctor, so that the strength of Flutiform inhaler they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Once control of asthma is achieved with the lowest strength of Flutiform inhaler administered twice daily treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone. As a general principle the dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Regular review of patients as treatment is stepped down is extremely important.

There are no data available for use of Flutiform inhaler in patients with COPD. Flutiform inhaler should not be used in patients with COPD.

Patients should be given the strength of Flutiform inhaler containing the appropriate fluticasone propionate dosage for the severity of their disease. Note: Flutiform 50 microgram/5 microgram per metered dose, strength is not appropriate in adults and adolescents with severe asthma. Prescribers should be aware that, in patients with asthma, fluticasone propionate is as effective as some other inhaled steroids when administered at approximately half the total daily dose (in micrograms). If an individual patient should require doses outside the recommended dose regimens, appropriate doses of the β₂ agonist and the inhaled corticosteroid in separate inhalers, or appropriate doses of the inhaled corticosteroid alone, should be prescribed.

Flutiform inhaler is delivered by a press-and-breathe pressurised metered dose inhaler (pMDI) which also contains an integrated dose indicator. Each inhaler will provide at least 120 actuations (60 doses).

Flutiform 50 microgram/5 microgram inhaler – only

Recommended dose for adults and adolescents aged 12 years and above:

Flutiform 50 microgram/5 microgram per actuation pressurised inhalation suspension - two inhalations (puffs) twice daily normally taken in the morning and in the evening.

If the patient's asthma remains poorly controlled the total daily dose of the inhaled corticosteroid can be increased by administering a higher strength of this combination product – i.e. Flutiform 125 microgram/5 microgram inhaler - two inhalations (puffs) twice daily.

For adults only:

The total daily dose can be further increased if asthma still remains poorly controlled by administering the highest strength of this combination product – i.e. Flutiform 250 microgram/10 microgram inhaler - two inhalations (puffs) twice daily. This highest strength is for use in adults only, it should not be used in adolescents aged 12 years and above.

Children under 12 years:

Experience in children under the age of 12 years is limited (see sections 4.4, 4.8, 5.1 & 5.3). Flutiform inhaler in any strength is not recommended for use in children less than 12 years of age; Flutiform inhaler should not be used in this young age group.

Flutiform 125 microgram/5 microgram inhaler – only

Recommended dose for adults and adolescents aged 12 years and above:

Flutiform