Recommended Dose: Flutiform inhaler is for oral inhalation only.
Flutiform 50 microgram/5 microgram inhaler (for patients ≥12 years): 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 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: Flutiform should not be used in this young age group. No data are available for this strength of Flutiform inhaler in children. Experience in children under the age of 12 year is limited. Flutiform inhaler in any strength is not recommended for use in children less than 12 years of age.
Mode of Administration: To ensure proper administration of the drug, the patient should be shown how to use the inhaler correctly by a physician or other health professionals. The correct use of the pressurized metered dose inhaler (pMDI) is essential for successful treatment. The patient should follow the instructions for use.
The actuator has an integrated dose indicator (counter) which counts down the number of actuations (puffs) remaining. When this is getting near to zero the patient should be advised to contact their prescriber for a replacement inhaler. The inhaler must not be used after the counter read "0".
Priming the inhaler: Before using the inhaler for the first time, or if the inhaler has not been used for 3 days or more, or after exposure of the freezing or refrigerated conditions the inhaler must be primed before use: Remove the mouthpiece cover and shake the inhaler well.
Actuate (puff) the inhaler whilst pointing it away from the face. This step must be performed 4 times.
The inhaler should always be shaken immediately before use.
Whenever possible patients should stand or sit in an upright position when inhaling from the inhaler.
Steps to follow when using the inhaler: (1) Remove the mouthpiece cover and check that the mouthpiece is clean, and free from dust and dirt. The inhaler should be shaken immediately before releasing each actuation (puff).
(2) Breathe out as far as is comfortable and as slowly and deeply as possible.
(3) Hold the canister vertically with its body upwards and put the lips around the mouthpiece. Hold the inhaler upright with a thumb(s) on the base of the mouthpiece and a forefinger/index finger(s) on the top of the inhaler. Do not bite the mouthpiece.
(4) At the same time, breathe in slowly and deeply through the mouth. After starting to breathe in press down on the top of the inhaler to release one actuation (puff) and continue to breathe in steadily and deeply.
(5) Patients should continue to hold their breath for as long as is comfortable (optimally about 10 seconds), then breathe out slowly. Do not breathe out into the inhaler.
(6) Keep the inhaler in a vertical position for about half a minute, shake the inhaler, and repeat steps 2 to 5. After use, replace the mouthpiece cover.
IMPORTANT: Do not perform steps 2 to 5 too quickly.
Patients may be advised to practice their technique in front of a mirror. If a mist appears following inhalation, either from the inhaler or from the sides of the mouth, the procedure should be repeated from step 2.
For patients with weak hands, it may be easier to hold the inhaler with both hands. Therefore the index fingers should be placed on the top of the inhaler canister and both thumbs on the base of the inhaler.
Patients should rinse their mouth, gargle with water or brush the teeth after inhaling and spit out the residue to minimize the risk of oral candidiasis or dysphonia.
Cleaning: The inhaler should be cleaned once a week.
Remove the mouth piece cover.
Do not remove the canister from the plastic casing.
Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.
Replace the mouthpiece cover in the correct orientation.
Do not put the metal canister into water.