Flutiform Inhalers

Flutiform is an inhaler (a pressurized inhalation suspension) that contains two active substances:

Fluticasone propionate, which belongs to a group of medicines called steroids. Steroids help reduce swelling and inflammation in the lungs.

Formoterol fumarate dihydrate, which belongs to a group of medicines called long-acting beta2-agonists. Long-acting beta2 agonists are long-acting bronchodilators that help keep the airways in the lungs open, making it easier to breathe.

These two active substances together help improve breathing. You should use this medication everyday, following your doctor's instructions.

Mechanism of action and pharmacodynamic effects

Flutiform inhaler contains fluticasone propionate and formoterol fumarate. The mechanisms of action of the individual components are described below. These drugs represent two classes of drugs (a synthetic corticosteroid and a selective long-acting β2-adrenergic receptor agonist) and as with other combinations of long-acting inhaled corticosteroids and β2-adrenergic agonists, additive effects are observed in terms of a reduction in exacerbations of asthma.

Fluticasone propionate

Fluticasone propionate is a synthetic trifluorinated glucocorticoid, with potent anti-inflammatory activity in the lungs when administered by the inhalation route. Fluticasone propionate reduces asthma symptoms and exacerbations, with fewer adverse effects than when systemically administered corticosteroids.

Formoterol fumarate

Flutiform inhaler uses include helping prevent respiratory problems such as asthma and helps prevent shortness of breath and shortness of breath. However, it does not work if you are already having an asthma attack, that is if you are already out of breath and wheezing. If this happens, you will need to use a quick-acting "rescue" medicine like salbutamol.

Formoterol fumarate is a selective, long-acting β2 adrenergic receptor agonist. Inhaled formoterol fumarate acts locally in the lung as a bronchodilator. The onset of the bronchodilator effect is rapid, between 1-3 minutes, and the duration of the effect is at least 12 hours after a single dose.

Flutiform inhaler uses include helping prevent respiratory problems such as asthma and helps prevent shortness of breath and shortness of breath. However, it does not work if you are already having an asthma attack, that is if you are already out of breath and wheezing. If this happens, you will need to use a quick-acting "rescue" medicine like salbutamol.

Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist again.

You should use your inhaler regularly, i.e. two puffs (puffs) in the morning and two puffs (puffs) at night every day, in order to get the most benefit from your inhaler, unless your doctor gives you other indications or recommend that you stop treatment. Do not administer more doses than prescribed. You should always use your inhaler exactly as your doctor has recommended. If you are not sure how much the inhaler should be given or how often you should use it, please consult your doctor or pharmacist.

Adults and adolescents 12 years of age or older

The usual Flutiform inhaler dose is two inhalations twice a day, that is, two inhalations (pulsations) in the morning and two in the evening. Your doctor will prescribe the dose necessary to treat your asthma. Teens should not use the highest-dose inhaler (Flutiform 250 micrograms / 10 micrograms).

Inhaler use

If during the use of Flutiform you feel that you have difficulty breathing or wheezing, you should continue to use Flutiform, but see your doctor as soon as possible as you may need further treatment. Once your asthma is well controlled, your doctor may want to gradually reduce the dose of Flutiform.

Slowly perform steps 2 through 5 below.

1. Remove the mouthpiece cover and check that your inhaler is clean and dust-free.
2. Shake the inhaler immediately before each discharge (pulse) to ensure that the contents of your inhaler are evenly mixed.
3. Sit upright or remain standing. Exhale as far as you feel comfortable and as slowly and deeply as possible.
4. Hold your inhaler upright and put the mouthpiece in your mouth, surrounding it with your lips. Hold the inhaler with your thumb (s) at the base of the mouthpiece and with your index finger (s) on top of the inhaler. Do not bite the mouthpiece.
5. Breathe in slowly and deeply through your mouth while simultaneously pressing down on the aerosol cartridge to release a discharge (pulsation). Continue to breathe steadily and deeply (if possible around 4-5 seconds).
6. While holding your breath, remove the inhaler from your mouth. Continue to hold your breath as long as you feel comfortable. Do not breathe out into the inhaler.
7. For the second discharge (press), hold the inhaler upright, then repeat steps 2 through 6.
8. Put on the mouthpiece cover.

Like all medicines, this inhaler can cause side effects, although not everybody gets them. Your doctor will prescribe the lowest dose necessary to control your asthma, which may reduce the chance of side effects.

All medications can cause allergic reactions, although serious allergic reactions occur rarely. Tell your doctor immediately if your eyelids, face, throat, tongue, or lips suddenly swell; if you have a skin rash or feel itchy, especially if it occurs all over your body; if you have symptoms such as dizziness, lightheadedness or fainting, or sudden changes in the way you breathe, such as increased wheezing or trouble breathing.

As with other inhalers, your breathing may worsen immediately after using the inhaler. You may notice increased wheezing and difficulty breathing. If this happens, stop using Flutiform and use your fast-acting "rescue" inhaler. Contact your doctor immediately. He or she will perform an evaluation and may start a different type of treatment. You should carry your ¿rescue¿ inhaler with you at all times.

Uncommon Flutiform inhaler side effects (may affect up to 1 in 100 people)

• Worsening of asthma.
• Headache
• Tremors
• Irregular heartbeat or palpitations.
• Dizziness
• Difficulty to sleep.
• Voice disturbances/hoarseness.
• Dry mouth, sores, or sore throat.
• Eruption

Rare Flutiform inhaler side effects (may affect up to 1 in 1,000 people)

• An increased amount of sugar in the blood. If you are diabetic you may need to check your blood sugar more often and adjust your usual treatment for diabetes. Your doctor may need to monitor you more closely.
• Candidiasis or other fungal infections of the mouth and throat.
• Inflammation of the paranasal sinuses (sinusitis).
• Fast heart rate.
• Chest pain associated with heart disease.
• Muscle spasms.
• Cough or shortness of breath.
• Diarrhea
• Indigestion
• Changes in taste.
• A feeling of dizziness or spinning.
• Abnormal dreams.
• Agitation
• Itchy skin
• High blood pressure.
• An unusual feeling of weakness.
• Swelling of hands, ankle feet.

Frequency not known: cannot be estimated from the available data

• Sleep problems, depression or feeling of worry, aggressiveness, anxiety, restlessness, nervousness, excessive excitement, or irritability. These effects are more likely to occur in children.
• The following side effects have been associated with formoterol fumarate, but have not been reported during clinical trials with this inhaler:
• Low potassium levels, which can cause muscle weakness, muscle spasms, or heart rhythm disturbances.
• An abnormal electrocardiogram that can potentially reveal an abnormal heart rhythm (QTc interval prolongation).
• High levels of lactic acid in the blood.
• Feeling unwell.
• Muscle pain.

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