Asthma: This preparation is a fixed-dose combination of Fluticasone Propionate and Formoterol Fumarate 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.

Fluticasone Propionate 125 mcg and Formoterol Fumarate 5 mcg inhaler is indicated in adults and adolescents aged 12 years and above.

COPD: This preparation is recommended when a long-acting β2 agonist/inhaled corticosteroid is indicated and patients are unable to use other long-acting β2 agonist/inhaled corticosteroid.

Fluticasone Propionate 125 mcg and Formoterol Fumarate 5 mcg inhaler is indicated in adults only.

This inhaler (a pressurised inhalation suspension) contains two active ingredients:

• Fluticasone propionate belongs to a group of medicines called steroids. Steroids help to reduce swelling and inflammation in the lungs.
• Formoterol fumarate dihydrate belongs to a group of medicines called long-acting beta-2 agonists. Long-acting beta-2 agonists are long-acting bronchodilators which help the airways in your lungs to stay open, making it easier for you to breathe.

Together, these two active ingredients help to improve your breathing. It is advised that you should use this medicine every day as directed by your doctor or asthma nurse.

This medicine helps to prevent breathing problems such as asthma and helps to stop you becoming breathless and wheezy. However, it does not work if you are already having an asthma attack, i.e., you are already breathless and wheezing. You will need to use a fast-acting 'reliever' medicine such as salbutamol if this happens.

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 this 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.

Patients should be given the strength of this inhaler containing the appropriate Fluticasone Propionate dosage for the severity of their disease.

Asthma:

Fluticasone Propionate 125 mcg & Formoterol Fumarate 5 mcg inhaler only

• The recommended dose for adults and adolescents aged 12 years and above: Two inhalations (puffs) twice daily, normally taken in the morning and in the evening.

• 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., Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg 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: No data are available for this strength of this inhaler in children.

• This inhaler in any strength is not recommended for use in children less than 12 years of age.

Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler only

• The recommended dose for adults: Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg inhaler – two inhalations (puffs) twice daily, normally taken in the morning and in the evening.

• Adolescents under 18 years and children: No data are available for this strength of this inhaler in children or adolescents. This inhaler in any strength is not recommended for use in children less than 12 years of age.

• This inhaler 250 micrograms/10 micrograms per actuation should not be used in adolescents.

COPD: Fluticasone Propionate 250 mcg & Formoterol Fumarate 10 mcg, two inhalations (puffs) twice daily, normally taken in the morning and in the evening.

Administration

Using an inhaler seems simple, but most patients do not know how to use it in the right way. If the inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use the inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

• Take off the cap.
• Shake the inhaler (at least six times) vigorously before each use.
• If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
• Breathe out as fully as comfortably possible and hold the inhaler upright.
• Place the actuator into the mouth between the teeth and close the lips around the mouthpiece.
• While breathing deeply and slowly through the mouth, press down firmly and fully on the canister to release the medicine.
• Remove the inhaler from the mouth. Continue holding the breath for at least 10 seconds or as long as it is comfortable.
• If the doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
• After use, replace the cap on the mouthpiece. After each treatment, rinse the mouth with water.
• Check your technique in front of a mirror from time to time. If you see a white mist during inhalation, you may not have closed your lips properly around the mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your inhaler at least once a week. Remove the canister and rinse the plastic actuator and cap in warm water, but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

No formal drug interaction studies have been performed with this inhaler. Fluticasone Propionate, an individual component of this inhaler, is a substrate of CYP 3A4. The effects of short-term co-administration of strong CYP 3A4 inhibitors (e.g., Ritonavir, Atazanavir, Clarithromycin, Indinavir, Itraconazole, Nelfinavir, Saquinavir, Ketoconazole, Telithromycin) together with this inhaler is of minor clinical relevance, but caution needs to be taken in long-term treatment and co-administration with such drugs should be avoided if possible.

This inhaler should not be used to treat acute asthma symptoms for which a fast and short-acting bronchodilator is required. Patients should be advised to have their medicine to be used for relief in an acute asthma attack available at all times.

The prophylactic use of this inhaler in exercise-induced asthma has not been studied. For such use, a separate rapid-acting bronchodilator should be considered. Patients should be reminded to take their maintenance dose of this inhaler as prescribed, even when asymptomatic. Patients should not be initiated on this inhaler during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with this inhaler. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of this inhaler.

This inhaler should not be used as the first treatment for asthma.

This inhaler should be administered with caution in patients with pulmonary tuberculosis, quiescent tuberculosis, or patients with fungal, viral or other infections of the airway. This inhaler should be used with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, cardiac arrhythmias or severe heart failure. Caution must be observed when treating patients with existing prolongation of the QTc interval. Formoterol itself may induce prolongation of the QTc interval.

As for all β2 agonists, additional blood sugar controls should be considered in diabetic patients. As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. This inhaler should be discontinued immediately, the patient assessed, and alternative therapy instituted if necessary.

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma and, more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained.

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Since this inhaler contains both Fluticasone Propionate and Formoterol Fumarate, the same pattern of undesirable effects as reported for these substances may occur. In the unlikely event of a hypersensitivity reaction to this inhaler, treatment should be initiated in accordance with standard treatment for any other hypersensitivity reaction, which may include the use of antihistamines and other treatment as required. This inhaler may need to be discontinued immediately and an alternative asthma therapy may need to be initiated if necessary. Dysphonia and candidiasis may be relieved by gargling or rinsing the mouth with water or brushing the teeth after using the product. Symptomatic candidiasis can be treated with topical antifungal therapy while continuing the treatment with this inhaler.

Pregnancy: There are limited data on the use of Fluticasone Propionate and Formoterol Fumarate, either administered alone or together but administered from separate inhalers, or on the use of this fixed-dose combination in pregnant women. Studies in animals have shown reproductive toxicity. Administration of this inhaler is not recommended during pregnancy, and should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. If this is the case, then the lowest effective dose needed to maintain adequate asthma control should be used.

Breastfeeding: It is not known whether Fluticasone Propionate or Formoterol Fumarate are excreted in human breast milk. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from this inhaler therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Fertility: There are no data available on effects on fertility following administration of this inhaler. In animal studies, no effects on fertility have been seen following administration of the individual active substances at clinically relevant doses.

Special patient groups: There is no need to adjust the dose in elderly patients.

Hepatic or renal: There are no data available for the use of this inhaler in patients with hepatic or renal impairment.

Paediatric population: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid, if possible, to the lowest dose at which effective control of asthma is maintained. In addition, consideration should be given to referring the patient to a paediatric respiratory specialist.

Only limited data are available in respect of the use of this inhaler in children under 12 years of age. This inhaler is not recommended for use in children under 12 years of age until further data become available.

There are no data available from clinical trials on overdose with this inhaler; however, data on overdose with both single drugs are given below:

Formoterol Fumarate: An overdose of Formoterol would likely lead to an exaggeration of effects that are typical for β2 agonists; in which case the following adverse experiences may occur: angina, hypertension or hypotension, palpitations, tachycardia, arrhythmia, prolonged QTc interval, headache, tremor, nervousness, muscle cramps, dry mouth, insomnia, fatigue, malaise, seizures, metabolic acidosis, hypokalaemia, hyperglycaemia, nausea and vomiting.

Fluticasone Propionate: Acute overdose with Fluticasone Propionate usually does not constitute a clinical problem. The only harmful effect after inhalation of a large amount of the drug over a short period is suppression of hypothalamic-pituitary-adrenocortical (HPA) axis function. HPA axis function usually recovers in a few days, as verified by plasma cortisol measurements. Treatment with the inhaled corticosteroid should be continued at the recommended dose to control asthma.

Respiratory corticosteroids

Store in a cool and dry place, protected from light.