Flomyst F (250 mcg+10 mcg)/puff

INDICATIONS

Asthma: This preparation is a fixed-dose combination of Fluticasone Propionate and Formoterol Fumarate is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting ß2 agonist) is appropriate:

For patients not adequately controlled with inhaled corticosteroids and "as required" inhaled short-acting ß2 agonist. Or, ... Read moreAsthma: This preparation is a fixed-dose combination of Fluticasone Propionate and Formoterol Fumarate is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting ß2 agonist) is appropriate:

For patients not adequately controlled with inhaled corticosteroids and "as required" inhaled short-acting ß2 agonist. Or,
For patients already adequately controlled on both an inhaled corticosteroid and a long-acting ß2 agonist.

Fluticasone Propionate 125 mcg and Formoterol Fumarate 5 mcg inhaler are indicated in adults and adolescents aged 12 years and above.COPD: This preparation is recommended when a long-acting ß2 agonist/Inhaled corticosteroid is indicated & patients are unable to use other long-acting ß2 agonist/Inhaled corticosteroid.Fluticasone Propionate 125 mcg and Formoterol Fumarate 5 mcg inhaler is indicated in adults only.

PHARMACOLOGY

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

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

DOSAGE

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 microgram/10 microgram 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.

INTERACTION

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.

SIDE EFFECTS

As with other inhalation therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Since Flutide inhaler contains both Fluticasone Propionate and FormoterolFumarate, the same pattern of undesirable effects as reported for these substances may occur. In the unlikely event of a hypersensitivity reaction to Flutide 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. Flutide 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 anti-fungal therapy whilst continuing the treatment with Flutide inhaler.

PREGNANCY & LACTATION

Pregnancy: There are limited data on the use of Fluticasone Propionate and FormoterolFumarate, either administered alone or together but administered from separate inhalers, or on the use of this fixed-dose combination, this inhaler 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 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 FormoterolFumarateare 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.

USE IN SPECIAL POPULATIONS

Special patient groups: There is no need to adjust the dose in elderly patients.Hepatic or renal: There are no data available for 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.

THERAPEUTIC CLASS

Respiratory corticosteroids

STORAGE CONDITIONS

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