European Prescribing Information

flutiform® (fluticasone propionate and formoterol fumarate) pressurised inhalation suspension European Prescribing Information

Please read the Summary of Product Characteristics before prescribing.

Presentation

Pressurised inhalation suspension, in a pressurised metered dose inhaler (pMDI), containing fluticasone propionate and formoterol fumarate dihydrate at strengths of 50 µg/5 µg, 125 µg/5 µg or 250 µg/10 µg per actuation.

Indications

Regular treatment of asthma where the use of a combination product (inhaled corticosteroid and long-acting β2-agonist) is appropriate:

For patients not adequately controlled with inhaled corticosteroids and ‘as required’ inhaled short-acting β2-agonist (SABA), or for patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2-agonist (LABA).

flutiform 50 µg/5 µg and 125 µg/5 µg per actuation are indicated for use in adults and adolescents 12 years and above. flutiform 250 µg/10 µg per actuation is only indicated for use in adults.

Dosage and administration

For inhalation use. The patient should be shown how to use the inhaler correctly by a physician or other healthcare professional.

Patients should be given the strength of flutiform containing the appropriate fluticasone propionate dose for their disease severity (note that flutiform 50 µg/5 µg per actuation is not appropriate in patients with severe asthma). The appropriate strength should be taken as two inhalations, twice-daily (normally in the morning and evening) and used every day, even when asymptomatic. flutiform should not be used in children under 12 years. Prescribers should be aware that in asthmatics, fluticasone propionate is as effective as some other inhaled steroids when administered at approximately half the total daily microgram dose.

Total daily dose can be increased if asthma remains poorly controlled by administering a higher strength inhaler. Appropriate doses of the β2-agonist and inhaled corticosteroid (ICS) in separate inhalers, or the ICS alone, should be prescribed if a patient requires doses outside the recommended dose regimens.

Patients should be assessed regularly and once asthma is controlled, treatment should be reviewed and stepped down to the lowest effective dose, or an ICS alone. It is extremely important to regularly review patients as their treatment is stepped down.

ICSs alone are first line treatment for most patients. flutiform is not intended for initial treatment of mild asthma. For patients with severe asthma the ICS therapy should be established before prescribing a fixed-dose combination product.

Patients on flutiform must not use an additional LABA. An inhaled SABA should be taken for immediate relief of asthma symptoms arising between doses.

The AeroChamber Plus® spacer device is recommended in patients who find it difficult to use inhalers; re-titration should always follow the introduction of a spacer device.

Patients should be advised to contact their prescriber when the flutiform dose counter is getting near zero.

Contra-indications

Hypersensitivity to the active substances or to any of the excipients.

Precautions and warnings

flutiform should not be used for the first treatment of asthma, to treat acute asthma symptoms or for prophylaxis of exercise-induced asthma. It should not be initiated during an exacerbation, during significantly worsening or acutely deteriorating asthma, and should not be stopped abruptly. Patients should use their flutiform maintenance treatment as prescribed, even when asymptomatic.

If a patient experiences serious asthma-related adverse events or exacerbations, they should continue treatment but also seek medical advice. Patients should be reviewed as soon as possible if there is any indication of deteriorating asthma control. In the case of sudden and progressive deterioration, which is potentially life-threatening, an urgent medical assessment should be carried out.

Use with caution in patients with: pulmonary tuberculosis; quiescent tuberculosis; fungal, viral or other infections of the airway; thyrotoxicosis; pheochromocytoma; diabetes mellitus (consider additional blood sugar controls); uncorrected hypokalaemia; predisposition to low levels of serum potassium; impaired adrenal function (monitor HPA axis function regularly) ; hypertrophic obstructive cardiomyopathy; idiopathic subvalvular aortic stenosis; severe hypertension; aneurysm or other severe cardiovascular disorders.

There is risk of potentially serious hypokalaemia with high doses of β2-agonists or concomitant treatment with β2-agonists and drugs that can induce or potentiate a hypokalaemic effect. Particular caution is recommended in unstable or acute severe asthma and other conditions when the likelihood for hypokalemia adverse effects is increased. Monitoring of serum potassium levels is recommended during these circumstances. Formoterol may induce prolongation of the QTc interval. Caution must be observed when treating patients with existing prolongation of QTc interval.

flutiform should be discontinued immediately if there is evidence of paradoxical bronchospasm.

Systemic effects with an ICS may occur, particularly at high doses for prolonged periods or when combined with potent CYP3A4 inhibitors, but are less likely than with oral corticosteroids. Use of a spacer device may also cause an increased systemic exposure. Increased exposure can be expected in patients with severe hepatic impairment.

Prolonged treatment with high doses of corticosteroids may result in adrenal suppression and acute adrenal crisis, particularly in adolescents and children or potentially as a result of trauma, surgery, infection or rapid dose reduction.

Patients should be advised that flutiform contains a small amount of ethanol; however this negligible amount does not pose a risk to patients.

flutiform is not recommended in children under 12 years of age.

Interactions

Caution is advised in long-term co-administration with strong CYP3A4 inhibitors (e.g. ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, ketoconazole and telithromycin); co-administration should be avoided if possible. Ritonavir in particular should be avoided, unless the benefits outweigh the risks of systemic side-effects.
Caution is advised with use of non-potassium sparing diuretics (e.g. loop or thiazide), xanthine derivatives, glucocorticosteroids, L-Dopa, L-thyroxine, oxytocin, alcohol or other adrenergic drugs.

There is an increased risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons. Hypokalaemia may increase the risk of arrhythmias in patients being treated with digitalis glycosides.

Concomitant use of β-adrenergic drugs can have a potentially additive effect.

Caution should be taken when using formoterol fumarate with drugs known to prolong the QTc interval, such as tricyclic antidepressants or MAOIs (and for two weeks following their discontinuation), as well as antipsychotics (including phenothiazines), quinidine, disopyramide, procainamide and antihistamines. Concomitant use of an MAOI or a similar agent, such as furazolidone or procarbazine, may precipitate hypertensive reactions.

β-blockers and formoterol fumarate may inhibit the effect of each other. β-blockers may produce severe bronchospasm in asthma patients, and they should not normally be treated with β-blockers including those that are used as eye drops to treat glaucoma. Under certain circumstances, e.g. as prophylaxis after myocardial infarction, cardioselective β blockers could be considered with caution

Pregnancy and lactation

flutiform is not recommended during pregnancy. It should only be considered if benefits to the mother outweigh risks to the foetus.

It is not known whether fluticasone propionate or formoterol are excreted in breast milk; a risk to the breast feeding infant cannot be excluded. A decision should be made on whether to discontinue breastfeeding or discontinue/abstain from flutiform.

Side-effects

Potentially serious side-effects: hyperglycaemia; depression; aggression; behavioural changes (predominantly in children); paradoxical bronchospasm; agitation; vertigo; palpitations; ventricular extrasystoles; angina pectoris; tachycardia; hypertension; dyspnoea; peripheral oedema; Cushings Syndrome; adrenal suppression; growth retardation; cataract and glaucoma; hypersensitivity reactions and QTc interval prolongation.

Please consult the SPC for details of non-serious side-effects and those reported for the individual molecules.

Legal category

POM

Package quantities

One inhaler containing 120 actuations
Multipack of 3 x 1 inhaler (120 actuations)
Not all pack sizes may be marketed

Shelf Life

2 years
In use shelf life: 3 months after opening the foil pouch

Date of preparation

July 2015

Date effective

August 2015

® FLUTIFORM is a registered trademark of Jagotec AG, and is used under licence.
® The ‘lung’ device (logo) is a registered trademark of Mundipharma AG.
® AEROCHAMBER and AEROCHAMBER PLUS are registered trademarks of Trudell Medical International.

Adverse events should be reported. Reporting to the applicable regulatory authorities should be in accordance with National requirements and to the applicable holder of the marketing authorization for flutiform, details of which can be found on the product packaging and/or inserts.  

You are now leaving flutiform.com and moving to an external website independently operated and not managed by Mundipharma International Ltd. Mundipharma International Ltd assumes no responsibility for the site or its content.

If you do not wish to leave this site, click Cancel or click OK to continue.

OK Cancel