Flutiform

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Flutiform on Prescriptsy

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Flutiform is a prescription-only combination inhaler containing two active ingredients: fluticasone propionate (an inhaled corticosteroid, or ICS) and formoterol fumarate dihydrate (a long-acting beta-2 agonist, or LABA).

It is used as regular maintenance treatment for asthma in adults and adolescents aged 12 years and over whose asthma is not adequately controlled by an inhaled corticosteroid alone.

Flutiform is manufactured by Mundipharma and is available as a pressurised metered-dose inhaler (pMDI) in three strengths: 50/5, 125/5, and 250/10 micrograms per actuation.

Asthma is a chronic inflammatory disease of the airways that affects approximately 5.4 million people in the United Kingdom.

It is characterised by variable airflow obstruction, bronchial hyperresponsiveness, and underlying airway inflammation.

When asthma is not adequately controlled with a regular low-to-medium dose inhaled corticosteroid alone, guidelines recommend adding a long-acting bronchodilator.

Combination ICS/LABA inhalers such as Flutiform deliver both the anti-inflammatory and the bronchodilator components in a single device, improving convenience and adherence.

The formoterol component of Flutiform has a notably rapid onset of action (1 to 3 minutes), which distinguishes it from salmeterol-containing alternatives and may improve patient confidence in the inhaler.

This page provides a comprehensive clinical overview of Flutiform, including its mechanism of action, dosing, side effects, safety warnings, and how to obtain a prescription in the UK.

Important safety information about Flutiform

• Flutiform is a preventer/controller inhaler and must not be used to treat acute asthma attacks.
• Always carry a separate reliever inhaler (such as salbutamol) for sudden symptoms.
• Take two inhalations twice daily at the same times each day, approximately 12 hours apart.
• Rinse your mouth with water and spit after each dose to reduce the risk of oral thrush.
• Do not stop Flutiform suddenly without medical advice.
• Flutiform is a prescription-only medicine (POM) for patients aged 12 and over.

Understanding asthma and the need for combination therapy

Asthma involves chronic inflammation of the bronchial airways, mediated by eosinophils, mast cells, T-lymphocytes, and their pro-inflammatory cytokines.

This inflammation causes the airway lining to swell, excess mucus to be produced, and the surrounding smooth muscle to contract, resulting in airflow obstruction.

The hallmark features are variable symptoms (wheeze, breathlessness, chest tightness, cough), triggers (allergens, exercise, cold air, infections), and reversibility with bronchodilator treatment.

The BTS/SIGN guideline on asthma management and NICE NG80 recommend a stepwise approach. At Step 2, all patients with persistent symptoms receive a regular low-dose ICS.

If asthma remains uncontrolled despite good inhaler technique and adherence, Step 3 involves adding a LABA to the ICS.

Clinical trials have consistently demonstrated that adding a LABA to an ICS provides greater improvement in lung function and symptom control than doubling the ICS dose alone.

Fixed-dose combination inhalers are preferred over separate inhalers because they guarantee that the LABA is always taken with the ICS (addressing the safety concern of LABA monotherapy) and simplify the treatment regimen, which improves adherence.

How Flutiform works: mechanism of action

Flutiform combines two complementary mechanisms of action in a single inhaler.

Fluticasone propionate is a potent synthetic glucocorticoid that binds to intracellular glucocorticoid receptors in airway cells.

The activated receptor complex translocates to the cell nucleus, where it upregulates anti-inflammatory gene transcription and suppresses the production of pro-inflammatory mediators, including interleukins, tumour necrosis factor-alpha, prostaglandins, and leukotrienes.

Over days to weeks of regular use, this reduces airway oedema, mucus hypersecretion, and bronchial hyperresponsiveness.

Fluticasone propionate has the highest glucocorticoid receptor binding affinity among commonly used ICS, providing potent topical anti-inflammatory activity with low systemic bioavailability (less than 1% from MDI due to extensive first-pass hepatic metabolism).

Formoterol fumarate is a selective beta-2 adrenoceptor agonist with both a rapid onset of action and a long duration of effect.

It stimulates beta-2 receptors on airway smooth muscle, activating adenylyl cyclase and increasing intracellular cyclic AMP (cAMP), which relaxes the smooth muscle and relieves bronchospasm.

Formoterol begins to work within 1 to 3 minutes (comparable to salbutamol) and provides bronchodilation for at least 12 hours.

This rapid onset is due to its moderate lipophilicity, which allows rapid engagement with the beta-2 receptor, while its long duration results from the molecule partitioning into the lipid bilayer of the cell membrane and acting as a depot for sustained receptor interaction.

The combination of anti-inflammatory and bronchodilator effects addresses both the underlying cause (inflammation) and the immediate symptom (bronchoconstriction) of asthma.

Synergistic interactions have been demonstrated: corticosteroids upregulate beta-2 receptor expression (preventing tachyphylaxis to the LABA), while LABAs activate glucocorticoid receptors through a ligand-independent mechanism, potentially enhancing the anti-inflammatory effect of the ICS.

Clinical evidence supporting Flutiform

Flutiform was evaluated in a comprehensive clinical development programme that included randomised controlled trials comparing it with fluticasone propionate alone, formoterol alone, and the established ICS/LABA combination fluticasone/salmeterol (Seretide).

Pivotal trials demonstrated that Flutiform provided significantly greater improvement in FEV1 (forced expiratory volume in 1 second) compared with either fluticasone or formoterol alone, confirming the benefit of the combination.

Non-inferiority trials showed that Flutiform provided comparable asthma control to fluticasone/salmeterol, with the additional advantage of a faster onset of bronchodilation due to the formoterol component.

Real-world effectiveness studies have further supported the role of ICS/LABA combinations in reducing exacerbation rates, emergency department visits, and oral corticosteroid use compared with ICS alone in patients with moderate to severe asthma.

UK prescribing guidance for Flutiform

BTS/SIGN and NICE NG80 recommend adding a LABA to a regular ICS at Step 3 of the asthma management pathway when asthma is not adequately controlled on a low-to-medium dose ICS alone, provided inhaler technique and adherence have been optimised and trigger avoidance addressed.

The guidelines state that the LABA should be prescribed as a fixed-dose combination with the ICS to ensure compliance with both components.

If adding a LABA provides a good clinical response, treatment should be continued.

If there is some benefit but control remains suboptimal, the ICS dose can be increased within the combination inhaler.

Flutiform is listed in the BNF as a suitable ICS/LABA combination inhaler.

It is one of several options, alongside Seretide (fluticasone/salmeterol), Symbicort (budesonide/formoterol), Fostair (beclometasone/formoterol), and Relvar Ellipta (fluticasone furoate/vilanterol).

The choice between these products depends on the ICS dose requirement, patient preference for device type (pMDI versus dry powder inhaler), and formulary availability.

Flutiform is uniquely positioned as the only pMDI combining fluticasone propionate with the rapid-onset LABA formoterol.

Flutiform compared with other ICS/LABA inhalers

Several ICS/LABA combination inhalers are available in the UK. Seretide (fluticasone/salmeterol) is available as both MDI (Evohaler) and dry powder (Accuhaler).

Salmeterol has a slower onset (10 to 20 minutes) than formoterol but a similar 12-hour duration.

Symbicort (budesonide/formoterol) uses the Turbohaler dry powder device and can be used as both maintenance and reliever therapy (MART regimen), which Flutiform cannot.

Fostair (beclometasone/formoterol) is available as MDI and NEXThaler dry powder, using extra-fine particle beclometasone for enhanced peripheral lung deposition.

Relvar Ellipta (fluticasone furoate/vilanterol) is a once-daily dry powder inhaler.

The key distinguishing feature of Flutiform is its combination of fluticasone propionate (the most potent available ICS per microgram) with formoterol (the fastest-onset available LABA) in a pMDI format.

This may be preferred for patients who want the rapid reassurance of feeling the bronchodilator effect soon after inhalation, while also receiving the potent anti-inflammatory benefits of fluticasone propionate.

The pMDI format is compatible with spacer devices, which is advantageous for patients with coordination difficulties.

Dosage and administration

Flutiform is taken as two inhalations twice daily. The three available strengths allow dose adjustment by changing the strength of the inhaler rather than the number of inhalations.

Flutiform 50/5 delivers a low ICS dose (200 mcg fluticasone per day), 125/5 delivers a moderate dose (500 mcg per day), and 250/10 delivers a high dose (1000 mcg per day).

Prescribers should aim to use the lowest strength that maintains good asthma control.

The inhaler should be shaken well before each actuation.

Patients should prime the inhaler by releasing three test sprays before first use or if the inhaler has not been used for more than 3 days.

Proper inhaler technique is essential for effective drug delivery: breathe out fully, seal lips around the mouthpiece, actuate while breathing in slowly and deeply, hold the breath for 10 seconds, and wait at least 30 seconds before the second inhalation.

Using a spacer is recommended for patients who struggle to coordinate pressing and breathing.

Side effects of Flutiform

Common side effects

Oral thrush (candidiasis) is the most common local side effect of the ICS component, occurring in up to 1 in 10 patients.

It can be minimised by spacer use and mouth rinsing. Dysphonia (hoarseness) results from local corticosteroid effects on the laryngeal muscles and is reversible.

Tremor is the most common systemic effect of the LABA component, affecting the hands and usually settling within a few days. Headache and palpitations may also occur.

Uncommon and rare side effects

Muscle cramps, throat irritation, cough, nausea, dizziness, insomnia, and skin reactions are uncommon. Tachycardia occurs infrequently.

Paradoxical bronchospasm is rare and requires immediate use of a reliever inhaler and medical review.

Systemic corticosteroid effects (adrenal suppression, bone density changes, growth effects in adolescents, cataracts, glaucoma) are rare at standard doses but may occur with prolonged high-dose therapy.

Hypokalaemia and hyperglycaemia may occur, particularly at high doses or in combination with other beta-2 agonists. Psychiatric effects (anxiety, agitation, behavioural changes) are very rare.

When to seek urgent help

Call 999 or go to A&E if you experience sudden severe breathing difficulty, chest pain, swelling of the face, lips, tongue, or throat, or signs of adrenal crisis (severe weakness, nausea, collapse) after stopping or reducing corticosteroids.

Call NHS 111 for persistent oral thrush, worsening asthma, frequent need for your reliever inhaler, or troublesome palpitations.

Report suspected adverse reactions via the Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and precautions

Not for acute relief

Flutiform must not be used to treat acute asthma symptoms. A separate reliever inhaler (salbutamol or terbutaline) must always be available. Increasing reliever use is a warning sign of deteriorating asthma control.

Adrenal suppression

Prolonged high-dose ICS therapy may suppress the hypothalamic-pituitary-adrenal axis. Patients transferred from oral corticosteroids to Flutiform are at particular risk. Gradual withdrawal of oral steroids under medical supervision is essential. Carry a steroid treatment card if on high-dose ICS.

Cardiovascular caution

Formoterol should be used with caution in patients with coronary artery disease, cardiac arrhythmias, severe hypertension, hypertrophic obstructive cardiomyopathy, thyrotoxicosis, phaeochromocytoma, and QT prolongation. Beta-blockers and formoterol are generally contraindicated in combination in asthma.

Drug interactions

CYP3A4 inhibitors (ritonavir, cobicistat, ketoconazole) dramatically increase systemic fluticasone exposure. Co-administration should be avoided. Beta-blockers may abolish the bronchodilator effect of formoterol. Concomitant use of other beta-2 agonists, methylxanthines (theophylline), and corticosteroids may potentiate hypokalaemia.

Pregnancy and breastfeeding

BTS/SIGN guidelines recommend that asthma treatment should not be withheld during pregnancy. Poorly controlled asthma carries risks of pre-eclampsia, preterm delivery, and low birth weight.

If Flutiform provided good control before pregnancy, it is reasonable to continue.

Small amounts of fluticasone and formoterol may pass into breast milk; clinically significant effects on the infant are unlikely at therapeutic inhaled doses.

How to get Flutiform in the UK

Flutiform is a prescription-only medicine available on the NHS. Your GP, asthma nurse prescriber, or hospital respiratory specialist can prescribe it following a clinical assessment.

This assessment will include a review of current asthma control, inhaler technique, adherence, and whether adding a LABA to your existing ICS is clinically appropriate.

Authorised online prescribers registered with the General Pharmaceutical Council (GPhC) can also prescribe Flutiform after a suitable clinical consultation.

The NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Optimising your asthma treatment with Flutiform

The effectiveness of Flutiform depends on correct inhaler technique, regular twice-daily use, and ongoing asthma management.

Ask your GP, pharmacist, or asthma nurse to check your inhaler technique at every review. Consider using a spacer device to improve drug delivery and reduce side effects.

Keep a record of your peak flow readings and symptom patterns to share with your healthcare team.

Ensure you have a written personalised asthma action plan that tells you what to do when symptoms change, when to increase treatment temporarily, and when to seek urgent help.

Avoid known triggers, stay up to date with annual influenza vaccination, maintain a healthy weight, and do not smoke.

Regular asthma reviews (at least annually, or more often if asthma is not well controlled) are essential to assess whether your treatment can be stepped down or whether adjustments are needed.

Sources

• Flutiform 125/5 Inhaler, Summary of Product Characteristics (EMC)
• Fluticasone with formoterol, British National Formulary (BNF)
• BTS/SIGN Guideline on the Management of Asthma
• NICE NG80: Asthma: diagnosis, monitoring and chronic asthma management
• Asthma, NHS
• MHRA Yellow Card Scheme