Relanio (Salmeterol/Fluticasone) 50/250 µg

Fixed-dose combination inhalation powder for long-term maintenance of asthma and COPD

Rx – Prescription Only LABA + ICS combination ATC: R03AK06
Active Ingredients
Salmeterol (as xinafoate) + Fluticasone propionate
Dosage Form
Inhalation powder, pre-dispensed dose
Strength
50 µg / 250 µg per inhalation
Duration of Effect
12 hours (bronchodilation)
Medically reviewed | Last reviewed: | Evidence level: 1A
Relanio is a prescription combination inhaler containing two active substances: salmeterol, a long-acting bronchodilator, and fluticasone propionate, an inhaled corticosteroid. Delivered as a pre-dispensed (metered) dry powder at 50 / 250 micrograms per dose, Relanio is used twice daily for the long-term maintenance treatment of asthma and symptomatic management of moderate-to-severe chronic obstructive pulmonary disease (COPD). It is not a rescue inhaler and should not be used during an acute asthma attack.
📅 Published:
🕐 Last reviewed:
Written and reviewed by iMedic Medical Editorial Team | Specialists in pulmonology and pharmacology

Quick facts about Relanio

Active Ingredients
Salmeterol + Fluticasone
LABA & inhaled corticosteroid
Drug Class
LABA / ICS
fixed-dose combination
ATC Code
R03AK06
respiratory system
Common Uses
Asthma & COPD
maintenance therapy
Available Form
Dry Powder
50 / 250 µg per dose
Prescription Status
Rx Only
prescription required

Key takeaways about Relanio

  • Two medicines in one inhaler: Relanio combines a long-acting bronchodilator (salmeterol) that keeps the airways open for 12 hours with an inhaled corticosteroid (fluticasone) that controls underlying airway inflammation.
  • Not a rescue inhaler: Relanio is for daily preventive use only. Always carry a separate short-acting bronchodilator such as salbutamol (albuterol) for immediate relief of sudden symptoms or asthma attacks.
  • Use twice daily, every day: Take one inhalation morning and evening, approximately 12 hours apart. Do not stop treatment suddenly even if you feel well – this can lead to worsening of your condition.
  • Always rinse your mouth after use: Rinsing with water (and spitting it out) reduces the risk of oral thrush and hoarseness caused by the steroid component.
  • Regular medical review matters: Your doctor should periodically check whether you still need the same strength, as the goal is to maintain control on the lowest effective dose of inhaled corticosteroid.

What Is Relanio and What Is It Used For?

Relanio is a prescription combination inhaler containing two complementary medicines: salmeterol, a long-acting beta-2 agonist (LABA) that relaxes the muscles in the airways to ease breathing, and fluticasone propionate, an inhaled corticosteroid (ICS) that reduces airway inflammation. It is used for the long-term treatment of asthma and the symptomatic management of moderate-to-severe chronic obstructive pulmonary disease (COPD).

Relanio belongs to a group of medicines known as fixed-dose LABA/ICS combinations, which are a cornerstone of modern respiratory therapy. Rather than requiring patients to use two separate inhalers, the two active ingredients are delivered together in a single device at every inhalation. This improves both the convenience of treatment and adherence, and has been shown in clinical trials to produce better long-term outcomes than taking the two drugs separately when the same dose is used.

The salmeterol component is a highly selective long-acting beta-2 adrenergic agonist. When inhaled, it binds to beta-2 receptors on the smooth muscle cells lining the bronchi and bronchioles, activating a cascade that relaxes these muscles and widens the airways. The onset of bronchodilation typically occurs within 10 to 20 minutes, peaks at about 2 to 3 hours, and lasts for 12 hours or longer – which is what makes twice-daily dosing possible.

The fluticasone propionate component is a potent topical corticosteroid. Delivered directly into the airways, it suppresses the multiple inflammatory pathways that drive chronic airway disease. It reduces the number and activity of eosinophils, mast cells, macrophages, lymphocytes, and neutrophils in the bronchial mucosa, and decreases the release of inflammatory mediators such as leukotrienes, cytokines, and histamine. The anti-inflammatory effect builds gradually over days to weeks, with maximum benefit typically seen after one to two weeks of regular use.

Relanio is indicated for the following conditions:

  • Asthma maintenance treatment: In adults and adolescents (generally aged 12 years and over for the 50/250 µg strength) whose asthma is not adequately controlled on an inhaled corticosteroid alone, or in patients who are already well controlled on both a LABA and an ICS at the same equivalent doses. The Global Initiative for Asthma (GINA) classifies ICS/LABA combinations as preferred maintenance therapy for moderate-to-severe asthma.
  • Chronic Obstructive Pulmonary Disease (COPD): For the symptomatic treatment of patients with moderate-to-severe COPD (FEV₁ less than 60% of predicted normal) who have a history of repeated exacerbations and significant symptoms despite regular bronchodilator therapy. In COPD, the combination has been shown to reduce the frequency of exacerbations and improve quality of life.
Important warning:

Relanio does not provide immediate relief during sudden breathing difficulties. Always carry a separate short-acting rescue inhaler (such as salbutamol/albuterol or terbutaline) for acute symptoms. If you find you are using your rescue inhaler more frequently than usual, or your symptoms are becoming harder to control, contact your healthcare provider as your treatment plan may need to be reviewed.

Relanio should be prescribed by a doctor familiar with the management of asthma or COPD, and patients should be reviewed regularly. Once stable control has been achieved, the goal of treatment in asthma is to maintain that control on the lowest effective dose of inhaled corticosteroid. This step-down approach helps minimise the small but real risk of long-term steroid-related side effects.

What Should You Know Before Taking Relanio?

Before starting Relanio, tell your doctor about all medical conditions you have – especially heart disease, high blood pressure, thyroid disorders, diabetes, tuberculosis, other lung or respiratory infections, epilepsy, and liver disease. You should not use Relanio if you are allergic to any of its ingredients. Always disclose all other medicines, including over-the-counter products and herbal supplements.

Contraindications

You must not use Relanio if you are hypersensitive (allergic) to salmeterol, fluticasone propionate, or any of the other ingredients of the medicine. Relanio contains lactose monohydrate as a carrier, which contains small amounts of milk proteins. Patients with a confirmed milk protein allergy should not use this product; however, lactose intolerance (the inability to digest lactose sugar) is different and generally does not cause problems with the small amount of inhaled lactose in dry powder inhalers.

Relanio is not suitable as rescue medication for acute bronchospasm or during an asthma attack. The onset of action is too slow to provide emergency relief, and attempting to use it as a reliever may delay the administration of appropriate acute treatment.

Warnings and Precautions

Discuss the following conditions with your doctor, pharmacist, or respiratory nurse before starting Relanio:

  • Cardiovascular disease: Salmeterol, like all beta-2 agonists, can increase heart rate, raise blood pressure, and occasionally provoke arrhythmias. Patients with ischaemic heart disease, heart failure, arrhythmias (including atrial fibrillation), hypertension, or hypertrophic obstructive cardiomyopathy should be carefully monitored.
  • Hyperthyroidism (overactive thyroid): Thyroid hormone amplifies the cardiovascular effects of beta-2 agonists. Tell your doctor if you have an overactive thyroid so that heart rate and rhythm can be monitored appropriately.
  • Diabetes mellitus: Both salmeterol and fluticasone can increase blood glucose levels, particularly at higher doses. Diabetic patients may need to monitor their blood sugar more frequently, especially when starting treatment or adjusting the dose.
  • Hypokalaemia (low potassium): Beta-2 agonists can cause a transient drop in serum potassium. The risk is higher when combined with corticosteroids, loop or thiazide diuretics, xanthines (such as theophylline), or during severe asthma attacks where low oxygen levels may worsen the effect.
  • Pulmonary tuberculosis (active or quiescent): Inhaled corticosteroids should be used with caution in patients with tuberculosis. Regular review is advised.
  • Chronic or untreated infections of the airways: Fluticasone suppresses local immune defence and may allow pulmonary or upper-airway infections to become established or worsen.
  • Hepatic impairment: Patients with severe liver disease may have higher systemic exposure to salmeterol and fluticasone because these substances are metabolised by the liver.
Paradoxical bronchospasm:

In rare cases, inhaling Relanio may trigger paradoxical bronchospasm – a sudden worsening of wheezing and shortness of breath immediately after inhalation. If this occurs, stop using Relanio at once, use your short-acting rescue inhaler, and seek medical attention urgently. Do not use Relanio again until a healthcare professional has reviewed your treatment.

Systemic effects of inhaled corticosteroids. When inhaled corticosteroids are used for prolonged periods at high doses, a small amount is absorbed into the bloodstream and may produce systemic effects. These are uncommon at recommended doses but can include suppression of the adrenal glands, reduced bone mineral density, cataracts, glaucoma, slowing of growth in children and adolescents, and increased susceptibility to infection. Your doctor will use the lowest effective dose and may order periodic assessments (eye examinations, bone density scans, or growth checks in children) if you are on long-term high-dose treatment.

Increased risk of pneumonia in COPD. Clinical studies have shown that patients with COPD taking inhaled corticosteroids (including in combination with salmeterol) have a higher incidence of pneumonia than those not using an ICS. The benefit of reduced exacerbations generally outweighs this risk, but patients should be aware of the symptoms of pneumonia (persistent cough, fever, increased sputum production, chest pain) and seek medical assessment if they occur. The overlap between worsening COPD and pneumonia can be difficult to distinguish clinically.

If your asthma worsens or your breathing deteriorates, or if you find yourself needing your short-acting rescue inhaler more often than normal, contact your doctor promptly. An increasing reliance on rescue medication is often an early warning sign that asthma control is declining and that preventer therapy needs to be adjusted.

Pregnancy and Breastfeeding

If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, discuss Relanio with your doctor before starting or continuing treatment. There is only limited experience with Relanio in pregnant women from controlled clinical trials. Animal studies with salmeterol and fluticasone at high doses have demonstrated reproductive toxicity, but in humans, the systemic exposure from inhaled therapy at recommended doses is very low. Importantly, uncontrolled asthma during pregnancy is associated with significant risks to both mother and baby, including pre-eclampsia, preterm delivery, low birth weight, and increased perinatal mortality. The overall evidence supports continuing effective asthma control during pregnancy, and your doctor will help you weigh the benefits and risks individually.

It is not known whether salmeterol or fluticasone pass into human breast milk in clinically meaningful amounts. A decision to continue breastfeeding while using Relanio, or to modify treatment, should be made together with your healthcare provider, taking into account the importance of breastfeeding for the infant and the importance of maintained asthma or COPD control for the mother.

Driving and Operating Machinery

Relanio is unlikely to affect your ability to drive or operate machinery in the vast majority of patients. Occasional side effects such as tremor, dizziness, or palpitations could theoretically impair performance, so you should exercise caution until you know how the medication affects you personally. If you experience any such symptoms, avoid driving or operating hazardous equipment and consult your doctor.

Lactose Content

Relanio contains lactose monohydrate as a carrier substance, at approximately 12 milligrams per delivered dose. This small amount is usually well tolerated, even by people with lactose intolerance. However, the lactose contains trace amounts of milk protein that may trigger an allergic reaction in patients with a confirmed milk protein allergy. If you have such an allergy, discuss alternative treatment options with your doctor.

How Does Relanio Interact with Other Drugs?

Relanio can interact with several common medications, including strong CYP3A4 inhibitors (such as ritonavir, cobicistat, ketoconazole, and itraconazole), beta-blockers, diuretics, and theophylline. Always tell your doctor and pharmacist about all medicines you take, including non-prescription medicines and herbal products such as St John's Wort.

Clinically significant drug interactions with Relanio fall into two broad categories: those that increase the plasma concentration of salmeterol or fluticasone (potentially raising the risk of adverse effects), and those that antagonise or amplify their pharmacological actions. Salmeterol is primarily metabolised in the liver by the cytochrome P450 enzyme CYP3A4, and fluticasone propionate is also a substrate for this enzyme – meaning both components are susceptible to interactions with CYP3A4 inhibitors and inducers.

Major Interactions

Important Drug Interactions with Relanio
Interacting Drug / Class Type Effect Recommendation
Ritonavir, cobicistat Strong CYP3A4 inhibitors (HIV/HCV antivirals) Markedly increase fluticasone and salmeterol levels, with risk of Cushing syndrome, adrenal suppression, QT prolongation, and cardiac arrhythmias Avoid combination; use only if benefit clearly outweighs risk
Ketoconazole, itraconazole Strong systemic azole antifungals Substantial rise in plasma salmeterol and fluticasone; increased cardiovascular and systemic corticosteroid effects Avoid co-administration where possible; consider alternative antifungal
Erythromycin, clarithromycin Moderate CYP3A4 inhibitors (macrolide antibiotics) May raise salmeterol exposure; potential for palpitations, tachycardia, QT effects Use with caution; monitor clinically if short-term course is required
Beta-blockers (propranolol, atenolol, sotalol, timolol eye drops) Beta-adrenergic antagonists Can reduce or completely abolish the bronchodilatory effect of salmeterol and precipitate severe bronchospasm Avoid non-selective beta-blockers; cardioselective agents only when strictly necessary under close supervision
Loop & thiazide diuretics (furosemide, bumetanide, hydrochlorothiazide) Potassium-depleting agents Additive hypokalaemia with increased risk of cardiac arrhythmias and muscle weakness Monitor serum potassium; consider supplementation in high-risk patients
Theophylline / aminophylline Methylxanthine bronchodilator Added potassium-lowering and cardiac-stimulating effects Monitor potassium and heart rate; adjust doses as clinically indicated
Systemic corticosteroids (prednisolone, dexamethasone) Oral or parenteral glucocorticoids Additive systemic corticosteroid exposure and potential hypokalaemia Used together only when clinically necessary; monitor for corticosteroid side effects
MAO inhibitors & tricyclic antidepressants Neurotransmitter modulators May intensify cardiovascular effects of salmeterol Use with caution, especially within two weeks of stopping an MAO inhibitor

The interaction between Relanio and strong CYP3A4 inhibitors is the most clinically important. When fluticasone metabolism is blocked, systemic fluticasone exposure can rise several-fold, producing corticosteroid-related adverse effects that mimic Cushing syndrome (moon face, weight gain, muscle weakness, skin changes) and adrenal suppression. Similarly, salmeterol accumulation raises the risk of cardiovascular events, including dangerous prolongation of the QTc interval. This is why current prescribing guidance specifically lists ritonavir and cobicistat (widely used in HIV and hepatitis C therapy) as agents to avoid together with inhaled fluticasone where possible.

Non-selective beta-blockers pose a different mechanistic risk: they physically block the receptors that salmeterol needs to stimulate. A patient with asthma who is given propranolol for migraine prophylaxis or timolol eye drops for glaucoma can experience a sudden loss of bronchodilator effect and severe wheezing. Cardioselective beta-blockers (bisoprolol, metoprolol) have a lower but not negligible risk and should only be used when the cardiovascular indication is compelling and no alternative exists.

Minor Interactions

A number of commonly used medicines and supplements can have minor interactions with Relanio that rarely require treatment changes but warrant awareness:

  • St John's Wort (Hypericum perforatum): A CYP3A4 inducer that may reduce plasma fluticasone levels and potentially decrease anti-inflammatory effect.
  • Rifampicin, carbamazepine, phenytoin, phenobarbital: Other CYP3A4 inducers that may reduce exposure to fluticasone over time.
  • Other beta-2 agonists (e.g. additional salbutamol, terbutaline, formoterol): Using other long-acting beta-2 agonists in addition to Relanio is generally inappropriate. Short-acting rescue beta-2 agonists can continue to be used for relief of acute symptoms.
  • Digoxin: Hypokalaemia induced by beta-2 agonists can increase sensitivity to digoxin toxicity.
  • QT-prolonging medications (certain antiarrhythmics, antipsychotics, antibiotics): Theoretical additive risk with high salmeterol exposure.

Always inform your doctor and pharmacist if you start any new medication, supplement, or over-the-counter product while using Relanio. Never change the dose of Relanio without medical advice, and do not stop treatment abruptly unless instructed to do so.

What Is the Correct Dosage of Relanio?

The standard dose of Relanio 50/250 µg is one inhalation twice daily – one in the morning and one in the evening, approximately 12 hours apart. The dose should be taken regularly even when you are symptom-free. Use exactly as prescribed by your doctor.

Relanio should always be used exactly as prescribed by your healthcare professional. The correct strength (50/100, 50/250, or 50/500 µg) is selected based on the severity of your disease and your response to previous therapy. Regular daily use is essential to achieve and maintain the anti-inflammatory benefit of the fluticasone component; improvement is typically noticeable within a few days but maximum benefit may take one to two weeks.

Adults and Adolescents (12 years and older)

Standard maintenance dose – Asthma

1 inhalation of Relanio 50/250 µg twice daily – one dose morning and one dose evening. This strength is suitable for patients with moderate persistent asthma not controlled by an inhaled corticosteroid alone, or those already well controlled on equivalent doses of salmeterol and fluticasone as separate inhalers. Maximum daily dose: two inhalations (equivalent to 100 µg salmeterol / 500 µg fluticasone).

Standard maintenance dose – COPD

1 inhalation of Relanio 50/250 µg twice daily is also the recommended dose for symptomatic treatment of patients with severe COPD (FEV₁ < 60% predicted normal) and a history of repeated exacerbations. The 50/500 µg strength may be preferred in selected patients where the higher inhaled corticosteroid dose is clinically justified.

Children

Children aged 4 to 11 years

Relanio 50/250 µg is not recommended for children under 12 years of age. Lower strength combinations (e.g. 50/100 µg) are typically used in paediatric asthma when a LABA/ICS combination is indicated. Your paediatrician will choose the correct strength for your child.

Children under 4 years

Relanio is not recommended for children under 4 years of age. Safety and efficacy data in this age group are insufficient, and alternative delivery methods and treatments are available.

Elderly

Elderly patients

No routine dose adjustment is required in elderly patients. However, older adults may be more susceptible to the cardiovascular effects of beta-2 agonists (tachycardia, palpitations, arrhythmia) and to systemic corticosteroid effects (bone loss, glaucoma, cataracts) with prolonged use. Regular review is recommended, particularly in patients with pre-existing heart disease, osteoporosis, or diabetes.

Patients with Hepatic or Renal Impairment

Liver and kidney disease

No dose adjustment is required in renal impairment. Patients with moderate-to-severe hepatic impairment may have higher plasma salmeterol concentrations; Relanio should therefore be used with caution in this group, and cardiovascular monitoring may be advisable.

Relanio 50/250 µg Dosage Summary
Patient Group Dose Frequency Maximum Daily Dose
Adults (≥ 18 years) 50/250 µg (1 inhalation) Twice daily (morning & evening) 2 inhalations
Adolescents (12–17 years) 50/250 µg (1 inhalation) Twice daily (morning & evening) 2 inhalations
Children 4–11 years Not recommended at this strength
Children < 4 years Not recommended
Elderly (≥ 65 years) 50/250 µg (1 inhalation) Twice daily 2 inhalations
Hepatic impairment 50/250 µg (1 inhalation) Twice daily, with caution 2 inhalations

How to Use the Relanio Inhaler

Relanio is supplied as a pre-dispensed (pre-metered) dry powder inhaler containing individual sealed doses of powder on a foil strip. The device has a dose counter that shows how many doses remain. Correct inhalation technique is essential to ensure the medication reaches deep into the lungs where it works. Your doctor, nurse, or pharmacist should demonstrate how to use the device when you are first prescribed it, and should check your technique at each follow-up visit.

  1. Check the dose counter. Make sure the inhaler is not empty. If the counter shows zero, discard the device and use a new one.
  2. Open the inhaler and load a dose. Hold the inhaler upright and open the mouthpiece cover or slide the dose lever as instructed for your specific device until you hear a click. One dose of powder is now ready to be inhaled.
  3. Breathe out gently, away from the inhaler. Exhale fully but comfortably. Never breathe out through the mouthpiece – moisture from your breath can clump the remaining powder and spoil future doses.
  4. Inhale the dose. Place the mouthpiece between your lips, seal them tightly around it, and breathe in quickly, deeply, and steadily through your mouth – not through your nose. A forceful inhalation ensures the powder is drawn fully into the lungs.
  5. Hold your breath. Remove the inhaler from your mouth and hold your breath for approximately 10 seconds (or as long as is comfortable). This gives the drug particles time to deposit in the airways rather than being exhaled.
  6. Close the inhaler. Slide the cover or lever back to its closed position. The dose counter should now show one fewer dose remaining.
  7. Rinse your mouth. Rinse with water, gargle, and spit it out – do not swallow. This removes any fluticasone deposited in the throat and greatly reduces the risk of oral thrush and hoarseness.

You may not taste or feel the powder on your tongue even when you have inhaled correctly – this is normal and does not mean the dose has failed. Clean the mouthpiece by wiping it with a dry tissue; do not wash the inhaler with water or allow it to become damp. Keep the device out of direct sunlight and extremes of temperature, and never store it in a bathroom where humidity can degrade the powder.

For parents and caregivers:

Children and adolescents using Relanio should be supervised until the inhalation technique is reliably established. Many children find a forceful inhalation counter-intuitive, and poor technique dramatically reduces the effective dose. Your pharmacist can provide placebo training devices to help practice.

Missed Dose

If you forget to take a dose of Relanio, take it as soon as you remember – unless it is almost time for your next scheduled dose. In that case, skip the missed dose entirely and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one, as doubling the dose increases the risk of side effects (particularly tremor, palpitations, and headache) without providing any additional clinical benefit.

Overdose

If you accidentally take more Relanio than prescribed – for example by taking two doses close together or if a child gets hold of the inhaler – contact your doctor, a poison control centre, or an emergency department for advice. Acute overdose from inhaled salmeterol and fluticasone is generally not life-threatening but can produce:

  • Rapid or pounding heartbeat (tachycardia, palpitations)
  • Marked trembling or shaking (tremor)
  • Headache and dizziness
  • Lowered blood potassium (hypokalaemia)
  • Raised blood glucose
  • Rarely, cardiac arrhythmias

Treatment of overdose is supportive and symptomatic. In severe cases, a cardioselective beta-blocker may be used with extreme caution under specialist supervision, because of the risk of precipitating bronchospasm. Chronic overuse of inhaled corticosteroids may lead to adrenal suppression; treatment should never be stopped abruptly in such cases, and gradual dose tapering may be required.

What Are the Side Effects of Relanio?

Like all medicines, Relanio can cause side effects although not everyone gets them. The most common are headache, throat irritation, hoarseness, oral thrush (candidiasis), tremor, and palpitations. Serious side effects such as paradoxical bronchospasm or severe allergic reactions are rare. Rinsing your mouth after each use significantly reduces the risk of local side effects.

Side effects of Relanio reflect the combined pharmacology of its two components. Salmeterol acts on beta-2 receptors not only in the lungs but also – to a lesser extent – in the heart, skeletal muscle, and metabolic tissues, accounting for symptoms such as tremor and palpitations. Fluticasone, while largely confined to the airways, can cause local effects in the mouth and throat (thrush, hoarseness) and, with long-term high-dose use, small systemic effects such as bone and adrenal changes. Most side effects are mild, transient, and tend to diminish with continued use.

Seek immediate medical attention if you experience:

Signs of a severe allergic (anaphylactic) reaction including swelling of the face, lips, tongue, or throat; difficulty breathing; sudden severe wheezing or coughing immediately after inhalation (paradoxical bronchospasm); chest pain or irregular heartbeat; sudden worsening of asthma despite using Relanio; or signs of pneumonia (persistent fever, productive cough, shortness of breath). These reactions are uncommon but require urgent assessment.

Very Common Side Effects

May affect more than 1 in 10 users

  • Headache
  • Nasopharyngitis (runny nose, sore throat, sneezing)

Common Side Effects

May affect up to 1 in 10 users

  • Oral candidiasis (white patches in mouth or throat – oral thrush)
  • Hoarseness / voice changes (dysphonia)
  • Throat irritation
  • Pneumonia (particularly in patients with COPD)
  • Bronchitis
  • Cough
  • Tremor (usually of the hands)
  • Palpitations (awareness of rapid heartbeat)
  • Muscle cramps

Uncommon Side Effects

May affect up to 1 in 100 users

  • Hyperglycaemia (raised blood glucose)
  • Cataracts
  • Cutaneous hypersensitivity reactions (rash, itching)
  • Nervousness, restlessness, anxiety, sleep disturbance
  • Tachycardia (fast heart rate)
  • Skin bruising (particularly in elderly patients on long-term treatment)

Rare Side Effects

May affect up to 1 in 1,000 users

  • Angioedema (swelling of face, lips, tongue, or throat)
  • Anaphylactic reactions
  • Cushing syndrome, Cushingoid features
  • Adrenal suppression
  • Growth retardation in children and adolescents
  • Decreased bone mineral density
  • Glaucoma
  • Cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia, extrasystoles)
  • Hypokalaemia (low blood potassium)
  • Paradoxical bronchospasm
  • Behavioural changes, including hyperactivity and irritability (predominantly in children)

Very Rare Side Effects

May affect up to 1 in 10,000 users

  • Depression, psychomotor disturbance, psychosis (particularly in children)
  • Oesophageal candidiasis
  • Sleep apnoea

Managing local side effects. Oral thrush and hoarseness are the two most common side effects from the fluticasone component. Both are related to the deposition of a small amount of steroid powder in the mouth and throat rather than reaching the lungs. The risk can be greatly reduced by always rinsing the mouth with water and spitting it out after each dose, brushing the teeth regularly, and using a spacer device if the inhaler is a metered-dose type (Relanio is a dry-powder device, so a spacer is not used). Oral thrush usually responds quickly to antifungal lozenges or gels; persistent hoarseness should be reviewed by a doctor.

Cardiovascular effects. Tremor and palpitations are direct consequences of beta-2 agonist activity. They are more common at the start of treatment and typically diminish within the first week as the body adjusts. Persistent or troublesome cardiac symptoms should be discussed with your doctor, as they may indicate a need for dose review or cardiovascular investigation.

Long-term steroid-related risks. When inhaled corticosteroids are used for prolonged periods at high doses, a small fraction of the drug enters the systemic circulation and can contribute to effects normally associated with oral steroids: adrenal suppression, Cushingoid features, accelerated bone loss, cataracts, glaucoma, skin thinning, and slower growth in children. These risks are much lower than those from oral corticosteroids but are not zero, which is why guidelines emphasise the use of the lowest effective ICS dose and regular review of therapy.

If you experience any side effects not listed here, or if any listed side effect becomes severe or persistent, inform your doctor, pharmacist, or nurse. Reporting suspected adverse reactions after authorisation of a medicine is important – it allows continued monitoring of the benefit/risk balance of the medicine. Report suspected side effects directly via the relevant national pharmacovigilance scheme (for example, the Yellow Card Scheme in the UK or the FDA MedWatch programme in the United States).

How Should You Store Relanio?

Store Relanio below 25 °C (77 °F), in a dry place, and out of the sight and reach of children. Do not freeze. Do not use the inhaler after the expiry date printed on the packaging. Once you remove the device from any protective packaging, it should generally be used within the shelf life stated in the patient information leaflet (typically 2 to 3 months).

Relanio is a dry powder formulation, which means the powder inside the inhaler is highly sensitive to moisture. Even small amounts of humidity can cause the particles to clump together, reducing the effective dose that reaches your lungs. Proper storage preserves the potency of the medicine throughout its stated shelf life.

  • Temperature: Store below 25 °C (77 °F). Do not freeze. Avoid placing the inhaler near radiators, in direct sunlight, or in a hot car.
  • Humidity: Keep the inhaler dry. Do not store it in the bathroom, near sinks, or in any humid environment.
  • Children: Keep out of the sight and reach of children at all times. Accidental overdose in a small child can cause significant cardiovascular effects.
  • Expiry date: Check the expiry date (EXP) printed on the packaging. This date refers to the last day of the stated month. Do not use the medicine after the expiry date.
  • In-use shelf life: Once you remove the device from its foil pouch or wrapper, the inhaler has a limited in-use shelf life (typically 2 to 3 months, as stated in the patient information leaflet). Mark the opening date on the device or packaging to help you track this.
  • Disposal: Do not throw used or unused inhalers into household waste or wastewater. Return them to your pharmacy for proper disposal. This helps protect the environment and prevents accidental exposure.

The dose counter on the inhaler indicates how many doses remain. When the counter begins to display low numbers (often highlighted in red for the final 10 doses), arrange for a replacement prescription so you do not run out. Once the counter reaches zero, the device is empty and must be discarded appropriately – attempting to use an empty inhaler is ineffective and can delay needed treatment.

What Does Relanio Contain?

Each delivered dose of Relanio 50/250 µg contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate as the active substances, together with lactose monohydrate (which contains small amounts of milk proteins) as the sole excipient.

Relanio has a deliberately minimal formulation, consisting only of the two active ingredients blended with a single carrier excipient:

Active Substances

  • Salmeterol xinafoate equivalent to 50 micrograms of salmeterol per metered dose. Salmeterol is a long-acting selective beta-2 adrenergic agonist (LABA). The xinafoate (1-hydroxy-2-naphthoate) salt is used because it provides good stability as a micronised dry powder.
  • Fluticasone propionate at 250 micrograms per metered dose. Fluticasone propionate is a potent topical glucocorticoid with high anti-inflammatory activity locally in the airways and relatively low systemic bioavailability after inhalation, which makes it well suited to long-term respiratory use.

Excipient

  • Lactose monohydrate (contains small amounts of milk proteins) – up to approximately 12 milligrams per delivered dose. Lactose serves as a carrier for the micronised active particles, improving powder flow through the device and ensuring a reproducible dose is released with each inhalation.

Device and Pack Sizes

Relanio is supplied in a plastic multi-dose dry powder inhaler containing a foil strip with 60 individually sealed blisters, each holding one metered dose of powder. A built-in dose counter displays the number of doses remaining. Typical pack sizes are:

  • 1 × 60 doses (single inhaler)
  • 3 × 60 doses (multi-pack with three inhalers, equivalent to 180 doses)

Not all pack sizes or strengths may be marketed in every country. Your pharmacist can confirm what is available locally.

The marketing authorisation holder is responsible for the quality and regulatory compliance of Relanio. Manufacturing takes place at authorised pharmaceutical facilities under Good Manufacturing Practice (GMP) standards overseen by the relevant competent authorities (such as the European Medicines Agency or the US Food and Drug Administration).

Frequently Asked Questions

No. Relanio is a maintenance (preventer) medication and must not be used for acute relief. The salmeterol component takes 10 to 20 minutes to start working, which is too slow to treat an asthma attack. Always carry a short-acting rescue inhaler (such as salbutamol/albuterol) for emergencies. If your rescue inhaler is not fully relieving your symptoms, or you are using it more than usual, contact your doctor or seek emergency care.

Some of the fluticasone powder inevitably deposits in the mouth and throat rather than reaching the lungs. This steroid residue can lead to two local side effects: oral thrush (a yeast infection that causes white patches and soreness) and hoarseness or voice changes. Rinsing your mouth with water and spitting it out – ideally combined with gargling and then brushing your teeth – washes away the residue and substantially reduces the risk of both problems.

The two components of Relanio have different timelines. The salmeterol (bronchodilator) begins to relax the airways within about 10 to 20 minutes of the first dose, reaches peak effect after 2 to 3 hours, and lasts for 12 hours or more. The fluticasone (anti-inflammatory) works more slowly, with benefits building up over days and reaching their maximum after 1 to 2 weeks of regular use. This is why Relanio must be taken every day as prescribed, even when you feel well – the underlying inflammation continues to be controlled by continuous treatment.

No, you should not stop Relanio without first speaking to your doctor. Feeling well typically means the medicine is working, not that it is no longer needed. Stopping suddenly can cause your asthma or COPD to worsen, sometimes severely. Long-term use of inhaled corticosteroids can also modestly affect your adrenal glands, and abrupt withdrawal after prolonged high-dose treatment may rarely cause adrenal insufficiency. If you feel your condition is well controlled and you want to reduce medication, your doctor will assess whether a gradual step-down in dose is appropriate.

The 50/250 µg strength of Relanio is generally not recommended for children under 12 years of age. Lower combination strengths (such as 50/100 µg) are used when a LABA/ICS combination is appropriate for paediatric asthma, always under the supervision of a paediatrician or respiratory specialist. Long-term use of inhaled corticosteroids in children can cause a small reduction in growth velocity, so height should be monitored. The benefits of effective asthma control in children almost always outweigh this small risk, and children with well-controlled asthma typically achieve their expected final adult height.

There is no specific direct interaction between Relanio and alcohol. Moderate alcohol consumption is generally considered safe, but heavy alcohol intake can worsen asthma symptoms in some people, contribute to weight gain (especially alongside steroid therapy), raise blood pressure, and affect blood glucose control. If you have any concerns, or if you drink heavily, discuss this with your doctor.

Long-term, high-dose use of any inhaled corticosteroid can contribute to a small reduction in bone mineral density over time, adding to other risk factors for osteoporosis (age, smoking, inactivity, low calcium intake, post-menopause). At the recommended dose of Relanio 50/250 µg twice daily, this risk is modest. Your doctor may recommend a DEXA bone density scan if you are on long-term high-dose therapy, especially if you have other risk factors. Adequate dietary calcium and vitamin D, weight-bearing exercise, and avoiding smoking all help protect bone health.

References

This article is based on evidence-based sources, international guidelines, and peer-reviewed publications:

  1. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2024 Update. Available at: ginasthma.org
  2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of COPD. 2024 Report. Available at: goldcopd.org
  3. European Medicines Agency (EMA). Summary of Product Characteristics: Salmeterol/fluticasone propionate fixed-dose combination. EMA product information database.
  4. British National Formulary (BNF). Salmeterol with fluticasone propionate. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk
  5. Calverley PMA, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease (TORCH trial). N Engl J Med. 2007;356(8):775-789. doi:10.1056/NEJMoa063070
  6. Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM; SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006;129(1):15-26. doi:10.1378/chest.129.1.15
  7. Cates CJ, Wieland LS, Oleszczuk M, Kew KM. Safety of regular formoterol or salmeterol in adults with asthma: an overview of Cochrane reviews. Cochrane Database of Systematic Reviews. 2014;(2):CD010314.
  8. Kew KM, Seniukovich A. Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease. Cochrane Database of Systematic Reviews. 2014;(3):CD010115.
  9. World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. 2023.
  10. U.S. Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS). 2017.
  11. British Thoracic Society / Scottish Intercollegiate Guidelines Network (BTS/SIGN). British guideline on the management of asthma. SIGN 158. 2019 (updated 2024).

Editorial Team

This article was written, fact-checked, and medically reviewed by the iMedic Medical Editorial Team, comprising licensed physicians with specialisations in pulmonology, clinical pharmacology, and respiratory medicine.

Medical Writing

iMedic Medical Editorial Team – evidence-based content following the GRADE framework and international respiratory guidelines (GINA 2024, GOLD 2024, BTS/SIGN).

Medical Review

iMedic Medical Review Board – independent panel of medical experts ensuring accuracy, completeness, and clinical relevance of all published content.

Evidence level: This article is based on Level 1A evidence (systematic reviews and meta-analyses of randomised controlled trials), regulatory product information (EMA SmPC, FDA labelling, BNF), and current international clinical practice guidelines.

Conflict of interest: The iMedic Medical Editorial Team has no conflicts of interest. iMedic receives no funding from pharmaceutical companies and maintains editorial independence.

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