Serevent Inhaler CFC-Free 25 micrograms/dose inhalation suspension – salmeterol for asthma and COPD

Serevent Inhaler CFC-Free is a pressurised inhalation suspension (metered-dose inhaler) containing salmeterol – a long-acting bronchodilator. Salmeterol keeps the airways open, making it easier to breathe in and out; its effect usually starts within 10 to 20 minutes and lasts at least 12 hours.

Each dose contains 25 micrograms of salmeterol, and one inhaler provides 120 doses. It is used regularly, twice a day, as add-on treatment of asthma together with an inhaled corticosteroid, to prevent exercise-induced asthma and in the treatment of chronic obstructive pulmonary disease (COPD). The propellant is norflurane, which has less impact on the environment than older inhalers.

What is Serevent used for and how is the inhaler used correctly?

Key information about the medicine

What is Serevent used for?

According to the summary of product characteristics, Serevent Inhaler CFC-Free is indicated for:

• Regular symptomatic add-on treatment of asthma (reversible airway obstruction), including nocturnal asthma, in patients not adequately controlled with inhaled corticosteroids.
• Prevention of exercise-induced asthma.
• Treatment of chronic obstructive pulmonary disease (COPD).

Serevent is not a first-line asthma medicine and does not replace inhaled or oral corticosteroids – it is used in addition to them.

How is Serevent used and dosed?

Use the medicine every day exactly as your doctor has prescribed. According to the package leaflet:

• Asthma – adults and adolescents aged 12 and over: usually two puffs twice a day; in more severe asthma the doctor may increase the dose to up to four puffs twice a day.
• Asthma – children aged 4 to 12: two puffs twice a day. Not recommended for children under 4.
• COPD – adults: two puffs twice a day.
• Before first use (or if you have not used the inhaler for a week or more) remove the cap, shake the inhaler and release two puffs into the air.
• Technique: sit or stand upright, shake the inhaler 4–5 times, breathe out as far as is comfortable, close your lips around the mouthpiece (do not bite it) and, just after you start to breathe in slowly and deeply through your mouth, press down on the canister. Hold your breath for a few seconds. Wait about half a minute before the next puff.
• If you see "mist" coming from the top of the inhaler or the sides of your mouth, repeat the procedure. Practise in front of a mirror the first few times. If you or your child find it hard to coordinate pressing and breathing in, a spacer (Volumatic) may help – ask your doctor.
• Cleaning: at least once a week wipe the mouthpiece and plastic casing with a dry cloth; do not remove the metal canister and do not put it in water.

The dose and frequency may only be increased on medical advice, as overuse of this type of medicine increases the risk of side effects.

Special patient groups

• Children aged 4 to 12: two puffs twice a day, with a parent helping with the technique; a spacer is often useful in children.
• Children under 4: insufficient data – use is not recommended. The COPD indication applies to adults only.
• Elderly patients and kidney impairment: no dose adjustment is needed.
• Liver impairment: no data on use.

Contraindications – when the medicine must not be used

• allergy (hypersensitivity) to salmeterol xinafoate or the excipient (norflurane).

Precautions and warnings

• Treatment should not be started during an acute, severe worsening of asthma.
• Before prescribing, your doctor may check your condition if you have an overactive thyroid, diabetes (the medicine may raise blood sugar) or heart disease, including a fast or irregular heartbeat.
• The medicine may lower blood potassium – this is more likely with diuretics, theophylline or corticosteroids; your doctor may ask for a blood test.
• As with other inhaled medicines, paradoxical bronchospasm may occur – a sudden worsening of breathing right after inhalation.
• Once asthma is controlled, your doctor may gradually reduce the dose of Serevent.

Interactions with other medicines, food and drink

Tell your doctor or pharmacist about all medicines you take, including other asthma medicines and medicines obtained without a prescription. It is particularly important to mention:

• ketoconazole or itraconazole (antifungals), ritonavir (HIV) or telithromycin (antibiotic) – increase the risk of side effects, including irregular heartbeat;
• beta-blockers (e.g. atenolol, propranolol, sotalol) – may reduce or block the effect of salmeterol and should be avoided unless your doctor decides otherwise;
• diuretics, theophylline or corticosteroids – a fall in blood potassium is more likely when used with salmeterol.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant, are planning a pregnancy or are breast-feeding, ask your doctor for advice before using this medicine. The doctor will decide on use after carefully weighing the benefits and possible risks for you and your baby.

Driving and using machines

There are no data on the effect of Serevent Inhaler CFC-Free on the ability to drive or use machines. Nervousness (uncommon) and dizziness (rare) may occur – if you experience them, do not drive.

Possible side effects

• Common (up to 1 in 10): muscle cramps; palpitations, headache, trembling – trembling is more likely with more than two puffs twice a day; these effects are short-lived and lessen as treatment continues.
• Uncommon (up to 1 in 100): skin rash, very fast heartbeat (more likely with more than two puffs twice a day), nervousness.
• Rare (up to 1 in 1,000): dizziness, sleeplessness, low blood potassium (irregular heartbeat, muscle weakness, cramps).
• Very rare (up to 1 in 10,000): allergic reactions (wheezing, cough, itching, swelling of the face, lips, tongue or throat), paradoxical bronchospasm, cardiac arrhythmias and extra heartbeats, raised blood sugar, irritation of the mouth and throat, nausea, painful swollen joints, chest pain.

Overdose, missed dose and stopping treatment

• Overdose: if you accidentally inhale more doses than recommended, ask your doctor or pharmacist for advice. A fast heartbeat, trembling, dizziness, headache, muscle weakness and joint pain may occur.
• Missed dose: take the next dose at the usual time; do not take a double dose.
• Stopping treatment: keep using the medicine until your doctor tells you otherwise; any dose reduction is decided by your doctor.

Related information

Alongside treatment of asthma and COPD, stopping smoking, avoiding known triggers, warming up before exercise as agreed with your doctor and regular check-ups that include your inhaler technique are important.

For care of an irritated throat, see also the category Throat problems – products in this category do not replace the medicine prescribed for you.

Composition, pack and manufacturer

• Active substance: salmeterol xinafoate – one metered dose contains 25 micrograms of salmeterol (21 micrograms delivered dose).
• Excipient: norflurane (HFA 134a) – propellant.
• Appearance and pack: white to off-white suspension in a pressurised aluminium canister with a metering valve, in a green plastic actuator with mouthpiece and cap; 120 doses; one inhaler and the leaflet per carton.
• Marketing authorisation holder: Evropa Lek Pharma d.o.o., Bore Stankovića 2, Belgrade. Manufacturer: Glaxo Wellcome Production, Zone Industrielle n°2, 23 rue Lavoisier, Evreux, France.
• Authorisation number: 515-01-03218-22-001 dated 15 June 2023.

Storage

• Store below 30 °C in the original package.
• The canister is pressurised: do not expose to temperatures above 50 °C, do not puncture, break or burn it, even when empty.
• Firmly replace the mouthpiece cap after each use.
• Shelf life: 2 years. Keep out of the sight and reach of children; return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Can Serevent replace my corticosteroid inhaler?

No. According to the leaflet, in asthma Serevent is always used together with an inhaled corticosteroid. Continue your corticosteroids at the same dose even when you feel better, unless your doctor tells you otherwise.

How quickly does Serevent start to work?

The effect usually starts 10 to 20 minutes after inhalation and lasts at least 12 hours, so it is used twice a day. For this reason it is not intended to stop a sudden attack – that is what the fast-acting reliever is for.

What does it mean if I see "mist" after a puff?

It means part of the dose was not inhaled – pressing the canister and breathing in were not coordinated. Repeat the procedure. If you keep finding this difficult, ask your doctor about a spacer (Volumatic).

Why do my hands tremble or my heart pound?

Trembling, palpitations and headache are common side effects that usually wear off during treatment; they are more likely at higher doses. Do not increase the dose yourself, and if the symptoms are marked or your heartbeat is irregular, see your doctor.

Sources

• ALIMS – Package leaflet, Serevent Inhaler CFC-Free 25 micrograms/dose (PIL, Serbian)
• ALIMS – Summary of Product Characteristics, Serevent Inhaler CFC-Free (SmPC, Serbian)

Sources checked on: 25 October 2026.