Spalmotil 2 mg tablets, 2 mg/5 mL oral solution and 5 mg/mL nebuliser solution (salbutamol) – for asthma and bronchospasm

Spalmotil is a medicine containing salbutamol, a bronchodilator from the group of selective beta-2 adrenergic receptor agonists. It relaxes the muscles of the airways, makes breathing easier and relieves chest tightness, wheezing and cough in asthma and similar lung diseases.

In Serbia it is authorised in three forms made by Galenika: 2 mg tablets, 2 mg/5 mL oral solution (suitable for children and adults who cannot use inhalers) and 5 mg/mL nebuliser solution, which is inhaled only with a nebuliser. The dosage differs for each form and age group.

What is Spalmotil used for and how are the tablets, syrup and nebuliser solution dosed?

Basic information about the medicine

What is Spalmotil used for?

• 2 mg tablets: treatment of asthma (eases airflow through the airways), chronic bronchitis and emphysema.
• 2 mg/5 mL oral solution: breathing problems in people with asthma and similar conditions (bronchospasm, reversible airway obstruction); suitable for children and adults who cannot use inhalers.
• 5 mg/mL nebuliser solution: treatment of breathing problems in asthma or other lung diseases, usually when other treatments do not help enough, and treatment of severe asthma attacks.

How is Spalmotil used and dosed?

Take the medicine exactly as prescribed by your doctor. Dosage according to the leaflet for each form:

• Tablets are swallowed with enough water; the oral solution is measured with the 5 mL spoon provided (marked at 1.25 and 2.5 mL) and can be taken with or without food.
• The nebuliser solution is put into the nebuliser reservoir, the prescribed amount of sterile saline is added if needed, and after inhalation any remaining solution is discarded and the nebuliser cleaned. Use it in a ventilated room and keep the mist away from the eyes.
• Children and adolescents under 18 should use a nebuliser only under the supervision of a specialist experienced in treating asthma.

Special patient groups

• Children: tablets and oral solution from 2 years; nebuliser solution from 18 months, under specialist supervision. The dose depends on age – see the table.
• Elderly patients: treatment starts with a lower dose (tablets 2 mg 3–4 times a day; oral solution 5 mL up to 3 times a day).
• People with heart or thyroid disease or diabetes: use with particular caution and on medical advice.

Contraindications – when the medicine must not be used

• allergy to salbutamol (salbutamol sulfate) or any of the excipients;
• premature labour or threatened miscarriage – the medicine must not be used to prevent or treat them.

Precautions and warnings

Talk to your doctor before use if you:

• have active asthma (frequent symptoms, flare-ups or limited physical ability) – your doctor may start or increase asthma controller medicines, e.g. inhaled corticosteroids;
• have high blood pressure, diabetes or an overactive thyroid;
• have heart disease – heart failure, irregular or fast heartbeat, angina;
• use xanthines (e.g. theophylline), corticosteroids for asthma or diuretics;
• use other nebulised medicines (e.g. ipratropium) or cold medicines (ephedrine, pseudoephedrine) together with the nebuliser solution.

Chest pain and shortness of breath may occur during treatment – tell your doctor, but do not stop the medicine until told to do so. The tablets contain lactose; the oral solution contains sorbitol (a source of fructose, may have a mild laxative effect); the nebuliser solution contains benzalkonium chloride, which can cause wheezing and breathing difficulties.

Interactions with other medicines, food and drink

Tell your doctor about all medicines you take, especially:

• beta-blockers (e.g. propranolol) and other medicines for irregular or fast heartbeat;
• other asthma medicines, including xanthines (theophylline, aminophylline) and corticosteroids (e.g. betamethasone, prednisolone);
• diuretics (e.g. furosemide, indapamide, bendroflumethiazide, bumetanide) and digoxin;
• MAO inhibitors (e.g. selegiline, rasagiline) and tricyclic antidepressants (e.g. clomipramine).

Pregnancy and breastfeeding

• If you are pregnant, breastfeeding or planning a pregnancy, ask your doctor. During pregnancy and breastfeeding Spalmotil is taken only if the doctor considers it necessary.

Driving and using machines

• For the tablets and oral solution, the effect on the ability to drive and use machines is not known; the nebuliser solution is unlikely to affect this ability.

Possible side effects

• Tablets: common – shaking (tremor), headache, dizziness, fast heartbeat or palpitations, nausea, muscle cramps; uncommon – raised blood sugar, pulmonary oedema; very rare – widening of blood vessels, restlessness (akathisia), hyperactivity.
• Oral solution: very common – tremor; common – headache, muscle cramps, palpitations, fast heartbeat; rare – low blood potassium, irregular heartbeat, widening of peripheral blood vessels; very rare – hyperactivity, muscle tension, allergic reactions.
• Nebuliser solution: common – tremor, headache, fast heartbeat; uncommon – irritation of the mouth and throat, muscle cramps; rare – low blood potassium, widening of peripheral blood vessels; very rare – sleep and behaviour disturbances, irregular heartbeat, paradoxical bronchospasm.
• Frequency not known (according to the leaflets): chest pain due to heart problems (e.g. angina), myocardial ischaemia, lactic acidosis (rapid breathing, stomach pain).

Overdose, missed dose and stopping treatment

• Overdose: contact your doctor or the nearest medical facility immediately. Fast heartbeat, shaking, hyperactivity and rapid breathing due to increased lactic acid may occur, and with tablets also low blood potassium with muscle cramps or weakness and irregular heartbeat.
• Missed dose: take it as soon as you remember, unless it is nearly time for the next dose; do not take a double dose.
• Stopping treatment: do not stop the medicine without talking to your doctor.

Related information

In asthma, avoiding known triggers (smoke, allergens, cold air), regular check-ups and a treatment plan agreed with your doctor are important. For using the nebuliser solution, see also the category Inhalers (nebulisers) – products in this category do not replace the medicine prescribed for you.

Composition, pack and manufacturer

• Tablets: each tablet contains 2 mg salbutamol (as salbutamol sulfate); excipients: lactose monohydrate; maize starch; microcrystalline cellulose; povidone K-25; magnesium stearate. Round, biconvex, white to off-white tablets; 60 tablets per carton.
• Oral solution: 5 mL contains 2 mg salbutamol (as salbutamol sulfate); excipients: sodium benzoate (E211); sorbitol, liquid, non-crystallising (E420); citric acid monohydrate; sodium citrate; saccharin sodium; banana flavour (contains propylene glycol); purified water. Clear, colourless, banana-scented solution; 200 mL bottle and 5 mL spoon.
• Nebuliser solution: 1 mL contains 5 mg salbutamol (as salbutamol sulfate); excipients: sodium dihydrogen phosphate dihydrate; benzalkonium chloride; sulfuric acid; purified water. Clear, almost colourless to pale yellow solution; 10 mL bottle with dropper.
• Marketing authorisation holder and manufacturer: Galenika AD Beograd, Batajnički drum b.b., Belgrade.
• Authorisation numbers: tablets – 000457580 2023 dated 10 June 2024; oral solution – 000457647 2023 dated 8 July 2024; nebuliser solution – 515-01-01892-21-001 dated 21 February 2022.

Storage

• Tablets and oral solution: do not store above 25 °C, keep in the original package to protect from light and moisture. Nebuliser solution: do not store above 25 °C, keep in the original package.
• Shelf life: tablets 2 years; oral solution 3 years, 28 days after first opening; nebuliser solution 3 years, 30 days after first opening.
• Keep out of the sight and reach of children. Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Which form of Spalmotil is suitable for children?

The oral solution is intended for children and adults who cannot use inhalers, and the tablets can be given to children from 2 years. The nebuliser solution is used in children from 18 months only under specialist supervision. The doctor chooses the form and dose according to age.

Can I drink the nebuliser solution?

No. The 5 mg/mL nebuliser solution is used only by inhalation with a nebuliser and must not be swallowed or injected.

How long can I use an opened bottle of syrup?

According to the leaflet, after first opening the oral solution should be used within 28 days, stored below 25 °C in the original package. An opened bottle of nebuliser solution can be used for 30 days.

Why do my hands shake after taking the medicine?

Shaking (tremor) is one of the most common side effects of salbutamol. If it is marked or comes with palpitations, chest pain or muscle cramps, contact your doctor.

Sources

• ALIMS – Patient information leaflet Spalmotil 2 mg tablete (PIL)
• ALIMS – Summary of product characteristics Spalmotil 2 mg tablete (SmPC)
• ALIMS – Patient information leaflet Spalmotil 2 mg/5 mL oralni rastvor (PIL)
• ALIMS – Summary of product characteristics Spalmotil 2 mg/5 mL oralni rastvor (SmPC)
• ALIMS – Patient information leaflet Spalmotil 5 mg/mL rastvor za raspršivanje (PIL)
• ALIMS – Summary of product characteristics Spalmotil 5 mg/mL rastvor za raspršivanje (SmPC)

Sources checked on: 25 October 2026.