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This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.
Description, Dosage, Side Effects, Contraindications. Data from EMA, URPL, openFDA and other regulatory sources.
| Salbutamol | Salmeterol | |
|---|---|---|
| Active Substances | Salbutamolum | Salmeterolum + Fluticasoni propionas |
| ATC Code | R03AC02 | R03AK06 |
| Form | Aerozol inhalacyjny, zawiesina | Proszek do inhalacji, podzielony |
| Dosage | 100 mcg/dawkę inh. | (50 mikrogramów + 250 mikrogramów)/dawkę |
| Route | wziewna | wziewna |
| Manufacturer | Exeltis Poland Sp. z o.o. | InPharm Sp. z o.o. |
| Indications | Asthalin Inhaler is indicated in adults, adolescents and children aged 4 to 11 years. For babies and children under 4 years of age, see sections 4.2 and 5.1. Asthalin Inhaler provides short-acting (4 to 6 hour) bronchodilation with fast onset (within 5 minutes) in reversible airways obstruction. It is particularly suitable for the relief and prevention of asthma symptoms. It should be used to relieve symptoms when they occur, and to prevent them in those circumstances recognised by the patient to precipitate an asthma attack (e.g. before exercise or unavoidable allergen exposure). Asthalin Inhaler may also be used in the treatment of the reversible component of airways obstruction. | — |
| Side Effects | Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) including isolated reports and not known (cannot be estimated from the available data). Very common and common events were generally determined from clinical trial data. Rare, very rare and unknown events were generally determined from spontaneous data. Immune system disorders Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse. Metabolism and nutrition disorders Rare: Hypokalaemia (especially in combination with xanthine derivatives, corticosteroids and diuretics) increased serum lactate levels and acidosis lactic. Psychiatric disorders Common: Tenseness Rare: Sleep disturbances and hallucinations (especially in children) Very rare : Insomnia, Hyperactivity Nervous system disorders Common: Headache, Dizziness, Fine tremor (particularly in hands) Cardiac disorders Common: Tachycardia Uncommon: Palpitations, Very rare : Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) –especially if used concomitantly with other ß 2 -agonists Not known : Myocardial ischaemia, chest pain (see section 4.4) Vascular disorders Rare: Peripheral vasodilatation. Respiratory, thoracic and mediastinal disorders Uncommon: Throat irritation Very rare: Paradoxical bronchospasm (with an immediate increase in wheezing after dosing). (As with other inhalation therapy, paradoxical bronchospasm may occur immediately after dosing. If this occurs, salbutamol should be discontinued immediately and, if needed, an alternative therapy instituted). Gastrointestinal disorders Uncommon : Mouth irritation Rare : nausea, vomiting, dry mouth, sore mouth. Skin and subcutaneous tissue disorders Very rare: Pruritus Musculoskeletal and connective tissue disorders Uncommon: Myalgia , muscle cramps Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. | — |
| Contraindications | Hypersensitivity to salbutamol or to any of the excipients listed in section 6.1. Non i.v. formulations of salbutamol are contraindicated for use in arresting uncomplicated premature labour and threatened abortion. | — |
| Warnings | As the canister is pressurised, it should not be punctured or disposed of by burning. | — |
Salbutamol (INN: Salbutamolum, ATC R03AC02) and Salmeterol (INN: Salmeterolum + Fluticasoni propionas, ATC R03AK06) differ in active substance, indications, and safety profile. The table above summarizes the clinical differences from regulatory documents.
Combination safety depends on mechanisms and your health profile. Use our interactions checker and always consult your doctor or pharmacist before combining medications.
Both drugs are approved when used per label. Safety is patient-specific — the better choice depends on your condition, other medications, allergies, and comorbidities. Consult a healthcare professional for personalized advice.
This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.