Salamol Inhaler

What is Salamol?

Salamol CFC-Free Inhaler is a pressurised inhalation suspension containing the active ingredient salbutamol sulphate. Salbutamol belongs to a class of medicines called bronchodilators, specifically short-acting beta-2 agonists (SABAs).

Mechanism of Action

Salbutamol works by relaxing the smooth muscles in the airways of the lungs. It selectively targets beta-2 receptors in the bronchial muscles, causing them to relax and allowing the airways to widen (bronchodilation). This makes it easier to breathe by reducing resistance in the respiratory airways and increasing airflow to the lungs.

The medication begins working within minutes of inhalation, with peak effects occurring within 30-60 minutes and lasting for 4-6 hours. Salamol is considered a "reliever" medication because it provides rapid symptom relief rather than preventing asthma attacks.

What is Salamol Used For?

Salamol CFC-Free Inhaler is indicated for the treatment and prevention of bronchospasm in conditions where reversible airway obstruction is a feature.

Approved Indications

• Asthma: For relief of acute bronchospasm and prevention of exercise-induced asthma
• Chronic Obstructive Pulmonary Disease (COPD): Including chronic bronchitis and emphysema

Target Patient Populations

• Adults and adolescents (12 years and older)
• Children under 12 years (with appropriate supervision)
• Patients with reversible airway obstruction

Before Using Salamol

Before starting treatment with Salamol, discuss your medical history with your doctor, particularly if you have any of the following conditions:

Medical History Assessment Checklist

• Heart disease or history of heart problems
• High blood pressure (hypertension)
• Irregular heart rhythm (cardiac arrhythmias)
• Overactive thyroid (thyrotoxicosis)
• Diabetes
• Low potassium levels (hypokalaemia)
• Allergies to salbutamol or any other medicines

Required Baseline Evaluations

Your doctor may recommend the following before prescribing Salamol:

• Lung function tests (spirometry)
• Cardiac evaluation if heart conditions are suspected
• Blood tests to check potassium levels if at risk
• Assessment of asthma control and current medication

Salamol Contraindications

Absolute Contraindications

Do NOT use Salamol if you:

• Are allergic to salbutamol or any other ingredients in this medicine
• Are using it for management of premature labour or threatened miscarriage

Risk Stratification Table

Special Population Considerations

Elderly Patients

Elderly patients may be more susceptible to the effects of salbutamol, particularly increased heart rate and tremor. Dose adjustment may be necessary based on renal and hepatic function.

Pediatric and Adolescent Patients

Salamol is suitable for children, but an adult should always supervise administration. Children may need help using the inhaler properly. Parents can assist by spraying the aerosol when the child begins to breathe in.

Renal or Hepatic Impairment

No specific dose adjustments are recommended for patients with renal or hepatic impairment, but caution is advised and patients should be monitored for potential side effects.

Salamol and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, including prescription, over-the-counter, and herbal products.

High-Risk Medication Combinations

Do NOT use Salamol with:

• Propranolol or other non-selective beta-blockers (may counteract the effects of salbutamol)

Medicines That May Interact with Salamol

• Other bronchodilators: Xanthine derivatives (aminophylline, theophylline) - increased risk of side effects
• Diuretics: May worsen hypokalaemia (low potassium)
• Corticosteroids: May enhance hypokalaemic effects
• Digoxin: Risk of digoxin toxicity if hypokalaemia occurs
• Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants: May potentiate cardiovascular effects

Timing Recommendations

If you are using both a preventer and reliever inhaler, use the preventer inhaler first, wait 5 minutes, then use Salamol if needed for immediate symptom relief.

Pregnancy & Breastfeeding

Pregnancy

Use during pregnancy is NOT recommended unless the expected benefit to the mother outweighs any possible risk to the baby. Some forms of salbutamol can be used for obstetric purposes, but the inhaled preparation MUST NOT be used for management of premature labour or threatened miscarriage.

Breastfeeding

Use during breastfeeding is NOT recommended unless the expected benefit to the mother outweighs any possible risk to the baby. Salbutamol may pass into breast milk and could potentially affect the infant.

Fertility

There is no evidence that salbutamol affects human fertility.

Driving & Machine Operation

Salamol Inhaler is not expected to affect your ability to drive or operate machinery. However, if you experience dizziness, tremor, or other side effects that could impair your abilities, you should avoid these activities until you know how the medication affects you.

Warning Signs to Watch For

• Tremor or shakiness in hands
• Dizziness or lightheadedness
• Palpitations or irregular heartbeat
• Headache

Salamol Ingredients

Active Ingredient

• Salbutamol sulphate (equivalent to 100 micrograms salbutamol per metered dose)

Inactive Ingredients (Excipients)

• Ethanol anhydrous (alcohol) - less than 100mg per puff
• Norflurane (HFA-134a) - propellant

Allergen Warnings

This product contains ethanol (alcohol). If you have a known allergy or sensitivity to alcohol, discuss with your doctor before using this inhaler.

How to Use Salamol Inhaler

Proper technique is essential for Salamol to work effectively. Follow these steps carefully.

Preparation

• Remove the cap from the inhaler
• Check that the mouthpiece is clean
• Shake the inhaler well before each use

Testing Your Inhaler

Before first use or if not used for 5 days or more, test spray the inhaler by firing two puffs into the air.

Salamol Dosage Guidelines

Adults and Adolescents (12 years and over)

Children (under 12 years)

Administration Instructions

Step-by-Step Guide

1. Remove the cap from the inhaler and check the mouthpiece is clean
2. Hold the inhaler upright with your thumb on the base and index finger on the top of the canister
3. Shake the inhaler vigorously up and down
4. Breathe out normally as far as comfortable
5. Place the mouthpiece between your lips and form a tight seal
6. Start breathing in slowly and deeply, then press down firmly on the canister to release a puff
7. Continue to breathe in slowly and deeply
8. Remove the inhaler from your mouth and hold your breath for 10 seconds (or as long as comfortable)
9. Breathe out slowly
10. If another puff is needed, wait about one minute and repeat from step 2

Cleaning Instructions

Clean your inhaler once a week to prevent blockage:

1. Remove the mouthpiece cap
2. Remove the metal canister from the plastic mouthpiece (do not wash the canister)
3. Rinse the plastic mouthpiece and cap under warm running water for at least 30 seconds
4. Shake off excess water and allow to dry thoroughly (preferably overnight)
5. Reassemble the inhaler once completely dry

Missed Dose Management

Since Salamol is used as needed for symptom relief, there is no fixed dosing schedule. If you forget to use your inhaler before exercise or when symptoms begin, use it as soon as you remember, then continue with your regular routine.

Overdose Information

If you accidentally use more Salamol than prescribed, or if someone else uses it without prescription, contact your nearest hospital emergency department or tell your doctor immediately.

Symptoms of Overdose

• Muscle tremor
• Headache
• Rapid heartbeat (tachycardia)
• Palpitations
• Flushing
• Low potassium levels (hypokalaemia)

Management

Take the inhaler and this leaflet with you to the hospital so healthcare professionals know what has been taken. Treatment is supportive and may include monitoring of heart function and potassium levels.

Possible Side Effects

Like all medicines, Salamol can cause side effects, although not everyone gets them.

Serious Side Effects - Seek Immediate Medical Attention

Stop using Salamol and tell your doctor or go to hospital immediately if:

• Your breathing problems worsen or you experience wheezing after a dose
• You have signs of serious allergic reaction (swelling of lips, face, neck; difficulty breathing; skin rash or hives)
• You experience chest pain, shortness of breath, or signs of a heart problem
• You don't feel better after 3 hours or longer following a dose

Common Side Effects (affecting less than 1 in 10 people)

• Tremor (shakiness)
• Headache
• Increased heart rate (tachycardia)

Uncommon Side Effects (affecting less than 1 in 100 people)

• Palpitations
• Mouth and throat irritation
• Muscle cramps

Rare Side Effects (affecting less than 1 in 1,000 people)

• Low potassium levels in blood (hypokalaemia)
• Flushing or redness of face/skin

Very Rare Side Effects (affecting less than 1 in 10,000 people)

• Rapid and irregular heartbeat (atrial fibrillation)
• Other heart rhythm disturbances
• Hyperactivity (especially in children under 12)

Frequency Not Known

• Decreased blood flow to heart (myocardial ischaemia)

How to Store Salamol

• Keep out of sight and reach of children
• Do not store above 25°C
• Do not refrigerate or freeze
• Protect from frost, direct sunlight and heat
• Do not expose to temperatures higher than 50°C
• Do not use after the expiry date printed on the carton and canister
• Do not use if the canister is damaged

Disposal

Do not throw away medicines via wastewater or household waste. Return any unused or expired inhalers to your pharmacist for safe disposal.

Pack Information

• Presentation: Pressurised container with metering valve and actuator
• Pack Size: Single inhaler containing 200 metered doses
• CFC-Free: Contains hydrofluoroalkane (HFA-134a) propellant instead of CFCs
• Manufacturer: IVAX Pharmaceuticals Ireland, Waterford, Ireland
• Marketing Authorisation Holder: Imhact Ltd., Dublin, Ireland

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