Salbutamol

• Medicine for oral inhalation (inhaler)
• Used for asthma and COPD
• Reduces respiratory distress
• Fast acting

Salbutamol is a fast-acting 'reliever’ inhaler. Salbutamol solutions are for inhalation use only, to be breathed in through the mouth. The active ingredient salbutamol causes the muscles in the airways to relax, opening up the airways. This makes it easier to breathe, reducing symptoms such as chest tightness, wheezing and coughing.

This medicine is prescribed by doctors to provide relief from symptoms of asthma and chronic obstructive pulmonary disease (COPD). This medicine is intended to treat asthma symptoms as they happen (emergency medicine). It is also used for prevention of asthma symptoms brought on by exercise or a known allergen exposure that cannot be avoided (e.g., smoke, cold air, pets).

Salbutamol is taken using an inhaler device. The package leaflet contains step-by-step introductions on how to prepare the inhaler for use and use your inhaler correctly. Follow these instructions closely. The guidelines for use are as follows:

• Remove the dustcap.
• Shake the inhaler before each use.
• Breathe out gently as far as comfortable. (Do not breathe out through the mouthpiece.)
• Place the mouthpiece gently between your lips.
• Take a strong and deep breath in. As soon as you take a breath, press down until you hear a click to release the medicine.
• Hold your breath for 5 to 10 seconds. Remove the mouthpiece from your mouth.
• Breathe out gently. If you need to take another inhalation, wait 30 seconds and repeat the above steps.
• Put the dustcap back on the mouthpiece after each use. Clean your inhaler every week (see instructions in the package leaflet).

A spacer is available separately for use in children. Spacers are empty tubes that are made from plastic and slot onto the mouthpiece of the inhaler on one end. They help you get the best from your asthma medicine.

For more information on how to use Salbutamol, please see the package leaflet.

Dosage

Always use Salbutamol Sandoz as directed by your doctor. Check with your doctor or pharmacist if you are not sure. The recommended dose for Salbutamol is:

Adults and adolescents aged 12 years and above

• For relief of symptoms of asthma attacks: one to two inhalations as needed.
• To prevent symptoms before exercise or whatever trigger your asthma attack: two inhalations 10-15 minutes prior to exercise or exposure.
• Maximum dose: eight inhalations in 24 hours.

Children aged 4 to 11 years

• For relief of symptoms of asthma attacks: one inhalation as needed.
• To prevent symptoms before exercise or whatever trigger your asthma attack: one inhalation 10-15 minutes prior to exercise or exposure. This may be increased to two inhalations.
• Maximum dose: eight inhalations in 24 hours.

Consult your doctor if your symptoms get worse or you need to use your reliever inhaler more often than usual. Do not increase the dose or frequency without your doctor's approval.

Alcohol/driving

This medicine does not interact with alcohol and will normally not affect your ability to drive or operate machinery.

If you use more Salbutamol than you should

If you have taken more inhalations than recommended, you should contact your doctor immediately. Symptoms of overdose include tremor, headache, rapid heartbeat, nausea and/or vomiting, restlessness, irritability, fits or sleepiness.

Do not use this Salbutamol if you are allergic to any of the ingredients in this medicine (see section 'What Salbutamol contains').

When should this medicine be used with caution?

Talk to your doctor before using Salbutamol Sandoz if you have any of the following conditions:

• A severe disease affecting the heart.
• A history of severe diseases affecting the heart, irregular heartbeat or angina pectoris (chest pain).

• Severe, untreated high blood pressure.
• Overactivity of the thyroid gland.
• Low levels of potassium in your blood.
• Blood vessel dilation (aneurysm).
• Diabetes (it is recommended that blood sugar levels are monitored when using Salbutamol Sandoz).
• Tumour of the adrenal gland (phaeochromocytoma). The adrenal gland are two glands on top of the kidneys.

Pregnancy and breastfeeding

This medicine should not be used by pregnant or breastfeeding women without consulting a doctor first.

Other medicines and Salbutamol

Some medicines can affect the way this medicine works, or the medicine itself can reduce the effectiveness of other medicines taken at the same time. Tell your doctor if you are using any of the following medicines:

• Medicines to treat heart and blood vessel conditions that cause the airways to narrow and contain an active substance ending in ‘-ol’, e.g. propranolol (beta blocker). These medicines can cause bronchospasms.
• Certain medicines for depression, such as monoamine oxidase inhibitors (e.g., moclobemide) or tricyclic antidepressants (e.g., amitriptyline).
• Medicines to induce or maintain anaesthesia (e.g., halothane).
• Medicines to treat irregular heartbeat (e.g., digoxin).
• Medicines for breathing problems (e.g., theophylline).
• Steroid medicines (e.g., cortisone).
• Diuretics (e.g., furosemide).

Please tell your doctor or pharmacist if you are taking or have recently taken any of these or other medicines, including herbal remedies and medicines obtained without a prescription.

Medicines can cause side effects, although some people may not experience any.

If you experience any of the following side effects, stop using Salbutamol and seek immediate medical attention:

• Symptoms of an allergic reaction, such as:
  • swelling of the face, tongue and/or throat
  • difficulty swallowing
  • itching, rash or reddened skin
  • difficulty breathing
• Chest pain (see 'frequency unknown')
• Increase in wheezing or shortness of breath immediately after dosing. This means your symptoms are getting worse and you need another form of treatment.

Other side effects that are known to be associated with Salbutamol include:

Common (may affect up to 1 in 10 users):

• Feeling shaky.
• Increased heart rate.
• Headache.
• Muscle cramps.

Uncommon (may affect up to 1 in 100 users):

• Palpitations (rapid heartbeat).
• Mouth or throat irritation.

Rare (may affect up to 1 in 1,000 users):

• Decrease in the level of potassium in your blood.
• Facial flushing.

Very rare (may affect up to 1 in 10,000 users):

• Allergic reactions (see beginning of this section).
• Weakness.
• Fainting.
• Increased restlessness.
• Increased irritability.
• Hallucinations.
• Sleep disturbances.
• Irregular heart rhythm.
• Chest pain.
• Itchy skin rash.
• Difficulty breathing directly after using the inhaler.

Frequency unknown:

• Chest pain has been reported with an unknown frequency in patients with heart problems such as angina. Contact your doctor if your experience these symptoms while using Salbutamol, but do not stop using this medicine unless your doctor tells you to.

Talk to your doctor or pharmacist if the side effects are severe or if you experience side effects that are not listed in the package leaflet.

The active substance of Salbutamol Sandoz is salbutamol. One metered dose contains 100 micrograms salbutamol (sulphate). The dose released via the mouthpiece is 90 micrograms salbutamol (sulphate).

The other ingredients are: norflurane (HFA 134a), anhydrous ethanol, oleic acid.

The manufacturer of Salbutamol Sandoz is:

Aeropharm GmbH François-Mitterrand-Allee 1
07407 Rudolstadt
Germany

Read the package leaflet before use.