SOLTEL Pressurised inhalation, suspension Ref.[7089] Active ingredients: Salmeterol

Posology

Asthma

Adults and adolescents over 12 years of age

Two actuations of 25 micrograms salmeterol twice daily.

In asthma patients with more severe airways obstruction up to four inhalations of salmeterol twice daily may be of benefit.

Paediatric population

The safety and efficacy of Soltel CFC-free Inhaler 25 micrograms have not been demonstrated in children. Therefore Soltel CFC-free Inhaler 25 micrograms should not be used in children 12 years of age and younger.

COPD

Adults aged 18 years and over

Two actuations of 25 micrograms salmeterol twice daily.

Paediatric population

There is no relevant indication for use of Soltel CFC-free Inhaler 25 micrograms in the paediatric population in the indication for COPD.

Special population

Renal impairment

There is no need to adjust the dose in elderly patients or in those with renal impairment.

Hepatic impairment

There are no data available on the use of salmeterol in patients with hepatic impairment.

Method of administration

For inhalation use only.

Soltel CFC-free Inhaler 25 micrograms should be used regularly. The full benefits of treatment will be apparent after several doses of the medicinal product. As there may be adverse reactions associated with excessive dosing with this class of medicinal product, the dosage or frequency of administration should only be increased on medical advice.

Instructions for use

Patients should be carefully instructed in the proper use of their inhaler (see Patient Information Leaflet).

1. Patients should remove the mouthpiece cover by gently squeezing the sides of the cover and check the mouthpiece inside and outside to see that it is clean.
2. Patients should shake the inhaler well, before use.
3. Before using for the first time patients should release two actuations into the air to make sure that it works. After cleaning or if the inhaler has not been used for a week patients should release one actuation into the air.
4. In a sitting or standing position, patients should hold the inhaler upright between fingers and thumb with their thumb on the base, below the mouthpiece.
5. Patients should breathe out as far as is comfortable and then place the mouthpiece in their mouth between their teeth and close their lips around it. Patients should be instructed not to bite the mouthpiece.
6. Just after starting to breathe in through their mouth patients should press down on the top of the inhaler to release salmeterol while still breathing in steadily and deeply.
7. While holding their breath, patients should take the inhaler from their mouth and take their finger from the top of the inhaler. They should continue holding their breath for as long as is comfortable.
8. If patients are going to take a further actuation, they should keep the inhaler upright and wait about half a minute before repeating steps 2 to 7.
9. After use patients should always replace the mouthpiece cover to keep out dust and fluff.

The mouthpiece cover is replaced by firmly pushing and snapping the cap into position.

Important

Patients should not rush stages 5, 6 and 7. It is important that they start to breathe in as slowly as possible just before operating their inhaler.

Patients should practise in front of a mirror for the first few times. If they see “mist” coming from the top of their inhaler or the sides of the mouth they should start again from stage 2.

People with weak hands may find it easier to hold the inhaler with both hands. Put the two forefingers on top of the inhaler and both thumbs on the base below the mouthpiece.

Soltel CFC-free Inhaler 25 micrograms should be used with a Volumatic spacer device by patients who find it difficult to synchronise aerosol actuation with inspiration of breath, which is often the case for the elderly.

The patient should be referred to the Volumatic instruction leaflet provided with the spacer device, for full details on its correct use.

If their inhaler has been exposed to low temperatures, the patient should take the metal canister out of the plastic case and warm it in their hands for a few minutes. Following warming, one actuation should be released into the air prior to use.

Cleaning the inhaler

The inhaler should be cleaned at least once a week by:

1. Removing the mouthpiece cover.
2. The canister must not be removed from the plastic casing.
3. Wiping the inside and outside of the mouthpiece and the plastic holder with a dry cloth or tissue.
4. Firing one spray to waste before next use.
5. Replacing the mouthpiece cover.

Patients must not put the metal canister into water.

Symptoms

The signs and symptoms of a salmeterol overdose are those typical of β₂-adrenergic stimulation including dizziness, increases in systolic blood pressure, tremor, headache and tachycardia. The preferred antidotes are cardioselective β blocking agents, which should be used with extreme caution in patients with a history of bronchospasm.

Additionally, hypokalaemia can occur and therefore serum potassium levels should be monitored. Potassium replacement should be considered.

Management

If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.

2 years.

Store below 30°C.

Do not freeze.

The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not puncture, break or burn even when apparently empty.

Pressurised aluminium canister containing a white suspension sealed with a metering valve, with a mid-green polypropylene actuator and a pale green polypropylene dust cap.

Each canister provides 120 actuations, each actuation containing 25 micrograms of salmeterol (as xinafoate) corresponding to a delivered dose (ex-actuator) of 21 micrograms salmeterol (as xinafoate).

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.