NEOVENTTM CFC-FREE

For inhalation use. NeoventTM 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.

Recommended Doses:

Asthma Adults and adolescents 12 years and older: Two actuations of 25 micrograms salmeterol twice daily. In asthma patients with more severe airways obstruction up to four inhalations of 25 micrograms of salmeterol twice daily may be of benefit.

Children below twelve years of age:

The safety and efficacy of NeoventTM CFC-free Inhaler 25 micrograms have not been demonstrated in children. Therefore NeoventTM CFC-free Inhaler 25 micrograms should is not recommended for use in children below twelve years of age.

COPD Adults:

Two actuations of 25 micrograms salmeterol twice daily.

Children:

There is no relevant indication for use of NeoventTM CFC-free Inhaler 25 micrograms in children.

Special patient groups:

There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available on the use of salmeterol in patients with hepatic impairment.

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. 2. Patients should check inside and outside of the inhaler including the mouthpiece for the presence of loose objects and to see that it is clean.

3. Patients should shake the inhaler well to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed. 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 10.

9. After use patients should always replace the mouthpiece cover to keep out dust and fluff. 10. 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. NeoventTM 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 children and 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.

Adverse effects 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) and very rare (< 1/10,000), including isolated reports.

Common and uncommon events were generally determined from clinical trial data. The incidence on placebo was not taken into account. Very rare events are generally determined from post-marketing spontaneous data. The following frequencies are estimated at the standard dose of 50 μg twice daily.

Frequencies at the higher dose of 100 μg twice daily have also been taken to account where appropriate. 4) Gastrointestinal disorders: Very rare: nausea Musculoskeletal, connective tissue and bone disorders: Common: muscle cramps Very rare: arthralgia General disorders and administration site conditions: Very rare: non-specific chest pain The pharmacological side effects of beta-2-agonist treatment, such as tremor, headache and palpitations have been reported, but tend to be transient and to reduce with regular therapy.

Tremor and tachycardia occur more commonly when administered at doses higher than 50 μg twice daily. As with other inhalational therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and fall in expiratory flow rate (PEFR) after dosing.

This should be treated immediately with a fast-acting inhaled bronchodilator. 4). 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.

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The management of asthma should normally follow a stepwise programme and patient response should be monitored clinically and by lung function tests. Salmeterol should not be used (and is not sufficient) as the first treatment for asthma.

Salmeterol is not a replacement for oral or inhaled corticosteroids. Its use is complementary to them. Patients must be warned not to stop steroid therapy and not to reduce it without medical advice even if they feel better on salmeterol.

Salmeterol should not be used to treat acute asthma symptoms for which a fast and short-acting inhaled bronchodilator is required. Patients should be advised to have their medicinal product to be used for the relief of acute asthma symptoms available at all times.

Increasing use of short-acting bronchodilators to relieve asthma symptoms indicates deterioration of asthma control. The patient should be instructed to seek medical advice if short-acting relief bronchodilator treatment becomes less effective or more inhalations than usual are required.

g. higher doses of inhaled corticosteroid or a course of oral corticosteroid). Severe exacerbations of asthma must be treated in the normal way. Although salmeterol may be introduced as add-on therapy when inhaled corticosteroids do not provide adequate control of asthma symptoms, patients should not be initiated on salmeterol during an acute severe asthma exacerbation, or if they have significantly worsening or acutely deteriorating asthma.

Serious asthma-related adverse events and exacerbations may occur during treatment with salmeterol. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on salmeterol.

Sudden and progressive deterioration in control of asthma is potentially life- threatening and the patient should undergo urgent medical assessment. Consideration should be given to increasing corticosteroid therapy. Under these circumstances daily peak flow monitoring may be advisable.

For maintenance treatment of asthma salmeterol should be given in combination with inhaled or oral corticosteroids. 1). Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of salmeterol. Regular review of patients as treatment is stepped down is important.

The lowest effective dose of salmeterol should be used. Paradoxical bronchospasm As with other inhalational therapy, paradoxical bronchospasm may occur with an immediate increase in wheezing and fall in expiratory flow rate (PEFR) after dosing.

This should be treated immediately with a fast-acting inhaled bronchodilator. 8). 8). Thyrotoxicosis Salmeterol should be administered with caution in patients with thyrotoxicosis. 8) and this should be considered when prescribing to patients with a history of diabetes mellitus.

Cardiovascular effects Cardiovascular effects such as increases in systolic blood pressure and heart rate may occasionally be seen with all sympathomimetic drugs, especially at higher than therapeutic doses. For this reason, salmeterol should be used with caution in patients with pre-existing cardiovascular disease.

Hypokalaemia Potentially serious hypokalaemia may result from beta-2 agonist therapy. Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics.

Serum potassium levels should be monitored in such situations. 1). It is not known if this was due to pharmacogenetic or other factors. Patients of black African or Afro-Caribbean ancestry should therefore be asked to continue treatment but to seek medical advice if asthma symptoms remained uncontrolled or worsen whilst using salmeterol.

Ketoconazole Concomitant use of systemic ketoconazole significantly increases systemic exposure to salmeterol. g. prolongation in the QTc interval and palpitations). 5). Inhaler technique Patients should be instructed in the proper use of their inhaler and their technique checked to ensure optimum delivery of the inhaled medicinal drug to the lungs.

As systemic absorption is largely through the lungs, the use of a spacer plus metered dose inhaler may vary the delivery to the lungs. It should be noted that this could potentially lead to an increase in the risk of systemic adverse effects so that dose adjustment may be necessary.

However, a pharmacokinetic study has been undertaken comparing Salmeterol Neolab 25 micrograms and another marketed salmeterol CFC-free pressurised metered dose inhaler each delivered through the Volumatic spacer device. The results confirm comparable systemic and pulmonary absorption for both products.

1). NeoventTM CFC-free Inhaler 25 micrograms contains soya lecithin and is contraindicated in patients who have peanut or soya allergies.