SEREVENT ACCUHALER

Serevent Accuhaler is for inhalation use only. Serevent Accuhaler should be used regularly. The full benefits of treatment will be apparent after several doses of the drug.

In reversible airways obstruction such as asthma Adults (including the elderly):

One inhalation (50 micrograms) twice daily, increasing to two inhalations (2 x 50 micrograms) twice daily if required.

Children 4 years and over:

One inhalation (50 micrograms) twice daily. The dosage or frequency of administration should only be increased on medical advice. There are insufficient clinical data to recommend the use of Serevent Accuhaler in children under the age of four.

In chronic obstructive pulmonary disease Adults (including the elderly):

One inhalation (50 micrograms) twice daily.

Children:

Not appropriate.

Special patient groups:

There is no need to adjust the dose in patients with impaired renal function.

Using the Accuhaler:

The Accuhaler should be used in a standing or sitting position. The device is opened and primed by sliding the lever. The mouthpiece is then placed in the mouth and the lips closed round it. The dose can then be inhaled and the device closed.

Adverse reactions 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.

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 50mcg twice daily.

Frequencies at the higher dose of 100mcg twice daily have also been taken to account where appropriate. 4) Common Tachycardia Uncommon Cardiac Disorders Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles).

4) Very rare Gastrointestinal Disorders Nausea Very Rare Muscle cramps CommonMusculoskeletal & Connective Tissue Disorders Arthralgia Very Rare System Organ Class Adverse Reaction Frequency General Disorders and Administration Site Conditions Non-specific chest pain Very Rare The pharmacological side effects of β2-agonist treatment, such as tremor, subjective palpitations and headache, 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 50mcg twice daily. 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. uk/yellowcard.

The management of asthma should normally follow a stepwise programme. Serevent should not be used (and is not sufficient) as the first treatment for asthma. 1). Its use is complementary to them. Asthmatic patients must be warned not to stop steroid therapy, and not to reduce it without medical advice, even if they feel better on salmeterol.

Serevent 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 bronchodilators, in particular short-acting inhaled β2- agonists, to relieve symptoms, indicates deterioration of asthma control. In this case, the patient should be instructed to seek medical advice. Although Serevent may be introduced as add-on therapy when inhaled corticosteroids do not provide adequate control of asthma symptoms, patients should not be initiated on Serevent 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 Serevent. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Serevent.

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 Serevent. Regular review of patients as treatment is stepped down is important.

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