Adverse reactions (Table 1) are ranked in descending order of frequency, as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, <1/1,000); very rare (< 1/10,000); unknown (frequency cannot be estimated from available data). Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

Table 1

*The percent of patients with serious asthma exacerbations in clinical studies was higher for Foradil than for placebo, and the biggest numerical imbalance was observed in children 5-12 years old (see Section 4.4 and 5.1).

** These adverse events were reported in patients treated with Foradil during the post-marketing experience.

The following undesirable effects have been observed with other Foradil formulations: cough and rash.

Section 4.9

The side effect hypertension has been added under Symptoms at the end.

Section 4.4

As present until........

Concomitant conditions

Special care and supervision, with particular emphasis on dosage limits, is required in patients receiving Foradil when the following conditions may exist:

Ischaemic heart disease, cardiac arrhythmias, especially third degree atrioventricular block, severe cardiac decompensation, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm, phaeochromocytoma, hypertrophic obstructive cardiomyopathy, thyrotoxicosis, known or suspected prolongation of the QT interval (QTc > 0.44 sec.; see section 4.5).

As present......

Section 4.5

As present until......

Administration of Foradil to patients being treated with monoamine oxidase inhibitors, macrolides or tricyclic antidepressants should be performed with caution, since the action of ß2-adrenergic stimulants on the cardiovascular system may be potentiated.

Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate a possible hypokalaemic effect of 2-agonists. Hypokalaemia may increase susceptibility to cardiac arrhythmias (for example, in patients treated with digitalis) (see Section 4.4).

There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.

The bronchodilating effects of formoterol can be enhanced by anticholinergic drugs.

As present.......

Section 4.8

Adverse reactions (Table 1) are ranked in descending order of frequency, as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, <1/1,000); very rare (< 1/10,000); not knownunknown (frequency cannot be estimated from available data). Within each frequency grouping, adverse reactions are ranked in order of decreasing seriousness.

The following in Table 1 has been updated:

In Metabolism and nutrition disorders, Not known changed to Unknown and ** is after Hypokalaemia, hyperglycaemia

In cardiac disorders Not known is changed to Rare and QT prolongation deleted for: Angina pectoris**, Electrocardiogram QT prolonged**. 

The following has been added at the end of the table:

The following paragraph has been added for **

** These adverse events were reported in patients treated with Foradil during the post-marketing experience.

4.2       Posology and method of administration

For use in adults (including the elderly) and in children 5 years of age and older

Foradil inhalation powder capsules should be used only with the inhaler device provided in the Foradil pack. There is no safety or efficacy data on the use of Foradil inhalation powder capsules with other marketed inhalation devices.

For use in Aadults (including the elderly)

Asthma

Regular maintenance therapy: 1 inhalation capsule (equivalent  to 12 micrograms formoterol) to be inhaled twice daily.  For more severe cases 2 inhalation capsules to be inhaled twice daily.  This dosing regimen provides symptomatic relief throughout day and night. The recommended maximum daily dose is 48 micrograms per day. 

Foradil should not be used to relieve the acute symptoms of an asthma attack. In the event of an acute attack, a short-acting beta2-agonist should be used (see Section 4.4 Special warnings and precautions for use).

Chronic Obstructive Pulmonary Disease

For regular maintenance therapy, 1 inhalation capsule (equivalent to 12 micrograms formoterol) to be inhaled twice daily.

For use in cChildren aged 5 and above

Asthma

For rRegular maintenance therapy: 1 inhalation capsule (equivalent  to 12 micrograms formoterol) to be inhaled twice daily.  For more severe cases the dose may be increased to 2 inhalation capsules to be inhaled twice daily after assessment by a physician.

Foradil should be taken twice daily.  The recommended maximum daily dose is 24 micrograms b.i.d. (4 capsules).per day.

Foradil should not be used to relieve the acute symptoms of an asthma attack. In the event of an acute attack, a short-acting beta2-agonist should be used (see Section 4.4 Special warnings and precautions for use).

Although Foradil has a rapid onset of action, current asthma management guidelines recommend that long-acting inhaled bronchodilators should be used for maintenance bronchodilator therapy.  They further recommend that in the event of an acute attack, a -agonist with a short duration of action should be used.

In accordance with the current management Guidelines, long-acting 2-agonists may be added to the treatment regimen in patients experiencing problems with high dose inhaled steroids.  Alternatively, where regular symptomatic treatment of asthma is required in addition to inhaled steroids, then long-acting 2-agonists can be used.  Patients should be advised not to stop or change their steroid therapy when Foradil is introduced.

If the symptoms persist or worsen, or if the recommended dose of Foradil fails to control symptoms (maintain effective relief), this is usually an indication of a worsening of the underlying condition.

Chronic Obstructive Pulmonary Disease

Not appropriate

Children under 5 years

Foradil is not recommended in children under the age of 5 years

Renal and hepatic impairment

There is no theoretical reason to suggest that Foradil dosage requires adjustment in patients with renal or hepatic impairment, however no clinical data have been generated to support its use in these groups.

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

One capsule contains 12 micrograms formoterol fumarate dihydrate.

25 mcg of lactose per capsule.

For a full list of excipients, see section 6.1 List of excipients.

• New warning relating to long acting beta agonists added

• Changed from "no effect" to "Patients experiencing dizziness or other similar side effects should be advised to refrain from driving or using machines"

• Side effects listed by frequency. No new side effects added

• New data added

• Gelatin added as excipient