ATIMOS MODULITE Pressurised inhalation solution Ref.[6862] Active ingredients: Eformoterol

Posology

The dosage depends on the type and severity of disease.

The following dosages are recommended for adults, including elderly patients, and adolescents aged 12 years and above.

Asthma

Adults and adolescents aged 12 years and above

Usually one actuation in the morning and evening (24 micrograms of formoterol fumarate dihydrate per day). In severe cases, up to a maximum of two actuations in the morning and evening (48 micrograms of formoterol fumarate dihydrate per day).

The maximum daily dose is 4 actuations (48 micrograms of formoterol fumarate dihydrate).

Children younger than 12 years of age

The safety and efficacy of Atimos Modulite in children younger than 12 years of age has not been established yet, therefore Atimos Modulite should not be used in children.

Chronic Obstructive Pulmonary Disease (COPD)

Adults (aged 18 years and above)

The usual dose is one actuation twice daily (one in the morning and one in the evening, 24 micrograms formoterol fumarate dihydrate per day).

The daily dose for regular use should not exceed 2 inhalations. If required, additional inhalations above those prescribed for regular therapy may be used for relief of symptoms, up to a maximum total daily dose of 4 inhalations (regular plus required). More than 2 inhalations should not be taken on any single occasion.

Patients should not use the inhaler beyond three months from the date of dispensing by the pharmacist (see section 6.4).

Although Atimos Modulite has a rapid onset of action, long-acting inhaled bronchodilators should be used for maintenance bronchodilator therapy.

Atimos Modulite is not intended to relieve acute asthma attacks.

In the event of an acute attack, a short-acting β₂-agonist should be used.

Patients should be advised not to stop or change their steroid therapy when Atimos Modulite is introduced.

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

Renal or hepatic impairment

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

Method of Administration

To ensure proper administration of the drug, the patient should be shown how to use the inhaler by a physician or other health professional.

Before the first use of the inhaler and after 3 days or more of non-use one actuation should be discharged in the air in order to ensure a faultless function. As far as possible patients should stand or sit in an upright position when discharging the inhaler.

1. Remove the protecting cap from the mouthpiece.
2. Breathe out as deeply as possible.
3. Hold the canister vertically with its body upwards and put the mouthpiece between well-closed lips.
4. Deeply inspire through the mouth and, at the same time, press on the upper part of the inhaler to actuate the puff.
5. Hold breath as long as possible without any effort and, finally, remove the inhaler from the mouth.

Should a further puff be inhaled, the inhaler should be kept in a vertical position for about half a minute, then steps 2 to 5 repeated.

After use, close with the protecting cap.

Important: do not perform steps 2 to 4 too quickly.

Should a part of gas be sprayed from the upper part of the inhaler or from the mouth side, operations should be performed again starting from step 2.

For patients with weak hand-grip it could be easier to hold the inhaler with both hands. Therefore, the upper part of the inhaler is held with both index fingers and its lower part is held with both thumbs.

The use of a spacer device with the inhaler is usually recommended for patients who have difficulty in coordinating inhalation with actuation, however, no clinical data are available for Atimos Modulite with spacers.

There is limited clinical experience on the management of overdose. An overdosage of Atimos Modulite would be likely to lead to effects that are typical of β₂-adrenergic agonists: headache, tremor, palpitations. Symptoms reported from isolated cases are tachycardia, prolonged QTc interval, ventricular arrhythmias, metabolic acidosis, hypokalaemia, hyperglycaemia, nausea, vomiting and somnolence.

Treatment of Overdose

Supportive and symptomatic treatment is indicated. Serious cases should be hospitalised. Use of cardioselective β-adrenergic blockers may be considered, but only subject to extreme caution since the use of β-adrenergic blocker medication may provoke bronchospasm.

Serum potassium should be monitored.

18 months (see also section 6.4).

Prior to dispensing to the patient: Store in a refrigerator at 2°C to 8°C (for a maximum of 15 months).

After dispensing: Do not store above 30°C (for a maximum of 3 months).

1 pressurised, aluminium container fitted with a metering valve, actuator and protective cap, containing a pressurised inhalation solution.

Each canister provides 50, 100 or 120 actuations.

Not all pack size may be marketed.

For pharmacies

Enter the date of dispensing to the patient on the pack.

Ensure that there is a period of at least 3 months between the date of dispensing and the expiry date printed on the pack.

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