SERETIDE Inhaler Ref.[50859] Active ingredients: Fluticasone Salmeterol

Dose

SERETIDE Inhaler is for inhalation only.

Patients should be made aware that SERETIDE Inhaler must be used regularly for optimum benefit, even when asymptomatic. Patients must be warned not to stop therapy or reduce it without medical advice, even if they feel better on SERETIDE.

Patients should be regularly reassessed by a doctor, so that the strength of SERETIDE they are receiving remains optimal and is only changed on medical advice.

The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Where effective control of symptoms is maintained with the lowest strength of the SERETIDE inhaler (25 mcg/50 mcg) given twice daily, the next step could include a test of inhaled corticosteroid alone. As an alternative, patients requiring a long-acting beta-2 agonist could be titrated to SERETIDE given once daily if, in the opinion of the prescriber, it would be adequate to maintain disease control. In the event of once daily dosing when the patient has a history of nocturnal symptoms, the dose should be given at night; and when the patient has a history of mainly day-time symptoms, the dose should be given in the morning.

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

Asthma

Patients should be given the strength of SERETIDE containing the appropriate fluticasone propionate dosage for the severity of their disease.

Patients should be instructed not to take additional doses to treat symptoms but to take a short-acting inhaled beta-2 agonist.

Adults and adolescents 12 years and older

Two inhalations of 25 mcg salmeterol and 50 mcg fluticasone propionate twice daily.

or

Two inhalations of 25 mcg salmeterol and 125 mcg fluticasone propionate twice daily.

or

Two inhalations of 25 mcg salmeterol and 250 mcg fluticasone propionate twice daily.

Paediatric population

Children 4 years and older: Two inhalations of 25 mcg salmeterol and 50 mcg fluticasone propionate twice daily.

Children under 4 years of age: There are insufficient clinical data at present to recommend use of SERETIDE in children aged under 4 years.

Chronic Obstructive Pulmonary Disease (COPD)

2 inhalations of 25 mcg/125 mcg twice daily.

For patients who require additional symptomatic control replace the 25 mcg/125 mcg strength with the 25 mcg/250 mcg strength.

The maximum daily dose is 2 inhalations 25 mcg/250 mcg twice daily (see Section 5 PHARMACOLIGICAL PROPERTIES, Clinical efficacy and safety).

Special populations

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

Method of administration

For instructions on the use and handling of this medicine, see Section 6.6 Special precautions for disposal and other handling.

It is not recommended that patients receive higher than approved doses of SERETIDE. It is important to review therapy regularly and titrate down to the lowest approved dose at which effective control of disease is maintained (see Section 4.2 Dose and method of administration)

The available information on overdose with SERETIDE, salmeterol and/or fluticasone propionate is given below:

Symptoms and signs

The expected symptoms and signs of salmeterol overdosage are those typical of excessive beta-2-adrenergic stimulation, including tremor, headache, tachycardia, increases in systolic blood pressure and hypokalaemia and raised blood glucose levels.

Acute inhalation of fluticasone propionate doses in excess of those approved may lead to temporary suppression of the hypothalamic-pituitary adrenal axis. This does not usually require emergency action as normal adrenal function typically recovers within a few days.

If higher than approved doses of SERETIDE are continued over prolonged periods, significant adrenocortical suppression is possible. There have been very rare reports of acute adrenal crisis, mainly occurring in children exposed to higher than approved doses over prolonged periods (several months or years); observed features have included hypoglycaemia associated with decreased consciousness and/or convulsions. Situations which could potentially trigger acute adrenal crisis include exposure to trauma, surgery, infection or any rapid reduction in the dosage of the inhaled fluticasone propionate component.

Treatment

There is no specific treatment for an overdose of salmeterol and fluticasone propionate. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764 766).

2 years.

Store below 30°C. Protect from frost and direct sunlight.

As with most inhaled medications in pressurised canisters, the therapeutic effect of this medication may decrease when the canister is cold.

Pressurised container. Do not expose to temperatures higher than 50°C. The canister should not be punctured, broken or burnt even when apparently empty.

SERETIDE Inhaler comprises a suspension of salmeterol xinafoate and fluticasone propionate in the non-CFC propellant HFA 134a. The suspension is contained in an aluminium alloy can sealed with a metering valve. The canisters are fitted into plastic actuators incorporating an atomising orifice and fitted with dustcaps. The canister has a counter attached to it, which shows how many actuations of medicine are left. The number of actuations left will show through a window in the back of the plastic actuator. SERETIDE Inhaler has been formulated in three strengths and one pack size, delivering 120 actuations per inhaler.

For detailed instructions for use, refer to the Patient Information leaflet.

Before using for the first time, the patient should test the inhaler by releasing puffs into the air until the counter reads 120 to make sure that it works.

If the inhaler has not been used for a week or more, the patient should release two puffs into the air before using.

Each time a puff is released the number on the counter will count down by one. In some cases dropping the inhaler may cause the counter to count down.

How to use the inhaler:

1. Remove the mouthpiece cover by gently squeezing the sides of the cover.
2. Check inside and outside of the inhaler including the mouthpiece for the presence of loose objects.
3. Shake the inhaler well to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed.
4. Hold the inhaler upright between fingers and thumb with your thumb on the base, below the mouthpiece.
5. Breathe out as far as is comfortable and then place the mouthpiece in your mouth between your teeth and close your lips around it, but do not bite it.
6. Just after starting to breathe in through your mouth, press down on the top of the inhaler to release salmeterol and fluticasone propionate, while still breathing in steadily and deeply.
7. While holding your breath, take the inhaler from your mouth and take your finger from the top of the inhaler. Continue holding your breath for as long as is comfortable.
8. To take a second inhalation keep the inhaler upright and wait about half a minute before repeating steps 3 to 7.
9. Afterwards, rinse your mouth with water and spit it out.
10. Immediately replace the mouthpiece cover in the correct position. The cap when correctly fitted will click into position. If it does not click into place, turn the cap the other way round and try again. Do not use excessive force.

DO NOT PUT THE METAL CANISTER INTO WATER.