Pefsal
(Salmeterol+Fluticasone)




COMPOSITION

Every dose of Pefsal contains

Active substance: salmeterol (as salmeterol xinafoate) 25 micrograms, fluticasone propionate 50 microgram, 125 microgram or 250 microgram.

Excipients: oleic acid, ethanol, hydrofluoroalkane 134 a.

THERAPEUTIC INDICATIONS

Pefsal is indicated in the regular treatment of asthma where use of a combination product (long-acting β2 agonist and inhaled corticosteroid) is appropriate:

- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short- acting β2 agonists;

- patients already adequately controlled on both inhaled corticosteroid and long-acting β2 agonists;

- as initial maintenance therapy in patients with moderate persistent asthma for whom rapid control of asthma with GCS is essential.

- as initial therapy in patients with COPD and a pre-bronchodilator FEV1 < 60% of predicted at study entry (before inhaled bronchodilators) and a history of recurrent aggravations and severe symptoms, nevertheless of regular bronchodilator therapy.

CONTRAINDICATIONS.

- Hypersensitivity to any of the components of the medicine.

- age under 4 years old.

ADVERSE EFFECTS

Infectious and parasitic diseases: common – oral and pharynx candidiasis, pneumonia (in CHPD patients)

Immune system: uncommon – skin hypersensitivity reactions, dyspnea, rarely - anaphylactic reactions.

Endocrine system: uncommon – cataract, rarely – glaucoma.

Metabolism and nutrition disorders: uncommon – hypokalemia, very rarely – hypokalemia.

Psychiatric disorders: uncommon – nervousness, sleep disturbances; rarely – behavioral changes, including hyperactivity and irritability (especially in children).

Nervous system: common – headache, uncommon – tremor.

Cardiac disorders: uncommon – palpitations, tachycardia, atrial fibrillation; rarely – arrhythmia, ventricular extrasystoles, supraventricular tachycardia and extrasystoles.

Respiratory, thoracic and mediastinal disorders: common – hoarseness, dysphonia; uncommon - oropharyngeal irritation.

Musculoskeletal and connective tissue disorders: common - muscle cramps, arthralgia.

DOSAGE AND ADMINISTRATION

Route of administration: inhalation use only.

Patients should be made aware that Pefsal must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, and the course of treatment and dosage may be only changed on medical advice.

Bronchial asthma.

The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Where the control of symptoms is maintained with the lowest strength of the combination given twice daily then the next step could include an increase of dose frequency to once daily.

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

If the therapy using inhaled GCS fails to provide sufficient disease management, GCS may be substituted by Pefsal in the therapeutically equivalent dose of administered GCS to improve the asthma control.

The therapeutic replacement of inhaled GCS with Pefsal may allow decreasing the dose of GCS required for asthma control in patients with controlled bronchial asthma using inhaled GCS only.

Recommended doses

Adults and adolescents 12 years and older: two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily; or two inhalations of 25 micrograms salmeterol and 125 micrograms fluticasone propionate twice daily; or two inhalations of 25 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.

Children 4 years and older: t wo inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily. There are no data available for use of Pefsal inhaler in children aged under 4 years.

Chronic Obstructive Pulmonary Disease

Maximum recommended dose for adult patients is two inhalations (25 micrograms of salmeterol and 250 micrograms of salmeterol) twice daily.

Special populations

Decreasing the dose of Pefsal in elderly patients and the patients with compromised liver or kidney functions is not required.

Instructions for use of inhaler for patients

Testing the inhaler:

Before using for the first time patients should remove the mouthpiece cover by gently squeezing the sides of the cover, shake the inhaler well, hold the inhaler between the fingers and thumb with their thumb on the base, below the mouthpiece and release puffs into the air to make sure that it works. If the inhaler with dose indicator is used, several puffs are released to air until the counter reads 120 to make sure that it works.

Use of the inhaler:

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.

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.

4. 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 mouth piece.

6. Just after starting to breathe in through their mouth, patients should press firmly down on the top of the inhaler to release Pefsal, 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. Patients should continue holding their breath for as long as is comfortable.

8. To take a second inhalation, patients should keep the inhaler upright and wait about half a minute before repeating steps 3 to 7.

9. Patients should rinse their mouth out with water and spit out.

10. Patients should immediately replace the mouthpiece cover in the correct orientation by firmly pushing and snapping the cap into position. This does not require excessive force; the cover should click into position.

The medicine may be administered through the spacer.

IMPORTANT

Patients should not rush stages 5, 6 and 7. It is important that patients start to breathe in as slowly as possible just before operating their inhaler. Patients should practice 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 their mouth they should start again from stage 2.

Patients should consider getting a replacement when the counter shows the number 000.

In case if the doctor gave other instruction for inhaler use, then the patient should follow them. In case of difficulties while using the inhaler, it is required to consult a doctor.

Small children can’t use the inhaler by themselves, and adults should assist them. You should wait until the child breath out fully, and bring the inhaler into action at the moment of inspiration. It is required to practice using the inhaler together with the child. Elder children and adults with weak hands are advised to hold the inhaler with two hands. Both forefingers should be placed onto the upper part of the inhaler, and both thumbs should be placed onto the base below the mouthpiece.

Cleaning the inhaler:

Your inhaler should be cleaned at least once a week.

1. Remove the mouthpiece cover.

2. Do not remove the canister from the plastic casing.

3. Wipe the inside and outside of the mouthpiece and the plastic casing with a dry cloth or tissue.

4. Replace the mouthpiece cover in the correct orientation. This does not require excessive force, the cover should click into position.

DO NOT PUT THE METAL CANISTER IN WATER

SPECIAL PRECAUTIONS

As other inhaled GCS drugs, Pefsal should be administered with caution in patients with acute or latent tuberculosis.

Pefsal should be administered with caution in patients with thyrotoxicosis.

Pefsal should be administered with caution in patients with fungal, viral or bacterial respiratory diseases. 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, Pefsal should be used with caution in patients with pre-existing cardiovascular diseases, including arrhythmias, supraventricular tachycardia, extrasystole, AF.

If the dosages of all sympathomimetic drugs exceed the recommended ones, it may result in transitory decreased serum potassium levels. That is why Pefsal should be administered with caution in patients with hypokalemia.

Any inhaled GCSs may lead to an increase in the incidence of systemic effects, especially in long-term administration of high doses. That is why the medicine should be administered with caution in patients with glaucoma, cataract, osteoporosis.

There have been very rare reports of increases in blood glucose levels and this should be considered when prescribing to patients with a history of diabetes mellitus.

PREGNANCY AND LACTATION

Administration of Pefsal to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.

MANUFACTURED FORM

120 dosed metered dose aerosol in a metal inhaler with a dosage device with or without the dosage indicator. Inhaler with a spray device with a protecting cap and leaflet in a carton box.

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