Symbion Bexicap

Generic Name: Dry Powder
Dosage Form: Inhaler
TG Name: Respiratory

1. What Symbion^® is and what it is used for?
Symbion^® Bexicap capsule is a combination of Formoterol Fumarate Dihydrate and Budesonide.
Symbion^® Bexicap is indicated in the regular treatment of asthma, where the use of a combination (long-acting, beta2-agonist and inhaled corticosteroid) has been found to be appropriate. It is also indicated in the symptomatic treatment of severe chronic obstructive pulmonary disease (COPD), with a history of repeated exacerbations despite regular therapy with long-acting bronchodilators.

2. Before you take Symbion^®
Symbion^® Bexicap is contraindicated in patients with a history of hypersensitivity to any of the components of the drug product.
It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly. Patients should be reminded to take their Symbion^® Bexicap Inhaler maintenance dose as prescribed, even when asymptomatic.

It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored.
There are no adequate data from use of Formoterol and Budesonide in pregnant women. Administration of Symbion^® Bexicap Inhaler in pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Budesonide is excreted in breast milk. However, at therapeutic doses no effects on the suckling child are anticipated. It is not known whether Formoterol passes into human breast milk.

Taking other medicines
In patients using potent CYP3A4 inhibitors, Symbion^® HFA Inhaler maintenance and reliever therapy is not recommended.

3. How to take Symbion^®?
Asthma
Adults (18 Years and Older)
Symbion^® 6/100 Bexicap capsule: 1-2 Bexicap capsules, twice daily
Maximum dose is 4 Bexicap capsules, twice daily
Symbion^® 6/200 Bexicap capsule: 1-2 Bexicap capsule, twice daily
Maximum dose is 4 Bexicap capsules twice daily
Adolescents (12-17 Years)
Symbion^® 6/100 Bexicap capsule: 1-2 Bexicap capsules, twice daily
Symbion^® 6/200 Bexicap: 1-2 Bexicap capsules, twice daily
Children (6-11 Years)
Symbion^® 6/100 Bexicap: 2 Bexicap capsules, twice daily
Single Maintenance and Reliever Therapy (For Symbion^® 6/100 Bexicap and 6/200 only)
Adults (18 years and older): The recommended maintenance dosage is 2 inhalations per day as maintenance therapy.
Not more than 6 inhalations should be taken on any single occasion.
COPD (Chronic Obstructive Pulmonary Disease)
Symbion^® 6/200 Bexicap: 2 Bexicap capsule, twice daily

How to use Bexicap?
Symbion^® Bexicap must not be swallowed. It should only be used with Bexihaler

1. Remove the protection cap from the Bexihaler
2. Hold the base of the inhaler firmly and open the inhaler by turning the mouthpiece in the direction of the arrows.
3. Take a capsule out of the blister strip. The capsules are packed dry and hygienic and consist of gelatin. Remove the capsule from the blister pack only immediately before you use it.
4. Place the capsule into the capsule chamber.
5. Check whether the capsule is completely inside the capsule chamber. If not, put the capsule in correctly.
6. Close the inhaler by turing the mouthpiece back to the closed position.
7. Hold the inhaler upright (with the mouthpiece upwards). Hold the push buttons between thumb and index finger. Use both fingers at the same time to press these buttons once, using quick, firm pressure. The capsule is now evenly punctured.
8. Breathe out not through the inhaler).
9. Tilt your head back slightly. Insert the mouthpiece of the inhaler completely into your mouth. Close your lips tight round the mouthpiece. Breathe in rapidly but steadily, as deeply as you can. The inhaler makes a rattling noise if it is operating properly. This is because the capsule spins around in the chamber as the powder disperse.
10. Remove the inhaler from your mouth. Hold your breath for about 5 – 10 seconds so that your lungs can take up the medication. Breathe out gently.
11. After completion of the inhalation, rinse your mouth with water, do not swallow. Open the inhaler and remove the empty capsule. Put the protection cap back on the inhaler.

Cleaning the Bexihaler^® (once every week)
Open the inhaler by turning the mouthpiece as far as possible in the direction of the arrows. Remove the mouthpiece from the base of the inhaler. Rinse the mouthpiece with lukewarm water. Before using the inhaler again, it should be completely dry. The capsule chamber can be cleaned with a little brush. Push the buttons a few times, so the perforation needles can be cleaned as well. Do not use water for the base of the inhaler and /or the perforation needles.

4. Possible side effects
Formoterol Fumarate Dihydrate: Most common adverse events with Formoterol are tremor, palpitations, headache etc. some uncommon and rare adverse events that occurred in the groups receiving Formoterol are cardiac arrhythmias, muscle cramps, and hypersensitivity reactions such as rash, oedema and angio-oedema etc.
Budesonide: The incidence of common adverse events with Budesonide are oropharyngeal candidiasis, hoarseness or throat irritation, dysphonia, back pain, nausea, sinusitis, adrenal suppression, etc.

5. How to store Symbion^®?
Bexicap must not be swallowed. Only to be used with Bexihaler. Avoid storage in direct sunlight or heat. Store below 30° C. Keep away from children.
Remove Bexicap capsule from the blister pack only immediately before use it in the Bexihaler as Bexicap capsule exposed to moisture may not be pierced easily.