Bexitrol F HFA 25/125

1. What Bexitrol® F is and what it is used for?
Bexitrol® F metered dose inhaler is a combination of Salmeterol Xinafoate BP and Fluticasone Propionate BP. Salmeterol Xinafoate is a selective, long acting beta-2 agonist used in the treatment of asthma and other forms of diffuse airways obstruction. Fluticasone Propionate is a corticosteroid with mainly glucocorticoid activity. Fluticasone Propionate is stated to exert a topical effect on the lungs without systematic effects at usual dose.
Bexitrol® F is indicated in the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate:

• patients not adequately controlled with inhaled corticosteroids and "as needed" inhaled short-acting beta-2-agonist or
• patients already adequately controlled on both inhaled corticosteroids and long-acting beta-2-agonist

2. Before you take Bexitrol® F
Bexitrol® F is contraindicated in patients with a history of hypersensitivity to any of the ingredients.

Special Warnings and Special Precautions
Consideration should be given to additional corticosteroid therapies, and to including administration of antibiotics if an infection is present. As with all inhaled medication containing corticosteroids, Bexitrol® F should be administered with caution in patients with active or quiescent pulmonary tuberculosis. Bexitrol® F should be administered with caution in patients with thyrotoxicosis.
Precaution for Paediatric Use
Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to paediatric patients. The long-term effects of this reduction including the impact of final adult height are unknown.
Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child.
There are no data available for human breast milk.

Taking other medicines
Both non-selective and selective b-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Due to the very low plasma concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely. Care should be taken when co-administering known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir), as there is potential for increased systemic exposure to Fluticasone Propionate.

3. How to take Bexitrol® F?
Adults and adolescents 12 years and older-
Two inhalations of 25 mg Salmeterol and 50 mg Fluticasone Propionate twice daily. or,
Two inhalations of 25 mg Salmeterol and 125 mg Fluticasone Propionate twice daily. or,
Two inhalations of 25 mg Salmeterol and 250 mg Fluticasone Propionate twice daily.

Important information for Patients
Prime your Bexitrol® F Inhaler
Bexitrol® F inhaler should be primed before using it for the first time. You should also prime your inhaler when the inhaler has not been used for more than 14 days or when the inhaler has been dropped.
To prime, simply shake the inhaler well and then spray 4 times into the air away from your face, shaking well before each spray.

How to use your inhaler correctly?

1. Remove the cap from the mouthpiece of the actuator
2. Make sure the mouthpiece is clean inside and outside.
3. Hold the inhaler by placing your index finger on top of the metal canister and thumb on the bottom of the plastic mouthpiece. Shake it well.
4. Raise the Inhaler to your mouth. Put the mouthpiece between your teeth, but do not bite it. Close your lips around the mouthpiece. Breathe out slowly and gently through the Inhaler until your lungs feel comfortably empty.
5. Tilt your head back slightly. Start to breathe in slowly through your mouth. As you start to breathe in, press down firmly on the top of the can to release your medicine continue to breathe in steadily and deeply.
6. Hold your breath. Remove the inhaler from your mouth. Continue to hold your breath as long as possible, up to 10 seconds. Then breathe out gently. If you are taking a second puff, wait about one minute, then repeat steps 3 to 6.
7. Replace the mouthpiece cap after each use

A handy tip for Children
Children and others who have weaker hands may have difficulty pressing down on the top of the can with just one hand. They can use both hands to make their Inhaler work.

Cleaning your Inhaler
Keeping the plastic actuator clean is very important to prevent medicine buildup and blockage. The actuator should be washed, shaken to remove excess water and air-dried thoroughly at least once a week. The inhaler may stop spraying if not properly cleaned.

How to clean your Inhaler?

1. Remove the metal canister from the plastic casing of the inhaler and remove the mouthpiece cover.
2. Rinse the actuator thoroughly with warm water.
3. Dry the actuator thoroughly inside and outside.
4. Replace the metal canister and the mouthpiece cover.
5. Do not put the metal canister in water.

In case of emergency situation when you feel you are not relieved despite using your inhaler, you can use inhaler along with spacer (a device that your doctor advise to use with your inhaler). This may save your life on the way to hospital. For more information, consult with your doctor.

4. Possible side effects
The following undesirable effects were commonly reported:
Hoarseness/dysphonia, throat irritation, headache, candidiasis of mouth and throat and palpitations.

5. How to store Bexitrol® F?
Pressurised canister, do not puncture, break or incinerate even when apparently empty.
Avoid storage in direct sunlight or heat.
Store below 30° C.
Keep away from eyes.
Keep away from children.