Xyflo 5

• Asthma prevention • Sneezing and runny nose due to allergies Prophylaxis and chronic treatment of asthma, acute prevention of Exercise-Induced Bronchoconstriction (EIB), and relief of symptoms of Seasonal & Perennial Allergic Rhinitis (AR).

Montelukast is a selective leukotriene receptor antagonist that blocks cysteinyl leukotrienes (LTC4, LTD4, LTE4), which are responsible for airway edema, smooth muscle contraction, and inflammatory processes associated with asthma and allergic rhinitis.

Adult Dose: Oral Chronic asthma Adult: As film-coated tab: 10 mg once daily in the evening. Allergic rhinitis Adult: 10 mg once daily. Prophylaxis of exercise-induced asthma Adult: 10 mg at least 2 hr prior to exercise; do not take additional doses w/in 24 hr. Elderly: No dosage adjustment needed. Hepatic impairment: Mild to moderate: No dosage adjustment needed. Child Dose: Asthma Prophylaxis and maintenance treatment in patients aged >12 months 15 years: 10 mg (conventional tablet) PO once daily in evening Exercise-Induced Bronchospasm Prophylaxis 6-15 years: 5 mg (chewable tablet) PO 2 hours before exercise; do not take additional dose within 24 hours >15 years: 10 mg PO 2 hours before exercise; do not take additional dose within 24 hours If taking drug for another indication, do not take additional dose to prevent EIB Perennial Allergic Rhinitis 15 years: 10 mg (conventional tablet) PO once daily Seasonal Allergic Rhinitis 15 years: 10 mg (conventional tablet) PO once daily Renal Dose: Renal impairment: No dosage adjustment needed.

Common: • Nausea • Vomiting • Headache • Diarrhea

[SAFE IF PRESCRIBED] Montelukast is generally considered safe to use during pregnancy. Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies.

[UNSAFE] Montelukast may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur. You have been prescribed Montelukast for asthma prevention and for the treatment of allergy symptoms such as sneezing and runny nose. It is a relatively safe medicine with very few side effects. Take Montelukast 2 hours before exercising if you have exercise-induced asthma. It does not work right away and should not be used to relieve sudden breathing problems. Use your rescue inhaler to control sudden difficulty in breathing. Do not discontinue use without consulting your doctor, even if you feel better.

Symptoms may include abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity. Employ supportive measures, clinical monitoring, and gastric decontamination if necessary.

Store in a cool & dry place below 30°C, protect from light & moisture. Keep out of the reach of children