What Budesonide/formoterol is used for: It is an inhaler that is used to treat asthma in adults, adolescents and children aged 6 years and older. Do not use Budesonide/formoterol If you are allergic to budesonide, formoterol or the other ingredient of this medicine, which is lactose (which contains small amounts of milk protein). Warnings & Precautions: Talk to your doctor or pharmacist before using Budesonide/ formoterol Inhalation aerosol if: • You are diabetic • You have a lung infection • You have high blood pressure or you have ever had a heart problem (including an uneven heartbeat, a very fast pulse, narrowing of the arteries or heart failure) • You have problems with your thyroid or adrenal glands • You have low levels of potassium in your blood • You have severe liver problems. • Contact your doctor if you experience blurred vision or other visual disturbances Possible Side Effects: Stop using the product and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue, feel faint, or have difficulty breathing. Stop using the product if you develop hives or itching of the face or body. Other medicines and Budesonide/formoterol In particular, tell your doctor or pharmacist if you are using any of the following medicines: • Beta-blocker medicines (such as atenolol or propranolol for high blood pressure), including eyedrops (such as timolol for glaucoma) • Medicines for a fast or uneven heart beat (such as quinidine) • Medicines like digoxin, often used to treat heart failure • Diuretics, also known as ‘water tablets’ (such as furosemide) • Steroid medicines that you take by mouth (such as prednisolone) • Xanthine medicines (such as theophylline or aminophylline) • Other bronchodilators (such as salbutamol) • Tricyclic anti-depressants (such as amitriptyline) and the anti-depressant nefazodone • Phenothiazine medicines (such as chlorpromazine and prochlorperazine) • Medicines called ‘HIV-protease inhibitors’ (such as ritonavir) to treat HIV infection • Medicines to treat infections (such as ketoconazole, itraconazole, voriconazole, Posaconazole, clarithromycin and telithromycin) • Medicines for Parkinson’s disease (such as leva-dopa) • Medicines for thyroid problems (such as levo-thyroxine) How to use Budesonide/formoterol: a) Using Budesonide/ formoterol Inhalation aerosol and a separate reliever inhaler Use your Budesonide/ formoterol Inhalation aerosol everyday. This helps to prevent asthma symptoms from happening. Adults (18 years and above) • The usual dose is 1 or 2 inhalations, twice a day. • Your doctor may increase this to 4 inhalations, twice a day. • If your symptoms are well controlled, your doctor may ask you to take your medicine once a day. Adolescents (12 to 17 years) • The usual dose is 1 or 2 inhalations, twice a day. • If your symptoms are well controlled, your doctor may ask you to take your medicine once a day. Children (6 to 11 years) The usual dose is 2 inhalations, twice a day. Budesonide/ formoterol Inhalation aerosol is not recommended to be used in children who are younger than 6 years. Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen. Always keep your ‘reliever inhaler’ with you to use when you need it. Do not use Budesonide/ formoterol Inhalation aerosol to treat asthma symptoms - use your reliever inhaler. b) Using Budesonide/ formoterol Inhalation aerosol as your only asthma inhaler Only use Budesonide/ formoterol Inhalation aerosol in this way if your doctor has told you to and if you are aged 12 or above. Use your Budesonide/ formoterol Inhalation aerosol everyday. This helps to prevent asthma symptoms from happening. You can take: • 1 inhalation in the morning and 1 inhalation in the evening or 2 inhalations in the morning or 2 inhalations in the evening How to store Budesonide/formoterol: Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Keep the container tightly closed. Do not use Budesonide if you notice any deterioration or damage to the outer packaging. Do not throw away any medicines via wastewater or household waste. Ingredients: Budesonide/ formoterol fumarate dihydrate 80 mcg/4.5mcg, inhalation aerosol A valid prescription should be available upon delivery