Symbicort Turbuhaler
(Budesonide/Formoterol Fumarate Dihydrate)

What Symbicort Turbuhaler is and what it is used for

DuoResp Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate.
• Budesonide belongs to a group of medicines called ‘corticosteroids’ also known as ‘steroids’. It works by reducing and preventing swelling and inflammation in your lungs and helps you to breathe more easily.
• Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting β2 adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This will help to open the airways and help you to breathe more easily.

How to take Symbicort Turbuhaler

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure.
• It is important to use DuoResp Spiromax every day, even if you have no asthma or COPD symptoms at the time.
• If you are using DuoResp Spiromax for asthma, your doctor will want to regularly check your symptoms.Asthma DuoResp Spiromax can be prescribed for asthma in two different ways. The amount of DuoResp Spiromax to use and when to use it depends on how it has been prescribed for you.
• If you have been prescribed DuoResp Spiromax and a separate reliever inhaler, read the section called (A) Using DuoResp Spiromax and a separate ‘reliever inhaler’.
• If you have been prescribed DuoResp Spiromax as your only inhaler, read the section called (B) Using DuoResp Spiromax as your only asthma inhaler. (A) Using DuoResp Spiromax and a separate ‘reliever inhaler’ Use your DuoResp Spiromax every day. This helps to prevent asthma symptoms from occurring. Version Valid For 7 Days from Page Teva Pharmaceuticals Europe B.V REG0124202 6.0 Effective Effective Date: 13-Jun-2017 48 of 67 49 Recommended dose: Adults (18 years and older) 1 or 2 inhalations (actuations), 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. Your doctor will help you to manage your asthma and will adjust the dose of this medicine to the lowest dose that controls your asthma. If your doctor feels that you need a lower dose than is available from your DuoResp Spiromax, your doctor may prescribe an alternative inhaler containing the same active substances as your DuoResp Spiromax but with a lower dose of the corticosteroid. However, do not adjust the number of inhalations your doctor has prescribed without talking to your doctor first. Use your separate ‘reliever inhaler’ to treat asthma symptoms when they happen. Always keep your ‘reliever inhaler’ with you and use it to relieve sudden attacks of breathlessness and wheezing. Do not use DuoResp Spiromax to treat these asthma symptoms. (B) Using DuoResp Spiromax as your only asthma inhaler Only use DuoResp Spiromax in this way if your doctor has told you to. Use your DuoResp Spiromax every day. This helps to prevent asthma symptoms from occurring. Recommended dose Adults (18 years and older) 1 inhalation in the morning and 1 inhalation in the evening or 2 inhalations in the morning or 2 inhalations in the evening. Your doctor may increase this to 2 inhalations twice a day. Also use DuoResp Spiromax as a ‘reliever inhaler’ to treat asthma symptoms when they occur.
• If you get asthma symptoms such as sudden attacks of breathlessness and wheezing, take 1 inhalation and wait a few minutes.
• If you do not feel better, take another inhalation.
• Do NOT take more than 6 inhalations at a single time. Always keep your DuoResp Spiromax with you and use it to relieve sudden attacks of breathlessness and wheezing. A total daily dose of more than 8 inhalations is not normally needed. However, your doctor may allow you to take up to 12 inhalations a day for a limited period. If you regularly need to use 8 or more inhalations a day, make an appointment to see your doctor. They may need to change your treatment. Do NOT use more than 12 inhalations in total in 24 hours. If you are doing exercise and you get asthma symptoms, use DuoResp Spiromax as described here. However, do not use DuoResp Spiromax just before exercise to stop asthma symptoms from happening. Chronic Obstructive Pulmonary Disease (COPD) Recommended dose: Adults (18 years and older): Version Valid For 7 Days from Page Teva Pharmaceuticals Europe B.V REG0124202 6.0 Effective Effective Date: 13-Jun-2017 49 of 67 50 2 inhalations twice a day. Your doctor may also prescribe another bronchodilator medicine, for example an anticholinergic (such as tiotropium or ipratropium bromide) for your COPD disease. Preparing your new DuoResp Spiromax Before using your DuoResp Spiromax for the first time, you need to prepare it for use as follows:
• Open the foil pouch by tearing at the notch at the top of the foil pouch and take out the inhaler
• Check the dose indicator to see that there are 120 inhalations in the inhaler.
• Write the date you opened the foil pouch on the label of the inhaler.
• Do not shake your inhaler before use. How to take an inhalation Every time you need to take an inhalation, follow the instructions below. 1. Hold your inhaler with the semi-transparent wine red mouthpiece cover at the bottom. 2. Open the mouthpiece cover by folding it down until one loud click is heard. Your medicine is actively metered. Your inhaler is now ready for use. 3. Breathe out gently (as far as is comfortable). Do not breathe out through your inhaler. 4. Place the mouthpiece between your teeth. Do not bite the mouthpiece. Close your lips around the mouthpiece. Take care not to block the air vents. Breathe in through your mouth as deeply and as hard as you can. Version Valid For 7 Days from Page Teva Pharmaceuticals Europe B.V REG0124202 6.0 Effective Effective Date: 13-Jun-2017 50 of 67 51 5. Remove your inhaler from your mouth. You may notice a taste when you take your inhalation. 6. Hold your breath for 10 seconds or as long as you comfortably can. 7.Then breathe out gently (do not breathe out through the inhaler). Close the mouthpiece cover. If you are to take a second inhalation, repeat steps 1 to 7. Rinse your mouth with water after every dose, and spit it out. Do not try to take your inhaler apart, remove or twist the mouthpiece cover, it is fixed to your inhaler and must not be taken off. Do not use your Spiromax if it has been damaged or if the mouthpiece has come apart from your Spiromax. Do not open and close the mouthpiece cover unless you are about to use your inhaler. Cleaning your Spiromax Keep your Spiromax dry and clean. If necessary you may wipe the mouthpiece of your Spiromax after use with a dry cloth or tissue. When to start using a new Spiromax
• The dose indicator tells you how many doses (inhalations) are left in your inhaler, starting with 120 inhalations when it is full. Version Valid For 7 Days from Page Teva Pharmaceuticals Europe B.V REG0124202 6.0 Effective Effective Date: 13-Jun-2017 51 of 67 52
• The dose indicator, on the rear of the device, shows the number of inhalations remaining in even numbers only.
• For inhalations remaining from 20 downwards to ‘8’, 6’,’4’,’2’ the numbers are displayed in red on a white background. When the numbers become red in the window, you should consult your doctor and obtain a new inhaler. Note:
• The mouthpiece will still ‘click’ even when your Spiromax is empty. If you open and close the mouthpiece without taking an inhalation the dose indicator will still register it as a count. This dose will be securely held inside the inhaler for when the next inhalation is due. It is impossible to accidentally take extra medicine or a double dose in one inhalation. Keep the mouthpiece closed all the time unless you are about to use your inhaler. Important information about your asthma or COPD symptoms If you feel you are getting breathless or wheezy while using DuoResp Spiromax, you should continue to use DuoResp Spiromax but go to see your doctor as soon as possible, as you may need additional treatment. Contact your doctor immediately if:
• Your breathing is getting worse or you often wake up at night with breathlessness and wheezing.
• Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual. These signs could mean that your asthma or COPD is not being properly controlled and you may need different or additional treatment immediately. Once your asthma is well controlled your doctor may consider it appropriate to gradually reduce the dose of DuoResp Spiromax. If you use more DuoResp Spiromax than you should It is important that you take your dose as advised by your doctor. You should not exceed your prescribed dose without seeking medical advice. If you use more DuoResp Spiromax than you should, contact your doctor, pharmacist or nurse for advice. The most common symptoms that may occur after if you use more DuoResp Spiromax than you should are trembling, headache or a rapid heartbeat. If you forget to use DuoResp Spiromax If you forget to take a dose, take it as soon as you remember. However do not take a double dose to make up for a forgotten dose. If it is nearly time for your next dose just take your next dose at the usual time. If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your ‘reliever inhaler’, then seek medical advice. If you stop using DuoResp Spiromax Do not stop using your inhaler without telling your doctor first. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the following happen to you, stop using DuoResp Spiromax and talk to your doctor immediately: Version Valid For 7 Days from Page Teva Pharmaceuticals Europe B.V REG0124202 6.0 Effective Effective Date: 13-Jun-2017 52 of 67 53

Rare side effects: may affect up to 1 in 1,000 people
• Swelling of your face, particularly around your mouth (tongue and/or throat and/or difficulty to swallow) or hives together with difficulties to breathe (angioedema) and/or sudden feeling of faintness. This may mean that you are having an allergic reaction, which may also include rash and itching.
• Bronchospasm (tightening of the muscles in the airways which causes wheezing and shortness of breath). If the wheezing comes on suddenly after using this medicine stop using it and talk to your doctor immediately.

Very rare side effects: may affect up to 1 in 10,000 people
• Sudden acute wheezing and/or shortness of breath immediately after using your inhaler (also referred to as ‘paradoxical bronchospasm’). If either of these symptoms occur, stop using DuoResp Spiromax straightaway and use your ‘reliever inhaler’. Contact your doctor immediately as you may need to have your treatment changed. Other possible side effects:

Common: may affect up to 1 in 10 people
• Palpitations (awareness of your heart beating), trembling or shaking. If these effects occur, they are usually mild and usually disappear as you continue to use DuoResp Spiromax.
• Thrush (a fungal infection) in the mouth. This is less likely to occur if you rinse your mouth out with water after using your medicine.
• Mild sore throat, coughing and a hoarse voice.
• Headache.
• Pneumonia (infection to the lung) in COPD patients. Tell your doctor if you have any of the following while taking DuoResp Spiromax they could be symptoms of a lung infection:
• Fever or chills
• Increased mucus production, change in mucus colour
• Increased cough or increased breathing difficulties

Uncommon: may affect up to 1 in 100 people
• Feeling restless, nervous, agitated, anxious or angry.
• Disturbed sleep.
• Feeling dizzy.
• Nausea (feeling sick).
• Fast heartbeat.
• Bruising of the skin.
• Muscle cramps.
• Blurred vision.

Rare:
• Low levels of potassium in your blood.
• Uneven heartbeat.

Very rare:
• Depression.
• Changes in behaviour, especially in children.
• Chest pain or tightness in the chest (angina pectoris).
• Disturbance of the heart’s electrical system (prolongation of the QTc-interval).
• An increase in the amount of sugar (glucose) in your blood.
• Taste changes, such as an unpleasant taste in the mouth. Version Valid For 7 Days from Page Teva Pharmaceuticals Europe B.V REG0124202 6.0 Effective Effective Date: 13-Jun-2017 53 of 67 54
• Changes in your blood pressure.
• Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include:
• changes in bone mineral density (thinning of the bones)
• cataract (clouding of the lens in the eye)
• glaucoma (increased pressure in the eye)
• a slowing of the rate of growth of children and adolescents
• an effect on the adrenal gland (a small gland next to the kidney) These effects happen very rarely and are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). United Kingdom The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. Ireland HPRA Pharmacovigilance, Earlsfort Terrace, IRL
•Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: [email protected] Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Symbicort Turbuhaler

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 or on the label of your inhaler after EXP. The expiry date refers to the last day of that month.
• Do not store above 25 oC. Keep the mouthpiece cover closed after removal of the foil wrapping.
• Use within 6 months of removing from the foil wrapping. Use the label on the inhaler to write down the opening date of the foil pouch.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.