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Description: Tobi Soli 300mg/5ml R92 Line/Plant: Catalent Proof No: 1 Date: 19 Dec 2012 Author: EL Software: InDesign CS6 Colours: PMS 287

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This is one of the most damaging bacteria for people with cystic fibrosis. If the infection is not properly controlled, it will continue to damage your lungs causing further roblems to your breathing. p Tobi kills the bacteria that cause infections in the lungs. The infection can be controlled successfully if the problem is tackled early. 2. BEFORE YOU USE TOBI Do not use Tobi: if you are allergic (hypersensitive) to tobramycin, any type of aminoglycoside antibiotic, or any of the other i ngredients in TOBI (listed in Section 6). If any of the above apply to you, do not take this medicine and talk to your doctor. Take special care with Tobi Tell your doctor if you have ever had any of the following conditions: Hearing problems (including ringing in your ears and dizziness) Kidney problems Chest tightness Blood in your sputum (the substance you cough up) Muscle weakness that lasts or becomes worse in time, symptom mostly related to condition such as myasthenia or Parkinson s disease If any of these apply to you, tell your doctor before you take Tobi. Inhaling medicines can cause chest tightness and this can appen h with Tobi. Your doctor will supervise your first dose of Tobi and check your lung function before and after dosing. If you are not already doing so, your doctor may ask you to use a bronchodilator, (e.g. salbutamol), before taking Tobi. If you are taking Tobi, strains of Pseudomonas can become resistant to the treatment over time. This can mean the medicine may not work as well as it should over time. Talk to your doctor if you are concerned about this. If you have it by an injection, tobramycin can sometimes cause hearing loss, dizziness and kidney damage, and can harm an unborn child. Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including edicines obtained m without a prescription. You should not take the following medicines while you are taking Tobi: Furosemide, a diuretic ( water tablet ) Urea or mannitol

Other medicines which may harm your kidneys or hearing. The following medicines can increase the chances of harmful effects occurring if they are given to you while you are receiving injections of tobramycin: Amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxins: these medicines may harm your kidneys. Platinum compounds (such as carboplatin and cisplatin): these medicines may harm your kidneys or hearing. Anticholinesterases, (such as neostigmine and pyridostigmine), or botulinum toxin: these medicines may cause muscle weakness to appear or become worse. If you are taking one or more of the above medicines, discuss with your doctor before you take TOBI. You should not mix or dilute Tobi with any other medicine in your nebuliser. If you are taking several different treatments for cystic fibrosis, you should take them in the following order: 1. bronchodilator therapy, such as salbutamol 2. chest physiotherapy 3. other inhaled medicines 4. then Tobi. Please check this order with your doctor as well. Pregnancy and breast-feeding If you want to become pregnant or are pregnant, you should talk to your doctor about the possibility of this medicine causing any harm to you or the unborn child. It is not known whether inhaling this medicine when you are pregnant causes side effects. When they are given by an injection, tobramycin and other aminoglycoside antibiotics can cause harm to an unborn child, such as deafness. If you are breast feeding your child, you should talk to your doctor before using your medicine. Driving and using machines Tobi should not affect your ability to drive and use machines. 3. HOW TO USE TOBI Always use Tobi exactly as your doctor has told you. You should check with your doctor if you are not sure. How much of this medicine you should take and how often you should take it The dose is the same for all persons aged 6 years and older Use two ampoules each day, for 28 days. Inhale the full contents of one ampoule in the morning, and one in the evening. Ideally, there should be a 12 hour gap between the doses.

TOBI 300 mg/5 ml Nebuliser Solution
Tobramycin Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Tobi is and what it is used for 2. Before you use Tobi 3. How to use Tobi 4. Possible side effects 5. How to store Tobi 6. Further information 1. WHAT TOBI IS AND WHAT IT IS USED FOR What is Tobi for? Tobi contains a medicine called tobramycin. This is an aminoglycoside antibiotic. Tobi is used in patients aged six years and older who have cystic fibrosis to treat chest infections caused by a bacteria called Pseudomonas aeruginosa Tobi fights the infection caused by Pseudomonas bacteria in your lungs, and helps to improve your breathing. When you inhale Tobi, the antibiotic can get directly into your lungs to fight against the bacteria causing the infection. For the best results of this medicine, take it as this leaflet instructs you. What is Pseudomonas aeruginosa? This is a very common bacteria that infects nearly everyone with cystic fibrosis at some time during their lives. Some people do not get this infection until later on in their lives, while others get it very young.

You must leave at least 6 hours between two Tobi inhalations. After taking your medicine for 28 days, you then have a 28 day break, where you don t inhale any Tobi, before starting another course It is important that you keep using the product twice each day during your 28 days on treatment and that you keep to the 28-day on, 28-day off cycle.

ON TOBI Take Tobi twice a day, every day for 28 days

OFF TOBI Do not take any Tobi for the next 28 days

Repeat cycle If you take more Tobi than you should If you inhale too much Tobi you may get a very hoarse voice. Make sure you tell your doctor as soon as possible. If Tobi is swallowed, don t worry but tell your doctor as soon as possible. If you forget to take Tobi If you forget to take Tobi and there are at least 6 hours to your next dose, take your dose as soon as you can. Otherwise, wait for your next dose. Do not double the dose to make up for the missed dose. The equipment you need for inhaling Tobi Tobi should be used with a clean and dry reusable nebuliser. The LC PLUS nebuliser (manufactured by PARI GmbH) is suitable for use with Tobi. Your doctor or physiotherapist can advise you on the proper use of Tobi and the equipment you need. You may need different nebulisers for your other inhaled medicines for cystic fibrosis. Preparing to inhale Tobi Wash your hands thoroughly with soap and water. Each Tobi foil pouch contains a tray with 14 ampoules. Cut or tear open the pouch. Remove one Tobi ampoule from the tray. Put the tray back in the foil pouch and keep it in the refrigerator. Lay out all the pieces of your nebuliser on a clean, dry paper or cloth towel. Make sure you have the suitable compressor, and tubing to connect the nebuliser and compressor.

576717 R92

Be careful to follow the appropriate instructions for use for your type of nebuliser, you must read the leaflet provided with the nebuliser by the manufacturer. Check that your nebuliser and compressor are working properly according to the manufacturer s instructions before you start to take your medicine. Use of Tobi with LC PLUS (PARI GmbH) For more detailed instructions on the use of the nebuliser, please read the leaflet provided with the PARI LC PLUS. 1. Remove the nebuliser top from the nebuliser bottom by twisting the top anticlockwise and then lifting it. Place the top on the towel and stand the nebuliser bottom upright on the towel. 2. Connect one end of the tubing to the compressor air outlet. Make sure that the tubing fits snugly. Plug the compressor into the electrical outlet. 3. Open the Tobi ampoule by holding the bottom tab with one hand and twisting off the top with your other hand. Squeeze all the contents of the ampoule into the nebuliser bottom.

9. Please remember to clean and disinfect your nebuliser after treatment according to the manufacturer s instructions. You should never use a dirty or clogged nebuliser. You should not share your nebuliser with other people. If you are interrupted, or need to cough or rest during your treatment, turn off the compressor to save your medicine. Turn the compressor on again when you are ready to restart your treatment. Leave out this dose if your next dose is due in less than 6 hours. 4. POSSIBLE SIDE EFFECTS Like all medicines, Tobi can cause side effects, although not everybody gets them. Some side effects can be serious chest tightness with difficulty breathing (rare) allergic reactions including hives and itching (very rare). If any of these serious side effects happen to you, stop taking Tobi and tell your doctor immediately. Your underlying lung disease may worsen while you are taking TOBI. This may be due to a lack of efficacy. Talk your doctor if this happens. Other side effects may include: Some side effects are uncommon (affecting less than 1 in 100 patients): shortness of breath, increased cough, voice alteration (hoarseness), and sore throat. Some side effects are rare (affecting less than 1 in 1000 patients): chest pain or general pain coughing up blood, producing more sputum (the substance you cough up) than normally, chest discomfort, asthma, fever feeling sick (nausea), being sick (vomiting), loss of appetite laryngitis (voice alteration with sore throat and difficulty swallowing) ringing in the ears (normally transient), hearing loss, dizziness rash weakness, headache mouth ulcers, taste disturbances. nose bleeds, runny nose worsening of lung function test results loss of voice Some side effects are very rare (affecting less than 1 in 10,000 patients): pain in and around the stomach (abdomen), diarrhoea ear pain, ear problems or sinusitis fungal infections of the mouth or throat, such as thrush

back pain swelling of lymph glands hyperventilating, low oxygen levels in your blood sleepiness generally feeling unwell If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. If you have had Tobi at the same time as or following repeated courses of tobramycin or another aminoglycoside antibiotic by injection, hearing loss has been reported as a side effect. Injections of tobramycin or other aminoglycosides can cause allergic reactions, hearing problems and kidney problems. People with cystic fibrosis have many symptoms of the disease. These may still happen while taking Tobi, but should not be any more frequent or seem worse than before. There have been common reports of symptoms whilst taking Tobi such as colour changes in sputum, chest infection, muscle pain, swelling on the lining of the nose or sinuses (nasal polyps) and ear infections. 5. HOW TO STORE TOBI Keep out of the reach and sight of children. Do not use Tobi after the expiry date which is stated on the box or pouch, or stamped on the ampoule. Do not use Tobi if you notice that it has gone cloudy, or if there are bits in the solution. Store at 2 8 C (in a refrigerator). If you don t have a refrigerator available (such as when you are transporting your medicine) you can store the foil pouches (opened or unopened) at room temperature (not above 25 C) for up to 28 days. Do not use Tobi ampoules which have been stored at room t emperature for more than 28 days. Store your ampoules in the original packaging as Tobi is sensitive to very strong light. Tobi is normally a slightly yellow colour but this can vary and sometimes it can be a darker yellow. This does not change the way Tobi works provided that the storage instructions have been followed. Never store an opened ampoule. Once opened an ampoule should be used immediately, and any remaining product should be discarded. 6. FURTHER INFORMATION What Tobi contains The active ingredient is tobramycin. One ampoule contains 300 mg of tobramycin as a single dose. The other ingredients are sodium chloride, water for injections, sodium hydroxide and sulphuric acid (for adjusting the level of acidity).

What Tobi looks like and contents of the pack Tobi is a clear, slightly yellow solution that comes in a ready-to-use ampoule. Ampoules are packed in foil pouches, one foil pouch contains 14 ampoules which corresponds to 7 days of treatment. Tobi is available in packs of 56, 112 or 168 ampoules, which is enough to last one, two or three cycles of treatment, respectively. Not all pack sizes may be available. Marketing Authorisation Holder and Manufacturer Novartis Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR UK Manufactured by: Novartis Pharmaceuticals UK Limited Wimblehurst Road Horsham West Sussex RH12 5AB UK Novartis Pharma GmbH, Roonstrasse 25, 90429 N rnberg Germany For further information please call 01 260 1255 (Ireland only) 01276 698370 (UK only) This leaflet was last revised in November 2012

4. Replace the nebuliser top, put the mouthpiece and the inspiratory valve cap in place on the nebuliser, then connect the compressor as indicated in your PARI LC PLUS nebuliser leaflet. 5. Turn on the compressor. Check that there is a steady mist coming from the mouthpiece. If there is no mist, check all tubing connections and that the compressor is working properly. 6. Sit or stand in an upright position so that you can breathe normally. 7. Place the mouthpiece between your teeth and on top of your tongue. Breathe normally, but only through your mouth (you may use a nose clip if your doctor agrees). Try not to block the airflow with your tongue. 8. Continue until all of the Tobi is gone and there is no longer any mist being produced. It should take about 15 minutes to take all the treatment. You may hear a spluttering sound when the nebuliser cup is empty.

576717 R92

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.