SALBULIN MDPI NOVOLIZER 100 MICROGRAMS / DOSE INHALATION POWDER

PACKAGE LEAFLET: INFORMATION FOR THE USER

SALBULIN MDPI NOVOLIZER 100 micrograms/dose inhalation powder
Salbutamol
Read all of this leaet carefully before you start using this medicine.
2. BEFORE YOU USE SALBULIN MDPI NOVOLIZER DO NOT take Salbulin MDPI Novolizer if:





Please inform your doctor if you are taking any other medicines including inhalers and even those medicines not prescribed by your doctor and bought without a prescription. Taking Salbulin MDPI Novolizer with food and drink Food and drink are not known to alter the effectiveness of Salbulin MDPI Novolizer Pregnancy and Breast-feeding If you are pregnant, thinking of becoming pregnant or breast-feeding you must discuss this with your doctor before using this medicine. If taken during pregnancy salbutamol will pass through the placenta and may cause the heart rate of the foetus (unborn baby) to increase. However, there is no evidence that salbutamol causes any malformations. Salbutamol also passes into a mothers milk and may cause some side effects in a breast-fed infant (see section 4 below). Driving and using machines No studies on the ability to drive and use machines have been performed. Important information about other ingredients of Salbulin MDPI Novolizer The powder also contains the ingredient lactose. You should not take Salbulin MDPI Novolizer if you are allergic to lactose. Normally, the content of lactose in a single dose does not cause any problems in persons with lactose intolerance. If you are concerned that you may have an intolerance, you must talk to your doctor. 3. HOW TO USE SALBULIN MDPI NOVOLIZER Always use Salbulin MDPI Novolizer exactly as instructed by your doctor. You must check with your doctor or the pharmacist if you are unsure. The label should remind you of how many actuations (puffs) to take and how often you should take them. Do not take more than your doctor has told you to. Your doctor or nurse should also have shown you how to use the Novolizer Device, but please read the instructions for using this device carefully before taking this medicine. These instructions can be found on the reverse of this leaet. The following information about the use of Salbulin MDPI Novolizer applies unless your doctor has instructed otherwise. Please also note that if you are changing from another salbutamol inhaler to Salbulin MDPI Novolizer you may nd that you have to adjust your dose. For adults and adolescents above 12 years of age For relief of symptoms: Start with 1 puff; if needed the dose may be increased to 2 puffs. You should leave at least 1 minute between each puff. A further dose should not be taken within 4 hours.

For prevention of exercise-induced asthma and wheezing before contact with a trigger: 2 puffs should be taken 10-15 minutes before exercise or contact with the trigger. Maximum daily dose: 8 puffs For children 6 -12 years of age For relief of symptoms: Start with 1 puff; if needed the dose may be increased to 2 puffs. You should leave at least 1 minute between each puff. A further dose should not be taken within 4 hours. For prevention of exercise-induced asthma and wheezing before contact with a trigger: 1 puff should be taken 10-15 minutes before exercise or contact with the trigger. If needed this may be increased to 2 puffs. Maximum daily dose: 4 puffs Children below 6 years of age Salbulin MDPI Novolizer is not recommended for use in children below the age of 6 because there is insufcient information on safety and effectiveness in this age group. You must not take more puffs than your doctor advises. If your asthma is getting worse you should discuss your treatment with your doctor, as you may need additional medicine for your chest condition. The following may indicate your asthma is getting worse:

4. POSSIBLE SIDE EFFECTS Like all medicines, Salbulin MDPI Novolizer can cause side effects, although not everybody gets them. The common side effects (more than 1 in 10 patients) you are most likely to notice when using Salbulin MDPI Novolizer include: unpleasant or unusual taste, irritation of the throat and mouth causing a cough, shakiness (usually in the hands), dizziness, restlessness, headache, sweating and feeling sick. Muscle cramp can also occur, but this is rare (fewer than 1 in 1000, but more than 1 in 10,000 patients). These effects, if noticed will usually wear off within 2 weeks of treatment. Very rarely (less than 1 in 10,000 patients) inammation of the kidney and a drop in blood platelets can occur. Sometimes some people may notice their heart beating faster or unevenly (palpitations), or feeling faint. These occur only rarely with inhaled salbutamol, but if you are affected tell your doctor. Very rarely, some people may experience chest pain (due to heart problems such as angina). Tell your doctor as soon as possible, but do not stop using this medicine unless told to do so. As with all inhalers it is possible for the powder to make you wheezy immediately after inhalation. This occurs rarely. If this happens you must call your doctor immediately. Allergic reactions to salbutamol, although very rare, have been reported. These include: rash, skin problems, swelling of the face, lips, eyes and throat, wheeziness, low blood pressure and collapse. If you notice any of these reactions contact your doctor immediately. Children using this medicine may rarely become hyperactive or excitable. They may also suffer sleep disturbance or hallucinations, although this is very rare. Lactose-monohydrate contains small amounts of milk proteins and can therefore cause allergic reactions. If any of the side effects gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. 5. HOW TO STORE SALBULIN MDPI NOVOLIZER Keep out of the reach and sight of children. Do not use Salbulin MDPI Novolizer after the expiry date which is stated on the label, the carton and the cartridge container. The expiry date refers to the last day of that month. The cartridges containing Salbulin MDPI Novolizer should be kept in their sealed outer container until required for use. When the Novolizer device is in-use it should be stored in a dry place to ensure that the powder cartridge inside is protected from moisture. Regardless of



Keep this leaet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. 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 leaet, please tell your doctor or pharmacist.



whether the cartridge is empty or not after 6 months a new cartridge should be inserted. It is recommended that you keep a record of when you replace the cartridges to help you remember when you will need to insert a new one. The Novolizer device should be replaced after 2000 inhalations. Therefore, a maximum of 10 cartridges should be used with one device. In any event it is recommended that you replace this device at least once a year. Do not store above 30C. Store in original package. Protect from moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Salbulin MDPI Novolizer contains Salbulin MDPI Novolizer is a dry powder for inhalation. The active substance is salbutamol. Each actuation (puff) contains 100 micrograms of salbutamol (as sulphate). The other ingredient is Lactose monohydrate. Contents of pack The following packs may be available: An Original sales pack which contains a Salbulin MDPI Novolizer dry powder inhaler device and a Salbulin MDPI Novolizer drug cartridge sealed in a plastic container with aluminium foil. Each cartridge contains 200 inhalations (puffs). A Rell pack which contains either 1 or 2 Salbulin MDPI Novolizer drug cartridges sealed in a plastic container with aluminium foil. These are for use with the Salbulin MDPI Novolizer dry powder inhaler device. Each rell cartridge contains 200 inhalations (puffs). Not all pack sizes may be marketed. The Manufacturer of this product is: Meda Pharma GmbH & Co. KG Benzstrae 1 D-61352 Bad Homburg, Germany or Vemedia Manufacturing B.V. Verrijn Stuartweg 60 NL-1112 AX Diemen, The Netherlands or Meda Manufacturing GmbH Neurather Ring 1 D-51063 Cologne, Germany The Marketing Authorisation Holder is: Meda Pharmaceuticals Ltd Skyway House, Parsonage Road, Takeley, Bishop's Stortford, CM22 6PU United Kingdom This medicinal product is authorised in the Member States of the EEA under the following names: United Kingdom: Salbulin MDPI Novolizer, 100 micrograms/dose inhalation powder Germany: Salbutamol MDPI Novolizer, 100 Mikrogramm/Dosis Pulver zur Inhalation.

you are allergic (hypersensitive) to salbutamol, lactose or milk protein

You should talk to your doctor before using Salbulin MDPI Novolizer if you can answer yes to any of the following questions:



do you have any heart or circulatory problems, particularly a recent heart attack or angina? do you suffer from high blood pressure? have you been told you have an aneurysm (a swelling or dilation of a blood vessel)? do you have an overactive thyroid gland? do you suffer from diabetes which is difcult to control? do you have a tumour near your kidney (a phaeochromocytoma)? are you about to have an operation requiring a general anaesthetic? are you taking any other medicines and/or inhalers for your asthma either prescribed by a doctor or bought from a pharmacy?

In this leaet 1. WHAT IS SALBULIN MDPI NOVOLIZER AND WHAT IT IS USED FOR. 2. BEFORE YOU USE SALBULIN MDPI NOVOLIZER 3. HOW TO USE SALBULIN MDPI NOVOLIZER. 4. POSSIBLE SIDE-EFFECTS. 5. HOW TO STORE SALBULIN MDPI NOVOLIZER. 6. FURTHER INFORMATION. 7. INSTRUCTIONS FOR USING THE NOVOLIZER DEVICE.

Your doctor may wish to alter your treatment or monitor your condition more closely if any of the above apply to you. Taking other medicines Treatment with salbutamol may cause hypokalaemia (low potassium in your blood) which can be aggravated by some other drugs. These include other drugs for asthma, such as xanthine derivatives (e.g. theophylline) or steroids (e.g. prednisolone), or drugs for other conditions such as water tablets (e.g. frusemide) or digoxin. You must mention to your doctor if you are taking any of these drugs, as your doctor may want to take a blood sample to monitor your potassium levels. If you are taking beta-blockers (e.g. atenolol) for high blood pressure or angina, or antidepressants (e.g. moclobemide, phenelzine, amitriptyline, clomipramide or imipramine) you should also tell your doctor. Some general anaesthetics may interact with salbutamol to cause heart problems and decrease blood pressure. Therefore, if you are having an operation, advise hospital staff that you are taking Salbulin MDPI Novolizer.



You nd that you need more puffs than usual Relief of your chest tightness is not sufcient You notice that the relief is not lasting as long

1. WHAT IS SALBULIN MDPI NOVOLIZER AND WHAT IT IS USED FOR. Salbulin MDPI Novolizer is a powder for inhalation containing the active substance salbutamol. Salbutamol belongs to a group of anti-asthmatic drugs known as bronchodilators which are used to relieve symptoms such as chest tightness, wheezing or cough caused by asthma or other conditions. Salbutamol can also be used to prevent asthma symptoms brought on by exercise and other 'triggers' such as pollen. For instructions for using the Novolizer Inhaler Device, see section 7 on the reverse side of this leaet.

IF YOUR BREATHING SUDDENLY BECOMES WORSE OR YOU ARE UNABLE TO TRIGGER THE NOVOLIZER DEVICE YOU MUST CONTACT YOUR DOCTOR IMMEDIATELY. If you have asthma your doctor may have instructed you on the use of a peak-ow meter. It is important to monitor your asthma and the effectiveness of the asthma treatments you have been given. If you inhale more doses than you should If you take more puffs than recommended you may notice that your heart beats faster than usual and you may feel shaky. These effects usually wear off in a few hours, but you should contact your doctor immediately. If you need to see another doctor or go to hospital If you see any other doctor or have to go to hospital for any reason, you should take all your inhalers and any other medicines with you including those bought without a prescription. If you have any further questions on the use of this product, ask your doctor or pharmacist.

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7. INSTRUCTIONS FOR USING THE NOVOLIZER DEVICE
Cartridge Dosage Counter Protective cap Lid Button

Using the Novolizer Device
1. When using the Novolizer Device always keep it horizontal. Remove the protective cap, by lightly squeezing the sides and sliding forwards ( ). 4.The loud click and the colour change from green to red in the control window indicate that you have inhaled correctly. The gures in the top window show the number of inhalations (puffs) remaining. Each inhalation is counted, but please note that gures in the top window count down in steps of 20 until 60 puffs remain and then in steps of 10 when it is below 60. This cartridge MUST be replaced when either:

Cleaning
1. You should clean your Novolizer Device regularly, or at least whenever you change the cartridge. To do this rst remove the protective cap. Then twist the mouthpiece anticlockwise slightly ( ). It will become loose and you can remove it ( ).

Replacement and Storage
1. The Novolizer Device can be relled using new cartridges containing Salbulin MDPI Novolizer. It is ideal for long-term usage, but you must remember to replace your Novolizer Device after 2000 puffs (10 cartridges). In any event you must replace it within a year. Make sure your Novolizer Device is protected from moisture. Remember to replace the cartridge every 6 months even if it is not empty.

Cartridge box

Control window

Introduction
The Novolizer Device is a breath-actuated dry powder inhaler. It helps to make inhaling simple and reliable. It includes safety features to ensure that you take the correct dose and it is also environmentally friendly as it does not use chlorouorocarbon (CFC) propellants. The following instructions for using the Novolizer Device are brief and easy to understand, but it is recommended that children use this device under the supervision of an adult. Please note that the Novolizer Device supplied for use with Salbulin MDPI Novolizer must only be used with this medicine.


2. To prime the Novolizer Device push down hard on the large coloured button until it stops ( ) (see picture). You will hear a loud double click and the colour of the control window will change from red to green. You can now release the large button. The colour green in the control window indicates that the Novolizer Device is now primed and ready to use. The large button should only be pressed immediately before inhaling.

0 appears in the middle of the counter window or every 6 months, even if the cartridge is not empty.

Please note: if there is no click and the colour in the control window does not change please repeat the procedure as described above. If you cannot manage to inhale correctly after several attempts, please consult your doctor, nurse or pharmacist .

Inserting a cartridge
1. When you rst get the Novolizer Device you will need to put the cartridge containing the medicine into the device. To do this, gently squeeze the ribbed surfaces on both sides of the lid. Move the lid forwards ( ) and off ( ). 4. Replace the lid into the lid guides from above ( ) and push down at towards the dosage button ( ) until it clicks into place.

2. Now turn the Novolizer Device upside down. Loosen the dispensing slide and move it forwards ( ) and upwards ( ). Any remaining powder can be removed from the dispensing slide by tapping it lightly. Clean the mouthpiece, the dispensing slide and the powder inhaler with a soft and dry lint-free cloth. DO NOT use water or detergent.

2. Remove the protective aluminium foil from the cartridge box and take out the new cartridge. Only do this just before you need to use the cartridge.

5. The Novolizer Device is now lled and ready for use. You can leave the cartridge in the Novolizer Device until 0 appears in the middle of the counter window; however, you must replace it with a new cartridge within 6 months of taking the cartridge out of its sealed outer container.

3. Breathe out deeply, but not into the Novolizer Device. Put your lips around the mouthpiece. Inhale the powder with a strong deep breath. During this breath you should hear a loud click. This click indicates that you have breathed in strongly enough for the Novolizer Device to work. Continue inhaling as strongly and deeply as you can. Hold your breath for a few seconds before breathing out slowly through your nose. If you need to take another dose repeat steps 2 and 3. Replace the protective cap on the mouthpiece.

3. After cleaning, re-insert the dispensing slide by sliding down at an angle ( ) and press back into position ( ). You will hear a click as it ts into position.

3. Insert the cartridge into the Novolizer Device with the dosage counter facing the mouthpiece ( ). Do not press the dosage button while inserting the cartridge.

6. When the cartridge needs replacing remove the lid as described in step 1 and lift out the used cartridge. Insert a new cartridge following steps 2 to 5.

4. Insert the mouthpiece so that the small pin ts into the groove on the Novolizer Device just below the colour control window ( ). Twist the mouthpiece clockwise ( ) so that it clicks into place. Finish by replacing protective cap.
This leaet was last approved in March 2009

Meda GmbH & Co. KG Meda Pharmaceuticals Ltd.