What You Need To Know About
BUDELIN NOVOLIZER
200 micrograms per actuation inhalation powder (budesonide)
This leaflet provides you with important information about BUDELIN NOVOLIZER 200 micrograms per actuation inhalation powder. You should read this leaflet very carefully. If you do not understand anything, or have any further questions you should ask your doctor or the pharmacist. Remember, this medicine has been prescribed for you personally. You should not pass it on to others even if their symptoms are the same as yours as it may harm them. You should keep this leaflet as you may need to read it again.
The full name of this medicine is BUDELIN NOVOLIZER 200 micrograms per actuation inhalation powder. Throughout this leaflet it will be referred to as Budelin Novolizer 200 micrograms.
Contents of this leaflet:
1. Budelin Novolizer 200 micrograms and what it is used for
2. Before you use Budelin Novolizer 200 micrograms
3. How to use Budelin Novolizer 200 micrograms
4. Possible side effects
5. Storing Budelin Novolizer 200 micrograms
6. Further Information
7. Instructions for using the Novolizer Device
Budelin Novolizer 200 micrograms inhalation powder contains the active substance budesonide. It also contains lactose monohydrate. The inhalation powder is in a cartridge which is inserted into the Novolizer Device. The powder is delivered to the lungs by breathing in through the mouthpiece of the Novolizer Device. Each cartridge contains enough powder for either 100 or 200 actuations (100 or 200 puffs) from the Novolizer Device depending on the size of the cartridge. Each actuation (puff) contains 200 micrograms of budesonide.
The Manufacturer of this product is:
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The Marketing Authorisation Holder is:
Budelin Novolizer 200 Micrograms And What It Is Used For
Budelin Novolizer 200 micrograms inhalation powder is a dry powder for the treatment of asthma. The powder is contained in a cartridge inserted into the Novolizer Device. The Novolizer Device is a multi-dose dry powder inhaler. When you breathe in through the mouthpiece of this device an accurate amount of the powder is delivered to your lungs.
The active ingredient in the inhalation powder is budesonide. Budesonide belongs to a group of medicines known as corticosteroids which are used to reduce inflammation. In asthma the airways of the lungs become inflamed and swollen making it difficult to breathe. Budesonide reduces and prevents this inflammation, swelling and irritation
of the airways, allowing you to breathe more easily. Budesonide is used to treat asthma and prevent the symptoms of asthma in patients who need regular treatment. It is a long-term treatment for persistent asthma and must be taken regularly
every day to prevent symptoms ocurring. It is therefore known as a ‘preventer’.
You should use Budelin Novolizer 200 micrograms regularly every day to prevent the appearance of your asthma symptoms and you should continue to use this medicine until your doctor advises you to stop. You should not use Budelin Novolizer 200 micrograms for treating acute symptoms of asthma, such as wheezing, shortness of breath or cough, as it will not
provide immediate relief of these symptoms.You should not use Budelin Novolizer 200 micrograms for treating a sudden attack of asthma or a severe continuous attack (status asthmaticus) as it will not provide relief. To relieve these symptoms you should use your blue ‘reliever‘ inhaler (which is a different medicine) and contact your doctor straight away.
Before You Use Budelin Novolizer 200 Micrograms
DO NOT take Budelin Novolizer 200 micrograms if:
- you have ever had an allergic reaction to budesonide or lactose.
- you have the rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor BEFORE taking this medicine.
If any of the above apply to you, you MUST tell your doctor.
If you can answer ‘yes’ to any of the following questions you should talk to your doctor BEFORE taking Budelin
Novolizer 200 micrograms:
- are you taking any other steroid medicines?
- are you currently suffering from tuberculosis (TB) or have you had TB in the past?
- are you currently suffering from a cold or chest infection?
- do you have liver problems?
- are you pregnant, think that you might be pregnant, or trying to become pregnant?
- are you breast-feeding?
- are you taking any other medicines and/or inhalers for your asthma either prescribed by a doctor or bought from a pharmacy?
- have you ever had an allergic reaction to any other inhalers?
If any of the above apply to you, you MUST tell your doctor. He/she may wish to alter your treatment or monitor your condition more closely.
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding you must discuss this with your doctor.
There is no evidence that budesonide will cause any malformations, although some effects, for example effects on growth of the baby or on the baby’s heart, however unlikely, cannot be ruled out completely. It is also not known whether budesonide passes into breast milk.
Budelin Novolizer 200 micrograms should only be used in pregnancy and breast-feeding if the expected benefits are
greater than the possible risks.
Important information about other ingredients of Budelin Novolizer 200 micrograms inhalation powder
The powder also contains the ingredient lactose. You must not use Budelin Novolizer 200 micrograms if you are allergic to lactose.
Using Budelin Novolizer 200 micrograms inhalation powder with food and drink
Food and drink are not known to alter the effectiveness of Budelin Novolizer 200 micrograms. However, to reduce the possibility of budesonide causing a thrush infection of the mouth and throat, it is recommended that you take this medicine before a meal and/or rinse your mouth out with water or brush your teeth after use.
Taking other medicines
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.
How To Use Budelin Novolizer 200 Micrograms
Always use Budelin Novolizer 200 micrograms 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 at the end of this leaflet.
Taking your medicine
The following information about the use of Budelin Novolizer 200 micrograms applies unless your doctor has told you something different.
Your doctor (or nurse) will prescribe an initial starting dose depending on the severity of your asthma. If your doctor has asked you to take only one dose daily, this should be taken in the evening. You may notice an improvement in your breathing within 24 hours after you first use Budelin Novolizer 200 micrograms, but it could be 1-2 weeks before you notice the full effect. Remember, for this treatment to work effectively you must use it regularly every day, even if your symptoms are under control or you have no symptoms at all. Once your symptoms are controlled your doctor will reduce the dose to the lowest dose that will maintain control of your symptoms.
For adults and adolescents above 12 years of age
The recommended starting dose is 200 to 800 micrograms budesonide daily.
This can be achieved by taking either, 1 inhalation once daily (200 micrograms), or 2 inhalations once daily (400 micrograms), or 1 inhalation twice daily (400 micrograms), or 2 inhalations twice daily (800 micrograms)
The maximum dose (during periods of severe asthma) is 1600 micrograms budesonide daily.
This dose is achieved by taking 4 inhalations twice daily.
For children 6 - 12 years of age
The recommended starting dose is 200 to 400 micrograms budesonide daily.
This can be achieved by taking either, 1 inhalation once daily (200 micrograms), or 2 inhalations once daily (400 micrograms), or 1 inhalation twice daily (400 micrograms)
The maximum dose (during periods of severe asthma) is 800 micrograms budesonide daily. This dose is achieved by
taking 2 inhalations twice daily.
If you think your symptoms are not being controlled sufficiently, if your breathing is getting worse, your peak flow is falling, you are using your blue ‘reliever‘ inhaler more often, or it does not appear to be working as well as usual, you must discuss this with your doctor as soon as possible. He/she may advise you to double the dose. For example, if you are using Budelin Novolizer 200 micrograms once daily this may be increased to twice daily. You should make sure that you have a blue ‘reliever‘ inhaler with you at all times so that you can treat any acute symptoms of asthma or symptoms that are getting worse immediately. It is possible that an increase in your symptoms may be due to an infection. In this case your doctor may prescribe antibiotics for you.
Budelin Novolizer 200 micrograms should not be stopped suddenly, unless you think that you are allergic to this medicine (please refer to the side effects mentioned below in Section 4). If you are concerned about the dose you are taking, even if you have no symptoms, you should contact your doctor.
If you develop wheeziness immediately after inhalation, you may need to use your blue ‘reliever‘ inhaler to help your breathing. Contact your doctor immediately.
Patients who have been taking steroid tablets
If you have been taking steroid tablets for your asthma, your doctor may ask you to reduce the number of tablets after you have been using Novolizer Budesonide 200 micrograms for about a week to 10 days. This will depend on how well your symptoms are controlled. He/she will tell you exactly how to do this and it may be possible eventually to stop taking the steroid tablets altogether while you are using Budelin Novolizer 200 micrograms.
You must not stop taking steroid tablets abruptly.
When you stop taking the steroid tablets you may feel generally unwell in spite of noticing some improvement in your asthma symptoms and in your breathing. You may also notice symptoms of other diseases such as eczema, allergic rhinitis or hayfever or pain in your joints or in your muscles. These symptoms were suppressed while you were taking the steroid
tablets and may appear as the dose of your steroid tablets is reduced. If you feel generally unwell or notice these other symptoms you should tell your doctor as soon as possible but you must NOT stop using Novolizer Budesonide 200 micrograms. Your doctor may need to give you some other treatment to relieve these symptoms.
There may be occasions after you have stopped taking steroid tablets and are only using Budelin Novolizer 200 micrograms that you will need to take steroid tablets again for a short period particularly during times of stress. Such occasions may occur if you get an infection, have an accident, have to go to hospital or have an operation. If you have been taking
high doses of inhaled steroids for a long time you may also need to take steroid tablets during periods of stress.
If you have been taking steroids for a long time your doctor may want to do some blood tests to monitor the activity of your adrenal gland.
Please make sure that you carry your steroid warning card with you at all times.
Patients who have severe liver problems
If you have severe liver problems your doctor may want to do some tests to monitor the activity of your adrenal gland.
If you miss a dose
If you forget to take a dose, you should not worry. Just take the next dose at the usual time.
If you inhale more doses than you should
If you take too many doses in one day, you should contact your doctor.
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.
Possible Side Effects
Like most medicines, budesonide not only produces a beneficial effect but may also cause some side effects.
The most common side effects you are likely to notice include:
- Sore throat and mouth (oral thrush).
Experience has shown that oral thrush may be reduced by inhaling this medicine before meals and by rinsing your mouth out with water or brushing your teeth after use. If you do develop oral thrush your doctor will be able to prescribe an anti-fungal medicine to treat this problem. - Mild irritation of the mouth and throat, hoarseness, cough and difficulty in swallowing.
There are some side effects, which occur only rarely, but are important for you to know about because you will need to contact your doctor if you notice any of them. These include the following:
- Like other inhaled medicines, budesonide may rarely cause paradoxical brochospasm. This is acute wheezing or shortness of breath or a feeling of tightness in the chest immediately after you have used the Novolizer Device. If this happens, do not take any more puffs of this medicine. You may need to use your blue ‘reliever’ inhaler straight away to help your breathing. Contact your doctor immediately.
- Rarely, allergic reactions to budesonide can occur. These include skin reactions such as rash, patchy swelling, redness, itching and bruising, and conditions known as urticaria and dermatitis, and angioneurotic oedema which is swelling of the face, lips, eyes and throat. If any of these allergic reactions occur, you must stop taking this medicine and
contact your doctor immediately.
If taken for long periods inhaled corticosteroids may cause some of the following:
- Like other steroids, budesonide may affect the adrenal gland reducing the normal production of steroids in your body. This is very rare and is more likely to happen if large doses are being taken over a long period of time. Symptoms that you may expect to notice if your adrenal gland is affected include anorexia (loss of appetite), abdominal
pain, weight loss, tiredness, headache, nausea (feeling sick), vomiting (being sick), you may feel faint and sweaty and it is possible you could have a fit. To monitor the effect of your medicine on the adrenal glands your doctor may ask you for a blood sample from time to time. - A rare effect of inhaled budesonide is a slowing of growth in children and adolescents so it is likely that children and adolescents taking this medicine for a long time will have their height checked regularly. Your doctor may want to refer you to a specialist.
- Other very rare effects of inhaled budesonide include decreased bone density (thinning of the bone), cataract and glaucoma, restlessness, nervousness and depression, increased susceptibility to infection and reduced ability to adapt to stress.
If you feel unwell, notice any of the above symptoms or side effects, notice any symptoms or side effects not mentioned above, or have any symptoms that concern you, please talk to your doctor or pharmacist.
Storing Budelin Novolizer 200 Micrograms
As with all medicines keep this product out of sight and reach of children. Do not use it after the expiry date printed on the label and carton. The cartridges containing Budelin Novolizer 200 micrograms should be kept in their sealed outer container until required for use. When a cartridge is inserted in the Novolizer Device the device should be stored in a dry place to ensure that the powder in the cartridge is protected from moisture. Regardless of whether the cartridge is empty or not after 3 months a new cartridge should be inserted into the Novolizer Device. It is recommended that you keep a record of when you replace the cartridges in your Novolizer Device 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 containing 200 puffs or 20 cartridges containing 100 puffs should be used with one Novolizer Device. In any event it is recommended that you replace the Novolizer Device at least once a year.
If for any reason you have any cartridges that are not completely used or a Novolizer Device that you no longer use, please take them back to your pharmacist or doctor for safe disposal.
Further Information
For further information about this product please contact the Marketing Authorisation Holder:
Bishop’s Stortford
Instructions For Using The Novolizer Device
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 chlorofluorocarbon (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 Budelin Novolizer 200 micrograms inhalation powder must only be used with this medicine.
Inserting a cartridge
1. When you first 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.
2. Remove the protective aluminium foil from the cartridge box and take out the cartridge. Only do this just before you need to use the cartridge.
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.
4. Replace the lid into the lid guides from above and push down flat towards the dosage button until it clicks into place.
5. The Novolizer Device is now filled 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 3 months of taking the cartridge out of its sealed outer container.
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.
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.
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.
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.
It is recommended that you use the Novolizer Device before meals and that you rinse your mouth with water or
brush your teeth after using it.
4. The loud click and the colour change from green to red in the control window indicate that you have inhaled correctly. The figures in the top window show the number of inhalations (puffs) left in steps of 20. Each inhalation is counted. When "0" appears in the middle of the counter window the cartridge must be replaced by a new one.
Remember to replace the cartridge every 3 months even if it 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.
Cleaning
1. You should clean your Novolizer Device regularly, or at least whenever you change the cartridge. To do this first remove the protective cap. Then twist the mouthpiece anticlockwise slightly. It will become loose and you can remove it.
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 dosage slide and the powder inhaler with a soft and dry lint-free cloth. DO NOT use water or detergent.
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 fits into position.
4. Insert the mouthpiece so that the small pin fits 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.
Replacement and Storage
1. The Novolizer Device can be refilled using new cartridges containing Budelin Novolizer 200 micrograms inhalation powder. It is ideal for long-term usage, but you must remember to replace your Novolizer Device after 2000 puffs (either 10 cartridges of 200 puffs or 20 cartridges of 100 puffs). In any event you must replace it within a year. Make sure your Novolizer Device is protected from moisture.
This leaflet was prepared in March 2009
Meda GmbH & Co. KG
© Meda Pharmaceuticals Ltd
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