Oxis Turbohaler 12
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OXIS TURBOHALER 6 _
OXIS TURBOHALER® 12
(formoterol fumarate)
This product is available in all the above names and strengths but will be referred to as Oxis Turbohaler throughout the following:
Patient Information Leaflet
This leaflet applies only to Oxis Turbohaler. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). Remember, this medicine is only for you, do not give it to anyone else even if their symptoms are similar to yours.
WHAT IS IN YOUR MEDICINE?
Oxis Turbohaler is a multi-dose dry powder turbo inhaler, which works by breathing in (inhaling) through the mouthpiece. Each Oxis Turbohaler contains 60 actuations. There are two strengths of Oxis Turbohaler. Please check carefully which strength your doctor has prescribed for you, as this will determine how much medicine you should take.
Oxis Turbohaler 6 - Each inhalation (puff) contains 6 micrograms of the active ingredient formoterol fumarate dihydrate and is available as a multidose dry powder turbo inhaler, with a turquoise turning grip and a white plastic body and cover. A Braille code identification is embossed at the bottom of the turning grip.
Oxis Turbohaler 12 - Each inhalation (puff) contains 12 micrograms of the active ingredient formoterol fumarate dihydrate and is available as a multidose dry powder turbo inhaler, with a turquoise turning grip and a white plastic body and cover. A Braille code identification is embossed at the bottom of the turning grip.
Warning: Oxis Turbohaler also contains lactose monohydrate.
The inhalation powder is white in colour.
Formoterol belongs to a group of medicines called long-acting beta 2 agonists. These medicines relax certain muscles, for example, they open up the airways of your lungs.
WHO HAS MADE YOUR MEDICINE?
Manufactured by AstraZeneca AB, S-151 85 Sodertalje, Sweden.
Procured from within the EU by the Product Licence Holder and repackaged by: S.C.A.C. Ltd., Unit 2a, Bandeath Industrial Estate, Throsk, Stirling,
FK7 7NP.
iPOMl PL No: 30984/0134
PL No: 30984/0135
WHAT IS YOUR MEDICINE FOR?
Oxis Turbohaler gives long lasting (up to 12 hours) relief of symptoms such as wheezing, shortness of breath or coughing in patients with asthma.
Oxis Turbohaler may also be used to prevent exercise-induced asthma when taken before exercise.
Oxis Turbohaler can also be used for the relief of symptoms such as cough, wheeze and shortness of breath in Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term disease of the airways in your lungs which commonly results from cigarette smoking.
BEFORE TAKING YOUR MEDICINE
Make sure that you have told your doctor about any other medicines that you are taking, including those that you have bought without a prescription. Please read the following questions carefully. They are being asked to help check that the medicine is suitable for you to take. If the answer to any of the questions is yes, discuss this with your doctor before taking this medicine
• Are you pregnant, thinking of becoming pregnant or breast-feeding? If you become pregnant whilst using Oxis Turbohaler you should talk to your doctor immediately.
• Are you diabetic? If so, you may need some additional blood sugar tests when you start taking Oxis Turbohaler.
• Do you have a heart problem or high blood pressure?
• Do you have an overactive thyroid gland?
• Do you have severe liver problems e.g. liver cirrhosis?
• Are you taking any of the following medicines?
- beta blockers by mouth (e.g. metoprolol) or eye drops (e.g. timolol)
- medicines for a rapid or irregular heart beat (e.g. quinidine)
- steroid medicines (e.g. prednisolone)
- xanthine derivatives (used for treating asthma, e.g. theophylline).
- antihistamines (e.g. terfenadine).
- tricyclic anti-depressants (e.g. amitriptyline) or monoamine oxidase inhibitors (e.g. phenelzine)
- phenothiazines (e.g. chlorpromazine, prochlorperazine) used to treat mental illnesses or severe nausea and vomiting).
• Are you taking any diuretics or water pills (e.g. frusemide)?
• Are you going to have a general anaesthetic?
As with other medicines of this type, if Oxis Turbohaler is taken with alcohol, or with medicines for Parkinson's disease or thyroid problems, you may experience an increase in heart rate.
Important: You should not take Oxis Turbohaler if you have had any reactions in the past when taking medicines containing formoterol or inhaled lactose. The very small amount of lactose in Oxis Turbohaler is unlikely to cause problems in lactose intolerant patients.
TAKING YOUR MEDICINE Dosage
Check carefully which strength of Oxis Turbohaler your doctor has prescribed.
Typical doses are shown in this leaflet, but your doctor may want you to take a slightly different dose. It is important to take your medicine as your doctor has told you. The instructions on the label should remind you of what the doctor has said.
Oxis Turbohaler can be used either as needed (to relieve acute symptoms), or as part of your regular maintenance programme.
You should continue to use your Oxis Turbohaler regularly, even when you start to feel better. If you stop taking it too soon you may become unwell again.
If you feel you are getting breathless or wheezy while using Oxis Turbohaler, you should continue to use Oxis Turbohaler but go to your doctor as soon as possible, as you may need additional treatment.
If Oxis Turbohaler is to be used by your child you should make sure that it is used correctly, as your doctor has told you.
If you are receiving regular treatment with a steroid inhaler it is important that you continue this treatment when starting to use Oxis Turbohaler.
Oxis Turbohaler 6 Adults aged >18 years.
Asthma maintenance
Your regular dose (also called maintenance dose) is prescribed by your doctor and helps to keep your asthma under control on a daily basis. Your maintenance treatment will normally be 1 or 2 inhalations (puffs) in the morning and/or at night. However, you may be told to take a higher dose.
Asthma Relief
In addition to your maintenance dose, your doctor may advise you to take additional doses, if necessary, to relieve your asthma symptoms. The recommended dose for the quick relief of symptoms is 1 or 2 inhalations (puffs) as required.
Exercise-induced Asthma
You may have been prescribed Oxis Turbohaler to prevent asthma symptoms caused by exercise. If you suffer from exercise-induced asthma, the recommended dose is 2 inhalations (puffs) before exercise.
IMPORTANT. The combined daily dose for asthma maintenance, asthma relief and exercise-induced asthma should not exceed 8 inhalations, however occasionally up to a maximum of 12 inhalations may be allowed in a 24 hour period. No more than 6 inhalations should be taken together at any one time.
COPD Maintenance
Your regular dose (also called a maintenance dose) is prescribed by your doctor and helps to keep your COPD under control on a daily basis. Your maintenance treatment will normally be 2 inhalations (puffs) once or twice daily. The daily dose for maintenance should not exceed 4 inhalations (puffs).
COPD Relief
In addition to your maintenance dose, your doctor may advise you to take additional doses, if necessary, to relieve your COPD symptoms. IMPORTANT. The combined daily dose for COPD maintenance and COPD relief should not exceed 8 inhalations. No more than 4 inhalations should be taken together at any one time.
Childien and Adolescents 0 yeais and oldei.
Asthma Maintenance
The regular dose (also called maintenance dose) will be prescribed by the child's doctor and will help keep their asthma under control on a daily basis. Normally, the recommended dose is 2 inhalations (puffs) once or twice daily.
Asthma Relief
In addition to a child's maintenance dose, their doctor may advise that the child takes additional doses, if necessary, to relieve their asthma symptoms. The recommended dose for the quick relief of symptoms is 1 -2 inhalations (puffs) as required.
Exercise-induced Asthma
A child may have been prescribed Oxis Turbohaler to prevent asthma symptoms caused by exercise. Normally, the recommended dose for exercise-induced asthma in children is 1 -2 inhalations (puffs) before exercise.
IMPORTANT. The combined daily dose for asthma maintenance, asthma relief and exercise-induced asthma in children should not exceed 4 inhalations, however occasionally up to a maximum of 8 inhalations may be allowed in a 24 hour period.
No more than 2 inhalations should be taken at any one time.
Oxis Turbohaler 12 Adults aged >18 yea!s.
Asthma maintenance
Your regular dose (also called maintenance dose) is prescribed by your doctor and helps to keep your asthma under control on a daily basis. Your maintenance treatment will normally be 1 inhalation (puff) in the morning and/or at night. However, you may be told to take a higher dose.
slowly.
5. If you are to take a second inhalation, repeat steps 2, 3 and 4.
6. Replace the cover tightly after use.
The Asthma Society of Ireland Eden House 15-17 Eden Quay Dublin 1
Asthma Information line:
1850 44 54 64.
Asthma Relief
In addition to your maintenance dose, your doctor may advise you to take additional doses, if necessary, to relieve your asthma symptoms. The recommended dose for the quick relief of symptoms is 1 inhalation (puff) as required.
Exercise-induced Asthma
You may have been prescribed Oxis Turbohaler to prevent asthma symptoms caused by exercise. If you suffer from exercise-induced asthma, the recommended dose is 1 inhalation (puff) before exercise.
IMPORTANT: The combined daily dose for asthma maintenance, asthma relief and exercise-induced asthma should not exceed 4 inhalations, however occasionally up to a maximum of 6 inhalations may be allowed in a 24 hour period. No more than 3 inhalations should be taken together at any one time.
COPD Maintenance
Your regular dose (also called a maintenance dose) is prescribed by your doctor and helps to keep your COPD under control on a daily basis. Your maintenance treatment will normally be 1 inhalation (puff) once or twice daily. However, you may be told to take a higher dose. The daily dose for maintenance should not exceed 2 inhalations (puffs).
COPD Relief
In addition to your maintenance dose, your doctor may advise you to take additional doses, if necessary, to relieve your COPD symptoms. IMPORTANT: The combined daily dose for COPD maintenance and COPD relief should not exceed 4 inhalations. No more than 2 inhalations should be taken together at any one time.
Children and Adolescents 6 years and older:
Asthma Maintenance
The regular dose (also called maintenance dose) will be prescribed by the child’s doctor and will help them keep their asthma under control on a daily basis. Normally, the recommended dose is 1 inhalation (puff) once or twice daily.
Asthma Relief
In addition to a child’s maintenance dose, their doctor may advise that the child takes additional doses, if necessary, to relieve their asthma symptoms. The recommended dose for the quick relief of symptoms is 1 inhalation (puff) as required.
Exercise-induced Asthma
A child may have been prescribed Oxis Turbohaler to prevent asthma symptoms caused by exercise. Normally, the recommended dose for exercise-induced asthma in children is 1 inhalation (puff) before exercise.
IMPORTANT: The combined daily dose for asthma maintenance, asthma relief and exercise-induced asthma in children should not exceed 2 inhalations, however occasionally up to a maximum of 4 inhalations may be allowed in a 24 hour period.
No more than 1 inhalation should be taken at any one time.
Contact your doctor immediately if:
• Your breathing is getting worse.
• You often wake up at night with asthma.
• You start getting chest tightness.
• You are not getting relief from your current dose.
• You frequently need to take more than your maintenance dose e.g. for more than 2 days in a week.
• You need to use your Oxis Turbohaler more frequently than normal before exercise, to help prevent exercise-induced asthma e.g. several times every week.
These signs could mean that your asthma or COPD is not being controlled properly and that you may need different or additional treatment immediately. Do not increase the regular dose without talking to your doctor first.
If you are taking other products which may cause hypokalaemia (low potassium levels), then your doctor may take blood samples to check the amount of potassium in your blood.
HOW TO USE YOUR TURBOHALER
Oxis Turbohaler is very easy to use. Simply follow the instructions given below.
1. Unscrew and lift off the white cover.
2. Load by holding your turbohaler UPRIGHT, with the turquoise grip at the bottom, as shown. Turn the turquoise grip fully in one direction as far as it will go. Then twist the turquoise grip back again as far as it will go. You should hear a ‘click’ sound. Your Oxis Turbohaler is now loaded. Only load the inhaler when you need to use it.
3. Breathe out gently, but DO NOT breathe out through the inhaler. Then, place the mouthpiece between your lips and BREATHE IN through your mouth as deeply and as hard as you can.
4. Remove the Turbohaler from your mouth and hold your breath for about 10 seconds, or for as long as is comfortable, then breathe out
As the amount of drug inhaled is very small, you may not be able to taste anything. However, you can still be confident that the dose has been inhaled if you have followed the instructions.
• Do not chew or bite on the mouthpiece.
• Do not use the inhaler if it has been damaged or the mouthpiece has become detached.
CLEANING INSTRUCTIONS
The outside of the mouthpiece should be cleaned regularly with a dry tissue. The mouthpiece should never be washed.
HOW WILL YOU KNOW WHEN YOUR INHALER IS EMPTY?
When a red mark first appears in the indicator window under the mouthpiece, there are approximately 20 doses left. You will need to see your doctor for another prescription. When the red mark reaches the bottom of the indicator window, your Turbohaler is empty. The grip will still twist and ‘click’, even when the inhaler is empty. Note: you may hear a sound when you shake your Turbohaler; this is not caused by the medicine but by a drying agent.
WHAT TO DO IF YOU TAKE TOO MANY DOSES
If you accidentally take too much in one day, contact your doctor or pharmacist.
WHAT TO DO IF YOU FORGET TO TAKE A DOSE
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose do not take the one you have missed, just take the next dose on time.
AFTER TAKING YOUR MEDICINE
Like all medicines, as well as the effects that are needed, Oxis Turbohaler may sometimes cause side effects such as:
• Headache
• Trembling or shaking
• Palpitations
Trembling and palpitations, if they occur, usually go away as treatment continues. Less common side effects include muscle cramps, restlessness, agitation, disturbed sleep, rapid heart rate and in rare cases skin rash, bronchospasm (tightening of the muscles in the airways) or changes in blood potassium levels, which may cause muscle weakness or paralysis, an irregular heart beat or confusion/disorientation. Nausea (feeling sick) and hypersensitivity reactions have also been reported. Dizziness, taste disturbances (taste changes), chest pain or tightness, changes in blood pressure or an increase in blood glucose may occur extremely rarely.
If you experience any of these side effects, or if you notice anything else unusual, tell your doctor or pharmacist.
STORING YOUR MEDICINE
• Keep Oxis Turbohaler in a safe place out of reach of children.
• Do not store above 30°C.
• Keep the cap screwed tightly onto your Turbohaler when you are not using it.
• Replace the cover properly after use.
• Do not use Oxis Turbohaler after the expiry date printed on the label.
If your inhaler fails to work properly or shows signs of deterioration, seek the advice of your pharmacist.
If your doctor tells you to stop using your medicine, take any unused medicine to your pharmacist for safe disposal. Only keep your medicine if your doctor tells you to.
Asthma Lifestyle Advice
Asthma can be controlled in different ways. Your doctor will work with you to decide on a treatment plan which best suits your individual needs and which should help to reduce your asthma symptoms and the number of asthma attacks.
There are also ways that you can help yourself, such as:
• Try to avoid or reduce contact with things that may trigger an asthma episode, for example, animal fur, smoking (including passive smoking), moulds, pollen and house dust mites.
• If you know that exercise is a trigger for your asthma, make sure that you have followed your doctor’s instructions before starting any exercise.
• Be honest with your doctor or asthma nurse about how asthma affects you day-to-day and develop with them a treatment plan that suits your particular lifestyle. Remember to take your asthma medication as your doctor has instructed.
• If you have any worries about your medication, discuss this with your local pharmacist, asthma nurse or doctor.
Further information can be obtained from:
Asthma UK or
Providence House Providence Place London N1 0NT
Helpline number: 0845 7 01 02 03 (Monday to Friday 9am to 7pm).
Oxis Turbohaler® and Turbohaler® are registered trademarks of AstraZeneca AB
Leaflet revision date: 18.05.2011
Ref: WP228