ASMANEX TWISTHALER 200 MICROGRAMS INHALATION POWDER

Active substance: MOMETASONE FUROATE MICRONISED

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Asmanex Twisthaler 200 micrograms Inhalation Powder
®

®

mometasone furoate

Read all of this leaflet carefully before you start using this medicine
Keep this leaflet. You may need to read it again.
If you have any further questions, please 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 mentioned in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Asmanex Twisthaler is and what it is used for
2. Before you use Asmanex Twisthaler
3. How to use Asmanex Twisthaler
4. Possible side effects
5. How to Store Asmanex Twisthaler
6. Further information
1. WHAT ASMANEX TWISTHALER IS AND WHAT IT IS USED FOR
Asmanex Twisthaler contains mometasone furoate, which belongs to a group of medicines called
corticosteroids or steroids as they are simply known.
Corticosteroids should not be confused with “anabolic” steroids that are misused by some athletes.
Corticosteroids are used to prevent asthma attacks because they have an anti-inflammatory effect.
They reduce swelling and irritation in the walls of the small air passages in the lungs. This helps to ease
breathing problems.
Asmanex Twisthaler is used regularly to control asthma in adults and adolescents, aged 12 years and over.
It can be used if you have not used a steroid before and your asthma is not controlled by other medicines.
It can also be used if you have been taking a different steroid either by mouth or by inhalation, to control
your asthma. Used regularly Asmanex Twisthaler will help to control asthma and prevent asthma attacks.
It is a “preventor”. Do not use this medicine for a sudden asthma attack. You should always carry the
bronchodilator (“reliever inhaler”) that your doctor has prescribed, just in case you have an asthma attack.
2. BEFORE YOU USE ASMANEX TWISTHALER
Do not use Asmanex Twisthaler:
– if you are allergic (hypersensitive) to mometasone furoate, to any other steroid or to any of the other
ingredients of Asmanex, including milk proteins.
Take special care when using Asmanex Twisthaler:
– if you have or have ever had tuberculosis (TB).
– if you have herpes simplex (virus) infection of the eye or any other type of infection.
– if you develop thrush (white patches in your mouth or on your throat) as this may need treatment. Your
doctor may also tell you to stop using Asmanex Twisthaler for a while or may decide to treat you with
a different type of inhaler. Rinsing your mouth with water or a mouthwash solution and then spitting
this out after you have finished taking your dose will help to prevent thrush.
Important things to remember when using Asmanex Twisthaler
– Get medical help immediately if you start wheezing or have difficulty breathing shortly after using
Asmanex. These symptoms may be an “allergic” reaction to this medicine.
– You should always have a bronchodilator inhaler (a 'reliever' inhaler) with you to quickly relieve the
symptoms of an asthma attack (such as coughing, wheezing and tightening of the chest).
– If you have an asthma attack and the attack does not improve after you use a ‘reliever’ inhaler or if your
peak flow measurement falls (your doctor will tell you the peak flow numbers that are right for you),
you should get medical help straight away. Tell your doctor as your asthma may be getting worse and
you may need to change your medicine.
– You may need to also take steroid tablets or syrup during a severe asthma attack, during other illnesses
or during times of stress. Your doctor may give you some steroid tablets or a syrup to carry with you as
well as a steroid warning card, which will give you advice on when and how to use them.
– If you are taking Asmanex and reducing the dose of steroid tablets or syrup you take, you may start to
get symptoms such as itchy, watery eyes or rash, which were controlled before. Your doctor will tell you
how to control these symptoms. During this time, if you begin to notice joint or muscle pain, feelings
of depression, tiredness or lethargy, you should tell your doctor.
– While using inhaled corticosteroids, patients should avoid coming into contact with anyone who has
measles or chicken pox. If you do come into contact with anyone who has either of these infections
tell your doctor. This is particularly important for children.
– Treatment with medicines like Asmanex Twisthaler may alter the normal levels of steroids in your body.
One effect of this might be that adolescents being treated for a long time might grow more slowly. Your
doctor will probably check your height from time to time.
– All steroids, especially when used for a long time, may alter the way your adrenal gland works. Your
doctor can carry out a blood test to check this.
– Remember to take this medicine, and any others that you are taking, with you if you have to go into hospital.
– Your doctor may test your lungs during your treatment, especially if you are about to stop taking
corticosteroid tablets.
Using other medicines
Tell your doctor if you are already taking medicines to treat a fungal or viral infection, such as ketoconazole,
itraconazole, ritonavir or nelfinavir. These medicines can increase the amount of steroid in your blood.
It is also important to tell your doctor before you start to use Asmanex Twisthaler if you are taking other
steroids, either by injection, by mouth or inhaled. Your doctor will tell you how to adjust the dose of these
other steroids.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
those that you have bought without a prescription.
Pregnancy and breast-feeding
Ask your doctor for advice if you are pregnant, planning to become pregnant, or if you are breast-feeding.
Driving and using machines
Asmanex Twisthaler is not likely to affect your ability to drive or use machines.
Special patient groups
This medicine should not be used by children under 12 years old.
Important information about some of the ingredients of Asmanex Twisthaler
This medicine contains a small amount of lactose (4.64 mg per day is the maximum recommended daily
dose). This amount does not normally cause problems in lactose intolerant people.
3. HOW TO USE ASMANEX TWISTHALER
Make sure that you know how to use the Twisthaler properly. Take care not to drop the inhaler as this may
cause the inhaler to malfunction. If you have any problems ask your doctor or pharmacist. Make sure you
know when and how many doses you should inhale. Your doctor should have told you and the instructions
should be on the pharmacist’s label. You should always follow your doctor’s instructions. Do not change
your dose unless your doctor has told you to.
For adults (including patients over 65 years) and adolescents aged 12 years and over, with mild to
moderate asthma, the recommended starting dose is 400 micrograms (1 dose or inhalation) once a day
in the evening requiring Asmanex 400 micrograms Inhalation Powder however, for some patients the
starting dose may be 200 micrograms (1 dose or inhalation) twice a day requiring Asmanex Twisthaler
200 micrograms Inhalation Powder. If your asthma is controlled, your doctor may reduce the dose to 200
micrograms (1 dose or inhalation) once a day in the evening. Depending on your symptoms, your doctor
may increase or decrease your daily dose to keep your asthma under control.
For patients with severe asthma who may be taking other steroid tablets or syrup, the usual starting dose
of Asmanex Twisthaler is 400 micrograms twice a day, which is the highest recommended dose. After
about one week of Asmanex Twisthaler treatment, your doctor may start to lower the dose of the other
corticosteroid very slowly until you can stop taking it altogether. It may then be possible to lower the dose
of Asmanex Twisthaler if your asthma is controlled well.
Instructions for the proper use of your inhaler
Remember that Asmanex Twisthaler produces a very fine powder, which you must inhale into your lungs. You
should be upright when using your Twisthaler. Follow these instructions carefully, to receive the correct dose.

Before removing the white cap, be sure the counter and the pointer on the cap are lined up. To open the
inhaler, remove the white cap. Hold the inhaler upright, with the pink base down. Grip the base and twist
the cap anticlockwise to remove it. As you remove the cap, the inhaler’s dose counter will count down
by one.
Ensure that the counter on the pink base and the pointer above the counter are in line with one another.
Keep the inhaler upright once the cap is removed and before inhaling your dose.
To inhale your dose,
a) Remove the cap from your inhaler [Figure 1]
b) Bring the inhaler up to your mouth, with the mouthpiece pointing toward you.
c) Insert the mouthpiece of the inhaler in your mouth, close your lips around the mouthpiece, and then
breathe in rapidly and deeply. [Figure 2]
d) Remove the inhaler from your mouth and hold your breath for about 10 seconds, or for as long as is
comfortable. Do not breathe out through the inhaler.
e) To close the inhaler, replace the inhaler cap immediately after each inhalation. The cap must be fully
replaced and turned to load the dose for the next inhalation. Do this by turning the cap clockwise,
while gently pressing the cap down until a click sound is heard and the cap is fully closed. [Figure 3]
The arrow on the cap must be fully lined up with the counter window. [Figure 4]

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Figure 1
Cap removal

Figure 2
Inhalation

Figure 3
Closing the inhaler

Figure 4
Closed Inhaler

After you have finished taking your dose, rinse your mouth with water or a mouthwash solution and then
spit this out. This will help to prevent thrush.
Keep your inhaler clean and dry at all times. Clean the outside of the mouthpiece with a dry cloth or tissue.
Do not wash the inhaler; avoid contact with water.
At the base of the inhaler there is a window, which contains a counter. This shows the number of doses
that are left in the inhaler. Do not use Asmanex Twisthaler if the counter is not working properly. Take it
to your doctor or pharmacist.
When you see “01” in the counter window, this means that there is only one dose left in the inhaler. After
dose 01, the counter will read “00”, the cap will lock, and you will not be able to use the inhaler again.
You should then throw the inhaler away.
To make sure you always have enough medicine get a repeat prescription from your doctor before your
inhaler is empty.
There is no set time for how quickly your treatment will take to work. Some patients may get some relief
within 24 hours after starting treatment; others may not get the maximum benefit for one to two weeks
or longer. Your doctor will tell you how long to use Asmanex Twisthaler for.
If you use more of this medicine than you should:
It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor.
You should not increase or reduce your dose without seeking medical advice. If you accidentally take a
larger dose than you were told to, tell your doctor
If you forget to take this medicine:
If you miss a dose just take the next dose when it is due. Do not take a double dose to make up for the
forgotten dose.
If you stop taking this medicine
Do not suddenly stop using this medicine even if your asthma seems to be better. Speak with your doctor first.
Your symptoms may come back if you stop using this medicine before your doctor has told you to do so.
If you think that your asthma is not getting any better or seems to be getting worse, after you have started
using Asmanex Twisthaler go back and see your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Asmanex Twisthaler can cause side effects, although not everyone gets them.
If you notice any of the following serious side effects, stop using this medicine and talk to your doctor
straightaway. You may need urgent medical treatment:
• Symptoms of a serious allergic reaction include swelling of your eyes, face, lips, mouth, tongue or
throat which may cause difficulty in swallowing or breathing, itchy rash, feeling faint and light headed
which may cause you to collapse.
If you notice an increase in coughing, wheezing, difficulty breathing or shortness of breath immediately after
inhaling the medicine use your “reliever” inhaler and contact your doctor straightaway. You should not use Asmanex
Twisthaler again until you have seen your doctor.
It is possible to have allergic (hypersensitivity) reactions to inhaled steroids. If this happens you may notice skin rash,
itching and redness and swelling of the eyes, face, lips and throat. If you have any of these symptoms you should
contact your doctor straightaway. You should not use Asmanex Twisthaler again until you have seen your doctor.
Tell your doctor as soon as possible if you develop a candida infection (thrush) in the mouth or throat (this
appears as white patches), hoarseness, a sore throat or headache.
Other uncommon (affects less than 1 person in 100) side effects include dry mouth and throat,
indigestion, weight increase and rapid or pounding heartbeat (palpitations). Contact your doctor if you
notice any of these symptoms.
Rarely, patients using inhaled steroids, including Asmanex Twisthaler, develop increased pressure in the
eye (including glaucoma) or cataracts. Contact your doctor if your vision is blurry or if you have eye pain.
Other possible side effects of steroids include slowing or change in the growth pattern in adolescents,
and thinning of the bones. Sleeping problems, depression or feeling worried, restlessness, nervousness,
excitability or irritability may also occur with the use of inhaled corticosteroids. These effects are more likely
to occur in children. Steroids may also affect your adrenal gland, causing weakness, fatigue or dizziness
and faintness when standing for a long time or after getting up from a sitting position. These effects are
much less likely to occur when taking inhaled corticosteroids than with steroids taken by mouth.
If any of the side effects gets serious or you notice any side effects not mentioned in this leaflet, please
inform your doctor or pharmacist.
5. HOW TO STORE ASMANEX TWISTHALER
Keep out of the reach and sight of children.
Do not store above 30°C. Do not refrigerate or freeze.
Store each Twisthaler in the original package in order to protect from moisture until it is needed, and then
use it within 3 months of first opening. Only open one Twisthaler at a time.
Do not use after the expiry date which is stamped on the carton, foil pouch and label. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via the wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help protect the environment.
6. FURTHER INFORMATION
What Asmanex Twisthaler contains
− The active substance is mometasone furoate 200 micrograms.
− The only other ingredient is lactose anhydrous (which contains trace amounts of milk proteins).
What Asmanex Twisthaler looks like and contents of the pack
200 micrograms of mometasone furoate is delivered from the mouthpiece of the Asmanex Twisthaler
with each inhalation. Inhalers are available with either 30 or 60 inhalations (doses), with each pack
containing one pouched inhaler (for either the 30 or 60 dose inhalers) or three individually packed
and pouched inhalers (only for the 60 dose inhalers). Not all pack sizes may be marketed. The inhaler
mouthpiece is white, with a pink-coloured base containing an open display window that shows the
number of inhalations that are left in the inhaler.
Marketing Authorisation holder and manufacturer
The holder of the Marketing Authorisation in the UK is Merck Sharp & Dohme Limited, Hertford
Road, Hoddesdon, Hertfordshire, EN11 9BU, UK.
The Marketing Authorisation Holder in Ireland is Merck Sharp & Dohme Ireland (Human Health)
Limited, Pelham House, South County Business Park, Leopardstown, Dublin 18, Ireland.
The manufacturer is Schering-Plough Labo NV, Heist-op-den Berg, Belgium.
For further information about this product contact the Marketing Authorisation holder, Merck
Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
This leaflet was last revised in May 2012
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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.

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