aclidinium (as bromide)
Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some common questions about BRETARIS GENUAIR.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your pharmacist or doctor will be able to advise you about the risks and benefits of using BRETARIS GENUAIR.
If you have any concerns about using this medicine, ask your pharmacist or doctor.
Keep this leaflet with the medicine.
You may need to read it again.
What BRETARIS GENUAIR is used for
The active ingredient of BRETARIS GENUAIR is aclidinium bromide, which belongs to a group of medicines called bronchodilators. Bronchodilators relax airways and help keep bronchioles open.
BRETARIS GENUAIR is a dry powder inhaler that uses your breath to deliver the medicine directly into your lungs. This makes it easier for chronic obstructive pulmonary disease (COPD) patients to breathe.
BRETARIS GENUAIR is indicated to help open the airways and relieve symptoms of COPD, a serious, long-term lung disease characterised by breathing difficulties. Regular use of BRETARIS GENUAIR can help you when you have ongoing shortness of breath related to your disease and will help you to minimise the effects of the disease on your everyday life.
Ask your doctor if you have any questions about why BRETARIS GENUAIR has been prescribed for you.
This medicine is only available with a doctor’s prescription.
It is not addictive.
Before you use BRETARIS GENUAIR
When you must not use it
Do not use BRETARIS GENUAIR:
if you are allergic to aclidinium bromide or any of the other ingredients of this medicine listed at the end of this leaflet
if you are allergic to atropine or related bronchodilator medicines, for example ipratropium, tiotropium or oxitropium..
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
In that case, return it to your pharmacist.
Before you start to use it
Tell your doctor if you have any of the following medical conditions:
if you have asthma
if you have had heart problems recently
if you see halos around lights, or coloured images (glaucoma)
if you have an enlarged prostate, problems passing urine, or a blockage in your bladder.
Your doctor may want to take special precautions if you have any of the above conditions.
BRETARIS GENUAIR is indicated for maintenance treatment of your chronic obstructive pulmonary disease; it should not be used to treat a sudden attack of breathlessness or wheezing. If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse you should contact your doctor for advice as soon as possible.
Dry mouth, which has been observed with medicines like BRETARIS GENUAIR, may, after using your medicine for a long time, be associated with tooth decay. Therefore, please remember to pay attention to oral hygiene.
Stop using BRETARIS GENUAIR and seek medical help immediately:
if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. These may be signs of a condition called bronchospasm.
If you require further advice, you should talk with your doctor or pharmacist.
Tell your doctor if you are pregnant, intend to become pregnant or are breastfeeding.
BRETARIS GENUAIR is not recommended for use during pregnancy or while breastfeeding. If it is necessary for you to use this medicine during pregnancy or while breastfeeding, your doctor will discuss with you the benefits and risks involved.
Children and adolescents
BRETARIS GENUAIR is not for use in children or adolescents below 18 years of age.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and BRETARIS GENUAIR may interfere with each other. These include medicines containing tiotropium, ipratropium or oxitropium (called anticholinergics).
You may need to take different amounts of your medicines or you may need to take different medicines. Your doctor and pharmacist have more information.
If you have not told your doctor about any of these things, tell him/ her before you start using BRETARIS GENUAIR.
How to use BRETARIS GENUAIR
Follow all directions given to you by your doctor and pharmacist carefully.
These directions may differ from the information contained in the leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much to use
The recommended dose is one inhalation twice a day in the morning and evening.
The effects of BRETARIS GENUAIR last for 12 hours; therefore, you should try to use your BRETARIS GENUAIR inhaler at the same time every morning and evening. This ensures that there is always enough medicine in your body to help you breathe more easily throughout the day and night. It will also help you to remember to use it.
How to use
See instructions on how to use the BRETARIS GENUAIR inhaler. If you are not sure of how to use BRETARIS GENUAIR, contact your doctor or pharmacist.
How long to use
Continue to use this medicine for as long as your doctor tells you to.
If it helps your breathing problems, your doctor may want you to keep using it for a long time.
This medicine helps to control your condition but it does not cure it.
If you want to stop treatment, first talk to your doctor, as your symptoms may worsen.
If you forget to use it
If you forget to have a dose of BRETARIS, inhale the dose as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.
Do not take a double dose to make up for the one that you missed.
This may increase the chance of you getting an unwanted side effect.
If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.
If you use too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have used too much BRETARIS. Do this even if there are no signs of discomfort or poisoning.
While you are using BRETARIS GENUAIR
Things you must do
Use this medicine exactly as your doctor has prescribed. Try not to miss any doses and use it even if you feel well.
If you do not follow your doctor’s instructions, you may not get relief from your breathing problems or you may have unwanted side effects.
If you find that the usual dose of BRETARIS is not giving as much relief as before, or does not last as long as usual, contact your doctor so that your condition can be checked.
This is important to ensure your COPD is controlled properly.
If you become pregnant while using this medicine, tell your doctor.
Your doctor can discuss with you the risks of using it while you are pregnant.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using BRETARIS GENUAIR.
Tell any other doctors, dentists, and pharmacists who treat you that you are using this medicine.
Things you must not do
Do not exceed the recommended daily dose – it will not help you to do this.
Do not take any other medicines for your breathing problems without checking with your doctor.
Do not give this medicine to anyone else, even if their condition seems similar to yours.
Do not use it to treat any other complaints unless your doctor tells you to.
Things to be careful of
Be careful driving, operating machinery or doing jobs that require you to be alert until you know how BRETARIS affects you.
This medicine has no or negligible influence on the ability to drive and use machines. This medicine may cause headache, dizziness, or blurred vision. If you are affected by either of these side effects do not drive or use machinery until the headache has cleared and your vision has returned to normal.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using BRETARIS GENUAIR.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by these lists of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
headache
inflammation of the sinuses (sinusitis)
sneezing (rhinitis)
common cold (nasopharyngitis)
cough
diarrhoea
vomiting
toothache
fall
nausea
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen:
you develop signs of an allergic reaction such as swelling of the face, lips, tongue, throat or other part of the body; severe dizziness or fainting, faster heart rate, redness, itching or rash on the skin.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
After using BRETARIS GENUAIR
Storage
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Keep the BRETARIS GENUAIR inhaler protected inside the sealed pouch until the administration period starts.
To be used within 90 days of opening the pouch.
Store below 30°C.
Disposal
If your pharmacist or doctor tells you to stop using the inhaler or the expiry date has passed, ask your pharmacist how to dispose of it properly.
Product description
What it looks like
BRETARIS is a white or almost white powder.
The GENUAIR inhaler device is white coloured with an integral dose indicator and a green dosage button. The mouthpiece is covered with a removable green protective cap. It is supplied in a sealed protective pouch.
Ingredients
Active Ingredient
The active substance is aclidinium bromide. Each delivered dose contains 375 micrograms aclidinium bromide equivalent to 322 micrograms of aclidinium.
Inactive Ingredient
BRETARIS also contains lactose monohydrate.
