aclidinium (as bromide) / formoterol (eformoterol) fumarate dihydrate
Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some common questions about BRIMICA GENUAIR 340/12.
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 BRIMICA GENUAIR 340/12.
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 BRIMICA GENUAIR 340/12 is used for
BRIMICA GENUAIR 340/12 contains two different medicines called aclidinium bromide and formoterol (eformoterol) fumarate dihydrate.
Both belong to a group of medicines known as bronchodilators. Bronchodilators relax airways and help keep bronchioles open.
BRIMICA GENUAIR 340/12 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.
BRIMICA GENUAIR 340/12 is used to help open the airways and relieve symptoms of COPD, a serious long-term lung disease characterised by breathing difficulties. Regular use of BRIMICA GENUAIR 340/12 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 BRIMICA GENUAIR 340/12 has been prescribed for you.
This medicine is only available with a doctor’s prescription.
It is not addictive.
Before you use BRIMICA GENUAIR 340/12
When you must not use it
Do not use BRIMICA GENUAIR 340/12 if you are allergic to aclidinium bromide, formoterol (eformoterol) fumarate dihydrate or to the other ingredient of this medicine listed at the end of this leaflet.
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 or pharmacist if you have any of the following medical conditions:
if you have asthma
if you have had heart problems recently
if you have epilepsy
if you have thyroid gland problems (thyrotoxicosis)
if you have a tumour in one of your adrenal glands (phaeochromocytoma)
if you have difficulty passing urine
if you have an eye problem called narrow angle glaucoma.
Your doctor may want to take special precautions if you have any of the above conditions.
BRIMICA GENUAIR 340/12 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.
If you see halos around lights and coloured images, have eye pain or discomfort or suffer temporary blurring of vision, see your doctor for advice as soon as possible.
Dry mouth, which has been observed with medicines like BRIMICA GENUAIR 340/12, 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 BRIMICA GENUAIR 340/12 and seek medical help immediately:
if you have sudden difficulty in breathing or swallowing, if you have swelling of the tongue, throat, lips or face, or a skin rash and/or itching. These may be signs of an allergic reaction.
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.
BRIMICA GENUAIR 340/12 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
BRIMICA GENUAIR 340/12 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 BRIMICA GENUAIR 340/12 may interfere with each other. These include:
any medicines that may be similar to BRIMICA GENUAIR 340/12 to treat breathing difficulties
medicines that lower the amount of potassium in your blood. These include:
steroids that you take by mouth (prednisolone)
diuretics (such as furosemide or hydrochlorthiazide)
certain medicines used to treat breathing conditions (such as theophylline).
medicines called beta blockers that may be used to treat high blood pressure or other heart problems (such as atenolol or propranolol) or to treat glaucoma (such as timolol)
medicines which can cause a change in your heart trace (electrocardiogram) known as QT interval prolongation. These include medicines for the treatment of:
depression, such as monoamine oxidase inhibitors or tricyclic antidepressants
bacterial infections (such as erythromycin, clarithromycin, telithromycin)
allergic reaction anti-histamines).
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 BRIMICA GENUAIR 340/12.
How to use BRIMICA GENUAIR 340/12
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 night, 12 hours apart.
The effects of BRIMICA GENUAIR 340/12 last for 12 hours; therefore, you should try to use your BRIMICA GENUAIR 340/12 inhaler at the same time every morning and at night. 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 BRIMICA GENUAIR 340/12 inhaler. If you are not sure of how to use BRIMICA GENUAIR 340/12, 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 BRIMICA 340/12, 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 BRIMICA GENUAIR 340/12. Do this even if there are no signs of discomfort or poisoning.
While you are using BRIMICA GENUAIR 340/12
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 BRIMICA 340/12 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 BRIMICA GENUAIR 340/12.
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 BRIMICA GENUAIR 340/12 affects you.
This medicine has no or negligible influence on the ability to drive and use machines. This medicine may cause headache 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 BRIMICA GENUAIR 340/12.
All medicines may have some unwanted side effects. Sometimes they are serious, but 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:
headaches
inflammation of the sinuses (sinusitis)
common cold (nasopharyngitis)
diarrhoea
vomiting
toothache
dry mouth
nausea
changes in voice
flu symptoms
changes in sense of taste
sore mouth or throat from inhaling the powder
being unable to sleep
dizziness
palpitation (feeling that your heartbeat is unusually fast or irregular)
muscle aching or cramp
trembling or shakiness
painful and/or frequent urination – these may be signs of a urinary tract infection
infection in the tissues at the base of a tooth
irritation in the throat
difficulty in breathing
blurred vision
swelling of hands, ankles or feet
Tell your doctor or pharmacist immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
you develop signs of an allergic reaction such as swelling of the face, lips, tongue, throat or other part of the body; difficulty in breathing, palpitations, severe dizziness or fainting; 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 BRIMICA GENUAIR 340/12
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 BRIMICA GENUAIR 340/12 inhaler protected inside the sealed pouch until the administration period starts.
To be used within 60 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
BRIMICA 340/12 is a white or almost white powder.
The BRIMICA GENUAIR 340/12 inhaler device is white coloured with an integral dose indicator and an orange dosage button. The mouthpiece is covered with an orange removable protective cap. It is supplied in a sealed pouch.
Ingredients
Active ingredients:
Each delivered dose contains:
396 micrograms aclidinium bromide (equivalent to 340 micrograms aclidinium) and 12 micrograms of formoterol (eformoterol) fumarate dihdyrate.
Inactive ingredients
BRIMICA GENUAIR 340/12 also contains lactose monohydrate.
