RELVAR ELIPTA inhalation powder 184 mcg. 22 mcg. 30 doses
RELVAR ELIPTA inhalation powder 184 mcg. / 22 mcg. 30 doses
What Relvar Ellipta and what it is used
Relvar Ellipta contains two active substances: fluticasone furoate and vilanterol . Relvar Ellipta available with different amounts of the active substance: fluticasone furoate 92 mcg / vilanterol 22 micrograms and 184 micrograms of fluticasone furoate / vilanterol 22 micrograms.
Relvar Ellipta 92/22 micrograms are used to regularly treat chronic obstructive pulmonary disease ( COPD ) and adult asthma in adults and adolescents over 12 years.
Relvar Ellipta 184/22 micrograms is used to treat asthma in adults and adolescents 12 years and above .
Relvar Ellipta should be used every day , not just when you have breathing problems or other symptoms of COPD and asthma. The drug should not be used to relieve a sudden attack of breathlessness or wheezing. In case you get fit you should use fast-acting inhaler ( such as salbutamol ) .
Fluticasone furoate belongs to a group of medicines called corticosteroids , often called just steroids. Corticosteroids reduce inflammation . They reduce swelling and irritation in the small airways in the lungs and thus gradually relieve respiratory problems . Corticosteroids also help prevent asthma attacks and worsening of COPD.
Vilanterol belongs to a group of medicines called long-acting bronchodilators . It relaxes the muscles of the small airways in the lungs . Helps that the airways to open and facilitate entry and exit of air from the lungs . When taken regularly , helps small airway to remain open .
When regularly taking these two substances together, they will help you better control your breathing problems than if you are taking medication alone.
Asthma is a serious , prolonged pulmonary disease in which muscles in the walls of the smaller airways are narrowed ( bronchoconstriction ) , swollen and irritated ( inflammation ) . Symptoms may come and go , and include shortness of breath , wheezing , chest tightness and cough.
Chronic obstructive pulmonary disease ( COPD ) is a serious , prolonged pulmonary disease in which airways become inflamed and thickened . Symptoms include shortness of breath , coughing, discomfort in the chest and slimy sputum . It has been found that Relvar Ellipta reduces exacerbation of COPD.
2 . What you should know before using Relvar Ellipta
Do not use Relvar Ellipta:
if you are allergic to fluticasone furoate vilanterol or any of the other ingredients of this medicine (listed in Section 6) ;
if you think that the above applies to you , do not use Relvar Ellipta before discussing it with your doctor.
Take special care with Relvar Ellipta
Before using Relvar Ellipta, your doctor needs to know:
if you have liver disease , as it is more likely to get side effects
if you have heart problems or high blood pressure;
if you have tuberculosis of the lungs or any prolonged or untreated infections ;
if you have a history of diabetes.
Consult your doctor before using this medicine if you think any of the above applies to you .
Breathing problems immediately after application
If breathing or wheezing get worse immediately after using Relvar Ellipta, stop using this medicine and seek immediate medical attention.
Infection of the lung
If using this medicine for the treatment of COPD , you may be at increased risk of developing lung infection called pneumonia. See section 4 " Possible side effects " for information about the symptoms that you should follow while using this medicine. Tell your doctor as soon as possible if you develop any of these symptoms.
Children and adolescents
This medicine is not recommended for children under 12 years to treat asthma or in children and adolescents of any age for the treatment of COPD.
Other medicines and Relvar Ellipta
Tell your doctor or pharmacist if you are taking , have recently taken or might take other medicines.
Some medicines may affect the way this medicine works or increase the likelihood of developing side effects .
beta- blockers such as metoprolol, used to treat high blood pressure or heart disease ;
ketoconazole used in the treatment of fungal infections ;
ritonavir used to treat HIV infection ;
long-acting beta2 -adrenergic agonists , such as salmeterol .
Tell your doctor or pharmacist if you are taking any of these medicines .
Relvar Ellipta should be used in pregnant women only if the expected benefits outweigh the possible risks.
If you are pregnant , think you may be pregnant or planning to become pregnant , talk to your doctor before taking this medicine.
It is not known whether this medication passes into breast milk . Therefore can not be excluded risk to the infant .
If you are breastfeeding , consult your doctor before taking Relvar Ellipta.
Driving and using machines
E unlikely this medicine affect your ability to drive or operate machinery.
Relvar Ellipta contains lactose
Consult your doctor before using this medicine if you have been diagnosed with an intolerance to some sugars or milk protein .
3 . How to use Relvar Ellipta
Always use this medicine exactly as your doctor tells you . If you are not sure, ask your doctor, nurse or pharmacist.
How much to take
The recommended dose for the treatment of asthma is an inhalation (92 micrograms of fluticasone furoate and 22 micrograms vilanterol ) once a day, at the same time each day .
If you have severe asthma , your doctor may decide that you should take one inhalation of a high concentration (184 micrograms of fluticasone furoate and 22 micrograms vilanterol ) . This dosage should also be taken once a day , at the same time each day .
The recommended dose for the treatment of COPD is an inhalation (92 micrograms of fluticasone furoate and 22 micrograms vilanterol ) once a day, at the same time each day .
The higher concentration of Relvar Ellipta is not suitable for the treatment of COPD.
Apply Relvar Ellipta at the same time each day , as he works for 24 hours.
It is very important to take this medicine every day exactly as your doctor tells you . This will help you to avoid the presence of symptoms during the day and at night.
Relvar Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing. If you receive such an attack , you must use fast acting inhaler ( such as salbutamol ) .
Consult your doctor if you have shortness of breath or wheezing more often than normal , or if you use more often acting inhaled medicine.
How to use Relvar Ellipta
Read " step-by- step " in section 6 of this leaflet for full details .
Should not prepare Relvar Ellipta in some special way , even when using it for the first time.
If your symptoms do not improve
If your symptoms ( shortness of breath, wheezing, cough) do not improve or worsen or use more often medication for quick relief of symptoms contact your doctor as soon as possible.
If you use more than the amount Relvar Ellipta
Ask your doctor or pharmacist if you accidentally take a dose higher than prescribed . You can feel your heart beating faster than usual, that dread or have a headache .
It is especially important to contact your doctor or pharmacist for advice if you are taking a higher dose than prescribed for an extended period of time. This is because higher doses Relvar Ellipta may decrease levels of steroid hormones normally produced by your body.
If you forget to take Relvar Ellipta
Do not take a double dose to make up for a missed dose. Inhale the next dose when the time for that.
If you get wheezing or shortness of breath or develop other symptoms of an asthma attack , use fast acting inhaler ( such as salbutamol ) and then seek medical assistance.
Do not stop taking Relvar Ellipta without medical advice
Take this medicine as long as your doctor recommends . It will be effective until you use it . Do not stop treatment even if you feel better unless your doctor tells you .
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
Breathing problems immediately after application
If breathing or wheezing get worse immediately after using this medicine , stop taking it immediately and seek medical advice.
Lung infection ( common side effect )
Tell your doctor if you experience any of the following while taking Relvar Ellipta - they can be symptoms of lung infection :
fever or chills ;
increased formation of sputum or change in color of sputum ;
Increase in coughing or increased breathing problems .
Other side effects are:
Very common side effects These may affect more than 1 in 10 people :
Common side effects These may affect up to 1 in 10 people :
inflamed, raised areas in the mouth or throat, caused by fungal infection ( thrush ) . Development of this side effect can be prevented if immediately after taking Relvar Ellipta rinse your mouth with water ;
lung inflammation ( bronchitis ) ;
infection of the nasal sinuses or throat ;
pain and irritation to the back of the mouth and throat ;
inflammation of the sinuses ;
itchy nose , runny or stuffy nose ;
change in voice ;
thinning of bones , resulting in a fracture ;
stomach pain ;
high temperature (fever ) ;
joint pain .
Uncommon side effects These may affect up to 1 in 100 people :
irregular heartbeat .
Adverse event reporting
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet . You can also report side effects directly through the national system of communication. As reported side effects , you can do your bit to get more information on the safety of this medicine.
5 . How to store Relvar Ellipta
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton after " EXP " . The expiry date refers to the last day of that month.
Do not store above 25 ° C.
Store in the original package to protect from moisture and do not open the cover of foil until ready for inhalation .
If stored in a refrigerator , the inhaler should be kept at room temperature for at least one hour before use.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Contents of the pack and other information
What does Relvar Ellipta
The active substances are : Fluticasone furoate and vilanterol . Each inhalation delivers a delivered dose (the dose that is released from the mouthpiece ) of 92 micrograms or 184 micrograms of fluticasone furoate and vilanterol 22 micrograms ( as trifenatat ) .
The other ingredients are lactose monohydrate and magnesium stearate.
Looks like Relvar Ellipta and contents of the pack
Relvar Ellipta is a white powder . The device is a light gray Ellipta pale inhaler mouthpiece cover and a dose counter . Relvar Ellipta is packaged in a nest of foil , with a release coating film . The socket comprises a sachet with a desiccant to reduce moisture in the package. After removing the cover of the socket , discard the desiccant - do not ingest or inhale . After opening the device should not be kept in the nest of foil .
The inhaler comprises two aluminum strip coated with a laminated film of a 14 or 30 doses .
Multipack contains 3 inhaler containing 30 doses .
Instructions step-by- step
What inhaler Ellipta?
When you first use the inhaler Ellipta, you do not need to check if it works properly and prepare it for use in some special way. Simply follow the instructions step by step.
The inhaler is packaged in a receptacle comprising a sachet of desiccant to reduce the moisture . Discard the sachet - do not ingest or inhale .
When you remove the inhaler from the nest , it will be in position "closed" . Do not open it until you are ready to inhale a dose of medicine.
1. Read this before you start
If the cover of the dispenser is opened and closed without the inhalable medicament , the dose will be lost . Lost dose will be retained inside the inhaler , but it can not be inhaled .
It is not possible to accidentally take more medicine or a double dose inhalation.
The dose counter
It shows how many doses of medicament remain in the inhaler .
Before the inhaler was used , the counter shows exactly 30 doses.
Toy counts with one less each time you open the lid.
When the remaining less than 10 doses , one half of the meter displays red.
After using the last dose , half of the reading shows red and appeared digit 0 . Your inhaler is empty now .
If you then open the inhaler dose counter will change from red to half full red.
Every time you open it , prepare a dose .
2 . How to prepare a dose
Open the lid when you are ready to take a dose . Do not shake the inhaler.
Slide the cover down until you hear a 'click' .
Now the medicament is ready for inhalation .
For confirmation , the dose counter counts down by 1 less .
If the counter is not counted , you hear a "click " inhaler will not release the drug. Take it back to the pharmacist and ask him.
3 . How to inhale the medicine
Hold the inhaler away from your mouth and exhale as possible.
Do not breathe into the inhaler .
Place the mouthpiece between your lips and close them tightly around him.
Do not block the fingers open air .
Breathe long , evenly and deeply. Hold your breath as you can (at least 3-4 seconds) .
Remove the inhaler from your mouth.
Breathe slowly and calmly .
It may not be possible to try the taste or feel the medicine , even when using the inhaler correctly.
4 . Close the inhaler and rinse your mouth
If you want to clean the mouthpiece , use a dry cloth before closing the lid.
Slide the cover up as far as he could to cover the mouthpiece.
After using the inhaler , rinse your mouth with water .
This will reduce the chance to get sores in your mouth or throat , and adverse reactions.