Relvar Ellipta 92 micrograms / 22 micrograms inhaled Powder, Divided Dose / 184 micrograms / 22 micrograms inhaled powder, divided dose fluticasone furoate/vilanterol
What Type Of Inhaler Is Relvar And What Is Relvar Used For
Relvar Ellipta contains two active substances: fluticasone furoate and vilanterol. Relvar Ellipta is available in two different strengths: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms.
The strength of 92/22 micrograms is used for regular treatment of chronic obstructive pulmonary disease ( COPD ) in adults, and asthma in adults and adolescents aged 12 years and older.
The strength of 184/22 micrograms is used to treat asthma in adults and adolescents aged 12 years and older.
The strength of 184/22 micrograms is not approved for the treatment of COPD.
Relvar Ellipta should be used every day and not just when you have breathing problems or other symptoms of COPD or asthma. It should not be used to relieve an acute attack of shortness of breath or wheezing. If you have such a seizure, you must use a fast-acting inhaler (for example salbutamol ). Contact a doctor if you do not have a fast-acting inhaler.
Fluticasone furoate belongs to a group of drugs called corticosteroids, or just “cortisone”. Corticosteroids reduce inflammation. They reduce swelling and irritation in the thin trachea in the lungs and gradually relieve breathing difficulties. Corticosteroids also help prevent asthma attacks and worsen COPD.
Vilanterol belongs to a group of medicines called long-acting bronchodilators. This relaxes the muscles in the thin trachea in the lungs. The airways widen and it becomes easier for the air to get in and out of the lungs. When taken regularly, it makes it easier for the thin trachea to stay open.
When you take these two active substances at the same time, they regularly help to keep your breathing difficulties under better control than if the drugs are given separately.
Asthma is a serious, chronic lung disease in which the muscles around the thin trachea contract ( bronchoconstriction ) and become swollen and irritated ( inflammation ). Symptoms can come and go and include
- Shortness of breath
- Wheezing/wheezing
- The feeling of pressure over the chest
- Coughing
Relvar Ellipta has been shown to reduce seizures and other symptoms of asthma.
Chronic obstructive pulmonary disease (COPD) is a serious, chronic disease with inflamed and thickened airways. Symptoms include shortness of breath, cough, chest discomfort, and cough. Relvar Ellipta may reduce flare-ups of COPD.
What You Need To 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 this applies to you, do not use Relvar Ellipta until you have talked to your doctor.
Warnings And Cautions
Talk to your doctor before using Relvar Ellipta
Talk to your doctor before using this medicine if you think any of these apply to you.
- If you have liver disease, the risk of side effects may be greater. If you have moderate or severe liver disease, your doctor will limit your dose to the lower strength of Relvar Ellipta (92/22 micrograms, once daily)
- If you have heart problems or high blood pressure
- If you have pulmonary tuberculosis or any other long-term or untreated infection
- If you have diabetes or high blood sugar
- If you have thyroid problems
- If you have low potassium levels in your blood
- If you experience blurred vision or other visual disturbances.
Talk to your doctor before using this medicine if you think any of these apply to you.
While using Relvar Ellipta
- Contact your doctor if you experience blurred vision or other visual disturbances.
- Contact your doctor if you experience increased thirst, frequent urination, or unexplained fatigue (signs of high blood sugar).
Acute breathing difficulties
If your breathing or wheezing worsens immediately after using Relvar Ellipta, stop using it and seek medical attention immediately.
Infection of the lungs
If you use this medicine for COPD, the risk of getting an infection in the lungs, ie. pneumonia, is elevated. See section 4 for information on the symptoms to be aware of when using this medicine. Tell your doctor as soon as possible if you get any of these symptoms.
Children And Young People
Do not give this medicine to children under 12 years of age for the treatment of asthma, or to children and adolescents, regardless of 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 any other medicines. If you are not sure what your medicine contains, talk to your doctor or pharmacist.
Some medicines may affect the way this medicine works or increase the risk of side effects. These drugs are:
- Beta-blockers, such as metoprolol, are used to treat high blood pressure or heart disease
- ketoconazole, for the treatment of fungal infections
- Ritonavir or cobicistat for the treatment of HIV infection
- Long-acting beta 2 agonists, such as salmeterol
Tell your doctor or pharmacist if you are taking any of these medicines. Your doctor may want to monitor you closely if you are taking these medicines as they may increase the side effects of Relvar Ellipta.
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not use this medicine if you are pregnant unless your doctor tells you to.
It is unknown whether the contents of this medicine are excreted in human milk.
If you are breastfeeding, talk to your doctor before using Relvar Ellipta. Do not use this medicine if you are breastfeeding unless your doctor tells you to.
If you are breastfeeding, talk to your doctor before using Relvar Ellipta.
Driving And Using Machines
This medicine is unlikely to affect your ability to drive or use machines.
Relvar Ellipta Contains Lactose
If you have been told by your doctor that you have an intolerance to some sugars or milk protein, contact your doctor before taking this medicine.
How To Use Relvar Ellipta
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How many doses should you take?
Asthma
The recommended dose for treating asthma is one inhalation (92 micrograms fluticasone furoate and 22 micrograms vilanterol) once daily at the same time each day.
If you have severe asthma, your doctor may decide to inhale once with the higher strength (184 micrograms of fluticasone furoate and 22 micrograms of vilanterol). This dose should also be taken once a day, at the same time each day.
CHARCOAL
The recommended dose for treating COPD is one inhalation (92 micrograms fluticasone furoate and 22 micrograms vilanterol) once daily at the same time each day.
The higher potency of Relvar Ellipta (184 micrograms fluticasone furoate and 22 micrograms vilanterol) is not suitable for the treatment of COPD.
Relvar Ellipta is intended for inhalation.
Use Relvar Ellipta at the same time each day as it is effective for over 24 hours
You must use this medicine every day, according to your doctor’s instructions. It helps you to be asymptomatic throughout the day and night.
Relvar Ellipta should not be used to relieve an acute attack of shortness of breath or wheezing. If you have such a seizure, you must use a fast-acting inhaler (for example salbutamol ).
If you experience shortness of breath or wheezing more often than usual, or if you use your fast-acting inhaler more often than usual, seek medical attention.
Relvar Ellipta How To Use
For complete information, see “Step-by-Step Instructions” after section 6 of this leaflet.
Relvar Ellipta is intended for inhalation. You do not need to prepare Relvar Ellipta in any special way, not even the first time you use it.
If your symptoms do not get better
If your symptoms (shortness of breath, wheezing, coughing) do not get better or worse, or if you use your fast-acting inhaler more often than usual:
contact a doctor as soon as possible.
If You Use More Relvar Ellipta Than You Should
If you have inadvertently used more Relvar Ellipta than your doctor advised, talk to your doctor or pharmacist. You may feel your heart beat faster than normal, feel shaky or have a headache.
If you have used more than you have been prescribed for a long time, you must consult a doctor or pharmacist. This is because high doses of Relvar Ellipta can reduce the number of steroid hormones produced naturally by the body.
If You Forget To Use Relvar Ellipta
Do not inhale a double dose to compensate for a missed dose. Only take the next dose at the usual time.
If you experience wheezing/wheezing or shortness of breath, or any other symptoms of an asthma attack, use your fast-acting inhaler (eg salbutamol ) and seek medical advice.
Do Not Stop Taking Relvar Ellipta Without Consulting A Doctor
Use this medicine for as long as your doctor prescribes it. It only has an effect as long as you use it. Do not stop using it unless your doctor tells you to, not even if you feel better.
If you have any further questions about the use of this product, ask your doctor, pharmacist, or nurse.
Relvar Ellipta Inhaler Side Effects
Like all medicines, Relvar Ellipta 184/22 side effects, although not everybody gets them.
Allergic reactions
Allergic reactions are rare (may have Relvar Ellipta inhaler side effects up to 1 in 1,000 people).
If you have any of the following symptoms after taking Relvar Ellipta stop taking this medicine and contact your doctor immediately.
- Skin rash ( hives ) or redness
- Swelling, sometimes in the face or mouth ( angioedema )
- Get very wheezing, cough, or have difficulty breathing
- The sudden feeling of weakness or dizziness (which may lead to collapse or unconsciousness)
Acute breathing difficulties
Breathing difficulties immediately after using Relvar Ellipta are rare:
If your breathing or wheezing worsens immediately after using this medicine, stop using it and seek medical attention immediately.
Pneumonia (Relvar Ellipta Inhaler Side Effects may affect more than 1 in 10 people)
Tell your doctor if you have any of the following symptoms while taking Relvar Ellipta as they may be symptoms of pneumonia:
- Fever or chills
- Increased mucus production changed the color of the mucus
- Increased cough or increased difficulty breathing
Other side effects are:
Very common side effects are
These can occur in more than 1 in 10 people:
- Headache
- Common cold.
Common side effects are
These can occur in up to 1 in 10 people:
- Painful, raised spots in the oral cavity or pharynx caused by fungal infection ( candida infection ). Rinse mouth with water immediately after taking Relvar Ellipta. In this way, this side effect can be avoided.
- Inflammation of the lungs ( bronchitis )
- Infection of the nasal sinuses or throat infection
- Influenza
- Pain and irritation further back in the mouth and the throat
- Sinusitis
- Itchy, runny, or stuffy nose
- Cough
- Voice problems
- The weakened skeleton can lead to fracture
- Abdominal pain
- Back pain
- Fever
- Joint pain
- Muscle cramps
Uncommon side effects are
These can occur in up to 1 in 100 people:
- Irregular heartbeats
- Dimsyn
- Elevated blood sugar (hyperglycemia)
Rare side effects
These can occur in up to 1 in 1,000 people:
- Increased heart rate ( tachycardia )
- Palpitations ( palpitation )
- Tremors
- Anxiety
How To Store Relvar Ellipta
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
- Do not store above 25 ° C.
- Store the inhaler in a sealed foil package to protect it from moisture. Do not open the foil package until just before the first use. Once the foil package has been opened, the inhaler can be used for up to 6 weeks, starting from the day the foil package has been opened. Write the date on which the inhaler is to be disposed of in the space provided on the label. The date should be written as soon as the inhaler has been removed from the foil package.
- If the inhaler is stored in a refrigerator, allow it to reach room temperature for at least one hour before use.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
- The active substances are fluticasone furoate and vilanterol.
- For 92/22 micrograms, each inhalation provides a dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as triphenate).
- For 184/22 micrograms, each inhalation provides a dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as triphenate).
- The other ingredients are lactose monohydrate (see section 2) and magnesium stearate.
What The Medicine Looks Like And The Contents Of The Pack
Relvar Ellipta is an inhalation powder, divided dose.
The Ellipta inhaler is light gray and has a yellow protective cap over the mouthpiece, as well as a dose counter. It is packed in a foil tray with a removable foil lid. The tray contains desiccant to reduce the moisture in the package. Discard the desiccant immediately after opening the trough lid – it must not be swallowed or inhaled. The inhaler does not need to be stored in the foil tray once it has been opened.
The inhaler contains two aluminum foil strips with 14 or 30 doses. Multipack contains 3×30 doses.
Marketing Authorisation Holder:
GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer:
Glaxo Wellcome Production
Industrial Zone No.2,
23 Rue Lavoisier,
27000 Evreux
France
Contact the representative of the marketing authorization holder to find out more about this medicine.
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