Revinty Ellipta Powder

REVINTY is used to treat asthma and chronic obstructive pulmonary disease (COPD). REVINTY should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting inhaler (such as salbutamol). Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called steroids or cortisone. Corticosteroids reduce inflammation. Vilanterol belongs to a group of medicines called bronchodilators. It relaxes the muscles of the small air passages in the lungs. This helps to open the airways and makes it easier for air to get in and out of the lungs.

Do not use REVINTY:

• if you are allergic (hypersensitive) to lactose or milk protein
• if you are allergic (hypersensitive) to fluticasone furoate, vilanterol or any other ingredients of REVINTY (listed in section 6).

If you think either of these applies to you, don’t use REVINTY until you have checked with your doctor.

Warnings and precautions:

Talk to your doctor before you use REVINTY:

• if you have liver disease, as you may be more likely to have side effects. If you have moderate or severe liver disease, your doctor will limit your dose to the lower strength of REVINTY ELLIPTA (100/25 μg once daily)
• if you have heart problems or high blood pressure
• if you have an overactive thyroid
• if you have ever been told you have diabetes or high blood sugar.
• if you have low blood potassium levels, as treatment with REVINTY can make this condition worse
• if you are taking medicines called beta-blocking medicines (such as atenolol or propranolol)
• if you have a serious lung infection e.g. tuberculosis (TB) or pneumonia.

Check with your doctor before you use REVINTY if you think any of these apply to you. If your breathing or wheezing gets worse straight after using REVINTY, stop using it, and get medical help immediately.

While you are using REVINTY contact your doctor if:

• you experience blurred vision or other visual disturbances
• you experience increased thirst, frequent urination or unexplained tiredness (signs of high blood sugar).

Children and adolescents:

Do not give REVINTY to children under the age of 12 years for the treatment of asthma, or in children and adolescents of any age for the treatment of COPD.

Other medicines and REVINTY:

Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicine.) Some medicines may affect how REVINTY works, or make it more likely that you’ll have side effects. These include:

• ketoconazole, to treat fungal infections
• ritonavir, to treat HIV infections
• beta-blocking medicines (such as atenolol or propranolol, used to treat heart disease).

Tell your doctor or pharmacist if you are taking this medicine.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before you start using REVINTY.

Pregnancy: You should not use REVINTY when pregnant.

Breastfeeding: You should not use REVINTY when breastfeeding.

Driving and using machines:

It is unlikely that REVINTY will affect your ability to drive or use machines. However, do not drive or use machinery if you do not feel well.

REVINTY contains lactose monohydrate: If you are known with the rare hereditary conditions of lactose/fructose or galactose intolerance you should not use REVINTY.

Always use REVINTY exactly as your doctor has told you to. Check with your doctor, nurse or pharmacist if you’re not sure. The usual dose of REVINTY for asthma and COPD is one inhalation of REVINTY 100/25 μg once daily at the same time each day. If you have severe asthma, your doctor may decide that you should use one inhalation of the higher strength of REVINTY inhaler. This dose is also used once daily at the same time each day. It is very important that you use REVINTY every day, as instructed by your doctor. REVINTY should not be used to relieve a sudden attack of breathlessness or wheezing. If you get this sort of attack you must use a quick-acting inhaler (such as salbutamol). If you feel you are getting breathless or wheezy more often than normal, or if you are using your quick-acting inhaler more than usual, see your doctor.

How to use the inhaler:

When you first use the Ellipta inhaler you do not need to check that it is working properly. It is ready for use straight away, and you do not need to prepare it for use in any special way. Just follow these step-by-step instructions. The inhaler is packaged in a tray. Do not open the tray until you are ready to inhale a dose of your medicine. When you are ready to use your inhaler, peel back the lid to open the tray. The tray contains a desiccant sachet, to reduce moisture. Throw this desiccant sachet away — don’t open, eat or inhale it. When you take the inhaler out of its box, it will be in the ‘closed’ position. Don’t open the inhaler until you are ready to inhale a dose of medicine. Write the “Discard by” date on the inhaler label in the space provided. The “Discard by” date is 6 weeks from the date you first open the tray. After this date, the inhaler should no longer be used.

Read this before you start: If you open and close the cover without inhaling the medicine, you will lose the dose. The lost dose will be securely held inside the inhaler, but it will no longer be available. It is not possible to accidentally take extra medicine or a double dose in one inhalation.

Prepare a dose:

Wait to open the cover until you are ready to take your dose. Do not shake the inhaler.

• Slide the cover down until you hear a “click”.

Your medicine is now ready to be inhaled. The dose counter counts down by 1 to confirm.

• If the dose counter does not count down as you hear the “click”, the inhaler will not deliver medicine. Take it back to your pharmacist for advice.
• Do not shake the inhaler at any time.

Inhale your medication:

• While holding the inhaler away from your mouth, breathe out as far as is comfortable. Don’t breathe out into the inhaler.
• Put the mouthpiece between your lips, and close your lips firmly around it. Don’t block the air vent with your fingers.
• Take one long, steady, deep breath in. Hold this breath for as long as possible (at least 3-4 seconds).
• Remove the inhaler from your mouth.
• Breathe out slowly and gently. You may not be able to taste or feel the medicine, even when you are using the inhaler correctly.

If you want to clean the mouthpiece, use a dry tissue, before you close the cover:

• Close the inhaler and rinse your mouth:

• Slide the cover upwards as far as it will go, to cover the mouthpiece.
• Rinse your mouth with water after you have used the inhaler if possible. This will make it less likely that you will develop a sore mouth or throat as side effects.

If you use too much REVINTY:

If you accidentally use a larger dose of REVINTY than your doctor has instructed, talk to your doctor or pharmacist. You may notice that your heart is beating faster than usual, you feel shaky or have a headache. If you have used larger doses than instructed for a long period of time, it is particularly important that you ask your doctor or pharmacist for advice. This is because larger doses of REVINTY may reduce the amount of steroid hormones produced naturally by your body.

If you forget to use REVINTY:

Don't take an extra dose to make up for a missed dose. Just take your next dose at the usual time. If you become wheezy or breathless, or develop any other symptoms of an asthma attack, use your quick-acting inhaler (e.g. salbutamol), then seek medical advice. Don’t stop REVINTY without advice:

Use REVINTY for as long as your doctor recommends. It will only be effective as long as you are using it. Don’t stop unless your doctor advises you to, even if you feel better.

REVINTY can have side effects. Not all side effects reported for REVINTY are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using REVINTY, please consult your doctor, pharmacist or other health care provider for advice.

Allergic reactions:

If any of the following happens, stop using REVINTY and tell your doctor immediately or go to the casualty department at your nearest hospital:

• skin rash (hives) or redness
• swelling, sometimes of the face or mouth (angioedema)
• becoming more wheezy, coughing or having difficulty in breathing
• suddenly feeling weak or lightheaded (may lead to collapse or loss of consciousness).

These are all very serious side effects. If you have them, you may have had a serious reaction to REVINTY. You may need urgent medical attention or hospitalisation.

Immediate breathing difficulties:

If your breathing or wheezing gets worse shortly after you inhaled REVINTY, stop using it immediately, and contact your doctor as soon as possible.

Infection of the lungs:

Tell your doctor if you have any of the following while taking REVINTY – they could be symptoms of a lung infection:

• fever or chills
• increased sputum production, change in sputum colour
• increased cough or increased breathing difficulties.

Frequent side effects include:

• headache
• common cold
• sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis). Rinsing your mouth out with water immediately after using REVINTY may help prevent this side effect developing
• infection of the lungs (pneumonia)
• inflammation of the airways of the lungs (bronchitis)
• infection of the nose sinuses or throat
• flu (influenza)
• pain and irritation in the back of the mouth and throat
• inflammation of the sinuses
• itchy, runny or blocked nose
• cough
• voice disorders, including hoarseness due to sores in the throat
• abdominal pain (stomach pain)
• joint pain
• back pain
• weakening of the bones, leading to fractures.
• high temperature (fever)
• muscle spasms.

Less frequent side effects include:

• heart palpitations
• heart beating faster (tachycardia)
• awareness of heartbeat (palpitations)
• increase in blood sugar (hyperglycaemia)
• anxiety
• tremor.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects:

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of REVINTY ELLIPTA.

Store at or below 25 °C. Following removal from the tray, the product may be stored for a maximum period of 6 weeks when stored at or below 25 °C. Write the date the inhaler should be discarded on the label in the space provided. The date should be added as soon as the inhaler has been removed from the tray. If stored in the refrigerator, allow the inhaler to return to room temperature for at least an hour before use. Store all medicines out of reach of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).