Brionex

Package leaflet: Information for the user

Brionex 25 micrograms/50 micrograms per dose pressurised inhalation suspension, 25 micrograms/125 micrograms per dose pressurised inhalation suspension, 25 micrograms/250 micrograms per dose pressurised inhalation suspension

salmeterol/fluticasone propionate
Generic medicine
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Brionex is and what it is used for
2. What you need to know before using Brionex
3. How to use Brionex
4. Possible side effects
5. How to store Brionex
6. Contents of the pack and other information

1. What Brionex is and what it is used for

Brionex contains two active substances: salmeterol and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways in the lungs open. This allows air to flow in and out more easily. The effects last for at least 12 hours.
• Fluticasone propionate is a corticosteroid that reduces swelling and irritation in the lungs.

Your doctor has prescribed this medicine to help prevent breathing problems such as asthma.
You must use Brionex every day as prescribed by your doctor. This ensures that the medicine works properly to control your asthma.
Brionex helps prevent the onset of breathlessness and wheezing. However, Brionex must not be used to treat a sudden attack of breathlessness or wheezing. If this occurs, you must use your fast-acting "reliever" (or "rescue") inhaler, such as salbutamol. You must always have your fast-acting "rescue" inhaler with you.

2. What you need to know before using Brionex

Do not use Brionex:

• If you are allergic to salmeterol, fluticasone propionate, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Brionex if you have:

• heart disease, including irregular or fast heartbeat;
• overactive thyroid gland;
• high blood pressure;
• diabetes mellitus (Brionex may increase blood sugar levels);
• low levels of potassium in the blood;
• tuberculosis (TB), currently or in the past, or other lung infections.

Contact your doctor if you experience blurred vision or other visual disturbances.
Other medicines and Brionex
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including medicines for asthma or any other medicines obtained without a prescription.
This is because it may not be appropriate to take Brionex together with other medicines.
Before starting to use Brionex, inform your doctor if you are taking the following medicines:

• Beta-blockers (such as atenolol, propranolol, and sotalol). Beta-blockers are mainly used to treat high blood pressure or other heart conditions.
• Medicines for treating infections (such as ketoconazole, itraconazole, and erythromycin), including some medicines used to treat HIV (such as ritonavir and medicines containing cobicistat). Some of these medicines may increase the amount of fluticasone propionate or salmeterol in the body. This may increase the risk of experiencing side effects with Brionex, including irregular heartbeat, or may worsen side effects. Your doctor may wish to monitor you closely if you are taking these medicines.
• Corticosteroids (taken by mouth or by injection). If you have recently taken one of these medicines, this may increase the risk that this medicine interferes with the adrenal gland.
• Diuretics, also known as "water pills", used to treat high blood pressure.
• Other bronchodilators (such as salbutamol).
• Xanthine-based medicines. These are often used to treat asthma.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
It is unlikely that Brionex will affect your ability to drive or operate machinery.
For athletes
Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to use Brionex

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.

• Take Brionex every day until your doctor tells you to stop treatment. Do not exceed the recommended dose. If you have any doubts, consult your doctor or pharmacist.
• Do not stop using Brionex, and do not reduce the dose of Brionex without first consulting your doctor.
• Brionex must be inhaled into the lungs through the mouth.
• Always keep track of the number of doses used. The inhaler is designed to deliver 120 actuations. However, it is not possible to determine when the inhaler is empty or when it has delivered 120 actuations. There may still be a small amount of liquid remaining in the container. Make sure the inhaler is replaced after 120 actuations have been delivered, to ensure you receive the correct amount of medicine with each dose.

Adults and adolescents aged 12 years and older

• Brionex 25/50 - 2 inhalations twice daily
• Brionex 25/125 - 2 inhalations twice daily
• Brionex 25/250 - 2 inhalations twice daily

Children aged 4 to 12 years

• Brionex 25/50 - 2 inhalations twice daily
• Brionex is not recommended for use in children under 4 years of age.

Symptoms may be well controlled by using Brionex twice daily. If this occurs, your doctor
may decide to reduce the dose to once daily. The dose may be adjusted as follows:

• once daily in the evening – if you have night-time symptoms
• once daily in the morning – if you have day-time symptoms

It is very important to follow your doctor's instructions regarding the number of inhalations and how
frequently to take the medicine.
If you are using Brionex for asthma, your doctor will regularly monitor your symptoms. If your asthma or
breathing worsens, inform your doctor immediately. You may notice your breathing becoming more
laboured, experience chest tightness more frequently, or need to use your fast-acting "rescue" medicine more often. If any of these conditions occur, continue taking Brionex but do not increase the number of doses you take. Your breathing condition could worsen and become particularly severe. Consult your doctor, as additional treatment may be necessary.

Instructions for use

• Your doctor, nurse, or pharmacist will show you how to use your inhaler. They should also check your inhaler technique at regular intervals. Incorrect or improper use of Brionex may mean it will not help control your asthma as it should.
• The medicine is contained in a pressurized canister fitted into a plastic holder with a mouthpiece.
• A new, full inhaler contains enough medicine to deliver at least 120 actuations. After 120 actuations, the inhaler may no longer contain sufficient medicine to deliver a complete dose.

Checking that the inhaler is working

1. When using the inhaler for the first time, check that it is working. To test the inhaler, remove the protective mouthpiece cap by gently pressing the sides with your thumb and index finger and pulling it off.
2. To ensure the inhaler works, shake it well, point the mouthpiece away from yourself, and press down on the canister to release one spray into the air. Repeat this step, shaking the inhaler before releasing a second spray into the air. The total number of actuations released into the air before using the inhaler must be two.
3. After these first two test actuations, you may begin using your inhaler.
4. If you have not used your inhaler for one week or more, or if the inhaler becomes very cold (below 0°C), release two sprays of medicine into the air.

Warnings
Never remove the metal canister from the inhaler at any time.
Only if the inhaler becomes very cold (below 0°C), remove the metal canister from the plastic holder and warm it in your hands for a few minutes before use. Never use anything else to warm it. After warming and before use, firmly press the canister to release two sprays into the air.

Using the inhaler
It is important to begin inhaling as slowly as possible just before using the inhaler.

1. Stand or sit upright when using your inhaler.
2. Remove the mouthpiece cap (Figure A).
3. Check inside and outside to ensure the mouthpiece is clean and free from dust or other deposits.
4. Shake the inhaler 4 or 5 times to ensure the contents are evenly mixed (Figure B).
5. Hold the inhaler upright with your thumb on the base, below the mouthpiece. Breathe out as much as possible (Figure C).
6. Place the mouthpiece in your mouth between your teeth. Close your lips around it. Do not bite the mouthpiece.
7. Breathe in slowly and deeply through your mouth. Just after starting to inhale, press firmly on the top of the canister to release one spray of medicine. Do this while still inhaling steadily and deeply (Figure D).
8. Hold your breath, remove the inhaler from your mouth, and remove your finger from the top of the inhaler. Continue holding your breath for a few seconds, or as long as possible.
9. Wait about half a minute between taking one spray and the next, then repeat steps 4 to 8.
10. Afterwards, rinse your mouth with water and spit it out and/or brush your teeth. This may help prevent the occurrence of oral thrush and hoarseness.
11. After use, always replace the mouthpiece cap to prevent dust from entering (Figure E). When the mouthpiece cap is correctly positioned, you will hear a click. Do not use excessive force.

Do not rush steps 5, 6, 7, and 8. It is important that you begin inhaling as slowly as possible just before using the inhaler. Use your inhaler in front of a mirror the first few times. If you see any product leaking, appearing as a "mist" from the top of your inhaler or from the sides of your mouth, restart from step 4.

As with all inhalers, caregivers of children must ensure that those prescribed Brionex use the correct inhalation technique as described above.

If you or your child finds it difficult to use the inhaler, your doctor or another healthcare professional may recommend using an AeroChamber Plus® spacer device with the inhaler. Your doctor, nurse, pharmacist, or another healthcare professional should show you how to use the spacer with the inhaler, how to care for the spacer, and answer any questions you may have. It is important that if you use a spacer with the inhaler, you do not stop using it without first discussing it with your doctor or nurse. Other spacer devices are not recommended for use with Brionex, and you must not switch from the AeroChamber Plus® device to another. It is also important that you do not change or stop using the spacer without talking to your doctor, who will advise you on how to modify your treatment. Always talk to your doctor before making any changes to your asthma treatment.

Older children or people with weak hands may find it easier to hold the inhaler with both hands. Place both index fingers on top of the inhaler and both thumbs on the bottom, under the mouthpiece.

Cleaning the inhaler
To prevent blockage of the inhaler, it is important to clean it at least once a week.
To clean the inhaler:

• Remove the mouthpiece cap.
• Never remove the metal canister from the plastic inhaler holder under any circumstances.
• Clean the outside and inside of the mouthpiece and the plastic holder with a dry cloth or tissue.
• Replace the protective cap on the mouthpiece. When correctly positioned, it will make a "click" sound as it reaches the correct position.
• Do not use excessive force.
• Do not place the metal canister in water.

If you use more Brionex than you should
It is important to use the inhaler as directed. If you accidentally take more than the recommended dose, consult your doctor or pharmacist. You may notice your heart beating faster than usual and feel tremors. You may also experience dizziness, headache, muscle weakness, and joint pain.
If you have taken higher doses for a long period of time, seek advice from your doctor or pharmacist. This is because higher doses of Brionex may reduce the amount of steroid hormones produced by the adrenal gland.

If you forget to use Brionex
Do not take a double dose to make up for a forgotten dose. Take only the next dose at the usual time.

If you stop treatment with Brionex
It is very important to take Brionex every day as prescribed. Continue taking it until your doctor tells you to stop. Do not stop taking it or suddenly reduce your dose of Brionex. This could worsen your breathing.
In addition, if you suddenly stop taking Brionex or reduce your dose, this could (very rarely) cause problems with the adrenal gland (adrenal insufficiency), which may sometimes lead to unwanted effects.

These unwanted effects may include any of the following:

• Stomach pain
• Tiredness and loss of appetite, feeling unwell
• Nausea and diarrhoea
• Weight loss
• Headache or drowsiness
• Low blood sugar levels
• Low blood pressure and seizures (fits)

When your body is under stress due to fever, trauma (such as after a car accident), infection, or surgery, adrenal insufficiency may worsen and one or more of the unwanted effects listed above may occur.
If any of these unwanted effects occur, consult your doctor or pharmacist. To prevent these symptoms from occurring, your doctor may prescribe additional doses of corticosteroid tablets (such as prednisolone).

If you have any doubts about how to use this medicine, consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. To reduce the likelihood of side effects occurring, your doctor will prescribe the lowest dose of Brionex needed to control your asthma.

Allergic reactions: You may notice that your breathing suddenly worsens after taking Brionex. You may experience wheezing and coughing or develop shortness of breath. You might also notice itching, skin rash (urticaria), or swelling (usually of the face, lips, tongue or throat), or you may suddenly feel your heart beating very fast, or feel weak and dizzy (which could lead to collapse or loss of consciousness). If you experience any of these symptoms, or if they occur suddenly after using Brionex, stop using Brionex immediately and contact your doctor without delay. Allergic reactions to Brionex are not common (affecting fewer than 1 in 100 people).

Other side effects are listed below:

Very common (may affect more than 1 in 10 people):

• Headache – which usually improves with continued treatment.
• In patients with Chronic Obstructive Pulmonary Disease (COPD), an increased frequency of colds has been reported.

Common (may affect up to 1 in 10 people):

• Oral or throat thrush (raised, painful, yellow-cream patches) in the mouth and throat. In addition, sore tongue, hoarseness, and throat irritation. Rinsing the mouth with water and spitting it out immediately and/or brushing teeth after each dose of medicine may help. Your doctor may prescribe an antifungal medicine to treat thrush.
• Joint pain, swelling of joints, and muscle pain.
• Muscle cramps.

The following side effects have also been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):

• Pneumonia and bronchitis (lung infection). Inform your doctor if you notice any of the following symptoms: increased sputum production, change in sputum colour, fever, chills, increased coughing, or worsening breathing problems.
• Bruising and fractures.
• Sinus inflammation (a feeling of pressure or fullness in the nose, cheeks, and behind the eyes, sometimes accompanied by throbbing pain).
• Decreased potassium levels in the blood (may cause irregular heartbeat, muscle weakness, cramps).

Uncommon (may affect up to 1 in 100 people):

• Increased blood sugar (glucose) levels (hyperglycaemia). If you have diabetes, more frequent blood glucose monitoring and possibly adjustment of your usual antidiabetic therapy may be required.
• Cataract (clouding of the eye's lens).
• Very fast heartbeat (tachycardia).
• Shaking sensation (tremor) and fast or irregular heartbeat (palpitations) – these side effects are usually harmless and tend to decrease with continued treatment.
• Chest pain.
• Feeling of anxiety (this effect occurs particularly in children).
• Disturbed sleep.
• Allergic skin rash.

Rare (may affect up to 1 in 1,000 people):

• Breathing difficulties or wheezing that worsens immediately after taking Brionex. If this occurs, stop using the Brionex inhaler immediately. Use your fast-acting "rescue" medicine to help with breathing and contact your doctor immediately.
• Brionex may affect the normal production of steroid hormones in the body, especially if taken at high doses for a prolonged period. Effects include:
  • Slowed growth in children and adolescents
  • Thinning of the bones
  • Glaucoma
  • Weight gain
  • Rounded (moon-shaped) face (Cushing's syndrome)

Your doctor will monitor you regularly for any of these side effects and will ensure you are taking the lowest effective dose of Brionex to control your asthma.

• Behavioural changes such as unusual hyperactivity and irritability (these effects occur mainly in children).
• Irregular heartbeat or extra heartbeats (arrhythmias). Inform your doctor, but do not stop taking Brionex unless your doctor tells you to.
• Fungal infection of the oesophagus (gullet), which may cause difficulty in swallowing.

Frequency not known (frequency cannot be estimated from the available data):

• Depression or aggression. These effects are more likely to occur in children.
• Blurred vision.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Brionex

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and packaging after EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• The container contains pressurized liquid. Do not expose to temperatures above 50°C. Protect the medicine from direct sunlight. Do not pierce, break, or burn the container, even if it appears to be empty.
• Do not use this medicine if you notice any visible signs of deterioration.
• As with most inhaled medicines in pressurized containers, the therapeutic effect of this medicine may decrease when the container is cold.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Brionex contains
The active substances are salmeterol and fluticasone propionate.
Each metered dose contains 25 micrograms of salmeterol (as salmeterol xinafoate) and 50, 125 or 250 micrograms of fluticasone propionate.
The other component is the propellant: norflurane (HFA 134a).

Description of Brionex and contents of the pack

• Brionex is available as a pressurized metered-dose inhaler delivering the medicine as a pressurized suspension ready for inhalation through the mouth into the lungs.
• The pressurized container holds a white, homogeneous suspension for inhalation.
• The container is placed in a plastic dispenser incorporating a mouthpiece and fitted with a dust-protective cap in lilac color.
• Alternatively, the container is placed in a plastic dispenser incorporating a mouthpiece and fitted with a dust-protective cap in purple color. Alternatively, the container is placed in a plastic dispenser incorporating a mouthpiece and fitted with a dust-protective cap in violet color.
• Each pack contains 1 inhaler. Each inhaler provides 120 doses.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
EBERLIFE FARMACEUTICI S.p.A., Via G. Porzio snc, 80143 Naples, Italy
Manufacturer:
Genetic S.p.A., Contrada Canfora, Fisciano 84084, Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Flusonide
Spain: Salmeterol/Fluticasona Genetic 25 microgramos/50 microgramos/inhalación, suspensión para inhalación en envase a presión.
Salmeterol/Fluticasona Genetic 25 microgramos/125 microgramos/inhalación, suspensión para inhalación en envase a presión.
Salmeterol/Fluticasona Genetic 25 microgramos/250 microgramos/inhalación, suspensión para inhalación en envase a presión.
Italy: Brionex
Greece: SALMETEROL + FLUTICASONE / Laboratorios Support Pharma

This Patient Information Leaflet was last reviewed in: January 2025