Salmeterol and fluticasone Mebel

Patient Information Leaflet: Information for the User

Salmeterol and Fluticasone Mebel 25 micrograms/50 micrograms per dose, pressurised suspension for inhalation
Salmeterol and Fluticasone Mebel 25 micrograms/125 micrograms per dose, pressurised suspension for inhalation
Salmeterol and Fluticasone Mebel 25 micrograms/250 micrograms per dose, pressurised suspension for inhalation
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 give it to other people, even if they have the same symptoms as yours, because it could be harmful to them.
• 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 Salmeterol and Fluticasone Mebel is and what it is used for
2. What you need to know before using Salmeterol and Fluticasone Mebel
3. How to use Salmeterol and Fluticasone Mebel
4. Possible side effects
5. How to store Salmeterol and Fluticasone Mebel
6. Contents of the pack and other information

1. What Salmeterol and Fluticasone Mebel is and what it is used for

Salmeterol and Fluticasone Mebel contains two active substances: salmeterol (as xinafoate) and fluticasone propionate.

• Salmeterol is a long-acting bronchodilator. Bronchodilators help keep the airways in the lungs open. This allows air to move 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 you prevent breathing problems such as asthma.
You must use Salmeterol and Fluticasone Mebel every day as prescribed by your doctor. This ensures that the medicine works properly to control your asthma.
Salmeterol and Fluticasone Mebel helps prevent the onset of breathlessness and wheezing. However, it must not be used to treat a sudden attack of breathlessness or wheezing. If this happens, you must use your fast-acting “reliever” (or “rescue”) inhaler, such as salbutamol. You must always carry your fast-acting “rescue” inhaler with you.

2. What you need to know before using Salmeterolo and Fluticasone Mebel

Do not use Salmeterolo and Fluticasone Mebel:

• If you are allergic (hypersensitive) to salmeterol, fluticasone propionate, or to the other component norflurane (HFA 134a).

Warnings and precautions
Talk to your doctor or pharmacist before using Salmeterolo and Fluticasone Mebel if you have:

• Heart disease, including irregular or rapid heartbeat;
• Overactive thyroid gland;
• High blood pressure;
• Diabetes mellitus (Salmeterolo and Fluticasone Mebel may increase blood sugar levels);
• Low potassium levels 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 Salmeterolo and Fluticasone Mebel
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This includes medicines for asthma or any other medicine obtained without a prescription. This is because it may not be appropriate to take Salmeterolo and Fluticasone Mebel together with other medicines.
Before starting to use Salmeterolo and Fluticasone Mebel, 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 to treat 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 your body. This may increase the risk of experiencing side effects with Salmeterolo and Fluticasone Mebel, including irregular heartbeat, or may worsen side effects. Your doctor may need to monitor you closely if you are taking these medicines.
• Corticosteroids (taken orally or by injection). If you have recently taken any of these medicines, this may increase the risk that this medicine interferes with adrenal gland function.
• 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, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
It is unlikely that Salmeterolo and Fluticasone Mebel will affect your ability to drive or operate machinery.
For those engaged in sports
Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use Salmeterol and Fluticasone Mebel

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

• Use Salmeterol and Fluticasone Mebel 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 your medicine or reduce the dosage without first consulting your doctor.
• This medicine must be inhaled into the lungs through the mouth.
• While using your medicine, always keep track of the number of doses used. The inhaler is designed to deliver 120 doses. However, it is not possible to determine when the inhaler is empty or when it has delivered 120 sprays. There may still be a small amount of liquid remaining in the container. Make sure the inhaler is replaced after 120 sprays have been delivered, so that you can be sure to receive the correct amount of medicine with each dose.

Adults and adolescents aged 12 years and older

• Salmeterol and Fluticasone Mebel 25/50 – 2 inhalations twice daily
• Salmeterol and Fluticasone Mebel 25/125 – 2 inhalations twice daily
• Salmeterol and Fluticasone Mebel 25/250 – 2 inhalations twice daily

Children aged between 4 and 12 years

• Salmeterol and Fluticasone Mebel 25/50 – 2 inhalations twice daily
• Salmeterol and Fluticasone Mebel is not recommended for use in children under 4 years of age.

Symptoms may be well controlled by using Salmeterol and Fluticasone Mebel 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 often you should take the medicine.
While using Salmeterol and Fluticasone Mebel for asthma, your doctor will regularly monitor your symptoms.
However, if your asthma or breathing worsens, inform your doctor immediately. You may notice that your breathing becomes more laboured, that you experience chest tightness more frequently, or that you need to use your "reliever" medicine (fast-acting) more often. If any of these conditions occur, you must continue using Salmeterol and Fluticasone Mebel but must 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 Salmeterol and Fluticasone Mebel may mean that it will not treat your asthma as effectively as it should.
• The medicine is contained in a pressurised canister placed in a plastic holder with a mouthpiece.
• A new inhaler contains enough medicine to deliver at least 120 doses. After 120 sprays, the inhaler may no longer contain sufficient medicine to deliver a complete dose.

Checking that the inhaler works

1. Before using the inhaler for the first time, you must check that it works. 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 properly, shake it well, point the mouthpiece away from you, and press down firmly on the canister to release one spray into the air. Repeat this step, shaking the inhaler again before releasing a second spray into the air. The total number of sprays released into the air before using the inhaler must be two.

3. After these first two test sprays, you may begin using your inhaler.

4. If you have not used your inhaler for one week or more, it must be tested. To test the inhaler, shake it well, point the mouthpiece away from you, and press down firmly on the canister to release two sprays into the air.

Warnings
If the inhaler becomes very cold (below 0°C), remove the metal pressurised 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 it and before use, press down firmly on the pressurised canister to release two sprays into the air.
Reordering
Before your inhaler runs out of medicine, you should reorder a new inhaler to ensure you do not run out of medicine.
Using the inhaler
It is important to start 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 deposited particles.
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 fully 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. Immediately after starting to inhale, press firmly on the top of the pressurized canister to release one puff of medicine. Do this while still inhaling steadily and deeply (Figure D).
8. Hold your breath, remove the inhaler from your mouth and your finger from the top of the inhaler. Continue holding your breath for a few seconds, or as long as possible.
9. Wait approximately half a minute between taking one puff of medicine 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 candidiasis 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 inhale as slowly as possible just before using the inhaler. For the first few times, use your inhaler while standing in front of a mirror. If you see a "mist" coming from the top of your inhaler or from the sides of your mouth, go back to step 4 and start again.

As with all inhalers, caregivers of children must ensure that those prescribed Salmeterolo and Fluticasone Mebel 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 your inhaler. Your doctor, nurse, pharmacist, or other 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 your inhaler, you do not stop using the spacer without first discussing it with your doctor or nurse. Other spacer devices are not recommended for use with Salmeterolo and Fluticasone Mebel, and you should not switch from the AeroChamber Plus® device to another. It is also important that you do not change or stop using the spacer without discussing it with your doctor, who will advise you on how to modify your therapy. Always talk to your doctor before making any changes to your asthma treatment.

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 underneath the base, below 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.
• Do not under any circumstances remove the pressurized canister from the plastic inhaler.
• Clean the outside and inside of the mouthpiece and the plastic casing with a dry cloth or tissue.
• Replace the protective cap on the mouthpiece. When correctly positioned, it will make a "click" sound when it reaches the correct position.
• Do not use excessive force.
• Do not wash or immerse any part of the inhaler in water.

If you use more Salmeterolo and Fluticasone Mebel than you should
It is important to use the inhaler as instructed. If you have accidentally taken more than the recommended dose, consult your doctor or pharmacist. You may notice that your heart beats 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 prolonged period, speak with your doctor or pharmacist for advice. This is because higher doses of Salmeterolo and Fluticasone Mebel may reduce the amount of steroid hormones produced by the adrenal gland.

If you forget to use Salmeterolo and Fluticasone Mebel
Do not take a double dose to make up for a missed dose. Take only the next dose at the usual time.

If you stop treatment with Salmeterolo and Fluticasone Mebel
It is very important that you take your medicine every day as prescribed. Continue taking it until your doctor tells you to stop. Do not stop taking it or suddenly reduce the dose. This could worsen your breathing.
In addition, if you suddenly stop taking this medicine or reduce the dose, this could (very rarely) cause problems with the adrenal gland (adrenal insufficiency), which sometimes may lead to adverse effects.
These adverse 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 adverse effects listed above may occur.
If any of these adverse effects occur, consult your doctor or pharmacist. To prevent these symptoms from occurring, your doctor may prescribe additional doses of oral corticosteroid tablets (such as prednisolone).

If you have any questions about the use of this medicine, consult your doctor, nurse, or pharmacist.

4. Possible side effects

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

Allergic reactions: You may notice that your breathing suddenly worsens after taking Salmeterolo and
Fluticasone Mebel. You may experience wheezing and coughing or develop shortness of breath.
You may also notice itching, skin rash (urticaria), or swelling (usually of the face, lips, tongue or throat),
or you may suddenly feel that your heart is beating very fast or feel weak and dizzy (which may cause
you to collapse or lose consciousness). If you experience any of these effects, or if they occur suddenly
after using this medicine, stop using it immediately and contact your doctor without delay.
Allergic reactions to salmeterol and fluticasone are uncommon (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 number of colds has been reported.

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

• Oral thrush (raised, painful, cream-coloured patches) in the mouth and throat. Also sore tongue, hoarse voice, and throat irritation. Rinsing your mouth with water and spitting it out immediately and/or brushing your teeth after each dose of medicine may help. Your doctor may prescribe an antifungal medicine to treat the thrush.
• Joint pain, joint swelling, 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 (you may experience irregular heartbeat, muscle weakness, or 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 may be required and your anti-diabetic therapy may need adjustment.
• Cataract (clouding of the eye's lens).
• Very fast heartbeat (tachycardia).
• Shaking sensation (tremor) and fast or irregular heartbeat (palpitations) – these side effects are generally 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 Salmeterolo and Fluticasone Mebel. If this occurs, stop using the Salmeterolo and Fluticasone Mebel inhaler immediately. Use your fast-acting "rescue" medicine to help your breathing and contact your doctor immediately.
• This medicine may affect the normal production of steroid hormones in the body, particularly if taken at high doses for a prolonged period. Effects may include: slowed growth in children and adolescents, thinning of the bones, glaucoma, weight gain, or a rounded (moon-shaped) face (Cushing's syndrome).

Your doctor will monitor you regularly to check for any of these side effects and will ensure you are
taking the lowest effective dose of Salmeterolo and Fluticasone Mebel 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 Salmeterolo and Fluticasone Mebel unless your doctor tells you to.
• Fungal infection of the oesophagus (gullet), which may cause difficulty 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, talk to 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 Salmeterol and Fluticasone Mebel

• 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 refrigerate or freeze.
• After use, firmly replace the mouthpiece cap and snap it into place. Do not use excessive force.
• The pressurized metal container holds a pressurized liquid. Do not expose it to temperatures above 50°C and protect it from direct sunlight. Do not pierce, break, or burn the container, even if it appears to be empty.
• As with most inhaled medicines in pressurized containers, the therapeutic effect of this medicine may decrease when the pressurized container is cold.

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

6. Pack contents and other information

What Salmeterolo e Fluticasone Mebel contains
Each metered dose (from the valve) 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).
This medicinal product contains fluorinated greenhouse gases.
Each 120-dose inhaler contains 11.2 g of HFA-134a, equivalent to 0.016 tonnes of
CO2 equivalent (global warming potential GWP = 1,430)

Description of the appearance of Salmeterolo e Fluticasone Mebel and pack contents

• Salmeterolo e Fluticasone Mebel is supplied in a metered dose inhaler which releases the medicine as a pressurized suspension ready for inhalation through the mouth into the lungs.
• The pressurized container holds a homogeneous inhalation suspension.
• The pressurized container is placed in a dispenser made of polypropylene equipped with a mouthpiece and a protective dust cap made of polypropylene in lilac colour. The pressurized container is placed in a dispenser made of polypropylene equipped with a mouthpiece and a protective dust cap made of polypropylene in purple colour. The pressurized container is placed in a dispenser made of polypropylene equipped with a mouthpiece and a protective dust cap made of polypropylene in violet colour.
• Each pack contains 1 inhaler. Each inhaler contains 120 actuations.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Mebel S.r.l., Via Cavour 107, 37062 Villafranca di Verona, Italy
Manufacturer
Genetic S.p.A. Contrada Canfora, Fisciano 84084, Salerno, Italy

This medicinal product is authorised in the European Economic Area countries under the
following names:
Slovenia: Salmeterol/flutikazon Mebel
Italy: Salmeterolo e Fluticasone Mebel
Cyprus: Salmeterol/Fluticasone Genetic
Greece: SALMETEROL+FLUTICASONE/BENNETT

This Patient Information Leaflet was last revised in 04/2026