Prospect: information for the user

Fluticasona Aldo-Unión 1 mg/ml suspension for inhalation by nebulizer

Fluticasone propionate

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Fluticasona Aldo-Unión 1 mg/ml and for what it is used

2. What you need to know before starting to use Fluticasona Aldo-Unión 1 mg/ml

3. How to use Fluticasona Aldo-Unión 1 mg/ml

4. Possible adverse effects

5. Storage of Fluticasona Aldo-Unión 1 mg/ml

6. Contents of the package and additional information

This medication contains the active ingredient fluticasone propionate, which belongs to a group of medications called corticosteroids, and is used by inhalation as an anti-asthmatic (for the treatment of asthma, a disease characterized by a reversible obstruction of the lower respiratory tracts).

Fluticasone propionate reduces swelling and inflammation of the lungs (anti-inflammatory action).

This medication is indicated for the prevention of severe chronic asthma in adults and adolescents over 16 years old who need inhaled treatment at high doses or with oral corticosteroids.

No use Fluticasona Aldo-Unión 1 mg/ml

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fluticasona Aldo-Unión 1 mg/ml.

Especially, consult your doctor if:

• You have active or latent tuberculosis (a contagious bacterial disease).

• You are diabetic.

• You suffer from a respiratory disease called Chronic Obstructive Pulmonary Disease (COPD).

• You are switching from oral steroid treatment to inhaled fluticasone treatment. In this case, your doctor will need to monitor you closely, regularly check your adrenal function, and gradually discontinue oral treatment after introducing inhaled treatment. For this reason, it is recommended that you carry a warning card indicating that you may need additional corticosteroid treatment during periods of stress.

If you need to use your reliever medication more often to control your asthma symptoms, it may be a sign that your asthma is not being well controlled and you should consult your doctor to consider changing your treatment.

Be aware that a sudden worsening of asthma can be life-threatening.

It is essential to use the dose prescribed by your doctor. Do not increase or decrease the dose without consulting your doctor. Do not stop using propionate fluticasone abruptly.

When inhaled corticosteroids (such as fluticasone propionate) are used, especially at high doses for prolonged periods, systemic effects (affecting the whole body) may occur. The likelihood of experiencing these effects is lower than with oral corticosteroids.

The possible systemic effects include Cushing's syndrome (a condition characterized by excessive levels of glucocorticoids in the blood, leading to obesity, lack of facial expression, red skin, extensive striae, and dense facial hair), cushingoid appearance, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts (opacity of the lens in the eye), glaucoma (a severe eye disease), and, less commonly, a range of psychological or behavioral effects, including hyperactivity, sleep disturbances, anxiety, depression, or aggression (especially in children) (see section 4). Therefore, it is essential to use the lowest possible dose of inhaled corticosteroid to maintain effective asthma control.

Inform your doctor if you experience blurred vision or other visual disturbances.

Switching from systemic corticosteroids to inhaled corticosteroids may trigger an allergic reaction.

If you experience difficulty breathing (bronchospasm with increased dyspnea) after using Fluticasona Aldo-Unión 1 mg/ml, stop taking the medication and consult your doctor immediately.

This medication is not suitable for use as the sole treatment for acute bronchospasm symptoms and does not replace emergency treatment involving oral or intravenous corticosteroids.

Children and adolescents

Fluticasona Aldo-Unión 1 mg/ml should be used with caution in children.

Regularly monitor the height of children receiving prolonged treatment with inhaled corticosteroids.

Rare cases of acute adrenal insufficiency have been reported in children exposed to higher-than-recommended doses (approximately 1 mg per day) for prolonged periods (several months or years).

Using Fluticasona Aldo-Unión 1 mg/ml with other medicines

Inform your doctor if you are taking or have recently taken other medicines, including those obtained without a prescription.

Particularly, inform your doctor or pharmacist if you are using any of the following medicines:

• ritonavir, a type of antiviral medication known as a "protease inhibitor",

• ketoconazole, a medication used to treat fungal infections.

Some medicines may increase the effects of Fluticasona Aldo-Unión 1 mg/ml, and your doctor will perform close monitoring if you are taking these medicines (including some HIV medications: ritonavir, cobicistat).

Using Fluticasona Aldo-Unión 1 mg/ml with food and drinks

This medication can be used at any time of the day, with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

It is unlikely that this medication will affect your ability to drive or operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Use of this medication

•Do not inject or ingest the liquid contained in each plastic ampoule. Use Fluticasona Aldo-Unión 1 mg/ml only through an aerosol generated by a nebulizer. Do not use this medication with ultrasonic nebulizers

•The liquid is introduced into the nebulizer and this produces a mist that is inhaled through a mouthpiece or a face mask for inhalation.

•Do not allow the liquid or the mist produced by the nebulizer to come into contact with the eyes.You can wear normal or safety glasses to protect your eyes.

•The use of a mouthpiece prevents the medication from affecting the face, which can occur if a mask is used for extended periods of time. If you prefer to use a mask, or if you are using a mask for your child, you must protect the skin of the face with a cream or wash your face well after treatment. If you use a mask, nasal inhalation may occur.

•Use the nebulizer in a well-ventilated room, as the mist released into the air could also be breathed in by others.

A complete ampoule of this medication (2 ml) provides a dose of 2 mg of fluticasone propionate.Each ampoule has a mark indicating half of its content (1 ml).

Patients should be treated with an initial dose of fluticasone propionate for nebulization appropriate for the severity of their disease.

Your doctor will prescribe the appropriate dosing regimen for this medication after evaluating the severity of your asthma and your individual response. Your doctor may gradually reduce the dose if your respiratory function stabilizes.

Adults and adolescents over 16 years old

For preventive treatment, the medication should be taken regularly even if you do not have symptoms.

The usual initial recommended dose is 0.25 mg of fluticasone propionate twice a day. Depending on your individual response, the dose may be increased (0.5-2 mg of fluticasone propionate twice a day) to achieve control of asthma, or reduced to the minimum effective maintenance dose.

Children and adolescents under 16 years old

The safety and efficacy of Fluticasona Aldo-Unión 1 mg/ml suspension for inhalation by nebulizer have not been established in children and adolescents under 16 years old.Current clinical data do not allow for adequate dosing recommendations in this patient population.

If you are using high doses of an inhaled steroid for a long period of time, you may need to use additional doses of steroids, for example in stressful situations, such as a car accident or before surgery. Your doctor may decide to prescribe a steroid supplement during that period.

Patients who have been treated with high doses of steroids, such as Fluticasona Aldo-Unión 1 mg/ml, for a long period of time, should not stop taking the medication abruptly and without informing their doctor.The sudden discontinuation of treatment may cause discomfort and symptoms such as vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar (hypoglycemia), and weight changes.

Instructions for use

1.The ampoule is supplied wrapped. Do not open the ampoule until you need it.

2.Make sure the content of the ampoule is well mixed before using it. Hold the ampoule in a horizontal position, secured by the lower end, gently tap the opposite end several times, and shake it. Repeat this procedure several times until all the content of the ampoule is completely mixed.

To open the ampoule, twist the top part firmly.

3.Introduce the suspension into the nebulizer following the product instructions for using the nebulizer.

Dilution of the suspension:

Do not dilute the content of the suspension unless your doctor tells you to

•If your doctor has told you to dilute the solution, pour the content of the ampoule into the nebulizer container

•Add the amount of physiological saline for injection that your doctor has indicated to use.

•Place the lid on the nebulizer container and gently shake it to mix the content.

After use:

•Use a new ampoule for each dose. Open a new one only when you are ready to use it. Dispose of any remaining liquid. Do not save it for reuse.

•Dispose of any remaining solution in the nebulizer container.

•Clean the nebulizer as recommended.

It is recommended to administer with a mouthpiece.

If a face mask is used for inhalation, wash your face well after treatment.

If you use more Fluticasona Aldo-Unión 1 mg/ml than you should

It is essential that you take your dose as indicated by your doctor. Do not increase or decrease your dose without medical supervision.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 915620420, indicating the medication and the amount ingested.

Acute inhalation of Fluticasona Aldo-Unión 1 mg/ml in doses higher than recommended may cause temporary suppression of adrenal function (see section 2). No emergency intervention is necessary if adrenal function returns to normal in a few days.

However, if high doses are used for extended periods, a certain degree of adrenal insufficiency may occur. Your doctor may request that you undergo tests to check the function of the adrenal gland.

If you forget to use Fluticasona Aldo-Unión 1 mg/ml

• Take the next dose when due.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Fluticasona Aldo-Unión 1 mg/ml

• Do not interrupt treatmenteven if you feel better, unless your doctor tells you to. In that case, do not stop Fluticasona Aldo-Unión 1 mg/ml abruptly.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Stop using the medication and contact your doctor immediately if any of the following symptoms appear after using Fluticasona Aldo-Union 1 mg/ml:

•allergic reactions characterized by:

• skin eruptions (cutaneous hypersensitivity);
• swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing (angioedema)

•difficulty breathing (dyspnea and/or bronchospasm, paradoxical bronchospasm)

Other side effects are:

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

•oral and throat candidiasis (painful yellowish-white plaques)

Common(may affect up to 1 in 10 people)

•cardinal signs

•hoarse voice (hoarseness).

Oral and throat problems can be reduced by taking specific measures, such as brushing your teeth or rinsing your mouth with water immediately after inhaling the dose.

•pneumonia (pulmonary infection) in patients with chronic obstructive pulmonary disease (COPD).

Very rare(may affect up to 1 in 10,000 people)

•esophageal phloxine (candidiasis);

•Cushing's syndrome, a disorder characterized by an excess of steroid hormones in the bloodstream, which manifests with a rounded facial appearance;

•growth retardation;

•bone thinning (decreased bone mineral density);

•eye problems such as cataracts (opacity of the lens) and glaucoma (increased intraocular pressure);

•adrenal gland effects (a small gland located next to the kidney);

•hyperglycemia;

•anaphylactic reactions.

Unknown frequency(cannot be estimated from available data):

Changes in sleep, depression or feeling of concern, restlessness, nervousness, excitability, or irritability (these effects are more likely to occur in children) and blurred vision.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions. Store the medication in an upright position, as shown in the packaging, within the packaging and the box.

Do not use this medication after the expiration date that appears on the packaging after «CAD». The expiration date is the last day of the month indicated.

Once the aluminum packaging is opened, the containers should be protected from light and used within a period of 1 month. Do not store above 25°C.

Opened containers should be stored in the refrigerator (at 5°C ±3°C) and used within a period of 24 hours from opening. Do not freeze.

Medications should not be disposed of through the drains or in the trash. Deposit the containers and medications that you do not need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications that you do not need.This will help protect the environment.

Composition of Fluticasona Aldo-Unión 1 mg/ml

•The active ingredient is fluticasone propionate.

•The other components are polysorbate 20, sorbitan monolaurate, sodium dihydrogen phosphate dihydrate, sodium phosphate dibasic anhydrous, sodium chloride, and water for injectable preparations.

Appearance of the product and contents of the packaging

•Fluticasona Aldo-Unión 1 mg/ml is presented in strips of 5 ampoules in an aluminum wrapper. They are packaged in boxes containing 20 ampoules of 2 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio Aldo-Unión, S.L.

Calle Baronesa de Maldá 73

08950 Esplugues de Llobregat (Barcelona)

Spain

Responsible for manufacturing

Genetic S.p.A

Contrada Canfora

84084 Fisciano (SA)

Last review date of this leaflet:August2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/