Fluticasone Aldo-Union 0.25 mg/ml suspension for nebulizer inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fluticasona Aldo-Unión 0.25 mg/ml inhalation suspension for nebuliser

Fluticasone propionate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Contents of the leaflet

1. What Fluticasona Aldo-Unión 0.25 mg/ml is and what it is used for
2. What you need to know before using Fluticasona Aldo-Unión 0.25 mg/ml
3. How to use Fluticasona Aldo-Unión 0.25 mg/ml
4. Possible side effects
5. How to store Fluticasona Aldo-Unión 0.25 mg/ml
6. Contents of the pack and other information

1. What Fluticasona Aldo-Unión 0.25 mg/ml is and what it is used for

This medicine contains the active substance fluticasone propionate, which belongs to a group of medicines called corticosteroids, and is used by inhalation as an anti-asthma agent (for the treatment of asthma, a disease characterized by reversible obstruction of the lower airways).

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

This medicine is indicated for:

• Prevention of severe chronic asthma in adults and adolescents over 16 years of age who require inhaled treatment with high doses or oral corticosteroids.
• Treatment of asthma exacerbation episodes in children and adolescents aged 4 to 16 years.

2. What you need to know before using Fluticasona Aldo-Unión 0.25 mg/ml

Do not use Fluticasona Aldo-Unión 0.25 mg/ml

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Fluticasona Aldo-Unión 0.25 mg/ml.

In particular, consult your doctor if:

• You have active or latent tuberculosis (a contagious disease caused by bacteria).
• You have diabetes.
• You suffer from a respiratory disease called Chronic Obstructive Pulmonary Disease (COPD).
• You are switching from oral steroid treatment to inhaled fluticasone. In this case, your doctor must monitor you closely, regularly check your adrenal function, and gradually discontinue the oral treatment after starting the inhaled therapy. For this reason, you are advised to carry an identification card indicating that you may require additional corticosteroid treatment during periods of stress.

Needing to use your symptom-relief medicines more frequently indicates worsening asthma control, and under such circumstances, you should consult your doctor to reassess your treatment. Please note that sudden worsening of asthma can be potentially life-threatening.

It is important that you use the dose prescribed by your doctor. Do not increase or reduce the dose without consulting your doctor. Do not stop treatment with fluticasone propionate abruptly.

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

Possible systemic effects include Cushing's syndrome (a condition characterized by excess glucocorticoids in the blood, causing obesity, facial puffiness, red-colored skin, extensive stretch marks, and excessive hair growth, especially on the face), Cushingoid appearance (typical of people with Cushing's syndrome), adrenal suppression (reduced function of the adrenal glands), growth retardation in children and adolescents, decreased bone mineral density, cataracts (clouding of the lens inside the eye), glaucoma (a serious eye disease), and, more rarely, a range of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (especially in children) (see section 4). Therefore, it is important that the dose of inhaled corticosteroid should be the lowest possible dose needed to maintain effective asthma control.

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

Switching from systemic corticosteroid therapy to inhaled corticosteroids may trigger an allergic condition.

If you experience breathing difficulties (bronchospasm with increased shortness of breath) after using Fluticasona Aldo-Unión 0.25 mg/ml, stop using the medicine and contact your doctor immediately.

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

Children and adolescents

Fluticasona Aldo-Unión 0.25 mg/ml should be used with caution in children.

Regular monitoring of height is recommended in children receiving long-term inhaled corticosteroid therapy.

Very rare cases of acute adrenal insufficiency have been reported in children exposed to higher than recommended doses (approximately 1 mg daily) over prolonged periods (several months or years).

Using Fluticasona Aldo-Unión 0.25 mg/ml with other medicines

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

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• ritonavir, an antiviral medicine known as a "protease inhibitor",
• ketoconazole, a medicine used to treat fungal infections.

Some medicines may increase the effects of Fluticasona Aldo-Unión 0.25 mg/ml, so your doctor will monitor you closely if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Using Fluticasona Aldo-Unión 0.25 mg/ml with food and drink

This medicine may be used at any time of day, with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant, breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

3. How to use Fluticasona Aldo-Unión 0.25 mg/ml

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Use of this medicine

• Do not inject or swallow the liquid contained in each plastic ampoule. Use Fluticasona Aldo-Unión 0.25 mg/ml only as a nebulized aerosol generated by a nebulizer. Do not use this medicine with ultrasonic nebulizers.
• The liquid is placed into the nebulizer, which produces a mist that is inhaled through a mouthpiece or a face mask.
• Do not allow the liquid or the mist produced by the nebulizer to come into contact with the eyes. You may wear regular or protective glasses to protect your eyes.
• Using a mouthpiece helps prevent the medicine from affecting the face, which may occur if a mask is used for prolonged periods. If you prefer to use a mask, or if you are using a mask for your child, you should protect the facial skin with a cream or wash the face thoroughly after treatment. Nasal inhalation may occur if a mask is used.
• Use the nebulizer in a well-ventilated room, as the mist released into the air could also be inhaled by other people.

One complete ampoule of this medicine (2 ml) provides a dose of 0.5 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 to the severity of their disease.

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

Adults and adolescents over 16 years

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

The usual recommended starting dose is 0.25 mg (half an ampoule of Fluticasona Aldo-Unión 0.25 mg/ml) twice daily. Depending on individual response, the dose may be increased (0.5–2 mg of fluticasone propionate twice daily) until asthma is controlled, or reduced to the lowest effective maintenance dose.

Children and adolescents from 4 to 16 years

For treatment of asthma exacerbation episodes, the recommended dosage regimen is 1 mg of fluticasone propionate (2 ampoules of Fluticasona Aldo-Unión 0.25 mg/ml) twice daily for up to 7 days of treatment. After that, the dose should be adjusted according to individual response.

If you are using high doses of an inhaled steroid for a long period of time, additional steroid doses may occasionally be needed, for example in stressful situations such as a traffic accident or before undergoing surgery. Your doctor may decide to prescribe a steroid supplement during such periods.

Patients who have been treated with high doses of steroids, such as Fluticasona Aldo-Unión 0.25 mg/ml, for a long period of time must not stop taking the medicine abruptly and without informing their doctor. Sudden discontinuation of treatment may cause discomfort and symptoms such as vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar (hypoglycaemia), and weight changes.

Instructions for use

1. The ampoule is supplied wrapped. Do not open the ampoule until needed.
2. Ensure the contents of the ampoule are well mixed before use. Hold the ampoule horizontally by the lower end, gently tap the opposite end several times, and shake. Repeat this procedure several times until the entire contents of the ampoule are completely mixed.

To open the ampoule, twist the top part firmly.

1. Put the suspension into the nebulizer following the product instructions for using the nebulizer.

Dilution of the suspension:

Do not dilute the suspension unless instructed by your doctor.

• If your doctor has instructed you to dilute the solution, pour the contents of the ampoule into the nebulizer container.
• Add the amount of physiological saline solution for injection as directed by your doctor.
• Place the cap on the nebulizer container and gently shake to mix the contents.

After use:

• Use a new ampoule for each dose. Open a new one only when you are ready to use it. Discard any unused liquid. Do not store it for later use.
• Discard any remaining solution in the nebulizer chamber.
• Clean the nebulizer as recommended.

Administration using a mouthpiece is recommended.

If a face mask is used for inhalation, wash the face thoroughly after treatment.

If you use more Fluticasona Aldo-Unión 0.25 mg/ml than you should

It is important to take your dose exactly as prescribed by your doctor. Do not increase or decrease your dose without medical supervision.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 915620420, indicating the medicine and the amount ingested.

Acute inhalation of Fluticasona Aldo-Unión 0.25 mg/ml in doses higher than recommended may cause temporary adrenal suppression (for symptoms, see section 2). Emergency intervention is not necessary if adrenal function returns to normal within a few days.

However, if doses higher than recommended are used for prolonged periods, a certain degree of adrenal insufficiency may occur. Your doctor may request tests to assess adrenal gland function.

If you forget to use Fluticasona Aldo-Unión 0.25 mg/ml

• Take the next dose at the usual time.
• Do not take a double dose to make up for forgotten doses.

If you stop using Fluticasona Aldo-Unión 0.25 mg/ml

• Do not stop treatment even if you feel better, unless your doctor tells you to. In such a case, do not stop Fluticasona Aldo-Unión 0.25 mg/ml abruptly.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Stop using the medicine and contact your doctor immediately if you experience any of the following symptoms after using Fluticasona Aldo-Unión 0.25 mg/ml:

• allergic reactions characterized by:

  • skin rash (cutaneous hypersensitivity)
  • swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing (angioedema)

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

Other adverse effects are:

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

• oral and throat candidiasis (painful creamy-yellow patches)

Common (may affect up to 1 in 10 people)

• bruising;
• hoarseness (dysphonia).

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

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

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

• oesophageal thrush (candidiasis);
• Cushing's syndrome, a disorder characterized by an excess of steroid hormones in the bloodstream, manifested by a rounded facial appearance;
• growth retardation;
• thinning of the bones (decreased bone mineral density);
• eye problems such as cataracts (clouding of the lens) and glaucoma (increased internal eye pressure);
• effects due to adrenal gland (a small gland located next to the kidney);
• hyperglycemia;
• anaphylactic reactions.

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

Sleep disturbances, depression or feeling anxious, 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 not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluticasone Aldo-Unión 0.25 mg/ml

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

This medicine does not require any special storage conditions. Store the medicine in an upright position, as shown on the packaging, within its wrapping and carton.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

After opening the aluminium wrapper, the containers must be protected from light and used within 1 month. Do not store above 25°C.

Opened containers must be stored in the refrigerator (between 5°C ±3°C) and used within 24 hours of opening. Do not freeze.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of any unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluticasona Aldo-Unión 0.25 mg/ml

• The active substance is fluticasone propionate.
• The other components are polysorbate 20, sorbitan monolaurate, sodium dihydrogen phosphate dihydrate, anhydrous disodium hydrogen phosphate, sodium chloride, water for injections.

Appearance of the medicine and contents of the pack

• Fluticasona Aldo-Unión 0.25 mg/ml is presented in strips of 5 ampoules in a wrapper.

Available in packs containing 20 ampoules of 2 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio Aldo-Unión, S.L.

Calle Baronesa de Maldá 73

08950 Esplugues de Llobregat (Barcelona)

Spain

Manufacturer

Genetic S.p.A

Contrada Canfora

84084 Fisciano (SA)

Date of the most recent revision of this leaflet: August 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/