Pavetod

Package leaflet: Information for the user

Pavetod 500 mcg/2ml Nebuliser Suspension, 2mg/2ml Nebuliser Suspension

Fluticasone propionate
Please 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 other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Pavetod is and what it is used for

This medicine contains the active substance fluticasone propionate, which belongs to a group of
medicines called corticosteroids, used as anti-asthma agents (for the treatment of asthma, an
inflammatory disease characterised by reversible obstruction of the lower airways) by inhalation.
Fluticasone propionate reduces swelling and inflammation in the lungs (anti-inflammatory action).
This medicine is indicated for the control of asthma and conditions involving bronchoconstriction
(reduction in the diameter of a bronchus).

2. What you need to know before using Pavetod

Do not use Pavetod

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

Warnings and precautions
Talk to your doctor or pharmacist before using Pavetod if:

• you have active or quiescent tuberculosis (TB, an infectious disease caused by a bacterium)
• you are a diabetic patient
• you have a respiratory disease called chronic obstructive pulmonary disease (COPD) and are switching from oral steroid therapy to inhaled fluticasone. In this case, you must be carefully monitored by your doctor, who will regularly check your adrenal function and gradually discontinue the oral therapy after starting the inhaled treatment. It is therefore advisable to carry a medical alert card indicating that you might require additional corticosteroid therapy during periods of stress.

If you experience shortness of breath (bronchospasm with increased dyspnea) after using Pavetod, stop taking the medicine and consult your doctor immediately.

Fluticasone propionate administered by nebulization is not indicated alone for treating symptoms of acute bronchospasm attacks. Pavetod Nebuliser Suspension does not replace emergency therapy, which instead requires corticosteroids administered orally or intravenously.

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

Asthma treatment should normally be managed within a therapeutic plan tailored to the severity of the disease. Your response to treatment must be monitored by your doctor, both clinically and through lung function tests.

The need to use asthma control medications more frequently indicates worsening disease control; in such circumstances, your treatment plan should be adjusted by your doctor.

Sudden worsening of asthma may be life-threatening, and in such cases your doctor must consider increasing the dose of corticosteroids.

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

With the use of inhaled glucocorticoids (such as fluticasone propionate), particularly when prescribed at high doses for prolonged periods, systemic effects (affecting the whole body) may occur. These effects are less likely than with oral glucocorticoid therapy.

Possible systemic effects include Cushing's syndrome (a clinical condition characterized by excess glucocorticoids in the blood, leading to obesity, expressionless facial appearance, red skin, widespread stretch marks, and excessive hair growth, especially on the face), Cushingoid appearance (typical of people with Cushing's syndrome), adrenal suppression (reduced adrenal function), growth retardation in children and adolescents, decreased bone mineral density, cataract (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, irritability, sleep disturbances, anxiety, depression, or behavioral disorders (particularly in children) (see section 4 "Possible side effects"). It is therefore important that the dose of inhaled corticosteroid should be the lowest effective dose that maintains adequate asthma control.

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

Very rare cases of acute adrenal crisis have been reported in children exposed to doses higher than recommended (approximately 1,000 micrograms per day) for prolonged periods (several months or years).

Contact your doctor if you experience blurred vision or other visual disturbances, which may be caused by cataract or glaucoma.

Other medicines and Pavetod
Tell your doctor, nurse, or pharmacist 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:

• ketoconazole, a medicine used to treat fungal infections.

Some medicines may increase the effects of Pavetod. Your doctor may wish to monitor you closely if you are taking these medicines (including some HIV treatments: ritonavir, cobicistat).

Pavetod with food and drink
Pavetod can be used at any time of day, with or without food.

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 Pavetod will affect your ability to drive vehicles or operate machinery.

3. How to use Pavetod

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor, nurse, or pharmacist.
You should be aware that treatment with this medicine is preventive in purpose and the medicine must be taken regularly, even in the absence of symptoms.
It takes 4–7 days for this medicine to take effect, and it is very important that you use it regularly.
Do not inject or swallow the liquid.
Take Pavetod Nebuliser Suspension only by inhalation using a nebuliser. Do not use Pavetod Nebuliser Suspension with ultrasonic nebulisers.

• The nebuliser produces a fine mist which is inhaled through a mouthpiece or a face mask.
• Each plastic container holds liquid.
• The liquid is placed into the nebuliser. The nebuliser then generates a fine mist which is inhaled through a mask or mouthpiece. Using a mouthpiece helps prevent the medicine from affecting the skin of 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. If using a mask, nasal inhalation may occur. Use the nebuliser in a well-ventilated room, as the mist released into the air may be partly inhaled by others nearby. Your doctor will prescribe the appropriate dosage for you after assessing the severity of your asthma and your individual response. If your respiratory function stabilises, your doctor may gradually reduce your dose.
  Adults and adolescents aged over 16 years
  The usual recommended dose is 250 mcg (half a container of 500 mcg) twice daily. The dose should then be adjusted to achieve asthma control (500–2000 mcg twice daily), or reduced according to individual response, until the lowest effective maintenance dose is reached. For treatment of acute exacerbations, a higher dose (at the upper end of the recommended dose range) is recommended for 7 days following the exacerbation. After this, dose reduction should be considered.
  Children (aged 4 to 16 years)
  The recommended dose is 250 mcg (half a container of 500 mcg) twice daily. Patients should be started on an initial dose of nebulised fluticasone propionate appropriate to the severity of their disease. The dose should then be adjusted to achieve asthma control, or reduced according to individual response, until the lowest effective maintenance dose is reached. For treatment of acute asthma exacerbations, the recommended dosage is 1 mg twice daily (2 containers of 500 mcg twice daily) for up to 7 days. Thereafter, the dose should be adjusted according to individual response. It is recommended that the height of children treated with steroids, including Pavetod Nebuliser Suspension, be monitored regularly by a doctor.

If you have been using high doses of inhaled steroids for a long time, you may sometimes need additional
steroid doses, for example during stressful situations such as a road accident or before surgery. Your
doctor may decide to prescribe additional steroids during such periods.
Patients who have been treated with high doses of steroids, including Pavetod Nebuliser Suspension, for a prolonged period should not stop taking the medicine suddenly without first consulting their doctor. Abruptly stopping treatment may cause discomfort and symptoms such as vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar levels (hypoglycaemia), and changes in weight.

Instructions for use
Use Pavetod via aerosol generated by a pneumatic (JET) nebuliser, as directed by your doctor.
Also refer to the instructions for use recommended by the manufacturer of the nebuliser.
Administration of Pavetod with ultrasonic nebulisers is not recommended.
Since many nebulisers operate with continuous flow, it is likely that some of the nebulised medicine will be released into the environment; therefore, it is advisable to administer Pavetod in a well-ventilated room.
Pavetod Nebuliser Suspension is not for injectable use.

In school-aged children:
Use of a mouthpiece is primarily recommended.
In younger children:
Use of a face mask for inhalation is recommended.

Before using Pavetod, mix the contents of the container thoroughly by holding it horizontally from the bottom end, tapping the opposite end several times, and shaking it. Repeat this process several times to ensure the entire contents are completely mixed.
To open the container, rotate the tab until it opens.
If you use a face mask for inhalation, protect your face with a protective cream and wash your face thoroughly after use. For prolonged use, a mouthpiece is recommended.
After each administration, rinse your mouth with water to reduce the risk of fungal infections of the mouth and throat (oropharyngeal candidiasis) and hoarseness (see section 4).

Dilution
Do not dilute the contents of the vial unless your doctor has instructed you to do so.

• If your doctor has instructed you to dilute the suspension, empty the contents of Pavetod into the nebuliser chamber. Add the amount of physiological saline solution for injection that your doctor has instructed you to use.

If you use more Pavetod than you should
If you accidentally ingest or inhale an excessive dose of Pavetod, contact your doctor immediately or go to the nearest hospital. Acute inhalation of Pavetod in doses higher than recommended may lead to temporary suppression of adrenal function (for symptoms, see “Warnings and precautions”). Emergency interventions are not necessary, as adrenal function returns to normal within a few days.

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

If you forget to use Pavetod
Do not take a double dose to make up for a missed dose.

If you stop using Pavetod
Do not stop treatment, even if you feel better, unless instructed by your doctor. If so, do not stop Pavetod abruptly.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking the medicine and contact your doctor immediately if you experience any of the following
symptoms after taking Pavetod:

• allergic reactions characterized by skin rashes (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 side effects include:
Very common (may affect more than 1 in 10 people)

• oral and throat thrush (raised, painful, yellow-cream coloured patches)

Common (may affect up to 1 in 10 people)

• bruising

• hoarseness (dysphonia). Mouth and throat problems can be reduced by taking specific precautions, such as brushing teeth or rinsing the mouth with water immediately after inhaling the dose. In addition, pneumonia (lung infection) has been reported in patients with chronic obstructive pulmonary disease (COPD).
  Very rare (may affect up to 1 in 10,000 people)

• oesophageal thrush (candidiasis);

• anxiety, sleep disorders and behavioural disturbances, including hyperactivity and irritability (mainly in children);

• increased blood sugar (glucose) levels (hyperglycaemia);

• growth retardation in young patients;

• Cushing's syndrome, a condition characterized by an excess of steroid hormones in the bloodstream, manifesting as a rounded facial appearance;

• thinning of the bones;

• eye problems such as cataract (clouding of the eye's lens) and glaucoma (increased internal pressure of the eye);

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

Not known (frequency cannot be determined from available data):

• depression, aggression. These effects are more likely to occur in children;
• blurred vision;
• nosebleeds.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pavetod

• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C. Store the product in an upright position in the original packaging to protect it from light and frost.
• After opening the aluminium pouch, the single-dose containers must be used within one month.
• Opened containers must be stored in the refrigerator at a temperature between 5°C ± 3°C and used within 24 hours of opening.
• Do not freeze.

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. Pack contents and other information

What Pavetod contains

• The active substance is fluticasone propionate. One 2 ml single-dose container contains 0.5 mg of fluticasone propionate.
• The other components are: Polysorbate 20, Sorbitan monolaurate, Monosodium phosphate dihydrate, Disodium phosphate anhydrous, Sodium chloride, Water for injections.

Description of the appearance of Pavetod and pack contents
Pavetod vials are packaged in an aluminum pouch containing a strip of 5 vials. Each carton contains 10 or 20 vials of 2 ml.

MARKETING AUTHORISATION HOLDER
Genetic S.p.A.
Via G. Della Monica, 26 - Castel San Giorgio (SA)

MANUFACTURER
Genetic S.p.A.
Contrada Canfora - Fisciano (SA)