PAVETOD 500 MCG/2 ML Nebulizable suspension

Зміст інструкції

1. Pavetod 500 mcg/2ml Suspension for nebulisation, 2mg/2ml Suspension for nebulisation
   1. What is Pavetod and what is it 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

Pavetod 500 mcg/2ml Suspension for nebulisation, 2mg/2ml Suspension for nebulisation

Fluticasone propionate

Read this leaflet carefully before you start to use this medicine as 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 get any side effects, even those not listed in this leaflet, tell 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 you use 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 is Pavetod and what is it used for

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

2. What you need to know before using Pavetod

Do not use Pavetod

• if you are allergic to fluticasone propionate or any of the other ingredients of this medicine (listed in section 6); Warnings and precautionsTalk to your doctor or pharmacist before using Pavetod if:
• you have active or inactive (latent) tuberculosis (TB, a contagious 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 treated with particular attention by your doctor, who will need to regularly monitor your adrenal function and gradually discontinue oral therapy following the introduction of inhaled therapy. It is therefore advisable to carry a card indicating that you may require supplementary corticosteroid therapy during periods of stress. If your breathing becomes difficult (bronchospasm with increased dyspnea) following the use of Pavetod, stop taking the medicine and consult your doctor immediately.

In fact, fluticasone propionate administered by nebulization is not indicated alone for
treating the symptoms of an acute bronchospasm attack. Pavetod Suspension for nebulization
does not replace emergency therapy, which instead occurs with corticosteroids administered
orally or intravenously.
Replacing systemic corticosteroid therapy with inhaled corticosteroids can
trigger allergic diseases.
Asthma treatment should normally be carried out as part of a therapeutic plan
adapted to the severity of the disease; your response to therapy should be verified by
your doctor, both clinically and through lung function tests.
The need to resort more frequently to drugs to control asthma symptoms indicates a worsening of disease control; in this circumstance your therapeutic plan
must be modified by your doctor.
A sudden worsening of asthma is potentially life-threatening and, in this case, the
doctor must consider the possibility of increasing the dosage of
corticosteroids.
It is important that you take the dose as prescribed by your doctor. Do not increase or
decrease the dose without asking your doctor for advice. Do not abruptly stop
treatment with fluticasone propionate.
With the use of inhaled glucocorticoids (such as fluticasone propionate), particularly when
prescribed at high doses for prolonged periods, systemic effects (on the whole
body) can occur. These effects are less likely to occur than with treatment with
glucocorticoids administered orally.
Possible systemic effects include Cushing's disease (a clinical condition characterized
by an excess of glucocorticoids in the blood, leading to obesity, lack of expression in the
face, red skin, widespread stretch marks and thick hair, especially on the face), cushingoid appearance
(typical of people affected by Cushing's disease), adrenal suppression (reduction of
adrenal function), growth retardation in children and adolescents, reduced bone mineral density, cataracts (clouding of the lens located inside the eye),
glaucoma (serious eye disease) and, more rarely, a number 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 is the lowest dose possible with which effective
asthma control is maintained.
It is recommended to regularly check the height of children receiving prolonged therapies
with corticosteroids via inhalation.
Very rare cases of acute adrenal crises have occurred in children exposed to doses higher than
those 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
cataracts or glaucoma.

Other medicines and Pavetod
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or
may take any other medicine, including medicines obtained without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, a medicine used to treat fungal infections. Some medicines can increase the effects of Pavetod. Your doctor may want to keep you under close observation if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat). Pavetod with food and drinkYou can use Pavetod at any time of the day, with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice 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 following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor, nurse or pharmacist.
You should be informed that treatment with this medicine is for preventive purposes and the medicine
must be taken regularly even in the absence of symptoms.
4-7 days are necessary for this medicine to take effect and it is very important that you use it
regularly.

Do not inject or ingest the liquid.
Administer Pavetod Suspension for nebulization only by means of aerosol generated by a
nebulizer. Do not use Pavetod Suspension for nebulization with ultrasonic nebulizers.

• The nebulizer produces a mist that is inhaled through a mouthpiece or an inhalation mask.
• Each plastic container contains liquid.
• The liquid is placed in the nebulizer. This generates a fine mist that is inhaled through a mask or a mouthpiece. Using a mouthpiece prevents the medicine from having effects on the skin of the face, which can happen if you use a mask for a long period of time. If you prefer to use a mask, or if you are using a mask for your child, it is necessary to protect the skin of the face with a cream or to wash your face thoroughly 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 may also be breathed in by others. Your doctor will prescribe the appropriate dosage for this medicine, following an assessment of the severity of asthma and your individual response. Your doctor may gradually reduce your dose if your respiratory function is stabilized. Adults and adolescents over 16 years of ageThe normally recommended dose is 250 mcg (half a 500 mcg container) 2 times a day. Subsequently, the dosage should be adjusted until asthma control is achieved (500-2000 mcg 2 times a day), or reduced according to individual response, to reach the minimum effective maintenance dose. For the treatment of exacerbation episodes, it is recommended to adopt a high dose (at the upper limit of the recommended dose range) for a period of 7 days following the exacerbation itself. Subsequently, the opportunity to reduce the dosage should be considered. Children (4 to 16 years of age)The recommended dose is 250 mcg (half a 500 mcg container) 2 times a day. Patients should be treated with an initial dose of fluticasone propionate for nebulization appropriate for the severity of their illness. Subsequently, the dosage should be adjusted until asthma control is achieved, or reduced according to individual response, to reach the minimum effective maintenance dose. In the treatment of asthma exacerbation episodes, the recommended dosage is 1 mg 2 times a day (2 containers of 500 mcg 2 times a day) for up to 7 days of treatment. Subsequently, the dosage should be adjusted according to individual response. It is recommended that the height of children treated with steroids, including Pavetod Suspension for nebulization, be regularly checked by the doctor.

If you are using high doses of an inhaled steroid for a long time, you may sometimes need to use
supplementary doses of steroids, for example during stressful circumstances, such as
a car accident or before surgery. The doctor may decide to prescribe you a steroid supplement during that period.
Patients who have been treated with high doses of steroids, including Pavetod Suspension for nebulization,
for a long period, should not stop taking the medicine suddenly without first informing their doctor. Sudden discontinuation of treatment can cause malaise and symptoms such as
vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood sugar levels(hypoglycemia) and changes in weight.
Instructions for use
Use Pavetodby aerosol generated by a pneumatic nebulizer (JET),
according to your doctor's instructions.
Also refer to the instructions for use recommended by the nebulizer manufacturer.
Administration of Pavetod with ultrasonic nebulizers is not recommended.
Since many nebulizers operate with continuous flow, the nebulized drug is likely to be
released into the environment; therefore, it is advisable that Pavetod be administered in a well
ventilated room.

Pavetod Suspension for nebulizationis not for injectable use.

In school-age children:
the use of a mouthpiece is mainly recommended.

In younger children:
the use of a facial inhalation mask is recommended.
Before using Pavetod, mix the contents of the container thoroughly by holding the container
horizontally from the lower end, tapping the opposite end several times and shaking it.
Repeat this operation several times so that all the contents of the container are completely
mixed.
To open the container, rotate the tab until it opens.
If you use an inhalation mask, you must protect your face with protective creams and after use you must
wash your face thoroughly. For prolonged use, it is advisable to use a mouthpiece.
After each administration, rinse your mouth with water to reduce the occurrence 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 told you to do so

• If your doctor has told you to dilute the suspension, empty the contents of Pavetod into the nebulizer ampoule. Add the amount of sterile saline solution that your doctor has told you to use. If you use more Pavetod than you shouldIn case of accidental ingestion/administration of an excessive dose of Pavetod, immediately inform your doctor or go to the nearest hospital. Acute inhalation of Pavetod in doses higher than those recommended can 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 those recommended are used for prolonged periods, a certain degree of adrenal suppression may occur. The doctor may request to perform tests
to verify the degree of functioning of the adrenal gland.

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

If you stop using Pavetod
Do not stop treatmenteven if you feel better unless your doctor prescribes it. In that
case, do not stop Pavetod abruptly. If you have any doubts about the use of this medicine, ask your
doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking it and contact your doctor immediately if you experience any of the following
symptoms after taking Pavetod:

• allergic reactions characterised by skin rashes (cutaneous hypersensitivity);
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing (angioedema);
• difficulty breathing (dyspnea and/or bronchospasm, paradoxical bronchospasm).

Other side effects include:
Very common(may affect more than 1 in 10 people)

• thrush in the mouth and throat (painful, creamy-yellow raised patches)

Common(may affect up to 1 in 10 people)

• bruising
• hoarseness. Problems of the mouth and throat can be reduced with some specific precautions, such as brushing your teeth or rinsing your mouth with water immediately after inhalation of 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)
• thrush (candidiasis) in the esophagus;
• anxiety, sleep disorders and behavioural disturbances, including hyperactivity and irritability (mainly in children)
• increased sugar (glucose) content in the blood (hyperglycemia)
• slowing of growth in young people;
• Cushing's syndrome, a condition characterised by an excess of steroid hormones in the bloodstream, which manifests with a rounded face;
• thinning of the bones
• problems with the eyes such as cataract (clouding of the lens of the eye) and glaucoma (increased pressure inside the eye)
• effects on the adrenal gland (a small gland located next to the kidney).

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 at a temperature above 25°C. Keep the product in its original packaging in an upright position to protect it from light and frost .
• After opening the aluminum pouch, the single-dose containers must be used within one month.
• Opened containers must be placed in a refrigerator and stored at a temperature between 5°C ± 3°C and used within 24 hours of opening.
• Do not freeze.

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

6. Contents of the pack and other information

What Pavetod contains

• The active ingredient is fluticasone propionate. One single-dose container of 2 ml contains 0.5 mg of fluticasone propionate.
• The other ingredients are: Polysorbate 20, Sorbitan monolaurate, Monobasic sodium phosphate dihydrate, Dibasic sodium phosphate anhydrous, Sodium chloride, Water for injections. Description of the appearance of Pavetod and contents of the packThe vials of Pavetod are packaged in a strip of 5 vials in an aluminum pouch. Each pack contains 10 or 20 vials of 2 ml. MARKETING AUTHORISATION HOLDERGenetic S.p.A. Via G. Della Monica, 26 - Castel San Giorgio (SA) MANUFACTURERGenetic S.p.A. Contrada Canfora - Fisciano (SA)