PRONTINAL 800 MICROGRAMMI Nebulizable suspension

Зміст інструкції

1. PRONTINAL 800 micrograms suspension for nebulizer
   1. What is Prontinal and what is it used for
   2. What you need to know before using Prontinal
   3. How to use Prontinal
   4. Possible side effects
   5. How to store Prontinal
   6. Contents of the pack and other information

PRONTINAL 800 micrograms suspension for nebulizer

Beclometasone dipropionate
Read this leaflet carefully before using 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 they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Prontinal and what is it used for

Prontinal contains the active ingredient beclometasone dipropionate. It belongs to a group of
medicines called corticosteroids, which have an anti-inflammatory action capable of reducing
swelling and irritation in the walls of the airways (e.g. nose, lungs), thus alleviating
breathing problems.
Prontinal is indicated in the treatment of asthma in adults and children up to 18 years of age when
the use of metered-dose or powder inhalers is unsatisfactory or inadequate.
Prontinal is also indicated in the treatment of recurrent wheezing (whistling) in children
up to 5 years of age.

2. What you need to know before using Prontinal

Do not use Prontinal:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine listed in section 6.

Warnings and precautions
Talk to your doctor or pharmacist before using Prontinal if any of the following
conditions apply to you:

• You are, or have been, undergoing treatment for tuberculosis.
• Your condition seems to be getting worse. Your wheezing or shortness of breath seems to be worsening or the inhaler seems less effective.
• The doctor may need to increase the dose of Prontinal, or prescribe you a course of oral corticosteroids or change the entire treatment.
• You have a chest infection. The doctor may prescribe a course of antibiotics.
• If you have an infection of the nasal and paranasal cavities, you should be treated with appropriate therapies, although this does not represent a specific contraindication to the use of Prontinal.
• If you develop an immediate increase in wheezing, shortness of breath and cough after using Prontinal, stop Prontinal immediately and contact your doctor.

Contact your doctor if you experience blurred vision or other visual disturbances.
Immediately after inhalation, rinse your mouth with water to reduce the frequency of oral fungal
infections.
Switching from oral corticosteroids to Prontinal
Switching from oral corticosteroids to treatment with corticosteroids via
inhalation
may cause you to feel unwell or you may develop a rash, eczema or
nasal discharge and sneezing (rhinitis).
If you experience these symptoms, contact your doctor as soon as possible. Do not stop treatment
with Prontinal unless your doctor tells you to.
If you have taken oral corticosteroids at high doses or for a prolonged period of time,
the dose may be gradually reduced, about a week after you have started treatment
with Prontinal. During this period, the doctor will regularly check the steroid levels in
your body.
If you have been treated for a prolonged period of time with high doses of corticosteroids via
inhalation, you may require additional treatment with corticosteroids at times of
stress. For example:

• during hospitalisation after a serious accident,
• before an operation,
• or if you have a chest infection or other serious illnesses. The doctor will decide if you need a course of oral corticosteroids or, possibly, an injection of corticosteroids and will also advise you how long you need to take the course of oral corticosteroids and how you should reduce them when you feel better.

Children and adolescents
If the child is under 5 years of age and has been using Prontinal for a long time for the
treatment of recurrent wheezing (whistling), the doctor will regularly monitor the child's height
to assess any slowing of growth and interruption of the
treatment.

Other medicines and Prontinal
Tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Some medicines can increase the effects of Prontinal and 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).
Tell your doctor if you are taking, have recently taken or may take any
other medicine containing corticosteroids, as these drugs can interact with Prontinal
worsening any side effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Since, during pregnancy, it is not possible to exclude delays in growth or harm to the fetus following
prolonged treatment with corticosteroids (such as beclometasone dipropionate
contained in Prontinal), in these cases the decision to use Prontinal is up to the doctor.
Corticosteroids pass into breast milk in small amounts. To date, no harm has been reported
to babies breastfed with breast milk. However, as a precaution, if
high amounts of beclometasone dipropionate are inhaled, it is advisable to avoid
breastfeeding for 4 hours after administering the drug.

Driving and using machines
It is unlikely that Prontinal can alter your ability to drive and use machines. However,
if you experience side effects such as dizziness and/or tremor, your ability to drive or
use machines may be affected.

3. How to use Prontinal

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor or pharmacist.
The initial dose must be prescribed by the doctor according to the frequency and severity of the
disease. The dose may then be adjusted by the doctor until effective symptom control is achieved.

The recommended initial doses are:
Adults and adolescents (from 12 years of age):

• 800-1600 micrograms twice a day, corresponding to a total daily dose of 1600 or 3200 micrograms.

Children (up to 11 years of age):

• 400-800 micrograms twice a day, corresponding to a total daily dose of 800 or 1600 micrograms.

Normally, the daily dose of 1600 micrograms should not be exceeded in children up to 11 years of age and 3200 micrograms in adults and adolescents.
In case of asthma, Prontinal must be used regularly on a daily basis. The doctor will decide the duration of treatment.
If the child suffers from recurrent wheezing (whistling), the duration of treatment should not exceed 3 months, unless otherwise prescribed by the pediatrician.
The Prontinal 800 microgram vial can be used to obtain 400 micrograms (half the content) using the half-dose line as described below.
Method of administration
Prontinal must be used exclusively by inhalation. Do not inject intravenously or use orally.
Prontinal must be administered by inhalation with a suitable device (pneumatic nebulizer) according to the doctor's instructions.
The use of Prontinal with ultrasonic nebulizers is not recommended.

Instructions for use:
The vial must be used according to the following instructions:

• 1. Bend the vial back and forth to loosen it from the strip (Figure A).
• 2. Carefully separate the vial from the strip, starting from the top, then in the center (Figure B), leaving the other vials in the pouch.
• 3. Shake vigorously and turn the vial upside down, so as to mix the suspension. Repeat this operation until the entire content is completely dissolved and mixed (Figure C).
• 4. Open the vial by rotating the opening tabs, as indicated by the arrow (Figure D).
• 5. Gently press the vial and pour the contents into the nebulizer ampoule (Figure E).

The vial must be opened immediately before administration.
If only half a dose of Prontinal 800 micrograms is needed, turn the vial upside down, make sure the half-dose line is clearly visible, and apply slight pressure. While holding the vial pressed, let the contents out until the suspension level reaches the half-dose line (do not go beyond). Once half of the content has been poured, close it with the cap by pressing it onto the vial. The vial closed in this way must be stored at 2◦C-8◦C (in the refrigerator) and the remaining quantity must be used within 12 hours of the first opening.
Dilution:
The doctor may decide that the dose needs to be diluted.
In this case, empty the contents of the vial into the nebulizer ampoule, then add the amount of sterile sodium chloride solution 9 mg/ml (0.9%, physiological solution) that the doctor has prescribed.
Close the ampoule, shake gently to mix the contents.
Dilution of the dose may be necessary to obtain a final volume suitable for the particular nebulizer used, to help in the administration of small volumes or if a prolonged administration time is preferred.
During nebulization
Position the mask or mouthpiece
Turn on the nebulizer.
Breathe normally. Nebulization should not last more than 10-15 minutes.
After nebulization
Do not forget to rinse your mouth, lips and the area of the face covered by the mask with water.
After inhalation, any unused suspension remaining in the nebulizer ampoule must be discarded.
Cleaning:
To clean the nebulizer, follow the manufacturer's instructions. It is important that the nebulizer is kept clean.

If you use more Prontinal than you should
It is important to use the dose, as recommended by the doctor. Do not increase or decrease the dose without consulting the doctor.
If you have used more Prontinal than you should, inform the doctor as soon as possible. The doctor may decide to check the levels of corticosteroids in the blood and, therefore, a blood sample may be necessary.

If you forget to use Prontinal
If you forget to use a dose, use it as soon as you remember. If it is almost time for the next dose, do notuse the missed dose, just use the next dose when due. Do not use a double doseto make up for the missed dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects have been reported. Tell your doctor as soon as possible if you notice any of
these side effects, but do not stop treatment unless you are told to do so. The doctor will try to avoid these effects by prescribing Prontinal at the lowest effective
dose possible.

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

• sore throat (pharyngitis, laryngitis). Gargling with water immediately after inhalation may help to prevent this effect.

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

• cough
• nausea and stomach pain
• thrush in the mouth, tongue and throat. Rinsing your mouth or gargling with water immediately after inhalation may help to prevent these effects.

Uncommon side effects(may affect up to 1 in 100 people):

• headache
• throat irritation, hoarseness
• worsening of shortness of breath, cough and wheezing (known as paradoxical bronchospasm). In this case, do not take another dose of Prontinal. Then contact your doctor immediately. It is likely that the doctor will decide to evaluate asthma or recurrent wheezing and, if necessary, start another course of treatment. You may be told that you should not use Prontinal again.

Rare side effects(may affect up to 1 in 1,000 people):

• cold sores (herpes simplex) painful blisters on the lips and in the mouth
• tremor (involuntary shaking)
• fatigue
• allergic reaction (swelling of the eyes, face, lips and throat with resulting severe difficulty in breathing, rash, hives, itching or redness).

Side effects of unknown frequency(frequency cannot be estimated based on available data)

• blurred vision

The following effects may also occur more likely in children:

• Problems with sleep, depression or worry, restlessness, nervousness, overexcitement or irritability.

At high doses for a long period of time, Prontinal can alter the normal production of
corticosteroids in the body. This in children and adolescents may lead to growth
delay, so it is important that their height is checked regularly by the doctor. Bone thinning and eye problems such as clouding of the lens
of the eye (cataract), increased pressure in the eye (glaucoma) have been reported.
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 national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Prontinal

Keep this medicine out of the sight and reach of children.
Do not use Prontinal after the expiry date, which is stated on the package, on the
blister and on the vial.
Store the vials in an upright position in the original packaging (cardboard box) to
protect the medicine from light.
After the first opening of the blister, write the date in the designated space on the blister. Do not
use the vials after 3 months from the date of the first opening of the blister.
After the first opening of the vial, store in a refrigerator (2  C-8  C). The remaining
quantity must be used within 12 hours of the first opening.
Do not use Prontinal if you notice that the packaging is damaged.
Do not dispose of any medicine in the drains 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 Prontinal contains
The active ingredient is beclometasone dipropionate.
Each 2 ml vial contains 800 micrograms of beclometasone dipropionate.
The vial has a half-dose line on one side (corresponding to 400 micrograms).
The other excipients are: polysorbate 20; sorbitan laurate; sodium chloride; water for
injections.

Description of Prontinal’s appearance and contents of the pack
Prontinal is a white or almost white nebulizer suspension.
The Prontinal suspension is supplied in polyethylene vials containing 2 ml. Strips of
5 vials are packaged in a sealed sachet, in packs of 20 vials (4 sachets).

Marketing authorisation holder and manufacturer
Dompè farmaceutici S.p.A. – Via San Martino 12 – 20122 Milano
Chiesi Farmaceutici S.p.A. – Parma Manufacturing Site, Via San Leonardo 96 43122 Parma