BECLONEB 800 MICROGRAMMI Nebulizable suspension

Зміст інструкції

1. BECLONEB 800 micrograms suspension for nebulizer
   1. WHAT IS BECLONEB AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU USE BECLONEB
   3. HOW TO USE BECLONEB
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE BECLONEB
   6. PACKAGE CONTENTS AND OTHER INFORMATION

BECLONEB 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 you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT IS BECLONEB AND WHAT IT IS USED FOR

BECLONEB 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.
BECLONEB is indicated in the treatment of asthma in adults and children up to 18 years of age when the use
of metered-dose inhalers or powder inhalers is unsatisfactory or inadequate.
BECLONEB is also indicated in the treatment of recurrent wheezing in children up to
5 years of age.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE BECLONEB

Do not use BECLONEB:

• if you are allergic to the active substance 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 BECLONEB if any of the following conditions apply to you:

• You have, or have had, treatment for tuberculosis.
• Your condition seems to be getting worse. Your wheezing or shortness of breath seems to be getting worse or the inhaler seems less effective.
• The doctor may need to increase the dose of BECLONEB, or prescribe a course of corticosteroid tablets 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, it must be treated with appropriate therapies, although this does not represent a specific contraindication to the use of BECLONEB. Contact your doctor if you experience blurred vision or other visual disturbances.

If you develop an immediate increase in wheezing, shortness of breath and cough after using BECLONEB, stop BECLONEB immediately and contact your doctor.
Rinse your mouth with water immediately after inhalation to reduce the frequency of oral fungal infections.
Switching from oral corticosteroids to BECLONEB
Switching from oral corticosteroids to treatment with inhaled corticosteroids may cause you to feel unwell or you may develop a rash, eczema or runny nose and sneezing (rhinitis).
If you experience these symptoms, contact your doctor as soon as possible. Do not stop treatment with BECLONEB 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 BECLONEB. 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 inhaled corticosteroids, you may require additional treatment with corticosteroids during times of stress. For example:

• during hospital stay 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 corticosteroid tablets or, possibly, an injection of corticosteroids and will also advise you how long you need to take the course of corticosteroid tablets 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 BECLONEB 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 treatment.

Other medicines and BECLONEB
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 BECLONEB and the 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 BECLONEB, worsening any side effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, 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 BECLONEB), in these cases the decision to use BECLONEB is up to the doctor.
Corticosteroids pass into breast milk in small amounts. To date, no harm has been reported to babies breastfed by mothers taking beclometasone dipropionate. However, as a precaution, if high amounts of beclometasone dipropionate are inhaled, it is recommended to avoid breastfeeding for the 4 hours following administration of the drug.

Driving and operating machinery
It is unlikely that BECLONEB will impair your ability to drive or operate machinery. However, if you experience side effects such as dizziness and/or tremor, your ability to drive or operate machinery may be affected.
Warning for athletes: the product contains substances prohibited for doping. Use other than for therapeutic indications, dosage regimen and route of administration as reported is prohibited.

3. HOW TO USE BECLONEB

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:

• 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, BECLONEB should be used regularly on a daily basis. The doctor will decide
the duration of treatment.
If the child suffers from recurrent wheezing, the duration of treatment should not exceed
3 months, unless otherwise prescribed by the pediatrician.
The BECLONEB 800 microgram vial can be used to obtain 400 micrograms (half
of the content) using the half-dose line as described below.
Method of administration
BECLONEB must be used exclusively by inhalation. Do not inject intravenously or use for
oral administration.
BECLONEB must be administered by inhalation with a suitable device (pneumatic nebulizer
) according to the doctor's instructions.
The use of BECLONEB 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 to mix the suspension. Repeat this operation until the entire contents are 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 BECLONEB 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 contents have 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%, saline 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 BECLONEB 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 BECLONEB 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 needed.

If you forget to use BECLONEB
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 scheduled. 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 everybody 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 your doctor tells you to.
The doctor will try to avoid these effects by prescribing BECLONEB 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). If this happens, do not take another dose of BECLONEB. 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 not to use BECLONEB 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 (shaking involuntarily)
• fatigue
• allergic reaction (swelling of the eyes, face, lips and throat with resulting severe breathing difficulties, rash, hives, itching or redness).

Side effects with unknown frequency(frequency cannot be estimated on the basis of the 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, BECLONEB may alter the normal production of
corticosteroids in the body. This in children and adolescents may lead to delayed growth, so
it is important that their height is checked regularly by the doctor. Thinning of the bones and problems with the eyes, 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, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE BECLONEB

Keep this medicine out of the sight and reach of children.
Do not use BECLONEB after the expiry date, which is stated on the package, the sachet and the vial.
Store the vials in an upright position in the original packaging (cardboard box) in order to
protect the medicine from light.
After the first opening of the sachet, write the date in the designated space on the sachet. Do not use the vials
after 3 months from the date of the first opening of the sachet.
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 BECLONEB if you notice that the packaging is damaged.
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. PACKAGE CONTENTS AND OTHER INFORMATION

What BECLONEB 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 the appearance of BECLONEB and contents of the pack
BECLONEB is a white or almost white nebulizer suspension.
The suspension of BECLONEB is supplied in polyethylene vials containing 2 ml (BECLONEB 800
micrograms). Strips of 5 vials are packaged in a sealed sachet, in packs of 10 vials (2
sachets), 20 vials (4 sachets).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
MASTER PHARMA s.r.l. – Via G. Chiesi, 1 - Parma

Manufacturer:
CHIESI FARMACEUTICI S.p.A., Parma Manufacturing Plant, Via S. Leonardo 96