Becloneb

PACKAGE LEAFLET: INFORMATION FOR THE USER

BECLONEB 800 micrograms suspension for nebuliser

Beclometasone dipropionate
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 using 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 BECLONEB IS AND WHAT IT IS USED FOR

BECLONEB contains the active substance beclometasone dipropionate. It belongs to a group of
medicines called corticosteroids, which have an anti-inflammatory action that reduces swelling and
irritation in the walls of the airways (e.g. nose, lungs), thereby relieving respiratory problems.
BECLONEB is indicated for the treatment of asthma in adults and children up to 18 years of age when
the use of pressurised metered dose inhalers or dry powder inhalers is unsatisfactory or inadequate.
BECLONEB is also indicated for the treatment of recurrent wheezing (wheeze) in children up to 5 years of age.

2. WHAT YOU SHOULD KNOW BEFORE USING 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 are, or have previously been, under treatment for tuberculosis.
• Your condition appears to worsen. You notice that wheezing or shortness of breath has increased, or that the inhaler is less effective.
• Your doctor may need to increase your dose of BECLONEB, prescribe a course of oral corticosteroids, or change your overall treatment.
• You have a chest infection. Your doctor may prescribe a course of antibiotics.
• If you have a nasal or paranasal sinus infection, you should be treated with appropriate therapies, although this does not specifically contraindicate 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, or coughing after using BECLONEB, stop using BECLONEB immediately and contact your doctor.
After inhalation, rinse your mouth with water to reduce the frequency of fungal infections in the oral cavity.

Switching from oral corticosteroids to BECLONEB
Switching from oral corticosteroids to inhaled corticosteroid therapy may cause general malaise, or you may develop a skin rash, eczema, nasal discharge, or sneezing (rhinitis).
If you experience these symptoms, contact your doctor as soon as possible. Do not stop treatment with BECLONEB unless instructed by your doctor.
If you have taken high-dose oral corticosteroids for a prolonged period, the dose may be gradually reduced approximately one week after starting treatment with BECLONEB. During this period, your doctor will regularly monitor steroid levels in your body.
If you have been treated for a prolonged period with high doses of inhaled corticosteroids, you may require additional corticosteroid treatment during periods of stress, for example:

• during hospitalization following a serious accident,
• before surgery,
• or if you develop a chest infection or other serious illness.
  Your doctor will decide whether you need a course of oral corticosteroids or possibly a corticosteroid injection, and will also advise you on how long the course of oral corticosteroids should last and how to taper them down when you feel better.

Children and adolescents
If a child is under 5 years of age and has been using BECLONEB for a long time to treat recurrent wheezing, the doctor will regularly monitor the child's height to assess for possible growth retardation and consider interrupting treatment.

Other medicines and BECLONEB
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines can increase the effects of BECLONEB, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Inform your doctor if you are taking, have recently taken, or might take any other corticosteroid-containing medicines, as these drugs may interact with BECLONEB and worsen potential side effects.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Since during pregnancy prolonged treatment with corticosteroids (such as beclometasone dipropionate contained in BECLONEB) cannot exclude the possibility of growth retardation or fetal harm, the decision to use BECLONEB in such cases rests with your doctor.
Corticosteroids pass into breast milk in small amounts. To date, no harm to breastfed infants has been reported. Nevertheless, as a precautionary measure, if high doses of beclometasone dipropionate are inhaled, breastfeeding should be avoided for 4 hours following administration of the drug.

Driving and using machines
It is unlikely that BECLONEB will affect your ability to drive or use machinery. However, if you experience side effects such as dizziness and/or tremor, your ability to drive or use machinery may be impaired.

Attention for athletes: This product contains substances prohibited in doping. It is forbidden to take this medicine in a manner different from the therapeutic indications, dosage regimen, or route of administration specified.

3. HOW TO USE BECLONEB

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The initial dose must be prescribed by your doctor according to the frequency and severity of the disease. The dose may then be adjusted by your doctor until effective symptom control is achieved.
The recommended starting doses are:
Adults and adolescents (from 12 years of age):

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

Children (up to 11 years of age):

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

The daily dose should normally not exceed 1600 micrograms 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. Your doctor will decide the duration of treatment.
If the child suffers from recurrent wheezing (wheeze), the duration of treatment should not exceed 3 months, unless otherwise prescribed by the paediatrician.
The BECLONEB 800 microgram vial may be used to obtain 400 micrograms (half the content) by using the half-dose marking as described below.

Method of administration
BECLONEB must be used exclusively by inhalation. Do not inject intravenously or use orally.
BECLONEB should be administered by inhalation using a suitable device (pneumatic nebulizer), according to your 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 forward and backward to loosen it from the strip (Figure A).
2. Carefully separate the vial from the strip, starting from the top, then the center (Figure B), leaving the other vials in the pouch.
3. Shake vigorously and invert the vial to mix the suspension. Repeat this procedure until the entire content is completely dissolved and homogeneously mixed (Figure C).
4. Open the vial by twisting the opening wings as indicated by the arrow (Figure D).
5. Gently squeeze the vial and pour the contents into the nebulizer chamber (Figure E).

The vial must be opened immediately before administration.
If only half the dose of BECLONEB 800 micrograms is required, invert the vial, ensure the half-dose line is clearly visible, and apply gentle pressure. While holding the vial squeezed, dispense the contents until the suspension level reaches the half-dose line (do not exceed this level). Once half the content has been poured, close the vial again by pressing the cap firmly onto it.
The vial closed in this way must be stored at 2°C–8°C (in the refrigerator), and the remaining amount must be used within 12 hours of the first opening.

Dilution
Your doctor may decide that the dose should be diluted.
In this case, empty the vial contents into the nebulizer chamber, then add the amount of sterile sodium chloride solution 9 mg/ml (0.9%, physiological saline) prescribed by your doctor.
After closing the chamber, gently shake to mix the contents.
Dilution of the dose may be necessary to obtain a final volume suitable for the specific nebulizer used, to assist in administering small volumes, or if a prolonged administration time is preferred.

During nebulization
Place the mask or mouthpiece.
Turn on the nebulizer.
Breathe normally. Nebulization should not last longer than 10–15 minutes.

After nebulization
Remember to rinse your mouth, lips, and facial area covered by the mask with water.
After inhalation, any unused suspension remaining in the nebulizer chamber must be discarded.

Cleaning
For cleaning 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 your doctor. Do not increase or decrease the dose without consulting your doctor.
If you have used more BECLONEB than you should, inform your doctor as soon as possible. Your doctor may decide to monitor corticosteroid levels in the blood, and a blood sample may therefore be required.

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 your next dose, do not take the missed dose; simply take the next dose at the scheduled time. Do not use a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been reported. Inform your doctor as soon as possible if you notice any
of these adverse reactions, but do not stop treatment unless instructed to do so.
Your doctor will try to prevent these effects by prescribing BECLONEB at the lowest effective dose possible.

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

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

Common adverse reactions (may affect up to 1 in 10 people):

• Cough
• Nausea and stomach discomfort
• Oral thrush (candidiasis) in the mouth, tongue, and throat. Rinsing the mouth or gargling with water immediately after inhalation may help prevent these effects.

Uncommon adverse reactions (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 BECLONEB. Contact your doctor immediately. Your doctor may need to reassess asthma or recurrent wheezing and, if necessary, initiate a different treatment regimen. You may be advised not to use BECLONEB again.

Rare adverse reactions (may affect up to 1 in 1,000 people):

• Cold sores (herpes simplex) – painful blisters on the lips and in the mouth
• Tremor (involuntary trembling)
• Fatigue
• Allergic reaction (swelling of the eyes, face, lips, and throat leading to severe breathing difficulties, rash, urticaria, itching, or redness).

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• Blurred vision.

The following effects may additionally occur more frequently in children:

• Sleep disturbances, depression or anxiety, restlessness, nervousness, overexcitement, or irritability.

At high doses over a prolonged period, BECLONEB may alter the normal production of corticosteroids in the body. In children and adolescents, this may lead to delayed growth; therefore, it is important that their height is regularly monitored by a doctor. Thinning of the bones (osteoporosis) and eye problems such as clouding of the eye's lens (cataract) and increased pressure in the eye (glaucoma) have also been reported.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report adverse reactions directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE BECLONEB

Keep this medicine out of sight and reach of children.
Do not use BECLONEB after the expiry date stated on the carton, sachet, and vial.
Store the vials upright in their original packaging (cardboard box) to protect the medicine from light.
After first opening the sachet, write the date in the designated space on the sachet. Do not use the vials more than 3 months after the sachet has been first opened.
After first opening the vial, store in a refrigerator (2 °C–8 °C). The remaining amount must be used within 12 hours of first opening.
Do not use BECLONEB if you notice that the packaging is damaged.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What BECLONEB contains
The active substance is beclometasone dipropionate.
Each 2 ml vial contains 800 micrograms of beclometasone dipropionate.
Each vial has a half-dose mark 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 the contents of the pack
BECLONEB is a white or almost white suspension for nebulizer.
BECLONEB suspension is supplied in polyethylene vials containing 2 ml (BECLONEB 800 micrograms). Strips of 5 vials are packed in a sealed pouch, with pack sizes of 10 vials (2 pouches), 20 vials (4 pouches).
It is possible that not all pack sizes are marketed.

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

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