Beclometasone Teva

Patient Information Leaflet: Information for the User

Beclometasone Teva 400 micrograms Suspension for Nebuliser, 800 micrograms Suspension for Nebuliser

Beclometasone dipropionate
Generic medicine
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 other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Beclometasone Teva is and what it is used for

Beclometasone Teva contains the active substance beclometasone dipropionate. Beclometasone must not be confused with the "anabolic" steroids abused by some athletes and taken as tablets or injections. 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.
Beclometasone Teva 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.
Beclometasone Teva is also indicated for the treatment of recurrent wheezing (wheezing breath) in children up to 5 years of age.

2. What you need to know before using Beclometasone Teva

Do not use Beclometasone Teva:

• 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 Beclometasone Teva 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 is getting worse, or that the inhaler is less effective.
• Your doctor may need to increase your dose of Beclometasone Teva, prescribe a course of oral corticosteroids, or change your entire treatment.
• You have a chest infection. Your 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 specifically contraindicate the use of Beclometasone Teva.

If you experience an immediate increase in wheezing, shortness of breath, or coughing after using
Beclometasone Teva, stop using Beclometasone Teva immediately and contact your doctor.
After each inhalation, rinse your mouth with water to reduce the frequency of fungal infections in the
mouth.

Switching from oral corticosteroids to Beclometasone Teva
Switching from oral corticosteroids to inhaled corticosteroid treatment may cause you to feel generally unwell, or you may develop a skin 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
Beclometasone Teva unless instructed by your doctor.
If you have taken high-dose oral corticosteroids for a prolonged period, the dose may be gradually reduced starting about one week after beginning treatment with
Beclometasone Teva.
During this period, your doctor will regularly monitor your corticosteroid levels.

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 you should continue taking oral corticosteroids and how to taper them as you start feeling better.

Contact your doctor if you experience blurred vision or other visual disturbances.

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

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

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 Beclometasone Teva) cannot exclude potential growth delays or fetal harm, the decision to use Beclometasone Teva will be made by 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 after administration of the drug.

Driving and using machines
It is unlikely that Beclometasone Teva 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.

3. How to use Beclometasone Teva

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The initial dose must be prescribed by your doctor depending on the frequency and severity of the
condition. The dose may then be adjusted by your doctor until effective control of symptoms is achieved.
Recommended initial 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, Beclometasone Teva 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 Beclometasone Teva 800 microgram vial may be used to obtain 400 micrograms
(half the content) by using the half-dose marking line, as described below.
Method of administration
Beclometasone Teva is for inhalation use only. Do not inject intravenously or use orally.
Beclometasone Teva should be administered by inhalation using a suitable device (a pneumatic nebulizer) as instructed by your doctor.
The use of Beclometasone Teva with ultrasonic nebulizers is not recommended.
Instructions for use
The vial should be used according to the following instructions:

1. Open the sachet and remove a strip of plastic containers. Detach one container from the strip by rotating and pulling it (Figure 1).

2. Shake the vial vigorously and turn it upside down to mix the suspension. Repeat this until the entire content is completely dissolved and mixed. Hold the container upright and open it by twisting the top tab (Figure 2).

3. Gently squeeze the vial and pour its contents into the nebulizer chamber (Figure 3).

The vial must be opened immediately before administration.
The 400 microgram vial is for single use only.
If only half the dose of Beclometasone Teva 800 micrograms is required, turn the vial upside down,
ensure the half-dose line is clearly visible, and gently press the vial. While maintaining pressure, allow the contents to be dispensed until the suspension level reaches the half-dose line, without exceeding it. Once half the content has been poured out, discard the remaining suspension.
Dilution:
Your doctor may decide that the dose should be diluted.
In this case, empty the contents of the vial into the nebulizer chamber, then add the amount of sterile sodium chloride solution 9 mg/ml (0.9%, physiological saline) prescribed by your doctor.
Close the chamber and gently shake to mix the contents.
Dilution of the dose may be necessary to achieve 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
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 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 Beclometasone Teva than you should:
It is important to use the dose prescribed by your doctor. Do not increase or reduce the dose without consulting
your doctor.
If you have used more Beclometasone Teva 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 Beclometasone Teva:
If you forget to take a dose, take it as soon as you remember. If it is almost time for the 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 a forgotten dose.
If you have any doubts about how to use this medicine, consult 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. Inform your doctor as soon as possible if you notice any of these side effects, but do not stop treatment unless your doctor has told you to do so. Your doctor will try to prevent these side effects by prescribing Beclometasone Teva at the lowest effective dose.

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

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

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

• Cough
• Nausea and stomach discomfort
• Oral thrush (fungal infection) in the mouth, tongue, and throat. Rinsing the mouth or gargling with water immediately after inhalation may help 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 Beclometasone Teva. Contact your doctor immediately. Your doctor will likely assess your asthma or recurrent wheezing and, if necessary, start a different treatment regimen. You may be advised not to use Beclometasone Teva 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 trembling)
• Tiredness
• Allergic reaction (swelling of the eyes, face, lips, and throat leading to severe breathing difficulties, rash, hives, itching, or redness).

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• Blurred vision

The following effects may additionally occur more frequently in children:

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

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

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 national reporting system at: 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 Beclometasone Teva

Keep this medicine out of the sight and reach of children.
Do not use Beclometasone Teva after the expiry date stated on the carton, sachet, and vial. The expiry date refers to the last day of that month.
Store the vials in their original packaging (cardboard box) to protect the medicine from light.
Do not use the vials more than 3 months after the date of first opening of the sachet.
Do not use Beclometasone Teva 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Beclometasone Teva contains
The active substance is beclometasone dipropionate.
Each vial contains 400 micrograms of beclometasone dipropionate in 1 ml.
Each vial contains 800 micrograms of beclometasone dipropionate in 2 ml.
The 800 microgram vial has a half-dose marking corresponding to half of its content (equivalent to 400 micrograms).
The other excipients are polysorbate 20, sorbitan laurate, sodium chloride and water for injectable preparations.

Description of the appearance of Beclometasone Teva and contents of the pack
Beclometasone Teva is a white or almost white suspension for nebuliser.
Strips of 5 vials are packed in a pouch, which is placed in a cardboard box. Each box contains 5, 10, 15, 20, 25, 30, 40, 50 or 60 vials, corresponding respectively to 1, 2, 3, 4, 5, 6, 8, 10 and 12 pouches.
Each multiple pack contains 40 vials (2 packs of 20 vials).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milano, Italy

Manufacturer
Norton Healthcare Limited T/A IVAX Pharmaceuticals UK
Aston Lane North, Whitehouse Vale Industrial Estate, Preston Brook, Runcorn, Cheshire
WA7 3FA, United Kingdom

Merckle GmbH,
Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany

This medicinal product is authorised in the European Economic Area countries under the following names:

France
BECLOMETASONE TEVA 400 microgrammes/1 ml, suspension for inhalation by nebuliser in single-dose container
BECLOMETASONE TEVA 800 microgrammes/2 ml, suspension for inhalation by nebuliser in single-dose container

Germany
Ventolair Steri-Neb 400 Mikrogramm Suspension für einen Vernebler
Ventolair Steri-Neb 800 Mikrogramm Suspension für einen Vernebler

Italy
Beclometasone Teva