BUDESONIDE 0.25 mg/ml Zawiesina do nebulizacji

Treść ulotki

1. BUDESONIDE SANDOZ
   1. What is Budesonide Sandoz and what is it used for
   2. What you need to know before using Budesonide Sandoz
   3. How to use Budesonide Sandoz
   4. Possible side effects
   5. How to store Budesonide Sandoz

BUDESONIDE SANDOZ

0.25 mg/mlSuspension for nebulizer
0.5 mg/mlSuspension for nebulizer
Equivalent medicine

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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• 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 Budesonide Sandoz is and what it is used for
• 2. What you need to know before you use Budesonide Sandoz
• 3. How to use Budesonide Sandoz
• 4. Possible side effects
• 5. How to store Budesonide Sandoz
• 6. Contents of the pack and other information.

1. What is Budesonide Sandoz and what is it used for

Budesonide belongs to a group of steroids called glucocorticoids that can be used to
reduce or prevent inflammatory reactions (inflammation) of the lungs.
Your medicine is used for the treatment of asthma. It is used in patients in whom other types of inhalers,
such as a pressurized inhaler or an inhaler containing dry powder are not satisfactory or are
inappropriate.
This medicine can also be used for the hospital treatment of very severe cases of
laryngotracheobronchitis (a disease of the throat that can cause difficulty breathing).

2. What you need to know before using Budesonide Sandoz

Do not use Budesonide Sandoz:

• if you are allergic to budesonide 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 Budesonide Sandoz if any of the following conditions apply to
you:

• If you have or have had tuberculosis
• If you have or have had liver disease or liver problems
• If you have a fungal, viral or other respiratory tract infection, for example a cold or lung infections.

Contact your doctor if you experience blurred vision or other visual disturbances.
If you are switching from corticosteroid tablets (such as prednisolone) to Budesonide Sandoz, you may feel a
general feeling of unwellness during discontinuation. You may also experience symptoms that were
suppressed by the corticosteroid tablets, such as allergic rhinitis (itching, stuffy or runny nose),
eczema (dry and itchy skin), muscle and joint pain. If this happens, ask your doctor for advice.
Budesonide Sandoz is not indicated for use in case of an attack of shortness of breath. A sudden
attack of shortness of breath should be treated with a short-acting bronchodilator.
If you experience more wheezing and/or shortness of breath immediately after using Budesonide Sandoz,
stop using budesonide nebulizer suspension immediately and consult your doctor.
To reduce the risk of contracting oral thrush (white patches on the tongue or in the mouth), rinse your
mouth with water (spit out the water - do not swallow) and brush your teeth after using Budesonide Sandoz.
Contact your doctor if you develop oral thrush.

Children and adolescents
In rare cases, long-term treatment with budesonide may slow down the normal growth of children and
adolescents. If your child is using this medicine for a long time, it is normal for the doctor to check their
height regularly.
Budesonide is a steroid. You should be aware that it may result in a positive doping test due to
the use of this medicine. You should discuss this with your doctor if you have any doubts.
For athletes, the use of the drug without therapeutic need constitutes doping and may still result in a positive doping test.

Other medicines and Budesonide Sandoz
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
Budesonide Sandoz and your doctor may want to monitor you closely if you are taking these
medicines:

• Medicines for the treatment of a fungal infection such as ketoconazole or itraconazole;
• Some medicines for the treatment of HIV: ritonavir, saquinavir, cobicistat
• Antibiotic medicines, erythromycin and clarithromycin;
• Other medicines that help you breathe
• Estrogens and contraceptive steroids.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant
while taking this medicine, you should inform your doctor as soon as possible.

Driving and using machines
Inhaled budesonide does not alter or alters negligibly the ability to drive vehicles and use
machinery.

3. How to use Budesonide Sandoz

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist.
The doctor will inform you about the correct dose to take, which will depend on the severity of your asthma.

Asthma
You may notice an improvement in your asthma within 3 days, but it may take 2-4 weeks
before the full effect is achieved. It is important that you continue to take the medicine as directed
by your doctor even if you feel better.

Adults (including the elderly) and adolescents from 12 years of age:
The usual dose is 0.5-2.0 mg of budesonide per day. This dose is usually taken at two
different times during the day, however if your asthma is stable and not severe, your doctor may advise
you to take the medicine once a day. The doctor will tell you how and when it is best to take the
medicine and you must always follow their instructions.

Infants and children (from 6 months to 11 years):
The usual dose is 0.25-1.0 mg of budesonide per day. The doctor will inform you about how your child should
take the medicine, but usually it will be at two different times during the day. However
if their asthma is stable and not severe, the doctor may advise taking the medicine once a
day.

Laryngotracheobronchitis:
The usual dose for infants and children with laryngotracheobronchitis is 2 mg. This dose is
administered as a single dose or in two doses of 1 mg spaced 30 minutes apart. Treatment may be
repeated every 12 hours, if necessary until improvement is visible, for a maximum of 36 hours.

Instructions for use:
The medicine must be used with a pneumatic nebulizer. The vapors produced are then inhaled
through a mouthpiece or an inhalation mask. Ultrasonic nebulizers must not be
used with this medicine.
Take the medicine following these instructions:

• 1. Separate one vial from the strip, leaving the rest in the aluminum pouch (see figure 1).
• 2. Gently shake the vial.
• 3. Open the vial by rotating the top (see figure 2).
• 4. Empty the liquid from the vial by pouring it into the nebulization chamber. Reposition the top of the nebulization chamber and carefully discard the empty vial.
• 5. Connect one part of the chamber to the mouthpiece or the nebulization mask and the other part to the pneumatic pump.
• 6. Gently shake the chamber again and then turn on the nebulizer. Breathe in the vapor calmly and deeply using the mouthpiece or the nebulization mask.
• 7. When no more vapor comes out of the mouthpiece or the nebulization mask, the treatment is complete.

• 8. Rinse your mouth with water (spit out the water - do not swallow) and wash your teeth. If you have used a nebulization mask, you should also wash your face well. It is important to perform these operations as they may reduce the risk of some undesirable effects associated with this medicine.
• 9. You must clean the nebulizer after each use. Wash the tank and the mouthpiece or the nebulization mask with warm water using a mild detergent according to the manufacturer's instructions. The nebulizer must be rinsed well and dried by reconnecting the tank to the pneumatic pump.

It is important that you follow the manufacturer's instructions that accompany the nebulizer. If you have any doubts
about using the nebulizer, inform your doctor or pharmacist.

The doctor may also prescribe:

• The doctor may consider adding steroids in tablets to your treatment during periods of stress (e.g. if you have an infection), or if you have taken a high dose of an inhaled steroid for a long time, or before an operation.
• If you have taken steroid tablets for asthma, your doctor may reduce the number of tablets you take after you have started treatment with Budesonide Sandoz. You may experience some symptoms as a result, which include a stuffy or runny nose, loss of energy, depression, eczema (a type of skin rash) and pain in the joints and/or muscles. If any of these symptoms worry you or persist, inform your doctor.
• The doctor may ask you to mix this medicine with solutions that contain other active ingredients that act on the respiratory system such as salbutamol, terbutaline, sodium cromoglycate and ipratropium bromide. If so, follow the instructions carefully. You should not mix this medicine unless specified by your doctor.

If you use more Budesonide Sandoz than you should
Contact your doctor or pharmacist as soon as possible. Remember to bring the package and each remaining vial
with you. It is important that you take your dose as specified on the pharmacist's label or as
advised by your doctor. Do not increase or reduce your dose without asking your doctor for advice.

If you forget to use Budesonide Sandoz
Do not take a double dose to make up for a missed dose. Take the next dose as usual.
If you have any doubts about using 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.
manifest.

All medicines can cause allergic reactions, although serious allergic reactions are very
rare. Tell your doctor immediately if you experience sudden shortness of breath, difficulty
breathing, swelling of the eyelids, face or lips, rash or itching
(especially if all over the body).
Rarely, inhaled medicines such as budesonide can cause acute shortness of breath and/or breathlessness.
If this happens, stop using the medicine immediately and seek medical help.
The following side effects have been reported.

Common:may affect up to 1 in 10 people
Soreness and/or irritation of the mouth (including oral thrush), hoarseness, sore throat, difficulty
swallowing and cough.

Uncommon:may affect up to 1 in 100 people
Cataract (clouding of the lens of the eye), depression or feeling worried, muscle spasms,
tremor, blurred vision.

Rare:may affect up to 1 in 1000 people
Skin reactions including itching, rash, bruising, inflammation, redness of the skin and/or
skin eruptions, swelling, delayed growth in children and adolescents, hypersensitivity (allergy to
the medicine) and bronchospasm (tightening of the muscles of the airways leading to asthma).
Voice problems.
Suppression of the adrenal gland (a small gland near the kidney) can also occur. The
main symptoms of adrenal suppression include headache, fatigue, feeling and being unwell,
weight loss, stomach pain and loss of appetite.
Feeling restless, nervous, overexcited, irritable or depressed (these effects are more
likely to occur in children).

Very rare side effects:may affect up to 1 in 10000 people
Decreased bone mineral density (thinning of the bones).

Not known:frequency cannot be estimated based on available data
Glaucoma (increased pressure in the eye), aggressiveness, increased motor activity (difficulty staying
still), sleep disorders. .
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 Budesonide Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging and on the aluminium sachet
after Expiry. The expiry date refers to the last day of that month.
Store the vials in the aluminium sachet and in their original carton to protect the medicine from
light and humidity.
Once opened, the single vial must be used within 12 hours. After this time, the vial and the
remaining contents must be discarded.
Once the aluminium sachet has been opened, the vials inside must be used within three months
(it is a good idea to mark the date of opening on the aluminium sachet to help remember).
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 contains Budesonide Sandoz:
• The active ingredient is budesonide.
• The other ingredients are disodium edetate, sodium chloride, polysorbate 80, citric acid, sodium citrate and water for injections Budesonide Sandoz 0.25 mg Suspension for nebulizercontains 0.5 mg of budesonide (0.25 mg/ml) as the active ingredient in each 2 ml vial.

Budesonide Sandoz 0.5 mg Suspension for nebulizercontains 1 mg of budesonide (0.5 mg/ml) as
the active ingredient in each 2 ml vial.

Description of the appearance of Budesonide Sandoz and contents of the pack
The medicine is presented as plastic vials containing 2 ml of a whitish-white suspension for
nebulization (converted into a fine vapor for inhalation).
The vials are packaged in strips of 4, 5, 8, 10 or 12 inside an aluminium sachet, in turn
packaged in a carton. The cartons are available in packs containing 5, 20, 24, 40 or 60 vials.
Not all packs may be marketed.

Marketing Authorisation Holder
Sandoz SpA,
L.go U. Boccioni 1,
21040 Origgio (VA)
Italy

Manufacturer
LABORATOIRE UNITHER 151 rue André Durouchez, CS 28028, 80084 Amiens Cedex 2
(France)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Denmark Budesonid Arrow
Belgium Budesonid Sandoz 0.25mg/ml and 0.5mg/ml vernevelsuspensie
Germany BUDENOBRONCH 0.5mg/2 ml and 1.0mg/2ml Suspension für einen
Vernebler
Spain Budesonida Aldo-Unión 0.25mg/ml and 0.5mg/ml suspension for inhalation by
nebulizer
Ireland Budesitan 0.5mg/2ml and 1.0mg/2ml Nebuliser Suspension
Italy Budesonide Sandoz 0.25 mg/ml and 0.5 mg/mlsuspension for nebulizer
Luxembourg Budesonid „Arrow“ 0.5mg/ml Suspension für einen Vernebler
Netherlands Budesonide Arrow 0.125mg/ml, 0.25mg/ml and 0.5mg/ml vernevelsuspensie in
ampul, 2ml.
Norway Budesonid Arrow inhalasjonsvæske til nebulisator, suspensjon 0.125mg/ml,
0.25mg/ml and 0.5mg/ml
Portugal Budesonido Arrow 0.25mg/ml and 0.5mg/ml, Suspensão para Inalação por Nebulização
Sweden Budesonid Arrow 0.125mg/ml, 0.25mg/ml and 0.5mg/ml suspension för nebulisator
United Kingdom Budesonide 0.25mg, 0.5mg Nebuliser Suspension