0.125 mg / ml, 0.25 mg / ml and 0.5 mg / ml suspension for nebuliser 
budesonide

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Budesonide Teva Pharma Nebulizer Suspension is and what it is used for 
2. What you need to know before you use Budesonide Teva Pharma Nebulizer Suspension 
3. How to use Budesonide Teva Pharma Nebulizer Suspension 
4 Possible side effects 
5. How to store Budesonide Teva Pharma suspension for nebulizer 
6. Contents of the packaging and other information 

What Budesonide Teva Pharma Nebulizer Suspension is and what it is used for

Budesonide belongs to a group of steroids called glucocorticosteroids that can be used to suppress or prevent inflammatory reactions (swelling) in the lungs.

This medicine can be used by adults, adolescents and children over 6 months.

Your medicine is used to treat asthma. It is used in patients where the use of other types of inhaler , e.g. an inhalation spray or powder inhaler, are unsuitable or do not provide sufficient effect.

Budesonide Teva Pharma suspension for nebulizer can also be used in hospitals for infants and children for the treatment of very severe false croup (pseudo crop; laryngitis subglottic).

Budesonide contained in Budesonide Teva Pharma may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before using Budesonide Teva Pharma nebulizer suspension

Do not use Budesonide Teva Pharma suspension for nebulizer:

  • if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor before using Budesonide Teva Pharma suspension for nebulizer if any of the following apply to you:

  • if you have or have had tuberculosis
  • if you have or have had liver disease or liver problem
  • if you have a fungal or viral infection or other infection of the respiratory tract e.g. a cold or respiratory infection.

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

Children and young people

In rare cases, growth in children and adolescents may decrease with long-term treatment with budesonide. If your child has been using this medicine for a long time, your doctor will usually want to check your child’s height regularly.

Other medicines and Budesonide Teva Pharma suspension for nebulizer

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

  • Some medicines may increase the effects of Budesonide Teva Pharma and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat)
  • medicines for fungal infections e.g. ketoconazole or itraconazole
  • antibiotics, erythromycin, and clarithromycin
  • other medicines to help you breathe
  • estrogen er and contraceptives that contain steroids er.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, do not use Budesonide Teva Pharma suspension for nebulizer unless your doctor prescribes it. If you become pregnant while taking this medicine, talk to your doctor as soon as possible.

Driving and using machines

Budesonide Teva Pharma suspension for nebulizer is unlikely to affect your ability to drive or use tools or machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to use Budesonide Teva Pharma nebulizer suspension

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will tell you what dose to take. Dose one varies depending on how severe your asthma is.

You may notice that your asthma improves within 3 days, but it can take between 2 – 4 weeks before the medicine has full effect. It is important that you continue to use your medicine according to your doctor’s instructions even if you feel better.

Asthma

The recommended dose is:

Adults (including the elderly) and young people aged 12 and over:

The usual dose is 0.5 mg to 2.0 mg of budesonide daily. This dose is usually divided into two separate sessions during the day, but if your asthma is stable and not severe, your doctor may advise you to take the medicine once a day. Your doctor will tell you how and when it is best to take your medicine and you should always follow your doctor’s instructions.

Children (from 6 months to 11 years):

The usual dose is 0.25 mg to 1.0 mg of budesonide daily. The doctor tells you how your child should take the medicine, usually, the dose is divided into two separate sessions during the day. If your child’s asthma is stable and not severe, your doctor may advise you to take the medicine once a day.

False croup

The usual dose for infants and children is 2 mg budesonide daily. This dose can be given as a single dose (2 ampoules of 0.5 mg/ml strength) or 1 mg followed by another 1 mg 30 minutes later. Dose one can be repeated every 12 hours up to a maximum of 36 hours or until improvement is achieved.

User manual:

Your medicine should be used with a jet nebulizer. The vapor that is formed is then inhaled through a nozzle or a face mask. Ultrasonic nebulizer should not be used with this medicine.

Take your medicine according to the following steps:

  1. Break the sterile plastic container (single-dose container) from the labeled strip by twisting and pulling (Figure 1).
  2. Gently shake the single-dose container with a circular motion for about 10 seconds, or until no precipitate is visible.
  3. Hold the single-dose container upright and turn off the upper part (Figure 2).
  4. Squeeze all the liquid contained in the single-dose container into the nebulizer container (Figure 3). Put the cap back on the nebulizer container and discard the single-dose container.
  5. Assemble one end of the nebulizer container with the nozzle or face mask and the other end with the air pump.
  6. Gently shake the nebulizer container again, then start the nebulizer. Inhale the vapor calmly and deeply through the mouthpiece or face mask.
  7. When no more steam comes out of the nozzle or face mask, the treatment is completed.
  8. Rinse mouth with water (spit out water – do not swallow). If you have used a face mask, you should also wash your face. It is important to do this as it may reduce the risk of certain side effects associated with this medicine.
  9. You must clean the nebulizer after each use. Clean the nebulizer container and the nozzle or face mask with warm water and mild detergent according to the manufacturer’s instructions. Rinse well and dry the nebulizer tank by connecting it to the air pump.

It is important that you always follow the manufacturer’s instructions that come with the nebulizer. If you are not sure how to use the nebulizer, talk to your doctor or pharmacist.

Your doctor may also prescribe the following:

  • Your doctor may consider adding steroid tablets to your treatment during periods of stress (eg if you have an infection ), or if you have been using a high dose of an inhaled steroid for a long time, or before an operation.
  • If you have been taking steroid tablets for your asthma, your doctor may reduce the number of tablets when you start using Budesonide Teva Pharma suspension for nebulizer. You may experience some symptoms as a result such as a stuffy or runny nose, lack of energy, depression, eczema (a type of rash), and joint and/or muscle pain. If any of these symptoms bother you or persist, consult a doctor.
  • Your doctor may want you to mix this medicine with 0.9% sodium chloride solution or solutions containing other active substances that affect breathing e.g. salbutamol, terbutaline, sodium cromoglycate, and ipratropium bromide. Follow the instructions for these medicines carefully. Mixture one should be used within 30 minutes. You should not mix this medicine unless your doctor tells you to.

If you see a doctor or hospital, remember to take the pack and the remaining single-dose containers with you. It is important that you take a dose as stated on the label of the package or as your doctor has informed you. Do not increase or decrease the dose without consulting a doctor.

If you forget to use Budesonide Teva Pharma suspension for nebulizer

Do not take the missed dose once or twice as much to make up for a forgotten dose. Simply take the next dose at the usual time.

Talk to your doctor or pharmacist if you have any further questions on the use of this product.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, but severe allergic reactions are very rare. Contact a doctor immediately if you suddenly experience wheezing, difficulty breathing, swollen eyelids, face or lips, rash, or itching (especially if it affects the whole body).

Drugs that are inhaled e.g. budesonide may in rare cases cause wheezing and/or shortness of breath. If this happens, stop using the medicine immediately and contact a doctor.

The following side effects have been reported:

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

  • Sores and/or irritation in the mouth (including fungal infection in the mouth), irritation in the throat, difficulty swallowing, and coughing.

Less common side effects are (may affect up to 1 in 100):

  • Anxiety
  • Depression
  • Tremors
  • Cataract (cloud of the lens of the eye)
  • Muscle cramps
  • Dimsyn

Rare side effects are (may affect up to 1 in 1000 people):

  • Skin reactions with itching, rash, bruising, inflammation, redness of the skin and / or skin rash, swelling, decreased growth in children and adolescents, hypersensitivity ( allergy to the drug) and bronchospasm (spasm of the tracheal muscles which causes wheezing).
  • Impaired adrenal function (a small gland near the kidney) may also occur. The main symptoms of adrenal insufficiency are headache, fatigue, nausea, vomiting, weight loss, stomach pain and loss of appetite.
  • Feeling restless, nervous, and irritated (these side effects are more likely to occur in children).
  • Hoarseness, changes in voice.

Very rare side effects are (may affect up to 1 in 10 000 users):

  • Change in bone density (thinning of the skeleton).

Has been reported (occurs in an unknown number of users):

  • Cataracts (increased pressure in the eye), aggression, sleep problems, and the feeling of being very hurried.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Budesonide Teva Pharma suspension for nebulizer

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton after EXP. and on the foil package and single-dose container after EXP. The expiration date is the last day of the specified month.

Do not freeze.

Store standing.

Once the foil package has been opened, the single-dose containers should be used within 3 months (it is a good idea to mark the opening date on the foil package to remember the date). Store the single-dose containers in the foil package. The opened foil package is stored in the outer carton. Sensitive to light.

Each single-dose container is for single use only.

Opened single-dose container: use immediately. Discard any remaining content.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is budesonide

Budesonide Teva Pharma 0.125 mg/ml suspension for nebulizer contains 0.25 mg of the active substance budesonide in each 2 mL dose container.

Budesonide Teva Pharma 0.25 mg/ml suspension for nebulizer containing 0.5 mg of the active substance budesonide in each 2 mL dose container.

Budesonide Teva Pharma 0.5 mg/ml suspension for nebulizer contains 1 mg of the active substance budesonide in each 2 mL dose container.

  • The other ingredients are disodium edetate, sodium chloride, Polysorbate 80 (E433), citric acid monohydrate (E330), sodium citrate (E331), and water for injections.

What the medicine looks like and contents of the pack

The medicine is supplied in single-dose plastic containers containing 2 ml of white to off-white sterile suspension for nebulization (turns into vapor for inhalation).

Strips with 5 single-dose containers are packed in a foil package which is then packed in a carton. Each carton contains 5, 10, 15, 20, 25, 30, 40, 50 or 60 single-dose containers .

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Teva Pharma BV Swensweg 5, 2031 GA Haarlem, The Netherlands.

Manufacturer:

Merckle GmbH

Ludwig-Merckle-Str. 3

89143 Blaubeuren

Germany

Muhammad Nadeem

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