Pulmicort 0.25mg ml
Pulmicort 0.25mg / ml
What is Pulmicort suspension for nebulizer and what it is used
What is Pulmicort suspension for nebulizer
Pulmicort suspension for nebulizer containing drug called budesonide. It belongs to a group of medicines called "corticosteroids".
How does Pulmicort suspension for nebulizer
Pulmicort suspension nebuliser alleviates and prevents inflammation of the airways.
What is it used Pulmicort suspension for nebulizer
Pulmicort suspension nebulizer is used in the regular treatment of asthma. It is used to treat many serious psevdokrup in infants and children.
2 Before using Pulmicort suspension for nebulizer
Do not use Pulmicort suspension for nebulizer
if you are allergic (hypersensitive) to budesonide or any of the other ingredients of Pulmicort.
Warnings and Precautions
If you switch from cortisone tablets Pulmicort, in some cases, a renewal of your previous allergic symptoms such as fever and eczema. Also, you may feel tired, have a headache, muscle and joint aches, and sometimes nausea and vomiting. This is due to the decreased total amount of cortisone in the body where the disease is treated locally in the lung. These symptoms disappear after taking some time therapy.
It is important to tell your doctor if you have impaired liver function.
After each application should rinse your mouth with water to minimize the risk of fungal infection of the mouth and throat.
If your asthma gets worse, you should contact your doctor. This could mean that the need dosage adjustments or other treatment is necessary.
In acute asthma attack must use your fast-acting antiasthmatic drug.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may affect or be affected by treatment with Pulmicort, eg. those containing ketoconazole or itraconazole (contained in antifungals), HIV-protease inhibitors (such as ritonavir and nelfinavir).
Pregnancy and lactation
Experience with the drug during pregnancy showed no increased risk of malformations. However, you should talk to your doctor before using Pulmicort during pregnancy because of asthma severity may change, which may require adjustment of therapy.
Budesonide is excreted in human milk. However, it is expected intake of therapeutic doses of Pulmicort affect the infant. Pulmicort can be used during lactation.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Pulmicort nebulizer suspension is unlikely to affect your ability to drive or operate machinery.
3 How to use Pulmicort suspension for nebulizer
Always use Pulmicort exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.
Your doctor prescribe the right dose for you.
The number of doses varies depending on the severity of your asthma.
You should use Pulmicort regularly, ie every day even if you have no symptoms.
Pulmicort suspension nebuliser is inhaled by the nebulizer device (inhaler). When you breathe in through the mouthpiece or face mask, the drug is inhaled air down the airway. Therefore, it is important to breathe evenly and safely when you inhale a dose, see "Instructions for Use".
Instructions for use
Pulmicort nebulizer suspension should be used only in special inhaler called a nebulizer.
1 Shake the suspension before use by gently shaking in a circular motion of a single dose unit.
2 Hold the single dose unit upright and open it by breaking a wing.
3 Squeeze the liquid in the chamber of the nebulizer.
Single dose unit is marked with a line (Pulmicort 0,25 mg / ml). This line indicates the volume of 1 ml, where a single dosage unit is held upside. If you will only be used 1 ml, empty the contents until the liquid level reaches the indicator line.
Keep an open single dose unit, protected from light. An open single-dose unit should be used within 12 hours. Shake the single dose unit before using the remaining liquid.
As always nebuliser contains 2 ml before opening must dilute it with saline (or other solution nebulizer if prescribed by your doctor) if you inhale only 1 ml of Pulmicort suspension for nebulizer.
When you inhale, it is important to breathe calmly and evenly through the mouthpiece of the nebulizer. To facilitate breathing in children can be used face mask.
Rinse your mouth with water after each inhalation to remove any residue of the drug in the mouth.
If using a face mask, make sure that the mask is tight as you inhale and wash your face after use.
Clean the camera nebulizer and mouthpiece or face mask in warm water using a mild detergent after each use. Rinse well and dry.
For more information, read the manufacturer's recommendations nebulizer.
If you use more than the amount of Pulmicort suspension for nebulizer
If once you take more than your prescribed dose probably will not experience any side effects. However, if a long period of time (months) receive higher doses than prescribed, there is a risk of side effects. If you think you suffer from side effects, contact your doctor or the hospital.
It is important to take the dose you are prescribed or as advised by your doctor. Should not raise or lower your dose without seeking medical advice.
If you forget to use Pulmicort suspension for nebulizer
If you forget to take a dose, take your next dose as usual.
4 Possible side effects
Like all medicines, Pulmicort can cause side effects, although not everybody gets them.
Common (more than 1 in 100 people are affected): Slight throat irritation, coughing, hoarseness, fungal infection of the mouth and throat.
Rare (less than 1 in 1,000 people are affected): hives or other skin rash, angioedema (swelling of face, lips, tongue and / or throat, sometimes combined with difficulty in breathing and swallowing), anaphylactic reaction (severe allergic reaction which causes difficulty in breathing or dizziness), restlessness, nervousness, depression, behavioral changes (especially in children), bronchoconstriction (tightening of the muscles of the respiratory tract), skin bruising, loss of voice.
Reported the following (affects an unknown number of users): Sleep disorders, anxiety, aggression, muscle spasms, tremors (psychomotor hyperactivity).
In some cases, when using the face mask, has been reported to inflammation of the skin. To avoid this, you should always wash your face after using a face mask, see "Instructions for Use".
Inhaled corticosteroids can affect the normal production of steroid hormones in your body, especially if you take them at high doses for prolonged periods of time. These effects include:
Cataract (clouding of the lens of the eye);
Glaucoma (increased pressure);
Growth retardation in children and adolescents (rare);
Influence the function of the adrenal glands (small glands adjacent to the kidneys) (rare).
The likelihood of the development of these effects is much smaller when taking inhaled corticosteroids than with corticosteroid in the form of tablets.
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
Adverse event reporting
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all listed in this leaflet. You may also report side effects directly (see. Detailed information below). As reported side effects, you can do your bit to get more information on the safety of this medicine.
5 How to store Pulmicort suspension for nebulizer
Keep each single dose unit in a closed foil bag. Sensitive to light.
Single dose unit should be stored upright. Do not store above 30 ° C.
The single dosage unit of an open foil bag should be used within 3 months.
An open single-dose unit should be used within 12 hours. Note: Even if it is used only 1 ml, the remaining volume is no longer sterile.
Keep out of reach of children.
Do not use Pulmicort after the expiry date stated on the carton after "EXP" or "EXP". The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6 Package Contents and more information
Contents of Pulmicort suspension for nebulizer
The active substance is budesonide. A single unit dose (2 ml) contains 0,5 mg of budesonide.
The other ingredients are disodium edetate, sodium chloride, polysorbate 80, citric acid (anhydrous), sodium citrate and water for injection. These ingredients are excipients in the manufacture of suspension.
Looks like Pulmicort suspension for nebulizer and contents of the pack
Each package (20 x 2 ml) contains 4 foil bag with 5 single dose units each containing 2 ml of sterile saline.
Each package (40 x 2 ml) contains 8 foil bag with 5 single dose units each containing 2 ml of sterile saline.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Astra Zeneca AB, Sweden.