Pulmicort 100 mcg. 200 doses

WHAT Pulmicort TURBUHALER AND WHAT IT IS USED
Pulmicort Turbuhaler is used in the regular treatment of asthma.
Pulmicort Turbuhaler alleviates and prevents the airway inflammation in asthma.
Pulmicort Turbuhaler is intended for regular use and gives quick relief in acute asthma attacks. It may take several weeks to the time of the full effect of the treatment.

2. BEFORE YOU USE Pulmicort TURBUHALER
Do not use Pulmicort Turbuhaler:
If you are allergic (hypersensitive) to budesonide.
Take special care with Pulmicort Turbuhaler
If you switch from cortisone tablets of Pulmicort Turbuhaler, in some cases resume your previous allergy symptoms such as runny nose and eczema. Also, you may feel tired, have a headache, muscle and joint aches, and sometimes nausea and vomiting. This is due to the lowering of the total amount of cortisone in the body when 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 administration 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 may mean that the need dosage adjustments or other treatment is necessary.
In acute asthma attack should use your fast acting antiasthmatic drug.

Taking other medicines
Please 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 Turbuhaler, 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 Turbuhaler during pregnancy, since the severity of asthma may change, which may require adjustment of therapy.
Budesonide is excreted in human milk. However, it is expected intake of Pulmicort Turbuhaler in therapeutic doses affect the infant. Pulmicort Turbuhaler can be used during breastfeeding.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
Pulmicort Turbuhaler does not affect your ability to drive or operate machinery.

3. HOW TO USE Pulmicort TURBUHALER
Always use Pulmicort Turbuhaler exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.
Your doctor prescribe the correct dose for you.
The number of doses varies depending on the severity of your asthma.
You should use Pulmicort Turbuhaler regularly, ie every day even if you have no symptoms.
Pulmicort Turbuhaler is totally under your breath. The drug is inhaled air down the airway. It is therefore important to breathe deeply and strongly when taking your dose, see. "Instructions for use".
Note that the amount of the drug is very small and can be difficult to feel.
You can not feel the taste of the drug or to find another way. However, if you followed the instructions, you can be sure that you have inhaled dose.

If you take more dose Pulmicort Turbuhaler
If once you take more than your prescribed dose, probably will not experience any side effects. However, if over an extended 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 take Pulmicort Turbuhaler
If you forget to take a dose, take the next dose as usual.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Pulmicort Turbuhaler can cause side effects, although not everybody gets them.

Common (greater than 1 in 100 people are affected): Mild irritation in the throat, 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), anxiety, nervousness, depression, changes in behavior (especially in children), bronchoconstriction (tightening of the muscles of the airways), skin bruising, loss of voice.

Reported the following (affects an unknown number of users): Sleep disorders, anxiety, aggression, muscle spasms, tremor (psychomotor hyperactivity).

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 eye pressure);
Growth retardation in children and adolescents (rare);
Interference with the function of the adrenal glands (small glands adjacent to the kidney) (rare).
The probability 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 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 any possible effects not listed in this leaflet. You can also report side effects directly (see. Details below). As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.
Bulgaria
Drug Agency
str. "Damyan Gruev" № 8
1303 Sofia
website: www.bda.bg

5. HOW TO STORE Pulmicort TURBUHALER
Keep out of the reach and sight of children.
Do not store above 30 ° C. Keep the inhaler with closed cap.
Do not use Pulmicort Turbuhaler after the expiry date stated on the packaging after "EXP" or "EXP". The expiry date refers to the last day of that month.
In order to protect the environment and safety, unused or expired drugs should be delivered to the pharmacy. Used single-dose inhalers must be submitted in pharmacy, as a minimum amount of drug in the inhaler always remains.
6. FURTHER INFORMATION
What Pulmicort Turbuhaler
The active substance is budesonide. One dose (inhalation) contains 100 micrograms or 200 micrograms of budesonide.

Pulmicort Turbuhaler looks like and contents of the pack
Pulmicort Turbuhaler is a multidose powder inhaler actuated by inhalation, made of plastic.
Each inhaler contains 100 micrograms of 200 doses.
Each inhaler 200 micrograms contains 100 doses.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
AstraZeneca AB, Sweden.

Manufacturer:
AstraZeneca AB, Sweden.

Instructions for use
Please read the complete instructions carefully before you start taking your medicine.
Turbuhaler is a multidose inhaler, by means of which apply very small amounts of powder. When you breathe in Turbuhalera, powder delivered to your lungs. It is therefore important to breathe heavily and deeply through the mouthpiece.

How to prepare a new inhaler for use
Before using Turbuhaler was first necessary to prepare it for use.
Unscrew the cap and lift it.
Hold the inhaler upright with the handle downwards. Do not hold the mouthpiece when turning the handle. Turn the handle all the way in one direction and then turn completely in the opposite direction.
No matter which way you turn it first. During this procedure you will hear a click.
Now the inhaler is ready for use and should not repeat again the above procedure. To take a dose, please follow the instructions below.

HOW TO USE Pulmicort TURBUHALER
To administer a dose, simply follow the instructions below.
1. Unscrew the cap and lift it.
2. Hold the inhaler upright with the handle downwards. Do not hold the mouthpiece when turning the handle. To load the inhaler with a dose turn the knob all the way in one direction and then turn completely in the opposite direction. No matter which way you turn it first. During this procedure you will hear a click.
3. Hold the inhaler away from your mouth. Exhale. Do not breathe out through the mouthpiece.
4. Carefully place the mouthpiece between your teeth, close your lips and inhale deeply and strongly in the device. Do not chew or bite the mouthpiece.
5. Remove the inhaler from your mouth before exhaling.
6. If prescribed more than one dose, repeat steps 2-5.
7. Recap by fasten tightly.
8. Rinse your mouth with water after you have inhaled the dose prescribed.

NOTE!
Never breathe out through the mouthpiece.
Always put the cap properly after use.
Since the quantity supplied powder is very small, you may not feel the taste after inhalation. However, you can be sure that the dose has been inhaled if you have followed the instructions.

Cleaning
Clean the outside of the mouthpiece regularly (weekly) with a dry cloth.
Do not use water to clean the mouthpiece.