Pressido

PRESSIDO 200 is an inhaler used for the prevention of the symptoms of asthma. When you breathe in through the mouthpiece of the inhaler, your breath carries the medicine to your lungs. PRESSIDO 200 acts directly on your airways to reduce inflammation. This helps to improve your asthma condition and to prevent asthma attacks from occurring.

Do not take PRESSIDO 200:

• if you are hypersensitive (allergic) to budesonide or any of the other ingredients of PRESSIDO 200 listed in section 6.1.
• if you have a lung infection.
• if you have a cold or chest infection or any problems with your breathing.
• if you have or have ever had tuberculosis (TB).

Warnings and precautions

Talk to your doctor or pharmacist before taking PRESSIDO 200. Your doctor or pharmacist will instruct you on the correct use of your PRESSIDO 200 inhaler. Each pack of PRESSIDO 200 contains an instruction leaflet that tells you the correct way to use it. Please read this carefully. It is important to use PRESSIDO 200 every day even if you have no asthma symptoms at the time. Your breathing may improve within 2 days. However it can take up to 4 weeks for the medicine to have its full effect. Be sure to rinse your mouth out with water after every time you use PRESSIDO 200. This is to help reduce the chance of developing thrush in your mouth. This water should not be swallowed.

PRESSIDO 200 can affect the adrenal gland (a small gland next to the kidney). Report to your doctor any side effects that you think might be caused by PRESSIDO 200 as your adrenal glands begin to produce much less hormone than usual. In some cases, they stop producing the hormone altogether. Symptoms may include:

• Unusual fatigue and muscle weakness
• Dizziness when standing
• Nausea, vomiting and/or diarrhea
• Loss of appetite
• Stomachache
• Weight loss
• Dark tanning of the skin
• Craving for salt

If you feel you are getting breathless or wheezy while using PRESSIDO 200, you should stop using PRESSIDO 200 and see your doctor as soon as possible, as you may need additional treatment. Contact your doctor immediately if:

• Your breathing is getting worse or you often wake up at night with asthma
• Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual.

These signs could mean that your condition is not being properly controlled and you may need different or additional treatment immediately. Inhaled corticosteroids such as PRESSIDO 200 can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time, for example 400 micrograms or more daily for several years. The effects include:

• Cushing's syndrome with a collection of signs and symptoms which may include high blood pressure, abdominal obesity but with thin arms and legs, reddish stretch marks, a round red face, a fat lump between the shoulders, weak muscles, weak bones, acne, and fragile skin that heals poorly
• a slowing of the rate of growth of children and adolescents.
• changes in bone mineral density (thinning of the bones).
• cataracts or glaucoma (increased pressure in the eye), sleeping problems, anxiety, depression, aggressiveness, increased motor activity (difficulty to stay still) and irritable. These effects are more likely to occur in children.

Inform your doctor if you have liver disease. You should tell your doctor if you have any of the following symptoms, which could be signs of chest infection: fever or chills, increased mucus production or change in mucus colour, increased cough or increased breathing difficulties. If you have been prescribed PRESSIDO 200 and still are using “steroid” tablets, your doctor may gradually (over a period of weeks or months) reduce your dose of tablets. You may even be able to eventually stop using the tablets. If your medicine is changed from “steroid” tablets to PRESSIDO 200 you may temporarily regain symptoms which may have bothered you earlier, e.g. weakness or pain in muscles and joints. If any of these symptoms bother you, or symptoms such as headache, tiredness, nausea or vomiting occur, contact your doctor.

Do not share medicines prescribed for you with any other person. Always take PRESSIDO 200 exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of PRESSIDO 200 is too strong or too weak talk to your doctor or pharmacist.

Shake the inhaler before use. The usual dose is:

In adults and children over 12 years of age: the dose can range from 200 micrograms up to 1600 micrograms each day. This is taken in divided doses, once or up to four times a day. When your asthma is under control the dose is usually lowered.

If you are using an inhaled bronchodilator in addition to PRESSIDO 200 you should use the bronchodilator several minutes before the inhalation of PRESSIDO 200 to minimise possible local side effects such as cough. Rinse the mouth after each dosage administration. Do not abruptly stop treatment with PRESSIDO 200 without speaking to your doctor first.

If you inhale more PRESSIDO 200 than you should In the event of overdosage consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison control centre.

If you forget to take PRESSIDO 200 If you forget to take a dose, skip the missed dose and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking PRESSIDO 200 Do not stop using PRESSIDO 200 without consulting your doctor. If you stop using PRESSIDO 200 abruptly, it may make your asthma worse.

PRESSIDO 200 can have side effects. Not all the side effects reported for PRESSIDO 200 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PRESSIDO 200, please consult your doctor, pharmacist or healthcare professional for advice.

If any of the following happens, stop taking PRESSIDO 200 and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• severe rash or itching

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to PRESSIDO 200. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Bronchospasm (tightening of the muscles in the airways which causes wheezing).
• Mood changes (such as depression)
• Adrenal gland suppression with symptoms of:
• Unusual fatigue and muscle weakness
• Dizziness when standing
• Nausea, vomiting and/or diarrhea
• Loss of appetite
• Stomachache
• Weight loss
• Dark tanning of the skin
• Craving for salt
• Pneumonia (infection in the lungs). Tell your doctor if you have any of the following while taking budesonide they could be symptoms of a lung infection:
• Fever or chills.
• Increased mucus production, change in mucus colour.
• Increased cough or increased breathing difficulties.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequently occurring side effects:

• Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth out with water after using your PRESSIDO 200 inhaler.
• Sore throat, coughing, dryness of mouth and throat and a hoarse voice.

Less frequent side effects:

• Cushing's syndrome with a collection of signs and symptoms which may include high blood pressure, abdominal obesity but with thin arms and legs, reddish stretch marks, a round red face, a fat lump between the shoulders, weak muscles, weak bones, acne, and fragile skin that heals poorly
• A slowing of the rate of growth of children and adolescents.
• Changes in bone mineral density (thinning of the bones).
• Cataracts (clouding of the lens in the eye) or glaucoma (increased pressure in the eye)
• Sleeping problems, anxiety, depression, aggressiveness, increased motor activity (difficulty to stay still) and irritable. These effects are more likely to occur in children.
• Trembling and shaking, headache
• Muscle cramps
• Bruising of the skin, thinning of the skin, skin rash, itching, contact dermatitis (a skin problem), hives
• Loss of voice
• Muscle spasm
• Nausea, diarrhoea, bad taste
• Tiredness and thirst

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of PRESSIDO 200.

Store at or below 30 °C. Avoid storage in direct sunlight or heat. The canister should not be punctured, broken or burnt even if it is apparently empty. KEEP OUT OF THE REACH OF CHILDREN.