Aeromide Budesonide Inhaler

AEROMIDE is used to treat and prevent symptoms of asthma. It belongs to a group of medicines called corticosteroids.

Do not use AEROMIDE:

• If you are hypersensitive (allergic) to budesonide or any of the other ingredients of AEROMIDE (see section 6).
• If you have pulmonary tuberculosis (TB).
• If you have any untreated bacterial, viral or fungal infections in your mouth, airways or lungs.
• If you are pregnant or breastfeeding your baby (see “Pregnancy and breastfeeding”).

Warnings and precautions

Take special care with AEROMIDE

• Always use AEROMIDE according to the instructions, this will ensure that AEROMIDE reaches the areas of your lungs that it should (see “How to take AEROMIDE”).
• Use AEROMIDE regularly even if you don’t have any symptoms.
• Rinse your mouth after inhaling your dose in order to avoid a fungal infection in your mouth.
• If you are taking other corticosteroid medicines by mouth. AEROMIDE will be given to you in combination with the previously used oral steroid dose for about ten days. After this period, a reduction of the oral corticosteroid will be started.
• You may experience uneasiness during the withdrawal period due to decreased steroid effect, which may result in the appearance of allergic or inflammatory symptoms such as swelling and irritation inside the nose, irritated and red skin, and muscle and joint pain.
• During the withdrawal of oral steroids, you may feel unwell in a non-specific way. You should continue using AEROMIDE whilst withdrawing the oral steroid. You may experience symptoms such as tiredness, headache, nausea and vomiting. In these cases, a temporary increase in the dose of oral corticosteroids might be necessary.
• You might also experience constriction of the airways (tightening of the chest) with an increase in wheezing after using AEROMIDE. If this occurs, treatment with AEROMIDE should be stopped immediately. Your doctor will assess you and suggest an alternative therapy.
• You should not use AEROMIDE for fast relief of sudden episodes of asthma where an inhaled short-acting bronchodilator (a medicine used to open up the airways to your lungs) is required. If you find that the short-acting bronchodilator treatment is not working or if you need more inhalations than usual, you should seek medical attention.
• Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. This may cause changes in bone mineral density (thinning of the bones), a slowing of the rate of growth of children and adolescents and an effect on the adrenal gland (a small gland next to the kidney).
• If you have a history of increased pressure in your eyes or an eye disorder called glaucoma.
• If you have to go for surgery or emergency treatment, always tell your doctor that you are using AEROMIDE.
• If you have a lung disease, known as Chronic Obstructive Pulmonary Disease (COPD) you are at risk of developing pneumonia, if you smoke, are of older age or have a low body mass index (BMI). Symptoms of pneumonia include coughing, fever, sweating, shaking chills, rapid/shallow breathing, shortness of breath, loss of appetite, low energy or fatigue.
• If you have a cold or chest infection or any problems with your breathing.
• If you have liver problems.
• If you are using long-term medicines to treat fungal or viral (such as itraconazole, ketoconazole and HIV protease inhibitors) since these medicines may increase the risk of experiencing side effects.
• AEROMIDE contains small amounts of ethanol (alcohol), less than 100 mg per inhalation.

Other medicines and AEROMIDE

Always tell your health care provider if you are taking any other medicine (This includes all complementary or traditional medicines). Tell your doctor if you are taking any of the following:

• Itraconazole and ketoconazole (antifungal medicine).
• HIV protease inhibitors (antiviral medicines).
• Oestrogens and contraceptive steroids.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist, or other health care provider for advice before taking this medicine.

Pregnancy

Do not use AEROMIDE if you are pregnant (see “Do not use AEROMIDE”). If you get pregnant while using AEROMIDE, do not stop using AEROMIDE, but consult your healthcare provider immediately. It is important for both the baby and mother to maintain suitable asthma treatment during pregnancy.

If you are pregnant, please consult your health care provider for advice before using AEROMIDE.

Breastfeeding

Do not use AEROMIDE if you are breastfeeding your baby (see “Do not use AEROMIDE”). If you are breastfeeding your baby, please consult your health care provider for advice before using AEROMIDE.

Driving and using machines

AEROMIDE is not likely to affect you being able to drive or use any machines.

Do not share medicines prescribed for you with any other person. Always use AEROMIDE exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Shake before use. Rinse your mouth after each dose.

Adults and children over 12 years: The usual dose is 200 μg (1 puff) twice daily. Your total daily dosage may be increased up to 1 600 μg (8 puffs), if your asthma is not responding to low dose therapy. Your doctor will tell you how long your treatment with AEROMIDE will last.

Do not stop your treatment with AEROMIDE suddenly. If you are using a bronchodilator inhaler with AEROMIDE, use the bronchodilator inhaler first and wait several minutes before using your AEROMIDE inhaler to minimise possible local side effects, such as cough. If your daily dose exceeds 400 μg (2 puffs), you should use a spacer device when inhaling AEROMIDE. Children need use a spacer irrespective of the dose.

How to use your inhaler correctly:

Follow the instructions carefully.

1. Before using the AEROMIDE inhaler for the first time or if it has not been used for a week or more, release one puff into the air.
2. Remove the mouthpiece cover and check the mouthpiece thoroughly to see that it is clean.
3. Shake vigorously.
4. Hold the inhaler between your index finger and thumb.
5. Breathe out gently through your mouth and immediately place the mouthpiece in the mouth between your teeth (do not bite it).
6. Grip the mouthpiece firmly with your lips.
7. Tilt your head slightly backwards.
8. Start breathing in slowly through your mouth. At the same time to press the canister down, to release the one dose while continuing breathe in steadily and deeply.
9. Remove the inhaler from your mouth.
10. Hold your breath for at least 10 seconds or for as long as it is comfortable.
11. Breathe out slowly.
12. If another dose is required, wait for at least one minute and repeat the steps.
13. After use, replace the mouthpiece cover.

Do not rush steps 4 – 8. It is important to breathe in slowly through your mouth just before pressing the canister. To be sure of using your inhaler properly, you may initially practise these steps in front of a mirror.

Children: Your child may need your help. To help your child, you must first learn the technique correctly, then properly guide your child to use the inhaler.

Cleansing:

1. Clean your inhaler at least once a week.
2. Gently pull the metal canister out of the adaptor of the inhaler.
3. Remove the mouthpiece cover.
4. Rinse the adaptor and the mouthpiece cover in warm water, but do not put the metal canister into the water.
5. Leave to dry in a warm place. Avoid excessive heat.
6. Replace the canister and the mouthpiece cover correctly.

If you have the impression that the effect of AEROMIDE is too strong or too weak, tell your doctor or pharmacist.

If you use more AEROMIDE than you should It is important that you take your dose as advised by your doctor or healthcare provider. In the event of an overdosage, consult your doctor or pharmacist for advice. If neither is available, contact the nearest hospital or poison control centre.

If you forget to use AEROMIDE Use your AEROMIDE inhaler as soon as you remember. If it is almost time for your next usual dose, skip the missed dose and continue using your AEROMIDE inhaler at your regular time. Do not use a double dose of AEROMIDE to make up for the forgotten individual doses.

AEROMIDE can have side effects. Not all side effects reported for AEROMIDE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking AEROMIDE, please consult your health care provider for advice.

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

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• Rash, hives or itching,
• Sudden wheezing after inhaling AEROMIDE.

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

Tell your doctor if you notice any of the following:

Frequent side effects:

• Thrush (a fungal infection in the mouth), pneumonia (infection of the lung) in COPD patients,
• Feeling nervous, restless, depressed,
• Psychosis (loss of contact with reality, impaired thoughts and emotions),
• Difficulty in speaking due to a physical disorder of the mouth, tongue, throat or vocal cords (dysphonia),
• Cold-like symptoms, throat irritation, cough, hoarseness,
• Dry mouth and throat, bad taste in your mouth,
• Unusual bleeding or bruising under the skin, thinning of your skin.

Less frequent side effects:

• Feeling worried - anxious, sleeping problems, feeling over excited or irritable aggressiveness, behavioural changes,
• Headache, trembling and shaking,
• Blurred vision,
• Constriction of air passages, difficulty breathing, wheezing,
• Nausea (feeling sick), diarrhoea,
• Bruising of the skin,
• Muscle cramps,
• Thirst, tiredness,
• Inability of the adrenal glands to function normally, affecting and hormone production and slowing of the rate of growth of children adolescents.

Side effects of unknown frequency:

• Increased pressure in the eye (glaucoma).

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, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc,org) found on SAHPRA website.

By reporting side effects, you can help provide more information on the safety of AEROMIDE.

Store all medicines out of reach of children. Store at or below 25°C. Do not freeze. Do not use after the expiry date stated on the carton. Return all unused capsules to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).