Asthavent Ecohaler Inhaler

ASTHAVENT ECOHALER contains salbutamol sulphate equivalent to salbutamol, which is one of a group of medicines called fast acting bronchodilators. Salbutamol relaxes the muscles in the walls of the air passages in the lungs. This helps to open up the airways and helps to relieve chest tightness, wheezing and cough, so you can breathe more easily. ASTHAVENT ECOHALER is used to ease breathing problems in asthma and other chest illnesses. ASTHAVENT ECOHALER can also be used to avoid getting worse in breathing problems in asthma and other chest illnesses. ASTHAVENT ECOHALER is used to treat and prevent reversible constriction of the airways (bronchospasm) due to bronchial asthma, chronic bronchitis, and emphysema.

Do not use ASTHAVENT ECOHALER

• If you are allergic (hypersensitive) to salbutamol, or any of the other components of ASTHAVENT ECOHALER (listed in Section 6).
• If you are taking propranolol, sotalol, timolol or other beta-blockers for heart disorders, high blood pressure or glaucoma, as these medicines counteract the effects of ASTHAVENT ECOHALER and should not be taken concurrently (see ‘Other medicines and ASTHAVENT ECOHALER’).
• If you are taking mono-amine oxidase inhibitors, including selegiline for Parkinson’s disease or moclobemide for depression, or within 14 days after stopping such medicines. Please ask your doctor or pharmacist for advice (see ‘Other medicines and ASTHAVENT ECOHALER’).
• If you are pregnant or breastfeeding your baby, as safety has not been established (see ‘Pregnancy, breastfeeding and fertility’).
• If you unexpectedly go into early labour (premature labour) or threatened abortion.

Warnings and Precautions

Take special care with ASTHAVENT ECOHALER if:

• Your difficult breathing persists or if your condition worsens.
• You require more ASTHAVENT ECOHALER inhalations than usual to relieve an acute attack.
• You suddenly find it increasingly difficult to breathe, or if you suddenly develop severe wheezing after using ASTHAVENT ECOHALER (see ‘Possible Side Effects’).

Stop using ASTHAVENT ECOHALER immediately and consult your doctor. Failure to respond promptly or fully to ASTHAVENT ECOHALER shows that you require urgent medical attention. Do NOT use more ASTHAVENT ECOHALER than recommended (see ‘How to use ASTHAVENT ECOHALER’). Excessive use of ASTHAVENT ECOHALER may lead to life-threatening irregular heart rhythms or heart arrest. If you have been diagnosed with heart disease, you need to discuss the use of ASTHAVENT ECOHALER with your doctor or pharmacist. If you are known with heart disease, abnormal heart rhythm, high blood pressure, heart failure, or previously had a heart attack or required a cardiac bypass operation or stent, you must inform your doctor immediately if you develop chest pain, palpitations, or swelling of the feet or ankles. If you have been diagnosed with an overactive thyroid gland, please discuss the use of ASTHAVENT ECOHALER with your doctor. If you find that you have to use increasing amounts of ASTHAVENT ECOHALER to control your breathing, you should not simply increase the use of ASTHAVENT ECOHALER beyond the recommended dose, as this may be dangerous to your health (see ‘How to use ASTHAVENT ECOHALER’).

Do not share your medicine with any other person. Always use ASTHAVENT ECOHALER exactly as described in this leaflet or as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are unsure.

Your doctor will tell you how long your treatment with ASTHAVENT ECOHALER will last. If you have the impression that the effect of ASTHAVENT ECOHALER is too strong or too weak, tell your doctor or pharmacist. ASTHAVENT ECOHALER produces a fine mist which you must inhale into your lungs. Make sure that you know how to use the inhaler properly. The instructions are given later on in this leaflet. If you have any problems ask your doctor, nurse or pharmacist. ASTHAVENT ECOHALER must be breathed in through the mouth.

Use one or two inhalations, repeated four-hourly if required. The bronchodilator effect of each administration of ASTHAVENT ECOHALER lasts for at least four hours and more frequent use should be unnecessary. You must not inhale more puffs, or use your inhaler more often, than the doctor told you to. Your doctor may have told you to take more than this as an emergency treatment if your wheezing or breathing gets very bad. It is very important that you keep to your doctor's instructions as to how many puffs to take and how often to use your inhaler.

After using your ASTHAVENT ECOHALER

• If your breathing or wheezing gets worse straight after using ASTHAVENT ECOHALER, stop using it immediately and tell your doctor as soon as possible.
• If the relief of wheezing or chest tightness is not as good as usual or does not last for as long as usual, tell your doctor as soon as possible. Your chest condition may be getting worse and you may need an extra medicine.
• If you need to use your ASTHAVENT ECOHALER much more often than normal, see your doctor as soon as possible.

How to use ASTHAVENT ECOHALER correctly:

Important Follow instructions carefully.

Before using ASTHAVENT ECOHALER for the first time

1. Remove the cap / cover from the mouthpiece and ensure that the mouthpiece is clean.
2. Hold the inhaler away from your face. Shake it well and release two puffs into the air.
3. Your ASTHAVENT ECOHALER is now ready for use. If your inhaler has not been used for a week or more, shake it well and release one puff into the air.

Using ASTHAVENT ECOHALER

1. Sit or stand upright. Remove the mouthpiece cap / cover and shake ASTHAVENT ECOHALER well. Hold it upright as shown, with the thumb at the base below the mouthpiece. Place either one or two fingers on top of the canister.
2. Breathe out fully, through your mouth.
3. Place the mouthpiece of the inhaler in your mouth between your teeth and close your lips around it (do not bite it). Start to breathe in slowly through your mouth. Press the canister down firmly and fully to release one spray while you continue to breathe in slowly and deeply.
4. Remove the ASTHAVENT ECOHALER from your mouth and hold your breath for at least 10 seconds, or as long as it is comfortable. Breathe out normally.
5. If another dose is required, wait for at least one minute. Shake ASTHAVENT ECOHALER well and repeat steps 2 to 4. After use, replace the mouthpiece cap / cover firmly and snap it into position.

NOTE Do not rush stages 2, 3 and 4. It is important to breathe in slowly through your mouth, just before pressing the canister. To ensure proper use of ASTHAVENT ECOHALER, you may initially practice these steps in front of a mirror until you are comfortable with the technique. If there is ‘mist’ escaping from the inhaler or the sides of your mouth, start again from step 1. This escaping mist indicates incorrect technique. If you find it difficult to use the device correctly, you may use a spacer device along with ASTHAVENT ECOHALER.

For children

Parents must assist those children who need help in using the ASTHAVENT ECOHALER correctly with/without a spacer.

How to know that your ASTHAVENT ECOHALER is nearly empty

When there are 40 puffs remaining, the colour of the numbers will change from green to red. This indicates that there are 40 or fewer puffs left in the ASTHAVENT ECOHALER. You should now consider getting a new ASTHAVENT ECOHALER, or asking your doctor whether you need another one. When the dose counter displays ‘0’, it means that there is no medicine left in the ASTHAVENT ECOHALER and you need to discard it. Your ASTHAVENT ECOHALER may not feel empty and it may continue to operate, but you will not receive the correct amount of medicine if you keep using this canister.

ASTHAVENT ECOHALER can have side effects. Not all side effects reported for ASTHAVENT ECOHALER are included in this leaflet. Should your general health worsen while using ASTHAVENT ECOHALER, please consult your doctor, pharmacist or other healthcare professional for advice.

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

• Allergic reactions, including swelling of the tongue, lips or face, hives, swelling of the throat with difficult breathing, low blood pressure, or collapse.
• Unexpected constriction of the airways with wheezing or tightness of the chest (see ‘Warnings and Precautions’). These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ASTHAVENT ECOHALER. 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:

• Chest pain, especially pain that goes up to the chin or down the left arm (see ‘Warnings and Precautions’).
• Shortness of breath. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Hyperactivity in children.
• Tremors (see ‘Warnings and Precautions’), headache.
• Rapid heart rate.

Less frequent side effects:

• Palpitations or irregular heart beat (see ‘Warnings and Precautions’).
• Redness of the feet, legs or hands due to dilation of blood vessels.
• Dryness and irritation of your mouth or throat (see ‘How to use ASTHAVENT ECOHALER’).
• Muscle cramps.

Side effects with unknown frequency:

• Confusion.
• Struggling to pass urine or inability to pass urine.
• Altered metabolism, reduced appetite, sweating.
• Nervousness, fear, sleeplessness, tenseness.
• Dizziness, light-headedness.
• Coughing.
• Increased salivation, nausea and vomiting.

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 “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 or to Cipla Medpro (Pty) Ltd. by e-mail: [email protected] or telephone: 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of ASTHAVENT ECOHALER.

Store at or below 25 °C and protected from direct sunlight. Do not freeze. Do not puncture, break or burn, even when apparently empty. Store all medicines out of reach of children. Do not use after the expiry date stated on the packaging material. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems, for example toilets.