IPRAVENT Pressurised inhalation, solution Ref.[27780] Active ingredients: Ipratropium

Posology

For inhalation use.

Children and adolescents

This pressurised metered dose inhaler is not to be used in children, 12 years of age and younger or adolescents 13 to 17 years of age.

Adults (including the elderly) with asthma or COPD

• 1 or 2 puffs to be inhaled three or four times daily.
• However, in early treatment some patients may need up to 4 puffs at a time to obtain maximum benefit.

The recommended dose should not be exceeded.

If therapy does not produce a significant improvement, if the patient’s symptoms are getting worse or if a reduced response to treatment becomes apparent, medical advice must be sought. In the case of acute or rapidly worsening dyspnoea (difficulty in breathing) a doctor should be consulted immediately.

Method of administration

The correct administration of ipratropium bromide from the inhaler is essential for successful therapy. It is imperative that patient’s inhaler technique should be checked to ensure optimum drug delivery of ipratropium bromide to the lungs from time to time.

It is advised to read the Patient Information Leaflet carefully before using this inhaler and to take note regarding how to use the inhaler, how to inhale from the inhaler correctly and how to clean the inhaler.

The canister should be pressed twice to release two metered doses into the air before the inhaler is used for the first time, or when the inhaler has not been used for 3 days or more, to ensure that the inhaler is working properly and that it is ready for use.

On each occasion on which the inhaler is used the following instructions should be followed:

1. Stand or sit upright while using the Ipravent Inhaler
2. Remove the mouthpiece cover.
3. Check inside and outside the mouthpiece of the inhaler to make sure that it is clean and free from dust and dirt and any loose objects before inhaling.
4. Hold the inhaler upright between the thumb(s) on the base of the mouthpiece and a forefinger(s)/index finger(s) on the top of the inhaler (the arrow on the base of the container should be pointing upwards), breathe out for as long as is comfortable, and as slowly and deeply as possible.
5. Immediately after breathing out place the mouthpiece in your mouth between your teeth and close your lips around it but do not bite it
6. Breathe in slowly and deeply, through the mouth and immediately after starting to breathe in press down firmly on the top of the inhaler to release one actuation (puff) and continue to breathe in steadily and deeply.
7. Hold the breath, remove the inhaler from the mouth and take away the finger from top of the inhaler. Continue to hold the breath for as long as is comfortable, for 10 seconds if possible.
8. Breathe out slowly Do not breathe out into the inhaler.
9. If a second inhalation is required you should wait at least one minute and then repeat steps 4 to 8.
10. Replace the mouthpiece cover after use.

IMPORTANT

• Do not inhale too quickly, start breathing in as slowly and steadily as possible just before pressing the inhaler
• Do not rush through the entire procedure
• Elderly patients and patients with weak hands may use the inhaler with both hands
• Practice inhalation technique in front of a mirror; if a mist is seen following inhalation, either from the inhaler itself or from the sides of the mouth, the inhalation procedure should be repeated

Cleaning

It is important to clean your inhaler regularly. Otherwise it may not work properly.

• Remove the canister and green mouthpiece cover.
• Wash and clean the white mouthpiece in warm soapy water.
• Rinse in warm water and allow to air dry without using any heating system.
• Make sure the small hole in the mouthpiece is washed through thoroughly.

Once the white mouthpiece is dry, replace the canister and the cap.

DO NOT PUT THE METAL CANISTER INTO WATER

Please read the Patient Information Leaflet for appropriate instructions for use/inhalation

The inhaler can be used with the Aerochamber Plus spacer device. This may be useful for patients, e.g. adult, who find it difficult to synchronise breathing in and inhaler actuation.

The canister is not transparent. It is therefore not possible to see when it is empty. The inhaler will deliver 200 actuations. When these have all been used (usually after 3-4 weeks of regular use) the inhaler may still appear to contain a small amount of fluid. However the inhaler should be replaced in order to ensure that each metered dose contains the correct amount of medicine.

If the Inhaler has been exposed to low temperatures, the patient should take the metal canister out of the plastic case and warm it in their hands for a minimum of two minutes.

WARNING

The plastic mouthpiece has been specially designed for use with Ipravent CFC-Free Inhaler to ensure that each metered dose contains the correct amount of medicine. The mouthpiece must never be used with any other metered dose inhaler nor must Ipravent CFC-Free Inhaler be used with any mouthpiece other than the one supplied with the product.

The mouthpiece should always be kept clean (as per the cleaning procedure mentioned above).

No symptoms specific to overdosage have been encountered. In view of the wide therapeutic window and topical administration of ipratropium bromide, no serious anticholinergic symptoms are to be expected. As with other anticholinergics, dry mouth, visual accommodation disturbances and tachycardia would be the expected symptoms and signs of overdose.

2 years.

Do not store above 25°C. Protect from direct sunlight, heat and frost.

The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not pierce the canister.

If the Inhaler has been exposed to low temperatures, the patient should take the metal canister out of the plastic case and warm it in their hands for a minimum of two minutes.

An Inhaler comprises of 19 ml pressurised pure aluminium anodized canister (containing 12.8 ml of solution) sealed with a 50 µl metering valve made up of a thermoplastic and a plastic actuator made up of polypropylene having a white mouthpiece fitted with a green mouthpiece cover.

Each canister contains 200 metered actuations of 20 micrograms of ipratropium bromide.

Ipravent CFC-Free Inhaler contains a propellant, HFA134a, and does not contain any chlorofluorocarbons (CFCs).

No special requirements for disposal.