Atrovent Forte Metered Dose Inhaler Consumer Medicine Information

Ipratropium bromide 40 mcg per actuation

What is in this leaflet

This leaflet answers some common questions about ATROVENT FORTE Metered Aerosol. It does not contain all available information. Nor does it take the place of talking to your doctor or pharmacist.

Keep this information with your metered aerosol. You may need to read it again later.

To find out more about ATROVENT FORTE

You should ask your doctor or pharmacist if you have any questions about your medicine or if you have any trouble before, during or after using ATROVENT FORTE.

What ATROVENT FORTE is used for

ATROVENT FORTE is used to make breathing easier for people with diseases such as asthma, emphysema, (a serious condition that makes breathing difficult), and chronic obstructive bronchitis.

ATROVENT FORTE improves air flow by relaxing the muscular tubes (air passages) that carry air to and from your lungs. It begins to act quickly after use but may take up to 2 hours to give maximum benefit.

This medicine is known as an anticholinergic bronchodilator. It is for relief of symptoms and should be part of a management program that is prescribed by your doctor.

Before you use ATROVENT FORTE

When not to use ATROVENT FORTE

The plastic mouthpiece has been specially designed for use with ATROVENT. The mouthpiece must never be used with any other metered aerosol nor must the ATROVENT metered aerosol be used with any mouthpiece other than the one supplied with the product.

Only use ATROVENT FORTE if a doctor has prescribed it for you. Never give it to someone else even if their symptoms seem to be the same as yours.

Do not use ATROVENT FORTE if you are allergic to it or to any of the ingredients. These ingredients are ipratropium bromide and soya lecithin in a mixture of CFC-containing propellant gases.

In some cases you should not use ATROVENT FORTE if you are allergic to certain other medicines. You must tell your doctor if you are allergic to any other medicine, particularly atropine or other anticholinergic medicines. If you are uncertain as to whether you have these allergies you should raise those concerns with your doctor.

You should never use ATROVENT FORTE after the EXPIRY DATE on the canister or carton.

Before you start to use ATROVENT FORTE

It is essential that your doctor knows your medical history before prescribing ATROVENT FORTE.

Before using ATROVENT FORTE, you must tell your doctor if you have, or have had, any of the following conditions:

  • An eye problem called "glaucoma";
  • Problems with passing urine;
  • Constipation;
  • Cystic fibrosis.

If you are uncertain as to whether you have, or have had, any of these conditions you should raise those concerns with your doctor.

Before using ATROVENT FORTE it is advisable to tell your doctor if you are taking any other medicines, obtained with or without a doctor's prescription. This is advisable even though ATROVENT FORTE is not known to affect, or be affected by, the activity of other medicines.

ATROVENT FORTE may be used with other medicines that relax the air passages for additional symptom relief when prescribed by a doctor.

Pregnancy

Care is recommended during pregnancy, particularly in the first three months. Ask for your doctor's advice if you are pregnant, or likely to become pregnant during your course of medication.

Breastfeeding

Care is recommended if you are breastfeeding. Ask for your doctor's advice if you are breastfeeding or likely to breastfeed during the course of your medication.

Children

Children should only use ATROVENT FORTE on medical advice and under the supervision of an adult who has been instructed in the proper use of the aerosol.

Using ATROVENT FORTE

How to use ATROVENT FORTE

Shake the metered aerosol before each puff. This will mix the medicine evenly so that a correct dose is delivered.

Each puff must be inhaled through the mouth properly for ATROVENT FORTE to work. At the end of this leaflet you will find instructions on how to correctly inhale ATROVENT FORTE.

If you have any problems with inhaling ATROVENT FORTE ask your doctor or pharmacist for advice.

Never spray ATROVENT FORTE in or around your eyes. Should this occur, immediately flush your eyes with cold tap water for several minutes

Recommended Dose

The recommended doses for adults is stated below. If your doctor has changed this dose you should ask for further information from your doctor or pharmacist.

Adults: 1 or 2 puffs 3 to 4 times a day (at regular intervals), up to a maximum of 8 puffs a day.

If you forget to take a dose

It is important to use ATROVENT FORTE as directed. If you miss a dose, take it as soon as you remember. However, if you remember when it is almost time for your next dose, take only your usual dose at that time.

Overdose

Seek medical advice if you have used more than the recommended or prescribed dose of ATROVENT FORTEand you experience signs of overdose as listed below.

Advice can be provided by a doctor, pharmacist or Poisons Information Centre (telephone 0800 POISON or 0800 764 766).

Signs of overdose may include fast or irregular heart beat, dry mouth, blurred vision, nausea, stomach pains, constipation and difficulty passing urine.

While you are using ATROVENT FORTE

Things you must do

Contact your doctor immediately if you experience eye pain or discomfort, or any disturbances with your sight (blurred vision, visual halos or coloured images) during or after using ATROVENT FORTE.

This is because there have been rare reports of narrow-angle glaucoma with the use of ATROVENT FORTE.

Tell your doctor if you need to use ATROVENT FORTE more frequently than prescribed or if you need more puffs than prescribed to relieve your symptoms. In these situations, your dose or treatment may need to be changed.

Tell your doctor or pharmacist if you begin taking any other medicine while you are using ATROVENT FORTE.

Effects on Ability to Drive or Operate Machinery

When used as recommended, and when there are no side effects, ATROVENT FORTE is not known to have any effect on the ability to drive or operate machinery.

Side effects

You should be aware that all prescription medicines carry some risks and that all possible risks may not be known at this stage despite thorough testing. Your doctor has weighed the risks of you taking ATROVENT FORTE against the benefits they expect it will have for you.

Ask for the advice of your doctor or pharmacist if you have any concerns about the effects of taking this medicine.

The more frequently reported side effects of ATROVENT FORTE are headache, nausea, dryness of the mouth, throat irritation and cough.

Less frequently reported side effects of ATROVENT FORTE include the following:

  • Fast or irregular heart beat;
  • Change in bowel movements;
  • Urinary retention (difficulty passing urine);
  • Narrow-angle glaucoma (a condition affecting the eyes). The following symptoms may be associated with narrow-angle glaucoma: red eyes, eye pain or discomfort, sight disturbances (blurred vision, visual halos or coloured images);
  • Direct contact of the spray with the eyes may temporarily affect the ability of the eyes to focus. However, in some patients this may cause the more serious eye problem of narrow-angle glaucoma mentioned above, to develop or worsen. Therefore, it is very important to follow the Directions for Use carefully and avoid contact with the eyes.
  • Worsening of breathing problems (induced by the inhalation process);
  • Allergic reactions: Most of the cases of allergic reactions have involved patients who have had a history of allergy to other drugs and/or foods. Allergic reactions may include skin rash, swelling of the tongue, lips and face, and difficulty breathing. Life-threatening allergic reactions have been reported.

Tell your doctor as soon as possible if you experience any side effects during or after using ATROVENT FORTE, so that these may be properly treated.

In addition, unexpected effects, not listed above, can occur with any medicine.

You should tell your doctor or pharmacist if you notice anything unusual, during or after using ATROVENT FORTE.

After using ATROVENT FORTE

Care and cleaning

Your aerosol may not work properly if it gets dirty and is not cleaned

Please follow the instructions under the heading Care and Cleaning in the Directions for Use at the end of this leaflet.

Storage

ATROVENT FORTE should be kept in a cool, dry place where the temperature stays below 25°C. Do not store in direct sunlight or heat. For example, do not leave it in the car on hot days.

The canister must never be forced open, punctured or thrown into a fire even when it seems empty. If this occurs, the canister may explode.

Keep your ATROVENT FORTE Metered Aerosol where young children cannot reach it.

Disposal

If your doctor has told you that you will not be needing ATROVENT FORTE any more, the unused medicine should be returned to your pharmacist so that it can be disposed of safely.

Product Description

What ATROVENT FORTE is

ATROVENT FORTE is the brand name of your medicine. It is a hand-operated metered aerosol that delivers 200 puffs of medication from a 10mL canister.

Ingredients

Each metered puff of ATROVENT FORTE contains ipratropium bromide 42 micrograms [equivalent to ipratropium bromide (anhydrous) 40 micrograms], which is delivered to your lungs by a mixture of propellant gases.

These gases (commonly known as CFCs) are:

  • Trichloromonofluoromethane
  • Dichlorodifluoromethane
  • Dichlorotetrafluoroethane

 

ATROVENT FORTE also contains soya lecithin as an emulsifier (mixing agent).

Distributor

ATROVENT FORTE is supplied in New Zealand by:

Boehringer Ingelheim (N.Z.) Limited
47 Druces Road
Wiri
Auckland
Telephone (09) 262-1356 of 0800 802 461

ATROVENT FORTEŽ is a registered trademark of Boehringer Ingelheim

This leaflet was prepared on 30 May 2002.

ATROVENT FORTE Metered Dose Inhaler

Ipratropium bromide 40 mcg per actuation

Directions for Use

How to use the metered aerosol

Note: Before first use of a new aerosol, prime the apparatus by activating the vial 2 or 3 times into the atmosphere.

  1. Remove the protective cap from the short end of the mouthpiece.
  2. Hold the aerosol with the arrow on the vial pointing upwards. Do not spray into or around the eyes.
  3. Shake the aerosol before each use (Figure 1)
  4. Breathe out fully, to the end of a normal breath.
  5. Place the open end of the mouthpiece between the lips but not past the teeth (Figure 2).
  6. Breathe in slowly through the mouth and at the same time firmly press the vial down once. Do not stop breathing when you press on the vial - continue to take a full, deep breath.
  7. Hold your breath for about ten seconds, then breathe out slowly. Remove the aerosol from your mouth.
  8. If a second or subsequent inhalation is necessary, start again from instruction 3.
  9. Replace the protective cap on the mouthpiece.

Care and Cleaning

In order to obtain the best service from your ATROVENT FORTE Metered Aerosol, these simple directions on maintenance should be carefully observed.

The most common causes of failure of the metering device of the aerosol to function are:

  1. Blockage of the 2 pin holes in the stem of the vial (A, B).
  2. A dirty or blocked mouthpiece.

1. Blockage of the pin holes in the stem of the vial

There are 2 pin holes in the stem of the vial, hole A at the side near the base of the stem and hole B at the end of the stem (see diagram).

If these holes become blocked, pull out the vial from the mouthpiece and clear them by rinsing well in clean, lukewarm water.

When dry, reassemble the vial for use by fitting the stem of the vial into the inner hole, at the base of the long end of the mouthpiece.

2. A dirty or blocked mouthpiece

Always replace the protective cap on the mouthpiece after use to prevent the inside of the apparatus becoming dusty.

The mouthpiece of the ATROVENT FORTE Metered Aerosol should be kept clean by washing regularly in warm soapy water, rinsing in clear water and drying on a clean tissue.

Remember to take out the vial before you wash the mouthpiece.

When removing the vial from the mouthpiece, pull out carefully to avoid bending the stem.

Never press the stem against a firm surface to check for function.

This may bend the stem and lead to malfunction of the aerosol.