Apoven

Ipratropium(i-pra-troe-pee-um)


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Apoven. Itdoes not contain all the available information.

It does not take the place of talking to your doctor and pharmacist.

All medicines have benefits and risks. Your doctor has weighedthe risks of you using Apoven against the benefits this medicine isexpected to have for you.

If you have any concerns about using this medicine, ask yourdoctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

Apoven contains ipratropium as the active ingredient.

What Apoven is used for

Ipratropium is a medicine which can be used to prevent or totreat the narrowing of the airways associated with asthma.

Ipratropium can also be used to relieve any reversible airwaysblockage associated with problems such as repeated infections affectingthe airways. Ipratropium works by opening up the narrowed airwaysto assist breathing.

Your doctor may have prescribed ipratropium for another reason. Ask your doctor if you have any questions about why ipratropium hasbeen prescribed for you.

This medicine is available only with a doctor’s prescription.

There is no evidence that ipratropium is addictive.

Before you use Apoven

When you must not use it

Do not use ipratropium if:

  • you have an allergy to atropine, ipratropium, otherasthma medicines or any of the ingredients listed at the end of thisleaflet

Some of the symptoms of an allergic reaction may includeskin rash, itching, difficulty breathing, wheezing, asthma attack,swelling of the lips, face, tongue or throat, low blood pressure orcollapse.

  • the packaging is torn or shows signs of tampering
  • the expiry date on the pack has passed.

If you use this medicine after the expiry date has passed, itmay not work as well or it may make you feel sick.

If you are not sure whether you should start using ipratropium,talk to your doctor.

Before you start to use it

You must tell your doctor:

  1. if you have any allergiesto any other medicines or any other substances, such as foods, preservativesor dyes
  2. if you have or have everhad any other health problems/medical conditions, including:
  • glaucoma, high pressure in the eye
  • difficulty in passing urine
  • constipation, inability to open bowels
  • cystic fibrosis.
  1. if you are pregnant orintend to become pregnant

Your doctor will discuss the risks and benefits of usingipratropium during pregnancy.

  1. if you are breast-feedingor plan to breast-feed

Your doctor will discuss the risks and benefits of usingipratropium when breast-feeding.

If you have not told your doctor about any of the above, tellthem before you begin using ipratropium.

Taking other medicines

Tell your doctor if you are taking/using any other medicines,including medicines that you buy without a prescription from yourpharmacy, supermarket or health food shop.

How to use Apoven

How much to use

Apoven is to be used under the direction of a doctor. Your doctorwill recommend a suitable dose for you.

How to use it

Apoven is to be delivered from an efficient device, called anebuliser, which produces a fine mist to breathe in.

Opening instructions for the single dose units:

Twist a single unit downwards to remove from the strip.

Flick the single dose unit so that the solution flows to thebottom.

Hold the base of the single dose unit and break the seal witha quick twisting action. Snap off the top.

Squeeze the contents of the single dose unit into the nebuliserbowl.

The ipratropium solution must not enter the eyes, be injectedor swallowed.

How long to use it

Your doctor will decide how long you will need to use Apoven.

If you use too much (overdose)

Immediately telephone your doctor or Poisons Information Centre(telephone 13 11 26), or go to casualty at your nearesthospital, if you think that you or anyone else may have used too muchor swallowed any of the Apoven single dose units. Do this even ifthere are no signs of discomfort or poisoning. You may need urgentmedical attention. Keep telephone numbers of these places/serviceshandy.

If you use too much Apoven you may have:

  • dry mouth
  • fast heart rate
  • difficulty in passing urine
  • constipation, inability to open bowels
  • eyesight difficulty
  • red, painful eyes with brow-ache or headache andpossibly followed by nausea or vomiting.

While you are using Apoven

Things you must do

If the symptoms of your asthma do not improve within a few days,or if they become worse, tell your doctor.

If you become pregnant while you are using ipratropium tellyour doctor.

If you are about to start taking/using any new medicine, tellyour doctor and pharmacist that you are using ipratropium.

Tell all the doctors, dentists and pharmacists who are treatingyou that you are using ipratropium.

Things you must not do

Do not give ipratropium to anyone else, even if they have thesame condition as you.

Do not use ipratropium to treat any other complaints unlessyour doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know howipratropium affects you. Ipratropium generally does not cause any problems with yourability to drive a car or operate machinery.

Side Effects

Tell your doctor or pharmacist as soon as possible if youdo not feel well while you are using ipratropium. Like other medicines, ipratropium can cause some side effects. If they occur, most are likely to be minor and temporary. However,some may be serious and need medical attention.

Ask your doctor or pharmacist to answer any questions you mayhave.

While using it

Tell your doctor if you notice any of the following and theyworry you:

  • mouth/ throat irritation
  • cough
  • headache
  • nausea
  • indigestion
  • constipation.

These are all mild side effects of ipratropium.

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

  • difficulty in passing urine
  • red, painful eyes with brow-ache or headache andpossibly followed by nausea or vomiting
  • eye pain
  • dilated pupils of the eyes
  • shortness of breath or difficulty breathing
  • swelling with fluid in the tissues
  • skin rash, may be itchy
  • changes in the way your heart beats eg. if younotice it beating faster or the beats are irregular.

These are all serious side effects of ipratropium. You may needurgent medical attention.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

Do not be alarmed by this list of possible side effects. Youmay not experience any of them.

After using Apoven

Storage

Apoven will generally be stored in the pharmacy or in a hospitalward.

If stored at home, keep your Apoven single dose units in theiroriginal packs until it is time to use them. If you take the Apoven single dose units out of the pack itmay not keep well.

Keep it in a cool dry place, protected from light where thetemperature stays below 25 deg C. Do not store it or any other medicinein the bathroom or near a sink.

Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above theground is a good place to store medicines.

Product description

What it looks like

Apoven is available in two strengths:

  • Apoven 250 equivalent to ipratropium 250 microgram/1mL available in packs of 30 single dose units. AUST R 75559
  • Apoven 500 equivalent to ipratropium 500 microgram/1mLavailable in packs of 30 single dose units. AUST R 82352

Ingredients

Apoven contains ipratropium as the active ingredient. Apovenalso contains:

sodium chloride BP

  • Water for Injections.
  • Apoven does not contain

preservatives, gluten, lactose, sucrose, tartrazine or any otherazo dyes.

Sponsor

Douglas Pharmaceuticals Australia Ltd
3/10 InglewoodPlace
Norwest Business Park
Baulkham Hills
NSW 2153

Date of Preparation:
12th September 2002

Published by MIMS March 2009