WebSite Connecticut: Atrovent Aerocaps

Atrovent Aerocaps

(ipratropium bromide)

Read all of this leaflet carefully before you start using this medicine

Keep this leaflet. You may need to read it again

If you have any further questions, ask your doctor or pharmacist

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours

If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What ATROVENT AEROCAPS are and what they are used for

2. Before you use ATROVENT AEROCAPS

3. How to use ATROVENT AEROCAPS

4. Possible side effects

5. How to store ATROVENT AEROCAPS

6. Further information

What Atrovent Aerocaps Are And What They Are Used For

The name of your medicine is ATROVENT AEROCAPS (called ATROVENT in the rest of this leaflet). An AEROCAP is a type of capsule that is put into an inhaler. ATROVENT is designed to be used in a type of inhaler called an AEROHALER. This side of the leaflet contains information on ATROVENT only. The other side explains how to use the AEROHALER. Please read both sides carefully.

ATROVENT contains a medicine called ipratropium bromide. This belongs to a group of medicines called bronchodilators. It is used to make breathing easier for people who have breathing difficulties, such as in chronic asthma or chronic obstructive pulmonary disease (COPD).

ATROVENT works by opening up your airways.

Before You Use Atrovent Aerocaps

Do not use ATROVENT if:

You are allergic (hypersensitive) to ipratropium bromide or any of the other ingredients in ATROVENT (listed in Section 6 below)

You are allergic (hypersensitive) to medicines that are similar to ATROVENT, such as atropine

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using ATROVENT.

Take special care with ATROVENT

Check with your doctor or pharmacist before using your medicine if:

You have cystic fibrosis

You have glaucoma or have been told that you may develop it

You are a man who has prostate problems

You have problems passing water (urine)

You are pregnant, likely to get pregnant or if you are breast-feeding

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using ATROVENT.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because ATROVENT can affect the way some other medicines work. Also some other medicines can affect the way ATROVENT works.

In particular, tell your doctor or pharmacist if you are taking any of the following:

Medicines for breathing problems called ‘ beta-agonists’ such as salbutamol

Medicines for breathing problems called ‘xanthine preparations’ such as theophylline or aminophylline

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using ATROVENT.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before using this medicine if you are pregnant, likely to get pregnant or are breast-feeding.

Important information about some of the ingredients of this medicine

ATROVENT contains glucose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before using this medicine.

How To Use Atrovent Aerocaps

Always use ATROVENT exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

Using this medicine

The AEROHALER pierces the AEROCAP so that you can breathe the powder it contains into your lungs. Make sure that you have an AEROHALER and that you can use it properly. Please see the instructions on the other side of this leaflet for how to use the AEROHALER.

Do not swallow this medicine

Do not let any of the powder get into your eyes

If any of the powder accidentally gets into your eyes you may get painful, stinging or red eyes, dilated pupils, blurred vision, see colours or lights. If this happens, talk to your doctor for advice. If affected, do not drive or use any tools or machines. If you get problems with your eyes at any other time, talk to your doctor for advice.

How much to use

Adults

One AEROCAP 3 or 4 times a day

Your doctor may prescribe a higher dose if he feels that it is necessary for you

Children under 12

ATROVENT is not recommended for children under 12 years.

Do not use more than your doctor has told you

See your doctor straight away if:

You feel that your medicine is not working as well as usual

You need to use your inhaler more than your doctor has recommended

Your doctor may need to check how well your medicine is working. In some cases your doctor may need to change your medicine.

If you use more ATROVENT than you should

If you use more of this medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to use ATROVENT

If you forget a dose, use it as soon as you remember

However, if it is nearly time for the next dose, skip the missed dose

Do not use a double dose to make up for a forgotten dose

Atrovent Aerocaps Side Effects

Like all medicines, ATROVENT can cause side effects, although not everybody gets them.

Stop using ATROVENT and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:

If after using ATROVENT you are wheezy or have other difficulties in breathing, do not use any more (unless you have been told to by your doctor)

Allergic reations - the signs may include skin rash, itching and nettle rash (affects less than 1 in 100 people). In severe cases the signs include swelling of your face, sudden difficulties in breathing and reduction of your blood pressure (affects less than 1 in 1000 people)

Palpitations (fast or uneven heart beats), quickening of the heart rate or irregular heart rhythm such as atrial fibrillation (affects less than 1 in 1000 people)

Increased heart rate (affects less than 1 in 100 people)

Stop using this medicine and see your doctor straight away if you have any of these side effects.

Other side effects include:

Very common (affects more than 1 in 10 people)

Cough and throat irritation when you have just used the inhaler

Common (affects less than 1 in 10 people)

Headache, dizziness

Dry mouth, diarrhoea, constipation or being sick (gastrointestinal motility disorder)

Uncommon (affects less than 1 in 100 people)

Itching, skin rash, nettle rash (urticuria)

Blurred vision or difficulty focusing

Tightening of your throat

Rare (affects less than 1 in 1000 people)

Feeling sick (nausea)

Problems passing water (urine), especially if you already have problems passing urine

Unexpected tightness of the chest

If any of the powder accidentally gets into your eyes, you may get painful stinging or red eyes, dilated pupils, blurred vision, see colours or lights. If you get problems with your eyes at any other time, talk to your doctor for advice.

If any of the side effects gets serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Atrovent Aerocaps

Keep out of the sight and reach of children.

If you remove an AEROCAP from the foil blister you must use it within one day.

Do not use this medicine after the expiry date which is printed on the packaging.

The AEROCAPS should be stored below 25°C and in the original packaging.

Further Information

What ATROVENT AEROCAPS contain

Each AEROCAP contains 41.7 micrograms of ipratropium bromide monohydrate (equivalent to 40 micrograms of ipratropium bromide) as the active ingredient.

The AEROCAPS also contain glucose. The capsule shell contains gelatin, and the colourings Titanium dioxide (E171), Indigo carmine (E132), Iron oxide yellow and Iron oxide black (E172).

What ATROVENT AEROCAPS look like and contents of the pack

The AEROCAPS are hard gelatin capsules that contain powder for you to breathe in.

The following packs are available:

A pack containing 1 AEROHALER and 100 ATROVENT AEROCAPS.

A refill pack containing 100 ATROVENT AEROCAPS.

The Product Licence for ATROVENT AEROCAPS is held by:

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

and the AEROCAPS are manufactured at:

Boehringer Ingelheim Pharma GmbH & Co. KG

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

This leaflet was revised in August 2007.

Instructions for Use

Aerohaler

(Multi dose)

The AEROHALER is an easy to use inhaler which allows you to breathe in the medicine from the capsules that your doctor has prescribed for your breathing problems. The magazine allows you to load up to 6 capsules at a time.

When using the AEROHALER you will be breathing the medicine (powder) in from one capsule at a time. This means that you will be breathing in an exact dose each time.

The magazine has been specially designed to show you how many full capsules you have left in the AEROHALER. This should make it easy for you to monitor how many doses you have taken.

The AEROHALER should be kept in the pouch provided. You can also keep a strip of extra capsules in the pouch. You can use your AEROHALER for up to one year to take your medication.

1. Opening the inhaler

Open the mouthpiece (white part).

2. Magazine

Lift the magazine up slightly and turn it round in a clockwise direction until the mark (s) is pointing to the number six. Then push the magazine down again.

3a. Inserting the ATROVENT capsules - to load 6 capsules -

Now peel back the foil on the aluminium strip, remove the capsules and put them into the holes in the magazine. Close the inhaler by pushing down the mouthpiece until it clicks.

Important: Only load the number of capsules you will need for that day. Once the capsules have been removed from the foil blister pack, they must be used within one day.

3b.- to load fewer than 6 capsules

Example: If you only need to put 4 capsules into the inhaler, turn the magazine until the mark (s) is pointing to 4. Then put the first capsule into the hole that the arrow in the diagram is pointing to. The other 3 capsules should be placed in the holes in an anticlockwise direction as shown in the diagram (in this case the two holes behind number 4 will remain empty). Close the inhaler by pushing down the mouthpiece until it clicks.

4. Preparing for inhalation

Hold the mouthpiece upwards. Push the white button until it clicks and release it immediately. This pierces the capsule, making the medicine available for inhalation.

5. Inhalation

Breathe out fully, then raise the AEROHALER to your mouth and close your lips around the mouthpiece.

Next breathe in slowly but deeply through the AEROHALER.

Do not worry if it seems hard to suck in the medicine, the design of the AEROHALER ensures that the medicine reaches your lungs, even if you are short of breath.

While holding your breath for as long as is comfortable, remove the mouthpiece from your mouth. Finally, breathe out slowly, preferably through your nose, not your mouth.

Important: Do not breathe out through the AEROHALER.

6. Preparing for the next dose

After inhalation (as described under Point 5), turn the magazine in a clockwise direction until it clicks. The next lower number will now appear above the mark (i.e. the 5 after the 6, or the 4 after the 5). In this way you will be able to see immediately how many full capsules are still in the magazine, available for inhalation.

7. Removing the capsules

If the mark is pointing at 1, this means that there is only one capsule left. Once in this position, the magazine cannot be turned any further. When you have used the last capsule open up the mouthpiece. Turn the AEROHALER upside down and shake out all the used capsules. Then close, or refill, the inhaler.

Cleaning the inhaler

From time-to-time the AEROHALER should be cleaned in lukewarm water to remove any remaining powder.

To do this you should open it up and remove the magazine from the spindle. Take care to dry the AEROHALER thoroughly. Shake the water out, then dry it using, for example, a hair drier on a cool-warm setting.

Important : Avoid excessive heat.