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IPROHALEX CFC-FREE 20 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SOLUTION

Active substance(s): IPRATROPIUM BROMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Iprohalex CFC-Free 20 micrograms per actuation
pressurised inhalation, solution
Ipratropium bromide
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Iprohalex CFC-Free is and what it is used
for
2. What you need to know before you use
Iprohalex CFC-Free
3. How to use Iprohalex CFC-Free
4. Possible side effects
5. How to store Iprohalex CFC-Free
6. Contents of the pack and other information

1. What Iprohalex CFC-Free is and what it
is used for

Follow these instructions to get the best results. If
anything is unclear after reading this leaflet, ask
your doctor, pharmacist or nurse.

The name of your medicine is Iprohalex CFC-Free
20 micrograms per actuation pressurised inhalation,
solution. This is an inhaler and contains a medicine
called ipratropium bromide. This belongs to a group
of medicines called bronchodilators. It is used to
make breathing easier for people with asthma or
‘chronic obstructive pulmonary disease’ (COPD),
often referred to as chronic bronchitis. You may
have difficulty breathing, shortness of breath,
wheezing or tightness in your chest.

The recommended dose is:
Adults (including the elderly)
• 1 or 2 puffs to be inhaled three or four times daily
• sometimes, in early treatment, up to 4 puffs at a
time may be taken

Iprohalex CFC-Free works by opening up your
airways.

2. What you need to know before you use
Iprohalex CFC-Free
Do not use Iprohalex CFC-Free if:
• you are allergic to ipratropium or any of the other
ingredients of this medicine listed in section 6
• you are allergic to similar medicines which
contain atropine or medicines like atropine
Do not use Iprohalex CFC-Free if any of the above
apply to you. If you are not sure, talk to your doctor
or pharmacist before using Iprohalex CFC-Free.
Warnings and precautions
Talk to your doctor or pharmacist before using
Iprohalex CFC-Free if:
• you have glaucoma, or have been told that you
may develop it
• you have problems passing water (urine)
• you are a man who has prostate problems
• you have cystic fibrosis
If any of the spray 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 you get
problems with your eyes at any other time, talk
to your doctor for advice. You may be developing
glaucoma, which will need treatment straight away.
If your eyes are affected in any way do not drive or
operate machinery.

Use in children
Children 6-12 years
• 1 or 2 puffs to be inhaled three times daily
Children under 6 years
Since there is insufficient data on the use of
ipratropium bromide in children under 6 years
ipratropium bromide should be used solely on
medical advice and under the supervision of an adult.
Do not exceed a total daily dose of 12 inhalations.
See your doctor straight away if:
• you feel that your inhaler is not working as well as
usual
• you need to use the 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.
Testing your inhaler
To make sure that your inhaler is working, test fire
it twice into the air before using it for the first time
and whenever your inhaler has not been used for 3
days or more.
Iprohalex CFC-Free contains a solution so it is not
required to shake the inhaler before its use.
For optimal results, the canister should be at room
temperature before use. If the inhaler gets very
cold, take the metal canister out of the plastic case
and warm it in your hands for at least two minutes
before use. Never use anything else to warm it up.
How to use your inhaler
1 Remove the protective cap from the mouthpiece
(fig. 1).
Fig 1.

If you are not sure if any of these apply to you, talk
to your doctor or pharmacist before using Iprohalex
CFC-Free.
Other medicines and Iprohalex CFC-Free
Please tell your doctor or pharmacist if you are
taking, have recently taken or might take any other
medicines, including any inhalers and medicines
obtained without a prescription. This includes herbal
medicines. This is because Iprohalex CFC-Free
can affect the way some other medicines work. Also
some other medicines can affect the way Iprohalex
CFC-Free works.

2 Hold the inhaler upright with the base of the
canister at the top (fig. 1), put your thumb on the
base below the mouthpiece and the index
finger/ middle finger on the top of the inhaler.
Breathe out as far as is comfortable, but do not
breathe into the mouthpiece (fig. 2).
Fig 2.

In particular, tell your doctor or pharmacist if you are
taking/have taken any of the following medicines:
• other inhalers to help you to breathe more easily
such as the reliever inhaler salbutamol
• medicines called ‘xanthines’ to help your
breathing such as theophylline and aminophylline
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before using
Iprohalex CFC-Free.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.

3 Place the mouthpiece in your mouth between
your teeth and close your lips firmly around it but
do not bite it.
4 Breathe in slowly and deeply, pressing down on
the top of the inhaler firmly at the same time; this
releases one metered dose (fig 3).
Fig 3.

Driving and using machines
You may feel dizzy, have difficulty in focusing, or
blurred vision while taking Iprohalex CFC-Free.
If this happens do not drive or use any tools or
machines.
Operations
If you attend a hospital appointment or are admitted
to hospital be sure to take your inhaler(s) and any
other medicines (in their packaging if possible) with
you. Some gases used in operations (anaesthetic
gases) may affect how your inhaler works. If you
are about to have surgery, make sure you mention
that you are taking Iprohalex CFC-Free to the
doctor, dentist or anaesthetist.

5 Hold your breath for 10 seconds, or as long as is
comfortable (fig. 4), then remove the mouthpiece
from your mouth breathe out slowly.
Fig 4.

3. How to use Iprohalex CFC-Free
Always use this medicine exactly as your doctor,
pharmacist or nurse has told you. Check with your
doctor, pharmacist or nurse if you are not sure.

6 If a second inhalation is required you should wait
at least one minute and then repeat steps 2 to 5.
7 After use always replace the mouthpiece cover.
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The mouthpiece has been specially designed for
use with this product only. Do not use any other
mouthpiece with the product and do not use the
mouthpiece provided here with any other product.
People with weak hands may find it easier to hold
the inhaler with both hands. Put the two forefingers
on top of the inhaler and both thumbs on the base
below the mouthpiece.
If you find breathing in and pressing the inhaler
at the same time (step 4) difficult you should talk
to your doctor, pharmacist or nurse, as you could
use a spacer device (Aerochamber Plus™) with
your inhaler. A spacer is a device designed to
make step 5 easier. A spacer is generally a plastic
container with a mouthpiece at one end and a hole
for inserting the mouthpiece of the inhaler at the
other end. The puff of medicine from your inhaler
is sprayed into the spacer and the puff of medicine
stays there, inside the spacer, until you breathe in
through your mouth from the spacer with the spacer
mouthpiece in your mouth and with your lips closed
around it. This means that you do not have to worry
about breathing in and pressing the inhaler at the
same time.
Cleaning
It is important to clean your inhaler regularly;
cleaning must be done at least once a week.
Otherwise it may not work properly.










remove the canister and cap
wash and clean the 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 mouthpiece is dry, replace the canister
and the cap

Make sure you do not run out of Iprohalex
CFC-Free.
The inhaler has been designed to deliver 200
metered doses of your medicine. However, it is not
possible to tell when the inhaler is empty and when
the 200 metered doses have been used. There
may still be a small amount of fluid left over in the
container. Please make sure that your inhaler is
replaced after you have taken 200 metered doses
(usually after 3-4 weeks of regular use) so that you
can be certain that you are getting the right amount
of your medicine in each puff.
If you use more Iprohalex CFC-Free than you
should
If you use more of this inhaler than you should, talk
to a doctor or go to a hospital straight away. Take
all your inhalers and any other medicines you are
taking (in their packaging if possible) with you. If
you take too much or too many puffs you may get a
dry mouth, a rapid heart rate or blurred vision.
If you forget to use Iprohalex CFC-Free
If you forget a dose, inhale it as soon as you
remember it. However, if it is time for the next dose,
skip the missed dose. Do not take a double dose to
make up for a forgotten dose.
If you stop using Iprohalex CFC-Free
Do not stop taking your medicine unless your doctor
tells you to do so.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

• problems passing water (urine), especially if you
already have problems passing urine
Rare (affects less than 1 in 1000 people)
• difficulty focusing
• nettle rash (urticaria)
If any of the side effects gets troublesome or
serious, or if you notice any side effects not listed in
this leaflet, tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
You can also report side effects directly via
the Yellow Card Scheme (www.mhra.gov.uk/
yellowcard). By reporting side effects, you can
help provide more information on the safety of this
medicine.

5. How to store Iprohalex CFC-Free
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the label and on the carton after EXP.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not freeze.
Store protected from direct sunlight.
The canister contains a pressurised liquid. Do not
expose to temperatures higher than 50°C.
Do not pierce or burn the canister even when it is
apparently empty.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other
information
What Iprohalex CFC-Free contains
The active substance is Ipratropium bromide.
One metered dose (ex-valve) contains 21
micrograms of ipratropium bromide monohydrate,
corresponding with 20 micrograms of ipratropium
bromide. This is equivalent to a delivered dose
(ex-actuator) of 17 micrograms ipratropium
bromide.
The other ingredients are 1,1,1,2-Tetrafluorethane,
absolute ethanol, purified water, and anhydrous
citric acid.
What Iprohalex CFC-Free looks like and
contents of the pack
Iprohalex CFC-Free 20 micrograms is a 19 ml
stainless steel pressurised container equipped with
a metering valve of 50 μl and a transparent plastic
actuator containing a mouthpiece with a green dust
cap.
The metering valve contains aluminium, stainless
steel, polyester and EPDM (ethylene propylene
diene monomer) polymer.
Each pressurised container contains 200
actuations.

4. Possible side effects

This medicine is available in boxes containing 1, 2,
3, 4, 5, 6 and 10 cans.

Like all medicines, Iprohalex CFC-Free can cause
side effects, although not everybody gets them.

Not all pack sizes may be marketed.

Tell your doctor straight away if you notice any the
following serious side effects - you may need urgent
medical treatment:
If after taking Iprohalex CFC-Free you are wheezy
or have
• other difficulties in breathing, do not take any
more (unless you have been told to by your
doctor)
You may need to take a fast-acting reliever
inhaler such as salbutamol to help your breathing.
Your doctor may decide that you need different
medicines to help your breathing.
• allergic reactions - the signs may include skin
rash and itching (affects less than 1 in 100 people)
In severe cases the signs include swelling of your
mouth and face, sudden difficulties in breathing
and reduction of your blood pressure.
• tightening of your throat (affects less than
1 in 100 people)
• palpitations (fast or uneven heart beats) or
quickening of the heart rate (affects less than 1 in
100 people)
• increased heart rate or irregular heart rhythm
such as atrial fibrillation (affects less than
1 in 1000 people)

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR.
UK
Manufacturer:
Laboratorio Aldo-Unión, S.A.
Calle Baronesa de Maldá 73,
08950 Esplugues de Llobregat
Spain
or
Aeropharm GmbH
Francois-mitterrand-allee 1, 07407 Rudolstadt
Germany
or

See your doctor straight away if you have any of
these side effects.

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben
Germany

The side effects described below have been
experienced by people taking Iprohalex CFC-Free
and they are listed as either common, uncommon
or rare.

This leaflet was last revised in 02/2015.

Common (affects less than 1 in 10 people)
• headache, dizziness
• dry mouth, feeling sick (nausea), stomach upset
or discomfort
• cough and throat irritation when you have just
used Iprohalex CFC-Free
Uncommon (affects less than 1 in 100 people)
• itching, skin rash
• unexpected tightness of the chest, swelling of the
throat, dry throat
• blurred vision, dilated pupils, glaucoma, painful,
stinging, red or swelling of the eyes, see colours
or lights
• diarrhoea, constipation or being sick, taste
disorders
• mouth or lip sores, swelling in the mouth (mouth
oedema)

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Artwork Proof Box
Ref: Licence application - National Phase
Proof no.
001.0

Date prepared:
02/02/2015

Colours:
Black
Dimensions: 170 x 540 mm

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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