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INHALVENT 20 MCG/ACTUATION PRESSURISED INHALATION SOLUTION

Active substance(s): IPRATROPIUM BROMIDE MONOHYDRATE

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PACKAGE LEAFLET
Package leaflet: Information for the use

Inhalvent 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.

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What is in this leaflet
1. What Inhalvent is and what it is used for
2. What you need to know before you use Inhalvent
3. How to use Inhalvent
4. Possible side effects
5. How to store Inhalvent
6. Contents of the pack and other information
1. What Inhalvent is and what it is used for
The name of your medicine is Inhalvent. 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.
Inhalvent works by opening up your airways.
2. What you need to know before you use Inhalvent
Do not use Inhalvent, 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, if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Inhalvent.
Warnings and precautions
Talk to your doctor or pharmacist before using Inhalvent, 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.
If you are not sure if any of these apply to you, talk to your doctor or pharmacist before using Inhalvent.
Other medicines and Inhalvent
Please tell your doctor or pharmacist if you are taking or 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 Inhalvent can affect the way some
other medicines work. Also some other medicines can affect the way Inhalvent works.
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 Inhalvent.
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.
Driving and using machines
You may feel dizzy, or have difficulty in focusing, or blurred vision while taking Inhalvent. 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 Inhalvent to the doctor, dentist or anaesthetist.

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3. How to use Inhalvent
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.
Follow these instructions to get the best results. If anything is unclear after reading this leaflet, ask your doctor, pharmacist or nurse.
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
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.
Inhalvent 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).
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).
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).
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.
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.
The mouthpiece has been designed specially 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

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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 Inhalvent.
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 Inhalvent 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 Inhalvent
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 Inhalvent
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.

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4. Possible side effects
Like all medicines, Inhalvent can cause side effects, although not everybody gets them.
Tell your doctor straight away if you notice any the following serious side effects - you may need urgent medical treatment:
If after taking Inhalvent 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)
See your doctor straight away if you have any of these side effects.
The side effects described below have been experienced by people taking Inhalvent and they are listed as either common, uncommon
or rare.
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 Inhalvent
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)
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.

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5. How to store Inhalvent
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 ºC.
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 Inhalvent 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, ethanol anhydrous, purified water, and anhydrous citric acid.
What Inhalvent looks like and contents of the pack
Inhalvent 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.
This medicine is available in boxes containing 1 can.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Newline Pharma S.L.
Vía Augusta 59, desp.114
08006 Barcelona (Spain)
Manufacturer:
Laboratorio Aldo-Unión, S.L.
Calle Baronesa de Maldá 73,
08950 Esplugues de Llobregat
Barcelona (Spain)
This medicinal product is authorised in the Member States of the EEA under the following names:
Netherland
Ipratropiumbromide Newline Pharma 20 microgram/ verstuiving aërosol, oplossing
Germany
Ipratropiumbromid Newline Pharma 20 Mikrogramm/ Sprühstoβ Druckgasinhalation, Lösung
Portugal
Ipratropium bromide Newline Pharma 20mcg/actuation Solução pressurizada para inalação
United Kingdom
Inhalvent 20micrograms/actuation pressurised inhalation, solution
Estonia
Ipratropium bromide Newline Pharma
This leaflet was last revised in June 2016

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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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