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RESPIGEN 100 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SUSPENSION

Active substance(s): SALBUTAMOL SULPHATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Respigen
100 micrograms per actuation pressurised inhalation suspension
(salbutamol sulphate)

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 further questions, ask your doctor, nurse 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 serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet:
1. What Respigen Inhaler is and what it is used for
2. Before you use Respigen Inhaler
3. How to use Respigen Inhaler
4. Possible side effects
5. How to store Respigen Inhaler
6. Further Information
The full product name as it appears at the top of the leaflet includes the strength and the
pharmaceutical form. However, throughout this leaflet the full product name has been
shortened and appears as Respigen Inhaler.

1.

WHAT RESPIGEN INHALER IS AND WHAT IT IS USED FOR

Respigen Inhaler contains salbutamol, which belongs to a group of medicines called shortacting ß2 agonists, bronchodilators or “relievers”. Salbutamol acts directly on the muscles in
the airways of the lung causing the muscles to relax. This widens or opens up the airways of
your lungs.
Respigen Inhaler is used by patients who have been diagnosed with asthma as it relieves the
symptoms of asthma. Respigen Inhaler can also be used to relieve symptoms such as chest
tightness, wheezing, shortness of breath and coughing in some other chest diseases.
Respigen Inhaler can also be used to prevent asthma symptoms that occur with exercise or on
exposure to an allergen, such as cat or dog hair, pollen or house dust.
You may also be using another inhaler regularly to help prevent asthma attacks, such as a
corticosteroid inhaler (e.g. beclometasone dipropionate). This inhaler is known as a
‘preventer’. You can safely use your ‘preventer’ inhaler with Respigen Inhaler. However,
before using Respigen Inhaler, it is important to let your doctor know if you are on any other
medication, including any inhalers.
Unlike salbutamol injection (and occasionally tablets), inhaled salbutamol cannot be used to
treat premature labour or threatened miscarriage.

2.

BEFORE YOU USE RESPIGEN INHALER

Do not use Respigen Inhaler

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 if you know you or your child are allergic to salbutamol or any of the other ingredients

(refer to Section 6 – Further Information).
Take special care with Respigen Inhaler
Tell your doctor, nurse or pharmacist:
 if you or your child are being treated for an overactive thyroid (thyrotoxicosis).
 if you or your child are being treated for high blood pressure.
Taking other medicines
Please tell your doctor, nurse or pharmacist if you or your child are taking or have recently
taken any other medicines, including any inhalers and medicines obtained without a
prescription but particularly those listed below:
 steroids e.g. beclometasone dipropionate for your asthma or steroid tablets
 diuretics (‘water’ tablets)
 medicine to reduce blood pressure e.g. atenolol
 medicine to control an irregular heart beat/rhythm, or very fast pulse
 tablets prescribed for your asthma to help your breathing, e.g. theophylline or
aminophylline
Using Respigen Inhaler with food and drink
You or your child can use Respigen Inhaler at any time of the day, with or without food.
Pregnancy and breast-feeding
Ask your doctor for advice before using Respigen Inhaler if you are pregnant, think that you
might be pregnant or intend to become pregnant, or if you are breast-feeding.
Driving and using machines
Using Respigen Inhaler should not affect your ability to drive or operate machinery.

3.

HOW TO USE RESPIGEN INHALER

Respigen Inhaler sprays a fine cloud of drug particles that you breathe in (inhale) through
your mouth into your lungs. It is important that you know how to use your inhaler properly.
Always use Respigen Inhaler exactly as your doctor has told you. The pharmacists’ label
should provide information on how, when and how many puffs to take. You should check
with your doctor, nurse or pharmacist if you are not sure.
Usual doses are as follows:
Adults (including the elderly and adolescents under 12 years of age)
 Take 1 puff to relieve asthma symptoms such as wheezing, breathlessness and
tightness in your chest, including bronchospasm. This may be increased to 2 puffs if
required.
 Take 2 puffs about 15 minutes before exercise or exposure to allergens
Children under 12 years of age
 Take 1 puff to relieve asthma symptoms such as wheezing, breathlessness and
tightness in your chest, including bronchospasm. This may be increased to 2 puffs if
required.
 Take 1 puff about 15 minutes before exercise or exposure to allergens. If 1 puff does
not provide relief from the symptoms of exercise or allergen exposure this dose can
be increased to 2 puffs.

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Children 12 years of age and more should take the same doses as adults.

You or your child should not take more than 8 puffs in 24 hours and 2 puffs should not
usually be taken more often than every 4 hours (up to a maximum total daily dose of 8 puffs
only).
For optimum benefit Respigen Inhaler should be used as required.
The above doses are described as usual doses. However, all patients are different, and your
doctor may have prescribed a different dose for you or your child.
If you find that you need to use Respigen Inhaler regularly every day or you notice that you
are needing to use your Respigen Inhaler more frequently than normal, this may mean that
your asthma is not very well controlled or it is getting worse. You should contact your doctor
or your asthma nurse straight away.
If Respigen Inhaler fails to give you at least 3 hours relief, tell your doctor, asthma nurse or
pharmacist as soon as possible.
Always remember:
 You or your child must not use Respigen Inhaler more often than your doctor told you to.
 You or your child must not stop using Respigen Inhaler unless your doctor tells you to

stop.
 You may be told to take more puffs than usual as emergency treatment if your breathing or

wheezing is very bad. It is very important to follow your doctor’s instructions on how,
when and how many puffs of your medicine to take.
 Should you visit another doctor or a dentist, or go to hospital, take ALL your medicines
and inhalers with you, including any medicines or tablets you have bought without a
prescription from the pharmacy, and all in their original packaging if possible.
Instructions for use
1. Remove the cap from the mouthpiece by holding it between thumb and forefinger and
squeezing gently whilst pulling them apart. Check that there are no objects in the
mouthpiece and that it is clean.
Testing your Respigen Inhaler
If the inhaler is new, or has not been used for more than one week, shake it well and fire 2
puffs into the air to check that it works.
2. Hold the inhaler upright with your thumb on the base and your first finger on the top of the
canister, as shown in the diagram and shake well.
3. Breathe out slowly through your mouth as far as is comfortable and then immediately
place the mouthpiece fully into your mouth and close your lips lightly around it, but do not
bite it.
4. Breathe in slowly and deeply and as you start to do so press the metal canister down firmly
with your first finger to spray the aerosol and release the medicine. Continue to breathe in
steadily and deeply.
5. Hold your breath and remove the mouthpiece from your mouth. Continue to hold your
breath for about 10 seconds, or as long as is comfortable, then breathe out slowly.

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6. Wait for about 1 minute before taking another puff, if needed. Then repeat steps 2 to 5.
7. Replace the cap on the mouthpiece by snapping it into place to protect the mouthpiece
from dirt and dust.
It is VERY important that you do not rush steps 3 and 4.
It is very important that you or your child breathe in slowly before pressing the metal canister.
It is a good idea to practise this in front of a mirror. If you see mist coming from your mouth
or the inhaler then you should repeat the instructions from step 2. However do not have more
than 4 goes at this whilst practising.
If you have difficulty in operating the inhaler with one hand, it is possible to use both hands.
At step 2 put both forefingers on top of the canister and place both thumbs on the base. Then
proceed as instructed.
Some people find it difficult to press their inhaler and breathe in at the same time. A spacer
device helps to overcome this problem. Respigen Inhaler can be used with the AeroChamber
Plus® spacer device. If you use the AeroChamber Plus® spacer device please follow the
instructions provided with it specifically in respect of cleaning the device prior to first use and
subsequent cleaning. Your doctor, nurse or pharmacist will be able to advise you about your
use of the AeroChamber Plus® spacer device. The use of the AeroChamber Plus® spacer
device may alter the amount of salbutamol which goes into your lungs and ends up in your
blood. If you notice any side effects such as tremor or a rapid or irregular heart beat
(palpitations) you should tell your doctor before you use your inhaler with the AeroChamber
Plus® spacer device again. Your doctor may need to change the dose of Respigen Inhaler or
may change your treatment altogether.
Respigen Inhaler should only be used with the AeroChamber Plus® spacer device, Respigen
Inhaler should not be used with any other spacer device as an alternative device may alter
the amount of salbutamol which goes into your lungs and ends up in your blood, and therefore
may increase any side effects.
Your doctor may give you or your child different instructions to these on how to use your
inhaler. If so please follow them. If you or your child have any difficulties in using this
inhaler please tell your doctor, nurse or pharmacist.
Cleaning your Inhaler
You should clean your inhaler once a week. To clean it:
1. Remove the metal canister by gripping it firmly and pulling it out of the plastic case. Then
remove the dust cap from the case.
2. Clean the mouthpiece and dust cap in warm water. You can also add a mild detergent or
baby bottle cleaning solution to the water; your pharmacist can advise you about this. If
you use a cleaning solution rinse the plastic case and dust cap in running water. DO NOT
put the metal canister into water.
3. Dry the case and dust cap in a warm place, but avoid direct heat.
4. Replace the dust cap and metal canister by reversing step 1.
If you or your child use more Respigen Inhaler than you should

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If you take more puffs than you have been told to take you may notice that you feel shaky and
that your heart is beating faster than normal. These effects usually wear off without treatment.
However, you should still tell your doctor as soon as possible.

4.

POSSIBLE SIDE EFFECTS

If your or your child breathing or wheezing gets worse immediately after using Respigen
Inhaler stop using it immediately and tell your doctor straight away. You or your child
may need a different “reliever” medicine to treat your symptoms.
Like all medicines, Respigen Inhaler can cause side effects, although not everybody gets
them.
Very rarely Respigen Inhaler can cause allergic reactions and the following might
occur:
 swelling of the face, eyes, tongue, lips or throat (also known as angioneurotic oedema)
 an allergic skin rash which is red and itchy and/or patchy and swollen (also know as
urticaria)
 difficulty in swallowing or breathing
 low blood pressure – you may feel light-headed or dizzy
 collapse
If you or your child experience any of these symptoms stop using Respigen Inhaler and see
a doctor straight away.
Some people may be very sensitive to Respigen Inhaler and notice their heart beating faster
than normal, palpitations, or feel their heartbeat is irregular or that there seem to be extra
beats. Patients may feel flushed. If you or your child experience any of these symptoms you
must contact your doctor straightaway, but do not stop using your medicine unless
instructed to do so.
The following side effects may also happen when using Respigen Inhaler:
Common (affects less than 1 in 10 people)
 shaking or tremor, most noticeable in the hands
 headache
Uncommon (affects less than 1 in 100 people)
 irritation in the mouth and/or throat
 muscle cramps
Rare (affects less than 1 in 1,000 people)
 chest pain, due to heart problems such as angina
 changes in behaviour such as restlessness or excitability
 increased blood flow to your extremities (peripheral dilation)
 a low level of potassium in your blood – from time to time your doctor may take a
blood sample to check the level of potassium in your blood.

If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor, asthma nurse or pharmacist as soon as possible.
If you notice that the relief of your chest tightness or wheezing is not as good as it was or
does not last as long as usual then tell your doctor as soon as possible. It is possible that your
asthma is getting worse and you need other medicines to treat it.

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5.

HOW TO STORE RESPIGEN INHALER






Keep out of the reach and sight of children
Do not use Respigen Inhaler after the expiry date shown on the label.
Do not store above 30C. Protect from frost and direct sunlight.
The canister contains a pressurised liquid. Do not expose to temperatures higher than
50C. Do not pierce the canister.
 If your Respigen Inhaler gets very cold, remove the metal canister from the plastic case
and warm it by rolling between your hands. Do not use any other source of heat to warm
it up.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of any unused or partly used and unwanted Respigen Inhalers.
These measures will help to protect the environment.

6.

FURTHER INFORMATION

What Respigen Inhaler Contains
Your medicine is in the form of a pressurised inhalation aerosol.
 The active substance is salbutamol
 The other ingredients are HFA 134a (a CFC-free propellant), oleic acid and ethanol,

anhydrous (7% w/w)
Each actuation (puff) from the aerosol contains 100 micrograms of the active ingredient
salbutamol (as salbutamol sulphate).
To help protect the environment, this product does not contain any chlorofluorocarbon (CFC)
propellants. This medicine contains a CFC-free propellant, 1,1,1,2-tetrafluoroethane, also
known as propellant HFA 134a and because of this you might notice that the medicine tastes
different, or that the spray feels different in your mouth or that the inhaler sounds different
when it is used. This does not affect the way in which your inhaler works.
What Respigen Inhaler looks like and contents of pack
Respigen Inhaler consists of a sealed metal canister, contained in a blue L-shaped plastic case
with a dust cap to protect the mouthpiece of the plastic case. Respigen Inhaler is supplied as a
single inhaler that contains approximately 200 actuations (200 puffs).
Marketing Authorisation Holder and Manufacturer
Generics [UK] Limited
Station Close
Potters Bar
Hertfordshire
EN6 1TL
This leaflet was last approved in July 2012.

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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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