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NEOVENTTM CFC-FREE INHALER 25 MICROGRAMS PER ACTUATION PRESSURISED INHALATION SUSPENSION.
Active substance(s): SALMETEROL XINAFOATE
The name of this medicine is NeoventTM CFC-free Inhaler 25 micrograms per
actuation pressurised inhalation, suspension which will be referred to as
NeoventTM Inhaler throughout this leaflet.
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 or pharmacist.
• 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 or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What NeoventTM Inhaler is and what it is used for
2. What you need to know before you use NeoventTM Inhaler
3. How to use NeoventTM Inhaler
4. Possible side effects
5. How to store NeoventTM Inhaler
6. Contents of the pack and other information
1. WHAT NEOVENTTM INHALER IS AND WHAT IT IS USED FOR
• NeoventTM Inhaler contains the medicine salmeterol. It is a long-acting
bronchodilator. It helps the airways in the lungs to stay open. This makes it
easier for air to get in and out. The effects can usually be noticed within 10
to 20 minutes and last for 12 hours or more.
• The doctor has prescribed NeoventTM Inhaler to help prevent breathing
problems. These could be caused by asthma. Taking NeoventTM Inhaler
regularly will prevent asthma attacks including asthma brought on by
exercise or at night.
• Taking NeoventTM Inhaler regularly will also help prevent breathing problems
caused by other chest illnesses such as chronic obstructive pulmonary
• NeoventTM Inhaler helps to stop breathlessness and wheezing coming on. It
does not work once you are breathless or wheezy. If that happens you need
to use a fast-acting “reliever” medicine, such as salbutamol.
• NeoventTM Inhaler is supplied to you in an inhaler. You breathe the medicine
through your mouth directly into your lungs.
• NeoventTM Inhaler contains norflurane and does not contain any
chlorofluorocarbons (CFCs). Norflurane-containing inhalers are less harmful
to the environment than older CFC-containing inhalers. NeoventTM Inhaler
may taste differently to older CFC-containing inhalers. This will make no
difference to how your medicine works.
If you are being treated for asthma, you should always be given both a
NeoventTM Inhaler and a steroid inhaler (or rarely steroid tablets) to use
together. Both inhalers must be used regularly.
Customer: Fannin PL 20417/0058
Change: Project 500
Size: 240 x 390mm Proof: 1
Date: 22 Mar 17
2. WHAT YOU NEED TO KNOW BEFORE YOU USE NEOVENTTM
Do not use NeoventTM Inhaler
• If you are allergic (hypersensitive) to salmeterol xinafoate or any of the other
ingredients in this medicine.
• If you are allergic to peanut or soya, do not use NeoventTM Inhaler as it
contains soya lecithin.
Take special care with NeoventTM Inhaler
• If your asthma or breathing gets worse tell your doctor straight away.
You may find that you feel wheezier, your chest feels tight more often or you
may need to use more of your fast-acting “reliever” medicine. If any of these
happen, do not increase your number of puffs of NeoventTM Inhaler. Your
chest condition may be getting worse and you could become seriously ill.
See your doctor as you may need a change in asthma treatment.
• If you have been prescribed NeoventTM Inhaler for your asthma, continue to
use any other asthma medication you are already taking including your
steroid inhaler or steroid tablets. Continue taking the same doses as before,
unless your doctor tells you otherwise. Do this even if you feel much better.
Do not stop using your steroid inhaler (or taking any steroid tablets)
when you start using NeoventTM Inhaler.
• Your doctor may want to check your health more regularly if you have an
overactive thyroid gland, heart disease, including an irregular or fast
heartbeat; or diabetes mellitus (as salmeterol may increase your blood
sugar). If you have diabetes your doctor may want to monitor your blood
sugar more frequently than usual and may need to adjust the treatment you
take for your diabetes.
Other medicines and NeoventTM Inhaler
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including asthma medicines and any inhalers, and including
medicines obtained without a prescription. This is because NeoventTM Inhaler may
not be suitable to be taken with other medicines.
• Please inform your doctor before using NeoventTM Inhaler, if you are currently
being treated for any fungal infections with medicines
containing ketoconazole or itraconazole, or if you are being treated for HIV with
ritonavir. These medicines may increase the risk of you experiencing side
effects with salmeterol, including irregular heart beats, or may make side
• Beta blockers should be avoided when using NeoventTM Inhaler, unless your
doctor tells you to take them. Beta blockers, including atenolol, propranolol and
sotalol, are mostly used for the treatment of high blood pressure or other heart
conditions. Please tell your doctor if you are taking β blockers or have recently
been prescribed β blockers as they may reduce or abolish the effects of
• Salmeterol can reduce the amount of potassium in your blood. If this happens,
you may notice an uneven heartbeat, muscle weakness or cramp. This is more
likely to happen if you use NeoventTM Inhaler with some medicines used to treat
high blood pressure (diuretics) and other medicines used to treat breathing
problems such as theophylline or steroids. Your doctor may ask you to have
blood tests to check the amount of potassium in your blood from time to time. If
you have any concerns discuss them with your doctor.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, planning to get pregnant or
breast-feeding; you should talk to your doctor or pharmacist before starting to use
NeoventTM Inhaler. They will assess if you can use NeoventTM Inhaler during this
Driving and using machines
The possible side effects associated with NeoventTM Inhaler are unlikely to affect
your ability to drive or use machines.
3. HOW TO USE NEOVENT
Always use this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
• If you are being treated for asthma, you should always be given both a
NeoventTM Inhaler and a steroid inhaler to use together.
• Use NeoventTM Inhaler every day until your doctor advises you to stop.
• You will start to feel your medicine working within the first day of use.
NeoventTM Inhaler is for inhalation through the mouth only.
Dosage for adults and adolescents 12 years and older with asthma
• The usual starting dose is 2 puffs twice a day.
• If you have more severe asthma, your doctor may increase your dose to 4 puffs
twice a day.
The safety and efficacy of NeoventTM Inhaler have not been demonstrated in
children. Therefore NeoventTM Inhaler should not be used in children 12
years of age and younger.
Dosage for adults with Chronic Obstructive Pulmonary Disease (COPD),
including bronchitis and emphysema
• The usual starting dose is 2 puffs twice a day.
Not applicable for children and adolescents.
Instructions for use
Your doctor or pharmacist should show you how to use your inhaler. They should
check how you use it from time to time. Incorrect use, not using the inhaler as
prescribed or not using it as described in this Leaflet, may mean that the medicine
will not work as it should and so will not help your asthma or COPD.
The medicine is contained in a pressurised canister in a plastic casing with a
Testing your inhaler
When you use the inhaler for the first time you should test if it works properly.
1. Remove the mouthpiece cover by gently pressing the sides with your thumb
and index finger.
2. Shake the inhaler well for a minimum of 10 seconds, point the mouthpiece
away from you and press the canister twice to release two puffs into the air. If
you have not used the inhaler for a week or more or if you have cleaned the
inhaler, you should release one puff into the air.
Using your inhaler
NeoventTM CFC-free Inhaler
Neovent CFC-free Inhaler 25 micrograms
per actuation pressurised inhalation, suspension
NeoventTM CFC-free Inhaler
PACKAGE LEAFLET: INFORMATION FOR THE USER
1. You should either stand up or sit upright when using the inhaler.
2. Remove the mouthpiece cover. Check the mouthpiece inside and outside to
see that it is clean (figure 1).
3. Shake the inhaler well for a minimum of 5 seconds before use (figure 2) to
ensure that any loose objects are removed and that the contents of the inhaler
are evenly mixed.
4. Hold the inhaler upright with your thumb on the base, below the mouthpiece.
5. Breathe out as far as is comfortable (figure 3).
6. Place the mouthpiece in your mouth between your teeth and close your lips
around it but do not bite it (figure 4).
7. Just after starting to breathe in as slowly as you can through your mouth, press
down on top of the inhaler to release a puff into your mouth while still
breathing in steadily and deeply (figure 4).
8. While holding your breath, take the inhaler from your mouth and take your
finger from the top of the inhaler. Continue holding your breath for as long as
is comfortable (figure 5).
9. If you are to take a second puff, wait about half a minute before repeating
steps 3 to 8.
10. After use always replace the mouthpiece cover to keep out dust and fluff. The
mouthpiece cover is replaced by firmly pushing and snapping it into position.
Practise in front of a mirror the first few times. If you see “mist” coming from the
top of your inhaler or the sides of your mouth you should start again.
If you find it difficult to use the inhaler, a Volumatic® spacer device may help to
overcome this problem. Contact your doctor or pharmacist. If you do need to use
the Volumatic® spacer device, please refer to the instruction leaflet provided with
the spacer device, which includes all the information you need to use the spacer
If the inhaler gets very cold, take the metal canister out of the plastic case and
warm it in your hands for a few minutes. Never use anything else to warm it up.
After warming up the inhaler, spray one puff in the air before use.
Cleaning your inhaler
To prevent your inhaler from getting blocked up it should be cleaned at least once
To clean your inhaler:
• Remove the mouthpiece cover.
• Do not remove the canister from the plastic casing at any time.
• Wipe the inside of the mouthpiece and the plastic casing with a dry cloth or
• Release one puff into the air before next using the inhaler to test the inhaler.
• Replace the mouthpiece cover.
Do not put the metal canister into water.
If you take more NeoventTM Inhaler than you should
It is important to use the inhaler as instructed. If you accidentally take a larger
dose than recommended you should contact your doctor or pharmacist. You may
notice your heart beating faster than usual and that you feel shaky and/or dizzy.
You may also have a headache, muscle weakness and aching joints.
If you forget to use NeoventTM Inhaler
If you forget to use your inhaler you should take the next dose when it is due.
Do not take a double dose to make up for a dose you have forgotten.
Rare (may affect up to 1 in 1,000 people)
• Difficulty in sleeping (insomnia).
• A fall in the amount of potassium in the blood (you may notice an irregular
heartbeat, muscle weakness and/or muscle cramp). Your doctor may ask you
to have blood tests to check the amount of potassium in your blood from time
to time. If you have any concerns discuss them with your doctor.
Very rare (may affect up to 1 in 10,000 people)
• Breathing difficulties or wheezing that gets worse straight after using
NeoventTM Inhaler. If this happens stop using your NeoventTM Inhaler. Use
your fast-acting “reliever” inhaler to help your breathing and tell your doctor
• Irregular heartbeat or your heart gives an extra beat (arrhythmia). If this
happens do not stop using NeoventTM Inhaler but tell your doctor.
• An increase in the amount of sugar (glucose) in your blood (hyperglycaemia).
If you have diabetes your doctor may want to monitor your blood sugar more
frequently than usual and may need to adjust the treatment you take for your
• Sore mouth or throat.
• Feeling sick (nausea).
• Aching, swollen joints.
• Chest pain.
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 at 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 NEOVENT
• Keep this medicine out of the sight and reach of children.
• Straight after use, replace the mouthpiece cover firmly and click into position.
Do not use excessive force.
• Store below 30ºC.
• Do not freeze.
• This canister contains a pressurised liquid. Do not expose to temperatures
higher than 50°C.
• Do not puncture, break or burn the canister, even if you think it is empty.
• Do not use NeoventTM Inhaler after the expiry date which is stated on the label
and the carton after the letters EXP. The expiry date refers to the last day of
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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
If you have any further questions on the use of this product, ask your doctor or
4. POSSIBLE SIDE EFFECTS
Like all medicines, NeoventTM Inhaler can cause side effects, although not
everybody gets them. To reduce the chance of side effects your doctor will
prescribe the lowest dose to control your asthma or COPD. The following side
effects have been reported by patients using NeoventTM Inhaler.
Allergic reactions: you may notice that your breathing suddenly gets worse
after using NeoventTM Inhaler. You may experience:
• Wheezing or coughing.
• Rash, itching, swelling (usually of the face, lips, tongue or throat).
If you experience any of these side effects or if they occur suddenly after using
NeoventTM Inhaler you should tell your doctor immediately. Allergic reactions to
NeoventTM Inhaler are very rare (occurring in less than 1 in 10,000 patients).
Other side effects are:
Common (may affect up to 1 in 10 people)
• Muscle cramps.
• Feeling shaky, fast or irregular heartbeat (palpitations), headache, shaking
hands (tremor). Tremors are more likely to occur if you are taking more than
two puffs twice daily. These side effects do not last long and occur less as
treatment with salmeterol continues.
Uncommon (may affect up 1 in 100 people)
• Very fast heart rate (tachycardia). This is more likely to occur if you are taking
more than two puffs twice daily.
• Feeling nervous.
What NeoventTM Inhaler contains
• The active substance is salmeterol (as xinafoate).
Each metered dose (ex-valve) contains 25 micrograms salmeterol (as
xinafoate). This is equivalent to a delivered dose (ex-actuator) of 21
micrograms salmeterol (as xinafoate).
• The other ingredients are anhydrous ethanol, soya lecithin (E322) and
norflurane (HFA 134a).
What NeoventTM Inhaler looks like and contents of the pack
NeoventTM Inhaler is a mid-green inhaler holding an aluminium canister with a
pale green mouthpiece cover. Each canister contains 120 actuations, each
actuation containing 25 micrograms salmeterol (as xinafoate).
Marketing Authorisation Holder
Fannin (UK) Limited, DCC Vital, Westminster Industrial Estate, Repton Road,
Measham, DE12 7DT, England.
Manufacturer Responsible For Batch Release
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR,
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
This leaflet was last revised in 03/2017.
This medicinal product is authorised in the Member States of the EEA
under the following names:
Germany Salmeterol HEXAL 25 Mikrogramm/Dosis, Druckgasinhalation,
Salmeterol Neolab 25 micrograms per metered dose,
pressurised inhalation suspension