- fluticasone propionate
- salmeterol xinafoate
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL 10949/0337, PL 10949/0339, PL 10949/0338.
Seretide 50, 125, 250 Evohaler
Package leaflet: Information for the user
25 microgram/50 microgram per metered dose pressurised inhalation, suspension
25 microgram/125 microgram per metered dose pressurised inhalation, suspension
25 microgram/250 microgram per metered dose pressurised inhalation, suspension
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Seretide is and what it is used for
2. What you need to know before you use Seretide
3. How to use Seretide
4. Possible side effects
5. How to store Seretide
6. Contents of the pack and other information
1 What Seretide is and what it is used for
Seretide contains two medicines, salmeterol and fluticasone propionate:
The doctor has prescribed this medicine to help prevent breathing problems such as asthma.
You must use Seretide every day as directed by your doctor. This will make sure that it works properly in controlling your asthma.
Seretide helps to stop breathlessness and wheeziness coming on. However Seretide should not be used to relieve a sudden attack of breathlessness or wheezing. If this happens you need to use a fast-acting ‘reliever’ (‘rescue’) inhaler, such as salbutamol. You should always have your fast-acting ‘rescue’ inhaler with you.
2 What you need to know before you use Seretide
Do not take Seretide:
If you are allergic to salmeterol, fluticasone propionate or to the other ingredient norflurane (HFA 134a).
Warnings and precautions
Talk to your doctor before using Seretide if you have:
Contact your doctor if you experience blurred vision or other visual disturbances.
Other medicines and Seretide
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines including medicines for asthma or any medicines obtained without a prescription. This is because Seretide may not be suitable to be taken with some other medicines.
Tell your doctor if you are taking the following medicines, before starting to use Seretide:
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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
Seretide is not likely to affect your ability to drive or use machines.
3 How to use Seretide
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults and adolescents aged 12 years and over
Children 4 to 12 years of age
Your symptoms may become well controlled using Seretide twice a day. If so, your doctor may decide to reduce your dose to once a day. The dose may change to:
It is very important to follow your doctor’s instructions on how many puffs to take and how often to take your medicine.
If you are using Seretide for asthma, your doctor will want to regularly check your symptoms.
If your asthma or breathing gets worse tell your doctor straight away. You may find that you feel more wheezy, your chest feels tight more often or you may need to use more of your fast-acting ‘reliever’ medicine. If any of these happen, you should continue to take Seretide but do not increase the number of puffs you take. Your chest condition may be getting worse and you could become seriously ill. See your doctor as you may need additional treatment.
Instructions for use
Testing your inhaler
1. When using your inhaler for the first time, test that it is working. Remove the mouthpiece cover by gently squeezing the sides with your thumb and forefinger and pull apart.
2. To make sure that it works, shake it well, point the mouthpiece away from you and press the canister to release a puff into the air. Repeat these steps, shaking the inhaler before releasing each puff, until the counter reads 120. If you have not used your inhaler for a week or more, release two puffs of medicine into the air.
Using your inhaler
It is important to start to breathe as slowly as possible just before using your inhaler.
1. Stand or sit upright when using your inhaler.
2. Remove the mouthpiece cover (as shown in the first picture). Check inside and outside to make sure that the mouthpiece is clean and free of loose objects.
3. Shake the inhaler 4 or 5 times 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. Breathe out as far as is comfortable.
5. Place the mouthpiece in your mouth between your teeth. Close your lips around it. Do not bite.
6. Breathe in through your mouth slowly and deeply. Just after starting to breathe in, press firmly down on the top of the canister to release a puff of medicine. Do this while still breathing in steadily and deeply.
7. Hold your breath, take the inhaler from your mouth and your finger from the top of the inhaler. Continue holding your breath for a few seconds, or as long as is comfortable.
8. Wait about half a minute between taking each puff of medicine and then repeat steps 3 to 7.
9. Afterwards, rinse your mouth with water and spit it out, and/or brush your teeth. This may help to stop you getting thrush and becoming hoarse.
10. After use always replace the mouthpiece cover straight away to keep out dust. When the mouthpiece cover is fitted correctly it will ‘click’ into position. If it does not ‘click’ into place, turn the mouthpiece cover the other way round and try again. Do not use too much force.
Do not rush steps 4, 5, 6 and 7. It is important that you breathe in as slowly as possible just before using your inhaler. You should use your inhaler whilst standing in front of a mirror for 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 from step 3.
As with all inhalers, caregivers should ensure that children prescribed Seretide Evohaler use correct inhalation technique, as described above.
If you or your child find it difficult to use the Evohaler, either your doctor or nurse or other healthcare provider may recommend using a spacer device such as the Volumatic or AeroChamber Plus with your inhaler. Your doctor, nurse, pharmacist or other healthcare provider should show you how to use the spacer device with your inhaler and how to care for your spacer device and will answer any questions you may have. It is important that if you are using a spacer device with your inhaler that you do not stop using it without talking to your doctor or nurse first. It is also important that you do not change the type of spacer device that you use without talking to your doctor. If you stop using a spacer device or change the type of spacer device that you use your doctor may need to change the dose of medicine required to control your asthma. Always talk to your doctor before making any changes to your asthma treatment.
Older children or 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 bottom below the mouthpiece. A special device called a Haleraid may also make it easier.
You should get a replacement when the counter shows the number 020. Stop using the inhaler when the counter shows 000 as any puffs left in the device may not be enough to give you a full dose. Never try to alter the numbers on the counter or detach the counter from the metal canister.
Cleaning your inhaler
To stop your inhaler blocking, it is important to clean it at least once a week.
To clean your inhaler:
Do not put the metal canister in water.
If you use more Seretide than you should
It is important to use the inhaler as instructed. If you accidentally take a larger dose than recommended, talk to your doctor or pharmacist. You may notice your heart beating faster than usual and that you feel shaky. You may also have dizziness, a headache, muscle weakness and aching joints.
If you have used larger doses for a long period of time, you should talk to your doctor or pharmacist for advice. This is because larger doses of Seretide may reduce the amount of steroid hormones produced by the adrenal gland.
If you forget to use Seretide
Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.
If you stop using Seretide
It is very important that you take your Seretide every day as directed. Keep taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of Seretide. This could make your breathing worse.
In addition, if you suddenly stop taking Seretide or reduce your dose of Seretide this may (very rarely) cause you to have problems with your adrenal gland (adrenal insufficiency) which sometimes causes side effects.
These side effects may include any of the following:
When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and you may have any of the side effects listed above.
If you get any side effects, talk to your doctor or pharmacist. To prevent these symptoms occurring, your doctor may prescribe extra corticosteroids in tablet form (such as prednisolone).
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. To reduce the chance of side effects, your doctor will prescribe the lowest dose of Seretide to control your asthma.
Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Seretide. You may be very wheezy and cough or be short of breath. You may also notice itching, a rash (hives) and swelling (usually of the face, lips, tongue or throat), or you may suddenly feel that your heart is beating very fast or you feel faint and light headed (which may lead to collapse or loss of consciousness). If you get any of these effects or if they happen suddenly after using Seretide, stop using Seretide and tell your doctor straight away. Allergic reactions to Seretide are uncommon (they affect less than 1 person in 100).
Other side effects are listed below:
Very Common (affects more than 1 person in 10)
Common (affects less than 1 person in 10)
The following side effects have also been reported in patients with Chronic Obstructive Pulmonary Disease (COPD):
Uncommon (affects less than 1 person in 100)
Rare (affects less than 1 person in 1000)
Frequency not known, but may also occur:
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5 How to store Seretide
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 Seretide Evohaler contains
What Seretide Evohaler looks like and contents of the pack
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
This medicinal product is authorised in the Member States of the EEA under the following names:*
Austria Seretide Dosieraerosol
Finland Seretide Evohaler
Greece Seretide Inhaler
Ireland Seretide Evohaler
The Netherlands Seretide
Portugal Seretaide Inalador
Sweden Seretide Evohaler
United Kingdom Seretide Evohaler
To listen to or request a copy of this leaflet in Braille, large print or audio please call free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name Seretide Evohaler
Reference number 10949/0337
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in December 2017.
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AeroChamber Plus is a registered trade mark of Trudell Medical International.
© 2017 GSK group of companies or its licensor.