GLAXOSMITHKLINE Seretide 100 Diskus User manual

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Package leaflet: Information for the user
Seretide®100 Diskus®50 microgram/100 microgram/
dose inhalation powder, pre-dispensed
Seretide®250 Diskus®50 microgram/250 microgram/
dose inhalation powder, pre-dispensed
Seretide®500 Diskus®50 microgram/500 microgram/
dose inhalation powder, pre-dispensed
salmeterol / fluticasone propionate
Your medicine is available using the above names but will be referred to as Seretide throughout
this leaflet.
Read all of this leaflet carefully before you start taking 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 symptoms and 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 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:
Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to
stay open. This makes it easier for air to get in and out. The effects last for at least 12
hours.
Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs.
The doctor has prescribed this medicine to help prevent breathing problems such as:
Asthma
Chronic Obstructive Pulmonary Disease (COPD). Seretide Diskus, at a dose of 50/500
micrograms, reduces the number of flare ups of COPD symptoms.
You must use Seretide every day as directed by your doctor. This will make sure that it works
properly in controlling your asthma or COPD.
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 lactose
monohydrate.
Warnings and precautions
Talk to your doctor before using Seretide if you have:
Heart disease, including an irregular or fast heart beat
Overactive thyroid gland
High blood pressure
Diabetes mellitus (Seretide may increase your blood sugar)
Low potassium in your blood
Tuberculosis (TB) now or in the past, or other lung infections
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:
ß blockers (such as atenolol, propranolol and sotalol). ß blockers are mostly used for high
blood pressure or other heart conditions.
Medicines to treat infections (such as ketoconazole, itraconazole and erythromycin)
including some medicines for HIV treatment (such as ritonavir, cobicistat-containing
products). Some of these medicines may increase the amount of fluticasone propionate or
salmeterol in your body. This can increase your risk of experiencing side effects with
Seretide, including irregular heart beats, or may make side-effects worse. Your doctor may
wish to monitor you carefully if you are taking these medicines.
Corticosteroids (by mouth or by injection). If you have had these medicines recently, this
might increase the risk of this medicine affecting your adrenal gland.
Diuretics, also known as ‘water tablets’ used to treat high blood pressure.
Other bronchodilators (such as salbutamol).
Xanthine medicines. These are often used to treat asthma.
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
Seretide is not likely to affect your ability to drive or use machines.
Seretide Diskus contains lactose
Seretide Diskus contains up to 12.5 milligrams of lactose monohydrate in each dose. The
amount of lactose in this medicine does not normally cause problems in people who are lactose
intolerant. The excipient lactose monohydrate contains small amounts of milk proteins, which
may cause allergic reactions.
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.
Use your Seretide every day, until your doctor advises you to stop. Do not take more than
the recommended dose. Check with your doctor or pharmacist if you are not sure.
Do not stop taking Seretide or reduce the dose of Seretide without talking to your doctor
first.
Seretide should be inhaled through the mouth into the lungs.
For asthma
Adults and adolescents aged 12 years and over
Seretide 50/100 Diskus - One inhalation twice a day
Seretide 50/250 Diskus - One inhalation twice a day
Seretide 50/500 Diskus - One inhalation twice a day
Children 4 to 12 years of age
Seretide 50/100 Diskus - One inhalation twice a day
Seretide is not recommended for use in children below 4 years of age.
For adults with Chronic Obstructive Pulmonary Disease (COPD)
Seretide 50/500 Diskus - One inhalation twice a day
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:
once at night - if you have night-time symptoms
once in the morning - if you have daytime symptoms.
It is very important to follow your doctor’s instructions on how many inhalations 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
Your doctor, nurse or pharmacist should show you how to use your inhaler. They should
check how you use it from time to time. Not using the Seretide Diskus properly or as
prescribed may mean that it will not help your asthma or COPD as it should.
The Diskus device holds blisters containing Seretide as a powder.
There is a counter on top of the Diskus which tells you how many doses are left. It counts
down to 0. The numbers 5 to 0 will appear in red to warn you when there are only a few
doses left. Once the counter shows 0, your inhaler is empty.
Using your inhaler
1. To open your Diskus, hold the outer case in one hand and put
the thumb of your other hand on the thumbgrip. Push your
thumb away from you as far as it will go. You will hear a click.
This will open a small hole in the mouthpiece.
2. Hold your Diskus with the mouthpiece towards you. You can hold
it in either your right or left hand. Slide the lever away from you
as far as it will go. You will hear a click. This places a dose of
your medicine in the mouthpiece. Every time the lever is pulled
back a blister is opened inside and the powder made ready for
you to inhale. Do not play with the lever as this opens the
blisters and wastes medicine.
3. Hold the Diskus away from your mouth, breathe out as far as is
comfortable. Do not breathe into your Diskus.
4. Put the mouthpiece to your lips; breathe in steadily and deeply
through the Diskus, not through your nose.
Remove the Diskus from your mouth. Hold your breath for about
10 seconds or for as long as is comfortable.
Breathe out slowly.
5. 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.
6. To close the Diskus, slide the thumbgrip back towards you, as
far as it will go. You will hear a click.
The lever will return to its original position and is reset. Your
Diskus is now ready for you to use again.
As with all inhalers, caregivers should ensure that children prescribed
Seretide Diskus use correct inhalation technique, as described above.
Cleaning your inhaler
Wipe the mouthpiece of the Diskus with a dry tissue to clean it.
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:
Stomach pain
Tiredness and loss of appetite, feeling sick
Sickness and diarrhoea
Weight loss
Headache or drowsiness
Low levels of sugar in your blood
Low blood pressure and seizures (fits)
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.

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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 or COPD.
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).
Pneumonia (infection of the lung) in COPD patients. (Common side effect)
Tell your doctor if you have any of the following while taking Seretide they could be symptoms
of a lung infection:
fever or chills
increased mucus production, change in mucus colour
increased cough or increased breathing difficulties
Other side effects are listed below:
Very Common (affects more than 1 person in 10)
Headache - this usually gets better as treatment continues.
Increased number of colds have been reported in patients with COPD.
Common (affects less than 1 person in 10)
Thrush (sore, creamy-yellow, raised patches) in the mouth and throat. Also sore tongue and
hoarse voice and throat irritation. Rinsing your mouth out with water and spitting it out
immediately and/or brushing your teeth after taking each dose of your medicine may help.
Your doctor may prescribe an anti-fungal medication to treat the thrush.
Aching, swollen joints and muscle pain.
Muscle cramps.
The following side effects have also been reported in patients with Chronic Obstructive
Pulmonary Disease (COPD):
Bruising and fractures.
Inflammation of sinuses (a feeling of tension or fullness in the nose, cheeks and behind the
eyes, sometimes with a throbbing ache).
A reduction in the amount of potassium in the blood (you may get an uneven heart beat,
muscle weakness, cramp).
Uncommon (affects less than 1 person in 100)
Increases in the amount of sugar (glucose) in your blood (hyperglycaemia). If you have
diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual
diabetic treatment may be required.
Cataract (cloudy lens in the eye).
Very fast heart beat (tachycardia).
Feeling shaky (tremor) and fast or uneven heart beat (palpitations) - these are usually
harmless and get less as treatment continues.
Chest pain.
Feeling worried (this effect mainly occurs in children).
Disturbed sleep.
Allergic skin rash.
Rare (affects less than 1 person in 1000)
Breathing difficulties or wheezing that get worse straight after taking Seretide. If
this happens stop using your Seretide inhaler. Use your fast-acting ‘reliever’ inhaler to
help your breathing and tell your doctor straight away.
Seretide may affect the normal production of steroid hormones in the body, particularly if
you have taken high doses for long periods of time. The effects include:
Slowing of growth in children and adolescents.
Thinning of the bones.
Glaucoma.
Weight gain.
Rounded (moon shaped) face (Cushing’s Syndrome).
Your doctor will check you regularly for any of these side effects and make sure you are
taking the lowest dose of Seretide to control your asthma.
Behavioural changes, such as being unusually active and irritable (these effects mainly occur
in children).
Uneven heartbeat or heart gives an extra beat (arrhythmias). Tell your doctor, but do not
stop taking Seretide unless the doctor tells you to stop.
A fungal infection in the oesophagus (gullet), which might cause difficulties in swallowing.
Frequency not known, but may also occur
Depression or aggression. These effects are more likely to occur in children.
Blurred vision
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 (see details below).
By reporting side effects you can help provide more information on the safety of this medicine.
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2
Tel: [phone] Fax: [phone]
Website: www.hpra.ie e-mail: medsaf[email protected]
5. How to store Seretide
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the label and carton after
EXP. The expiry date refers to the last day of that month.
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 contains
The active substances are salmeterol and fluticasone propionate. Each pre-dispensed dose
contains 50 micrograms of salmeterol (as salmeterol xinafoate) and 100, 250 or 500
micrograms of fluticasone propionate.
The other ingredient is lactose monohydrate (which contains milk proteins).
What Seretide looks like and contents of the pack
The Seretide Diskus contains a foil strip. The foil protects the powder for inhalation from the
effects of the atmosphere.
Each dose is pre-dispensed.
The device is packed in a carton which holds 1 Diskus containing 60 inhalations.
Manufacturer
Manufactured by: Glaxo Wellcome Operations, Priory Street, Ware, Hertfordshire SG12 0DJ, UK
or
Glaxo Wellcome Production, Zone Industrielle No.2, 23 rue Lavoisier, 27000 Evreux, France
or
Glaxo Wellcome GmbH & Co, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany
or
Glaxo Operations UK Limited, Priory Street, Ware, Hertfordshire SG12 0DJ, United Kingdom
or
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware,
Hertfordshire SG12 0DJ, UK
or
Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany
or
A. Menarini Manufacturing Logistics and Services S.r.l., Via Sette Santi, 3 –Firenze –Italy.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR, UK.
PPA holder: Imbat Ltd., Unit L2, North Ring Business Park, Santry, Dublin 9.
Distributed by: Eurodrug Ltd., Unit L2, North Ring Business Park, Santry, Dublin 9.
PPA1151/006/003 –50/100mcg
PPA1151/006/002 –50/250mcg
PPA1151/006/001 –50/500mcg
This medicinal product is authorised in the Member States of the EEA under the
following names:
Austria
Seretide Diskus
Belgium
Seretide Diskus
Croatia
Seretide Diskus
Cyprus
Seretide Diskus
Czech Republic
Seretide Diskus
Denmark
Seretide
Estonia
Seretide Diskus
Finland
Seretide Diskus
France
Seretide Diskus
Germany
atmadisc Diskus
Greece
Seretide Diskus
Hungary
Seretide Diskus
Iceland
Seretide Diskus
Ireland
Seretide Diskus
Italy
Seretide Diskus
Luxembourg
Seretide Diskus
Malta
Seretide Diskus
The Netherlands
Seretide Diskus
Portugal
Seretaide Diskus
Romania
Seretide Diskus
Slovakia
Seretide Diskus
Spain
Seretide Accuhaler
Sweden
Seretide Diskus
United Kingdom
Seretide Accuhaler
Leaflet revision & issue date (ref): 22.05.18
Seretide®& Diskus®are trademarks of GlaxoSmithKline group of companies.
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information:
Product name: Seretide Diskus
Reference No: PPA1151/006/001-3