SERETIDE 250 ACCUHALER

Active substance: SALMETEROL XINAFOATE MICRONISED

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Assessed against UK PIL dated January
2013

PATIENT INFORMATION LEAFLET

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By kanagasabaic at 11:55 am, Jul 31, 13

SeretideTM 250 AccuhalerTM

If you are pregnant, planning to get pregnant or breast-feeding, talk to your doctor
before taking Seretide Accuhaler. Your doctor will assess whether you can take
Seretide Accuhaler during this time.

(salmeterol xinafoate / fluticasone propionate)
This medicine will be referred to as Seretide Accuhaler throughout this Patient
Information Leaflet. Please note that the leaflet also contains information about
other strengths (Seretide™ 100 and 500 Accuhaler™).
Counter
Full
Empty
60

Outer Case

Pregnancy and breast-feeding

0

Thumbgrip

Driving and using machines
Seretide Accuhaler is not likely to affect your ability to drive or use machines.
Important information about some of the ingredients of Seretide
Accuhaler
Seretide Accuhaler contains up to 12.5 milligrams of lactose in each dose. The
amount of lactose in this medicine does not normally cause problems in people
who are lactose intolerant.
3. How to use Seretide Accuhaler

Mouthpiece
Lever




Read all of this leaflet carefully before you start taking this medicine.





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. 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 or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Seretide Accuhaler is and what it is used for
Before you use Seretide Accuhaler
How to use Seretide Accuhaler
Possible side effects
How to store Seretide Accuhaler
Further information




1. What Seretide Accuhaler is and what it is used for
Seretide Accuhaler 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 Accuhaler, at a dose
of 50/500 micrograms, reduces the number of flare ups of COPD symptoms.
You must use Seretide Accuhaler every day as directed by your doctor. This will
make sure that it works properly in controlling your asthma or COPD.
Seretide Accuhaler helps to stop breathlessness and wheeziness coming
on. It does not work once you are breathless or wheezy. If that happens you
need to use a fast acting ‘reliever’ medication, such as salbutamol.

For asthma
Adults and adolescents aged 12 years and over
TM
TM
Seretide 100 Accuhaler - One inhalation twice a day
TM
TM
• Seretide
250 Accuhaler - One inhalation twice a day
TM
TM
• Seretide
500 Accuhaler - One inhalation twice a day


Children 4 to 12 years of age
TM
TM
• Seretide
100 Accuhaler - One inhalation twice a day
TM
TM
• Seretide
Accuhaler is not recommended for use in children below 4 years
of age.
For adults with Chronic Obstructive Pulmonary Disease (COPD)
TM
TM
Seretide 500 Accuhaler - One inhalation twice a day



Your symptoms may become well controlled using Seretide Accuhaler 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 Accuhaler 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 Accuhaler 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


2. Before you use Seretide Accuhaler
Do not take Seretide Accuhaler if:




You are allergic (hypersensitive) to salmeterol xinafoate, fluticasone propionate or
to the other ingredient lactose monohydrate.

Use your Seretide Accuhaler every day, until your doctor advises you to stop.
Always use Seretide Accuhaler exactly as your doctor has told you. Don’t exceed
the recommended dose. Check with your doctor or pharmacist if you’re not sure.

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
Accuhaler properly or as prescribed may mean that it will not help your asthma
or COPD as it should.
The Seretide Accuhaler device holds blisters containing Seretide as a powder.
There is a counter on top of the Seretide Accuhaler 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.

Take special care with Seretide Accuhaler

Using your inhaler

Your doctor will supervise your treatment more closely if you have medical
conditions such as:
• heart disease, including an irregular or fast heartbeat
• overactive thyroid gland
• high blood pressure


• diabetes mellitus (Seretide Accuhaler may increase your blood sugar)
• low potassium in your blood
• Tuberculosis (TB) now or in the past.
If you have ever had any of these conditions, tell your doctor before you use
Seretide Accuhaler.

1. To open your Seretide Accuhaler, 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.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines. This includes medicines for asthma or any medicines obtained
without a prescription. This is because Seretide Accuhaler 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 Accuhaler:
• Beta-blockers (such as atenolol, propranolol, sotalol). Beta-blockers are mostly
used for high blood pressure or other heart conditions.
• Antiviral and antifungal medicines (such as ritonavir, ketoconazole and
itraconazole). 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 Accuhaler, including irregular
heartbeats, or may make side effects worse.
• 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.

2. Hold your Seretide Accuhaler 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 Seretide Accuhaler away from your mouth, breathe out as far as is
comfortable. Do not breathe into your Seretide Accuhaler.

4. Put the mouthpiece to your lips; breathe in
steadily and deeply through the Seretide
Accuhaler, not through your nose.
Remove the Seretide Accuhaler 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. This may help to stop
you getting thrush and being hoarse.
6. To close the Seretide Accuhaler, 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 Seretide Accuhaler is now ready for you to
use again.
Cleaning your inhaler
Wipe the mouthpiece of the Seretide Accuhaler with a dry tissue to clean it.
If you use more Seretide Accuhaler 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 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 Accuhaler may
reduce the amount of steroid hormones produced by the adrenal gland.

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.
• Cloudy lens in the eye.
• Very fast heartbeat (tachycardia).
• Feeling shaky 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.
• Rash.


Rare (affects less than 1 person in 1000)
Breathing difficulties or wheezing that get worse straight after taking
Seretide Accuhaler. 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 Accuhaler 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 includes:
- 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 Accuhaler to control your asthma.
• Behavioural changes, such as being unusually active and irritable (these effects
may occur in children).
• Uneven heartbeat or heart gives an extra beat (arrhythmias). Tell your doctor,
but do not stop taking Seretide Accuhaler unless they tell you to stop.


If you forget to use Seretide Accuhaler

Frequency not known, but may also occur:
• Depression or aggression. These effects are more likely to occur in children.

If you forget to use your inhaler, take your next dose when it is due. Do not take a
double dose to replace the one you forgot.

If any of the side effects become serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

If you stop using Seretide Accuhaler

5. How to store Seretide Accuhaler

It is very important that you take your Seretide Accuhaler every day as
directed. Keep taking it until your doctor tells you to stop. Do not stop or suddenly
reduce your dose of Seretide Accuhaler. This could make your breathing
problem worse and very rarely side effects could occur. These include:
• stomach pain
• tiredness and loss of appetite
• sickness and diarrhoea
• weight loss
• headache or drowsiness
• low levels of potassium in your blood
• low blood pressure and seizures.



Very rarely, if you get an infection or at times of extreme stress (such as after a
serious accident or if you have surgery), you may get similar side effects.
To prevent these symptoms occurring, your doctor may prescribe extra
corticosteroids (like prednisolone).
If you have any further questions on using the inhaler, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Seretide Accuhaler 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 Accuhaler to control your asthma or COPD.
Allergic reactions: you may notice your breathing suddenly gets worse after
using Seretide Accuhaler. You may be very wheezy and cough. You may also
notice itching and swelling (usually of the face, lips, tongue, or throat). If you get
these effects or if they happen suddenly after using Seretide Accuhaler,
tell your doctor straight away. Allergic reactions to Seretide Accuhaler 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)
• 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 after taking each puff may help. Your doctor may
prescribe an antifungal 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):
• Pneumonia and bronchitis (lung infection). Tell your doctor if you notice any of
the following symptoms: increase in sputum production, change in sputum
colour, fever, chills, increased cough, increased breathing problems.
• 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
heartbeat, muscle weakness, cramp).









Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use Seretide Accuhaler after the expiry date which is stated on the
label and carton.
If your doctor tells you to stop using the Accuhaler, please take it back to the
pharmacist for safe disposal. Only keep the Accuhaler if your doctor tells you
to.
If your Accuhaler fails to work properly or you notice any other signs of
deterioration in the blisters, you should seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6. Further information
What Seretide Accuhaler contains
Each blister contains: powder for inhalation providing 50 micrograms of salmeterol
(as the xinafoate) and 250 micrograms of fluticasone propionate.
The other ingredient is lactose monohydrate (which contains milk proteins).
What Seretide Accuhaler looks like and contents of the pack
Seretide Accuhaler is a two tone purple circular device in moulded plastic
containing white inhalation powder in foil strips and with a dose counter indicating
the number of doses remaining.
The device is packed in carton, which holds one Accuhaler each containing 60
inhalations.
POM

PL No: 29510/0007

This product is manufactured by Glaxo Wellcome Production, Zone Industrielle
no. 2, 23 Rue Lavoisier, Evreux, F-27000, France and is procured from within the
EU by the Product Licence holder: Pharma-XL Ltd, Unit 6 Colonial Way, Watford,
Herts WD24 4PR. Repackaged by O.P.D Laboratories Ltd, Watford, Herts WD24
4PR.
Leaflet revision and issue date (Ref.) 07.06.2013.
Seretide and Accuhaler are Trade Marks of the GlaxoSmithKline Group of
Companies.
To request a copy of this leaflet in Braille, large print or audio please call 01923
332 796.

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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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