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VIANI 500 ACCUHALER

Active substance(s): FLUTICASONE PROPIONATE / SALMETEROL

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Transcript
2 Before you use seretide

Do not take Seretide if:
You are allergic (hypersensitive) to salmeterol xinafoate, fluticasone
propionate or to the other ingredient lactose monohydrate.

Take special care with Seretide
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 may increase your blood sugar)
• low potassium in your blood
• Tuberculosis (TB) now or in the past.

Package Leaflet: Information for the User

Seretide® 500
Accuhaler®/
Viani® 500 Accuhaler®
(salmeterol xinafoate/fluticasone
propionate)
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.
Your medicine is called by any of the above names, but will be
referred to as Seretide.
Other strengths are also available.

In this leaflet:
1 What Seretide is and what it is used for
2 Before you use Seretide
3 How to use Seretide
4 Possible side effects
5 How to store Seretide
6 Further 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
Accuhaler, 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. 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.

If you have ever had any of these conditions, tell your doctor
before you use Seretide.

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 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:
• Beta-blockers (such as atenolol, propranolol, sotalol). Betablockers 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,
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.

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

For adults with Chronic Obstructive Pulmonary Disease
(COPD)
• Seretide 500 Accuhaler - 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 Accuhaler properly or as prescribed may mean
that it will not help your asthma or COPD as it should.
• The Accuhaler device holds blisters containing Seretide as a
powder.
• There is a counter on top of the 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.

Using your inhaler

1

To open your 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

Driving and using machines
Seretide is not likely to affect your ability to drive or use machines.

Important information about some of the ingredients of
Seretide
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
• Use your Seretide every day, until your doctor advises you to stop.
• Always use Seretide exactly as your doctor has told you. Don’t
exceed the recommended dose. Check with your doctor or
pharmacist if you’re not sure.
For asthma

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

Children 4 to 12 years of age
• Seretide 100 Accuhaler - One inhalation twice a day
• Seretide is not recommended for use in children below 4 years of
age.

2

Hold your 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
4

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

Put the mouthpiece to your lips;
breathe in steadily and deeply
through the Accuhaler, not through your
nose.
Remove the 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 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 Accuhaler is now ready for you to use again.

Cleaning your inhaler
Wipe the mouthpiece of the Accuhaler 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 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
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 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 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 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 after using Seretide. 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, 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)
• 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. Rinsing your mouth out
with water and spitting it out immediately after taking each puff may
help. Your doctor may prescribe an anti fungal medication to treat
the thrush.
• Aching, swollen joints and muscle pain.

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).
Uncommon (affects less than 1 person in 100)
• Very fast heartbeat (tachycardia).
• Feeling shaky and fast or uneven heart beat (palpitations) - these
are usually harmless and get less as treatment continues.
• Muscle cramps.
• Feeling worried (this effect mainly occurs in children).
• Throat irritation. Rinsing your mouth out with water and spitting it
out immediately after taking each puff may help.
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 includes:
- slowing of growth in children and adolescents
- thinning of the bones
- cataract and 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.
• 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.
• Disturbed sleep and 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 they tell you to
stop.
• Rash.
Frequency not known, but may also occur:
• Depression or aggression. These effects are more likely to occur in
children.
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.
5 How to store Seretide
• Keep out of the sight and reach of children.
• Do not store above 30°C.
• Do not use Seretide after the expiry date which is stated on the
label and carton.
• If the device doesn't appear to be working properly, becomes
damaged or if you notice any signs of deterioration, consult your
pharmacist for advice.
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 contains
• Each blister contains powder for inhalation providing 50
micrograms of salmeterol (as the xinafoate) and 500 micrograms of
Fluticasone propionate, as the active ingredients.
• The other ingredient is lactose monohydrate (which contains milk
proteins).

What Seretide Accuhaler looks like and contents of the pack
• The Serertide Accuhaler contains a foil strip. The foil protects the
powder for inhalation from the effects of the atmosphere.
• Each dose is pre-dispensed.
• The Accuhaler is a two tone purple circular inhaler device, with a
retractable lid and dose counter, containing a foil strip with 60
blisters
Manufacturer
Glaxo Wellcome GmbH & Co.
Industriestr, 32-36, 23843 Bad Oldesloe,
Germany.
Glaxo Wellcome Production, Evreux, France.
Procured from within the EU. Product Licence Holder and
repackaged by: S.C.A.C. Ltd., Unit 2a, Bandeath Industrial Estate,
Throsk, Stirling, FK7 7NP.
PL 30984/0055

®

®

Seretide 500 Accuhaler /
®
®
Viani 500 Accuhaler
POM

Leaflet date: 22.10.2013
®

®

Seretide and Accuhaler are registered trademarks of the Glaxo
Group Limited.

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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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