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SERETIDE 500 ACCUHALER

Active substance(s): FLUTICASONE / FLUTICASONE PROPIONATE / FLUTICASONE PROPIONATE MICRONISED / SALMATEROL XINAFOATE / SALMETEROL / SALMETEROL XINAFOATE / SALMETEROL XINAFOATE MICRONISED

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Transcript
Assessed against UK PIL dated August 2014
By Aneela Mahmood at

PACKAGE LEAFLET: INFORMATION FOR THE USER
SERETIDE® 250 ACCUHALER®
SERETIDE® 500 ACCUHALER®
(salmeterol, fluticasone propionate)

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.

Your medicine is available as either of the above names but will be
referred to as Seretide throughout this leaflet.
This product is also available in multiple strengths and other strengths
will be referred to throughout the leaflet.
Outer Case

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Thumbgrip

Mouthpiece
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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.
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
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.
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 (hypersensitive) to salmeterol, fluticasone propionate or
to the other ingredient lactose monohydrate.
Warnings and precautions
Your doctor will supervise your treatment more closely if you have
medical conditions such as:
 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
If you have ever had any of these conditions, tell your doctor before you
use Seretide.
Other medicines and Seretide
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:
 β blockers (such as atenolol, propranolol and sotalol). β blockers are
mostly used for high blood pressure or other heart conditions.
 Medicines to treat infections (such as ritonavir, ketoconazole,
itraconazole and erythromycin). 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.
 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 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.


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 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.
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.
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. Hold the Accuhaler away from your mouth, breathe out as far as is
comfortable. Do not breathe into your Accuhaler.
4. 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, and/or brush your teeth.
This may help to stop you getting thrush
and becoming 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.
As with all inhalers, caregivers should ensure that children prescribed
Seretide Accuhaler use correct inhalation technique, as described
above.
Cleaning your inhaler
Wipe the mouthpiece of the Accuhaler with a dry tissue to clean it.

Mock up 

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 missed 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 about 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 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 your heart 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)
 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):
 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 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 heart beat or heart gives an extra beat (arrhythmias). Tell
your doctor, but do not stop taking Seretide unless the doctor tells
you to stop.
Frequency not known, but may also occur:
 Depression or aggression. These effects are more likely to occur in
children.
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 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
carton {EXP}. The expiry date refers to the last day of that month.

 If your medicine shows any signs of discolouration or deterioration,
consult your pharmacist who will tell you what to do.

 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
 The active substances are 50 micrograms salmeterol (as salmeterol
xinafoate) and 250 or 500 micrograms fluticasone propionate.
 The other ingredient is lactose monohydrate (which contains milk
proteins).
What Seretide Accuhaler looks like and contents of the pack
 The plastic Accuhaler device is light and dark purple in colour with a
dose counter indicating the number of doses remaining.
 The Accuhaler contains foil strips with blisters which contain a white
powder. The foil protects the powder for inhalation from the effects
of the atmosphere.
 Each dose is pre-dispensed.
 The devices are packed in cartons which hold one Accuhaler
containing 60 inhalations.
Manufacturer and Product Licence holder
Seretide Accuhaler is manufactured by Glaxo Wellcome Production,
Zone Industrielle No.2 23 rue Lavoisier 27000 Evreux, France.
Or
Glaxo Wellcome Operations, Priory Street, Ware, Hertfordshire SG12
ODJ, United Kingdom.
Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: G-Pharma Ltd., Dakota Avenue,
Salford M50 2PU
PL 16369/1391 Seretide 250 Accuhaler
PL 16369/1392 Seretide 500 Accuhaler

POM

01/12/2014
Seretide® and Accuhaler® are registered trademarks of the
GlaxoSmithKline group of companies

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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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