Skip to Content

UK Edition. Click here for US version.

SIRDUPLA 25 MICROGRAM/125 MICROGRAM PER METERED DOSE PRESSURISED INHALATION SUSPENSION

Active substance(s): FLUTICASONE PROPIONATE / SALMETEROL XINAFOATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user
Sirdupla
25 microgram/125 microgram per metered dose
pressurised inhalation, suspension
25 microgram/250 microgram per metered dose
pressurised inhalation, suspension
salmeterol/fluticasone propionate
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 Sirdupla is and what it is used for
2. What you need to know before you use Sirdupla
3. How to use Sirdupla
4. Possible side effects
5. How to store Sirdupla
6. Contents of the pack and other information

1. What Sirdupla is and what it is used for
Sirdupla 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.
Sirdupla is indicated for use in adults 18 years of age
and older only.
Sirdupla is NOT indicated for use in children 12 years of
age and younger or adolescents 13 to 17 years of age.
The doctor has prescribed this medicine to help prevent
breathing problems such as asthma.
You must use Sirdupla every day as directed by your doctor.
This will make sure that it works properly in controlling your
asthma.
Sirdupla helps to stop breathlessness and wheeziness
coming on. However Sirdupla 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.

Adults aged 18 years and over
• Sirdupla 25/125 - 2 puffs twice a day
• Sirdupla 25/250 - 2 puffs twice a day
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 Sirdupla 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 Sirdupla 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 Sirdupla properly or as prescribed
may mean that it will not help your asthma as it should.
• The medicine is contained in a pressurised canister in a
plastic casing with a mouthpiece.
• There is a counter on the back of the inhaler which tells
you how many doses are left. Each time you press the
canister, a puff of medicine is released and the counter
will count down by one.
• Take care not to drop the inhaler as this may cause the
counter to count down.
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 (figure 1).
2. To make sure that the inhaler works, shake it well, point
the mouthpiece away from you and press the canister
firmly to release a puff into the air. Repeat these steps at
least three times, shaking the inhaler before releasing
each puff, until the counter reads 120. If you have not used
your inhaler for a week or more, or your inhaler gets very
cold (below 0ºC) you should 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.

2.

2. What you need to know before you
use Sirdupla
Do not take Sirdupla if:
You are allergic (hypersensitive) to salmeterol, fluticasone
propionate or any of the other ingredients of this medicine
(listed in section 6).
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 (Sirdupla 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 Sirdupla.
Children and adolescents
This medicine should not be used in children or
adolescents under the age of 18 years.
Other medicines and Sirdupla
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This includes
medicines for asthma or any medicines obtained without a
prescription. This is because Sirdupla 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 Sirdupla:
• 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 Sirdupla,
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
Sirdupla is not likely to affect your ability to drive or use
machines.

3. How to use Sirdupla
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 Sirdupla 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 Sirdupla or reduce the dose of Sirdupla
without talking to your doctor first.
• Sirdupla should be inhaled through the mouth into
the lungs.

Component Type Leaflet
Affiliate Item Code 508092
TrackWise PR No. N/A
MA No.

04569/1449 - 1450

Packing Site/Printer 3M
Supplier Code 6206 1072 1
Pharma Code 368
Sign-offs

Vendor Job No.

N/A

1. Stand up or sit upright when using your inhaler.
2. Remove the mouthpiece cover (figure 1). 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 (figure 2).
4. Hold the inhaler upright with your thumb on the base,
below the mouthpiece. Breathe out as far as is
comfortable (figure 3).
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 (figure 4).
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
(figure 5).
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. The mouthpiece cover will ‘click’
into position. 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.
If you find it difficult to use your inhaler, either your doctor
or other healthcare provider may recommend using a spacer
device such as the 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.
Only the AeroChamber Plus® spacer device should be
used with Sirdupla. Other spacing devices should not
be used with Sirdupla and you should not switch from
one spacer device to another. If you stop using a spacer
device 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.
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.
You should get a replacement when the counter shows the
number 20 (figure 6). Stop using the
6.
inhaler when the counter shows 0 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
plastic casing.

29.04.15

No. of colours
Colours

Proof No. 9
Client Market UK

Keyline/Drawing No.N/A
Barcode Info N/A
Dimensions 160 x 507 mm

5.

4.

Date:
Description Salmeterol/Fluticasone 25/125 & 25/250 mcg

3.

Non-Print
Colours

1
Black

Page Count

1/2

Black
20%

Keyline

Main Font Myriad Pro

Body Text Size 11pt /11pt

Cleaning your inhaler
To stop your inhaler blocking, it is important to clean your
inhaler at least once a week.
To clean your inhaler
• Remove the mouthpiece cover.
• Do not remove the canister from the plastic casing at any time.
• Wipe the inside and outside of the mouthpiece and the
plastic casing with a dry cloth or tissue.
• Replace the mouthpiece cover. It will ‘click’ into place.
Do not use too much force.
Do not wash or put any parts of your inhaler in water.
If you use more Sirdupla 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 Sirdupla may reduce the amount of
steroid hormones produced by the adrenal gland.
If you forget to use Sirdupla
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 Sirdupla
It is very important that you take your Sirdupla every day as
directed. Keep taking it until your doctor tells you to
stop. Do not stop or suddenly reduce your dose of
Sirdupla. This could make your breathing worse.
In addition, if you suddenly stop taking Sirdupla or reduce your
dose of Sirdupla 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
Sirdupla to control your asthma.
Allergic reactions: you may notice your breathing
suddenly gets worse immediately after using Sirdupla.
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 Sirdupla, stop using Sirdupla
and tell your doctor straight away. Allergic reactions to
Sirdupla 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 chronic obstructive pulmonary disease (COPD).
COPD is a long-term lung disease that causes shortness of
breath, coughing and frequent chest infections. The term
COPD includes conditions known as chronic bronchitis and
emphysema.
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 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.
• Throat irritation. Rinsing your mouth out with water and
spitting it out immediately after taking each puff may help.
• 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), or a rapid and irregular
heartbeat (atrial fibrillation).
• 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 Sirdupla. If this happens stop
using your Sirdupla inhaler. Use your fast-acting
“reliever” inhaler to help your breathing and tell your
doctor straight away.

• Sirdupla 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
Sirdupla 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
Sirdupla 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.
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 Sirdupla
• Keep this medicine out of the sight and reach
of children.
• Do not use Sirdupla 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 store above 25°C.
• The canister contains a pressurised liquid. Do not expose to
temperatures higher than 50°C, protect from direct sunlight.
Do not pierce or burn the canister even when empty.
• As with most inhaled medicinal products in pressurised
canisters, the therapeutic effect of this medicinal product
may decrease when the canister is cold.
Do not throw away 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 Sirdupla contains
• Each metered dose (ex valve) contains 25 micrograms of
salmeterol (as salmeterol xinafoate) and 125 or 250
micrograms of fluticasone propionate. This is equivalent to
a delivered dose (ex actuator) of 21 micrograms of
salmeterol and 110 or 220 micrograms of fluticasone
propionate. The other ingredients are the propellant,
norflurane (HFA 134a) and ethanol, anhydrous.
What Sirdupla looks like and contents of the pack
• Sirdupla is supplied to you in a metered dose inhaler which
delivers your medicine in a pressurised suspension for you
to inhale through your mouth into your lungs.
• The pressurised canister contains a white to off white
suspension for inhalation.
• The canisters are fitted into a white plastic casing
incorporating a mouthpiece and fitted with mauve or
burgundy dustcaps.
• The devices are packed in cartons of 1 inhaler. Each inhaler
contains 120 metered doses.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Mylan
Potters Bar
Hertfordshire
EN6 1LT
UK
Manufacturer:
3M Health Care Ltd
Derby Road
Loughborough
Leicestershire
LE11 5SF
UK
Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland

This leaflet was last revised in 04/2015
AeroChamber Plus is a trademark of Trudell Medical International
3M is a trademark of 3M Company

Date:
Description Salmeterol/Fluticasone 25/125 & 25/250 mcg
Component Type Leaflet
Affiliate Item Code 508092
TrackWise PR No. N/A
MA No.

04569/1449 - 1450

Packing Site/Printer 3M
Supplier Code 6206 1072 1
Pharma Code 368
Sign-offs

Vendor Job No.

N/A

29.04.15

No. of colours
Colours

Proof No. 9
Client Market UK

Keyline/Drawing No.N/A
Barcode Info N/A
Dimensions 160 x 507 mm

508092
6206 1072 1

Non-Print
Colours

1
Black

Page Count

2/2

Black
20%

Keyline

Main Font Myriad Pro

Body Text Size 11 pt / 11pt

Expand view ⇕

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.

Hide