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SIRDUPLA 25 MICROGRAM/250 MICROGRAM PER METERED DOSE PRESSURISED INHALATION SUSPENSION

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

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Package leaflet: Information for the patient

Read all of this leaflet carefully before you start
using 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 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 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 active substances, 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 glucocorticosteroid 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’
inhaler, such as salbutamol. You should always have
your fast-acting ‘reliever’ inhaler with you.

TBC

Sirdupla
25 microgram/125 microgram per metered dose
pressurised inhalation, suspension
25 microgram/250 microgram per metered dose
pressurised inhalation, suspension
salmeterol (as xinafoate)/fluticasone propionate

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.
When you are using Sirdupla, your doctor will want to
regularly check your symptoms.
Your symptoms may become well controlled using Sirdupla
twice a day. If so, your doctor may decide to reduce your dose.
However, 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 0°C)
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.

3.

2. What you need to know before you use
Sirdupla
Do not use Sirdupla:
If you are allergic to salmeterol, fluticasone or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Sirdupla if you
have medical conditions such as:
• Heart disease, including an irregular or fast heart beat
• An 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
Contact your doctor if you experience blurred vision or other
visual disturbances.
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 ketoconazole,
itraconazole, telithromycin 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).
• Medicines which can increase heart rate (these may be
called β agonists).
• Xanthine medicines. These are often used to treat asthma.
• Some medicines may increase the effects of Sirdupla and
your doctor may wish to monitor you carefully if you are
taking these medicines (including some medicines for HIV:
ritonavir, cobicistat).
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
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.

4.

5.

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 dust or other loose particles.
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 inhaler when the counter shows
6.
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.

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 forgotten dose.
Just take your next dose at the usual time.
If you stop using Sirdupla
It is very important that you take 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 (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 glucocorticosteroids in tablet form.
If you have any further questions on 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.
Contact your doctor immediately if you notice any of
the following side effects:
• Signs of an allergic reaction: 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 your heart beating very fast or you
feel faint and light headed (which may lead to collapse or
loss of consciousness).
• Breathing difficulties or wheezing that gets worse
straight after taking Sirdupla.
- If this happens stop using this medicine. Use your
fast-acting “reliever” inhaler to help your breathing.
• Uneven, rapid and irregular heart beat (atrial fibrillation).
Other side effects are listed below:
Very common (may affect more than 1 in 10 people)
• Headache - this usually gets better as treatment continues.
• An 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 (may affect up to 1 in 10 people)
• Thrush (sore, creamy-yellow, raised patches) in the mouth
and throat. Also sore tongue, 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 also
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.
• Bruising and bone 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 (may affect up to 1 in 100 people)
• 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.
• Very fast heart beat (tachycardia).
• Feeling shaky (tremor) or sensation of thumping in your
chest (palpitations) - these are usually harmless and get less
as treatment continues.
• Chest pain.
• Feeling worried or anxious.
• Disturbed sleep.
• Allergic skin rash.

Rare (may affect up to 1 in 1,000 people)
• This medicine may also rarely affect the normal production
of steroid hormones (produced by the adrenal gland) in
the body, particularly if you have taken high doses for long
periods of time. The effects include:
- Thinning of the bones.
- Glaucoma (raised pressure in the eye which can cause
vision problems) or cataract (cloudy lens in the eye).
- Weight gain.
- Rounded (moon shaped) face (Cushing’s Syndrome).
- When used in children and adolescents, slowing of growth.
• 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.
Not known (frequency cannot be estimated from the
available data):
• 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, pharmacist
or nurse. 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 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 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 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 Sirdupla contains
• Each metered dose (ex valve) contains 25 micrograms
of salmeterol (as salmeterol xinafoate) and 125 or
250 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 1TL,
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.
Mylan
Dublin Respiratory,
Unit 25 Baldoyle Industrial Estate,
Grange Road,
Baldoyle,
Dublin 13,
Ireland.

This leaflet was last revised in 06/2017
AeroChamber Plus is a registered trademark of Trudell Medical International
3M is a trademark of 3M Company

1215520

Expand Transcript

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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