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LIFSAR 50 MICROGRAM/500 MICROGRAM PER METERED DOSE INHALATION POWDER

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

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Package leaflet: Information for the user
Lifsar ® 50 microgram/500 microgram per metered dose
Inhalation powder
Salmeterol/fluticasone propionate
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 Lifsar is and what it is used for
2. What you need to know before you use Lifsar
3. How to use Lifsar
4. Possible side effects
5. How to store Lifsar
6. Contents of the pack and other information

1. What Lifsar is and what it is used for
The name of your medicine is Lifsar ® 50 microgram/500 microgram per metered dose
Inhalation powder (called Lifsar throughout this leaflet). Lifsar is an inhaler that contains two
active ingredients, 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 to prevent breathing problems associated with
Chronic Obstructive Pulmonary Disease (COPD). Lifsar reduces the number of flare ups of
symptoms related to COPD.
You must use Lifsar every day, as prescribed by your doctor. This will ensure that
the medicine works properly in controlling these symptoms.

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Lifsar helps to stop breathlessness and wheeziness coming on. However, Lifsar should not
be used to relieve a sudden attack of breathlessness of 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.
Lifsar is intended for use in adults with COPD 18 years of age and older only.
Not for use in asthma.

2. What you need to know before you use Lifsar
Do not use Lifsar
 If you are allergic to salmeterol, fluticasone propionate or the other ingredient in this
medicine (listed in section 6).
Warnings and precautions
Your doctor will supervise your treatment more closely if you have or have ever had:
 Heart disease, including irregular or fast heartbeat.
 Overactive thyroid gland.
 High blood pressure.
 Diabetes mellitus (Lifsar may increase your blood sugar).
 Low potassium in your blood.
 Tuberculosis (TB) now or in the past, or other lung infection.
Talk to your doctor before using Lifsar if any of the above applies to you.
Children and adolescents
Do not give this medicine to children and adolescents less than 18 years of age, because it may
not be safe or effective. Lifsar is intended for use in adults 18 years of age and older only.
Other medicines and Lifsar
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, before you start using Lifsar. This includes other medicines for COPD, other inhalers
or any medicines obtained without a prescription. This is because Lifsar may not be suitable to be
taken with some other medicines.

In particular tell your doctor if you are taking any of the following:
 Beta blockers (such as atenolol, propranolol, sotalol). Beta blockers are mostly used
for high blood pressure and heart conditions.
 Medicines to treat infections caused by viruses and fungi (such as ritonavir,
ketoconazole, itraconazole and erythromycin). Some of these medicines may increase the
amount of fluticasone propionate or salmeterol in your body, which can increase your risk
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of experiencing side effects, including irregular heartbeats, or may make side effects
worse.
Corticosteroids (taken by mouth or by injection). If you have used these medicines
recently, this might increase the risk of Lifsar affecting the function of 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.
Medicines for HIV, ritonavir or cobicistat may increase the effects of Lifsar and your
doctor may wish to monitor you carefully if you are taking these medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this medicine. Your doctor will assess whether you can
take this medicine or not.
Driving and using machines
Lifsar is unlikely to affect your ability to drive or use machines.
Lifsar contains lactose monohydrate (a type of sugar)
Lifsar contains up to 7 milligrams of lactose monohydrate in each dose.
The amount of lactose in this medicine does not normally cause problems in people who are
lactose intolerant. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

3. How to use Lifsar
Always use this medicine exactly as your doctor has told you. Check with your doctor,
pharmacist or nurse if you are not sure.






Inhalation use.
Use Lifsar every day, until your doctor advises you to stop.
Do not take more than the recommended dose.
Do not stop taking Lifsar or reduce the dose of Lifsar without talking to your doctor first.
Lifsar should be inhaled through the mouth into the lungs.

Adults
The usual dose is one inhalation, twice a day.
It is very important to follow your doctor’s instructions on how many inhalations to take and how
often to take your medicine.

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Use in children and adolescents
This medicine is not for use in children and adolescents less than 18 years of age, because it may
not be safe or effective.
If your breathing gets worse or is not well controlled even if Lifsar is used regularly as
prescribed by your doctor, tell your doctor straight away. You may feel more wheezy, your
chest feels tight more often or you may need more of your fast-acting ‘reliever’ medicine). If any
of these happen, you should continue to take Lifsar but do not increase the number of inhalations
you take. Your chest condition could be getting worse and you could become seriously ill. See
your doctor straight away as you may need additional treatment.
How to use your inhaler
Your doctor, nurse or pharmacist should show you how to use your inhaler. They should check
on how you use it from time to time. If you do not use the inhaler properly or as prescribed, the
medicine might not help your COPD and your symptoms as it should.
Lifsar releases a powder which is inhaled into the lungs.

Note: The number shown at the dose indicator window refers to the initial number of inhalations
(60) in the device and it does not change even if the device is empty. The green colour in the dose
indicator window will show approximately how many inhalations are left (see below in text the
section “When should the inhaler be replaced“).
Instructions for use
The basic principles for using Lifsar are
1. OPEN: Remove the white cover.
2. INHALE: Place your lips around the mouthpiece and inhale deeply.
3. CLOSE TO CLICK: Replace the cover fully.
Please carefully read the instructions for use below before using Lifsar for the first time.
Follow the instructions below every time you need to take an inhalation.
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1. OPEN





Fig. 01

Hold the device with two hands: one hand on the grey base and
the other on the protective white cover.
Remove the white protective cover from the grey base by
twisting both in opposite directions. (Fig. 01). You will feel
a small resistance when the cover is half opened.

The green colour in the dose ready window confirms to you that
your inhaler is ready for use (Fig. 02).

2. INHALE






Fig. 02

Fig. 03

Hold the inhaler firmly by the grey base, away from your
mouth. Breathe out slowly as far as it is comfortable.
Do not breathe out through the inhaler.
Place your lips around the grey mouthpiece (Fig. 03) without
covering any of the air inlets with the lips. Do not chew or
bite the mouthpiece.
Breathe in as deeply and as hard as you can through your
mouth (not through your nose).
Do not stop inhaling when you hear a soft “plopping” sound.
The soft “plopping” sound during the inhalation process
indicates that the dose has been released.
Remove the inhaler from your mouth and hold
your breath for an additional 5 – 10 seconds or as long as
is comfortable before breathing out slowly through your nose
and returning to normal breathing.

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 The green colour in the dose ready window should now have
disappeared, showing that the dose has been successfully
delivered (Fig. 04).

Fig. 04

Note: The amount of medicine you inhale is very small and you may not be able to taste it.
However, you can be confident that you have taken the dose and the medicine is in your
lungs if the green colour in the dose ready window has disappeared.
3. CLOSE TO CLICK





Fig. 05

Twist the white protective cover back firmly onto the grey base
until it clicks (Fig. 05). The alignment lines on the cover
and base should match.
If you need more than one inhalation, as instructed
by the physician, repeat the above steps.

Rinse your mouth with water and/or brush your teeth after
taking your dose. Do not swallow the water you used for rinsing
your mouth or brushing your teeth, spit it out. This will
minimise the risk of oropharyngeal candidiasis (thrush, a fungal
infection, in your mouth and/or throat) and hoarseness (Fig. 06).

Fig. 06

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When should you replace the inhaler
Fig. 07

 The number of initial inhalations (60) in your device
is shown in the dose indicator window (Fig. 07).
This number doesn´t change even if the device is
empty.
 The green colour in the dose indicator window will
show you approximately how many inhalations
of the medicine are left in the device. Hold your
inhaler upright at eye level to check how much is left
in the container.
 When the green colour reaches the level of the red
line, it means there are approximately 10 inhalations
left in the device. (Fig. 07 – 10 remaining doses).
Continue using the inhaler, but see your doctor as
soon as possible, not later than within the next 5
days, for a new prescription.
 When the green indicator is no longer visible the
inhaler is empty (Fig. 07 – Empty).

Cleaning the inhaler
 If the mouthpiece gets dirty, you can clean it by wiping the outside of it with a dry, clean
tissue. Do not use water or other liquids.
Other information about the inhaler
 Always close the white protective cover of the inhaler when it is not being used.
 Protect the inhaler against moisture.
 The white protective cover will still twist and “click” even when the inhaler is empty.
 The sound heard when the inhaler is shaken is produced by a drying agent
and not by the medicine. Therefore, sound does not tell how much medicine is left
in the inhaler.
 The dose is loaded by closing the protective cover firmly until it clicks. Do not re-open
the inhaler unless you intend to take a dose.
 If the device is dropped without the protective cover, then the cover should be replaced before
the next dose is taken.
If you use more Lifsar 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, pharmacist or nurse. You may notice your heart beating faster
than usual and you may feel shaky. You may also have dizziness, a headache, muscle weakness
and aching joints.
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If you have used larger doses for a long period of time, you should talk to your
doctor, pharmacist or nurse for advice. This is because larger doses of this medicine may reduce
the amount of steroid hormones produced by your adrenal gland.
If you forget to use Lifsar
If you forget to use your inhaler, take your next inhalation when it is due.
Do not take a double inhalation to make up for a forgotten one.
If you stop using Lifsar
It is very important you use the inhaler every day, as the doctor recommended.
Keep taking your medicine until your doctor tells you to stop. Do not stop or suddenly
reduce your dose of Lifsar. This can make your breathing worse. Very rarely, if you suddenly
stop using your inhaler or suddenly reduce the dose, this can cause you to have problems with
your adrenal gland (adrenal insufficiency) and you may experience side effects. These 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. To prevent these symptoms occurring, your doctor may prescribe extra corticosteroids in
tablet form (such as prednisolone).
If you do get any of the side effects listed above, or any other side effects, talk to your doctor or
pharmacist straight away.
If you have any further questions on the use of this medicine or device, ask your
doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions: you may notice your breathing suddenly gets worse immediately after
using Lifsar. 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 Lifsar, stop using Lifsar and tell your doctor straight away. Allergic reactions to
Lifsar are uncommon (they affect less than 1 person in 100).
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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 has been reported.
Common (affects less than 1 person in 10):
 Thrush (sore, creamy-yellow, raised patches) in the mouth and throat. Also sore tongue,
throat irritation and hoarse voice. 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 you an anti-fungal medication to treat the thrush.
 Aching, swollen joints and muscle pain.
 Muscle cramps.
 Pneumonia (in COPD patients) and bronchitis (lung infection). Tell your doctor if you
have any of the following while taking Lifsar, they could be symptoms of a lung
infection:
- Fever or chills.
- Increased mucus production, change in mucus colour.
- Increased cough or increased breathing difficulties.
 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 of the amount of potassium in the blood (you may get uneven heartbeats,
muscle weakness, cramp).
Uncommon (affects less than 1 person in 100):
 Increase 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 (cataract).
 Very fast heartbeat (tachycardia).
 Feeling shaky (tremor) with fast or uneven heart beat (palpitations) - these are usually
harmless and occur 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 which worsen immediately after taking Lifsar.
If this happens, stop using Lifsar. Use your fast-acting “reliever” inhaler to help your
breathing and tell your doctor immediately.
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Lifsar 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 the above side effects and will make sure
you are taking the lowest dose of salmeterol/fluticasone propionate to control your
disease.
 Behavioural changes, such as being unusually active and irritable (these effects mainly
occur in children).
 Uneven heartbeats or heart gives an extra beat (arrhythmias). Tell your doctor, but do not
stop taking Lifsar unless the doctor tells you to stop.
Frequency not known, but may also occur:
 Depression, aggression (mainly in children).
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 any 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 Lifsar
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.
Keep the white protective cover tightly closed in order to protect from moisture.
Once opened, use within 30 days.
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 Lifsar inhaler contains
The active substances are salmeterol (as salmeterol xinafoate) and fluticasone propionate.
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of
45 micrograms of salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone
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propionate. This corresponds to a metered dose of 50 micrograms of salmeterol (as salmeterol
xinafoate) and 500 micrograms of fluticasone propionate.
The other ingredient is lactose monohydrate.
What Lifsar inhaler looks like and contents of the pack
Lifsar is the PulmoJet inhaler containing white powder. The inhaler has two components, a
removable white protective cover and the main body. The main body is grey and white, with a
grey mouthpiece and a grey base with a purple- or grey-coloured bottom. Lifsar is available in
cartons with one inhaler containing 60 inhalations.
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Manufacturer(s)
Fisons Limited TA Aventis Pharma (Holmes Chapel)
72 London Road, Holmes Chapel, Crewe, Cheshire
CW4 8BE
UK
This leaflet was last revised in 02/2017

Other sources of information
Patient information video is available on the website: www.pulmojet.com and by scanning the
QR Code included in the PIL and outer carton with a smartphone.

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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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