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TRITENVA 50 MICROGRAM/500 MICROGRAM PER METERED DOSE INHALATION POWDER

Active substance(s): FLUTICASONE PROPIONATE / SALMETEROL XINAFOATE

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Package leaflet: Information for the user
Tritenva 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 Tritenva is and what it is used for
2. What you need to know before you use Tritenva
3. How to use Tritenva
4. Possible side effects
5. How to store Tritenva
6. Contents of the pack and other information

1. What Tritenva is and what it is used for
The name of your medicine is Tritenva 50 microgram/500 microgram per metered dose
Inhalation powder (called Tritenva throughout this leaflet). Tritenva 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). Tritenva reduces the number of flare ups of
symptoms related to COPD.
You must use Tritenva every day, as prescribed by your doctor. This will ensure that
the medicine works properly in controlling these symptoms.

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Tritenva helps to stop breathlessness and wheeziness coming on. However, Tritenva 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.
Tritenva 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 Tritenva
Do not use Tritenva
If you are allergic (hypersensitive) 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 (Tritenva 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 Tritenva 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. Tritenva is intended for use in adults 18 years of age and older only.
Other medicines and Tritenva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, before you start using Tritenva. This includes other medicines for COPD, other
inhalers or any medicines obtained without a prescription. This is because Tritenva 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 Tritenva 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.
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
Tritenva is unlikely to affect your ability to drive or use machines.
Tritenva contains lactose monohydrate (a type of sugar)
Tritenva 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 Tritenva
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 Tritenva every day, until your doctor advises you to stop.
Do not take more than the recommended dose.
Do not stop taking Tritenva or reduce the dose of Tritenva without talking to your doctor
first.
Tritenva 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.
Use in children and adolescents
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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 Tritenva 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 Tritenva 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.
Tritenva 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 your device and it doesn´t change even if the device is empty. The green colour in the
dose indicator window will show you approximately how many inhalations are left (see below in
text the section „When you should replace your inhaler“).
The basic principles for using Tritenva 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 Tritenva for the first time.
Follow the instructions below every time you need to take an inhalation.

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Instructions for use
1. OPEN

Fig. 01

Hold the device with two hands: one hand on the grey base and
the other on the protective white cover. You can hold your device
in any position.
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 is comfortable.
Do not breathe through the inhaler.
Place your lips around the grey mouthpiece (Fig. 03). Do not
cover any of the air inlets with your 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. Breathe out slowly through your nose and return
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to normal breathing.

The green colour in the dose ready window will now have
disappeared. This confirms 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).
It is important that you fully rotate the cover until you hear
the click as this loads your next dose of medicine. The alignment
lines on the cover and base should match.

If you need more than one dose
If the doctor told you that you have to take more than one inhalation, repeat the 3 steps above.
After you have taken your dose rinse your mouth with water (Fig.
06) and/or brush your teeth. Do not swallow the water you used for
rinsing your mouth or brushing your teeth, spit it out.
This will reduce the risk of you developing oropharyngeal
candidiasis (Thrush, a fungal infection, in your mouth and/or throat ) and
developing hoarseness.

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 you have approximately 10 inhalations
left in the device. (Fig. 07 – 10 remaining doses).
Continue using the inhaler, but see your doctor as
soon as possible to get a new prescription.
When the green indicator is no longer visible, there
are no inhalations left and your current inhaler must
be replaced with a new one (Fig. 07 – Empty).

Cleaning your inhaler
If the mouthpiece gets dirty, you can clean it by wiping it with a dry, clean tissue. Do not use
water or other liquids to clean the mouthpiece.
Always close the white protective cover of the inhaler when you are not using it.
Protect the inhaler against moisture.
Other information about your inhaler
The white protective cover will still twist and “click” even when the inhaler is empty.
The sound you hear as you shake the inhaler is produced by a drying agent and not
by the medicine. The sound does not tell you how much medicine is left in your inhaler.
If you load the inhaler more than once, by mistake, before taking your dose, you will still only
receive one dose.
If the device is dropped without the cap, then the cap should be replaced before the next dose
is taken.
If you use more Tritenva 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 Tritenva
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 Tritenva
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 Tritenva. 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 Tritenva. 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 Tritenva, stop using Tritenva and tell your doctor straight away. Allergic reactions
to Tritenva 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 and bronchitis (lung infection). Tell your doctor if you notice any
of the following symptoms: Increase in the liquid/phlegm which you cough up from your
lungs (sputum), change in sputum colour, fever, chills, increased cough and 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 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 Tritenva.
If this happens, stop using Tritenva. Use your fast-acting ‘reliever’ inhaler to help your
breathing and tell your doctor immediately.
Tritenva 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.
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- 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 Tritenva 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 Tritenva
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 Tritenva 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
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.
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What Tritenva inhaler looks like and contents of the pack
Tritenva 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. Tritenva 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 07/2015

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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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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