SERETIDE 25/250 EVOHALER

Active substance: SALMETEROL

View full screen / Print PDF » Download PDF ⇩

Transcript
Package Leaflet: Information for the User

Seretide® 25/125 Evohaler®
Seretide® 25/250 Evohaler®
(salmeterol xinafoate, fluticasone propionate)
This product is available in both strengths but will be referred to as Seretide
Evohaler throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Seretide Evohaler is and what it is used for
2. Before you use Seretide Evohaler
3. How to use Seretide Evohaler
4. Possible side effects
5. How to store Seretide Evohaler
6. Further information

1. What Seretide Evohaler is and what it is used for
Seretide Evohaler 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.
You must use Seretide Evohaler every day as directed by your doctor. This will
make sure that it works properly in controlling your asthma.
Seretide Evohaler helps to stop breathlessness and wheeziness coming
on. It does not work once you are breathless or wheezy. If that happens
you need to use a fast acting ‘reliever’ medication, such as salbutamol.

2. Before you use Seretide Evohaler
Do not take Seretide Evohaler if:
You are allergic (hypersensitive) to salmeterol xinafoate, fluticasone propionate
or to the other ingredient norflurane (HFA 134a).

• Seretide 125 & 250 micrograms Evohaler is not recommended for children
below 12 years of age.
Your symptoms may become well controlled using Seretide Evohaler twice a
day. If so, your doctor may decide to reduce your dose to once daily. 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 Evohaler 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 Evohaler 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
Evohaler 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 Seretide Evohaler 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.
2. To make sure that it works, shake it well,
point the mouthpiece away from you and
press the canister to release a puff into the air.
Repeat these steps, shaking the inhaler before releasing each puff, until
the counter reads 120. If you have not used your inhaler for a week or
more, release two puffs of medicine into the air.

Take special care with Seretide Evohaler
Your doctor will supervise your treatment more closely if you have medical
conditions such as:
• heart disease, including an irregular or fast heartbeat
• overactive thyroid gland
• high blood pressure
• diabetes mellitus (Seretide Evohaler may increase your blood sugar)
• low potassium in your blood
• Tuberculosis (TB) now, or in the past.
If you have ever had any of these conditions, tell your doctor before you use
Seretide Evohaler.

Taking other medicines
Please 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 Evohaler 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 Evohaler:
• Beta-blockers (such as atenolol, propranolol and sotalol). Beta-blockers are
mostly used for high blood pressure or other heart conditions.
• Antiviral and antifungal medicines (such as ritonavir, ketoconazole and
itraconazole). 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 Evohaler, 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.

Pregnancy and breast-feeding
If you are pregnant, planning to get pregnant, or breast-feeding, talk to your
doctor before taking Seretide Evohaler. Your doctor will assess whether you
can take Seretide Evohaler during this time.

Driving and using machines
Seretide Evohaler is not likely to affect your ability to drive or use machines.

3. How to use Seretide Evohaler
• Use your Seretide Evohaler every day, until your doctor advises you to stop.
• Always use Seretide Evohaler exactly as your doctor has told you. Don’t
exceed the recommended dose. Check with your doctor or pharmacist if
you’re not sure.

Adults and adolescents aged 12 years and over
• Seretide 125 microgram Evohaler: 2 puffs twice a day
• Seretide 250 microgram Evohaler: 2 puffs twice a day

Using your inhaler
It is important to start to breathe as slowly as possible just before
using your inhaler.

1. Stand or sit upright
when using your inhaler.
2. Remove the mouthpiece
cover (as shown in the first
picture). Check inside and
outside to make sure that the
mouthpiece is clean and free
of 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.
4. Hold the inhaler upright with your thumb on
the base, below the mouthpiece. Breathe out as
far as is comfortable.
5. Place the mouthpiece in your mouth
between your teeth. Close your lips around it.
Do not bite.
6. Breathe in through your mouth. 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.
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.
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. This may help to stop you getting thrush and being hoarse.

10. After use always replace the mouthpiece cover straight away to
keep out dust. When the mouthpiece cover is fitted correctly it will
‘click’ into position. If it does not ‘click’ into place, turn the mouthpiece
cover the other way round and try again. Do not use too much force.

If you or your child find it difficult to use Seretide Evohaler, either the
VolumaticTM or Aerochamber Plus TM spacer device may be used. Before
starting to use a spacer device for the first time or if you need to change
your make of spacer device, talk to your doctor, nurse or pharmacist. A
special device called a Haleraid TM may also make it easier.
You should get a replacement when the counter shows the number 020.
Stop using the inhaler when the counter shows 000 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 metal canister.

Uncommon (affects less than 1 person in 100)
• Very fast heartbeat (tachycardia).
• Feeling shaky and fast or uneven heartbeat (palpitations) – these are usually
harmless and get less as treatment continues.
• Muscle cramps.
• Feeling worried (this effect mainly occurs in children).
• Throat irritation. Rinsing your mouth out with water and spitting it out
immediately after taking each puff may help.

Rare (affects less than 1 person in 1000)

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
Evohaler may reduce the amount of steroid hormones produced by the adrenal
gland.

• Breathing difficulties or wheezing that get worse straight after taking
Seretide. If this happens stop using your Seretide Evohaler. Use your fast
acting ‘reliever’ inhaler to help your breathing and tell your doctor straight
away.
• Seretide Evohaler 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
- cataract and 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 Evohaler to control your
asthma.
• 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.
• Disturbed sleep and behavioural changes, such as being unusually active
and irritable (these effects mainly occur in children).
• Uneven heartbeat or heart gives an extra beat (arrhythmias). Tell your doctor,
but do not stop taking Seretide Evohaler unless they tell you to stop.
• Rash.

If you forget to use Seretide Evohaler

Frequency not known, but may also occur:

Cleaning your inhaler
To stop your inhaler blocking, it is important to clean it at least once a week.
To clean your inhaler:
• Remove the mouthpiece cover.
• Do not remove the metal 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 when fitted correctly. If
it does not ‘click’ into place, turn the mouthpiece cover the other way round
and try again. Do not use too much force.
Do not put the metal canister in water.

If you use more Seretide Evohaler 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 a headache, muscle weakness and aching joints.

If you forget to use your inhaler, take your next dose when it is due.
Do not take a double dose to replace the one you forgot.

If you stop using Seretide Evohaler
It is very important that you take your Seretide Evohaler every day as directed.
Keep taking it until your doctor tells you to stop. Do not stop or suddenly
reduce your dose of Seretide Evohaler. This could make your breathing
problem worse and very rarely side effects could occur.
These include:
• Stomach pain
• Tiredness and loss of appetite
• Sickness and diarrhoea
• Weight loss
• Headache or drowsiness
• Low levels of potassium in your blood
• Low blood pressure and seizures
Very rarely, if you get an infection or at times of extreme stress (such as after a
serious accident or if you have surgery), you may get similar side effects.
To prevent these symptoms occurring, your doctor may prescribe extra
corticosteroids (like prednisolone).
If you have any further questions on using your inhaler, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, Seretide Evohaler 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 Evohaler to control your asthma.
Allergic reactions: you may notice your breathing suddenly gets worse
after using Seretide Evohaler. You may be very wheezy and cough. You may
also notice itching and swelling (usually of the face, lips, tongue, or throat). If
you get these effects or if they happen suddenly after using Seretide
Evohaler, tell your doctor straight away. Allergic reactions to Seretide
Evohaler 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. Rinsing your mouth out with water and spitting
it out immediately after taking each puff may help. Your doctor may prescribe
an antifungal medication to treat the thrush.
• Aching, swollen joints and muscle pain.
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).

• Depression or aggression. These effects are more likely to occur in children.
If any of the side effects become serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Seretide Evohaler
• Keep out of the sight and reach of children.
• Straight after use, replace the mouthpiece cover firmly and click it into
position. Do not use excessive force.
• Do not store your Seretide Evohaler above 25°C.
• Do not store Seretide Evohaler in a cold place, as your medicine may not
work as well.
• Do not use after the expiry date printed on the carton and the canister label.
The expiry date refers to the last day of that month
• The metal canister contains a pressurized liquid. Do not puncture, break or
burn it even when apparently empty.
Medicines should not be disposed of via waste water 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 Evohaler contains
• Each metered actuation contains 25 micrograms of the active ingredient
salmeterol (as the xinafoate) together with either 125 or 250 micrograms of
the active ingredient fluticasone propionate.
• The other ingredient is norflurane (HFA 134a).

What Seretide Evohaler looks like and the contents of the pack
• Seretide 25/125 Evohaler is a pressurised metered dose inhaler with a metal
canister covered with a purple plastic cover and mouthpiece with a light
purple dust cover.
• Seretide 25/250 Evohaler is a pressurised metered dose inhaler with a metal
canister covered with a dark purple plastic cover and mouthpiece with a
lighter purple dust cover.
• The device is packed in cartons containing one Evohaler.
• Each canister provides 120 puffs or metered doses of a pressurised
inhalation suspension.

Manufacturer
This product is manufactured by Glaxo Wellcome Production, Zone Industrielle
N°2, 23 Rue Lavoisier, 27000 Evreux, France. Procured from within the EU
and repackaged by Mediwin Limited, Product Licence Holder: Mediport Limited
13 Martello Enterprise Centre, Courtwick Lane, Littlehampton, BN17 7PA,
United Kingdom.
POM
PL No: 18980/0360 Seretide 25/125 Evohaler
PL No: 18980/0361 Seretide 25/250 Evohaler
SERETIDE, EVOHALER, HALERAID AND VOLUMATIC ARE
TRADEMARKS OF THE GLAXOSMITHKLINE GROUP OF COMPANIES.
AEROCHAMBER PLUS IS A TRADEMARK OF TRUDELL MEDICAL
INTERNATIONAL.
Date of leaflet preparation: 20/11/2012

REF: ####
MCP-0360-0361-S0009

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
(web4)