Informations for option: Seretide 250 Evohaler, show 2 options

Select option:

1. Seretide 250 Evohaler
2. Seretide 250 Evohaler
3. Seretide 250 Evohaler

Document: document 5 change

• document 0
• document 1
• document 2
• document 3
• document 4
• document 5
• document 6
• document 7
• document 8
• document 9
• document 10
• document 11
• document 12
• document 13
• document 14
• document 15
• document 16
• document 17
• document 18
• document 19
• document 20
• document 21
• document 22
• document 23
• document 24
• document 25
• document 26
• document 27
• document 28
• document 29
• document 30
• document 31
• document 32
• document 33
• document 34
• document 35
• document 36
• document 37
• document 38
• document 39
• document 40
• document 41
• document 42
• document 43
• document 44
• document 45
• document 46
• document 47
• document 48
• document 49
• document 50
• document 51
• document 52
• document 53
• document 54
• document 55
• document 56
• document 57
• document 58
• document 59
• document 60
• document 61
• document 62
• document 63
• document 64
• document 65
• document 66
• document 67
• document 68
• document 69
• document 70
• document 71
• document 72
• document 73
• document 74
• document 75
• document 76
• document 77
• document 78
• document 79
• document 80
• document 81
• document 82
• document 83
• document 84
• document 85
• document 86
• document 87
• document 88
• document 89
• document 90
• document 91
• document 92
• document 93
• document 94
• document 95
• document 96
• document 97
• document 98
• document 99

---

PACKAGE LEAFLET: INFORMATION FOR THE USER SERETIDE® 125 EVOHALER® / SERETIDE® 250 EVOHALER® (fluticasone propionate/salmeterol xinafoate)

This products is available in the above names and strengths but will be referred to as Seretide throughout the remainder of 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 get 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 is and what it is used for

2.    Before you use Seretide

3.    How to use Seretide

4.    Possible side effects

5.    How to store Seretide

6.    Further information

1.    What Seretide is and what it is used for

Seretide contains two medicines, salmeterol and fluticasone:

•    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 is a corticosteroid which reduces swelling and irritation in the lungs.

•    The medicine is contained in a pressurised canister in a plastic casing with a mouthpiece.

•    There is a counter on the back of the 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.

Using your inhaler

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

Pregnancy and breast-feeding

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

If you or your child find it difficult to use Seretide, either the Volumatic™ or Aerochamber Plus spacer device may be used. Before starting to use a spacer device, talk to your doctor, nurse or pharmacist. A special device called a Haleraid™ may also make it easier.

Driving and using machines

Seretide is not likely to affect your ability to drive or use machines.

3.    How to use Seretide

•    Use your Seretide every day, until your doctor advises you to stop.

•    Always use Seretide exactly as your doctor has told you.

Adults and adolescents aged 12 years and over

•    Seretide 25/125 Evohaler - 2 puffs twice a day

•    Seretide 25/250 Evohaler - 2 puffs twice a day

Seretide is not recommended for use in children below 4 years of age.

Your symptoms may become well controlled using Seretide 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 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 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 properly or as prescribed may mean that it will not help your asthma as it should.

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.

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 than you should

It is important to use your 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 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.

If you forget to use Seretide

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

It is very important that you take your Seretide every day as directed. Keep taking it until your doctor tells you to stop. Do not stop or suddenly reduce your dose of Seretide. 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 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 to control your asthma.

Allergic reactions: you may notice your breathing suddenly gets worse after using Seretide. 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, tell your doctor straight away. Allergic reactions to Seretide are very rare (they affect less than 1 person in 10,000).

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, throat 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.

•    Feeling shaky and fast or uneven heartbeat (palpitations) - these are usually harmless and get less as treatment continues.

•    Muscle cramps.

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).

Uncommon (affects less than 1 person in 100)

•    Rash

•    Very fast heartbeat (tachycardia).

Very rare (affects less than 1 person in 10,000)

•    Breathing difficulties or wheezing that get worse straight after taking Seretide. If this happens stop using your Seretide. Use your fast-acting ‘reliever’ inhaler to help your breathing and tell your doctor straight away.

•    Seretide 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 to control your asthma.

•    Uneven heartbeat or heart gives an extra beat (arrhythmias). Tell your doctor, but do not stop taking Seretide unless they tell you to stop.

•    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.

•    Feeling worried, disturbed sleep and behavioural changes, such as being unusually active and irritable (these effects mainly occur in children).

•    Aching, swollen joints and muscle pain.

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

•    Keep all medicines out of the reach and sight of children.

•    Do not store above 25°C. Protect from frost and direct sunlight.

•    Clean your Evohaler on a weekly basis as described under ‘Cleaning’.

•    WARNING: The metal canister is pressurised. Do not puncture, break or burn it even when apparently empty.

•    Do not use after the date shown as ‘EXP’on the carton and label.

•    If you are told to stop taking this medicine, RETURN ANY SERETIDE EVOHALERS TO YOUR PHARMACIST to be destroyed

Medicines should not be disposed of via wastewater 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 contains

•    Seretide 125 Evohaler: Each metered actuation contains salmeterol 25 micrograms (as the xinafoate) and 125 micrograms of fluticasone propionate as the active ingredients.

•    Seretide 250 Evohaler: Each metered actuation contains salmeterol 25 micrograms (as the xinafoate) and 250 micrograms of fluticasone propionate as the active ingredients.

•    Seretide Evohaler also contains a CFC-free propellant, norflurane (HFA134a).

•    Seretide Evohaler delivers your medicine as a pressurised white to off white suspension for inhalation for you to inhale, which delivers your medicine directly into your lungs.

What Seretide looks like and contents of the pack

•    Seretide Evohaler delivers your medicine as a pressurised white to off white suspension for inhalation for you to inhale.

•    The medicine is in a pressurised metered dose evohaler containing 120 metered actuations with a purple plastic device and a lighter purple cap. The can has a counter attached to show you how many puffs of medicine you have left. The number will show through a window in the back of the purple plastic device. Each time the actuator is pressed a dose of the medicine is released and the counter will count down by one.

Manufacturer

Glaxo Wellcome Productions, Evreux, France.

Procured from within the EU. Product Licence Holder and repackaged by: S.C.A.C. Ltd., Unit 2a, Bandeath Industrial Estate, Throsk, Stirling,

FK7 7NP.

PL 30984/0145    Seretide® 125 Evohaler®

PL 30984/0144 Seretide® 250 Evohaler®

Seretide® 125 Evohaler® / Seretide® 125 Evohaler®    27.05.2011

Seretide®, Evohaler®, Volumatic™and Haleraid™are registered trademarks of Glaxo Group Limited.