Informations for option: Seretide 125 Evohaler, show 2 options

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Older children or 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. A special device called a Haleraid® 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.

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

If you forget to use Seretide

Do not take a double dose to make up for a missed dose. Just take your next dose at the usual time.

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 worse.

In addition, if you suddenly stop taking Seretide or reduce your dose of Seretide this may (very 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 corticosteroids in tablet form (such as prednisolone).

If you have any further questions about the use of this medicine, ask your doctor, nurse or pharmacist.

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 Seretide to control your asthma.

Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Seretide. 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 that your heart is 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 Seretide, stop using Seretide and tell your doctor straight away. Allergic reactions to Seretide 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 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 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 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.

•    Throat irritation. Rinsing your mouth out with water and spitting it out immediately after taking each puff may help.

•    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 heartbeat, muscle weakness, cramp).

Uncommon (affects less than 1 person in 100)

•    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.

•    Cataract (cloudy lens in the eye).

•    Very fast heartbeat (tachycardia).

•    Feeling shaky (tremor) and fast or uneven heart beat (palpitations) -these are usually harmless and get 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 that get worse straight after taking Seretide. If this happens stop using your Seretide inhaler.

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

-    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.

•    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 Seretide unless the doctor tells you to stop.

Frequency not known, but may also occur:

•    Depression or aggression. These effects are more likely to occur in children.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Seretide

•    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 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 use Seretide after the expiry date which is stated on the label and carton.

•    If you notice signs of your medicine deteriorating, consult your pharmacist.

•    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. Contents of the pack and other information

What Seretide contains

•    Each metered dose (ex valve) contains 25 micrograms of salmeterol (as xinafoate) and 125 micrograms of fluticasone propionate. This is equivalent to a delivered dose (ex actuator) of 21 micrograms of salmeterol and 110 micrograms of fluticasone propionate.

•    Also contains propellant norflurane (HFA 134a).

What Seretide looks like and contents of the pack

Seretide is an aerosol metered-dose inhaler with a dark purple plastic device and a light purple cap. A counter is visible through a window in the back of the inhaler. The pressurised canister contains a white to off white suspension for inhalation.

Seretide 125 Evohaler is available in a pack size containing 120 metered actuations.

Manufacturer:

Glaxo Wellcome Production, Zone Industrielle No.2, 23 Rue Lavoisier, la Madeleine, 27000 Evreux, France. Procured from within the EU and repackaged by the Product Licence holder: G-Pharma Ltd, Dakota Avenue, Salford, M50 2PU

Seretide 125 Evohaler

Leaflet revision: 23/12/2014

Seretide® and Evohaler® are registered trademarks of the GlaxoSmithKline group of companies.