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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 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

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 the inhaler, ask your doctor or pharmacist.

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 or COPD.

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 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 after taking each puff 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.

•    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.

•    Cloudy lens in the eye.

•    Very fast heartbeat (tachycardia).

•    Feeling shaky 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.

•    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 includes:

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

Frequency not known, but may also occur:

•    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

•    Keep out of the sight and reach of children

•    Do not store above 30°C.

•    Do not use Seretide after the expiry date which is stated on the label and carton.

•    If the device doesn't appear to be working properly, becomes damaged or if you notice any signs of deterioration, consult your pharmacist for advice.

•    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

•    Each blister contains powder for inhalation providing 50 micrograms of salmeterol (as the xinafoate) and either 100, 250 or 500 micrograms of fluticasone propionate, as the active ingredients.

•    The other ingredient is lactose monohydrate (which contains milk proteins).

What Seretide® looks like and contents of the pack

•    The Seretide® Accuhaler contains a foil strip. The foil protects the powder for inhalation from the effects of the atmosphere.

•    Each dose is pre-dispensed.

•    The Accuhaler is a two tone purple circular Inhaler device, with a retractable lid and dose counter, containing a foil strip with 60 blisters.

Manufacturer

Glaxo Wellcome Production, Evreux, France

Procured from within the EU.

Parallel Import Product Licence holder:

G.Pharma Ltd. Dakota Ave. Salford M50 2PU

PL 16369/0610    Seretide® 100 Accuhaler®

PL 16369/0609    Seretide® 250 Accuhaler®    ^POM

PL 16369/0608    Seretide® 500 Accuhaler®

12/06/2013

Seretide® and Accuhaler® are registered trademarks of the GlaxoSmithKline group of companies