Seretide

• Inhalation medicine
• Used for asthma and COPD
• Reduces occurrence of asthma attacks
• Use every day

Seretide contains two medicines:

• Salmeterol: 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: a corticosteroid. This medicine reduces swelling and irritation in the lungs.

Seretide is used to prevent breathing problems such as wheezing and shortness of breath in patients with asthma and chronic obstructive pulmonary disease (COPD).

Seretide is an inhalation medicine. It is used daily to prevent breathing problems. Seretide helps to stop breathlessness and wheeziness coming on. However, Seretide should not be used to relieve a sudden attack of breathlessness or wheezing. If this happens you need to use a fast-acting reliever ('rescue inhaler') such as salbutamol.

Seretide is available in various strengths and forms, including:

• Seretide Evohaler (25/50, 25/125, 25/250)
• Seretide Accuhaler (50/100, 50/250, 50/500)

Please refer to the package leaflet of this medicine for instructions on how to use your Evohaler or Accuhaler correctly. The general guidelines for use are listed below.

• Clean the device according to the instructions in the package leaflet.
• Breathe out gently as far as comfortable. (Do not breathe out through the mouthpiece.)
• Place the mouthpiece gently between your lips.
• Breathe in steadily through the mouthpiece to inhale the medicine that is released. (For the Evohaler: breathe in as soon as you press down and hear a click. The medicine in the Accuhaler is released sooner.
• Remove the mouthpiece and hold your breath for a few seconds.
• Breathe out slowly.
• If you need to take more than one inhalation, repeat these steps.
• Rinse your mouth after use.

Dosage

Seretide is available in various strengths. Strength, the number of inhalations and inhalation frequency must be determined by a doctor.

Alcohol/driving

This medicine does not interact with alcohol and will normally not affect your ability to drive or operate machinery.

Used too much/forgot to take/stop taking Seretide

If you use more Seretide than prescribed by your doctor, symptoms such as tremor, headache, rapid heartbeat may occur. Tell your doctor if you have used too much Seretide for a prolonged period of time.

If you forget to take a dose, skip the missed dose and continue your dosing schedule as usual. Do not

take a double dose to make up for a forgotten one.

Do not stop or suddenly reduce your dose of Seretide. This could make the side effects worse. Follow the instructions given by the doctor when it is time to stop treatment with this medicine.

Do not use Seretide if you are allergic to any of the ingredients in this medicine (see section 'What Seretide contains').

When should this medicine be used with caution?

Regular check-ups by your doctor can be necessary in some cases. For instance, if you have:

• A heart disease, such as rapid or irregular heartbeat.
• Overactivity of the thyroid gland.
• High blood pressure.
• Diabetes (Seretide may increase your blood sugar).
• Low potassium in your blood.
• Tuberculosis now or in the past.

Talk to your doctor before using Seretide if you have, or have had, any of the above-listed conditions or symptoms.

Pregnancy and breastfeeding

Consult a doctor before using Seretide if you are pregnant or breastfeeding.

Other medicines and Seretide

Seretide is known to interact with some medicines. Talk to your doctor if you are taking any of these medicines:

• Beta-blockers (e.g., atenolol, propranolol, sotalol). Beta-blockers are mostly used for high blood pressure and other heart conditions.
• Antiviral and antifungal medicines (e.g., ritonavir, ketoconazole, 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 or make side effects worse.
• Corticosteroids (by mouth or injection). If you have had these medicines recently, this might increase the risk of this medicine affecting your adrenal gland.

Also tell your doctor if you are taking, have recently taken or will take any other medicines, including herbal remedies and medicines obtained without a prescription.

Medicines can cause side effects, although some people may not experience any. Side effects that are known to be associated with Seretide include:

Very common (may affect more than 1 person in 10):

• Headache (this usually gets better as treatment continues).
• Increased number of colds (reported in patients with COPD).

Common (may affect less than 1 person in 10):

• Fungal infections in the mouth or throat (thrush). Sore tongue and hoarse voice. Rinsing your mouth out with water and spitting it out immediately after taking each dose of your medicine may help.
• Aching, swollen joints and muscle pain.

The following side effects have also been reported in patients with COPD.

• Lung infections. Tell you doctor if you have any of the following symptoms: increased mucus production, mucus changing colour, fever, chills, increased coughing, increase in breathing problems.
• Bruising and fractures.
• Inflammation of the 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 irregular heartbeat, muscle weakness, cramps).

Uncommon (may affect less than 1 person in 100):

• Allergic reaction (see the package leaflet). Seek immediate medical advice if you have an allergic reaction.
• Very fast heartbeat (tachycardia).
• Feeling shaky (tremor) and fast or irregular heartbeat (palpitations). These symptoms are usually harmless and get less as treatment continues.
• Muscle cramps.
• Restlessness (mainly in children).
• Irritation of the throat. Rinsing your mouth out with water and spitting it out immediately after taking each dose of your medicine may help.

Please refer to the package leaflet for a list of rare side effects, and side effects when taking high doses of Seritide for a prolonged period of time. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

The other substances are:

• Seretide Evohaler: 25 micrograms salmeterol (as salmeterol xinafoate) and 50, 125, or 250 micrograms fluticasone propionate. The other ingredient is norflurane (HFA 134a).
• Seretide Accuhaler: 50 micrograms salmeterol (as salmeterol xinafoate) and fluticasone propionate (100, 250 or 500 micrograms). The other ingredient in this medicine is lactose monohydrate (which contains milk proteins).

The manufacturer of Seretide Evohaler is:

Glaxo Wellcome Production Zone Industrielle No.2
23 Rue Lavoisier
27000 Evreux
France

The manufacturers of Seretide Accuhalerare:

Glaxo Wellcome Production Zone Industrielle No.2
23 Rue Lavoisier
27000 Evreux
France

Glaxo Wellcome GmbH & Co. Industriestrasse 32-36
D-23843
Bad Oldesloe
Germany

Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street
Ware, Hertfordshire
SG12 0DJ
United Kingdom

Read the package leaflet before use.