Seretide Diskus

• Severe chronic obstructive pulmonary disease (the Seretide 500 accuhaler is the only Seretide product that contains the correct dose of active ingredients for this use).

How does it work?

• Seretide accuhaler and evohaler both contain two active ingredients, fluticasone and salmeterol.
• Fluticasone is a type of medicine known as a corticosteroid. Corticosteroids are hormones that are produced naturally by the adrenal glands. They have many important functions, including control of inflammatory responses. Fluticasone is a synthetic corticosteroid and is used to decrease inflammation in the lungs. (NB. Corticosteroids are often simply called steroids, but it should be noted that they are very different from another group of steroids, called anabolic steroids, which have gained notoriety because of their abuse by some athletes and body builders.)
• When fluticasone is inhaled into the lungs it is absorbed into the cells of the lungs and airways. Here it works by preventing the release of certain chemicals that are important in the immune system. These chemicals are normally involved in producing immune and allergic responses that result in inflammation. By decreasing the release of these chemicals in the lungs and airways, inflammation is reduced.
• In asthma, the airways tighten due to inflammation and can also be blocked by mucus. This makes it difficult for air to get into and out of the lungs. By reducing the inflammation and excess mucus formation, fluticasone helps prevent asthma attacks.
• Salmeterol is a type of medicine called a long-acting beta 2 agonist. It works by acting on receptors in the lungs called beta 2 receptors. When salmeterol stimulates these receptors it causes the muscles in the airways to relax. This allows the airways to open and makes it easier to breathe.
• Salmeterol doesn't open the airways as quickly as short-acting beta 2 agonists such as salbutamol or terbutaline, however, it does keep the airways open for much longer. The effects of salmeterol last for about 12 hours, whereas those of salbutamol or terbutaline last for about 3 to 5 hours. This means salmeterol is used to prevent asthma attacks, wheezing, chest tightness or shortness of breath, rather than to relieve them.

How is this medicine taken?

Fluticasone and salmeterol are taken using an inhaler device. Inhaling the medicine allows it to act directly in the lungs where it is needed most. It also reduces the potential for side effects in other parts of the body, as the amount absorbed into the blood through the lungs is lower than if the medicines were taken by mouth.

Seretide inhalers are usually used regularly twice a day, sometimes reducing to once a day if your asthma is well controlled. However, you should follow the instructions given by your doctor regarding when to use your inhaler and how many inhalations you should use each day. Don't exceed the prescribed dose.

It is very important to learn how to use your inhaler correctly, as otherwise you won't be breathing the right dose of medicine into your lungs. Instructions will be provided with your inhaler. However, your doctor, nurse or pharmacist can also show you how to use your inhaler and can check that you are using it correctly.

Seretide is available as two different types of inhaler device; the evohaler and the accuhaler.

• Seretide evohaler is a metered dose inhaler (sometimes called an MDI or aerosol inhaler) that delivers the medicine as a fine spray or mist. With this inhaler you have to co-ordinate pressing down the canister and breathing in the spray. Follow this link for general instructions on how to use a metered dose inhaler. Seretide evohaler can also be used with a spacer device such as the Volumatic or AeroChamber Plus. If you do use a spacer it is important that you always use the same make of spacer with Seretide evohaler, because changing makes can change the amount of medicine that is delivered to your lungs.
• Seretide accuhaler is a dry powder inhaler. It comes pre-loaded with blisters containing individual doses of the medicine as a powder. To take a dose you have to slide the lever on the inhaler. This opens a blister inside the inhaler, making a dose ready for you to inhale. You then breathe out fully, put the mouthpiece to your lips and breathe in steadily and deeply through your mouth. More detailed instructions are provided with the accuhaler.
• Inhaled corticosteroids can sometimes cause a fungal infection in the mouth called oral thrush. To minimise the chances of this you should rinse your mouth with water or clean your teeth after inhaling each dose. Using a spacer device can also help avoid this problem. Consult your doctor if you develop white patches in your mouth or throat, as these are symptoms of thrush and it may need to be treated.
• If you forget to take a dose, just take your next dose when it is due. Do not take a double dose to make up for a missed dose.
• Do not stop using your inhaler regularly, even if you don't have any symptoms, unless advised to by your doctor.

Use with caution in

• People with a history of tuberculosis infection in the lungs.
• Heart disease.
• Irregular heartbeats (arrhythmias).
• High blood pressure (hypertension).
• Overactive thyroid gland (hyperthyroidism).
• Diabetes.
• People with low levels of potassium in their blood (hypokalaemia).

Not to be used in

• People with known sensitivity or allergy to any ingredient.
• Seretide is not recommended for children under four years of age.
• This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
• If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• It is important that asthma is well controlled in pregnant women because severe asthma attacks can be dangerous to the pregnancy. Wherever possible, asthma medications should be taken by inhaler, as this minimises the amount of medicine that enters the bloodstream and crosses the placenta. The manufacturer states that Seretide should be used with caution during pregnancy. However, it is generally considered that asthma inhalers can be taken as usual during pregnancy. For further medical advice talk to your doctor or pharmacist.
• Salmeterol may pass into breast milk in small amounts. It is not known if fluticasone passes into breast milk. However, in general, asthma inhalers can be used as normal during breastfeeding, because the amount of medicine that passes into the breast milk after using an inhaler is negligable and unlikely to harm the baby. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Very common 

• Headache.
• Increased number of colds in people with COPD.

Common

• Thrush infection of the mouth and throat (oral thrush). This can usually be avoided by rinsing the mouth out with water and spitting it out immediately after each time you use your inhaler. If you do get oral thrush your doctor can prescribe an antifungal medicine to treat it.
• Throat irritation.
• Hoarse voice.
• Muscle cramps.
• Pain in the muscles or joints.
• Sinusitis in people with COPD.
• Low level of potassium in the blood in people with COPD (hypokalaemia).
• Pneumonia and bronchitis in people with COPD.
• Bruising or bone fractures in people with COPD.

Uncommon

• Shaking, usually of the hands (tremor).
• Anxiety.
• Sleep disorders.
• Awareness of your heartbeat (palpitations).
• Increased heart rate (tachycardia).
• Chest pain.
• Cataracts.

Rare

• Unexpected narrowing of the airways (paradoxical bronchospasm - see warning section above).
• Abnormal heartbeats (arrhythmias).
• Glaucoma.
• Behavioural changes, including hyperactivity and irritability (mostly in children).

Systemic steroid effects such as Cushing's syndrome (moon-shaped face), suppression of the adrenal glands, slowed growth in children and adolescents or decreased bone mineral density may occur, usually only after taking high doses for prolonged periods of time - see warning section above.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to make sure that the combination is safe.

People who are using salmeterol should not take medicines called beta-blockers, such as atenolol, propranolol or timolol. This is because beta-blockers have an opposite action to this medicine and can cause the airways to narrow. This can result in breathing difficulties for people with asthma or COPD. This problem has also sometimes been seen with eye drops containing beta-blockers, eg used for glaucoma.

Salmeterol and fluticasone can sometimes cause a serious decrease in the levels of potassium in the blood (hypokalaemia). This effect can be increased by the following medicines, which can also lower levels of potassium in the blood:

• diuretics, such as bendroflumethiazide and furosemide.
• other beta 2 agonists, such as salbutamol
• other corticosteroids, such as prednisolone
• xanthine derivates, such as theophylline or aminophylline.

Since a low blood potassium level can have serious adverse effects, people with severe asthma or COPD, who may be taking several of these medicines, should have their blood potassium levels monitored regularly.

The following medicines may increase the amount of salmeterol or fluticasone that is found in the bloodstream after inhaling this medicine:

• the azole antifungals ketoconazole, itraconazole or voriconazole
• the macrolide antibiotics clarithromycin or telithromycin
• protease inhibitors for HIV infection such as ritonavir
• telaprevir.

These medicines can therefore increase your exposure to fluticasone and salmeterol and so increase the risk of side effects on the rest of the body. Due to the risk of systemic steroid side effects, such as decreased production of natural steroid hormones by the adrenal glands (adrenal suppression) and Cushing's syndrome, Seretide is not recommended for people who are taking ritonavir. The antifungals ketoconazole and itraconazole should be used with caution in people using Seretide. Long courses of treatment with these antifungals should be avoided where possible.

If you have any more questions please ask your Pharmacist.

Remember to keep all medicines out of reach of children
Please Note: We have made every effort to ensure that the content of this information sheet is correct at time of publish, but remember that information about drugs may change. This sheet does not list all the uses and side-effects associated with this drug. For full details please see the drug information leaflet which comes with your medicine. Your doctor will assess your medical circumstances and draw your attention to any information or side-effects which may be relevant in your particular case.

References:

http://www.seretide.co.nz/asthma/how-to-use-seretide.html

https://www.medicines.org.uk/emc/medicine/4416

http://www.netdoctor.co.uk/medicines/allergy-and-asthma/a7520/seretide-fluticasone-and-salmeterol/