There are no data available from clinical trials on overdose with Seretide, however data on overdose with both drugs are given below: The signs and symptoms of salmeterol overdose are dizziness, increases in systolic blood pressure, tremor, headache and tachycardia. 5. Long courses of treatment with these antifungals should be avoided where possible. **Total control of asthma; no symptoms, no SABA use, greater than or equal to 80% predicted morning peak expiratory flow, no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy. If so, your doctor may decide to reduce your dose to once a day. The amount of medicine that passes into breast milk after using an inhaler is negligable and unlikely to have any harmful effects on a nursing infant. Seretide 50 is the lowest dose of Evohaler and contains 25mcg salmeterol and 50mcg fluticasone. Increases in the amount of sugar (glucose) in your blood (hyperglycaemia). Patients should be instructed in the proper use of their inhaler and their technique checked to ensure optimum delivery of the inhaled medicinal product to the lungs. They work to help relax the airways and to ease breathing, as well as to reduce the inflammation associated with asthma symptoms. Fluticasone propionate is a corticosteroid which reduces swelling and irritation in thelungs. Your Accuhaler is now ready for you to use again. In a 3-year COPD study, older patients, patients with a lower body mass index (<25kg/m2) and patients with very severe disease (FEV1<30% predicted) were at greatest risk of developing pneumonia regardless of treatment. No placebo comparator was included in this study. Seretide is available in other strengths. Start typing to retrieve search suggestions. 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 counter cannot be reset and is permanently attached to the canister. For more information talk to your doctor or pharmacist. Seretide is used for people with severe COPD who have repeated attacks of breathlessness, despite using long-acting bronchodilators such as formoterol or salmeterol on a regular basis. 6. Two multi-centre 26-week studies were conducted to compare the safety and efficacy of salmeterol-FP versus FP alone, one in adult and adolescent subjects (AUSTRI trial), and the other in paediatric subjects 4-11 years of age (VESTRI trial). In the event of once daily dosing when the patient has a history of nocturnal symptoms the dose should be given at night and when the patient has a history of mainly daytime symptoms the dose should be given in the morning. Instructions will be provided with your inhaler. If you have any further questions, ask your doctor or pharmacist. Feeling shaky (tremor) and fast or uneven heart beat (palpitations) these are usually harmless and get less as treatment continues. SERETIDE is indicated for the regular treatment of asthma (Reversible Obstructive Airways Disease) in adults, adolescents and children aged 4 years and over, where use of a combination product (bronchodilator and inhaled corticosteroid) is appropriate. Use your fast-acting reliever inhaler to help your breathing and tell your doctor straightaway. Children and adolescents <16years taking high doses of fluticasone propionate (typically 1000 micrograms/day) may be at particular risk. The pharmacological side effects of 2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. *Well controlled asthma was achieved more rapidly with Seretide than with ICS alone. Studies have shown that salmeterol and fluticasone propionate, and their metabolites, are excreted into the milk of lactating rats. NAME OF THE MEDICINAL PRODUCT Seretide Evohaler 25/50 microgram per metered dose pressurised inhalation, suspension. No difference in the risk of MCMs was identified following first trimester exposure to FP alone versus salmeterol-FP. This includes any possible side effects not listed in this leaflet. However, animal studies showed no effects of salmeterol or fluticasone propionate on fertility. If an individual patient should require dosages outside the recommended regimen, appropriate doses of 2 agonist and/or corticosteroid should be prescribed. Ask your pharmacist how to throw away medicines you no longer use. Seretide may affect the normal production of steroid hormones in the body, particularly if you have taken high doses for long periods oftime. Inhaler technique. Therapy should be down-titrated under physician supervision. Use your Seretide every day until your doctor advises you to stop. Stopping treatment is likely to make your breathing problems flare-up again. If you get any side effects, talk to your doctor or pharmacist. 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. Do not take a double dose to make up for a forgotten dose. Both non-selective and selective blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Uneven heart beat or heart gives an extra beat (arrhythmias). Each Seretide 250Accuhaler blister contains 50micrograms of salmeterol (as the xinafoate) and 250micrograms of fluticasone propionate. The inhaler should be shaken immediately before releasing each puff. 2. The following inhalers contain both salmeterol and fluticasone as the active ingredients: This content is imported from YouTube. As with all inhalers, caregivers should ensure that children prescribed Seretide Evohaler use correct inhalation technique, as describedabove. Seretide Evohaler 25 microgram/250 microgram per metered dose pressurised inhalation, suspension. The expiry date refers to the last day of thatmonth. Some of these medicines may increase the amount of fluticasone propionate or salmeterol in your body. Feeling shaky (tremor) and fast or uneven heart beat (palpitations) these are usually harmless and get less as treatment continues. The extent of the adrenal impairment may require specialist advice before elective procedures. The expiry date refers to the last day of thatmonth. You should always have your fast-acting rescue inhaler with you. 3Shake the inhaler 4or 5times to ensure that any loose objects are removed and that the contents of the inhaler are evenlymixed. For the primary safety endpoint, non-inferiority was achieved for both trials (see Table below). For the full list of excipients, see section 6.1. If you have used larger doses for a long period of time, you should talk to your doctor or pharmacist for advice. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children) (see Paediatric population sub-heading below for information on the systemic effects of inhaled corticosteroids in children and adolescents). The lever will return to its original position and isreset. Used daily, Seretide Evohaler can help prevent asthma attacks and control symptoms, such as wheeze or a night-time cough. You must use Seretide every day as directed by your doctor. 7Hold your breath, take the inhaler from your mouth and your finger from the top of the inhaler. This resulted in a greater reduction of plasma cortisol as compared with fluticasone propionate alone. For the properties of the components please consider, Seffalair Spiromax 12.75/100 and 12.75/202 dry powder inhalers are not interchangeable with other fluticasone with salmeterol preparations, as the delivered doses differ. Tiredness and loss of appetite, feeling sick. Pneumonia (infection of the lung) in COPD patients. Anticholinergics. M, Volumatic spacer devices are compatible with Seretide Evohaler pressurised metered-dose inhalers. Allergic reactions to Seretide are uncommon (they affect less than 1person in100). Bronchodilators help the airways in the lungs to stay open. If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist. As with most inhaled medicinal products in pressurised canisters, the therapeutic effect of this medicinal product may decrease when the canister iscold. Information for other strengths of Seretide (i.e. These measures will help protect the environment. Allergic reactions to Seretide are uncommon (they affect less than 1person in100). Evohaler and Seretide are registered trademarks of the GSK group of companies. Increased blood sugar level (hyperglycaemia). Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs. When stabilised, treatment should be continued with an inhaled corticosteroid at the recommended dose. 06:54, 6 JUN 2023. 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). I think Seretide is used for asthma. There was an increased reporting of lower respiratory tract infections (particularly pneumonia and bronchitis) in a 3-year study in patients with Chronic Obstructive Pulmonary Disease (COPD) receiving salmeterol and fluticasone propionate as a fixed-dose combination administered via the Diskus/Accuhaler compared with placebo (see section 4.8). The canisters are fitted into purple plastic actuators incorporating an atomising mouthpiece and fitted with dustcaps. Do not use too muchforce. (Common side effect). All rights reserved. Seretide Evohaler 25 microgram/50 microgram per metered dose pressurised inhalation, suspension. However Seretide should not be used to relieve a sudden attack of breathlessness or wheezing. Start your 2 minute consultation. If you have any further questions, ask your doctor or pharmacist. You should get a replacement when the counter shows the number020. Every time the lever is pulled back a blister is opened inside and the powder made ready for you to inhale. This includes any possible side effects not listed in this leaflet. Patients should be made aware that Seretide Evohaler must be used daily for optimum benefit, even when asymptomatic. Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 0DJ, United Kingdomor, Glaxo Wellcome Production, Zone Industrielle No. An Accuhaler is an easy to use inhaler which is designed to release a dose of medicine into your lungs when you take a breathin. In these cases, the recommended initial dose is two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily. Other bronchodilators (such as salbutamol). If they see "mist" coming from the top of their inhaler or the sides of their mouth they should start again from stage 3. Consideration should be given to increasing corticosteroid therapy. The Accuhaler is a circular inhaler that contains dry powder. Just take your next dose at the usualtime. As with all inhalers, caregivers should ensure that children prescribed Seretide Accuhaler use correct inhalation technique, as describedabove. Fluticasone propionate given by inhalation at recommended doses has a glucocorticoid anti- inflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma, with less adverse effects than when corticosteroids are administered systemically. Original (products.mhra.gov.uk). Seretide is not likely to affect your ability to drive or use machines. View or print the patient leaflet as PDF. Replace the mouthpiece cover in the correct orientation. Available from 39.25 + prescription fees and delivery costs. Inflammation of sinuses (a feeling of tension or fullness in the nose, cheeks and behind the eyes, sometimes with a throbbingache). Talk to your doctor before using Seretide if you have: Contact your doctor if you experience blurred vision or other visual disturbances. Make sure that your doctor knows if you are. a If the resulting upper 95% CI estimate for the relative risk was less than 2.0, then non-inferiority was concluded. For fluticasone with salmeterol. Seretide Evohaler 25 microgram/125 microgram per metered dose pressurised inhalation, suspension. Afungal infection in the oesophagus (gullet), which might cause difficulties in swallowing. The adjusted mean change from baseline in mean morning peak expiratory flow over Weeks 1-12 was 37.7L/min in the Diskus group and 38.6L/min in the MDI group. A risk to breastfed newborns/infants cannot be excluded. Just take your next dose at the usualtime. If your doctor wants you to stop treatment with Seretide your dose should be tapered down gradually, to allow your adrenal glands to start producing adequate amounts of natural steroids again. Our clinician can advise you on a suitable dose and explain how often you should use your inhaler. Thrush infection of the mouth and throat (. Patients should shake the inhaler well to ensure that any loose objects are removed and that the contents of the inhaler are evenly mixed. You must use Seretide every day as directed by your doctor. If your asthma or breathing gets worse tell your doctor straight away. It is important to use the inhaler as instructed. Older children or people with weak hands may find it easier to hold the inhaler with both hands. You must use Seretide every day as directed by your doctor. Consideration should be given to referring the child or adolescent to a paediatric respiratory specialist. Tell your doctor if you are taking the following medicines, before starting to use Seretide: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Patients should consider getting a replacement when the counter shows the number 020. b If the resulting upper 95% CI estimate for the relative risk was less than 2.675, then non-inferiority was concluded. The safety of long-term treatment with salmeterol-FP metered dose inhaler (25/50 micrograms, 1 or 2 inhalations twice daily) was evaluated in a 16-week, open-label, extension treatment period. Seretide Evohaler helps control breathing immediately. The effects last for at least 12hours. In a small study in healthy volunteers, the slightly less potent CYP3A inhibitor ketoconazole increased the exposure of fluticasone propionate after a single inhalation by 150%. It will click into place when fitted correctly. Serious Asthma-Related Events in the 26-Week AUSTRI and VESTRI Trials, Composite endpoint (Asthma-related hospitalisation, endotracheal intubation, or death). Do not expose to temperatures higher than 50C, protect from direct sunlight. 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