Rolenium Elpenhaler 250/50 Mcg Inhalation

Description

Rolenium contains two medicines, salmeterol and fluticasone propionate: Salmeterol is 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 is a corticosteroid which reduces swelling and irritation in the lungs. The doctor has prescribed this medicine to help prevent breathing problems such as: Asthma. Chronic Obstructive Pulmonary Disease (COPD). Rolenium at a dose of 500/50 micrograms, reduces the number of flare ups of COPD. You must use Rolenium every day as directed by your doctor. This will make sure that it works properly in controlling your asthma or COPD. Rolenium helps to stop breathlessness and wheeziness coming on. However, Rolenium 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. You should always have your fast-acting ‘rescue’ inhaler with you. How to use Use your Rolenium every day until your doctor advises you to stop. Do not take more than the recommended dose. Check with your doctor or pharmacist if you are not sure. Do not stop taking Rolenium or reduce the dose of Rolenium without talking to your doctor first. Rolenium should be inhaled through the mouth into the lungs. After use rinse your mouth with water and spit it out. For adults and adolescents aged 12 years and over with asthma Rolenium 100/50 microgram/ dose: One inhalation twice a day. Rolenium 250/50 microgram/ dose: One inhalation twice a day Rolenium 500/50 microgram/dose: One inhalation twice a day. For children aged 4 to 12 years with asthma Rolenium 100/50 microgram/ dose: One inhalation twice a day. Rolenium is not recommended for use in children below 4 years of age. For adults with Chronic Obstructive Pulmonary Disease (COPD) Rolenium 500/50 microgram/dose: One inhalation twice a day. Your symptoms may become well controlled using Rolenium twice a day. If so, your doctor may decide to reduce your dose to once a day. The dose may change to: - Once at night - if you have night-time symptoms. - Once in the morning - if you have daytime symptoms. Warnings and precautions Do not take Rolenium if You are allergic to salmeterol and/or fluticasone propionate or any of the other ingredients of this medicine. Warnings and precautions Talk to your doctor or pharmacist before using Rolenium if you have: Heart disease, including an irregular or fast heartbeat. Overactive thyroid gland. High blood pressure. Diabetes mellitus (Rolenium may increase your blood sugar). Low potassium in your blood. Tuberculosis (TB) now or in the past, or other lung infections. Side Effects Allergic reactions: you may notice your breathing suddenly gets worse immediately after using Rolenium. 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 your heart beating very fast or you feel faint and light headed (which may lead to collapse or loss of consciousness). If you get these effects or if they happen suddenly after using Rolenium, tell your doctor straight away. Allergic reactions to Rolenium are uncommon (they may affect up to 1 in 100 people). Pneumonia (infection of the lung) in COPD patients (Common side effect). Tell your doctor if you have any of the following while taking Rolenium they could be symptoms of a lung infection: • Fever or chills. • Increased mucus production, change in mucus color • Increased cough or increased breathing difficulties. Other side effects are listed below: Very common: may affect more than 1 in 10 people • Headache: this usually gets better as treatment continues. • Increased number of colds has been reported in patients with COPD. Common: may affect up to 1 in 10 people • Thrush (sore, creamy-yellow, raised patches) in the mouth and throat. Also, sore tongue and hoarse voice and throat irritation. Storage Information Store below 30°C. Drug Interactions Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines for asthma or any medicines obtained without prescription. Tell your doctor if you are taking the following medicines, before starting to use Rolenium: Β- blockers (such as atenolol, propranolol, sotalol). Β- blockers are mostly used for high blood pressure or other heart conditions. Medicines to treat infections (such as ritonavir, cobicistat, ketoconazole, itraconazole and erythromycin). Some medicines may increase the effects of Rolenium and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat). This can increase your risk of experiencing side effects with Rolenium, including irregular heartbeats, or may make side effects worse. Corticosteroids (by mouth or by injection). If you have had these medicines recently, this might increase the risk of this medicine affecting your adrenal gland. Diuretics, also known as ‘water tablets’ used to treat high blood pressure. Other bronchodilators (such as salbutamol). Xanthine medicines. These are often used to treat asthma. Ingredients The active substances are fluticasone propionate and salmeterol xinafoate. The other ingredient is lactose monohydrate.