Your doctor has prescribed this medicine to prevent breathing problems in:<\/p>\n\n\n\n
- Asthma<\/li>
- Chronic obstructive pulmonary disease\u00a0(COPD).\u00a0Salmex 50 micrograms \/ 500 micrograms per\u00a0dose\u00a0reduce the number of worsening periods of COPD.<\/li><\/ul>\n\n\n\n
Salmex must be taken regularly every day according to the doctor’s instructions for it to work in the best way and give control of your\u00a0asthma\u00a0or COPD.<\/p>\n\n\n\n
Salmex prevents breathing problems and wheezing.\u00a0However, Salmex should not be used to relieve a sudden onset of shortness of breath or wheezing.\u00a0If this happens, take a fast-acting “if needed”\u00a0inhaler<\/strong>, such as\u00a0salbutamol.\u00a0You should always have your fast-acting “if needed”\u00a0inhaler\u00a0with you.<\/strong><\/p>\n\n\n\n
Salmeterol\u00a0and fluticasone propionate contained in Salmex may also be approved for the treatment of other conditions not mentioned in this product information.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n
What you need to know before you use Salmex<\/h2>\n\n\n\n
Do not take Salmex:<\/h2>\n\n\n\n
if you are allergic to\u00a0salmeterol, fluticasone propionate, or the other ingredient\u00a0lactose monohydrate.<\/p>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor before using Salmex if you have:<\/p>\n\n\n\n
- Cardiovascular disease, including irregular or rapid heartbeat<\/li>
- Increased thyroid function (\u00a0hyperthyroidism\u00a0)<\/li>
- High\u00a0blood pressure<\/li>
- Diabetes\u00a0(as Salmex may increase blood sugar)<\/li>
- Decreased potassium content in the blood<\/li>
- or have had\u00a0tuberculosis\u00a0(TB) or other\u00a0lungs\u00a0infection.<\/li><\/ul>\n\n\n\n
Contact a doctor if you experience blurred vision or other visual disturbances.<\/p>\n\n\n\n
Other medicines and Salmex<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, or might take any other medicines.\u00a0This also includes\u00a0asthma\u00a0medications and over-the-counter medications.\u00a0This is because the effect of the treatment can be affected if Salmex and certain other medicines are taken at the same time.<\/p>\n\n\n\n
Tell your doctor if you are taking any of the following medicines before you start using Salmex:<\/p>\n\n\n\n
- \u03b2-blockers (eg atenolol, propranolol, and sotalol).\u00a0\u03b2-blockers are most commonly used to treat high\u00a0blood pressure\u00a0or other heart conditions<\/li>
- Medicines used to treat\u00a0infections\u00a0(eg\u00a0ketoconazole, itraconazole, and erythromycin) include certain medicines used to treat\u00a0HIV\u00a0(eg ritonavir, medicines containing cobicistat).\u00a0Some of these medicines may increase the amount of fluticasone propionate or\u00a0salmeterol\u00a0in the body.\u00a0This may increase the risk of\u00a0side effects\u00a0with Salmex, including irregular heartbeat, or aggravate the\u00a0side effects.\u00a0Your doctor may want to monitor you closely if you are taking these medicines.<\/li>
- Cortisone\u00a0(tablets or in\u00a0injection\u00a0).\u00a0If you have recently been treated with these drugs, it may increase the risk of affecting the function of the adrenal glands<\/li>
- Diuretics, also known as diuretics, are used to treat high\u00a0blood pressure<\/li>
- Other bronchodilators (eg\u00a0salbutamol\u00a0)<\/li>
- Xanthines.\u00a0These are often used to treat\u00a0asthma.<\/li><\/ul>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
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.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Salmex is unlikely to affect your ability to drive or use machines.\u00a0You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n
Salmex contains lactose<\/h2>\n\n\n\n
Salmex contains approximately 13.5 mg\u00a0of lactose monohydrate\u00a0per\u00a0dose.\u00a0This amount normally does not cause any problems for lactose-intolerant people.\u00a0The excipient lactose\u00a0monohydrate\u00a0contains small amounts of milk protein, which may cause allergic reactions.<\/p>\n\n\n\n
How to use Salmex<\/h2>\n\n\n\n
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n
- Use Salmex every day until your doctor advises you to stop.\u00a0Do not use more than the recommended\u00a0dose.\u00a0Ask your doctor or pharmacist if you are unsure.<\/li>
- Do not stop taking Salmex or reduce the\u00a0dose\u00a0of Salmex without talking to a doctor first.<\/li>
- Salmex should be inhaled through the mouth into the lungs.<\/li><\/ul>\n\n\n\n
For asthma:<\/strong><\/p>\n\n\n\n
Adults and young people from 12 years<\/strong><\/p>\n\n\n\n
- Salmex 50 micrograms \/ 100 micrograms \/ dose 1 inhalation twice daily<\/li>
- Salmex 50 micrograms \/ 250 micrograms \/ dose 1 inhalation twice daily<\/li>
- Salmex 50 micrograms \/ 500 micrograms \/ dose 1 inhalation twice daily<\/li><\/ul>\n\n\n\n
Children from 4 years and up to 12 years<\/strong><\/p>\n\n\n\n
- Salmex 50 micrograms \/ 100 micrograms \/ dose 1 inhalation twice daily<\/li>
- Salmex is not recommended for children under 4 years of age.<\/li><\/ul>\n\n\n\n
For adults with chronic obstructive pulmonary disease (COPD)<\/strong><\/p>\n\n\n\n
- Salmex 50 micrograms \/ 500 micrograms \/ dose 1 inhalation twice daily<\/li><\/ul>\n\n\n\n
If the symptoms are well controlled when you take Salmex twice a day, your doctor may reduce the dose to 1 inhalation once a day. Dose one can be changed to:<\/p>\n\n\n\n
- 1 time in the evening – if you have problems at night.<\/strong><\/li>
- Once in the morning – if you have problems during the day.<\/strong><\/li><\/ul>\n\n\n\n
It is very important to follow your doctor’s instructions on how many inhalations you should take and how often.<\/p>\n\n\n\n
If you use Salmex for\u00a0asthma, your doctor will want to monitor your symptoms regularly.<\/p>\n\n\n\n
Contact a doctor immediately if your\u00a0asthma\u00a0or breathing worsens.\u00a0<\/strong>If you feel that your breathing becomes more wheezing\/wheezing, that the feeling of tightness in your chest increases, or that you need to take more of your fast-acting bronchodilator medication, continue to take Salmex but do not increase the number of\u00a0doses.\u00a0Your breathing problems may worsen and you may become seriously ill.\u00a0Contact your doctor as you may need additional asthma treatment.<\/p>\n\n\n\n
Instructions for use<\/strong><\/p>\n\n\n\n
- Your doctor, nurse, or pharmacist should show you how to use the inhaler.\u00a0From time to time, they should also check how you use it.\u00a0It is important that Salmex is used correctly and as prescribed so that you can have the intended effect on your\u00a0asthma\u00a0or COPD.<\/li>
- The Salmex inhaler contains blisters containing salmeterol\/fluticasone propionate as powder.<\/li>
- A dose counter on the top of the Salmex inhaler shows how many\u00a0doses\u00a0you have left.\u00a0The dose counter counts down to 0.<\/li>
- Numbers 5 to 0 are marked with a black dot to warn that only a few\u00a0doses\u00a0are left.\u00a0When the dose counter shows 0, the inhaler is empty.<\/li><\/ul>\n\n\n\n
How to use the inhaler<\/strong><\/p>\n\n\n\n
1. To open the Salmex inhaler, hold it as shown. Move the thumb grip in the direction of the arrow as far as it will go – a click will be heard. A small hole in the nozzle has now been opened. See picture 1.<\/p>\n\n\n\n
<\/a><\/figure>\n\n\n\n
2. Hold the Salmex inhaler with the mouthpiece facing you. You can hold it in either the right or left hand. Move the feed lever away from you, as far as it will go – a click will be heard. The powder dose is now ready to be inhaled from the mouthpiece. See picture 2.<\/p>\n\n\n\n
<\/a><\/figure>\n\n\n\n
Each time the lever is pulled out, a powder dose is opened that is ready to be inhaled. Do not play with the feed lever as this will open the powder doses and waste medicine.<\/p>\n\n\n\n
3. Keep the Salmex inhaler away from your mouth. Exhale as deeply as you feel comfortable. Never exhale through the inhaler.<\/p>\n\n\n\n
4. Then bring the Salmex inhaler to your mouth and close your lips around the mouthpiece.\u00a0Inhale steadily and deeply through the\u00a0inhaler\u00a0n, not through the nose.\u00a0See picture 3.<\/p>\n\n\n\n
Remove the Salmex inhaler from your mouth.<\/p>\n\n\n\n
Hold your breath for about 10 seconds or as long as it feels comfortable. Exhale slowly.<\/p>\n\n\n\n
<\/a><\/figure>\n\n\n\n
5. The risk of fungal infection and hoarseness is reduced if you rinse your mouth with water and spit it out and\/or brush your teeth after each inhalation.\u00a0<\/p>\n\n\n\n
- Once in the morning – if you have problems during the day.<\/strong><\/li><\/ul>\n\n\n\n
- 1 time in the evening – if you have problems at night.<\/strong><\/li>
- Salmex 50 micrograms \/ 500 micrograms \/ dose 1 inhalation twice daily<\/li><\/ul>\n\n\n\n