{"id":9034,"date":"2021-03-24T07:25:41","date_gmt":"2021-03-24T07:25:41","guid":{"rendered":"https:\/\/zeepedia.com\/?p=9034"},"modified":"2021-04-12T11:01:16","modified_gmt":"2021-04-12T11:01:16","slug":"formatris-novolizer","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/formatris-novolizer\/","title":{"rendered":"Formatris Novolizer &#8211; Formoterol Fumarate Dihydrate uses, dose and side effects"},"content":{"rendered":"\n<p> 12 micrograms\/dose\u00a0inhaled powder<br><strong>formoterol fumarate dihydrate<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Formatris Novolizer is and what it is used for<\/h2>\n\n\n\n<p>Formatris Novolizer belongs to a group of medicines called long-acting beta-agonists&nbsp;you or&nbsp;bronchodilators.&nbsp;The active substance in Formatris Novolizer has a&nbsp;dilating&nbsp;(relaxing and dilating) effect on the smooth muscles of the airways, increasing airflow and facilitating breathing.<br><\/p>\n\n\n\n<p>Formatris Novolizer is used as a regular adjunct to maintenance treatment with inhaled corticosteroids for&nbsp;asthma&nbsp;and, if necessary, to prevent exertional asthma symptoms such as wheezing, shortness of breath, and cough.&nbsp;The effect sets in within 1-3 minutes and lasts up to 12 hours.<br><\/p>\n\n\n\n<p>Formatris Novolizer is also used to relieve symptoms such as shortness of breath and cough in adults with&nbsp;chronic obstructive pulmonary disease&nbsp;(COPD).&nbsp;This is a&nbsp;chronic&nbsp;lung disease that is often caused by cigarette smoking.<br><\/p>\n\n\n\n<p>Formoterol fumarate dihydrate contained in Formatris Novolizer may also be approved for the treatment of other conditions not mentioned in this product information.&nbsp;Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before using Formatris Novolizer<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Formatris Novolizer<\/h2>\n\n\n\n<p>If you are allergic to formoterol or any of the other ingredients of this medicine (listed in section 6).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor or pharmacist before using Formatris Novolizer if you have:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>cardiovascular disease<\/li><li>diabetes<\/li><li>disturbed thyroid function<\/li><li>pheochromocytoma&nbsp;(a hormone-producing&nbsp;tumor&nbsp;in the adrenal medulla)<\/li><li>very high&nbsp;blood pressure<\/li><li>aneurysm&nbsp;(carotid artery hernia)<\/li><li>liver cirrhosis&nbsp;(severe liver disease)<\/li><li>low potassium in the blood<\/li><\/ul>\n\n\n\n<p>If you are not sure if any of the above conditions apply to you, talk to your doctor or pharmacist before using Formatris Novolizer.<br><\/p>\n\n\n\n<p>If you get tracheal cramps, stop treatment immediately and contact a doctor.<br><\/p>\n\n\n\n<p>In the event of an&nbsp;acute&nbsp;severe asthma attack, you should use short-acting asthma medication.<br><\/p>\n\n\n\n<p>If you have difficulty breathing or wheezing, continue to take Formatris Novolizer, but contact your doctor as soon as possible as you may need further treatment.&nbsp;When your&nbsp;asthma&nbsp;is under control, your doctor may decide to gradually reduce the&nbsp;dose&nbsp;of Formatris Novolizer.&nbsp;Do not&nbsp;increase the dose&nbsp;without talking to a doctor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children<\/h2>\n\n\n\n<p>Children under 6 years of age should not use Formatris Novolizer.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Formatris Novolizer<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<br><\/p>\n\n\n\n<p>The effect of Formatris Novolizer may be increased with concomitant use of medicines for:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>treatment of i.a.&nbsp;obstructive pulmonary disease, inflammatory diseases (&nbsp;cortisone&nbsp;)<\/li><li>treatment with&nbsp;diuretics&nbsp;for high&nbsp;blood pressure&nbsp;(&nbsp;diuretics&nbsp;) and cardiac glycosides for&nbsp;heart failure&nbsp;(&nbsp;digoxin&nbsp;), especially if the potassium level in the blood is already low<\/li><li>treatment of depression and mental conditions (&nbsp;tricyclic antidepressants,&nbsp;MAO inhibitors,&nbsp;and phenothiazines)<\/li><li>treatment of&nbsp;allergies&nbsp;is with&nbsp;antihistamines&nbsp;(eg terfenadine, astemizole, mizolastine)<\/li><li>treatment with certain types of&nbsp;antibiotics&nbsp;(erythromycin)<\/li><li>treatment with bronchodilator anticholinergics (eg ipratropium)<\/li><li>treatment of&nbsp;Parkinson&#8217;s disease&nbsp;(&nbsp;L-dopa&nbsp;)<\/li><li>treatment of reduced production of thyroid hormone (levothyroxine)<\/li><li>treatment with drugs for heart rate disorders (such as&nbsp;quinidine,&nbsp;disopyramide,&nbsp;procainamide&nbsp;)<\/li><li>treatment with xanthine-containing drugs (such as theophylline or aminophylline) used to treat&nbsp;asthma<\/li><li>treatment with other medicines that work in the same way as Formatris Novolizer, such as other beta-agonists&nbsp;(eg&nbsp;salbutamol&nbsp;)<\/li><li>treatment with&nbsp;ephedrine&nbsp;(used to treat&nbsp;asthma&nbsp;or as a decongestant of mucous membranes)<\/li><\/ul>\n\n\n\n<p>Also, tell your doctor or dentist that you are using Formatris Novolizer if you are going to receive anesthetics in connection with surgery or dental procedures.<br><\/p>\n\n\n\n<p>The effect of Formatris Novolizer can reduce the concomitant use of beta-blockers (such as atenolol and propranolol for high&nbsp;blood pressure&nbsp;), including&nbsp;eye drops&nbsp;(such as&nbsp;timolol&nbsp;against&nbsp;glaucoma&nbsp;).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Formatris Novolizer with alcohol<\/h2>\n\n\n\n<p>Concomitant use of alcohol can affect the risk of heart side effects.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>Experience of treatment during pregnancy is limited.<br><\/p>\n\n\n\n<p>It is not known if formoterol passes into breast milk.<br><\/p>\n\n\n\n<p>If you are pregnant or breast-feeding, 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<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Formatris Novolizer is unlikely to affect your ability to drive or use machines.&nbsp;However, some&nbsp;side effects, such as dizziness, can occur in very rare cases.<\/p>\n\n\n\n<p>You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention.&nbsp;One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or&nbsp;side effects.&nbsp;Descriptions of these effects and&nbsp;side effects&nbsp;can be found in other sections.&nbsp;Read all the information in this leaflet for guidance.&nbsp;If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Formatris Novolizer contains lactose<\/h2>\n\n\n\n<p>Formatris Novolizer contains&nbsp;lactose.&nbsp;If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.&nbsp;The amount of&nbsp;lactose&nbsp;in this medicine does not normally cause problems in people who are lactose intolerant.<\/p>\n\n\n\n<p>Lactose&nbsp;contains smaller amounts of milk protein which can cause allergic reactions.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use Formatris Novolizer<\/h2>\n\n\n\n<p>Always use this medicine exactly as your doctor has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<br><\/p>\n\n\n\n<p><strong>Dosage<\/strong><\/p>\n\n\n\n<p>Dose&nbsp;one is determined by the doctor, who adjusts it individually for you.<br><\/p>\n\n\n\n<p><strong>Asthma<\/strong><\/p>\n\n\n\n<p>Formatris Novolizer 12 micrograms\/dose can be used both as regular maintenance treatment with an inhaled corticosteroid and as a temporary preventative treatment for exercise-induced asthma.&nbsp;If you use Formatris Novolizer regularly as a maintenance treatment, you should continue to do so even if you do not feel any symptoms.<br><\/p>\n\n\n\n<p><strong><em><strong><em>The recommended&nbsp;dose<\/em><\/strong>&nbsp;for adults, from 18 years<\/em><\/strong><br><\/p>\n\n\n\n<p><em>Preventive maintenance medication<\/em><\/p>\n\n\n\n<p>1&nbsp;inhalation&nbsp;once or twice a day, in the morning and\/or at night.<br><\/p>\n\n\n\n<p><em>Extensive dosing<\/em><\/p>\n\n\n\n<p>In addition to the maintenance dose, additional&nbsp;inhalations can&nbsp;be taken to relieve the symptoms up to a total daily dose of 6&nbsp;inhalations&nbsp;per day (maintenance and, if necessary, dosing in total).&nbsp;You should not take more than a maximum of 3&nbsp;inhalations&nbsp;at the same time.<\/p>\n\n\n\n<p>If you need to inhale more than 2 times a day and\/or 2 days a week in addition to the maintenance dose, it may be a sign that your&nbsp;asthma&nbsp;is unstable.&nbsp;You should then contact your doctor.<br><\/p>\n\n\n\n<p><em>Prevention of exercise-induced asthma<\/em><\/p>\n\n\n\n<p>1&nbsp;inhalation&nbsp;before exertion.<br><\/p>\n\n\n\n<p><strong><em>The recommended&nbsp;dose&nbsp;for children and adolescents over 6 years<\/em><\/strong><br><\/p>\n\n\n\n<p><em>Preventive maintenance medication<\/em><\/p>\n\n\n\n<p>1&nbsp;inhalation&nbsp;once or twice a day, in the morning and\/or at night.<br><\/p>\n\n\n\n<p><em>Prevention of exercise-induced asthma<\/em><\/p>\n\n\n\n<p>1&nbsp;inhalation&nbsp;before exertion.<br><\/p>\n\n\n\n<p><strong>COPD (&nbsp;chronic obstructive pulmonary disease&nbsp;)<\/strong><br><\/p>\n\n\n\n<p><strong><em>The recommended&nbsp;dose&nbsp;for adults, from 18 years<\/em><\/strong><\/p>\n\n\n\n<p>The usual&nbsp;dose&nbsp;is 1&nbsp;inhalation&nbsp;in the morning and 1&nbsp;inhalation&nbsp;in the evening.&nbsp;Some patients may take the full daily dose at one time, ie.&nbsp;2&nbsp;inhalation&nbsp;is only in the morning.&nbsp;Your doctor will decide what is best for you.&nbsp;You should not take more than 2&nbsp;inhalations&nbsp;at the same time.&nbsp;The total&nbsp;dose&nbsp;should not exceed 2&nbsp;inhalations&nbsp;per day.&nbsp;In addition to your maintenance&nbsp;dose, your doctor may&nbsp;prescribe a&nbsp;dose&nbsp;if needed.<br><\/p>\n\n\n\n<p>Information on how to use the Novolizer inhaler can be found at the end of this leaflet.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use more Formatris Novolizer then you should<\/h2>\n\n\n\n<p>The most common symptoms that can be felt if you take too much&nbsp;dose&nbsp;are tremors, headaches, and palpitations.<\/p>\n\n\n\n<p>If you have ingested too much medicine or if e.g.&nbsp;If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you forget to use Formatris Novolizer<\/h2>\n\n\n\n<p>If you forget to take your&nbsp;dose&nbsp;at one time, take it as soon as you remember or wait until the next time.&nbsp;Do not take a double&nbsp;dose&nbsp;to make up for a forgotten&nbsp;dose.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you stop using Formatris Novolizer<\/h2>\n\n\n\n<p>Do not stop or end treatment or change the&nbsp;dose&nbsp;without consulting a doctor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">4. Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause&nbsp;side effects,&nbsp;although not everybody gets them.<br><\/p>\n\n\n\n<p><em>Common (may affect up to 1 in 10 people)<\/em>:&nbsp;Headache, tremors, and palpitations.<br><\/p>\n\n\n\n<p><em>Uncommon (may affect up to 1 in 100 people)<\/em>: Anxiety, restlessness, sleep disturbances, muscle cramps, increased heart rate.<br><\/p>\n\n\n\n<p><em>Rare (may affect up to 1 in 1,000 people<\/em>&nbsp;): Heartbeat changes,&nbsp;hypersensitivity reactions&nbsp;such as&nbsp;bronchospasm&nbsp;(spasm of the trachea), skin rash, hives (&nbsp;urticaria&nbsp;) and&nbsp;itching, nausea, decreased \/ elevated potassium levels in the blood.<br><\/p>\n\n\n\n<p><em>Very rare (may affect up to 1 in 10,000 people)<\/em>: Variations in&nbsp;blood pressure, taste changes, dizziness, angina (chest pain), high blood sugar, prolonged heart rate interval.&nbsp;Treatment with drugs such as Formatris Novolizer may result in elevated levels of&nbsp;insulin, free fatty acids,&nbsp;glycerol,&nbsp;and&nbsp;ketone bodies&nbsp;(a by-product of the breakdown of fatty acids) in the blood.<br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Formatris Novolizer<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<br><\/p>\n\n\n\n<p>Store in the box.&nbsp;Moisture sensitive.<\/p>\n\n\n\n<p><em>Broken packaging:<\/em>&nbsp;No special storage instructions.<br><\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the cartridge label and the outer carton after \u201cEXP\u201d or EXP.&nbsp;The expiration date is the last day of the specified month.<br><\/p>\n\n\n\n<p>The cassette must be replaced every 6 months.<br><\/p>\n\n\n\n<p>Drug residues may remain in the empty packages.&nbsp;Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required.&nbsp;These measures will help to protect the environment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">6. Contents of the packaging and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>The active substance is formoterol fumarate dihydrate.&nbsp;A measured&nbsp;dose&nbsp;contains 12 micrograms of formoterol fumarate dihydrate.&nbsp;Each&nbsp;dose&nbsp;delivered&nbsp;(the&nbsp;dose&nbsp;leaving the mouthpiece) from Formatris Novolizer contains 10.2 micrograms of formoterol fumarate dihydrate.<\/li><li>The other ingredient is&nbsp;lactose monohydrate&nbsp;(which contains small amounts of milk protein).<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p>1 powder inhaler and 1 cartridge with at least 60&nbsp;doses.<\/p>\n\n\n\n<p>1 powder inhaler and 3 cassettes with at least 60&nbsp;doses&nbsp;in each.<br><\/p>\n\n\n\n<p>Hospital packaging:<\/p>\n\n\n\n<p>10 x (1 powder inhaler and 1 cartridge with at least 60&nbsp;doses&nbsp;).<br><\/p>\n\n\n\n<p>Packaging for refilling:<\/p>\n\n\n\n<p>Pack of 1, 2, or 3 cassettes with at least 60&nbsp;doses&nbsp;in each.<br><\/p>\n\n\n\n<p>Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorisation Holder<\/h2>\n\n\n\n<p>Meda AB<\/p>\n\n\n\n<p>Box 906<\/p>\n\n\n\n<p>170 09 Solna<\/p>\n\n\n\n<p>Tel: 08-630 19 00<\/p>\n\n\n\n<p>Email: info@meda.se<br><\/p>\n","protected":false},"excerpt":{"rendered":"<p> 12 micrograms\/dose inhaled powder<br \/>\nformoterol fumarate dihydrate<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2206,2200],"tags":[2475,2482,2483,2481,2476,2479,2480,2477,2212,2328],"class_list":["post-9034","post","type-post","status-publish","format-standard","hentry","category-f","category-medicines","tag-formatris-novolizer","tag-formatris-novolizer-dose","tag-formatris-novolizer-side-effects","tag-formatris-novolizer-use","tag-formoterol-fumarate-dihydrate","tag-formoterol-fumarate-dihydrate-dose","tag-formoterol-fumarate-dihydrate-side-effects","tag-formoterol-fumarate-dihydrate-uses","tag-medicine","tag-powder"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9034","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=9034"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9034\/revisions"}],"predecessor-version":[{"id":9915,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/9034\/revisions\/9915"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=9034"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=9034"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=9034"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}