{"id":18474,"date":"2022-02-17T16:40:51","date_gmt":"2022-02-17T16:40:51","guid":{"rendered":"https:\/\/zeepedia.com\/?p=18474"},"modified":"2022-02-18T11:10:26","modified_gmt":"2022-02-18T11:10:26","slug":"mydriasert","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/mydriasert\/","title":{"rendered":"Mydriasert | Lamellar tropicamide and phenylephrine hydrochloride | uses, dose and side effects"},"content":{"rendered":"\n<p>0.28 mg \/ 5.4 mg&nbsp;eye<br>lamellar tropicamide and phenylephrine hydrochloride<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Mydriasert is and what it is used for<\/h2>\n\n\n\n<p>Mydriasert is an ophthalmic product, which means that it is only intended for the treatment of eyes.<\/p>\n\n\n\n<p><strong>Mydriasert may only be given by healthcare professionals.<\/strong><\/p>\n\n\n\n<p>Mydriasert will be placed under your lower eyelid by healthcare professionals.&nbsp;It is used to obtain&nbsp;mydriasis&nbsp;(dilation of the&nbsp;pupil&nbsp;one) before a surgical procedure or examination.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Mydriasert<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Mydriasert in the following cases:<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to tropicamide or phenylephrine hydrochloride or any of the other ingredients of this medicine (listed in section 6),<\/li><li>for patients with a blocked&nbsp;ventricular angle&nbsp;&#8211;&nbsp;glaucoma&nbsp;or who are at risk of sudden onset&nbsp;glaucoma&nbsp;(increase in ocular pressure),<\/li><li>for children under 12 years.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>As this medicine causes long-term visual disturbances, you must remember that someone must accompany you when you go to the doctor&#8217;s office (see Possible&nbsp;side effects&nbsp;).<\/li><li>if you feel discomfort after placing the lamella, inform your doctor: it is possible that the lamella has moved or, more rarely, is pushed out.<\/li><li>If you suffer from severely dry eyes, your doctor may drip saline into your eye to reduce the risk of eye irritation.<\/li><li>Tell your doctor if you suffer from high&nbsp;blood pressure&nbsp;, atherosclerosis (thickening of the artery wall), heart disease,&nbsp;hyperthyroidism&nbsp;(increased activity of the thyroid gland) or prostate problems.<\/li><li>in some people, mydriatics (products that dilate the&nbsp;pupil&nbsp;) can trigger an attack of&nbsp;acute&nbsp;glaucoma&nbsp;(due to a sudden increase in pressure in the eye).<\/li><li>The use of soft hydrophilic contact lenses is not recommended during treatment.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>Mydriasert should not be used in children under 12 years of age as children appear to be more susceptible to the risk of serious\u00a0side effects.<\/p>\n\n\n\n<p>Mydriasert is not recommended for use in children and adolescents aged 12 to 18 years due to a lack of adequate clinical experience.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Mydriasert<\/h2>\n\n\n\n<p>Tell your doctor if you are taking other medicines that dilate the\u00a0pupils\u00a0(mydriatics) besides Mydriasert so that your doctor knows the total amount of mydriatics you are receiving.<\/p>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.\u00a0Even if Mydriasert is used topically in the eye, such information can be important as different drugs can affect each other&#8217;s effects.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p>There are no data on the use of Mydriasert or its active substances in pregnant women.\u00a0Therefore, Mydriasert should be used during pregnancy only if needed.<\/p>\n\n\n\n<p>Use during breastfeeding is not recommended.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Do not drive or use machines as Mydriasert may cause severe visual disturbances for a few hours (blinded due to prolonged dilation of the&nbsp;pupil&nbsp;).<\/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 sharpened vigilance.\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<h2 class=\"wp-block-heading\">Mydriasert contains phenylephrine hydrochloride<\/h2>\n\n\n\n<p>Athletes should be warned that this medicine contains an active substance (phenylephrine hydrochloride) which may give positive results in tests used in doping control.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Mydriasert<\/h2>\n\n\n\n<p><strong>MAY ONLY BE GIVEN BY HEALTHCARE PROFESSIONALS.<\/strong><\/p>\n\n\n\n<p>Mydriasert is intended for use in adults.&nbsp;Mydriasert must not be swallowed.<\/p>\n\n\n\n<p>The care staff will place a lamella under the lower eyelid of the eye to be treated\/examined.\u00a0The staff will remove the lamella after the\u00a0pupil\u00a0has expanded sufficiently, before the operation or examination.\u00a0The lamella should not be left in the eye for more than 2 hours.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you use too much Mydriasert<\/h2>\n\n\n\n<p>As only one lamella will be placed in the eye of healthcare professionals, the risk of using a larger amount of Mydriasert than recommended is not likely.\u00a0However, if healthcare professionals need to use pupil dilating\u00a0eye drops\u00a0in addition to Mydriasert, there may be a risk of an overdose of the active substances in Mydriasert.<\/p>\n\n\n\n<p>Symptoms of an overdose of the active substances in Mydriasert may include extreme tiredness, sweating, dizziness, slow heartbeat,\u00a0coma, headache, rapid heartbeat,\u00a0dry mouth,\u00a0dry skin, unusual drowsiness, hemorrhage, and prolonged dilation of the\u00a0pupils.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n<p>Common: may affect up to 1 in 10 people:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>sveda,<\/li><li>dimsyn,<\/li><li>feeling uncomfortable due to feeling the lamella or that the lamella has moved.<\/li><\/ul>\n\n\n\n<p>Uncommon: may affect up to 1 in 100 people:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>tear flow,<\/li><li>irritation,<\/li><li>blinded due to prolonged dilation of&nbsp;pupil&nbsp;one,<\/li><li>inflammation&nbsp;of the cornea (superficial punctate keratitis).<\/li><\/ul>\n\n\n\n<p>Rare: may affect up to 1 in 1,000 people:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>allergic reactions:&nbsp;inflammation&nbsp;of the eyelids (&nbsp;blepharitis&nbsp;),&nbsp;inflammation&nbsp;of the conjunctiva (&nbsp;conjunctivitis&nbsp;).<\/li><\/ul>\n\n\n\n<p>Very rare: may affect up to 1 in 10,000 people:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>seizures.<\/li><\/ul>\n\n\n\n<p>A small wound on the surface of the eye (wound on the cornea) and\u00a0inflammation\u00a0in the surface of the eye (swelling of the cornea) have been observed when the lamella is inadvertently left in the eye.<\/p>\n\n\n\n<p>In some patients, Mydriasert may trigger an attack of\u00a0acute\u00a0glaucoma\u00a0(sudden increase in pressure in the eye): if abnormal symptoms occur after\u00a0administration\u00a0(\u00a0redness, pain, and visual disturbances), consult a physician immediately for advice.<\/p>\n\n\n\n<p>Although unlikely, the active substances in Mydriasert may cause the following&nbsp;side effects&nbsp;which need to be considered:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>increased&nbsp;blood pressure&nbsp;, palpitations,<\/li><li>very rare are serious events such as abnormal heart rhythm (&nbsp;cardiac arrhythmia&nbsp;),<\/li><li>tremors, pallor, headache,&nbsp;dry mouth&nbsp;.<\/li><\/ul>\n\n\n\n<p><strong>Additional&nbsp;side effects&nbsp;are in children<\/strong><\/p>\n\n\n\n<p>No known frequency (can not be calculated from the available data)<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>fluid or swelling in the lungs<\/li><li>pallor around the eyes of premature babies<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Mydriasert<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the sachet after EXP.<\/p>\n\n\n\n<p>Do not store above 25 \u00b0 C.<\/p>\n\n\n\n<p>Use immediately after opening the sachet.<\/p>\n\n\n\n<p>Do not use Mydriasert if you notice that the opening of the sachet or the lamella has been damaged.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contents of the pack 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 substances are tropicamide 0.28 mg and phenylephrine hydrochloride 5.4 mg for each eye lamella.<\/li><li>The other ingredients are ammonio methacrylate copolymer (type A), polyacrylate dispersion 30%, glycerol dibehenate and ethylcellulose.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and contents of the pack<\/h2>\n\n\n\n<p>Mydriasert is delivered in a\u00a0sachet.<\/p>\n\n\n\n<p>Mydriasert looks like an oblong, small tablet (4.3 mm x 2.3 mm).<\/p>\n\n\n\n<p>Each pack contains an additional bag of&nbsp;sterile&nbsp;disposable forceps used to place Mydriasert in the eye.<\/p>\n\n\n\n<p>Packaging: 1 slat and 1 tweezer, 10 slats and 10 tweezers, 20 slats and 20 tweezers, 50 slats and 50 tweezers or 100 slats and 100 tweezers.<\/p>\n\n\n\n<p>Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Laboratories THEA<\/p>\n\n\n\n<p>12, Rue Louis Bl\u00e9riot<\/p>\n\n\n\n<p>63017 Clermont-Ferrand Cedex 2<\/p>\n\n\n\n<p>France<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>BENAC<\/p>\n\n\n\n<p>27A, Avenue Paul Langevin<\/p>\n\n\n\n<p>17180 P\u00e9rigny<\/p>\n\n\n\n<p>France<\/p>\n\n\n\n<p><strong>This medicinal product has been authorized in the EEA Member States under the following names:<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>Austria, Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Holland, Portugal, Spain, Sweden, England<\/td><td>Mydriasert<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Mydriasert is an ophthalmic product, which means that it is only intended for the treatment of eyes.<\/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":[2200,15580],"tags":[18122,18125,18130,18133,18126,18129,18123,18131,18127,18124,18132,18128],"class_list":["post-18474","post","type-post","status-publish","format-standard","hentry","category-medicines","category-m","tag-mydriasert","tag-mydriasert-side-effects","tag-phenylephrine-hydrochloride","tag-phenylephrine-hydrochloride-side-effects","tag-tropicamide","tag-tropicamide-side-effects","tag-what-is-mydriasert","tag-what-is-phenylephrine-hydrochloride","tag-what-is-tropicamide","tag-what-mydriasert-is-used-for","tag-what-phenylephrine-hydrochloride-is-used-for","tag-what-tropicamide-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18474","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=18474"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18474\/revisions"}],"predecessor-version":[{"id":18500,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18474\/revisions\/18500"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=18474"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=18474"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=18474"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}