{"product_id":"brunistill-0-025-20-monodose-collirio-soluzione","title":"Brunistill 0.025% 20×single-dose eye drops solution","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eBRUNISTILL is indicated in the symptomatic treatment of seasonal allergic conjunctivitis.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eA single-dose container of 0.5 ml of solution contains: \u003cu\u003eActive ingredient\u003c\/u\u003e: Ketotifen: 125 micrograms (as hydrogen fumarate), equal to 250 micrograms\/ml. For the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eGlycerol (E422), Sodium Hydroxide, Purified water.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eHypersensitivity to the active substance ketotifen or to any of the excipients listed in section 6.1.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003eDosage\u003c\/u\u003e \u003ci\u003eAdults, elderly and children (over 3 years):\u003c\/i\u003e a drop of eye drops in the conjunctival sac twice a day. The contents of a single-dose container are sufficient for administration in both eyes. \u003cu\u003eMethod of administration\u003c\/u\u003e Contents and container remain sterile until the original closure is opened. To avoid the risk of contamination, do not touch any surface with the tip of the container.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eStore at a temperature not exceeding 25°C.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNo special precautions.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eIf you are using other medicines for ocular use, you should leave at least 5 minutes between one application and another. Oral administration of ketotifen may potentiate the effects of CNS depressants, antihistamines and alcohol. Although these phenomena have not been observed with BRUNISTILL, the possibility of such effects cannot be excluded.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eAdverse drug reactions from clinical trials (Table 1) are listed according to MedDRA classification. Within each systemic organ class, adverse drug reactions are classified by frequency with the most frequent first. Within each frequency grouping, reactions are presented in order of decreasing severity. The following side effects have been reported at the recommended dose: The frequency listed below is defined using the following convention: very common (≥ 1\/10), common (≥ 1\/100 to \u003c1\/10); uncommon (from ≥ 1\/1000 \u003c1\/100); rare (from ≥ 1\/10,000 to \u003c 1\/1,000); very rare (\u003c1\/10,000), not known (frequency cannot be estimated from the available data).\u003c\/p\u003e\n\u003cp\u003eEye disorders: - Adverse events: eye irritation, eye pain, punctate keratitis, punctate epithelial erosion. Frequency: Common.\u003c\/p\u003e\n\u003cp\u003eEye disorders: - Adverse events: blurred vision (during instillation), dry eye, eyelid disorders, conjunctivitis, photophobia, conjunctival hemorrhages. Frequency: Uncommon.\u003c\/p\u003e\n\u003cp\u003eNervous system disorders: - Adverse events: headache. Frequency: Uncommon.\u003c\/p\u003e\n\u003cp\u003eSystemic disorders and conditions relating to the administration site - Adverse events: drowsiness. Frequency: Uncommon.\u003c\/p\u003e\n\u003cp\u003eSkin and subcutaneous tissue disorders: - Adverse events: rash, eczema, urticaria. Frequency: Uncommon.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders: - Adverse events: dry mouth. Frequency: Uncommon.\u003c\/p\u003e\n\u003cp\u003eImmune system disorders: - Adverse events: hypersensitivity. Frequency: Uncommon.\u003c\/p\u003e\n\u003cp\u003e\u003ci\u003eAdverse drug reactions from post-marketing experience (frequency not known).\u003c\/i\u003e The following post-marketing events were also observed: hypersensitivity reactions including local allergic reactions (mostly contact dermatitis, eye swelling, eyelid pruritus and edema), systemic allergic reactions including facial swelling\/edema (in some cases associated with contact dermatitis) and exacerbation of pre-existing allergic conditions such as asthma and eczema. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit\/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it\/it\/responsabili\".\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNo cases of overdose have been found. Oral intake of the contents of a single-dose container would be equivalent to 0.1 mg of Ketotifen, equal to 5% of a recommended daily oral dose for a 3-year-old child. Clinical results indicated no serious signs or symptoms following ingestion of a dose of up to 20 mg of ketotifen.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cu\u003ePregnancy\u003c\/u\u003e No clinical data are available on the use of BRUNISTILL during pregnancy. Animal studies with toxic oral doses have shown an increase in pre- and postnatal mortality, but have not shown teratogenic effects. Systemic levels of ketotifen after ophthalmic application are much lower than those achieved after oral administration. However, caution should be used when prescribing the medicine to pregnant women. Breastfeeding Although data from consecutive animal studies following oral administration demonstrate the excretion of the active ingredient in breast milk, it is unlikely that topical administration in women can produce detectable quantities of active ingredient in breast milk. Mothers who use BRUNISTILL eye drops can therefore breastfeed. Fertility No data are available on the effect of ketotifen hydrogphen fumarate on fertility in humans.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eIf a patient has blurred vision or drowsiness, he or she should refrain from driving vehicles and using machinery.\u003c\/p\u003e","brand":"Bruschettini","offers":[{"title":"Default Title","offer_id":51730204688711,"sku":"037448026","price":14.25,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/bruschettini-srl-brunistill-0-025-20xmonodose-collirio-soluzione-farmacia-dottor-tili-1213791396.jpg?v=1767139150","url":"https:\/\/www.dottortili.com\/en-eu\/products\/brunistill-0-025-20-single-dose-hills-solution","provider":"Farmacia Dottor Tili","version":"1.0","type":"link"}