Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Carbomer
Laboratoires Thea
S01XA; S01XA20
Carbomer
2.5 milligram(s)/gram
Eye gel
Product not subject to medical prescription
Other ophthalmologicals; artificial tears and other indifferent preparations
Marketed
2003-08-22
Turn over IN THIS LEAFLET: 1. What LIQUIVISC is and what it is used for 2. Before you use LIQUIVISC 3. How to use LIQUIVISC 4. Possible side effects 5. How to store LIQUIVISC 6. Further information 1. WHAT LIQUIVISC IS AND WHAT IT IS USED FOR LIQUIVISC is a substitute for tears and contains a lubricant called Carbomer 974P. It is an eye gel used for the relief of the SYMPTOMS OF DRY EYE (such as soreness, burning, irritation or dryness) caused by your eyes not producing enough Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you have to use any other eye medicine during treatment with LIQUIVISC: first use the other eye medicine, wait 15 minutes, then use LIQUIVISC. PREGNANCY AND BREAST-FEEDING If you are pregnant or breast-feeding, CONTACT your DOCTOR for advice BEFORE you start using LIQUIVISC. He/she will decide if you can use LIQUIVISC. tears. 2. BEFORE YOU USE LIQUIVISC DO NOT USE LIQUIVISC: • IF YOU ARE ALLERGIC (hypersensitive) to Carbomer or any of the other ingredients of LIQUIVISC listed in Section 6, “What LIQUIVISC contains”. TAKE SPECIAL CARE WITH LIQUIVISC: • IF YOU WEAR SOFT CONTACT LENSES: you must remove them before using LIQUIVISC eye gel. After using LIQUIVISC, wait at least 30 minutes before putting your lenses back DRIVING AND USING MACHINES Your sight may become blurred for a short time just after using LIQUIVISC. You should not drive or use machines until your sight is clear again. LIQUIVISC CONTAINS BENZALKONIUM CHLORIDE This medicine contains 0,0015 mg benzalkonium chloride in each drop which is equivalent to 0,06 mg/g. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 30 minutes afterwards. in. See also in Section 2, “LIQUIVISC CONTAINS BENZALKONIUM CHLORIDE”. • IF YOUR CONDITION WORSENS OR HAS NOT IMPROVED after having started treatm Прочитать полный документ
Health Products Regulatory Authority 06 May 2021 CRN00CCCG Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT LIQUIVISC 2.5 mg/g, eye gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Carbomer 974P 2.5 mg/g. Excipient with known effect: benzalkonium chloride (0.06 mg/g). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye gel Slightly yellow and opalescent gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of dry eye syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Ocular use. ADULTS (INCLUDING THE ELDERLY): Instil one drop of the gel into the inferior conjunctival cul-de-sac 1 to 4 times daily according to the degree of ocular trouble. CHILDREN AND ADOLESCENTS AGED TO 18 YEARS: The safety and efficacy of LIQUIVISC 2.5 mg/g eye gel in children and adolescents at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available. After instillation, the bottle should be stored vertically with the dropper downwards to facilitate the formation of drops when next used. Do not touch the eye with the dropper tip. Replace the cap after use. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the components of the product. Health Products Regulatory Authority 06 May 2021 CRN00CCCG Page 2 of 4 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This medicine contains 0.0015 mg benzalkonium chloride in each drop. Benzalkonium chloride is commonly used as a preservative in ophthalmic products and has been reported rarely to cause punctate keratopathy and/or ulcerative keratopathy. Benzalkonium chloride has also been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use. Contact lenses: Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Patients Прочитать полный документ