Lakrimont
Package leaflet: Information for the user
Lakrimont 2mg/gEYE GEL
Carbomer 980
Readallofthisleafletcarefullybeforeyoustartusingthismedicine because it contains important information for you
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you
- Keepthisleaflet.Youmayneedtoreaditagain.
- Ask your pharmacist if you need more information or advice
- Ifyou get any side effectstalk to yourdoctororpharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse after a few days
What is in this leaflet
1. What Lakrimontisandwhatitisusedfor
2. What you need to know beforeyouuseLakrimont
3. Howto useLakrimont
4. Possibleside effects
5. Howto storeLakrimont
6. Contents of the pack and otherinformation
1. What Lakrimont is and what it is used for
Lakrimontisaneyegelandeachtube contains 10gramsofthe medicine.Itisusedasasubstitutefor naturaltears(thatis,asartificialtears).Itisusedtotreataconditioncalled“dryeyes”wherethe tearsare notproduced in sufficientquantitiesorareofpoorquality. Thegelprotectsand lubricatesthesurfaceof youreye.
2. What you need to know before you useLakrimont
Do notuseLakrimont
- ifyouareallergic(hypersensitive)tocarbomeroranyofthe otheringredientsofLakrimont (seesection6)
Warnings and Precautions
Do notinjectorswallow
Wearing contact lenses is not recommended during treatment with this ophthalmic gel. If you cannot avoid wearing contact lenses, remove the lenses before using the gel, and wait at least 30 minutes before re-inserting them. You should do this because the preservative, cetrimide, can cause staining of soft contact lenses.
Replacethe capafteruse
Ifsymptomscontinueorworsen, thepatientshould bereviewedbyaneyespecialist
The preservative, cetrimide, can cause eye irritation
Children and adolescents aged to 18 years:
The safety and efficacy of Lakrimont in children and adolescents at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available
Other medicines and Lakrimont
Pleasetellyour doctororpharmacistifyouhaveanyothereyedisorderandareusingorhaverecentlyused anyothermedicinesforyoureyes, includingmedicinesobtained withoutaprescription.
Incaseyou useanyadditionallocaloculartreatmentthereshouldbe anapplicationintervalofatleast15 minutesbetweenthe twomedications.
Lakrimont alwaysshouldbe the lastmedicationinstilledsincethiseyegelmayprolongthe ocular residencetimeofothereyedrops
Pregnancy, breast-feeding and fertility
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. Consideringthenegligiblesystemic penetration ofcarbomerafterocularadministration, no effectduringpregnancyorlactation isexpected. Lakrimont can beused duringpregnancyorlactation.
Driving and using machines
Lakrimont maytemporarilybluryourvision dueto theviscosityofthecarbomer, so do notdriveor operatemachineryifyourvision becomesblurred immediatelyafteryou haveapplied thedrops. Waituntil your visionclears.
Lakrimont contain the preservative cetrimide, which can cause eye irritation and is known to discolour soft contact lenses. Lakrimont is not to be used while wearing contact lenses
3. How to useLakrimont
AlwaysuseLakrimont exactlythewayyourdoctororpharmacisthastold you. You should check with yourdoctororpharmacistifyou arenotsure.
Adultsand theelderly:Theusualdoseis1 drop in each eye3 or4 timesperdayorasrequired.
In case you use any additional local ocular treatment (e.g. glaucoma eye drops), there should be an
application interval of at least 15 minutes between the two medications. Lakrimont should
always be the last medication instilled.
Children and adolescents aged to 18 years:
The safety and efficacy of Lakrimont in children and adolescents at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available
Instructionsfor use
The tip of the container should not come into contact with any surface including the eye, as this may cause injury to the eye and contaminate the solution
Alwayswash yourhandsbeforeapplyingeyegel. Applyonedrop ofLakrimont ineachaffectedeye in thefollowingway:
1. Removethe cap
2. Tiltyourhead backwardsand hold thetubeverticallyaboveyoureyewith onehand, thedroppertip pointingdownwards
3. Gentlypulldown yourlowereyelid with theotherhand
4. Lookupwardsand insertonesmalldrop into thegap between thelowereyelid and theeye
5. Releasethe lowereyelid.Blinkafewtimestospreadthe gelevenlyoveryour eye
6. Wipe awayanyexcessgelfromaroundthe eyelids.
If symptoms persist or worsen, consult your eye specialist.
4. Possible side effects
LikeallmedicinesLakrimont cancauseunwantedeffects,althoughnot everybodygetsthem.
Very common side effects (affects more than 1 user in 10)
Ocular effects: blurred vision (temporary), sensation of “sticky” eyelids
Common side effects (affects more than 1 in 100 people)
Ocular effects: Eye irritation (transient)
Additional adverse reactions have been reported:
Effects on the immune system: hypersensitivity
Ocular effects: eye pain, eye swelling eye pruritus, eyelid oedema, ocular hyperaemia
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
[To be completed nationally]
5. How to storeLakrimont
Keep outofthesight and reach ofchildren
Do not use Lakrimont after the expiry date which is stated on the tube and on the carton after (EXP). The expiry date refers to the last day of that month.
Do not use the tube 28 days after first opening even if the tube is not empty
Store below 25°C
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
WhatLakrimont contains
The active substance is carbomer 980. 1 gram eye gel contains 2mg carbomer 980.
- Theotheringredients arecetrimide, sorbitol, disodiumedetate, sodiumhydroxideand waterfor injections.
WhatLakrimont lookslikeand contentsofthepack
Lakrimontisasterile,clearandcolourlesseyegelina laminatedplastictube containing10gramsof the eyegel.
Itisavailableinpacksof1tube or3tubes.Notallpacksizesmaybe marketed.
Marketing Authorisation Holderand Manufacturer
MarketingAuthorisationHolder:
Blumont Pharma Ltd
23 Moortown Close
Grantham, Lincs, NG31 9GG
United Kingdom
Manufacturer:
Excelvision
27 ruedelaLombardiere
07104 AnnonayCedex
France
Thismedicinalproductisauthorised in theMemberStatesoftheEEAunderthefollowingnames:
Sweden, Denmark, Norway:Lakrimont
Thisleafletwas lastrevised in 2015-11-23