Lakrimont
SUMMARYOFPRODUCT CHARACTERISTICS
1 NAME OFTHE MEDICINALPRODUCT
Lakrimont 2mg/gEyeGel
2 QUALITATIVEANDQUANTITATIVE COMPOSITION
One grameyegelcontains2mgcarbomer 980.
Excipients with known effect
Cetrimide0.1mg/g.
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICALFORM
Eyegel.
Clearandcolourlessgel.
4 CLINICALPARTICULARS
4.1 Therapeuticindications
Symptomatictreatmentofdryeyesyndrome.
4.2 Posology andmethodofadministration
Forocularuse.
Adults (including the elderly)
1 dropinto theinferiorconjunctivalsacoftheaffectedeye(s),3-4 timesdailyorasrequired, dependingupon symptomsresolution. No dosage adjustment is necessary in the elderly (over 65 years).
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.
Method of administration
The container must be held vertically to ensure properly sized drops. The drops should be instilled into the lower conjunctival sac by gently pulling the lower eyelid down and looking up.
The tip of the container should not come into contact with any surface, including the eye due to the risk of contamination and eye injury.
Incaseofanyadditionallocaloculartreatment(e.g.glaucomatherapy)thereshouldbean applicationintervalofatleast15minutesbetweenthetwo medications. Lakrimont shouldalways bethelastmedicationinstilled.
4.3 Contraindications
Hypersensitivityto carbomerortoany oftheexcipients ofthisproduct.
4.4 Special warningsandprecautions foruse
Thewearingofcontactlensesisinadvisableduringtreatmentwith thisophthalmicgel.
If wearing contact lenses is unavoidable, the lenses should be removed prior to administration of the gel, and should not be reinserted until at least 30 minutes after administering the gel. ThepreservativeinLakrimont,cetrimide,maycauseeyeirritationand may discolour softcontactlenses.
Recap the tube after use.
Ifsymptomscontinueorworsen, thepatientshould bereviewed byan eyespecialist.
4.5 Interactionwithothermedicinalproducts andotherforms ofinteraction
There are no known interactions with Lakrimont.
Nointeraction studieshavebeen performed withLakrimont.
Lakrimont shouldalwaysbethelastmedicationinstilledsincethiseyegelmayprolong the ocularresidencetimeofothereyedrops
4.6 Fertility, Pregnancy andlactation
Pregnancy
No adequate preclinical studies with Lakrimont have been conducted, however no contra-indications are to be expected if the product is used as directed.
Breast-feeding
No adequate preclinical studies with Lakrimont have been conducted, however no contra-indications are to be expected if the product is used as directed.
Fertility
No adequate preclinical studies with Lakrimont have been conducted, however no contra-indications are to be expected if the product is used as directed.
Consideringthe negligiblesystemicpenetration ofcarbomerafterocularadministration, no effectduringpregnancyorlactation isexpected.Lakrimont can beusedduring pregnancyorlactation.
4.7 Effects on abilitytodriveandusemachines
Accordingto theproductviscosity, Lakrimont maycauseblurredvisionforafew minutesafterinstillation, which mayimpairtheabilityto driveorto usemachinery. The patientshould waituntilthissymptomhascleared beforedrivingorusingmachinery.
4.8 Undesirableeffects
Eye Disorders:
Very Common (≥1/10): Blurred vision, feeling of “sticky” eyelids
Common (≥1/100 to <1/10) Eye irritation (transient)
The frequency of the following adverse reactions are not known:
Immune system disorders: hypersensitivity
Eye Disorders: Eye pain, eye swelling, eye pruritus, eyelid oedema, ocular hyperaemia
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued 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:
[To be completed nationally]
4.9 Overdose
Nocaseofoverdosagehasbeenreportedwitheyegelsof0.2%carbomer980.
5 PHARMACOLOGICALPROPERTIES
5.1 Pharmacodynamicproperties
Pharmacotherapeuticgroup:Ophthalmologicals,artificialtears.ATC-code:S01XA20
Lakrimontisaliquidgelcontaining carbomer980,ahighmolecularweightpolymer. Thegelspreadsrapidlyovertheocularsurfaceandformsaformsatransparentfilm which lubricatesandtemporarilysupplementstheinsufficienttearfluid.
5.2 Pharmacokinetic properties
Theretention timeofthegelontheocularsurfaceisabout15 minutes. Cornealpenetrationis unlikelyduetothehigh molecularweightofcarbomer(4 mio D).
5.3 Preclinical safety data
Preclinical data based on studies of local tolerance after repeated administration reveal no special risk (see section 4.6)
Non-clinicaldatarevealnospecialhazardforhumans basedontheavailablestudiesofsafety pharmacology,acuteandchronictoxicity, genotoxicity, carcinogenicpotentialand toxicityto reproduction.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cetrimide Disodiumedetate Sorbitol
Sodiumhydroxide (forpHadjustment)
Waterforinjections.
6.2 Incompatibilities
In theabsenceofcompatibilitystudies,thismedicinalproductmustnotbemixedwith other medicinalproducts.
6.3 Shelf life
Beforefirstopening:3 years.
Afterfirstopening:Usewithin 28days.
6.4 Special precautions for storage
Storebelow25°C.
6.5 Nature and contents of container
PolyfoillaminatetubewithaHDPE cannulaand HDPE closurecontaining10ggel. Packsof1x 10gor3 x 10g.
Notallpacksizesmaybe marketed.
6.6 Special precautions fordisposal
Anyunused productorwastematerialshould bedisposedofinaccordancewithlocal requirements.
7 MARKETINGAUTHORISATIONHOLDER
Blumont Pharma Ltd. 23 Moortown Close
Grantham,
NG31 9GG
United Kingdom
8 MARKETINGAUTHORISATIONNUMBER(S)
[To be completed nationally]
9 DATE OFFIRSTAUTHORISATION/RENEWALOFTHE AUTHORISATION
[To be completed nationally]
10 DATE OFREVISIONOFTHETEXT
2016-04-21