23318002
`Whatisin this leaflet:
`Contact lens wearers
`If you have suffered or are
`2.WHATYOU NEED TO
`release the lowereyelid.
`Importantinformation about
`1.What MONOPOSTis and what
`If you use MONOPOST with other
`KNOW BEFORE YOU USE
`someofthe ingredients of
`If you wear contact lenses, you
`currently suffering fromaviral
`Monopost
`MONOPOST
`it is used for
`should remove them before
`.
`eye drops
`infection of the eye caused by
`| Wait at least 5 minutes between
`MONOPOSTcontains
`the herpes simplex virus (HSV).
`2.Whatyou need to know before
`using MONOPOST.After using
`50 micrograms/ml
`‘using MONOPOSTand using
`you use MONOPOST
`Children
`macrogolglycerol hydroxystearate
`MONOPOSTyoushould wait
`eye drops,
`3.How to use MONOPOST
`‘othereye drops.
`(derived from castoroil) which
`MONOPOST hasnot been
`15 minutes before putting your
`solution in single-dose container
`4,Possible side effects
`contact lenses backin.
`may causeskin reactions.
`:
`If you use more MONOPOST
`investigatedin children (below
`5.How to store MONOPOST
`Instructions for use
`,
`than you should
`18 years).
`3.HOW TO USE MONOPOST
`6.Contents of the pack and other
`‘If you put too many drops into
`Other medicines and
`The drops are supplied in
`information
`Usual dose
`‘your eye, you may have some
`MONOPOST
`single-dose units. Use the
`: minorirritation in your eye and
`* Always use MONOPOSTexactly
`solution from one single dose
`IHAT MONOPOS:
`MONOPOSTmayinteract with
`unit for administration to the
`
`
`your eyes maywater andturn red.
`as your doctorhastold you.
`ae ate)s3
`other medicines. Tell your doctor
`This should pass, butif you are
`
`affected eye(s) immediately after
`5.Pressa finger against the
`Check with your doctor or
`or pharmacist if you are using,
`worried talk to your doctor.
`comerofthe affected eye by the
`MONOPOSTbelongs to a
`pharmacistif you are notsure.
`opening the container. Since
`have recently used or might use
`nose. Hold for 1 minute whilst
`The usual dose for adults
`sterility cannot be maintained
`group of medicines known as
`Contact your doctor as soon
`any other medicines.
`keeping the eye closed.
`after opening, throw away the
`prostaglandins.It lowers the
`(including the elderly) is one
`as possible if you swallow
`Pregnancy and breast-feeding
`containerimmediately after using
`pressure within your eye by
`drop oncea dayin the affected
`MONOPOSTaccidentally.
`Do not use MONOPOSTwhen
`the solution. Open a new single-
`increasing the natural outflow of
`eye(s). The besttime to dothis
`
`you are pregnantor breast-
`dose unit each time you use
`fluid from inside the eye into the
`is in the evening.
`If you forget to use MONOPOST
`7}
`Do not use MONOPOSTmore
`MONOPOST.
`feeding.
`bloodstream.
`: Carry on with the usual dosage
`*
`at the usualtime. Do nottake a
`If you are pregnantor breast-
`Theseinstructionstell you how to
`MONOPOSTis usedto treat
`than once a day, because the
`: double dose to makeup for a
`feeding, think you may be
`effectivenessof the treatment
`use the drops:
`conditions known as open
`‘
`forgotten dose.If you are unsure
`pregnantorare planning to
`can be reducedif you
`1. Washyour handsandsit or
`angle glaucoma and ocular
`have a baby,ask your doctor or
`administerit more often.
`‘aboutanything talk to your doctor
`hypertension. Both of these
`stand comfortably.
`+ or pharmacist.
`pharmacistfor advice before using
`conditionsarelinked with an
`* Always use MONOPOSTexactly
`this medicine.
`2. Use yourfingerto gently pull
`asthis leaflet tells you or as
`‘
`Ifyou stop using MONOPOST
`increase in the pressure within
`down the lowereyelid of your
`* Talk to your doctorif you want to
`Driving and using machines
`your doctorhastold you, until
`youreye, eventually affecting your
`affected eye.
`stop using MONOPOST.
`When you use MONOPOSTyou
`yourdoctortells you to stop.
`6. Repeatin yourothereyeif your
`eye sight.
`3.Placethetip ofthe single-
`might have blurredvision,for a
`Check with your doctor, or
`If you have any further questions
`dose containerclose to, but not
`doctor has told you to dothis.
`short time.If this happensto you,
`pharmacist or nurse if you are
`onthe useof this medicine, ask
`7. Throw away the single-dose
`touching youreye.
`not sure.
`do notdrive or use anytools
`yourdoctor, or pharmacist or
`containerafter use. Do notkeepit
`4. Squeezethe single-dose
`nurse.
`or machines until yourvision
`to useit again.
`container gently so that only one
`becomesclear again.
`drop goesinto youreye, then
`
`
`
`Latanoprost Readallof this leaflet
`
`carefully before you start
`using this medicine because
`it contains important
`information for you.
`- Keepthisleaflet. You may
`needto readit again.
`If you have any further
`questions, ask your doctor, or
`pharmacist or nurse.
`This medicine has been
`prescribed for you only. Do
`Notpassit on to others. It
`may harm them, evenif their
`signsofillness are the same
`as yours.
`If you get anyside effects,talk
`to your doctor, or pharmacist
`or nurse. This includes any
`Possible side effects notlisted
`in this leaflet. See Section 4.
`
`©
`
`
`
`23315602
`
`AND
`
`MONOPOST Do not use MONOPOST
`
`* Ifyou areallergic
`(hypersensitive) to latanoprost
`or anyofthe otheringredients
`ofthis medicine (listed in
`section 6).
`+
`If you are pregnantortrying to
`becomepregnant.
`+
`If you are breast feeding.
`Warnings and precautions
`Talk to your doctor, or
`pharmacist or nurse before using
`MONOPOSTif you think any of
`thefollowing apply to you:
`If you are about to have or
`have had eye surgery (including
`cataract surgery).
`If you suffer from eye problems
`(such aseyepain,irritation or
`inflammation,blurred vision).
`If you know that you suffer from
`dry eyes.
`If you have severe asthma
`or your asthmais not well
`controlled.
`If you wearcontact lenses. You
`canstill use MONOPOST, but
`follow theinstruction for contact
`lens wearers in Section 3.
`
`000001
`
`Exhibit 1046
`Exhibit 1046
`ARGENTUM
`ARGENTUM
`IPR2017-01053
`IPR2017-01053
`
`000001
`
`

`

`6.CONTENTS OF THE
`PACK AND OTHER
`
`eile] What MONOPOSTcontains
`
`Theactive substance is
`latanoprost.
`1 mleye dropssolution contains
`50 microgramsoflatanoprost.
`The otheringredients are:
`macrogolglycerol hydroxystearate
`AO,sorbitol, carbomer 974P,
`macrogol 4000,disodium
`edetate, sodium hydroxide
`(for pH-adjustment), water for
`injections.
`What MONOPOSTlooks like
`and contentsof the pack
`This medicine is an eye drops,
`solution in a single-dose
`container. The solution looks
`slightly yellow and cloudy.It
`contains nopreservative,
`The single-dose containers are
`packed in a sachetof 5 units,
`eachsingle-dose container
`holding 0.2 mlof solution.
`A packsize contains 5 (1 sachet
`of 5), 10 (2 sachets of 5), 30 (6
`sachets of 5) or 90 (18 sachets
`of5) single-dose containers.
`Notall pack sizes may be
`available.
`
`Marketing Authorisation Holder
`and Manufacturer
`Marketing Authorisation Holder
`LABORATOIRES THEA
`12, RUE LOUIS BLERIOT
`63017 CLERMONT-FERRAND
`CEDEX 2
`FRANCE
`Manufacturer
`EXCELVISION
`27, RUE DE LA LOMBARDIERE
`ZI LA LOMBARDIERE
`07100 ANNONAY
`FRANCE
`This leaflet waslast revised in
`07/2014.
`
`23318002
`
`23315602
`
`N2345U30ASP/1014
`
`Othéa
`
`® H
`
`OW TO STORE
`MONOPOST
`Keep this medicine outof the
`sight and reachofchildren.
`Do notuse this medicine after
`the expiry date whichis stated on
`the carton, sachet and single-dose
`container. The expiry date refers
`to the last day of that month.
`Store below 25°C.
`Afterfirst opening of the sachet:
`use the single-dose containers
`within 7 days.
`After first opening of the single-
`dosecontainer, use immediately
`and throw awaythe single-dose
`containerafter use.
`Donot throw away any medicines
`via wastewater or household
`waste. Ask your pharmacist how
`to throw away medicines you no
`longer use. These measureswill
`help to protect the environment.
`
`Patients have also reported the
`following side-effects: fluid filled
`area within the coloured part
`ofthe eye(iris cyst), headache,
`dizziness, palpitations, muscle
`pain,joint pain and developing a
`viral infection of the eye caused
`by the herpes simplex virus
`(HSV).
`Reportingof side effects
`If you get anyside effects,talk
`to your doctor, or pharmacist or
`nurse. This includes any possible
`side effects notlisted in this
`leaflet.
`You can also report side effects
`directly via the Yellow Card
`Scheme.
`Website:
`www.mhra.gov.uk/yellowcard
`Byreporting side effects you can
`help provide more information on
`the safety of this medicine.
`
`4.POSSIBLE SIDE EFFECTS
`Like all medicines, this medicine
`can causeside effects, although
`not everybody gets them.
`Very common:mayaffect more
`than 1 in 10 people
`+ A gradual change in your eye
`colourbyincreasing the amount
`of brown pigmentin the
`coloured part of the eye known
`astheiris.
`-
`Ifyou have mixed-colour eyes
`(blue-brown,grey-brown,
`yellow-brown orgreen-
`brown)you are morelikely
`to see this change thanif
`you have eyesof one colour
`(blue, grey, green or brown
`eyes).
`Any changesin your eye
`colour may take years
`to developalthoughit
`is normally seen within
`8 monthsoftreatment.
`- The colour change may be
`permanent and may be
`morenoticeable if you use
`MONOPOSTin only oneeye.
`There appears to be no
`problemsassociated with the
`changein eye colour.
`
`- The eye colour change
`doesnot continue after
`MONOPOSTtreatmentis
`stopped.
`Rednessof the eye.
`+ Eyeirritation (a feeling of
`burning, grittiness, itching,
`stinging or the sensation of a
`foreign bodyin the eye).
`+ A gradual change to eyelashes
`ofthe treated eye and the
`fine hairs around the treated
`eye, seen mostly in people
`of Japaneseorigin. These
`changesinvolve an increase of
`the colour (darkening), length,
`thickness and numberof your
`eyelashes.
`Common:mayaffect up to 1
`in
`10 people
`*
`Irritation or disruption to the
`surface ofthe eye, eyelid
`inflammation (blepharitis) and
`eye pain.
`Uncommon:mayaffect up to 1
`in 100 people
`+ Eyelid swelling, dryness of the
`eye,inflammationorirritation
`of the surface of the eye
`(keratitis), blurred vision and
`conjunctivitis.
`Skin rash.
`
`Rare: mayaffect up to 1 in
`1,000 people
`Inflammationof theiris, the
`coloured part of the eye
`(iritis/uveitis), swelling of the
`retina (macular oedema),
`symptoms of swelling or
`scratching/damageto the
`surface of the eye, swelling
`aroundthe eye (periorbital
`oedema) misdirected
`eyelashes oran extra row of
`eyelashes, sensitivity to light
`(photophobia).
`Skin reactions on the eyelids,
`darkening of the skin of the
`eyelids.
`Asthma, worsening of asthma
`and shortness of breath
`(dyspnoea).
`Very rare: mayaffect up to 1 in
`10,000 people
`whoalso have heart disease.
`+ Worseningof angina in patients
`* Chestpain.
`+ Sunken eye appearance (eye
`sulcus deepening).
`
`000002
`
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`
`