Monopost
`50 micrograms/ml
`eye drops,
`solution in single-dose container
`Latanoprost
`Read all of this leaflet
`carefully before you start
`using this medicine because
`it contains important
`information for you.
`, Keep this ieaflet. You may
`need to read it again.
`,
`If you have any further
`questions, ask your doctor, or
`pharmacist or nurse.
`- This medicine has been
`prescribed for you only. Do
`not pass it on to others. It
`may harm them, even if their
`signs of illness are the same
`as yours.
`If you get any side effects, taik
`to your doctor, or pharmacist
`or nurse. This includes any
`possible side effects not listed
`in this leaflet. See Section 4.
`
`
`
`
`
`-
`
`AND
`
`What is in this leaflet:
`1.What MONOPOST is and what
`it is used for
`2.What you need to know before
`you use MONOPOST
`3.How to use MONOPOST
`4.Possible side effects
`5.How to store MONOPOST
`6.Contenls of the pack and other
`information
`HAT MONOPOS
`
`
`USED FOR
`
`MONOPOST belongs to a
`group of medicines known as
`prostagiandins. it lowers the
`pressure within your eye by
`increasing the natural outflow of
`fluid from inside the eye into the
`bloodstream.
`MONOPOST is used to treat
`conditions known as open
`angie glaucoma and ocular
`hypertension. Both of these
`conditions are linked with an
`increase in the pressure within
`your eye, eventually affecting your
`eye sight.
`
`2.WHAT YOU NEED TO
`KNOW BEFORE YOU USE
`MONOPOST Do not use MONOPOST
`-
`If you are allergic
`(hypersensitive) to latanoprost
`or any of the other ingredients
`of this medicine (listed in
`section 6).
`-
`If you are pregnant or trying to
`become pregnant.
`-
`If you are breast feeding.
`Warnings and precautions
`Taik to your doctor, or
`pharmacist or nurse before using
`MONOPOST if you think any of
`the foiiowing apply to you:
`-
`If you are about to have or
`have had eye surgery (inciuding
`cataract surgery).
`If you suffer from eye problems
`(such as eye pain, irritation or
`inflammation, blurred vision).
`If you know that you suffer from
`dry eyes.
`If you have severe asthma
`or your asthma is not well
`controlled.
`If you wear contact lenses. You
`can stiii use MONOPOST, but
`foiiow the instruction for contact
`lens wearers in Section 3.
`
`-
`-
`
`-
`
`-
`
`©
`
`Important information about
`some of the ingredients of
`MONOPOST
`MONOPOST contains
`macrogolgiycerol hydroxystearate
`(derived from Castor oil) which
`may cause skin reactions.
`3.HOW TO USE MONOPOST
`Usual dose
`- Always use MONOPOST exactiy
`as your doctor has toid you.
`Check with your doctor or
`pharmacist if you are not sure.
`- The usual dose for adults
`(including the elderly) is one
`drop once a day in the affected
`eye(s). The best time to do this
`is in the wening.
`- Do not use MONOPOST more
`than once a day, because the
`effectiveness of the treatment
`can be reduced if you
`administer it more often.
`- Always use MONOPOST exactiy
`as this leaflet tells you or as
`your doctor has told you, until
`your doctor tells you to stop.
`Check with your doctor, or
`pharmacist or nurse if you are
`not sure.
`
`-
`
`If you have suffered or are
`currentiy suffering from a virai
`infection of the eye caused by
`the herpes simpia virus (HSV).
`Children
`MONOPOST has not been
`investigated in children (below
`18 years).
`other medicines and
`MONOPOST
`MONOPOST may interact with
`other medicines. Tell your doctor
`or pharmacist if you are using,
`have recently used or might use
`any other medicines.
`Pregnancy and breast-feeding
`Do not use MONOPOST when
`you are pregnant or breast-
`feeding.
`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 using
`this medicine.
`Driving and using machines
`When you use MONOPOST you
`might have blurred vision, for a
`short time. If this happens to you,
`do not drive or use any tools
`or machines until your vision
`becomes clear again.
`
`Contact lens wearers
`If you wear contact lenses, you
`should remove them before
`using MONOPOST. After using
`MONOPOST you should wait
`15 minutes before putting your
`contact ienses back in.
`Instructions for use
`The drops are supplied in
`singierdose units. Use the
`soiution from one single dose
`unit for administration to the
`affected eye(s) immediately after
`opening the container. Since
`sterility cannot be maintained
`after opening, throw away the
`container immediately after using
`the soiution, Open a new single-
`dose unit each time you use
`MONOPOST.
`These instructions tell you how to
`use the drops:
`1. Wash your hands and sit or
`stand comfortabiy.
`2. Use your finger to gently puil
`down the lower eyeiid of your
`affected eye.
`3. Place the tip of the single-
`dose container ciose to, but not
`touching your eye.
`4. Squeeze the single-dose
`container gentiy so that oniy one
`drop goes into your eye, then
`
`000001
`
`release the lower eyeiid.
`
`
`
`5. Press a finger against the
`comer of the affected eye by the
`nose. Hold for i minute whilst
`keeping the eye closed.
`
`
`
`23318002
`If you use MONOPOST with other
`.
`eye drops
`1 Wait at least 5 minutes between
`I using MONOPOST and using
`other eye drops.
`If you use more MONOPOST
`than you should
`;
`if you put too many drops into
`I
`1 your eye, you may have some
`minor irritation in your eye and
`your eyes may water and turn red.
`This should pass, but if you are
`worried taik to your doctor.
`Contact your doctor as soon
`as possible if you swaiiow
`MONOPOST accidentally.
`If you forget to use MONOPOST
`1 Carry on with the usual dosage
`at the usual time. Do not take a
`1
`I doubie dose to make up for a
`I
`forgotten dose. if you are unsure
`about anything talk to your doctor
`I or pharmacist.
`I
`If you stop using MONOPOST
`‘ Talk to your doctor if you want to
`stop using MONOPOST.
`6. Repeat in your other eye if your
`if you have any further questions
`doctor has toid you to do this.
`on the use of this medicine, ask
`7. Throw away the single-dose
`your doctor, or pharmacist or
`container after use. Do not keep it
`nurse.
`to use it again.
`
`23315602
`
`Exhibit 1046
`
`ARGENTUM
`
`Exhibit 1046
`ARGENTUM
`IPR2017-01053
`
`IPR2017-01053
`
`000001
`
`

`

`4 055 LE SIDE EFFECTS
`Like all medicines, this medicine
`can cause side effects, although
`not everybody gets them.
`Very common: may affect more
`than 1 in 10 people
`- A gradual change in your eye
`colour by increasing the amount
`of brown pigment in the
`coloured part of the eye known
`as the iris.
`,
`If you have mixedcolour eyes
`(bluebrown, greyrbrown,
`yellow-brown or green-
`brown) you are more likely
`to see this change than if
`you have eyes of one colour
`(blue, grey, green or brown
`eyes).
`- Any changes in your eye
`colour may take years
`to develop although it
`is normally seen within
`8 months of treatment.
`, The colour change may be
`permanent and may be
`more noticeable if you use
`MONOPOST in only one eye.
`- There appears to be no
`problems associated with the
`change in eye colourt
`
`- The eye colour change
`does not continue after
`MONOPOST treatment is
`stopped.
`- Redness of the eye.
`- Eye irritation (a feeling of
`burning, grittiness, itching,
`stinging or the sensation of a
`foreign body in the eye).
`- A gradual change to eyelashes
`of the treated eye and the
`fine hairs around the treated
`eye, seen mostly in people
`of Japanese origin. These
`changes involve an increase of
`the colour (darkening), length,
`thickness and number of your
`eye lashes.
`Common: may affect up to 1
`in
`10 people
`-
`Irritation or disruption to the
`surface of the eye, eyelid
`infiammao'on (blepharitis) and
`eye pain.
`Uncommon: may affect up to 1
`in 100 people
`- Eyelid swelling dryness of the
`eye, inflammation or irritation
`of the surface of the eye
`(keratitis), blurred vision and
`conjunctivitis.
`- Skin rash.
`
`Rare: may affect up to 1 in
`1,000 people
`- Inflammation of the iris, the
`coloured part of the eye
`(iritis/uveitis), swelling of the
`retina (macular oedema),
`symptoms of swelling or
`scratching/damage to the
`surface of the eye, swelling
`around the eye (periorbital
`oedema) misdirected
`eyelashes or an 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: may affect up to 1 in
`10,000 people
`- Worsening of angina in patients
`who also have heart disease.
`- Chest pain.
`- Sunken eye appearance (eye
`sulcus deepening).
`
`©>
`
`Patients have also reported the
`following side-effects: fluid filled
`area within the coloured part
`of the 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).
`Reporting of side effects
`If you get any side effects, talk
`to your doctor, or pharmacist or
`nurse. This includes any possible
`side effects not listed in this
`leaflet.
`You can also report side effects
`direaly via the Yellow Card
`Scheme.
`Website:
`ww.mhra.gov.uk/yellowcard
`By reporting side effects you can
`help provide more information on
`the safety of this medicine.
`
`HOW TO STORE
`MONOPOST
`Keep this medicine out of the
`sight and reach of children.
`Do not use this medicine after
`the expiry date which is stated on
`the carton, sachet and singledose
`container. The expiry date refers
`to the last day of that month.
`Store below 25°C.
`After first opening of the sachet:
`use the singiedose containers
`within 7 days.
`After first opening of the singie
`dose container, use immediately
`and throw away the single—dose
`container after use.
`Do not throw away any medicines
`via wastewater or household
`waste. Ask your pharmacist how
`to throw away medicines you no
`longer use. These measures will
`help to protect the environment.
`
`Marketing Authorisation Holder
`and Manufacturer
`Marketing Authorisation Holder
`LABORATOIRES THEA
`12, RUE LOUlS BLERIOT
`630W CLERMONT—FERRAND
`CEDEX 2
`FRANCE
`Manufacturer
`EXCELVlSlON
`27, RUE DE LA LOMBARDIERE
`Zl LA LOMBARDIERE
`07 i 00 ANNONAY
`FRANCE
`This leaflet was last revised in
`07/201 4.
`
`6.CONTENTS OF THE
`PACK AND OTHER
`INFORMATION What MONOPOST contains
`The active substance is
`latanoprost.
`1 ml eye drops solution contains
`50 micrograms of latanoprost.
`The other ingredients are:
`macrogolglycerol hydroxystearate
`40, sorbitol, carbomer 974P,
`macrogol 4000, disodium
`edetate, sodium hydroxide
`(for pH-adjustment), water for
`injections.
`What MONOPOSI' looks like
`and contents of the pack
`This medicine is an eye drops,
`solution in a single-dose
`container. The solution looks
`slightly yellow and cloudy It
`contains no preservative.
`The single-dose containers are
`packed in a sachet of 5 units,
`each singlerdose container
`holding 0.2 ml of solution.
`A pack size contains 5 (1 sachet
`of 5), i0 (2 sachets of 5), 30 (6
`sachets of 5) or 90 (18 sachets
`of 5) single-dose containers.
`Not all pack sizes may be
`available.
`
`Orhéa
`
`23318002
`
`23315602
`
`N2345usoAsP/ror4
`
`000002
`
`000002
`
`