ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRAVATAN 40 micrograms/ml eye drops, solution
2.
Each ml of solution contains 40 micrograms of travoprost.
Excipients
: each ml of solution contains polyquaternium-1 (POLYQUAD) 10 microgram, propylene
glycol 7.5 mg, polyoxyethylene hydrogenated castor oil 40 (HCO-40) 2 mg (see section 4.4.)
For a full list of excipients, see section 6.1.
3.
Eye drops, solution.
Clear, colourless solution.
4.
Decrease of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma
(see section 5.1).
Use in adults, including the elderly population
The dose is one drop of TRAVATAN in the conjunctival sac of the affected eye(s) once daily.
Optimal effect is obtained if the dose is administered in the evening.
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may
reduce the systemic absorption of medicinal products administered via the ocular route and result in a
decrease in systemic adverse reactions.
If more than one topical ophthalmic medicinal product is being used, the medicinal products must be
administered at least 5 minutes apart (see section 4.5).
If a dose is missed, treatment should be continued with the next dose as planned. The dose should not
exceed one drop in the affected eye(s) daily.
When substituting another ophthalmic antiglaucoma agent with TRAVATAN, the other agent should
be discontinued and TRAVATAN should be started the following day.
Paediatric population
The efficacy and safety of TRAVATAN in patients below the age of 18 years have not been
established and its use is not recommended in these patients until further data become available.
Hepatic and renal impairment
TRAVATAN has been studied in patients with mild to severe hepatic impairment and in patients with
mild to severe renal impairment (creatinine clearance as low as 14 ml/min). No dosage adjustment is
necessary in these patients.
2
Method of Administration
For ocular use.
The patient should remove the protective overwrap immediately prior to initial use. To prevent
contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding
areas or other surfaces with the dropper tip of the bottle.
Hypersensitivity to the active substance or to any of the excipients.
TRAVATAN may gradually change the eye colour by increasing the number of melanosomes
(pigment granules) in melanocytes. Before treatment is instituted, patients must be informed of the
possibility of a permanent change in eye colour. Unilateral treatment can result in permanent
heterochromia. The long term effects on the melanocytes and any consequences thereof are currently
unknown. The change in iris colour occurs slowly and may not be noticeable for months to years. The
change in eye colour has predominantly been seen in patients with mixed coloured irides, i.e.,
blue-brown, grey-brown, yellow-brown and green-brown; however, it has also been observed in
patients with brown eyes. Typically, the brown pigmentation around the pupil spreads concentrically
towards the periphery in affected eyes, but the entire iris or parts of it may be become more brownish.
After discontinuation of therapy, no further increase in brown iris pigment has been observed.
In controlled clinical trials, periorbital and/or eyelid skin darkening in association with the use of
TRAVATAN has been reported in 0.4% of patients.
TRAVATAN may gradually change eyelashes in the treated eye(s); these changes were observed in
about half of the patients in clinical trials and include: increased length, thickness, pigmentation,
and/or number of lashes. The mechanism of eyelash changes and their long term consequences are
currently unknown.
TRAVATAN has been shown to cause slight enlargement of the palpebral fissure in studies in the
monkey. However, this effect was not observed during the clinical trials and is considered to be
species specific.
There is no experience of TRAVATAN in inflammatory ocular conditions; nor in neovascular,
angle-closure, narrow-angle or congenital glaucoma and only limited experience in thyroid eye
disease, in open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative
glaucoma.
Caution is recommended when using Travatan in aphakic patients, pseudophakic patients with a torn
posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid
macular oedema.
Skin contact with TRAVATAN must be avoided as transdermal absorption of travoprost has been
demonstrated in rabbits.
TRAVATAN contains propylene glycol which may cause skin irritation.
TRAVATAN contains polyoxyethylene hydrogenated castor oil 40 which may cause skin reactions.
In patients with known predisposing risk factors for iritis/uveitis, TRAVATAN can be used with
caution.
3
Prostaglandins and prostaglandin analogues are biologically active materials that may be absorbed
through the skin. Women who are pregnant or attempting to become pregnant should exercise
appropriate precautions to avoid direct exposure to the contents of the bottle. In the unlikely event of
coming in contact with a substantial portion of the contents of the bottle, thoroughly cleanse the
exposed area immediately.
Patients must be instructed to remove contact lenses prior to application of TRAVATAN and wait
15 minutes after instillation of the dose before reinsertion.
No interaction studies have been performed.
Women of child-bearing potential/contraception
TRAVATAN must not be used in women of child bearing age/potential unless adequate contraceptive
measures are in place (see section 5.3).
Pregnancy
Travoprost has harmful pharmacological effects on pregnancy and/or the foetus/new-born child.
TRAVATAN should not be used during pregnancy unless clearly necessary.
Breastfeeding
It is unknown whether travoprost from eye drops is excreted in human breast milk. Animal studies
have shown excretion of travoprost and metabolites in breast milk. The use of TRAVATAN by
breast-feeding mothers is not recommended.
As with any eye drop, temporary blurred vision or other visual disturbances may affect the ability to
drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision
clears before driving or using machinery.
In clinical studies involving over 4400 patients, TRAVATAN (benzalkonium chloride
preserved) was administered once daily as monotherapy or adjunctive therapy to timolol 0.5%.
No serious ophthalmic or systemic undesirable effects related to the product were reported in
any of the clinical studies. The most frequently reported treatment-related undesirable effect
with TRAVATAN (benzalkonium chloride preserved) monotherapy was hyperaemia of the eye
(22.0%), which included ocular, conjunctival, or scleral hyperaemia. Hyperaemia was mild in
83.6% of those patients who experienced it. Almost all patients (98%) who experienced
hyperaemia did not discontinue therapy as a result of this event. In phase III clinical studies
ranging from 6 to 12 months in duration, hyperaemia decreased over time. In a post approval
long-term clinical study of 5 years duration involving 502 patients, TRAVATAN was
administered once daily. No serious ophthalmic or systemic undesirable effects related to
TRAVATAN were reported in the clinical study. The most frequently reported treatment-related
undesirable effect with TRAVATAN was iris hyperpigmentation (29.5%) (see section 4.4).
Hyperaemia of the eye assessed as related to the use of TRAVATAN was reported at an
incidence of 10.0% with 2% of patients reporting hyperemia of the eye discontinuing study
participation due to the undesirable effect.
4
The following undesirable effects were assessed to be treatment-related with TRAVATAN
(benzalkonium chloride-preserved) monotherapy and are classified according to the following
convention: very common (≥1/10), common (>1/100 to <1/10), uncommon
(>1/1,000 to ≤1/100), rare (>1/10,000 to ≤1/1000), or very rare (≤1/10,000). Within each
frequency grouping, undesirable effects are presented in decreasing order of seriousness.
TRAVATAN (benzalkonium chloride-preserved)
System Organ Classification
Frequency
Preferred Term
Infections and infestations
Uncommon
herpes simplex, keratitis herpetic
Immune system disorders
Uncommon
hypersensitivity, drug hypersensitivity, seasonal
allergy
Nervous system disorder
Common
headache
Uncommon
dysgeusia, dizziness, visual field defect
Eye disorders
Very common ocular hyperaemia, iris hyperpigmentation
Common
punctate keratitis, anterior chamber inflammation,
eye pain, photophobia, eye discharge, ocular
discomfort, visual acuity reduced, vision blurred,
dry eye, eye pruritus, lacrimation increased,
erythema of eyelid, eyelid oedema, growth of
eyelashes, eyelash discolouration
Uncommon
corneal erosion, uveitis, keratitis, eye inflammation,
photopsia, blepharitis, conjunctival oedema, halo vision,
conjunctivitis, conjunctival follicles, hypoaesthesia eye,
meibomianitis, ectropion, anterior chamber pigmentation,
mydriasis, cataract, eyelid margin crusting, asthenopia
Cardiac disorders
Uncommon
heart rate irregular, palpitations, heart rate
decreased
Vascular disorders
Uncommon
blood pressure decreased, blood pressure increased,
hypotension, hypertension
Respiratory, thoracic and
mediastinal disorders
Uncommon
dyspnoea, asthma, respiratory disorder,
oropharyngeal pain, cough, dysphonia, nasal
congestion, throat irritation
Gastrointestinal disorders
Uncommon
peptic ulcer reactivated, gastrointestinal disorder,
constipation
Skin and subcutaneous
tissue disorders
Common
skin hyperpigmentation (periocular)
Uncommon
dermatitis allergic, periorbital oedema, dermatitis
contact, erythema, rash, hair colour changes, hair
texture abnormal, hypertrichosis, madarosis
Musculoskeletal, connective
tissue and bone disorders
Uncommon
musculoskeletal pain
General disorders and
administrative site
conditions
Uncommon
asthenia, malaise
5
In 2 clinical trials involved in the development of TRAVATAN (polyquaternium-preserved),
201 patients were exposed for up to 3 months. No serious ophthalmic or systemic undesirable effects
related to the product were reported in either of the clinical trials. The most frequently reported
treatment-related undesirable effect with TRAVATAN (polyquaternium-preserved) was hyperaemia
of the eye (18.9%), which included ocular or conjunctival hyperaemia. One patient (0.5%)
discontinued study participation due to hyperemia of the eye.
The following undesirable effects were assessed to be treatment-related (with TRAVATAN
(polyquaternium-1-preserved) as monotherapy) and are classified according to the following
convention: very common (≥1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to ≤1/100), rare
(>1/10,000 to ≤1/1000), or very rare (≤1/10,000). Within each frequency grouping, undesirable
effects are presented in decreasing order of seriousness.
TRAVATAN (polyquaternium-1-preserved)
System Organ Classification Frequency
Adverse Reaction
Nervous system disorders
Uncommon
headache
Eye disorders
Very common
ocular hyperaemia
Common
punctate keratitis, eye pain, photophobia,
ocular discomfort, dry eye, eye pruritus.
Uncommon
visual acuity reduced, lacrimation increased,
erythema of eyelid, eyelid margin crusting
Gastrointestinal disorders
Uncommon
dry mouth
Skin and subcutaneous tissue
disorders
Common
skin hyperpigmentation, skin
discolouration
Adverse reactions identified from post-marketing experience that have not been reported
previously in clinical trials with TRAVATAN as monotherapy include the following.
Ocular: macular oedema (see also section 4.4)
Systemic: bradycardia, tachycardia, asthma aggravated, vertigo, tinnitus, PSA increased, hair
growth abnormal.
No cases of overdose have been reported. A topical overdose is not likely to occur or to be associated
with toxicity. A topical overdose of TRAVATAN may be flushed from the eye(s) with lukewarm
water. Treatment of a suspected oral ingestion is symptomatic and supportive.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Ophthalmologicals-antiglaucoma preparations and miotics-prostaglandin
analogues
ATC code: S01E E04
6
Mechanism of action
Travoprost, a prostaglandin F
2
analogue, is a highly selective full agonist which has a high affinity for
the prostaglandin FP receptor, and reduces the intraocular pressure by increasing the outflow of
aqueous humour via trabecular meshwork and uveoscleral pathways. Reduction of the intraocular
pressure in man starts about 2 hours after administration and maximum effect is reached after
12 hours. Significant lowering of intraocular pressure can be maintained for periods exceeding
24 hours with a single dose.
In a clinical trial, patients with open-angle glaucoma or ocular hypertension who were treated with
TRAVATAN (polyquaternium-preserved) dosed once-daily in the evening demonstrated 8 to 9 mmHg
reductions (approximately 33%) in intraocular pressure from 24 to 26 mmHg baseline. Data on
adjunctive administration of TRAVATAN with timolol 0.5% and limited data with brimonidine 0.2%
were collected during clinical trials that showed an additive effect of TRAVATAN with these
glaucoma medications. No clinical data are available on adjunctive use with other ocular hypotensive
medications.
Secondary pharmacology
Travoprost significantly increased optic nerve head blood flow in rabbits following 7 days of topical
ocular administration (1.4 micrograms, once-daily).
TRAVATAN preserved with polyquaternium-1 induced minimal ocular surface toxicity, compared to
eye drops preserved with benzalkonium chloride, on cultured human
corneal cells and following
topical ocular administration in rabbits.
5.2 Pharmacokinetic properties
Absorption
Travoprost is an ester prodrug. It is absorbed through the cornea where the isopropyl ester is
hydrolysed to the active free acid. Studies in rabbits have shown peak concentrations of 20 ng/g of the
free acid in aqueous humour one to two hours after topical dosing of TRAVATAN. Aqueous humour
concentrations declined with a half-life of approximately 1.5 hours.
Distribution
Following topical ocular administration of TRAVATAN to healthy volunteers, low systemic exposure
to active free acid was demonstrated. Peak active free acid plasma concentrations of 25 pg/ml or less
were observed between 10 and 30 minutes post-dose. Thereafter, plasma levels declined rapidly to
below the 10 pg/ml assay quantitation limit before 1 hour post-administration. Due to the low plasma
concentrations and rapid elimination following topical dosing, the elimination half-life of active free
acid in man could not be determined.
Biotransformation
Metabolism is the major route of elimination of both travoprost and the active free acid. The systemic
metabolic pathways parallel those of endogenous prostaglandin F
2
which are characterised by
reduction of the 13-14 double bond, oxidation of the 15-hydroxyl and -oxidative cleavages of the
upper side chain.
Elimination
Travoprost free acid and its metabolites are mainly excreted by the kidneys. TRAVATAN has been
studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal
impairment (creatinine clearance as low as 14 ml/min). No dosage adjustment is necessary in these
patients.
7
5.3
Preclinical safety data
In ocular toxicity studies in monkeys, administration of travoprost at a dose of 0.45 microgram, twice
a day, was shown to induce increased palpebral fissure. Topical ocular administration of travoprost to
monkeys at concentrations of up to 0.012% to the right eye, twice daily for one year resulted in no
systemic toxicity.
Reproduction toxicity studies have been undertaken in rat, mice and rabbit by systemic route. Findings
are related to FP receptor agonist activity in uterus with early embryolethality, post-implantation loss,
foetotoxicity. In pregnant rat, systemic administration of travoprost at doses more than 200 times the
clinical dose during the period of organogenesis resulted in an increased incidence of malformations.
Low levels of radioactivity were measured in amniotic fluid and foetal tissues of pregnant rats
administered
3
H-travoprost. Reproduction and development studies have demonstrated a potent effect
on foetal loss with a high rate observed in rats and mice (180 pg/ml and 30 pg/ml plasma,
respectively) at exposures 1.2 to 6 times the clinical exposure (up to 25 pg/ml).
6.
6.1 List of excipients
Polyquaternium-1
Polyoxyethylene hydrogenated castor oil 40 (HCO-40)
Boric acid (E284)
Mannitol (E421)
Sodium chloride
Propylene glycol (E1520)
Sodium hydroxide and/or hydrochloric acid (to adjust pH)
Purified water
6.2 Incompatibilities
None known.
Specific
in vitro
interaction studies were performed with TRAVATAN and medicinal products
containing thiomersal. No evidence of precipitation was observed.
6.3 Shelf life
2 years.
Discard 4 weeks after first opening.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
2.5 ml oval bottle with dispensing plug and screw cap, all polypropylene, presented in an overwrap.
Cartons containing 1 or 3 bottles.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
8
7.
Alcon Laboratories (UK) Ltd.
Boundary Way
Hemel Hempstead
Herts HP2 7UD
United Kingdom.
8.
EU/1/01/199/001-002
9.
Date of first authorisation :27.11.2001
Date of last renewal: 06.10.2006
Detailed information on this product is available on the website of the European Medicines Agency
http://www.ema.europa.eu
9
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDERS
RESPONSIBLE FOR BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
10
A. MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer responsible for batch release
S.A. Alcon-Couvreur N.V.,
Rijksweg 14,
B-2870 Puurs,
Belgium.
or
Alcon Cusí, S.A.,
Camil Fabra 58,
08320 El Masnou,
Barcelona,
Spain.
The printed package leaflet of the medicinal product must state the name and address of the
manufacturer responsible for the release of the concerned batch.
B. CONDITIONS OF THE MARKETING AUTHORISATION
Medicinal product subject to medical prescription
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not Applicable
OTHER CONDITIONS
Risk Management Plan
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in
the Pharmacovigilance Plan, as agreed in version 3.0 (dated 15 October 2010) of the Risk
Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and
any subsequent updates of the RMP agreed by the CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any
updated RMP should be submitted at the same time as the following Periodic Safety Update Report
(PSUR).
In addition, an updated RMP should be submitted
•
When new information is received that may impact on the current Safety Specification,
Pharmacovigilance Plan or risk minimisation activities
•
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
reachedAt the request of the European Medicines Agency
PSURs
The MAH will submit PSURs on a yearly basis until otherwise agreed by the CHMP
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A. LABELLING
13
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON FOR SINGLE BOTTLE 2.5 ml + CARTON FOR 3x2.5 ml BOTTLES
1.
TRAVATAN 40 micrograms/ml eye drops, solution
travoprost
2.
STATEMENT OF ACTIVE SUBSTANCE
1 ml of solution contains 40 micrograms of travoprost
3.
LIST OF EXCIPIENTS
Polyquaternium-1, polyoxyethylene hydrogenated castor oil 40 (HCO-40), boric acid, mannitol,
sodium chloride, propylene glycol, sodium hydroxide and/or hydrochloric acid (to adjust pH) and
purified water.
See the package leaflet for further details.
4.
Eye drops, solution
1 x 2.5 ml
3 x 2.5 ml
5.
METHOD AND ROUTE OF ADMINISTRATION
Ocular use. Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
Exp:
Discard 4 weeks after first opening.
Opened:
Opened (1):
Opened (2)
Opened (3)
14
9.
SPECIAL STORAGE CONDITIONS
10 SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Alcon Laboratories (UK) Ltd.
Boundary Way
Hemel Hempstead
Herts, HP2 7UD
United Kingdom.
12. MARKETING AUTHORISATION NUMBERS
EU/1/01/199/001 1 x 2.5 ml
EU/1/01/199/002 3x 2.5 ml
13. BATCH NUMBER
Lot:
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription
15. INSTRUCTIONS ON USE
16
INFORMATION IN BRAILLE
Travatan
15
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
BOTTLE LABEL
1.
TRAVATAN 40 micrograms/ml eye drops,.
travoprost
2.
METHOD OF ADMINISTRATION
Read the package leaflet before use.
<Open here>
3.
EXPIRY DATE
Exp:
Discard 4 weeks after first opening.
Opened:
4.
BATCH NUMBER
Lot:
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
2.5 ml
6.
OTHER
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
OVERWRAP
1.
TRAVATAN 40 micrograms/ml eye drops, solution.
travoprost
2.
METHOD OF ADMINISTRATION
Read the package leaflet before use.
3.
EXPIRY DATE
Exp:
Discard 4 weeks after first opening
4.
BATCH NUMBER
Lot:
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
2.5 ml
6. OTHER
17
B. PACKAGE LEAFLET
18
PACKAGE LEAFLET : INFORMATION FOR THE USER
TRAVATAN 40 micrograms/ml eye drops, solution
Travoprost
Read all of this leaflet carefully
before you start using this medicine.
Keep this leaflet.
You may need to read it again. If you have any further questions after reading it,
please ask your doctor or your pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet
1 What TRAVATAN is and what it is used for
2. Before you use TRAVATAN
3. How to use TRAVATAN
4. Possible side effects
5. How to store TRAVATAN
6. Further information
1. WHAT TRAVATAN
IS AND WHAT IT IS USED FOR
TRAVATAN
contains travoprost,
one of a group of medicines called
prostaglandin analogues
. It
works by reducing the pressure in the eye. It may be used on its own or with other drops e.g.
beta-blockers, which also reduce pressure.
TRAVATAN eye drops are used to treat high pressure in the eye.
This pressure can lead to an
illness called
glaucoma.
2. BEFORE YOU USE TRAVATAN
Do not use TRAVATAN
If you are allergic
to travoprost or any of the other ingredients of TRAVATAN.
Ask your doctor for advice if this applies to you.
Take special care with TRAVATAN
Use of TRAVATAN is not recommended
in those
under 18
years of age. If this applies to
you ask your doctor for advice.
TRAVATAN may increase
the length, thickness, colour and/or number of your
eyelashes
and
may cause unusual hair growth on your eyelids.
TRAVATAN
may
change the colour of your iris
(the coloured part of your eye). This change
may be permanent.
TRAVATAN
may rarely cause
breathlessness
or
wheezing
or increase the symptoms of
asthma
. If you are concerned about changes in your breathing pattern when using TRAVATAN
advise your doctor as soon as possible.
19
Travoprost
may be
absorbed through the skin.
If any
of the product comes into
contact with
the skin,
it should be
washed off
straight away. This is especially important in women who are
pregnant or are attempting to become pregnant.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Pregnancy and breast feeding
Do not use TRAVATAN if you are pregnant.
If you think that you may be pregnant speak with your
doctor right away.
If you could become pregnant you must use adequate contraception whilst you use
TRAVATAN.
Do not use TRAVATAN if you are breast feeding,
TRAVATAN may get into your milk.
Ask your doctor for advice before taking any medicine
Driving and using machines
You may find that your vision is blurred for a time just after you use TRAVATAN. Do not drive or
use machines until this has worn off.
Important information about some of the ingredients
TRAVATAN contains
hydrogenated castor oil
and
propylene glycol
which may cause skin
reactions and irritation.
3. HOW TO USE TRAVATAN
Always use TRAVATAN exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
The usual dose is
1 drop in the affected eye or eyes, once a day
-in the evening.
Only use TRAVATAN in both eyes if your doctor told you to. Use it for as long as your doctor told
you to.
Only
use TRAVATAN for dropping in your eyes.
1
2
3
4
Immediately before using a bottle for the first time, tear open the overwrap pouch, take the
bottle out (
picture 1
) and write the date of opening on the label in the space provided
Wash your hands
Twist off the cap
Hold the bottle, pointing down, between your thumb and fingers
Tilt your head back. Pull down your eyelid with a clean finger, until there is a ‘pocket’ between
the eyelid and your eye. The drop will go in here (
picture 2
)
20
Bring the bottle tip close to the eye. Use a mirror if it helps
Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
It
could infect the drops
Gently squeeze the bottle to release one drop of TRAVATAN at a time. (
picture 3
)
After using TRAVATAN,
press a finger into the corner of your eye
, by the nose (
picture 4
).
This helps to stop TRAVATAN getting into the rest of the body
If you take drops in both eyes, repeat the steps for your other eye
Close the bottle cap firmly immediately after use
If a drop misses your eye
, try again.
Only use one bottle at a time
. Do not open the pouch until you need to use the bottle.
If you use more TRAVATAN than you should,
rinse it all out with warm water. Don’t put in any
more drops until it’s time for your next regular dose.
If you forget to use TRAVATAN,
continue with the next dose as planned.
Do not
use a double dose
to make up. Never use more than one drop in the affected eye(s) in a single day.
If you stop using TRAVATAN
without speaking to your doctor, the pressure in your eye will not be
controlled which could lead to loss of sight.
If you wear soft contact lenses.
Do not use the drops with your lenses in. After using the drops wait
15 minutes before putting your lenses back in.
If you are using other eye drops,
leave at least 5 minutes between putting in TRAVATAN and the
other drops.
If you have any further questions on the use of this product ask a doctor or pharmacist.
Now turn over
4.
POSSIBLE SIDE EFFECTS
Like all medicines, TRAVATAN can cause side effects although not everybody gets them
.
You can usually carry on using the drops
, unless the effects are serious. If you’re worried, talk to a
doctor or pharmacist. Do not stop taking TRAVATAN without speaking to your doctor.
Very common side effects
(Affects more than 1 user in 10)
Effects in the eye:
Redness , changes in the colour of the iris (coloured part of the eye)
Common side effects
(Affects 1 to 10 users in 100)
Effects in the eye
: inflammation inside the eye, pain or swelling, irritation, discharge, sensitivity to
light, blurred, reduced or abnormal vision, dryness, itching, increased tear production, abnormal or
decreased sensation; irritation, itching, redness, pain, swelling or crusting of the eyelid; discolouration
of the eyelashes, increased or decreased growth or number of eyelashes.
Effects in the body
: headache, darkening of skin around the eye(s).
Uncommon side effects
(Affects 1 to 10 users in 1,000)
21
Effects in the eye
: inflammation or infection of the conjunctiva (conjunctivitis) or cornea, halo vision,
corneal disorder, allergy, tired eyes, increase in pupil size.
Effects in the body
: asthma, shortness of breath, increased or decreased blood pressure, irregular,
increased, or decreased heart rate, dizziness, viral infection, cough, generalised weakness, increased
allergic symptoms, throat irritation, stuffy nose, voice changes, gastrointestinal discomfort or ulcer,
dry mouth, constipation, redness or itching of the skin, shoulder pain, bad taste.
Additional side effects that have been reported include:
Effects in the eye:
inflammation of the back of the eye.
Effects in the body:
worsening of asthma, ringing in ears, increased prostate antigen.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5. HOW TO STORE TRAVATAN
Keep out
of the reach and sight of children.
Do not use TRAVATAN after the expiry date which is stated on the bottle and the box after ‘Exp’.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
You must throw away the bottle 4 weeks after you first opened it,
to prevent infections, and use a
new bottle. Write down the date you opened it in the space on each bottle label and box.
Medicines should not be disposed of via wastewater or in household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help protect the environment.
6.
FURTHER INFORMATION
What TRAVATAN contains
The active substance
is travoprost 40 micrograms/ml.
The other ingredients are:
Polyquaternium-1, polyoxyethylene hydrogenated castor oil 40 , propylene
glycol, sodium chloride, boric acid, mannitol and purified water.Tiny amounts of hydrochloric acid or
sodium hydroxide are added to keep acidity levels (pH levels) normal.
What TRAVATAN looks like and the contents of the pack
TRAVATAN is a liquid (a clear, colourless solution) supplied in a pack containing a 2.5 ml plastic
bottle with a screw cap or in a pack containing three 2.5 ml plastic bottles with screw caps. Each
bottle is placed in a pouch. Not all pack sizes may be marketed.
The marketing authorisation holder Manufacturer
S.A. Alcon-Couvreur N.V
Alcon Cusí, S.A
Boundary Way
Rijksweg 14
Camil Fabra 58
Hemel Hempstead
B-2870 Puurs
08320 El Masnou
Herts HP2 7UD
Belgium
Spain
United Kingdom.
22
Alcon Laboratories (UK) Ltd.
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder.
België/Belgique/Belgien
Luxembourg/Luxemburg
SA Alcon-Couvreur NV
+ 32 (0)3 890 27 11 (België/Belgique/Belgien)
Lietuva
Alcon Pharmaceuticals Ltd. atstovybė
+ 370 5 2 314 756
България
Алкон България ЕООД
+ 359 2 950 15 65
Magyarország
Alcon Hungária Gyógyszerkereskedelmi Kft.
+ 36-1-463-9080
Česká republika
Alcon Pharmaceuticals (Czech Republic) s.r.o
.
+ 420 225 377 333
Nederland
Alcon Nederland BV
+ 31 (0) 183 654321
Danmark
Alcon Danmark A/S
+ 45 3636 3434
Norge
Alcon Norge AS
+ 47 23 25 25 50
Deutschland
Alcon Pharma GmbH
+ 49 (0)761 1304-0
Österreich
Alcon Ophthalmika GmbH
+ 43 (0)1 596 69 70
Ελλάδα
Κύπρος
Άλκον Λαμποράτορις Ελλάς ΑΕΒΕ
+ 30 210 68 78 300 (Ελλάδα)
Polska
Alcon Polska Sp. z o.o.
+ 48 22 820 3450
Eesti
Alcon Eesti
+ 372 6 313 214
Portugal
Alcon Portugal – Produtos e Equipamentos
Oftalmológicos, Lda.
+ 351 214 400 300
España
Alcon Cusí, S.A.
+ 34 93 497 7000
România
S.C. Alcon Romania S.R.L.
: + 40 21 203 93 24
France
Laboratoires Alcon
+ 33 (0)1 47 10 47 10
Slovenija
Alcon d.o.o.
+ 386 1 422 5280
Ireland
Malta
United Kingdom
Alcon Laboratories (UK) Ltd.
+ 44 (0) 1442 34 1234 (United Kingdom)
Slovenská republika
Alcon Pharmaceuticals Ltd – oz
+ 421 2 5441 0378
Ísland
Alcon Danmark A/S
+ 45 3636 3434
Suomi/Finland
Alcon Finland Oy
+358 207 871 600
23
Italia
Alcon Italia S.p.A.
+ 39 02 81803.1
Sverige
Alcon Sverige AB
+ 46 (0)8 634 40 00
E-post: receptionen@alconlabs.com
Latvija
Alcon Pharmaceuticals Ltd
+ 371 7 321 121
This leaflet was last approved in
Detailed information on this product is available on the website of the European Medicines Agency
http://www.ema.europa.eu
24
Source: European Medicines Agency
- Please bookmark this page (add it to your favorites).
- If you wish to link to this page, you can do so by referring to the URL address below this line.
https://theodora.com/drugs/eu/travatan.html
Copyright © 1995-2021 ITA all rights reserved.