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TRAVOPROST RAFARM 40 MICROGRAMS/ML EYE DROPS SOLUTION

Active substance(s): TRAVOPROST / TRAVOPROST

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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).

1. What Travoprost is and what it is used for

Uncommon side effects (Affects 1 to 10 users in 1000)

Travoprost 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.
Travoprost eye drops are used to treat high pressure in the eye in adults. This pressure can
lead to an illness called glaucoma.

Effects in the eye: inflammation or infection of the conjunctiva (conjunctivitis) or cornea,
halo vision, corneal disorder, allergy, tired eyes, increase in pupil size.

Warnings and precautions
Talk to your doctor or pharmacist before using Travoprost.
• Use of Travoprost is not recommended in those under 18 years of age. If this applies to
you ask your doctor for advice.
• Travoprost may increase the length, thickness, colour and/or number of your eyelashes
and may cause unusual hair growth on your eyelids.
• Travoprost may change the colour of your iris (the coloured part of your eye). This
change may be permanent.
• Travoprost may rarely cause breathlessness or wheezing or increase the symptoms of
asthma. If you are concerned about changes in your breathing pattern when using
Travoprost advise your doctor as soon as possible.
• 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.
Children and adolescents
Travoprost is not recommended in patients below the age of 18.
Other medicines and Travoprost
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
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.
Pregnancy
Do not use Travoprost 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 Travoprost.
Breast feeding
Do not use Travoprost if you are breast feeding, Travoprost may get into your milk.
Driving and using machines
You may find that your vision is blurred for a time just after you use Travoprost. Do not
drive or use machines until this has worn off.
Travoprost contains Benzalkonium chloride. It may cause eye irritation. Benzalkonium
chloride is known to discolour soft contact lenses. Avoid contact with soft contact lenses.
Remove contact lenses prior to application and wait at least 15 minutes before
reinsertion.

Additional side effects that have been reported include:
Effects in the eye: inflammation of the back of the eye, sunken eyes.
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.
Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme, Website: www.mhra.gov.uk/yellowcard
By reporting side affects you can help provide more information on the safety of this
medicine.

5. How to store Travoprost
Keep this medicine out of the sight and reach of children.
Do not use Travoprost 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. Keep the bottle in the
outer container.
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.
Do not throw away any medicines via wastewater or in household waste. Ask your
pharmacist how to throw away medicines no longer required. These measures will help
protect the environment.

6.Contents of the pack and other information
What Travoprost contains
• The active substance is travoprost 40 micrograms/ml.
• The other ingredients are: Benzalkonium chloride, Macrogol-15-Hydroxystearate,
Trometamol, Boric acid, EDTA disodium, Mannitol and Water for Injection. Tiny amounts
of hydrochloric acid or sodium hydroxide are added to adjust the pH.
What Travoprost looks like and contents of the pack
Travoprost is a liquid (a clear, colourless solution) in a 5 ml plastic dropper bottle with a
white screw cap and a tamper evident ring. Each bottle contains 2.5 ml solution.
Travoprost is supplied in a pack of 1 bottle or three bottles. Not all pack sizes may be
marketed.
Marketing Authorisation Holder:
Rafarm S.A., 12, Korinthou Str, 15451, Neo Psihico, Athens, Greece

3. How to use Travoprost

Manufacturer:
Rafarm S.A., Thesi Pousi-Hatzi Agiou Louka, Paiania-Attiki, TK 19002, P.O. 37, Greece

Always use Travoprost exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.

Distributor:
Creo Pharma Ltd, Felsted Business Centre, Felsted, Essex CM6 3LY, UK

The usual dose is 1 drop in the affected eye or eyes, once a day – in the evening.
Only use Travoprost for dropping in your eyes.

This leaflet was last revised in February 2017

Date
14/11/2016
05/12/2016
15/12/2016
18/01/2017
02/02/2017
03/02/2017
03/02/2017
03/02/2017
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Instructions for use

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1. Before using this medicine for the first time, make
sure the tamper evident ring is unbroken.
2. Wash your hands and sit or stand comfortably.
3. Unscrew the cap.
4. Remove the tamper evident ring from the bottle.
5. Use your finger to gently pull down the lower
eyelid of your affected eye.

14/11/2016
Creo Pharma
UK
CRE-TRV-PIL-255

6. Place the tip of the bottle close to your eye or
eyelid, avoiding touching the tip of the dropper
bottle on the eye lids/surrounding area or other
surfaces due to the risk of contamination and
resultant serious eye infection.
7. Squeeze the bottle gently so that only one drop
goes into your eye and then release the lower
eyelid.

Travoprost Eye Drops
40 mcg/ml
135 x 550 mm

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If a drop misses your eye, try again.

8. After using Travoprost, press a finger into the
corner of your eye by the nose for 2 minutes. This
helps to stop Travoprost getting into the rest of the
body.
9. Repeat in your other eye if your doctor has told you
to do this.
10. Put the cap back on the bottle.
The dispenser tip is designed to provide a single drop; do NOT enlarge the hole of the
dispenser tip.
After dispensing all doses, a small amount of the medicine will remain in the bottle. You
should not be concerned because an extra amount of Travoprost has been added, and
you have used the full amount of Travoprost that your doctor prescribed. Do not attempt
to remove the excess medicine from the bottle.
If you use more Travoprost 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 Travoprost
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 Travoprost
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 Travoprost and the other drops.
If you have any further questions on the use of this product ask a doctor or pharmacist.

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Do not use Travoprost:
• If you are allergic to travoprost or any of the other ingredients of this medicine (listed in
section 6).

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2. What you need to know before you use Travoprost

Effects in the body: asthma, shortness of breath, increased or decreased blood pressure,
irregular, increased, or decreased heart rate, dizziness, viral infection, cough, generalized
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.

1

What is in this leaflet:
1. What Travoprost is and what it is used for
2. What you need to know before you use Travoprost
3. How to use Travoprost
4. Possible side effects
5. How to store Travoprost
6. Contents of the pack and other information

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 Travoprost without speaking to
your doctor.
The following side effects have been reported from the use of the active substance of
Travoprost in clinical trials or from the post-marketing experience:

Important
Please ensure that the texts and layout are to
your satisfaction as the studio cannot accept
liability for any errors overlooked.
All Bar Codes and Braille text must be verified
by the client/manufacturer/printer. The studio is
unable to do this and cannot accept liability for
any errors.
Colours may not reproduce accurately on this
proof. You should refer to Pantone Reference
Guides for accurate colour match.

Read all of this leaflet carefully before you start using this medicine because it
contains important information for you
• 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 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 of the side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet (see section 4).

Like all medicines, Travoprost can cause side effects, although not everybody gets them.

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Travoprost 40 micrograms/ml eye drops, solution

4. Possible side effects

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Package leaflet: Information for the user

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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