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PROSTADROP 40 MICROGRAMS/ML EYE DROPS SOLUTION

Active substance(s): TRAVOPROST

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NEW PROPOSED PIL – CLEAN VERSION
Package leaflet: Information for the user
Travoprost Rafarm 40 micrograms/ml eye drops, solution
(Travoprost)
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).
What is in this leaflet:
1. What Travoprost Rafarm is and what it is used for
2. What you need to know before you use Travoprost Rafarm
3. How to use Travoprost Rafarm
4. Possible side effects
5. How to store Travoprost Rafarm
6. Contents of the pack and other information

1. What Travoprost Rafarm is and what it is used for
Travoprost Rafarm 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. betablockers, which also reduce pressure.
Travoprost Rafarm eye drops are used to treat high pressure in the eye in adults. This pressure can
lead to an illness called glaucoma.

2. What you need to know before you use Travoprost Rafarm
Do not use Travoprost Rafarm:
- If you are allergic to travoprost or any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Travoprost Rafarm
-

Use of Travoprost Rafarm is not recommended in those under 18 years of age. If this applies
to you ask your doctor for advice.
Travoprost Rafarm may increase the length, thickness, colour and/or number of your
eyelashes and may cause unusual hair growth on your eyelids.
Travoprost Rafarm may change the colour of your iris (the coloured part of your eye). This
change may be permanent.
Travoprost Rafarm 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
Rafarm advise your doctor as soon as possible.

-

Travoprost Rafarm 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 Rafarm is not recommended in patients below the age of 18.
Other medicines and Travoprost Rafarm
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 Rafarm 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 Rafarm.
Breast feeding
Do not use Travoprost Rafarm if you are breast feeding, Travoprost Rafarm 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 Rafarm. Do not drive
or use machines until this has worn off.
Travoprost Rafarm 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.

3. How to use Travoprost Rafarm
Always use Travoprost Rafarm exactly as your doctor has told you. 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 Travoprost Rafarm for dropping in your eyes.
Instructions for use
1.
2.
3.
4.
5.

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

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.

If a drop misses your eye, try again.
8. After using Travoprost Rafarm, press a finger into the corner of your eye by the nose for 2 minutes.
This helps to stop Travoprost Rafarm 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 Rafarm has been added, and you have used the full
amount of Travoprost Rafarm that your doctor prescribed. Do not attempt to remove the excess
medicine from the bottle.
If you use more Travoprost Rafarm 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 Rafarm
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 Rafarmwithout 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 Rafarm and the other drops.
If you have any further questions on the use of this product ask a doctor or pharmacist.

4. Possible side effects
Like all medicines, Travoprost Rafarm 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 Travoprost Rafarm without speaking to your doctor.
The following side effects have been reported from the use of the active substance of Travoprost
Rafarm in clinical trials or from the post-marketing experience:
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 1000)
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, 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.
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 national reporting system.
Medicines and Healthcare Products Regulatory AgencyAddress151 Buckingham Palace Road
SW1W 9SZ London
CountryUnited Kingdom
info@mhra.gsi.gov.uk
By reporting side affects you can help provide more information on the safety of this medicine.

5. How to store Travoprost Rafarm
Keep this medicine out of the sight and reach of children.

Do not use Travoprost Rafarm 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.
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 Rafarm 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 Rafarm looks like and contents of the pack
Travoprost Rafarm 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 Rafarm is
supplied in a pack of 1 bottle or three bottles. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
RAFARM S.A.,
12, Korinthou Str, 15451, Neo Psihico, Athens,
Greece

Manufacturer
Rafarm S.A.
Thesi Pousi-Hatzi Agiou Louka, Paiania-Attiki, TK 19002, P.O. 37, Greece
This leaflet was last revised in October 2016

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Further information

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