Skip to Content

PROVASTOR 40 MICROGRAMS/ML EYE DROPS SOLUTION

Active substance(s): TRAVOPROST

View full screen / Print PDF » Download PDF ⇩
Transcript
Fond type: Times New Roman
Fond size: 9pt
Leaflet size: 135x450mm
date of revision: 10/6/2014
version: 4

802481

Package leaflet: Information for the user
Provastor 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 Provastor is and what it is used for
2. What you need to know before you use Provastor
3. How to use Provastor
4. Possible side effects
5. How to store Provastor
6. Contents of the pack and other information
1. What Provastor is and what it is used for
Provastor 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.
Provastor 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 Provastor
Do not use Provastor:
- 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 Provastor
- Use of Provastor is not recommended in those under 18 years of age. If this applies to you
ask your doctor for advice.
- Provastor may increase the length, thickness, colour and/or number of your eyelashes and may
cause unusual hair growth on your eyelids.
- Provastor may change the colour of your iris (the coloured part of your eye). This change may be
permanent.
- Provastor may rarely cause breathlessness or wheezing or increase the symptoms of asthma. If
you are concerned about changes in your breathing pattern when using Provastor advise your
doctor as soon as possible.
- Provastor 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
Provastor is not recommended in patients below the age of 18.
Other medicines and Provastor
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 Provastor 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 Provastor.
Breast feeding
Do not use Provastor if you are breast feeding, Provastor may get into your milk.
Driving and using machines
You may find that your vision is blurred for a time just after you use Provastor. Do not drive or
use machines until this has worn off.
Provastor 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 Provastor
Always use Provastor 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 Provastor for dropping in your eyes.
Instructions for use
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.

6. Place the tip of the bottle close toyour eye or eyelid, avoiding touching the tip of the dropper
bottle on the eye lids/surrounding area or ther 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 Provastor, press a finger into the corner of your eye by the nose for 2 minutes.

135x450mm
This helps to stop Provastor 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 Provastor has been added, and you have used the
full amount of Provastor that your doctor prescribed. Do not attempt to remove the excess
medicine from the bottle.
If you use more Provastor 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 Provastor
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 Provastor
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 Provastor 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, Provastor 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 Provastor without speaking to your doctor.
The following side effects have been reported from the use of the active substance of Provastor
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)
Effcts 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 effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Provastor
Keep this medicine out of the sight and reach of children.
Do not use Provastor 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 Provastor 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 Provastor looks like and contents of the pack
Provastor 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. Provastor is supplied
in a pack of 1 bottle or three bottles. Not all pack sizes may be marketed.
Marketing Authorisation Holder: Rafarm, 12 Korinthou, 154 51 Neo Psychiko, 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 06/2014
Other sources of information

Expand view ⇕

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.

Hide