Travoprost Rafarm 40 micrograms/ml eye drops solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Travoprost Rafarm 40 micrograms/ml eye drops solution

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to others, even if they have the same symptoms as you, since it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Travoprost Rafarm is and what it is used for.
2. What you need to know before using 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, which belongs to a group of medicines called prostaglandin analogues. It works by reducing pressure in the eye. It can be used alone or in combination with other eye drops, for example beta-blockers, which also reduce pressure in the eye.

Travoprost Rafarm is used to reduce elevated pressure in the eye in adults. This pressure may lead to a condition called glaucoma.

2. What you need to know before using Travoprost Rafarm

Do not use Travoprost Rafarm

• if you are allergic to travoprost or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

This medicine may:

• increase the length, thickness, color, and/or number of your eyelashes and may cause unusual eyelash hair growth on your eyelids.
• change the color of the iris (the colored part of the eye). This change may be permanent.
• rarely cause shortness of breath, noisy breathing, or worsen asthma symptoms. If you are concerned about changes in your breathing while using this medicine, consult your doctor as soon as possible.
• be absorbed through the skin, and therefore, should not be used in pregnant women or women trying to become pregnant.

If the product comes into contact with the skin, it should be removed immediately by washing.

Children and adolescents

Travoprost Rafarm must not be used in children and adolescents under 18 years of age.

Using Travoprost Rafarm with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

Do not use Travoprost Rafarm if you are pregnant. If you think you may be pregnant, tell your doctor immediately. If you are able to become pregnant, you should use an appropriate method of contraception while using this medicine.

Do not use Travoprost Rafarm if you are breastfeeding. This medicine may pass into breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

You may experience blurred vision immediately after applying this medicine. Do not drive or operate machinery until this effect has worn off.

Travoprost Rafarm contains benzalkonium chloride

This medicine may cause eye irritation because it contains benzalkonium chloride.

Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them. This medicine may discolor soft contact lenses.

Travoprost Rafarm contains macrogol-15-hydroxystearate

This medicine may cause skin reactions because it contains macrogol-15-hydroxystearate.

3. How to use Travoprost Rafarm

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults: 1 drop in the affected eye(s) once daily in the evening. Travoprost Rafarm should only be applied to both eyes if your doctor has specifically instructed you to do so. Continue treatment for the entire duration prescribed by your doctor.

Travoprost Rafarm is for ophthalmic use only (eye drops).

• Immediately before using a bottle for the first time, open the packaging pouch, remove the bottle, and write the date of opening in the space provided on the label.
• Wash your hands.
• Unscrew the cap.
• Hold the bottle upside down between your fingers.
• Tilt your head backward. Gently pull down the eyelid of the eye with one finger to form a pouch, into which the drop should be instilled (Figure 1).
• Bring the tip of the bottle close to the eye. A mirror may be helpful.
• Do not touch the eye, eyelid, surrounding areas, or any other surface with the dropper tip, as the drops could become contaminated.
• Gently squeeze the bottle so that one drop of Travoprost Rafarm falls into the eye (Figure 2).
• After using Travoprost Rafarm, press your finger against the inner corner of the eye (near the nose). This helps prevent Travoprost Rafarm from passing into the rest of the body.
• If applying drops to both eyes, repeat the above steps for the other eye.
• Close the bottle immediately after using the product.
• Use only one bottle at a time. Do not open the pouch until you need to use the bottle.

If a drop misses the eye, try again.

If you use more Travoprost Rafarm than you should

If you have applied more Travoprost Rafarm than recommended, you can remove the excess by rinsing your eyes with lukewarm water. Do not apply further drops until your next scheduled dose.

In case of accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to use Travoprost Rafarm

If you forget to apply Travoprost Rafarm, simply apply the next dose as scheduled. Do not apply a double dose to make up for the missed dose. Never apply more than 1 drop per day to the affected eye(s).

If you stop using Travoprost Rafarm

Do not stop using this medicine without consulting your doctor. Your eye pressure will not be controlled, which could lead to vision loss.

If you are using another eye drop

Wait at least 5 minutes between applying Travoprost Rafarm and any other eye drops.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience adverse effects, you can generally continue using the drops unless the effects are severe. If you are concerned about these effects, consult your doctor or pharmacist. Do not stop using this medicine without first consulting your doctor.

The following adverse effects have been observed with travoprost:

Very common (may affect more than 1 in 10 people)

• Eye redness
• Changes in the color of the iris (the colored part of the eye)

Common (may affect between 1 and 10 in 100 people)

Eye effects:

• Inflammation inside the eye
• Eye pain or swelling
• Eye irritation
• Eye discharge
• Light sensitivity
• Blurred, reduced, or abnormal vision
• Dry eyes
• Itchy eyes
• Increased tear production
• Decreased or abnormal sensation
• Changes, irritation, itching, redness, pain, swelling, or crusting of the eyelids
• Changes in eyelash color
• Increased or decreased eyelash growth or number of eyelashes

Body effects:

• Headache
• Darkening of the skin around the eyes

Uncommon (may affect between 1 and 10 in 1,000 people)

Eye effects:

• Inflammation or infection of the conjunctiva (the thin membrane covering the inner surface of the eyelid and the white part of the eye) or cornea
• Visual halos
• Corneal disorder
• Eye allergy
• Tired eyes
• Increase in pupil size

Body effects:

• Asthma
• Shortness of breath
• Increase or decrease in blood pressure
• Irregular, increased, or decreased heart rate
• Dizziness
• Viral infection
• Cough
• Generalized weakness
• Worsening of allergic symptoms
• Throat irritation
• Nasal congestion
• Voice changes
• Gastrointestinal ulcer or discomfort
• Dry mouth
• Constipation
• Skin inflammation, redness, or itching
• Shoulder pain
• Bad taste in the mouth

Additional adverse effects that have been reported include:

Eye effects:

• Inflammation of the back of the eye, sunken eyes

Body effects:

• Worsening of asthma
• Ringing in the ears
• Increase in prostate-specific antigen (a protein produced by the prostate)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Travoprost Rafarm

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

To avoid infection, the bottle must be discarded 4 weeks after first opening, and a new bottle should be used. Record the date of opening in the spaces provided on the label of each bottle and on the carton.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Travoprost Rafarm

• The active substance is travoprost 40 micrograms/ml.
• The other components are benzalkonium chloride, macrogol-15-hydroxystearate, trometamol, boric acid (E-284), disodium EDTA, mannitol (E-421), and water for injections. Very small amounts of hydrochloric acid or sodium hydroxide are added to maintain normal acidity levels (pH levels).

Appearance of the product and contents of the pack

Travoprost Rafarm is a liquid (a colourless and transparent solution) supplied in a box containing one plastic bottle with a dropper dispenser and a screw cap.

Each bottle contains 2.5 ml of solution.

Pack sizes containing 1 bottle.

Marketing Authorization Holder

Rafarm S.A.

12 Korinthou str., N. Psihiko

15451, Attiki

Greece

Manufacturer

Rafarm S.A.

Thesi Pousi-Hatzi Agiou Louka, Paiania-Attiki, TK 19002, P.O. 37, Greece

Local Representative

Cipla Europe NV, Spanish branch

C/Guzmán el Bueno, 133 Edif Britannia-28003- Madrid

Spain

Date of the most recent revision of this leaflet: November 2014.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/