Label: Information for the User

Travoprost Rafarm 40 micrograms/mL eye drops solution

Read this label carefully before you start using this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Travoprost Rafarmcontains travoprostwhich is part of a group of medications called prostaglandin analogs. It works by reducing pressure in the eye. It can be used alone or with other eye drops, for example with beta-blockers, which also reduce pressure in the eye.

Travoprost Rafarmis used to reduce high pressure in the eye in adults.This pressure may lead to a disease calledglaucoma.

No use Travoprost Rafarm

• If you are allergic to travoprost or any of the other components of this medication (listed in section 6).

Warnings and Precautions

This medication may:

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

In case of contact with the product on the skin, it should be removed by washing immediately.

Children and Adolescents

Travoprost Rafarm should not be used in individuals under 18 years of age.

Use of Travoprost Rafarm with Other Medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications, 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 can become pregnant, you should use an appropriate contraceptive method while using this medication.

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

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

Driving and Operating Machines

You may notice blurred vision immediately after applying this medication. Do not drive or use machines until this effect has disappeared.

Travoprost Rafarm contains benzalkonium chloride

This medication may produce eye irritation due to the presence of benzalkonium chloride.

Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them. May alter the color of soft contact lenses.

Travoprost Rafarm contains macrogol-15-hydroxystearate

This medication may cause skin reactions due to the presence of macrogol-15-hydroxystearate.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults:1 drop in the affected eye(s), once a day at night.Only Travoprost Rafarm should be applied in both eyes if your doctor instructs you to do so. Follow the treatment for the entire period of time indicated by your doctor.

Travoprost Rafarm should only be used as eye drops.

• Immediately before using a bottle for the first time, open the packaging bag, remove the bottle, and note the opening date in the reserved space on the label.
• Wash your hands.
• Remove the cap.
• Hold the bottle upside down between your fingers.
• Incline your head backward. Gently separate your eyelid from your eye with your finger, until a pouch forms, in which the drop should fall(Figure 1).
• Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.
• Do not touch your eye, eyelid, nearby areas, or other surfaces with the dropper,because the drops could become infected.
• Press the bottle gently to allow one drop of Travoprost Rafarm to fall each time(Figure 2).
• After using Travoprost Rafarm,press the edge of your eye, next to your nose, with your finger. This helps to prevent Travoprost Rafarm from passing into the rest of your body.
• If you apply drops in 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 packaging bag until you need to use the bottle.

If a drop falls outside the eye,try again.

If you use more Travoprost Rafarm than you should

If you have applied more Travoprost Rafarm than you should have, you can remove it by washing your eyes with warm water. Do not apply more drops until your next scheduled dose.

In case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Travoprost Rafarm

If you forget to apply Travoprost Rafarm, continue with the next scheduled dose.Do notapply a double dose to compensate for the missed dose. Never apply more than 1 drop per day in the affected eye(s).

If you interrupt treatment with Travoprost Rafarm

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

If you are using another eye drop

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

If you have any other questions about using this product, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

If you experience side effects, you can usually continue using the drops unless the side effects are severe. If these side effects concern you, consult your doctor or pharmacist. Do not stop using this medication without consulting your doctor.

The following side effects have been observed with travoprost:

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

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

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

Eye effects:

• Inflammation within the eye
• Eyelid pain or swelling
• Eye irritation
• Eye discharge
• Sensitivity to light
• Blurred, reduced, or abnormal vision
• Eye dryness
• Eye itching
• Increased tear production
• Reduced or abnormal sensation
• Alterations, irritation, itching, redness, pain, swelling, or crusts on the eyelids
• Change in eyelash color
• Increased or decreased eyelash growth or number

Body effects:

• Headache
• Darkening of the skin around the eyes

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

Eye effects:

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

Body effects:

• Asthma
• Shortness of breath
• Increased or decreased blood pressure
• Irregular, increased, or decreased heart rate
• Dizziness
• Viral infection
• Cough
• General weakness
• Increased allergic symptoms
• Throat irritation
• Stuffy nose
• Changes in voice
• Ulcer or gastrointestinal discomfort
• Dry mouth
• Constipation
• Skin inflammation, redness, or itching
• Shoulder pain
• Bad taste in the mouth

Additional reported side effects include:

Eye effects:

• Posterior eye inflammation, sunken eyes.

Body effects:

• Worsening of asthma
• Tinnitus
• Increased prostate antigen (a protein produced by the prostate).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

To prevent infections,you must discard the bottle 4 weeks after opening it for the first time,and use a new bottle. Note the opening date in the reserved spaces on the label of each bottle and the box.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Travoprost Rafarm

• The active ingredient 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 injection preparations. 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 packaging

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

Each vial contains 2.5 ml of solution.

Containers containing 1 vial.

Holder of the marketing authorization

Rafarm S.A.

12 Korinthou str., N. Psihiko

15451, Attiki

Greece

Responsible for manufacturing

Rafarm S.A.

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

Local Representative

Cipla Europe NV subsidiary in Spain

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

Spain

Last review date of this leaflet: November 2014.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/