TRAVOPROST RAFARM 40 micrograms/ml eye drops solution

Introduction

Package Leaflet: Information for the User

Travoprost Rafarm 40 micrograms/ml eye drops, solution

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, ask your doctor or 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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. Storing Travoprost Rafarm.
6. Contents of the pack and other information.

1. What Travoprost Rafarm is and what it is used for

Travoprost Rafarm contains travoprostwhich belongs to a group of medicines called prostaglandin analogues. It works by reducing the pressure in the eye. It can be used on its own or with other eye drops that reduce pressure in the eye, for example beta-blockers.

Travoprost Rafarm is used to reduce high pressure in the eye in adults.This pressure can lead to a condition 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

This medicine may:

• increase the length, thickness, color and/or number of your eyelashes and may cause unusual hair growth on your eyelids.
• change the color of your iris (the colored part of your eye). This change may be permanent.
• cause, on rare occasions, shortness of breath or wheezing or increase symptoms of asthma. 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 by pregnant or breast-feeding women.

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

Children and adolescents

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

Using Travoprost Rafarm with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those obtained without a prescription.

Pregnancy and breast-feeding

Do not use Travoprost Rafarm if you are pregnant.If you could be pregnant, tell your doctor. If you can become pregnant, you should use an effective method of birth control while using this medicine.

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

You may notice blurred vision immediately after using this medicine. Do not drive or use machines until this effect has gone.

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 applying the product and wait at least 15 minutes before putting them back. It 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

Use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose:

Adults: 1 drop in the affected eye(s) once daily, in the evening.You should only use Travoprost Rafarm in both eyes if your doctor has told you to do so. Continue with the treatment for as long as your doctor tells you to.

Travoprost Rafarm should only be used as eye drops.

• Immediately before using a bottle for the first time, open the protective foil pouch, take out the bottle and write the date you opened it on the space provided on the label.
• Wash your hands.
• Remove the cap.
• Hold the bottle upside down between your fingers.
• Tilt your head back. Gently pull the lower eyelid down to form a pocket, where the drop should fall (Figure 1).
• Bring the tip of the bottle close to your eye. You may find it easier to do this in front of a mirror.
• Do not touch your eye, eyelid, or surrounding areas with the dropper,because the drops could become contaminated.
• Gently squeeze the bottle to release one drop of Travoprost Rafarm at a time (Figure 2).
• After using Travoprost Rafarm, press the edge of your eyenext to your nose. This helps prevent Travoprost Rafarm from getting into the rest of your body.
• If you are putting drops in both eyes, repeat the steps for the other eye.
• Close the bottle immediately after use.
• Use one bottle at a time.Do not open the pouch until you need to use the bottle.

If a drop misses your eye,try again.

If you use more Travoprost Rafarm than you should

If you have used more Travoprost Rafarm than you should, rinse your eyes with warm water. Do not put in any more drops until it is time for your next dose.

In case of accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to use Travoprost Rafarm

If you forget to use Travoprost Rafarm, continue with the next dose as planned. Do nottake a double dose to make up for a forgotten dose. Never use more than one drop per day in the affected eye(s).

If you stop using Travoprost Rafarm

Do not stop using this medicine without talking to your doctor. The pressure in your eye will not be controlled, which could lead to loss of vision.

If you are using another eye drop

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

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

4. Possible side effects

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

If you get any side effects, you can usually continue to use your drops, unless the effects are serious. If you are worried about any side effects, talk to your doctor or pharmacist. Do not stop using this medicine without talking to your doctor.

The following side effects have been seen with travoprost:

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

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

Common(may affect up to 1 in 10 people)

Eyes:

• inflammation inside the eye
• eye pain or swelling
• eye irritation
• eye discharge
• sensitivity to light
• blurred, reduced or abnormal vision
• dry eye
• itchy eye
• increased tear production
• decreased or abnormal sensation
• changes, irritation, itching, redness, pain, swelling or crusts on the eyelids
• change in eyelash color
• increase or decrease in eyelash growth or number.

Body:

• headache
• darkening of the skin around the eyes

Uncommon(may affect up to 1 in 100 people)

Eyes:

• inflammation or infection of the conjunctiva (the thin membrane that covers the white part of the eye) or cornea
• halo vision
• corneal disorder
• eye allergy
• tired eyes
• increase in pupil size

Body:

• asthma
• shortness of breath
• increase or decrease in blood pressure
• irregular, increased or decreased heart rate
• dizziness
• viral infection
• cough
• general weakness
• increase in allergic symptoms
• throat irritation
• stuffy nose
• voice changes
• stomach ulcers or discomfort
• dry mouth
• constipation
• skin inflammation, redness or itching
• shoulder pain
• bad taste

Additional side effects have been reported:

Eyes:

• inflammation of the back of the eye, sunken eyes.

Body:

• worsening of asthma
• ringing in the ears
• increase in prostate antigen (a protein produced by the prostate).

Reporting of side effects

If you get any side effects, 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 Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Travoprost Rafarm

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

No special storage precautions are required.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date is the last day of the month shown.

To avoid infections, you must discard the bottle 4 weeks after you first open it, and use a new bottle. Write the date you opened it on the space provided on the label of each bottle and on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of 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 (E-284), disodium edetate, mannitol (E-421) and water for injections. Small amounts of hydrochloric acid or sodium hydroxide may be added to maintain normal levels of acidity (pH levels).

Appearance and contents of the pack

Travoprost Rafarm is a liquid (a clear, colorless solution) in a carton containing a plastic bottle with a dropper dispenser and screw cap.

Each bottle contains 2.5 ml of solution.

Packs containing 1 bottle.

Marketing authorisation 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 last revision of this leaflet: November 2014.

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