LEACHIM 40 MICROGRAMS/ML EYE DROPS IN SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Leachim 40 micrograms/ml eye drops, solution

Travoprost

Read the package leaflet carefully before you start using this medicine because it contains important information for you.

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

Contents of the package leaflet

1. What is Leachim and what is it used for
2. What you need to know before you start using Leachim
3. How to use Leachim
4. Possible side effects
5. Storing Leachim
6. Package contents and further information

1. What is Leachim and what is it used for

Leachim contains travoprost, which belongs to a group of medicines called prostaglandin analogues. It works by reducing the pressure in the eye. It can be used alone or with other eye drops, for example with beta-blockers, which also reduce the pressure in the eye.

Leachim is used to reduce high pressure in the eye in adults, adolescents, and children from 2 months of age. This pressure can lead to a disease called glaucoma.

2. What you need to know before you start using Leachim

Do not use Leachim

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

Talk to your doctor if you are in this situation.

Warnings and precautions

Talk to your doctor or pharmacist before you start using Leachim

• Leachim may increase the length, thickness, color, and/or number of your eyelashes. Changes such as unusual hair growth on the eyelids or around the eye have also been observed.

• Leachim may change the color of the iris (the colored part of the eye). This change may be permanent. It may also cause a change in the color of the skin around the eye.

• If you have had cataract surgery, talk to your doctor before you start using Leachim.

• If you have or have had eye inflammation (iritis and uveitis), talk to your doctor before you start using Leachim.
• Leachim may, in rare cases, cause shortness of breath or wheezing or increase asthma symptoms. If you are concerned about changes in your breathing while using Leachim, talk to your doctor as soon as possible.

• Travoprost may be absorbed through the skin. If the medicine comes into contact with the skin, it should be washed off immediately. This is especially important in pregnant or breastfeeding women.

• If you wear soft contact lenses, do not apply the drops while wearing them. After applying the drops, wait 15 minutes before putting the lenses back in.

Children and adolescents

Leachim can be used in children from 2 months of age to less than 18 years with the same dose as in adults. The use of Leachim is not recommended in children under 2 months of age.

Using Leachim with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

Do not use Leachim if you are pregnant. If you think you may be pregnant, tell your doctor. If you can become pregnant, you must use an effective method of birth control while using Leachim.

Do not use Leachim if you are breastfeeding. Leachim may pass into breast milk. Talk to your doctor before using any medicine.

Driving and using machines

Immediately after applying Leachim, you may notice that your vision becomes blurry. Do not drive or use machines until these effects have disappeared.

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3. How to use Leachim

Follow the instructions for administration of this medicine exactly as told by your doctor or the doctor treating the child. If you are unsure, talk to your doctor, the doctor treating the child, or pharmacist.

The recommended dose is

One drop in the affected eye(s) once a day - at night.

Leachim should only be applied to both eyes if your doctor tells you to do so. Continue the treatment for the whole period of time prescribed by your doctor or the doctor treating the child.

Leachim should only be used as eye drops for your eye(s) or your child's eye(s).

• Immediately before using a bottle for the first time, write the date of opening on the space provided on the carton.
• Wash your hands.
• Remove the cap.
• Hold the bottle, upside down, between your thumb and the rest of your fingers.
• Tilt your head or the child's head gently backwards. Gently pull the lower eyelid down until a pocket is formed, where the drop should fall.

• Bring the tip of the bottle close to the eye. You may find it helpful to use a mirror.
• Do not touch the eye, eyelid, or surrounding areas with the dropper tip, because the drops could become contaminated.

• Gently squeeze the bottle to release one drop of Leachim at a time.
• After using Leachim, gently close your eyes, press the edge of the eye, next to the nose, for at least 1 minute. This helps prevent Leachim from entering the rest of the body.
• If you are applying drops to both eyes, repeat the steps for the other eye.
• Close the bottle tightly after use.
• Use one bottle at a time.
• If a drop falls outside the eye, try again.

If you or the child are using other eye medicines, such as eye drops or ointments, wait at least 5 minutes between applying Leachim and the other eye medicines.

If you or the child get too much Leachim

You can flush it out with warm water. Do not apply more drops until the next dose is due.

If you forget to use Leachim

Continue with the next dose as planned. Do not apply a double dose to make up for the forgotten dose. Never apply more than one drop in the affected eye(s) in one day.

If you stop using Leachim

Do not stop using Leachim without talking to your doctor or the doctor treating the child first, as the pressure in your eye or the child's eye may not be controlled, which could lead to loss of vision.

If you have any further questions about using this medicine, ask your doctor, the doctor treating the child, or pharmacist.

4. Possible side effects

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

You can normally continue your treatment as long as the side effects are not serious. If they worry you, talk to your doctor or pharmacist. Do not stop using Leachim without talking to your doctor.

The following side effects have been observed with eye drops containing travoprost:

Very common side effects: may affect more than 1 in 10 people

Eye effects:redness of the eye.

Common side effects: may affect up to 1 in 10 people

Eye effects:changes in iris color (the colored part of the eye), eye pain, eye discomfort, dry eye, itching of the eye, irritation of the eye.

Uncommon side effects: may affect up to 1 in 100 people

Eye effects:corneal disorder, eye inflammation, iris inflammation, inflammation inside the eye, inflammation with or without damage to the surface of the eye, sensitivity to light, eye discharge, eyelid inflammation, redness of the eyelid, swelling around the eye, itching of the eyelid, blurred vision, increased tear production, conjunctivitis (inflammation or infection of the conjunctiva), abnormal turning out of the lower eyelid, cloudy eye, crusts on the eyelid, eyelash growth.

Other effects:increased allergic symptoms, headache, irregular heartbeat, cough, stuffy nose, sore throat, darkening of the skin around the eye(s), darkening of the skin, abnormal hair texture, excessive hair growth.

Rare side effects: may affect up to 1 in 1,000 people

Eye effects: flashes of light, eyelid eczema, abnormally positioned eyelashes growing inwards towards the eye, eye swelling, reduced vision, halo vision, decreased sensation in the eye, inflammation of the eyelid glands, pigmentation inside the eye, increased pupil size, thickening of the eyelashes, change in eyelash color, tired eyes.

Other effects:viral eye infection, dizziness, bad taste, irregular or decreased heartbeat, increased or decreased blood pressure, shortness of breath, asthma, nasal inflammation or allergy, nasal dryness, voice changes, gastrointestinal ulcer or discomfort, constipation, dry mouth, skin redness or itching, rash, change in hair color, loss of eyelashes, joint pain, muscle pain, general weakness.

Frequency not known: cannot be estimated from the available data

Eye effects:inflammation of the back of the eye, sunken eyes.

Other effects:depression, anxiety, insomnia, feeling of false movement, ringing in the ears, chest pain, irregular heartbeat, increased heart rate, worsening of asthma, diarrhea, nosebleeds, abdominal pain, nausea, vomiting, itching, abnormal hair growth, painful or involuntary urination (painful or involuntary urination), increased prostate cancer marker.

In children and adolescents, the most common side effects observed with travoprost are redness of the eye and eyelash growth. Both side effects were observed with a higher incidence in children and adolescents compared to adults.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Leachim

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

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

This medicine does not require any special storage conditions. Keep the bottle in the carton to protect it from light.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Package contents and further information

What Leachim contains

The active substance is travoprost 40 micrograms/ml.

The other ingredients are: poly(dronium) chloride, macrogolglycerol hydroxystearate 40, propylene glycol (E1520), sodium chloride, boric acid (E284), mannitol (E421), and purified water. Sodium hydroxide or hydrochloric acid to adjust the pH.

Appearance and package contents

Leachim is a clear and colorless solution, practically free of particles, presented in a carton containing 1, 3, or 6 plastic bottles, each with a screw cap. Each bottle contains 2.5 ml of solution.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

ALFRED E. TIEFENBACHER (GmbH & Co. KG)

Van-der-Smissen-Straße 1

22767 Hamburg

Germany

Manufacturer

S.C. ROMPHARM COMPANY S.R.L.

Eroilor Street, no. 1A

075100 Otopeni, Ilfov.

Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain Leachim 40 micrograms/ml eye drops, solution

Netherlands Leachim 40 microgram/ml oogdruppels, oplossing

France Leachim 40 microgrammes/ml, collyre en solution

United Kingdom Leachim 40 microgram/ml eye drops, solution

Italy Leachim 40 microgrammi/ml collirio, soluzione

Date of last revision of this package leaflet: October 2020