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PACKAGE LEAFLET: INFORMATION FOR THE USER Latanoprost 0.005 % w/v eye drops solution

Active ingredient: Latanoprost

In this leaflet:

1.    What Latanoprost is and what it is used for

2.    What do you need to know before you use Latanoprost

3.    How to use Latanoprost

4.    Possible side effects

5.    How to store Latanoprost

6.    Contents of the pack and    further information

1. WHAT LATANOPROST IS AND WHAT IT IS USED FOR

-    Latanoprost, the active ingredient of Latanoprost, is a substance classed under the prostaglandins. It lowers the pressure in your eye, by increasing the natural drainage of fluid from the eye to the blood.

-    Latanoprost is used to treat a certain type of chronic glaucoma, called open-angle glaucoma, and it is also used to treat a condition called ocular hypertension. Both conditions are associated with an increase of the pressure in your eye and may eventually affect your eyesight.

2. WHAT DO YOU NEED O KNOW BEFORE YOU USE LATANOPROST

Latanoprost can be used in adult men and women (including the elderly) but it is

not recommended for use in children and adolescents.

Do not use Latanoprost

-    if you are allergic (hypersensitive) to latanoprost or any of the other ingredients

of Latanoprost.

Take special care with Latanoprost

-    if you have a certain kind of chronic glaucoma, called chronic narrow-angle glaucoma.

-    if    you have glaucoma and do not have a lens or an artificial lens.

-    if    your doctor diagnosed that you are at risk for cystoid macular oedema,

a condition that may be caused by diabetes.

-    If    you have been told that you have a torn posterior lens capsule.

-    if    you have glaucoma caused by pigment formation in the angle of the

anterior chamber of the eye.

-    if you have glaucoma caused by inflammations in the eye or growth of new blood vessels (neovascularization) in the eye.

-    if you have congenital glaucoma.

-    before or after cataract operations.

-    if you have a disorder of the blood vessels in the eyes or retina caused by diabetes.

-    if you suffer from asthma.

-    if you have dry eyes; your doctor will check this carefully.

-    if you have a disorder which may affect the cornea; your doctor will check this carefully.

-    In patients who have an increased risk of certain types of inflammation of the eye (iritis, uveitis), Latanoprost should be used with caution in these patients.

Please tell your doctor if any of the above warnings is applicable in your case, or has been applicable in the past.

During use of Latanoprost, the colour of the eye(s) may change gradually. This occurs particularly in people with eyes that have more than one colour (blue brown, grey brown, green brown or yellow brown). The discolouration usually starts during the first 8 months of treatment. In most cases the discolouration is slight. The discolouration no longer increases after stopping the treatment. The discolouration may be permanent. Discolouration has never been seen in people with pure blue eyes. Discolouration has rarely been seen in people with pure grey, green or brown eyes. The skin around the eyes may change colour. This discolouration is temporary and can also recover during continued use.

Latanoprost may gradually change eyelashes and vellus hair (short fine and light coloured hair) in the treated eye and surrounding areas; these changes include increased length, thickness, pigmentation, number of lashes hairs and misdirected growth of eyelashes.

Children

Safety and effectiveness in children has not been established. Therefore Latanoprost is not recommended for use in children.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Interaction of Latanoprost with other medicines is possible.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

The safety of this medicinal product for use in human pregnancy has not been established. It has potential hazardous pharmacological effects with respect to the course of pregnancy, to the unborn or the neonate. Therefore, Latanoprost should not be used during pregnancy.

Breast-feeding

Latanoprost and its metabolites may pass into breast milk and Latanoprost should therefore not be used in nursing women or breast feeding should be stopped.

Driving and using machines

Do not drive a vehicle or use tools or machines if you experience symptoms of blurred vision.

Important information about some of the ingredients of Latanoprost

Benzalkonium chloride may cause eye irritation. It may also discolour soft contact lenses. Therefore you should avoid contact of soft contact lenses with

Latanoprost and remove these prior to applying the drops. After application, please wait at least 15 minutes before putting your contact lenses back in.

3.    HOW TO USE LATANOPROST

Always use Latanoprost exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

General instructions

The usual dosage for adults, including elderly patients, is 1 drop once daily in the affected eye or eyes. The best time for administration is the evening. If you are also using other eye drops you must wait at least 5 minutes before administering those other eye drops. When you squeeze the dropper, be careful to let only one drop fall into the affected eye. Do not use Latanoprost more often than once daily, because the effect of the treatment may decrease with excessive administration. Use Latanoprost until your doctor advises you to stop the administration. As a rule, Latanoprost is not used in children.

If you wear contact lenses, you should remove these before using Latanoprost. You should wait for 15 minutes after administration of Latanoprost before putting your contact lenses in again.

Instructions for use

The following steps will help you to use Latanoprost correctly:

1.    Wash your hands and make sure you are standing or sitting comfortably.

2.    Unscrew the outer cap.

3.    Use your finger to carefully pull the lower eyelid of the affected eye down.

4.    Hold the upper part of the dropper close to the eye, but make sure not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle. Gently squeeze the dropper slightly so that only one drop falls into your eye. Then, let go of the lower eyelid.

Press a finger against the corner of the affected eye by the nose for 1 minute. Repeat this procedure for the other eye if your doctor has instructed you to do so.

5.    Screw the outer cap back onto the dropper.

You may find it easier to apply your drops in front of a mirror.

If you use more Latanoprost than you should

Immediately contact your doctor if you have used too much Latanoprost or if you have accidentally swallowed Latanoprost. If you administer too many drops in the eye, you may feel a slight irritation in the eye. Your eyes may water and become red.

If you forget to take Latanoprost

Carry on with the usual dose at the usual time. Do not take a double dose to make up for a forgotten dose. You should check with your doctor or pharmacist if you are not sure.

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

4.    POSSIBLE SIDE EFFECTS

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

The following side effects have been reported.

Very common (affects more than 1 in 10 patients)

Eye

The eye colour may become browner and darker; discolouration and increased thickness, length, pigmentation and number of the eyelashes and vellus hair (short fine and light coloured hair); eye irritation (burning, grittiness, itching, stinging); you may have a sensation that something is in your eye(s).

Mild to moderate conjunctival hyperaemia (enlargement of conjuctival blood vessels).

Common (affects less than 1 in 10 patients)

Eye

Inflammation of the edges of the eyelid, painful eyes.

Transient punctuate epithelial erosions (damage of epithelium of cornea in a pinpoint pattern), mostly without symptoms

Uncommon (affects less than 1 in 100 patients)

Eye

Swollen and puffy eyelids.

Dry eye.

Keratitis (inflammation of cornea of eye).

Vision blurred.

Conjunctivitis (acute inflammation of conjunctiva).

Skin

Skin rash.

Rare (affects less than 1 in 1000 patients)

Eye

Certain types of inflammation of the eye (iritis, uveitis), swelling and damaging of the cornea (oedema of the cornea), swelling around the eye socket (periorbital oedema), dark discolouration of the skin of the eyelids, skin rash on the eyelids, ingrown eyelashes which may lead to irritation of the eye; an increased dark discolouration.

Swelling of Retina.

Misdirected eyelashes or an extra row of eyelashes.

Respiratory system

Attacks of tightness in the chest due to cramps of the muscles of and swelling of the mucous membrane of the airways, often with coughing and slime production (asthma); worsening of existing asthma; breathlessness (dyspnoea).

Very rare: affects less than 1 in 10,000 patients Heart

A worsening of an existing pain and/or tight feeling in the chest (angina pectoris) may occur.

General disorders

Chest pain.

Patients have also reported the following side-effects: headache, dizziness, palpitations, muscle pain and joint pain.

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

Not known (frequency cannot be estimated from the available data):

Herpetic keratitis, iris cycst Headache, Dizziness,

Palpitations.

Reporting of side effects

If you get any side effects, talk to your doctor or ,pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE LATANOPROST

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Before Latanoprost is first opened store and transport it under refrigeration at 2°C-8°C and protected from light. Do not freeze.

Keep the bottle in the outer carton in order to protect from light.

Once opened, the drops should be stored in a fridge (2-8^oC) and can be used for up to four weeks.

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 to protect the environment.

6.    CONTENTS OF THE PACK AND FURTHER INFORMATION

What Latanoprost contains

-    The active substance is latanoprost.

One ml of eye drops contains 50 micrograms of latanoprost.

2.5 ml of eye drops, solution (content of a bottle) contains 125 micrograms of latanoprost.

-    The other ingredients are benzalkonium chloride, sodium dihydrogen phosphate monohydrate (E339a), anhydrous disodium phosphate (E339b), sodium chloride and water for injection

What Latanoprost looks like and contents of the pack

Latanoprost is a clear colourless solution.

Latanoprost is available in pack sizes of 1 x 2.5ml, 3 x 2.5ml, and 6 x 2.5ml cartons.

Not all pack sizes may be marketed.

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