Read all of this leaflet carefully before you start using this medicine.

•    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. Do not pass it on to others.

It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Latanoprost eye drops are and what they are used for

2.    Before you use Latanoprost eye drops

3.    How to use Latanoprost eye drops

4.    Possible side effects

5.    How to store Latanoprost eye drops

6.    Further information

1.    What Latanoprost eye drops are and what they are used for

Latanoprost eye drops lower the pressure within your eye by increasing the natural flow of fluid from inside the eye into the blood stream. Latanoprost pelongs to a group of medicines called prostaglandins.

_atanoprost eye drops are used to treat open angle glaucoma and ocular hypertension. These conditions are caused by an increase in the pressure n your eye. If they are not treated they may affect your eyesight.

2.    Before you use Latanoprost eye drops

Do not use Latanoprost eye drops

•    if you are allergic (hypersensitive) to the active substance latanoprost or any of the other ingredients of Latanoprost eye drops.

Take special care with Latanoprost eye drops

Tell your doctor if you have

•    severe asthma, or your asthma is not well controlled.

•    had eye surgery such as cataract surgery or are about to have eye surgery.

•    damage to the area around the lens of your eye.

•    any medical condition that could affect your vision (such as diabetes).

•    Swelling of the back of the eye (an eye condition known as macular oedema) or any other inflammation of the eye.

_atanoprost eye drops are used in open angle glaucoma and ocular hypertension. Tell your doctor if you have another type of glaucoma.

_atanoprost eye drops can cause a permanent colour change in your eye. They can also affect your eyelashes and the skin around your eyes (see section 4). Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including other eye drops and any other medicines taken without a prescription.

_atanoprost eye drops and other medicines taken at the same time can affect each other.

Do not take Latanoprost eye drops with any other medicines containing prostaglandin because this may increase the pressure in your eye(s).

Pregnancy and breast-feeding _atanoprost eye drops must not be used during pregnancy.

_atanoprost may pass into breast milk and must not be used when breast feeding.

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

Driving and using machines

As with other eye drops, if your vision is blurred when you first put your drops in, wait until this wears off before you drive or operate machinery.

Important information about some of the ingredients of Latanoprost eye drops

A preservative in Latanoprost eye drops called benzalkonium chloride may cause eye irritation and can discolour soft contact lenses.

If you wear contact lenses:

•    Do not use Latanoprost eye drops while your contact lenses are in your eyes.

•    Remove contact lenses before using Latanoprost eye drops.

•    Wait at least 15 minutes after using Latanoprost eye drops before putting your lenses back in.

3. How to use Latanoprost eye drops

Always use Latanoprost eye drops exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

The usual dose for adults, including elderly patients is

One drop of Latanoprost eye drops should be dropped into the affected eye(s) once daily. The best time to do this is in the evening.

Latanoprost eye drops should not be used in children.

Using with other eye drops:

If you have to use other eye drops you should wait for at least five minutes before using them.

How to use Latanoprost eye drops Follow the steps below to help you use Latanoprost eye drops properly:

1.    Wash your hands and sit or stand comfortably.

2.    Unscrew the outer protective cap.

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

4.    Place the tip of the bottle close to, but not touching your eye.

5.    Squeeze the bottle gently so that only one drop goes into your eye and then release the lower eyelid.

6.    Press a finger against the corner of the affected eye by the nose. Hold for 1 minute whilst keeping the eye closed.

7.    Repeat in your other eye if your doctor has told you to do this.

8.    Put the cap back on the bottle.

If you use more Latanoprost eye drops than you should

If you put too many drops in your eye, you may feel some slight irritation in the eye or have some redness around the eye. If this does not stop or Latanoprost eye drops are accidentally swallowed contact your doctor as soon as possible. If you forget to use Latanoprost eye drops

If you forget to apply your drops at the usual time, just skip that dose. Do not take a double dose to make up for the missed dose. Instead, just wait until the next time you are supposed to take it, and then take your normal dose.

If you stop using Latanoprost eye drops

Latanoprost eye drops should be used until your doctor tells you to stop. If you stop using this medicine the pressure in your eye couldincrease.

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

Continued overleaf

4. Possible side effects

ike all medicines, Latanoprost eye drops can cause side effects, although not everybody gets them.

Most side effects are related to the eye:

Latanoprost eye drops may cause a gradual change in eye colour and this may become permanent. The iris (the coloured part of the eye) may become browner in colour and appear darker. Changes to the colour of the iris occurred in 33% of patients. The other side effects on the eyes are usually temporary. Latanoprost may cause your eye lashes to darken, increase in number, appear thicker and longer. Sometimes lashes may grow in the "wrong” direction. Tell your doctor if these lashes cause irritation. Your eyelashes may return to normal when you stop treatment with Latanoprost eye drops. Latanoprost eye drops may cause unusual hair growth on your eyelids.

A small number of people have noticed that their eye lids or skin around the eye look darker after using Latanoprost eye drops for some time. These changes may be more noticeable if you are only treating one eye.

Your eyes might look blood-shot and feel irritated. They might sting, itch or you may feel a burning sensation. Your eyes might feel dry or your vision may be blurred. If this happens to you stop taking the drops and contact your doctor.

Possible side effects are listed below on the basis of how often they occur. f you have any difficulty in breathing, ncluding asthma, pain in your chest or worsening of your angina it is very mportant that you stop taking the eye drops and contact your doctor immediately.

Very common: (occur in more than 1 user in 10):

increased eye colouration; eye irritation or redness changes in eyelashes and other hair near the eye (increased length, thickness, colour and number).

Common: (occur in 1 to 10 users in 100): slight damage to the cornea (front part of the eye) which lasts for a short time irritation or swelling around the edges of the eyelids; eye pain.

Uncommon: (occur in 1 to 10 users in ,000):

•    eyelid swelling;

•    dry eye;

•    inflammation of the cornea (front part of the eye);

•    blurred vision;

•    conjunctivitis

•    skin rash.

Rare: (occur in 1 to 10 users in 10,000): inflammation of the inner, middle or coloured part of your eye; eyelashes growing in the wrong direction sometimes resulting in eye irritation

darkening of eye lids or skin around the eye. These changes may be more noticeable if you are only treating one eye.

growth of an extra row of eyelashes asthma, worsening of asthma and difficulty in breathing.

Very rare: (occur in less than 1 in 10,000 users, including isolated cases): worsening of angina (chest pain). chest pain.

There have also been reports of the following:

headache, dizziness. awareness of your heartbeat (palpitations) muscle pain; joint pain.

f any of the side effects gets serious, or if you notice any side effects not isted in this leaflet, please tell your doctor or pharmacist.

5.    How to store Latanoprost eye drops

Keep out of the reach and sight of children.

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

Store in a refrigerator (2°C - 8°C).

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

After first opening the bottle: do not store above 25°C and use within 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.    Further information

What Latanoprost eye drops contain

The active substance is latanoprost 50 micrograms in one ml.

The other ingredients are: sodium chloride, benzalkonium chloride, sodium dihydrogen phosphate, anhydrous disodium phosphate, water for injections

What Latanoprost eye drops look like and contents of the pack Dropper polyethylene container of 5 ml with tamper evident polyethylene screw cap.

Each bottle contains 2.5 ml eye drops solution corresponding to approximately 80 drops of solution.

Pack sizes: 1 x 2.5 ml 3 x 2.5ml

Not all packaging sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Tubilux Pharma S.p.A.

Via Costarica 20/22 00040 Pomezia (RM) - Italy This medicinal product is authorised in the Member States of the EEA under the following names:

Italy: Latanoprost Tubilux Pharma 0,005% collirio, soluzione Spain: Latanoprost cinfa

50 microgramos/ml colirio en solucion

UK:    Latanoprost 0.005% w/v

eye drops solution.

PL17918/0014

This leaflet was last revised in February 2014

M

MARTJNDALE PHARMA

Bampton Road, Harold Hill, Romford, RM3 8UG, UK

100mm Measurement Verification Bar

2644-B