Package leaflet: Information for the user

Latanoprost 50 micrograms/ml eye drops, solution

Latanoprost

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 the doctor treating your child or your pharmacist.

-    This medicine has been prescribed for you or for your child. Do not pass it on to others. It may harm them, even if their signs of illness 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 the doctor treating your child or your pharmacist.

What is in this leaflet

1.    What Latanoprost is and what it is used for

2.    What 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 other information

1.    What Latanoprost is and what it is used for

Latanoprost belongs to a group of medicines known as analogues of a physiological ingredient of the body named prostaglandin. It works by increasing the natural outflow of fluid from inside the eye into the bloodstream.

Latanoprost is used to treat conditions known as open angle glaucoma and ocular hypertension. Both of these conditions are linked with an increase in the pressure within your eye, eventually affecting your eye sight.

Latanoprost is also used to treat increased eye pressure and glaucoma in all ages of children and babies.

2.    What you need to know before you use Latanoprost Latanoprost can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Latanoprost has not been investigated in prematurely born infants (less than 36 weeks gestation).

Do not use Latanoprost:

-    if you are allergic (hypersensitive) to latanoprost or any of the other ingredients of this medicine (listed in section 6)

-    if you are pregnant or trying to become pregnant

-    if you are breast feeding.

Warnings and precautions

Talk to your doctor, or the doctor treating your child or your pharmacist before you use Latanoprost or before you give this to your child if you think any of the following apply to you or your child:

-If you or your child are about to have or have had eye surgery (including cataract surgery)

-If you or your child suffer from eye problems (such eye pain, irritation or inflammation, blurred vision)

-If you or your child suffer from dry eyes

-If you or your child have severe asthma or the asthma is not well controlled

-If you or your child wear contact lenses. You can still use Latanoprost, but follow the instruction for contact lens wearers in Section 3 -If you have suffered or are currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV).

Other medicines and Latanoprost

Latanoprost may interact with other medicines. Please tell your doctor, the doctor treating your child or pharmacist if you or your child are taking, have recently taken or might take any other medicines including those medicines (or eye drops) obtained without a prescription.

Pregnancy and breast-feeding

Do not use Latanoprost when you are pregnant.

Do not use Latanoprost when you are breast-feeding.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

When you use Latanoprost you might have blurred vision, for a short time. If this happens to you, do not drive or use any tools or machines until your vision becomes clear again.

Latanoprost contains benzalkonium chloride

Latanoprost contains a preservative called benzalkonium chloride. This preservative may cause eye irritation or disruption to the surface of the eye. Benzalkonium chloride can be absorbed by contact lenses and is known to discolour soft contact lenses. Therefore, avoid contact with soft contact lenses.

If you or your child wear contact lenses, they should be removed before using Latanoprost.After using Latanoprost you should wait 15 minutes before putting the contact lenses back in. See the instructions for contact lens wearers in Section 3.

3. How to use Latanoprost

Always use this medicine exactly as your doctor or the doctor treating your child has told you. Check with your doctor or the doctor treating your child or pharmacist if you are not sure.

The usual dosage for adults (including the elderly) and children is one drop once a day in the affected eye(s). The best time to do this is in the evening.

Do not use Latanoprost more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.

Use Latanoprost as instructed by your doctor, or the doctor treating your child until they tell you to stop.

Contact lens wearers If you or your child wear contact lenses, they should be removed before using Latanoprost.

After using Latanoprost you should wait 15 minutes before putting the contact lenses back into the eyes.

Instructions for use

1.    Wash your hands and sit or

stand comfortably._

2.    Twist off the outer cap (which can be thrown away).

3.    Unscrew the protective

inner cap. The protective cap should be retained._

4.    Remove the loose collar

before use._

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

6.    Place the tip of the bottle

close to, but not touching your eye._

7.    Squeeze the bottle gently

so that only one drop goes into your eye, then release the lower eyelid._

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

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

10. Put the protective inner cap back on the bottle.

If you use Latanoprost with other eye drops wait at least 5 minutes between using Latanoprost and taking other eye drops.

If you use more Latanoprost than you should

If you put too many drops into the eye, it may lead to some minor irritation in the eye and the eyes may water and turn red. This should pass, but if you are worried contact your doctor or the doctor treating your child for advice. Contact your doctor as soon as possible if you or your child swallows Latanoprost accidentally.

If you forget to use Latanoprost

Carry on with the usual dosage at the usual time. Do not take a double dose to make up for a forgotten dose. If you are unsure about anything talk to your doctor or pharmacist.

If you stop using Latanoprost

You should speak to your doctor

or the doctor treating your child

if you want to stop taking Latanoprost.

4. Possible side effects

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

Very common effects (likely to affect more than 1 in 10 people):

•    A gradual change in your eye colour by increasing the amount of brown pigment in the coloured part of the eye known as the iris. If you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown) you are more likely to see this change than if you have eyes of one colour (blue, grey, green or brown eyes). Any changes in your eye colour may take years to develop although it is normally seen within 8 months of treatment. The colour change may be permanent and may be more noticeable if you use Latanoprost in only one eye.

There appears to be no problems associated with the change in eye colour. The eye colour change does not continue after Latanoprost treatment is stopped.

•    Redness of the eye.

•    Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye).

•    A gradual change to eyelashes of the treated eye and the fine hairs around the treated eye, seen mostly in people of Japanese origin. These changes involve an increase of the colour (darkening), length, thickness and number of your eye lashes.

Common effects (likely to affect less than 1 in 10 people):

•    Irritation or disruption to the surface of the eye, eyelid inflammation (blepharitis) and eye pain.

Uncommon effects (likely to affect less than 1 in every 100 people):

•    Eyelid swelling, dryness of the eye, inflammation or irritation of the surface of the eye (keratitis), blurred vision and conjunctivitis.

•    Skin rash.

Rare effects (likely to affect less than 1 in every 1000 people):

•    Inflammation of the iris, the coloured part of the eye (iritis/uveitis); swelling of the retina (macular oedema), symptoms of swelling or scratching/damage to the surface of the eye, swelling around the eye (periorbital oedema) misdirected eyelashes or an extra row of eyelashes, light sensitivity (photophobia).

•    Skin reactions on the eyelids, darkening of the skin of the eyelids.

•    Asthma, worsening of asthma and shortness of breath (dyspnoea).

Very rare effects (likely to affect less than 1 in 10,000 people):

•    Worsening of angina in patients who also have heart disease, chest pain, sunken eye appearance (eye sulcus deepening).

Patients have also reported the following side-effects: fluid filled area within the coloured part of the eye (iris cyst), headache, dizziness, palpitations, muscle pain, joint pain and developing a viral infection of the eye caused by the herpes simplex virus (HSV).

Side effects seen more often in children compared to adults are runny itchy nose and fever.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via Yellow Card Scheme, Website:

www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Latanoprost

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 carton and bottle after EXP. 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 opening the bottle do not store above 25°C and use within 4 weeks. When you are not using Latanoprost, keep the bottle in the outer carton, in order to protect it from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Latanoprost contains

-The active substance is 0.005% (50 micrograms/ml) latanoprost. -The other ingredients are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate (E339a) and disodium hydrogen phosphate anhydrous (1509) dissolved in water for injections.

What Latanoprost looks like and contents of the pack

Latanoprost eye drops solution is a clear, colourless liquid. Latanoprost is available in pack sizes of 1, 3 and 6 cartons. Not all pack sizes may be marketed.

Low density polyethylene (LDPE) bottle of 5 ml with low density polyethylene (LDPE) dropper insert and high density polyethylene (HDPE) tamper-evident screw cap.

Each bottle contains 2.5ml of Latanoprost eye drops solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Noridem Enterprises Ltd,

Evagorou & Makariou Mitsi Building 3, Suit. 115, 1065 Nicosia, Cyprus.

Manufacturer: DEMO S.A., 21st km National Road Athens-Lamia, 14568 Krioneri, Athens, Greece.

This medicinal product is authorised in the Member States of the EEA under the following names:

Cyprus: Latanoprost DEMO 50 micrograms/ml o90aAgiK£$ OTaYOV££, SiaAuga Germany: Latanoprost DEMO 50 Mikrogramm/ml Augentropfen, Losung

United Kingdom: Latanoprost 50 micrograms/ml eye drops, solution

This leaflet was last revised in 12/2014.

If this leaflet is difficult to see or read, please contact the following address for help:

Fannin Limited, Fannin House, South County Business Park, Leopardstown, Dublin 18, Ireland Tel +353-12907000.