PACKAGE LEAFLET: INFORMATION FOR THE USER

Latanoprost 0.005% eye drops, solution Latanoprost

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

-    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 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 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 the doctor treating your child or pharmacist.

In this leaflet:

1.    What Latanoprost is and what it is used for

2.    Before you use Latanoprost

3.    How to use Latanoprost

4.    Possible side effects

5.    How to store Latanoprost

6.    Further information

1. WHAT LATANOPROST IS AND WHAT IT IS USED FOR

Latanoprost belongs to a group of medicines known as prostaglandin analogues. 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 in adults. 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. 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 Latanoprost eye drops solution (see section 6 for the list of ingredients in your medicine).

-    Pregnant or trying to become pregnant

-    Breast feeding.

Take special care with Latanoprost

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 as eye pain, irritation or inflammation, blurred vision)

- If you or your child suffers 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 useLatanoprost, 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)

Taking other medicines

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

Pregnancy

Do not use Latanoprost when you are pregnant. Tell your doctor immediately if you are pregnant, think you are pregnant, or are planning to become pregnant.

Breast-feeding

Do not use Latanoprost when you are breast feeding.

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.

Important information about some of the ingredients of Latanoprost

Latanoprost eye drops solution 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 usingLatanoprost. 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 Latanoprost exactly as your doctor or the doctor treating your child has told you. You should 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 by 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 usingLatanoprost. After using Latanoprost you should wait 15 minutes before putting the contact lenses back into the eye.

Instructions for use

1.    Wash your hands and sit or stand comfortably.

2.    Unscrew the protective cap. The protective cap should be retained.

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, 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 protective 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 use a double dose to make up for the dose you have forgotten. 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 takingLatanoprost.

4. POSSIBLE SIDE EFFECTS

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

These side effects may occur with certain frequencies, which are defined as follows:

Very common	affects more than 1 user in 10
Common:	affects 1 to 10 users in 100
Uncommon:	affects 1 to 10 users in 1,000
Rare:	affects 1 to 10 users in 10,000
Very rare:	affects less than 1 user in 10,000
Not known:	frequency cannot be estimated from the available data

Very common effects:

•    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:

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

Uncommon effects:

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

Skin rash.

Rare effects:

•    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 (growing inwards) or an extra row of eyelashes.

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

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

Very rare effects:

•    Worsening of angina in patients who also have heart disease. Chest pain.

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 and 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.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please contact you doctor or pharmacist.

5.    HOW TO STORE LATANOPROST

Keep out of the reach and sight of children.

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

Store the unopened bottle in a refrigerator (between 2°C and 8°C), protected from light.

After opening the bottle it is not necessary to store the bottle in a refrigerator but do not store it above 25°C. Use within 4 weeks of opening. When you are not using Latanoprost, keep the bottle in the outer carton, in order to protect it from light.

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 solution contains

The active substance is latanoprost. 1 ml of eye drops contains 50 micrograms latanoprost.

The other ingredients are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate (E339a) and anhydrous disodium hydrogen phosphate (E339b) dissolved in water for injections.

What Latanoprost eye drops solution looks like and contents of the pack

Latanoprost eye drops solution is a clear, colourless liquid.

Latanoprost is available in a pack size of 1 carton.

Each carton contains one bottle of Latanoprost. Each bottle contains 2.5ml of Latanoprost eye drops solution.

Marketing Authorisation Holder and Manufacturer

Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 OLD, United Kingdom

This leaflet was last revised in 02/2012.

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