PACKAGE LEAFLET: INFORMATION FOR THE USER    saraoooLrooo

Latanoprost 0.005% w/v 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 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 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

A SANDOZ

What Latanoprost is and what it is used for

Latanoprost belongs to a group of medicines known as prostaglandins analogues. It works by increasing the natural outflow of fluid from inside the eye into the blood stream.

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 eyesight.

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

What you need to 2 know before you use Latanoprost

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 the

preservative benzalkonium chloride which may cause eye irritation.

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.

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 (see section 6 for the list of ingredients in your medicine).

•    pregnant or trying to become pregnant.

•    breast-feeding.

Warnings and precautions

Talk to your doctor or the doctor treating your child or your pharmacist before you take 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 no longer have an eye lens, your or your child’s posterior eye capsule has broken when putting in an artificial lens, an artificial lens was put in the anterior eye chamber or if you or your child have known risk factors (e.g. damage to the retina or retinal vein thrombosis) for the occurrence of macular oedema (accumulation of liquid at the back of the eye)

•    if you or your child are about to have or have had eye surgery

•    if you or your child have severe asthma or the asthma is not well controlled

•    if you or yor child suffer from dry eyes

•    if you or your child suffer from eye problems such as eye pain, irritation or inflammation, blurred vision

•    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

Please tell your doctor, the doctor treating your child or pharmacist if you or your child are taking or have recently taken any other medicines.

Concomitant use of two or more prostaglandin analogues is not

recommended since this may lead to an increase of the intraocular pressure.

Pregnancy,breast-feeding and fertility

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

How to use Latanoprost

Always use Latanoprost 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 your are not sure.

Dosage

The usual dose for adults (including the elderly) and children is:

One drop in the affected eye(s) once daily. 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

Please follow these instructions carefully when using Latanoprost eye drops solution. It is recommended that you wash your hands before putting in your eye drops.

Do not allow the tip of the container to touch your eye or areas around your eye. It may become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the container, keep the tip of the container away from contact with any surface.

1.    You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.

2.    To open the bottle unscrew the cap by turning it until the tamper-proof seal breaks.

3.    Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye (Fig. 1).

4. Invert the bottle, and press gently as shown (Fig. 2 and 3) until a single drop as instructed by your doctor is dispensed into your eye.

Do not touch your eye or eyelid with the tip of the container.

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5.    Gently close your eye and press a finger against the corner of the affected eye by the nose. Hold for 1 minute whilst keeping the eye closed.

6.    Repeat steps 3, 4 and 5 with the other eye if instructed to do so by your doctor.

7.    Reclose the bottle by turning the cap firmly immediately after use.

8.    The dispenser tip is designed to provide a pre-measured drop; therefore, do not enlarge the hole of the dispenser tip.

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 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 taking Latanoprost.

•    Accumulation of liquid at the back of the eye (macular oedema)

•    Symptomatic corneal oedema and erosions

•    Swelling around the eye

•    Growth of lashes in the "wrong" direction which may cause eye irritation

•    Growth of an extra row of eyelashes

•    Localized skin reaction on the eyelids

•    Darkening of skin of eyelids

•    Light sensitivity (photophobia)

•    Asthma, worsening of asthma symptoms, breathlessness (dyspnoea)

Very rare side effects (may affect up to 1 in 10000 people)

•    Worsening of angina pectoris symptoms

•    sunken eye appearance (eye sulcus deepening)

•    Chest pain

Frequency not known

(frequency cannot be estimated from the available data)

•    Headache

•    Dizziness

•    Palpitations (rapid or strong heartbeat)

•    Muscle pain

•    Joint pain

•    Fluid filled area within the coloured part of the eye (iris cyst)

•    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.

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.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Latanoprost

4 Possible side effects

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

The following have been seen with Latanoprost:

Very common side effects (may 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.

•    Mild to moderate redness of eyes

•    Burning sensation, grittiness, itching, stinging and foreign body sensation

•    Changes of eyelash and vellus hair such as increased length, thickness, pigmentation and number (especially applies to patients with Japanese origin)

Common side effects (may affect up to 1 in 10 people)

•    Transient punctual alterations of the corneal tissue (usually not causing discomfort)

•    Inflammation of the eyelids (blepharitis)

•    Irritation or disruption to the surface of the eye

•    Eye pain

Uncommon side effects (may affect up to 1 in 100 people )

•    Swelling of the eyelids

•    Dry eye

•    Inflammation or irritation of the surface of the eye (keratitis)

•    Painful watering of the eye

•    Blurred vision

•    Discharge from the eye with itching, redness and swelling

•    Skin rash

•    Conjunctivitis

Rare side effects (may affect up to 1 in 1000 people )

•    Uncomfortable sensitivity to light or painful red eye

•    Inflammation of the iris, the coloured part of the eye (iritis/uveitis)

•    Symptoms of swelling or scratching/damage to the surface of the eye

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 label and carton. The expiry date refers to the last day of that month.

Before Latanoprost is first opened: Store in a refrigerator (2°C to 8°C).

After first opening: Do not store above 25°C.

Store in the original container in order to protect from light.

Latanoprost should be used within 4 weeks after the bottle is first opened but not after the expiry date.

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

Contents of the pack and other information

What Latanoprost 0.005% w/v eye drops, Solution contains

The active substance is latanoprost.

1 ml of Latanoprost contains 50 microgram (equivalent to 0.005% w/v) of latanoprost.

1 drop contains approximately 1.5 microgram of latanoprost.

The other ingredients are: benzalkonium chloride, sodium dihydrogen phosphate dihydrate (E339), sodium chloride, anhydrous disodium phosphate (E339), water for injections. Sodium hydroxide or hydrochloric acid are used for adjusting the pH value.

What Latanoprost 0.005% w/v eye drops, Solution looks like and contents of the pack

Eye drops, solution.

Latanoprost eye drops, solution is a colourless solution.

5 ml LDPE bottle with LDPE dropper and HDPE screw cap.

Pack sizes: 1 x 2.5 ml, 3 x 2.5 ml and 6 x 2.5 ml. Not all pack sizes may be marketed.

Marketing authorization holder:

Sandoz Ltd., Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Aeropharm GmbH, Frangois-Mitterrand-Allee 1,

07407 Rudolstadt, Germany or Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,

39179 Barleben, Germany or Lek Pharmaceuticals d.d, Verovskova 57, 1526 Ljubljana Slovenia.

This leaflet was last revised in 12/2013.

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