Latanoprost 0.005% W/V Eye Drops Solution
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3. HOW TO USE LATANOPROST EYE DROPS
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 pharmacist.
- This medicine has been prescribed for you or for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor (or the doctor treating your child) or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Latanoprost eye drops are and what they are used for
2. What you need to know 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. Contents of the pack and other information
1. WHAT LATANOPROST EYE DROPS ARE AND WHAT THEY ARE USED FOR
Latanoprost eye drops is a solution for use only in your eyes.
It contains a drug called latanoprost which belongs to a group of medicines called prostaglandins.
Latanoprost eye drops are used to lower raised pressure in your eye caused by a condition known as glaucoma or ocular hypertension (high pressure in the eye).
Latanoprost eye drops are also used to treat increased eye pressure and glaucoma in all ages of children and babies.
It works by increasing the natural outflow of fluid from inside the eye into the blood stream. If raised pressure in the eye is not treated it may affect your eyesight.
The effect (pressure lowering) will start within 3 - 4 hours after applying the drops, reaching maximum effect after 8 - 12 hours. The effect lasts for at least 24 hours.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST EYE DROPS
Latanoprost eye drops can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Latanoprost eye drops have not been investigated in prematurely born infants (less than 36 weeks gestation). Efficacy and safety data in children < 1 year are very limited.
Do not use Latanoprost eye drops:
- If you know you are (or your child is) allergic (causing red, itchy, swollen and watering eyes) to latanoprost or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions:
Talk to your doctor (or the doctor treating your child) or pharmacist before you use (or give your child) Latanoprost eye drops if you think any of the following apply to you (or your child):
- If the colour of your (or your child's) eyes is mixed, such as yellow-brown, grey-brown, blue-brown or green-brown using Latanoprost eye drops may cause eye colour to become browner. Change of colour is not seen in clear blue eyes, and very seldom in uniform grey, green or brown eyes. The changes usually happen gradually within the first 8 months of treatment or maybe later. You can continue treatment even if these changes occur as Latanoprost eye drops will still work. Please discuss with your
(or your child's) doctor before starting therapy as he/she will want to follow your treatment. Treatment of one single eye may cause a difference in eye colours.
- If your (or your child's) eye lid(s) or skin around the eye(s) turns darker brown.
- If you (or your child) have recently had, or are going to have eye surgery.
- If you (or your child) have ever been treated in the past for infections of the eye known as iritis and uveitis or a disease known as dry-eye syndrome.
Your (or your child's) doctor will be able to tell you about these.
- If you (or your child) have suffered or are currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV).
- If you (or your child) have severe asthma or the asthma is not well controlled.
- If you have (or your child has) an eye from which the lens is absent (aphakic) or you have (or your child has) partial or complete opacity of the lens of one or both eyes, which might impair vision or cause blindness (pseudoaphakic).
- If you (or your child) wear contact lenses. You can still use Latanoprost eye drops, but follow the instruction for contact lens wearers in Section 3.
Other medicines and Latanoprost eye drops
Tell your doctor (or the doctor treating your child) or pharmacist if you (or your child) are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
If you are using other types of eye drops together with Latanoprost eye drops, these should be put in 5 minutes before or 5 minutes after the application of Latanoprost eye drops.
Pregnancy and breast-feeding
Pregnancy
Do not use Latanoprost eye drops if you are pregnant, think you are pregnant, or are planning to become pregnant.
Breast-feeding
Do not use Latanoprost eye drops when you are breast-feeding.
Driving and using machines
Latanoprost eye drops has minor or moderate influence on the ability to drive and use machines. As with other eye drops your eyesight might be blurred or slightly impaired particularly when you first put the drops in. Wait until this wears off before you drive or use machines.
Important information about some of the ingredients of Latanoprost eye drops
Latanoprost eye drops contain benzalkonium chloride which may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.
Always use Latanoprost eye drops 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 childrenis one drop once a day in the affected eye(s). The best time to do this is in the evening. Do not use Latanoprost eye drops more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.
Use Latanoprost eye drops as instructed by your doctor (or the doctor treating your child) until they tell you to stop.
Instructions for use
1 .Wash your hands before using the drops.
2. Twist off the outer protective cap with the "wings".
3. Twist off the inner protective cap.
4. Lean your (or your child's) head backwards.
Pull down the lower eye-lid carefully with your forefinger.
5. Place the tip of the bottle close to but not touching the eye and press gently so that one drop goes into the eye to be treated.
6. Apply pressure on the nasal corner of the eye for 1 minute after application of eye drop, in order to minimise reabsorption of the active ingredient into the blood.
7. The protective cap should be replaced after use.
5. HOW TO STORE LATANOPROST EYE DROPS
If you (or your child) wear contact lenses
These must be removed before you put in the drops and should not be put back in until 15 minutes after you have applied the eye drops.
If you use more Latanoprost eye drops 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 eye drops accidentally. Always take the bottle or this leaflet with you.
If you forget to use Latanoprost eye drops
If you miss a dose continue with the next dose as normal.
Do not take a double dose to make up for a forgotten dose.
If you stop using Latanoprost eye drops
Do not stop the treatment unless told to do so by your doctor (or the doctor treating your child).
You should speak to your doctor (or the doctor treating your child) if you want to stop taking Latanoprost eye drops.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:
Very common side effects (affects more than 1 user in 10):
- 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 eye drops 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 eye drops 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.
Unknown side effects (frequency cannot be estimated from the available data):
- Fluid filled area within the coloured part of the eye (iris cyst).
- Headache.
- Dizziness.
- Palpitations (irregular or rapid heartbeats).
- Muscle ache and painful joints.
- Viral infection of the eye caused by the herpes simplex virus (HSV).
Additional side effects in children
Side effects seen more often in children compared to adults are:
- Runny itchy nose.
- Fever.
If you get any side effects, talk to your doctor (or the doctor treating your child) or pharmacist. This includes any side effects not listed in this leaflet.
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C). Do not freeze.
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 4 weeks.
Do not use this medicine after the expiry date which is stated on the carton after EXP The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the solution is not clear and colourless.
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 eye drops contain
The active substance is latanoprost.
1 ml of eye drops contains 50 micrograms of latanoprost.
2.5 ml bottle of eye drops contains 125 micrograms of latanoprost.
The other ingredients are benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, purified water.
See section 2 of this leaflet for important information about benzalkonium chloride.
Common side effects (affects 1 to 10 users in 100):
- Irritation or disruption to the surface of the eye, eyelid inflammation (blepharitis) and eye pain.
Uncommon side effects (affects 1 to 10 users in 1,000):
- Eyelid swelling, dryness of the eye, inflammation or irritation of the surface of the eye (keratitis), blurred vision and conjunctivitis.
- Skin rash.
Rare side effects (affects 1 to 10 users in 10,000):
- 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.
- Skin reactions on the eyelids, darkening of the skin of the eyelids.
- Asthma, worsening of asthma and shortness of breath (dyspnoea).
What Latanoprost eye drops look like and contents of the pack
Eye drops, solution. A clear colourless solution.
Pack sizes:1 x 2.5ml eye drops, 3 x 2.5ml eye drops, 6 x 2.5ml eye drops. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder: Arrow Generics Limited,
Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom.
Manufacturer: Arrow Generiques SAS,
26 Avenue Tony Garnier, 69007 Lyon, France.
This leaflet was last revised on 05/2013.
Very rare side effects (affects less than 1 user in 10,000):
- Worsening of angina in patients who also have heart disease.
- Chest pain.