Latanoprost 0.005% W/V Eye Drops Solution
Original Artwork Scale = 1:1 (100%) 50mm
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.
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 the Yellow Card Scheme at: 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 EYE DROPS
Keep out of the reach and sight 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 Latanoprost eye drops after the expiry date which is stated on the carton and the bottle after EXP The expiry date refers to the last day of that month.
Do not use Latanoprost eye drops if you notice that the solution is not clear and colourless.
The other ingredients are benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, purified water.
What Latanoprost eye drops look like and contents of the pack
Eye drops, solution.
A clear colourless solution.
Pack sizes: 1 x 2.5 ml eye drops,
3 x 2.5 ml eye drops, 6 x 2.5 ml eye drops.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder: Teva UK Limited, Eastbourne, BN22 9AG.
Manufacturer:
Merckle GmbH,
Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren, Germany.
This leaflet was last revised in 03/2014
PL 00289/1668
PACKAGE LEAFLET: INFORMATION FOR THE USER
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:
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.
FURTHER INFORMATION
What Latanoprost eye drops contain:
The active substance is latanoprost.
1 ml of eye drops contains 50 micrograms of latanoprost.
One drop contains approximately 1.56 micrograms of latanoprost.
2.5 ml bottle of eye drops contains 125 micrograms of latanoprost.
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
OWHAT 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).
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.
Latanoprost eye drops is/are also used to treat increased eye pressure and glaucoma in all ages of children and babies.
©BEFORE YOU USE
LATANOPROST EYE DROPS
Do not use Latanoprost eye drops:
• If you are allergic (causing red, itchy, swollen and watering eyes) to latanoprost or any of the other ingredients of this medicine (listed in section 6).
Take special care with Latanoprost eye drops:
• If the colour of your eyes is mixed, such as yellow-brown, grey-brown, blue-brown or green-brown using Latanoprost eye drops may cause your 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 doctor before starting therapy as he will want to follow your treatment. Treatment of one single eye may cause a difference in eye colours.
• If your eye lid(s) or skin around the eye(s) turns darker brown • If you have recently had, or are going to have a surgical operation on your eyes
• If you 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 doctor will be able to tell you about these.
• If you have asthma tell your doctor • If you have an eye from which the lens is absent (aphakic) or you have partial or complete opacity of the lens of one or both eyes, which might impair vision or cause blindness (pseudoaphakic).
Latanoprost eye drops should be used with caution in patients with a history of herpetic keratitis, and should be avoided in cases of active herpes simplex keratitis and in patients with a history of recurrent herpetic keratitis specifically associated with prostaglandin analogues.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
Definitive drug interaction data are not available.
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
The unborn child might be affected. Therefore Latanoprost eye drops should not be used during pregnancy.
If you are pregnant, think you may be pregnant or are planning to have a baby, please tell your doctor.
Breast-feeding
The child might be affected. Latanoprost eye drops should not be used when breast-feeding.
Driving and using machines
As with other eye drops your eyesight might be blurred or slightly impaired particularly when you first put the drops in. 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 eye drops
Latanoprost eye drops contains benzalkonium chloride. This preservative may cause eye irritation. Benzalkonium chloride may be absorbed by contact lenses and it is known to discolour soft contact lenses. Therefore, avoid contact with contact lenses. Remove contact lenses prior to application of Latanoprost eye drops and wait at least 15 minutes before putting them back in (see section 3 "HOW TO USE LATANOPROST EYE DROPS").
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.
Adults (including the elderly) and children (from birth to 18 years of age):
The usual dosage is 1 drop in the affected eye(s) 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.
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 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.
If you 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.
Prematurely born infants
Latanoprost has not been investigated in prematurely born infants (less than 36 weeks gestation).
If you use more Latanoprost eye drops than you should
An overdose can cause irritation in your eyes. Your eyes may become itchy, red and may stick together. Contact your doctor or nearest hospital if you have used far too much Latanoprost eye drops, or if you or someone else drinks the fluid by accident. 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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 POSSIBLE SIDE EFFECTS
Like all medicines, Latanoprost eye drops 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):
• The iris might turn darker brown, especially in people with mixed eye colour i.e. yellow-brown, grey-brown, blue-brown or green-brown eyes. See Section 2 "Take special care with Latanoprost eye drops"
• Redness of the eye
• Eye irritation (burning, grittiness, itching, stinging, including feeling that there is a foreign body in your eye)
• a gradual change to eyelashes and to fine hairs around the treated eye (darkening, thickening, lengthening, increased number) (mostly in Japanese people).
Common side effects (affects 1 to 10 users in 100):
• Irritation or disruption to the surface of the eye
• Inflammation of the eyelid (blepharitis)
• Eye pain.
Uncommon side effects (affects 1 to 10 users in 1,000):
• Puffy, swollen and sore eyelids (oedema)
• Dry eyes
• Infection of the cornea (keratitis)
• Blurred vision
• Conjunctivitis
• Skin rash.
Rare side effects (affects 1 to 10 users in 10,000):
• Inflammation of the front of the eye including the iris (iritis/uveitis)
• Blurred vision from swelling at the back of the eye
• Swelling and small scratches to the front surface of the eye
• Swelling of the skin around the eyes
• Changes in the texture of the fine hair on the eyelids and direction of growth of the eyelashes sometimes resulting in eye irritation
• Localised skin reaction on the eyelids
• Worsening of asthma symptoms and sudden asthma attacks with breathlessness
• Darkening of eye lids
• Growth of extra eyelashes from the glands of the upper or lower eyelid (distichiasis).
Very rare side effects (affects less than 1 user in 10,000):
• Chest pain
• Worsening of chest pain (angina) in patients suffering with heart disease
• sunken eye appearance (eye sulcus deepening).
Unknown side effects (frequency cannot be estimated from the available data):
• Palpitations (irregular or rapid heartbeats)
• Headache
• Dizziness
• Muscle ache and painful joints
• Fluid filled area within the coloured part of the eye (iris cyst)
• Inflammation of the cornea of the eye caused by the herpes simplex virus (herpetic keratitis).