Latanoprost 0.005% W/V Eye Drops Solution
777222WTH/6J
Read all of this leaflet carefully before you (or a child in your care) 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 pharmacist.
- This medicine has been prescribed for you 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
In the next sections, the word “you” means you or a child in your care.
What is in this leaflet:
1. What Latanoprost eye drops are and what they are used for
2. What do 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
Do not take Latanoprost eye drops with any other medicines containing prostaglandin because this may increase the pressure in your eye(s).
If you have to use other eye drops you should wait for at least five minutes before using them.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Latanoprost eye drops should not be used during pregnancy.
Latanoprost may pass into breast milk and should not be used when breast feeding.
Driving and using machines
When you use Latanoprost eye drops 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 eye drops contain benzalkonium chloride.
This preservative may cause irritation and can discolour soft contact lenses.
1. WHAT LATANOPROST EYE DROPS ARE AND WHAT THEY ARE USED FOR
3. HOW TO USE LATANOPROST EYE DROPS
Latanoprost belongs to a group of medicines called prostaglandins. Latanoprost eye drops lower the pressure within your eye by increasing the natural flow of fluid from inside the eye into the blood stream.
Latanoprost eye drops are used to treat open angle glaucoma and ocular hypertension. These conditions are caused by an increase in the pressure in your eye. If they are not treated they may affect your eyesight.
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)
2. WHAT DO YOU NEED TO KNOW BEFORE YOU USE LATANOPROST EYE DROPS
Do not use Latanoprost eye drops
- if you are allergic to the active substance latanoprost or any of the other ingredients of this medicine (listed in section 6).
Warning and precautions
Talk to your doctor or pharmacist before using Latanoprost eye drops, if you or your child have now or have had in the past:
• eye surgery such as cataract surgery or are about to have eye surgery.
• eye problems (such as eye pain, irritation or inflammation, blurred vision).
• dry eyes
• severe asthma, or your asthma is not well controlled
• viral infection of the eye caused by the herpes simplex virus (HSV).
If you wear contact lenses, they should be removed before using Latanoprost eye drops. After using Latanoprost eye drops you should wait 15 minutes before putting the contact lenses back in. See instructions for contact lens wearers in Section 3.
Other medicines and Latanoprost eye drops
Tell your doctor or pharmacist if
you or your child are taking, have recently taken or might take any other medicines (or eye drops).
Latanoprost eye drops and other medicines taken at the same time can affect each other.
Always use Latanoprost eye drops exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for adults (including elderly) and children is one drop of Latanoprost eye drops dropped into the affected eye(s) once daily.
The best time to do this is in the evening.
How to use Latanoprost eye drops Follow the steps below to help you use Latanoprost eye drops properly:
1. Wash your hands and sit or stand comfortably.
2. Unscrew the outer protective cap.
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 and 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 cap back on the bottle.
If you use Latanoprost eye drops with other eye drops
Wait at least 5 minutes between using Latanoprost eye drops and taking other eye drops.
Contact lens wearers
If you wear contact lenses, they should be removed before using Latanoprost eye drops. After using Latanoprost eye drops you should wait 15 minutes before putting the contact lenses back in.
If you use more Latanoprost eye drops than you should
If you put too many drops in your eye, you may feel some slight irritation in the eye or have some redness around the eye. If this does not stop or Latanoprost eye drops is accidentally swallowed contact your doctor as soon as possible.
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.
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If you forget to use Latanoprost eye drops
If you forget to apply your drops at the usual time, just skip that dose. Do not take a double dose to make up for the missed dose. Instead, just wait until the next time you are supposed to take it, and then take your normal dose.
If you stop using Latanoprost eye drops
Latanoprost eye drops should be used until your doctor tells you to stop. If you stop using this medicine the pressure in your eye could increase.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very Common: (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, greeen 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 appear to be no problems associated with the change in eye colour. The 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). If this happens to you stop taking the drops and contact your doctor.
• 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 eyelashes.
Common: (may affect up to 1 in 10 people):
• slight damage to the cornea (front part of the eye) which lasts for a short time
• irritation or swelling around the edges of the eyelids (blepharitis)
• eye pain
• light sensitivity (photophobia)
Uncommon: (may affect up to 1 in 100 people):
• eyelid swelling
• dry eye
• inflammation or irritation of the surface of the eye (keratitis)
• blurred vision
• pink eye (conjunctivitis)
• skin rash
Rare: (may affect up to 1 in 1,000 people):
• inflammation of the coloured part of your 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)
• eyelashes growing in the wrong direction sometimes resulting in eye irritation. Tell your doctor if these lashes cause irritation. Your eyelashes may return to normal when you stop treatment with Latanoprost eye drops.
• growth of an extra row of eyelashes
• asthma, worsening asthma and difficulty in breathing. If you have any difficulty in breathing, including asthma, it is very important that you stop taking the eye drops and contact your doctor immediately.
• skin reaction on the eyelids
• darkening of eyelids or skin around the eye. These changes may be more noticeable if you are only treating one eye.
Very rare: (may affect up to 1 in 10,000 people):
• sunken eye appearance (eye sulcus deepening)
• worsening of angina in patients who also have heart disease
• chest pain. If you have pain in your chest or worsening of your angina it is very important that you stop taking the eye drops and contact your doctor immediately.
Not known: (frequency cannot be estimated from available data):
• developing a viral infection of the eye caused by the herpes simplex virus (HSV)
• headache, dizziness
• fluid filled area within the coloured part of the eye (iris cyst)
• awareness of your heartbeat (palpitations)
• muscle pain; joint pain
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 side effects
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.
5. HOW TO STORE LATANOPROST EYE DROPS
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 (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 first opening the bottle: do not store above 25°C and use within four weeks.
Do not use Latanoprost eye drops if you notice the bottle is damaged or eye drops don't look right in some other way.
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 contains
The active substance is latanoprost 50 micrograms in one ml.
The other ingredients are: sodium chloride, benzalkonium chloride, sodium dihydrogen phosphate monohydrate, anhydrous disodium phosphate, water for injections
What Latanoprost eye drops looks like and contents of the pack
Dropper polyethylene container of 5 ml with tamper evident polyethylene screw cap.
Each bottle contains 2.5 ml eye drops solution corresponding to approximately 80 drops of solution.
Pack size: 1 x 2.5 ml
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva, One Onslow Street,
Guildford, Surrey, GU1 4YS, UK Manufacturer
Tubilux Pharma S.p.A., Via Costarica 20/22 - 00071 Pomezia (RM)-Italy
This leaflet was last revised in October 2015.
© 2015 Zentiva 777222WTH/6J
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