Latanoprost 50 Micrograms/Ml Eye Drops Solution
Out of date information, search anotherPackage Leaflet: Information for the user
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Even if you have already used Latanoprost or a similar medicine before, we advise you to read this text carefully. The information may have been changed.
• 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 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 your pharmacist.
This includes any possible side effects not listed in this leaflet.
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
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. WHAT YOU NEED TO KNOW 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.
Do not use Latanoprost
• If you are allergic to latanoprost or any of the other ingredients of this medicine listed in section 6
• If you are pregnant
• If you are breast feeding
Warnings and precautions
Talk to your doctor or the doctor treating your child or your pharmacist before taking 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 use Latanoprost, but follow the instruction for contact lens wearers in Section 3
• If you have suffered or are currently suffering from viral infection of the eye caused by the herpes simplex virus (HSV)
Children & adolescents
There is limited experience with Latanoprost in infants less than one year of age.
Latanoprost has not been investigated in prematurely bom infants (less than 36 weeks gestation).
In children between the ages of birth and 3 years that suffer from Primary Congenital Glaucoma (PCG) surgery remains the first choice treatment.
Other medicines and Latanoprost
Latanoprost may interact with other medicines. Tell your doctor, the doctor treating your child or your pharmacist if you or your child are taking or have recently taken any other medicines.
Pregnancy & breast feeding Do not use this medicine:
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.
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
Latanoprost contains Benzalkonium Chloride
Latanoprost contains a preservative called benzalkonium chloride. This preservative may cause eye irritation or dismption 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, remove them before using this medicine. After using this medicine 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 this medicine exactly as described in this leaflet or as your doctor or the doctor treating your child has told you. Check with your doctor or the doctor treating your child, or your pharmacist, if you are not sure.
The recommended dose 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 this medicine more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.
Use this medicine 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 using this medicine. After using this medicine you should wait 15 minutes before putting the contact lenses back into the eye.
Instructions for use
• First wash your hands
• Avoid touching the eye (or any other surface) with the tip of the bottle
• If you wear soft contact lenses, they should be removed before using the eye drops and wait at least 15 minutes before reinserting
• These drops are supplied in a plastic bottle with an insert cap assembly, with a tamper proof dust cover. When using the bottle for the first time, snap off the dust cover by turning it clockwise to break the seal.
• Unscrew the inner cap
• Tilt your head back and look at the ceiling
• Pull the lower eyelid gently downwards
• Hold the bottle upside down above the eye and gently squeeze the bottle to release a drop into your eye
• Keep the affected eye closed and press your fingertip against the inside comer of the closed eye, and hold for 1 minute. This is important because it reduces the
amount of dmg that goes into the rest of your body
• Repeat for the other eye if necessary
• Recap the bottle after every use, tighten the inner cap on the nozzle
If you use this medicine with other eye drops
Wait at least 5 minutes between using Latanoprost and applying (or using) 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 or your pharmacist if you want to stop taking Latanoprost.
If you have any further questions on the use of this medicine, ask your doctor or the doctor treating your child or your pharmacist.
• Skin reactions on the eyelids, darkening
of the skin of the eyelids.
• Asthma, worsening of asthma and shortness of breath (dyspnoea).
Very rare effects (may affect up to 1 in 10,000 people):
• 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).
Additional side effects in children
Side effects seen more often in children compared to adults are: runny itchy nose and fever.
If you get any side effects, talk to your doctor or the doctor treating your child or your pharmacist. This includes any possible side effects not listed in this leaflet.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are related to the eye: Latanoprost may cause a gradual change in your eye colour and this may become permanent.
Very common effects (may affect more than 1 in 10 people):
• A gradual change in your eye colour (an increase in the amount of brown pigment in the coloured part of your eye). 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. 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. Your eye colour will not continue to change after you have stopped using Latanoprost.
• 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 (may affect up to 1 in 10 people):
• Irritation or disruption to the surface of the eye, eyelid inflammation (blepharitis) and eye pain.
Uncommon effects (may affect up to 1 in 100 people):
• Eyelid swelling, dryness of the eye, inflammation or irritation of the surface of the eye (keratitis), blurred vision and conjunctivitis.
• Skin rash.
Rare effects (may affect up to 1 in 1,000 people):
• 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.
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 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use . These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Latanoprost contains
The active substance is latanoprost 1 ml of solution contains 50 micrograms latanoprost.
The other ingredients (excipients) are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous and water for injections.
What Latanoprost looks like and contents of the pack
Latanoprost Eye Drops, Solution is a clear, colourless liquid.
Latanoprost Eye Drops, Solution is available in pack sizes of 1, 3 and 6 cartons. Not all pack sizes may be marketed.
Each carton contains one bottle of Latanoprost. Each bottle contains 2.5ml of Latanoprost Eye Drops, Solution.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: FDC Pharma
Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, P015 7FE, UK Tel: + 44 (0) 1489 565222 Fax: + 44 (0) 1489 565222 Email: fdcil@btconnect.com
Manufacturer:
FDC International Ltd.,
Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, P015 7FE, UK
PL number:
PL 35638/0003 (2.5 ml)
This leaflet was last revised in March 2012.
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE LATANOPROST