Latanoprost 50 Micrograms/Ml Eye Drops Solution
Latanoprost 50micrograms/ml Eye Drops Solution
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.
• The full name of this medicine is Latanoprost 50micrograms/ml Eye Drops Solution but within the leaflet it will be referred to as Latanoprost eye drops.
In this leaflet:
11 What Latanoprost eye drops are and what they are used for
^1 Before you use Jl How to use 5 Possible side effects 5| How to store 6| Further information
j What Latanoprost eye drops are and what they are used for
Latanoprost are eye drops used in patients with a condition known as open angle glaucoma which causes an increase in pressure in the eye.
The active ingredient in Latanoprost eye drops is one of a group of medicines known as prostaglandins. Latanoprost eye drops are a medicine that lowers the pressure within your eye by increasing the natural outflow of fluid from inside the eye into the blood stream.
2) Before you use
Do not use Latanoprost eye drops if you
• are allergic (hypersensitive) to latanoprost or any of the other ingredients of Latanoprost eye drops.
Use in children and adolescents
Latanoprost eye drops is not recommended for use in children and adolescents below 18 years.
Take special care with Latanoprost eye drops if you
• have severe asthma, or your asthma is not well controlled.
• have a certain form of glaucoma known as chronic narrow-angle glaucoma!
• have glaucoma at the same time as having no lens or artificial lens.
• have glaucoma caused by pigments forming within the eye's angle chamber.
• have glaucoma caused by eye inflammation or new blood vessels forming within the eye.
• have congenital glaucoma.
• before or after cataract surgery.
• have a vascular disorder affecting the eye or abnormalities of the retina, as a result of diabetes.
• suffer from dry eyes; your doctor will closely monitor this.
• have a disorder in which the cornea may be affected; your doctor will closely monitor this.
• wear contact lenses. You can still use Latanoprost eye drops, but follow the instructions for contact lens wearers in section 3 (How to use).
Tell your treating doctor if any of the above warnings apply to you, or have ever applied to you in the past.
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.
It is possible that Latanoprost eye drops may interact with other medicines:
The effect of prostaglandins or prostaglandin derivatives (used in increased eye pressure) can be influenced by Latanoprost eye drops. Combining these with Latanoprost eye drops is not recommended, as the eye pressure may increase.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
It cannot be excluded that the child might be affected. Latanoprost eye drops should not be used during pregnancy or 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.
Important information about some of the ingredients of Latanoprost eye drops
Latanoprost eye drops contains a preservative called benzalkonium chloride which may cause eye irriation. Benzalkonium chloride is known to discolour soft contact lenses. Therefore, avoid contact with soft contact lenses.
If you wear contact lenses, follow the instructions for contact lens wearers in section 3 (How to use).
How to use
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.
The usual dose is: one eye drop in the affected eye(s) once daily. The best time to do this is in the evening.
Take care when squeezing the bottle, so that you insert only one drop into the affected eye.
Do not use Latanoprost eye drops more than once a day, because the effect of treatment can be reduced if used more frequently.
If you have to use other eye medicinal products you should wait for at least five minutes after using Latanoprost eye drops before using your other eye medicinal product.
If you wear contact lenses
If you wear contact lenses, you should remove them before using Latanoprost eye drops. After using Latanoprost eye drops you should wait 15 minutes before putting your contact lenses back in.
Latanoprost eye drops are not recommended for use in children and adolescents below 18 years.
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Follow the steps below to help you use Latanoprost eye drops properly:
1. Wash your hands and sit or stand comfortably.
2. Twist off the 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, 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. Replace cap on the bottle.
If you use more Latanoprost eye drops than you should
Be careful when you are squeezing the bottle so that you only put one drop into the affected eye. If you put too many drops in your eye, you may feel some slight irritation in the eye.
If Latanoprost eye drops are accidentally swallowed, you should contact your doctor.
If you forget to use Latanoprost eye drops
If you forget to use your eye drops at the usual time, wait until it is time for your next dose.
Do not put an extra drop into your eye to make up for the one you may have missed.
If you stop using Latanoprost eye drops
Use Latanoprost eye drops until your doctor tells you to stop using it.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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 (affects more than 1 user in 10):
• eye colour discolouration (turning browner and darker);
• red and streaming eyes, a burning, prickling, itching and stinging feeling in the eyes; it may feel as if there is something in your eye(s);
• increase in number of - or darkening, thickening or lengthening of - eyelashes and fine hair on the eyelids.
Common (affects 1 to 10 users in 100):
• inflammation of the eyelid edges
• temporary erosions on the surface of the eye (usually not causing discomfort)
• eye pain.
Uncommon (affects 1 to 10 users in 1,000):
• swollen eyelids
• dry eyes
• inflammation of the cornea
• blurred vision
• conjunctivitis
• skin rash.
Rare (affects 1 to 10 users in 10,000):
• certain forms of eye inflammation (iritis, uveitis)
• swelling (oedema) and erosions on the cornea
• swelling around the orbit of the eye (periorbital oedema)
• in-grown eyelashes, which may occasionally lead to eye irritation
• asthma, worsening of asthma symptoms and shortness of breath (dyspnoea)
• skin rash of the eyelids
• dark discolouration of the eyelid skin
• growth of an extra row of eyelashes.
Very rare (affects less than 1 user in 10,000):
• chest pain
• worsening symptoms of angina pectoris.
Other side effects which have been reported since latanoprost was marketed (frequency unknown):
• headache
• dizziness
• palpitations
• muscle ache and painful joints.
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.
How to store
Keep out of the reach and sight of children.
Do not use Latanoprost eye drops after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Keep the bottle in the outer carton in order to protect from light.
Before opening the bottle:
Store in a refrigerator (2°C - 8°C).
This medicinal product should also be kept refrigerated during transport from the manufacturer to the pharmacy. It is although not necessary for you to keep it refrigerated during transport e.g. from the pharmacy to your home.
After first opening the bottle:
Do not store above 25°C and use within four weeks.
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.
6| Further information What Latanoprost eye drops contain
• The active substance is latanoprost. One ml of eye drop, solution, contains 50micrograms latanoprost. One drop contains approximately 1.5micrograms latanoprost.
• The other ingredients are benzalkonium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous, sodium chloride, purified water.
What Latanoprost eye drops look like and contents of the pack
Latanoprost is a clear, colourless eye drop solution in a plastic bottle with a dropper and plastic cap. Each bottle contains 2.5ml eye drops, solution corresponding to approximately 80 drops of solution.
Latanoprost eye drops are available in packs of 1 bottle.
Marketing Authorisation Holder
Actavis Group PTC ehf, Reykjavikurvegur 76-78,
220 Hafnarjordur, Iceland
Manufacturers
HBM Pharma s.r.o, Sklabinska 30,
036 80 Martin,
Slovak Republic
Jadran Galenski Laboratorij d.d.,
Pulac 4A, 51000 Rijeka, Croatia
This leaflet was last revised in May2014
Actavis, Barnstaple, EX32 8NS, UK
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AAAG8363