Latanoprost 50 Micrograms/Ml Eye Drops Solution
PACKAGE LEAFLET: INFORMATION FOR THE USER
LATANOPROST-
50 micrograms/ml EYE DROPS SOLUTION latanoprost
Read all of this leaflet carefully before you start using this medicine. 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 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 the doctor treating your child or your pharmacist. See section 4.
In this leaflet:
1. What LATANOPROST is and what it is used for
2. Before you use LATANOPROST
3. How to use LATANOPROST
4. Possible side effects
5. How to store LATANOPROST
6. Further information
1. WHAT LATANOPROST IS AND WHAT IT IS USED FOR
LATANOPROST is a medicine for the treatment of increased intraocular pressure (pressure inside the eye). The active ingredient Latanoprost is one of a group of medicines known as prostaglandins.
Fluid known as aqueous humour is produced inside the eye. This fluid is then drained back into the bloodstream, thereby maintaining the required pressure within the eye. If this outflow is obstructed, pressure within the eye increases. The active ingredient latanoprost promotes the outflow of aqueous humour.
LATANOPROST is used:
- to reduce inner eye pressure in patients with open-angle glaucoma (damage to the optic nerve, caused by excessive pressure within the eye).
- to reduce inner eye pressure in patients who suffer from a condition known as ocular hypertension.
LATANOPROST is also used to treat increased eye pressure and glaucoma in all ages of children and babies.
2. 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. LATANOPROST has not been investigated in prematurely born infants (less than 36 weeks gestation).
Do not use LATANOPROST
- if you are allergic (hypersensitive) to latanoprost, or any of the other ingredients of LATANOPROST (see section 6. "Further information").
- if you are pregnant or trying to become pregnant
- if you are breast feeding
Take special care with LATANOPROST
Talk to your doctor or the doctor treating your child or your pharmacist before you take 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 have severe asthma, or the asthma is not well controlled
- if you or your child have had your eye lens removed
- if the posterior capsule (back membrane) of your or your child's eye was torn during implantation of an artificial lens
- if you or your child have had an artificial lens fitted
- if you or your child have any known risk factors for macular oedema (fluid build-up at the back of the eye). For example, risk factors may include diabetes-related damage to the retina or a blood clot in a vein within the retina (retinal vein thrombosis)
- if you or your child have recently had, or about to have eye surgery
- if you or your child have any known risk factors for eye irritations or inflammations
- if you have had or are currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV).
Using other medicines
Please tell your doctor, the doctor treating your child, or the pharmacist if you or your child are taking/using or have recently taken/used any other medicines, including medicines obtained without a prescription.
LATANOPROST and some other medicinal products may affect each other. This mutual influencing of effect is also known as an interaction.
Currently there is no definitive data available on interactions with LATANOPROST. Your doctor will decide whether you or your child can use LATANOPROST together with other medicines.
Elderly patients
LATANOPROST is also suitable for the treatment of elderly patients.
Contact lens wearers
Tell your doctor if you or your child wear contact lenses.
Please note the instructions in "Important information about some of the ingredients of LATANOPROST".
Pregnancy and breast-feeding
Pregnancy
Please tell your doctor if you are pregnant or planning a pregnancy. Not enough is known about the risks of using LATANOPROST during pregnancy. You must therefore not use LATANOPROST during pregnancy.
Breast-feeding
You must not breastfeed if you are using LATANOPROST.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
After putting in LATANOPROST eye drops, your vision may become temporarily impaired.
If you should experience blurred vision - particularly after just putting in LATANOPROST eye drops - you should
- not drive any vehicles.
- not use any tools or machines.
Important information about some of the ingredients of LATANOPROST
This medicinal product contains 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 putting them back in. Benzalkonium chloride is known to discolour soft contact lenses.
This medicine contains as an excipient approximately 90 mmol phosphate buffer. In patients with corneal disorders the risk of corneal calcifications exists. These patients should use phosphate-free preparations or such where the phosphate concentration is not higher than in the tear fluid (1.45 mmol/l).
3. HOW TO USE LATANOPROST
Always use LATANOPROST exactly as your doctor or the doctor treating your child has told you. You should check with your doctor or the doctor treating your child or the pharmacist if you are not sure.
Unless otherwise prescribed by the doctor, the usual dose is: Adults, including elderly patients and children: insert one drop once a day into each affected eye. The best time to do this is in the evening.
If you are using other eye drops in addition to LATANOPROST, these should be used at least 5 minutes apart.
Directions for use
1. Wash your hands and sit or stand in a comfortable position.
2. Remove the outer protective cap from the bottle.
3. Use your fingertip to gently pull down the lower lid of the affected eye.
4. Place the tip of the bottle close to, but not touching the eye. Carefully squeeze the bottle until one drop falls into your eye. Please make sure that you do not squeeze the bottle too hard, so that no more than one drop
falls into the affected eye.
5. Let go of your eyelid.
6. Press a finger against the corner of the affected eye by the nose. Hold for 1 minute whilst keeping the eye closed. This will prevent the drop from being absorbed into the body. If prescribed by your doctor, repeat the procedure in your other eye. If the drop should miss your eye, apply another drop.
7. Close the bottle.
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Your doctor or the doctor treating your chilld will tell for how long you or your child should use the eye drops.
If you use more LATANOPROST than you should
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If too many drops have gone 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.
Tell a doctor immediately if you, your child or anyone else has swallowed the eye drops by mistake, or if you or your child have been using the drops more often than prescribed.
Keep the pack of this medicine ready, so that the doctor can find out more about the medication. He/she will then decide what to do next.
If you forget to use LATANOPROST
If you or your child have forgotten to use your eye drops, continue your treatment as normal at the next dose. The daily dose of one drop into the affected eye should not be exceeded. Do not use a double dose to make up for a forgotten dose.
If you stop using LATANOPROST
Do not interrupt or stop your treatment with LATANOPROST without talking to your doctor or the doctor treating your child first.
If you or your child do not use LATANOPROST regularly or if you or your child frequently forget to use it, the success of the treatment may be at risk.
Increased intraocular pressure (pressure within the eye) can damage the optic nerve and worsen your eyesight. Blindness may occur. Normally, you can barely feel increased intraocular pressure. The disorder can only be diagnosed via an examination by an eye specialist. If you or your child suffer from increased intraocular pressure, regular eye tests are necessary, together with measurements of inner eye pressure. Pressure within the eye should be measured at least every 3 months. Visual field measurements and optic nerve examinations should be performed at least once a year.
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 can cause side effects, although not everybody gets them.
The following frequencies are used in evaluating side effects:
|
Very common: |
affects more than 1 user in 10 |
|
Common: |
affects 1 to 10 users in 100 |
|
Uncommon: |
affects 1 to 10 users in 1,000 |
|
Rare: |
affects 1 to 10 users in 10,000 |
|
Very rare: |
affects less than 1 user in 10,000 |
|
Not known: |
frequency cannot be estimated from the available data |
Very common:
- change in eye colour: LATANOPROST can slowly and permanently change eye colour, particularly in eyes of mixed colour (e.g. green-brown or blue-brown eyes).
The iris becomes browner and appears darker. Treatment of only one eye may permanently result in eyes with different colour
- redness of the eye
- eye irritation (including a slight feeling if there is something in your eyes)
- the eyelashes may become darker, thicker and longer, unusual hair growth on the eyelids (mostly in Japanese population)
Common:
- inflammation of the eyelid margins (blepharitis)
- eye pain
- light sensitivity (photophobia)
Uncommon:
- fluid accumulation in the eyelid
- dry eye
- inflammation of the cornea (keratitis)
- blurred vision
- conjunctivitis
- skin rash
Rare:
- fluid accumulation (oedema) in the eye region and cornea, as well as at the back of the eye (macular oedema), corneal tissue changes
- inflammation of the iris or the middle layer of the eye (iritis/ uveitis)
- dark discolouration of the eyelid skin,
- skin irritation on the eyelid
- misdirected eyelashes sometimes causing eye irritation, increased growth, darkening and thickness of eyelashes there could grow a second row of eyelashes
- asthma, worsening of existing asthma, shortness of breath
Very rare:
- worsening of existing feelings of a tightness in the chest (angina pectoris)
- chest pain
- sunken eye appearance (eye sulcus deepening).
Not known:
- fluid filled area within the coloured part of the eye (iris cyst).
- developing a viral infection caused by the herpes simplex virus (HSV)
- palpitations. This is when you experience an awareness of your heartbeat or when the heart may be beating irregularly.
- headache
- dizziness
- pain in the muscles or joints.
Side effects seen more often in children compared to adults are runny 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 of the cornea due to calcium build-up during treatment.
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.
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.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy
5. HOW TO STORE LATANOPROST
Keep out of the reach and sight of children.
Do not use LATANOPROST after the expiry date which is stated on the bottle label and carton after "EXP". The expiry date refers to the last day of that month.
Please note the following storage instructions:
Unopened bottles: Store in a refrigerator at 2° C - 8° C.
After first opening the bottle: Do not store above 25° C.
Once opened, you must discard the bottle - with any remaining contents - after 4 weeks. Otherwise, there is a risk of eye infection.
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 contains
The active substance is: latanoprost 1 ml eye drops, solution contains 50 micrograms latanoprost.
2.5 ml of eye drops, solution (content of a bottle) contains 125 micrograms of latanoprost.
- The other ingredients are:
Sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, purified water and benzalkonium chloride.
What LATANOPROST looks like and contents of the pack
LATANOPROST is a clear, colourless liquid packed in a transparent dropper bottle with a screw cap.
LATANOPROST is available in the following pack sizes:
1 dropper bottle containing 2.5 ml eye drops,
3 dropper bottles, each containing 2.5 ml eye drops,
6 dropper bottles, each containing 2.5 ml eye drops.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Beacon Pharmaceuticals Ltd., 85 High Street, Tunbridge Wells, TN1 1YG, UK.
Manufacturer
S.C. ROMPHARM COMPANY S.R.L., Eroilor Street, no. 1A, Otopeni 075100, Ilov., Romania.
This leaflet was last revised in 04/2014.
Beacon
PHARMACEUTICALS