Patient leaflet - LATANOPROST 50 MICROGRAMS / ML EYE DROPS SOLUTION
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Package leaflet: Information for the user
Latanoprost 50 micrograms/ml Eye Drops Solution
Read all of this leaflet carefully before you 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 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 or your child 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. See section 4.
- 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.
What is in this leaflet:
I^What Latanoprost eye drops are and what they are used for
^iWhat you need to know before you use Latanoprost eye drops
3,How to use Latanoprost eye drops
^Possible side effects
5,How to store Latanoprost eye drops
^Contents of the pack and other information
JWhat Latanoprost eye drops are and what they are used for
Latanoprost eye drops belong 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 eye drops are used to treat conditions known as open angle glaucoma and ocular hypertension. Both of these conditions are linked with an increase in the pressure within your eye, eventually affecting your eye sight.
Latanoprost eye drops are also used to treat increased eye pressure and glaucoma in all ages of children and babies.
^iWhat you need to know before you use Latanoprost eye drops
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 has not been investigated in prematurely born infants (less than 36 weeks gestation).Do not use Latanoprost eye drops if you
- are allergic to latanoprost or any of the other ingredients of this medicine (listed in section 6).
- are pregnant or trying to become pregnant
- breast-feeding.
Warnings and precautions
Talk to your doctor or the doctor treating your child or your pharmacist before using Latanoprost eye drops 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 eye drops, but follow the instructions for contact lens wearers in Section 3
- If you or your child have suffered or are currently suffering from a viral infection of the eye caused by the herpes simplex virus (HSV)
Other medicines and Latanoprost eye drops
Latanoprost eye drops may interact with other medicines: Tell your doctor, the doctor treating your child or pharmacist if you or your child are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding Do not use Latanoprost eye drops when you are pregnant. Tell your doctor immediately if you are pregnant, think you are pregnant, or are planning to become pregnant.
Breast-feeding
Do not use Latanoprost eye drops when you are 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 medicine contains 0.5 mg benzalkonium chloride in each 2.5ml bottle which is equivalent to 0.2 mg/ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using Latanoprost eye drops and put them back 15 minutes afterwards. See the instructions for contact lens wearers in Section 3.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
How to use Latanoprost eye drops
Always use this medicine 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 pharmacist if you are not sure.
The usual dosage 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 Latanoprost eye drops more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often. Use Latanoprost eye drops as instructed by your doctor or 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 Latanoprost eye drops. After using Latanoprost eye drops you should wait 15 minutes before putting your contact lenses back into the eyes.
Instructions for use:
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1. Wash your hands and sit or stand comfortably.
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2. Twist off the cap.
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3. Use your finger to gently pull down the lower eyelid of your affected eye.
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4. Place the tip of the bottle close to, but not touching your eye.
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5. Squeeze the bottle gently so that only one drop goes into your eye, then release the lower eyelid.
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6. Press a finger against the corner of the affected eye by the nose. Hold for 1 minute whilst keeping the eye closed.
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7. Repeat in your other eye if your doctor has told you to do this.
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8. Replace cap 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
If you use more Latanoprost eye drops 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 eye drops accidentally.
If you forget to use Latanoprost eye drops
Carry on with the usual dosage at the usual time. Do not take 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 eye drops
You should speak to your doctor or the doctor treating your child if you want to stop taking Latanoprost eye drops.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following are known side effects of using Latanoprost eye drops:
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, green 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 appears to be no problems associated with the change in eye colour. The eye 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).
- 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 (may affect up to 1 in 10 people):
- Irritation or disruption to the surface of the eye, eyelid inflammation (blepharitis), eye pain and light sensitivity (photophobia), conjunctivitis.
Uncommon (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.
- Inflammation of the coloured part of the eye (uveitis).
- Skin rash.
- Headache, dizziness.
- Chest pain (angina); awareness of heart rhythm (palpitations).
- Asthma and shortness of breath (dyspnoea).
- Muscle pain, joint pain.
- Swelling of the retina (macular oedema).
Rare (may affect up to 1 in 1,000 people):
- Inflammation of the iris (iritis);
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.
- Skin reactions on the eyelids, darkening of the skin of the eyelids.
- Worsening of asthma
- Viral infection of the eye caused by the herpes simplex virus (HSV).
- Fluid filled area within the coloured part of the eye (iris cyst).
- Drug reaction inflammation to the membranes around the eye (pseudopemphigoid of ocular conjunctiva)
- Severe itching of the skin.
Very rare (may affect up to 1 in 10,000 people):
- Unstable angina, sunken eye appearance (eye sulcus deepening).
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.
Additional side effects in children
Side effects seen more often in children compared to adults are runny itchy nose and fever.
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: or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 sight and reach of children.
Do not use this medicine 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 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.
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.
^Contents of the pack and other 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, 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 Accord, Barnstaple, EX32 8NS, UK
Manufacturers
HBM Pharma s. r. o.
Sklabinska 30, 036 80 Martin
Slovak Republic
Jadran Galenski Laboratorij d.d. Svilno 20, Rijeka, 51000, Croatia
This leaflet was last revised in December 2020
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