Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
2. What do you need to know before you use Latanoprost eye drops
1 WHAT LATANOPROST EYE DROPS ARE
AND WHAT THEY ARE USED FOR
Latanoprost belongs to a group of medicines called prostaglandin analogues.
Latanoprost eye drops lower the pressure within your eye by increasing the natural fl ow of fl uid 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 aff ect 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 has 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 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 infl ammation, 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 or your child wear contact lenses, you can still use Latanoprost eyes drops, but follow the instruction for contact lenses wearers in section 3.
Other medicines and Latanoprost eye drops Latanoprost eyes drops may interact with other medicines. Please tell your doctor, the doctor treating your child or pharmacist if you or your child are using or have used any other medicines including those medicines (or eye drops) obtained without a prescription. In particular, speak to your doctor or pharmacist if you know that you are using prostaglandins, prostaglandin analogues or prostaglandin derivatives.
PACKAGE LEAFLET: Information for the user
Pregnancy, breast-feeding and fertility You should not use Latanoprost eyes drops if you are pregnant or breast-feeding unless your doctor considers it necessary. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
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 contains benzalkonium chloride and phosphate buff ers. This medicine contains 0.2 mg/ml benzalkonium chloride. 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 this medicine and put them back 15 minutes afterwards (see 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.
This medicine contains 9.34 mg/ml phosphates. If you suff er from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.
3 HOW TO USE LATANOPROST EYE DROPS
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 aff ected 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 fi nger to gently pull down the lower eyelid of your aff ected 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 fi nger against the corner of the aff ected 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 are
accidentally swallowed contact your doctor as soon as possible. Do not use Latanoprost eye drops more than once a day, because the eff ectiveness of the treatment can be reduced if you administer it more often.
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 eff ects, although not everybody gets them. The following are known side eff ects of using Latanoprost eye drops.
Very Common (may aff ect 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). If you experience eye irritation severe enough to make your eyes water excessively, or make you consider stopping this medicine, talk to your doctor, pharmacist or nurse promptly (within a week). You may need your treatment to be reviewed to ensure you keep receiving appropriate treatment for your condition. A gradual change to eyelashes of the
treated eye and the fi ne 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 aff ect up to 1 in 10 people): Irritation or disruption to the surface of
the eye, eyelid infl ammation (blepharitis), eye pain, light sensitivity (photophobia), conjunctivitis.
Uncommon (may aff ect up to 1 in 100 people): Eyelid swelling, dryness of the eye,
infl ammation or irritation of the surface of the eye (keratitis), blurred vision, infl ammation of the coloured part of the eye (uveitis), swelling of the retina (macular oedema). Skin rash. Chest pain (angina), awareness of heart
rhythm (palpitations). Asthma, shortness of breath (dyspnoea). Nausea, vomiting Chest pain. Headache, dizziness. Muscle pain, joint pain.
Rare (may aff ect up to 1 in 1,000 people): Infl ammation 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, scarring of the surface of the eye, fl uid
fi lled area within the coloured part of the eye (iris cyst). Skin reactions on the eyelids, darkening
of the skin of the eyelids. Worsening of asthma. Severe itching of the skin. Developing a viral infection of the eye
caused by the herpes simplex virus (HSV).
Very rare (may aff ect up to 1 in 10,000 people): Worsening of angina in patients who
also have heart disease, sunken eye appearance (eye sulcus deepening).
Side eff ects seen more often in children compared to adults are a runny itchy nose and fever.
Reporting side eff ects If you get any side eff ects talk to your doctor or pharmacist. This includes any possible side eff ects not listed in this leafl et. You can also report side eff ects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side eff ects you can help provide more information on the safety of this medicine.
5 HOW TO STORE LATANOPROST EYE
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 fi rst 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
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 sizes: 1 x 2.5ml, 3 x 2.5ml, 6 x 2.5ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom
Manufacturer: Zentiva k.s. U Kabelovny 130 Prague 10, 102 37 Czech Republic
This leafl et was last revised in March 2022.
Latanoprost 0.005% w/v eye drops solution comes as eye drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Latanoprost 0.005% w/v eye drops solution is latanoprost.
Medicines with the same active substance, strength and form include: Latanoprost 0.005% w/v eye drops solution. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Latanoprost 0.005% w/v eye drops solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Reduction of elevated intraocular pressure (IOP)
• in patients with open-angle glaucoma and ocular hypertension in adults (including the elderly).
• in paediatric patients with elevated IOP and paediatric glaucoma.
Posology
Adults (including the elderly)
Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if latanoprost eye drops is administered in the evening.
The dosage of latanoprost eye drops should not exceed once daily since it has been shown that more frequent administration decreases the IOP-lowering effect.
If one dose is missed, treatment should continue with the next dose as normal.
Paediatric population
Latanoprost eye drops may be used in paediatric patients at the same posology as in adults. No data are available for preterm infants (less than 36 weeks gestational age). Data in the age group < 1 year are limited (see section 5.1).
Method of administration
As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the instillation of each drop.
Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes.
If more than one topical ophthalmic medicinal product is being used, the medicinal products should be administered at least five minutes apart.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Iris pigmentation changes
Latanoprost eye drops may gradually change eye colour by increasing the amount of brown pigment in the iris. Before treatment is instituted, patients should be informed of the possibility of a permanent change in eye colour. Unilateral treatment can result in permanent heterochromia.
This change in eye colour has predominantly been seen in patients with mixed- coloured irides, i.e. blue-brown, grey-brown, yellow-brown and green-brown. In studies with latanoprost, the onset of the change is usually within the first 8 months of treatment, rarely during the second or third year, and has not been seen after the fourth year of treatment. The rate of progression of iris pigmentation decreases with time and is stable for five years. The effect of increased pigmentation beyond five years has not been evaluated. In an open 5-year latanoprost safety study, 33% of patients developed iris pigmentation (see section 4.8). The iris colour change is slight in the majority of cases and often not observed clinically. The incidence in patients with mixed colour irides ranged from 7 to 85%, with yellow-brown irides having the highest incidence. In patients with homogeneously blue eyes, no change has been observed and in patients with homogeneously grey, green or brown eyes, the change has only rarely been seen.
In a long-term observational paediatric study evaluating hyperpigmentation changes in the eye among patients with paediatric glaucoma, iris colour darkening and localised iris pigmentation were observed to a slightly greater extent in patients exposed to latanoprost group compared with the unexposed group (see section 5.1).
The colour change is due to increased melanin content in the stromal melanocytes of the iris and not to an increase in number of melanocytes. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may become more brownish. No further increase in brown iris pigment has been observed after discontinuation of treatment. It has not been associated with any symptom or pathological changes in clinical trials to date.
Neither naevi nor freckles of the iris have been affected by treatment. Accumulation of pigment in the trabecular meshwork or elsewhere in the anterior chamber has not been observed in clinical trials. Based on 5 years clinical experience, increased iris pigmentation has not been shown to have any negative clinical sequelae and latanoprost eye drops can be continued if iris pigmentation ensues. However, patients should be monitored regularly and if the clinical situation warrants, latanoprost eye drops treatment may be discontinued.
There is limited experience of latanoprost use in chronic angle-closure glaucoma, open-angle glaucoma of pseudophakic patients and in pigmentary glaucoma. There is no experience of latanoprost use in inflammatory and neovascular glaucoma or inflammatory ocular conditions. Latanoprost eye drops has no or little effect on the pupil, but there is no experience in acute attacks of closed-angle glaucoma. Therefore, it is recommended that latanoprost eye drops should be used with caution in these conditions until more experience is obtained.
There are limited study data on the use of latanoprost during the peri-operative period of cataract surgery. Latanoprost eye drops should be used with caution in these patients.
Latanoprost eye drops should be used with caution in patients with a history of herpetic keratitis, and should be avoided in cases of active herpes simplex keratitis and in patients with a history of recurrent herpetic keratitis specifically associated with prostaglandin analogues.
Reports of macular oedema have occurred (see section 4.8) mainly in aphakic patients, in pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema (such as diabetic retinopathy and retinal vein occlusion). Latanoprost eye drops should be used with caution in aphakic patients, in pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema.
In patients with known predisposing risk factors for iritis/uveitis, latanoprost eye drops can be used with caution.
There is limited experience from patients with asthma, but some cases of exacerbation of asthma and/or dyspnoea were reported in post marketing experience. Asthmatic patients should therefore be treated with caution until there is sufficient experience, see also section 4.8.
Periorbital skin discolouration has been observed, the majority of reports being in Japanese patients. Experience to date shows that periorbital skin discolouration is not permanent and in some cases has reversed while continuing treatment with latanoprost.
Latanoprost may gradually change eyelashes and vellus hair in the treated eye and surrounding areas; these changes include increased length, thickness, pigmentation, number of lashes or hairs and misdirected growth of eyelashes. Eyelash changes are reversible upon discontinuation of treatment.
Use of contact lenses
Latanoprost eye drops contains benzalkonium chloride, which is commonly used as a preservative in ophthalmic products. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Contact lenses should be removed before using this medicine and may be reinserted after 15 minutes (see section 4.2).
Benzalkonium chloride
Latanoprost eye drops contains benzalkonium chloride, commonly used as a preservative in ophthalmic products. From the limited data available, there is no difference in the adverse event profile in children compared to adults. Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye. Irritation may have an effect on treatment adherence in children. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Latanoprost eye drops should be used with caution in dry-eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.
.
Paediatric population
Efficacy and safety data in the age group < 1 year are very limited (see section 5.1). No data are available for preterm infants (less than 36 weeks gestational age).
In children from 0 to < 3 years old that mainly suffer from primary congenital glaucoma (PCG), surgery (e.g. trabeculotomy/goniotomy) remains the first-line treatment.
Definitive drug interaction data are not available.
There have been reports of paradoxical elevations in IOP following the concomitant ophthalmic administration of two prostaglandin analogues. Therefore, the use of two or more prostaglandins, prostaglandin analogues or prostaglandin derivatives is not recommended.
Paediatric population
Interaction studies have only been performed in adults.
Pregnancy
The safety of this medicinal product for use in human pregnancy has not been established. It has potential hazardous pharmacological effects with respect to the course of pregnancy, to the unborn or the neonate. Therefore, latanoprost eye drops should not be used during pregnancy.
Breast-feeding
Latanoprost and its metabolites may pass into breast milk, latanoprost eye drops should therefore not be used in breast-feeding women or breast feeding should be stopped.
Fertility
Latanoprost has not been found to have any effect on male or female fertility in animal studies (see section 5.3).
Latanoprost eye drops has minor influence on the ability to drive and use machines. In common with other eye preparations, instillation of eye drops may cause transient blurring of vision. Until this has resolved, patients should not drive or use machines.
Summary of the safety profile
The majority of adverse reactions relate to the ocular system. In an open 5-year latanoprost safety study, 33% of patients developed iris pigmentation (see section 4.4). Other ocular adverse reactions are generally transient and occur on dose administration.
Tabulated list of adverse reactions
Adverse reactions are categorized by frequency as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000), not known (frequency cannot be estimated from the available data).
System Organ Class
Frequency
Adverse reaction
Infections and infestations
Rare
Herpetic keratitis1,2.
Nervous system disorders
Uncommon
Headache1; dizziness1.
Eye disorders
Very common
Iris hyperpigmentation; mild to moderate conjunctival hyperaemia; eye irritation (burning, grittiness, itching, stinging and foreign body sensation); eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation and number of eyelashes).
Common
Punctate keratitis, mostly without symptoms; blepharitis; eye pain; photophobia; conjunctivitis1.
Uncommon
Eyelid oedema; dry eye; keratitis1; vision blurred; macular oedema including cystoid macular oedema1; uveitis1.
Rare
Iritis1; corneal oedema1; corneal erosion; periorbital oedema; trichiasis1; distichiasis; iris cyst1,2; localised skin reaction on the eyelids; darkening of the palpebral skin of the eyelids; pseudopemphigoid of ocular conjunctiva1,2.
Very rare
Periorbital and lid changes resulting in deepening of the eyelid sulcus.
Cardiac disorders
Uncommon
Angina; palpitations1.
Very rare
Angina unstable.
Respiratory, thoracic and mediastinal disorders
Uncommon
Asthma1; dyspnoea1.
Rare
Asthma exacerbation.
Gastrointestinal disorders
Uncommon
Nausea1, vomiting1
Skin and subcutaneous tissue disorders
Uncommon
Rash.
Rare
Pruritus.
Musculoskeletal and connective tissue disorders
Uncommon
Myalgia1; arthralgia1.
General disorders and administration site conditions
Uncommon
Chest pain1.
1 ADR identified post-marketing.
2 ADR frequency estimated using “The rule of 3”.
Phosphate buffers
Cases of corneal calcification have been reported very rarely in association with the use of phosphate-containing eye drops in some patients with significantly damaged corneas.
Description of selected adverse reactions
No information is provided.
Paediatric population
In two short-term clinical trials (≤ 12 weeks) involving 93 (25 and 68) paediatric patients, the safety profile was similar to that in adults and no new adverse events were identified. The short-term safety profiles in the different paediatric subsets were also similar (see section 5.1). Adverse events seen more frequently in the paediatric population as compared to adults are: nasopharyngitis and pyrexia.
In a long-term observational paediatric study involving 115 patients, the safety profile was consistent with that reported in previous paediatric studies and no new adverse events were identified (see section 5.1).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms
Apart from ocular irritation and conjunctival hyperaemia, no other ocular side effects are known if latanoprost eye drops is overdosed.
Treatment
If latanoprost eye drops are accidentally ingested the following information may be useful: one bottle contains 125 micrograms of latanoprost. More than 90% is metabolised during the first pass through the liver. Intravenous infusion of 3 micrograms/kg in healthy volunteers induced no symptoms, but a dose of 5.5-10 micrograms/kg caused nausea, abdominal pain, dizziness, fatigue, hot flushes and sweating. In monkeys, latanoprost has been infused intravenously in doses of up to 500 micrograms/kg without major effects on the cardiovascular system.
Intravenous administration of latanoprost in monkeys has been associated with transient bronchoconstriction. However, in patients with moderate bronchial asthma, bronchoconstriction was not induced by latanoprost when applied topically on the eyes in a dose of seven times the clinical dose of latanoprost.
If overdosage with latanoprost eye drops occurs, treatment should be symptomatic.
Ask anything about Latanoprost 0.005% w/v eye drops solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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