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.
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.
• If you are allergic (hypersensitive) to latanoprost or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
• 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 a viral infection of the eye caused by the herpes simplex virus (HSV)
Other medicines and Latanoprost
Pregnancy and breast-feeding
Driving and using machines
Latanoprost contains Benzalkonium chloride and phosphate buffers
This medicine contains 0.2 mg/ml of benzalkonium chloride.
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Talk to your doctor or the doctor treating your child or pharmacist before using Latanoprost or before you give this to your child if you think any of the following apply to you or your child:
Latanoprost 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.
You should not use latanoprost 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.
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.
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. 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 6.3 mg phosphates in each millilitre which is equivalent to approximately 0.2 mg phosphates per drop.
Contact lens wearers
Instructions for use 1. Wash your hands and sit or stand comfortably. 2. Unscrew the protective cap. The protective cap should be retained.
Figure 1
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If you suffer 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.
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 pharmacist if you are not sure.
The recommended 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 more than once a day, because the effectiveness of the treatment can be reduced if you administer it more often.
Use Latanoprost as instructed by your doctor or by the doctor treating your child until they tell you to stop.
If you or your child wear contact lenses, they should be removed before using Latanoprost. After using Latanoprost you should wait 15 minutes before putting the contact lenses back into the eyes.
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.
Figure 2
If you use Latanoprost with other eye drops Wait at least 5 minutes between using Latanoprost and taking other eye drops
Contact your doctor as soon as possible if you or your child swallows latanoprost accidentally.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following are known side effects of using Latanoprost:
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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. 7. Repeat in your other eye if your doctor has told you to do this. 8. Put the protective cap back on the bottle.
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.
If you forget to use Latanoprost 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 You should speak to your doctor or the doctor treating your child if you want to stop taking Latanoprost. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
sensitivity (photophobia), conjunctivitis.
Very rare (may affect up to 1 in 10,000 people):
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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 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 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 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, light
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), swelling of the retina (macular oedema). • Skin rash. • Chest pain (angina), awareness of heart rhythm (palpitations). • Asthma, shortness of breath (dyspnoea). • Chest pain. • Headache, dizziness. • Muscle pain, joint pain. • Nausea, vomiting.
Rare (may affect up to 1 in 1000 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, scarring of the surface of the eye, fluid filled 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).
Side effects seen more often in children compared to adults are runny itchy nose and fever.
Keep this medicine out of the sight and reach of children.
Store the unopened bottle in a refrigerator (2°C - 8°C). Do not freeze.
6. Content of the pack and other information
What Latanoprost contains
What Latanoprost looks like and contents of the pack
Latanoprost eye drops is a clear, colourless aqueous solution. Latanoprost is available in pack sizes of 1, 3 or 6 bottles. Not all pack sizes may be marketed.
Each bottle contains 2.5 ml of Latanoprost eye drops.
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• Worsening of angina in patients who also have heart disease, 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.
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, Website: www.mhra.gov.uk/yellowcard 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.
Do not use this medicine after the expiry date which is stated after EXP on the carton and bottle label. The expiry date refers to the last day of that month.
After first opening of the bottle: store below 25°C. Four weeks after first opening, this product should be disposed of, even if it has not been completely used up.
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.
The active substance is 50 micrograms/ml latanoprost. The other ingredients are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate anhydrous, Sodium hydroxide /or Hydrochloric acid 1N (for pH adjustment), Water for injections.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Neon Healthcare Ltd. 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom
Manufacturer
Rafarm S.A. Thesi Pousi-Xatzi Agiou Louka, Paiania-Attiki, 19002, P.O. Box 37, Greece
This leaflet was last revised in: 07/2022
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Latanoprost 50 micrograms/ml eye drops, solution comes as eye drops containing 50micrograms/ml. 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 50 micrograms/ml eye drops, solution is latanoprost.
Medicines with the same active substance, strength and form include: Xalatan 50 micrograms/ml eye drops solution. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Latanoprost 50 micrograms/ml 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).
Reduction of elevated IOP 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 is administered in the evening.
The dosage of latanoprost 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, solution 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 (4 patients) 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 latanoprost or to any of the excipients listed in section 6.1.
Iris pigmentation changes
Latanoprost 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 inpatients 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 can be continued if iris pigmentation ensues. However, patients should be monitored regularly and if the clinical situation warrants, latanoprost treatment may be discontinued.
There is limited experience of latanoprost in chronic angle closure glaucoma, open angle glaucoma of pseudophakic patients and in pigmentary glaucoma. There is no experience of latanoprost in inflammatory and neovascular glaucoma or inflammatory ocular conditions. Latanoprost 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 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 should be used with caution in these patients.
Latanoprost 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 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 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.
Preservative
Latanoprost eye drops solution contains benzalkonium chloride, which is 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 stimul
us 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. 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.
Contact lenses
Contact lenses may absorb benzalkonium chloride and these should be removed before applying latanoprost but may be reinserted after 15 minutes (see section 4.2).
Paediatric population
Efficacy and safety data in the age group < 1 year (4 patients) 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.
Long-term safety in children has not yet been established.
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 should not be used during pregnancy.
Breast-feeding
Latanoprost and its metabolites may pass into breast milk and latanoprost 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 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.
a. 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.
b. 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
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
Very Rare
<1/10,000
Infections and infestations
Herpetic keratitis*§
Nervous system disorders
Headache*; dizziness*
Eye disorders
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)
Punctate keratitis, mostly without symptoms; blepharitis; eye pain; photophobia; conjunctivitis*
Eyelid oedema; dry eye; keratitis*; vision blurred; macular oedema including cystoid macular oedema*; uveitis*
Iritis*; corneal oedema*; corneal erosion; periorbital oedema; trichiasis*; distichiasis; iris cyst*§; localised skin reaction on the eyelids; darkening of the palpebral skin of the eyelids; pseudopemphigoid of ocular conjunctiva*§
Periorbital and lid changes resulting in deepening of the eyelid sulcus
Cardiac disorders
Angina; palpitations*
Angina unstable
Gastrointestinal disorders
Nausea*, vomiting*
Respiratory, thoracic and mediastinal disorders
Asthma*; dyspnoea*
Asthma exacerbation
Skin and subcutaneous tissue disorders
Rash
Pruritus
Musculoskeletal and connective tissue disorders
Myalgia*; arthralgia*
General disorders and administration
Chest pain*
*ADR identified post-marketing
§ADR frequency estimated using “The Rule of 3”
Adverse reactions reported in phosphate containing eye drops:
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.
c. Description of selected adverse reactions
No information is provided.
d. 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, website: 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 is overdosed.
Treatment
If latanoprost is accidentally ingested the following information may be useful: One bottle contains 125 micrograms 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 occurs, treatment should be symptomatic.
Ask anything about Latanoprost 50 micrograms/ml 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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