Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Travoprost may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for 2. What you need to know before you use Travoprost 3. How to use Travoprost 4. Possible side effects 5. How to store Travoprost 6. Contents of the pack and other information 1. WHAT TRAVOPROST IS AND WHAT IT IS USED FOR Travoprost eye drops are used to treat high pressure in the eye in adults, adolescents and children from 2 months old onward. This pressure can lead to an illness called glaucoma. High pressure in the eye. Your eyeballs contain a clear, watery liquid which feeds the inside of the eye. Liquid is always emptying out of the eye, and more liquid is always being produced. If the eye fills up faster than it empties, the pressure inside the eye builds up. If it gets too high, it can damage your sight. Travoprost is one of a group of medicines for glaucoma called prostaglandin analogues. It works by increasing the outflow of liquid, which lowers the pressure in the eye. It may be used on its own or with other drops e.g. beta-blockers, which also reduce pressure. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TRAVOPROST Do not use Travoprost
TRAVOPROST Always use this medicine exactly as your doctor or the doctor treating your child has told you. Check with your doctor, the doctor treating your child or pharmacist if you are not sure. Only use Travoprost for dropping in your or your child's eyes.
The recommended dose is One drop in the affected eye or eyes, once a day – in the evening. Only use Travoprost in both eyes if your doctor told you to. Use this medicine for as long as your doctor or the doctor treating your child told you to. • Immediately before using a bottle for the first time, tear-off the overwrap pouch (picture 1). Take out the bottle and write the date of opening on the label in the space provided.
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience side effects, you can usually carry on using the drops, unless the side effects are serious. If you are worried, talk to your doctor or pharmacist. Do not stop using Travoprost without speaking to your doctor. The following side effects have been seen with Travoprost. Very common (may affect more than 1 in 10 people) Effects in the eye:
TRAVOPROST 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 bottle and the box after 'EXP'. The expiry date refers to the last day of that month. Do not use this medicine if you notice that the tamper evident seal has been broken or damaged before you first open it. Before opening, keep bottle in overwrap pouch in order to protect from moisture. After first opening, this medicine does not require any special storage conditions. You must throw away the bottle 4 weeks after you first opened it, to prevent infections, and use a new bottle. Write down the date you opened the bottle in the space on each bottle label and box. 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.
1010268-P7.1B
Packaging Information: Product Name: Travoprost 40mcg/ml eye drops, solution Pl No:17277/0318 Dimensions: 160mm x 400mm Type:Leaflet Version No:7.1B Date amended: 10.1.25 Font:Tahoma Average font size: 8 Reason for change:New cutter guide for Balkanpharma packing site Software:Adobe Indesign Created by: NR
Colour: Pantone: PMS Black
What Travoprost contains
Travoprost 40 micrograms/ml eye drops, solution comes as eye drops containing 40micrograms/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 Travoprost 40 micrograms/ml eye drops, solution is travoprost.
Medicines with the same active substance, strength and form include: TRAVATAN 40 micrograms/mL eye drops solution, Travoprost Mylan 40 micrograms/ml Eye Drops. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Travoprost 40 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.
Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1).
Decrease of elevated intraocular pressure in paediatric patients aged 2 months to < 18 years with ocular hypertension or paediatric glaucoma (see section 5.1).
Posology
Use in adults, including the elderly population
The dose is one drop of Travoprost Pharmathen in the conjunctival sac of the affected eye(s) once daily. Optimal effect is obtained if the dose is administered in the evening.
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
If more than one topical ophthalmic medicinal product is being used, the medicinal products must be administered at least 5 minutes apart (see section 4.5).
If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily.
When substituting another ophthalmic antiglaucoma medicinal product with Travoprost Pharmathen, the other medicinal product should be discontinued and Travoprost should be started the following day.
Hepatic and renal impairment
Travoprost has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 mL/min). No dose adjustment is necessary in these patients (see section 5.2).
Paediatric population
Travoprost can be used in paediatric patients from 2 months to < 18 years at the same posology as in adults. However, data in the age group 2 months to < 3 years (9 patients) is limited (see section 5.1).
The safety and efficacy of travoprost in children below the age of 2 months have not been established. No data are available.
Method of administration
For ocular use.
For patients who wear contact lenses, please refer to section 4.4.
The patient should remove the protective overwrap immediately prior to initial use. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eye colour change
Travoprost may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes. Before treatment is instituted, patients must be informed of the possibility of a permanent change in eye colour. Unilateral treatment can result in permanent heterochromia. The long term effects on the melanocytes and any consequences thereof are currently unknown. The change in iris colour occurs slowly and may not be noticeable for months to years. The 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; however, it has also been observed in patients with brown eyes. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may be become more brownish. After discontinuation of therapy, no further increase in brown iris pigment has been observed.
Periorbital and eye lid changes
In controlled clinical trials, periorbital and/or eyelid skin darkening in association with the use of travoprost has been reported in 0.4% of patients. Periorbital and lid changes including deepening of the eyelid sulcus have also been observed with prostaglandin analogues.
Travoprost may gradually change eyelashes in the treated eye(s); these changes were observed in about half of the patients in clinical trials and include: increased length, thickness, pigmentation, and/or number of lashes. The mechanism of eyelash changes and their long term consequences are currently unknown.
Travoprost has been shown to cause slight enlargement of the palpebral fissure in studies in the monkey. However, this effect was not observed during the clinical trials and is considered to be species specific.
There is no experience of travoprost in inflammatory ocular conditions; nor in neovascular, angle-closure, narrow-angle or congenital glaucoma and only limited experience in thyroid eye disease, in open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative glaucoma. Travoprost should therefore be used with caution in patients with active intraocular inflammation.
Aphakic patients
Macular oedema has been reported during treatment with prostaglandin F2a analogues. Caution is recommended when using travoprost in aphakic patients, pseudophakic patients with a torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema.
Iritis/uveitis
In patients with known predisposing risk factors for iritis/uveitis, travoprost should be used with caution.
Contact with the skin
Skin contact with travoprost must be avoided as transdermal absorption of travoprost has been demonstrated in rabbits.
Prostaglandins and prostaglandin analogues are biologically active materials that may be absorbed through the skin. Women who are pregnant or attempting to become pregnant should exercise appropriate precautions to avoid direct exposure to the contents of the bottle. In the unlikely event of coming in contact with a substantial portion of the contents of the bottle, thoroughly cleanse the exposed area immediately.
Excipients
Travoprost Pharmathen contains benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses. Contact with soft contact lenses is to be avoided.
Patients must be instructed to remove contact lenses prior to application of Travoprost Pharmathen and wait 15 minutes after instillation of the dose before reinsertion.
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.
Travoprost Pharmathen contains macrogolglycerol hydroxystearate 40 which may cause skin reactions.
Paediatric population
Efficacy and safety data in the age group 2 months to < 3 years (9 patients) is limited (see section 5.1). No data are available for children below the age of 2 months.
In children < 3 years old that mainly suffer from PCG (primary congenital glaucoma), surgery (e.g. trabeculotomy/goniotomy) remains the first line treatment.
No long-term safety data are available in the paediatric population.
No interaction studies have been performed.
Women of child-bearing potential/contraception
Travoprost must not be used in women of child-bearing age/potential unless adequate contraceptive measures are in place (see section 5.3).
Pregnancy
Travoprost has harmful pharmacological effects on pregnancy and/or the foetus/new-born child. Travoprost should not be used during pregnancy unless clearly necessary.
Breast-feeding
It is unknown whether travoprost from the eye drops is excreted in human breast milk. Animal studies have shown excretion of travoprost and metabolites in breast milk. The use of travoprost by breast-feeding mothers is not recommended.
Fertility
There are no data on the effects of travoprost on human fertility. Animal studies showed no effect of travoprost on fertility at doses more than 250 times the maximum recommended human ocular dose.
Travoprost has no or negligible influence on the ability to drive and use machines, however as with any eye drop, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.
Summary of the safety profile
In clinical trials with travoprost, the most common adverse reactions were ocular hyperaemia and iris hyperpigmentation, occurring in approximately 20% and 6% of patients respectively
Tabulated list of adverse reactions
The following adverse reactions are classified according to the following convention: 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), or very rare (<1/10,000), or not known (frequency cannot be estimated from the available data). Within each frequency group, adverse reactions are presented in decreasing order of seriousness. The adverse reactions were obtained from clinical studies and post marketing data with travoprost.
System Organ Class
Frequency
Adverse Reactions
Immune system disorders
Uncommon
hypersensitivity, seasonal allergy
Psychiatric disorders
Not known
depression, anxiety, insomnia
Nervous system disorders
Uncommon
headache
Rare
dizziness, visual field defect, dysgeusia
Eye disorders
Very common
ocular hyperaemia
Common
iris hyperpigmentation, eye pain, ocular discomfort, dry eye, eye pruritus, eye irritation
Uncommon
corneal erosion, uveitis, iritis, anterior chamber inflammation, keratitis, punctate keratitis, photophobia, eye discharge, blepharitis, erythema of eyelid, periorbital oedema, eyelids pruritus, visual acuity reduced, vision blurred, lacrimation increased, conjunctivitis, ectropion, cataract, eyelid margin crusting, growth of eyelashes
Rare
iridocyclitis, ophthalmic herpes simplex, eye inflammation, photopsia, eczema eyelids, conjunctival oedema, halo vision, conjunctival follicles, hypoaesthesia eye, trichiasis, meibomianitis, anterior chamber pigmentation, mydriasis, asthenopia, eyelash hyperpigmentation, eyelash thickening
Not Known
macular oedema, lid sulcus deepened
Ear and labyrinth disorders
Not known
vertigo, tinnitus
Cardiac disorders
Uncommon
palpitations
Rare
heart rate irregular, heart rate decreased
Not known
chest pain, bradycardia, tachycardia, arrhythmia
Vascular disorders
Rare
blood pressure diastolic decreased, blood pressure systolic increased, hypotension, hypertension
Respiratory, thoracic and mediastinal disorders
Uncommon
cough, nasal congestion, throat irritation
Rare
dyspnoea, asthma, respiratory disorder, oropharyngeal pain, dysphonia, rhinitis allergic, nasal dryness
Not known
asthma aggravated, epistaxis
Gastrointestinal disorders
Rare
peptic ulcer reactivated, gastrointestinal disorder, constipation, dry mouth
Not known
diarrhoea, abdominal pain, nausea, vomiting
Skin and subcutaneous tissue disorders
Uncommon
skin hyperpigmentation (periocular), skin discolouration, hair texture abnormal, hypertrichosis
Rare
dermatitis allergic, dermatitis contact, erythema, rash, hair colour changes, madarosis
Not Known
pruritus, hair growth abnormal
Musculoskeletal and connective tissue disorders
Rare
musculoskeletal pain, arthralgia
Renal and urinary disorders
Not known
dysuria, urinary incontinence
General disorders and administration site conditions
Rare
asthenia
Investigations
Not known
prostatic specific antigen increased
Paediatric Population
In a 3 month phase 3 study and a 7 days pharmacokinetic study, involving 102 paediatric patients exposed to travoprost, the types and characteristics of adverse reactions reported were similar to what has been observed in adult patients. The short-term safety profiles in the different paediatric subsets were also similar (see section 5.1). The most frequent adverse reactions reported in the paediatric population were ocular hyperaemia (16.9%) and growth of eyelashes (6.5%). In a similar 3 month study in adult patients, these events occurred at an incidence of 11.4% and 0.0%, respectively.
Additional adverse drug reactions reported in paediatric patients in the 3 month paediatric study (n=77) compared to a similar trial in adults (n=185) included erythema of eyelid, keratitis, lacrimation increased, and photophobia all reported as single events with an incidence of 1.3% versus 0.0% seen in adults
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).
No cases of overdose have been reported. A topical overdose is not likely to occur or to be associated with toxicity. A topical overdose of travoprost may be flushed from the eye(s) with lukewarm water. Treatment of a suspected oral ingestion is symptomatic and supportive.
Ask anything about Travoprost 40 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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