Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Relestat, 0.5 mg/ml, eye drops, solution.
⚠ This medicine appears to have been discontinued
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 Epinastine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Relestat is an anti-allergic medicine. It is an eye drops solution used to treat the symptoms of seasonal allergic conjunctivitis, a seasonal allergic disease affecting the eye. The main symptoms treated by Relestat include watery eyes and eyes or eyelids which are itchy, red or swollen.
What you need to know before you take it
e Relestat Do not use Relestat:
- if you are allergic to epinastine hydrochloride or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using Relestat. •
if you wear soft contact lenses: you must remove them before using the Relestat eye drops. After using Relestat, wait at least 15 minutes before putting your lenses back in. See also in section 2, "Relestat contains benzalkonium chloride".
•
if you have to use any other eye drops during treatment with Relestat: leave at least 10 minutes between putting in Relestat and the other drops.
Other medicines and Relestat Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. If you have to use any other eye drops during treatment with Relestat, please see above under "Warnings and precautions" in this section. Pregnancy and breast-feeding Pregnancy If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Breast-feeding It is not known whether Relestat passes into breast milk. Ask your doctor or pharmacist for advice before using this medicine during breast-feeding. Driving and using machines Your sight may become blurred for a short time just after using Relestat. You should not drive or use machines until your sight is clear again. Relestat contains benzalkonium chloride and phosphates This medicine contains 0.5 mg benzalkonium chloride in each 5 ml of solution which is equivalent to 0.1 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 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 23.75 mg phosphates in each 5 ml, which is equivalent to 4.75 mg/ml. 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 (see section 4).
How to take it
Relestat Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Use in children Relestat should not be used in children below 12 years of age.
Use in adults and adolescents (12 years of age and older)
The recommended dose is 1 drop in each eye that needs treatment, twice a day, for example in the morning and in the evening. You should use Relestat every day that you experience eye symptoms during the allergy season but for no longer than 8 weeks. Instructions for use You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first begin to use it. Apply your eye drops in the following way:
1. Wash your hands. Tilt your head back and look at the ceiling. 2. Gently pull the lower eyelid down until there is a small "pocket". 3. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment. 4. Let go of the lower lid, and close your eye for 30 seconds. If a drop misses your eye, try again. To avoid contamination of the solution in the bottle, do not let the tip of the dropper touch your eye or anything else. Replace and tighten the cap straight after use. Wipe off any excess liquid from your cheek with a clean tissue. The proper application of your eye drops is very important. If you have any questions ask your doctor or pharmacist. If you use more Relestat than you should If you use more drops of Relestat than you should, it is unlikely to cause you any harm. Put your next drop(s) in at the usual time. If you are worried, talk to your doctor or pharmacist. If you forget to use Relestat If you forget a dose apply it as soon as you remember, unless it is almost time for your next dose, in which case you should miss out the forgotten dose. Then, use your next dose at the usual time and continue with your normal routine. Do not use a double dose to make up for a forgotten dose. If you stop using Relestat Relestat should be used as advised by your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. None of the side effects are likely to be serious; most side effects are likely to be mild and only affect the eye. If the following happens, stop using Relestat and contact your doctor immediately or go to your nearest hospital: • • •
asthma (an allergic disease affecting the lungs that causes breathing difficulties) if you experience symptoms of angioedema (swelling of face, tongue or throat; difficulty swallowing; hives and breathing difficulties)
The following side effects may also occur: Common (may affect up to 1 in 10 people) •burning sensation or irritation of the eye (mostly mild) Uncommon (may affect up to 1 in 100 people) General side effects: • headache • swelling and irritation inside the nose, which may cause a runny or blocked nose and sneezing • unusual taste in your mouth
Possible side effects
affecting the eye: • red eyes • dry eyes • itchy eyes • difficulty in seeing clearly • discharge from the eyes Not known (frequency cannot be estimated from the available data): increased tear production • eye pain • allergic reaction affecting the eyes • swelling of the eyes • swelling of the eyelids • skin rash and redness Other side effects reported with eye drops containing phosphate This medicine contains 23.75 mg phosphates in each 5 ml which is equivalent to 4.75 mg/ml. 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 (see section 2). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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.
How to store it
Relestat 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 label of the bottle and on the box after EXP. Do not use this medicine if you notice that the eye drops have shown signs of deterioration, for example change in colour, and take the product back to your pharmacist. Do not store above 25°C. Keep the bottle in the box in order to protect from light. You must throw away the bottle 28 days after you first opened it, even if there are still some drops left. This will guard against infection. To help you remember, write down the date that you opened it in the space on the 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.
Contents of the pack and other information
What Relestat contains The active substance is epinastine hydrochloride. One ml of eye drops, solution, contains 0.5 mg of epinastine hydrochloride. The other ingredients are benzalkonium chloride (a preservative), disodium edetate, sodium chloride, sodium dihydrogen phosphate dihydrate, sodium hydroxide/hydrochloric acid (to adjust pH) and purified water. What Relestat looks like and contents of the pack Relestat is a clear and colourless eye drops solution in a plastic bottle with a screw-cap. When unopened, each bottle is about half full and contains 5 ml of solution. Each pack contains 1 bottle. Marketing Authorisation Holder AbbVie Ltd. Maidenhead SL6 4UB UK +44(0) 1628-561090 Manufacturer Allergan Pharmaceuticals Ireland
Castlebar Road Westport County Mayo Ireland This medicinal product is authorised in the Member States of the EEA under the following names: Name of the Member State Austria, Belgium, Denmark, Germany, Greece, Hungary, Ireland, Italy, Luxemburg, Netherlands, Portugal, Spain, Sweden, United Kingdom Czech Republic, France, Slovak Republic
Name of the medicinal product RELESTAT PURIVIST
This leaflet was last revised in August 2025
To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the Marketing Authorisation Holder.
Frequently asked questions about Relestat, 0.5 mg/ml, eye drops, solution.
How do I take Relestat, 0.5 mg/ml, eye drops, solution.?
Relestat, 0.5 mg/ml, eye drops, solution. comes as eye drops containing 0.5mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Relestat, 0.5 mg/ml, eye drops, solution.?
The active substance in Relestat, 0.5 mg/ml, eye drops, solution. is epinastine hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Relestat, 0.5 mg/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.
Can I get Relestat, 0.5 mg/ml, eye drops, solution. without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: epinastine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of the symptoms of seasonal allergic conjunctivitis.
4.2. Posology and method of administration
Posology
The recommended dose for adults is one drop instilled in each affected eye twice daily, during the symptomatic period.
There is no experience in clinical studies with the use of Relestat for more than 8 weeks.
Elderly
Relestat has not been studied in elderly people. Post-marketing safety data from the tablet formulation of epinastine hydrochloride (up to 20 mg once daily) indicates that there are no particular safety issues for elderly compared with adult patients. As such, no dosage adjustment is considered to be necessary.
Paediatric population
The safety and efficacy in children ≥ 12 years has been established in clinical trials. Relestat may be used in adolescents (12 years of age and older) at the same dosage as in adults.
The safety and efficacy of Relestat in children aged less than 3 years have not been established. No data are available. There are limited data on the safety in children aged 3-12 years described in section 5.1.
Patients with hepatic impairment
Relestat has not been studied in patients with hepatic impairment. Post-marketing safety data from the tablet formulation of epinastine hydrochloride (up to 20 mg once daily) indicates that the incidence of adverse reactions was higher in this group compared with adult patients without hepatic impairment. The daily dose of a 10 mg epinastine hydrochloride tablet is more than 100-fold higher than the daily dose following Relestat. In addition, the metabolism of epinastine in humans is minimal (<10%). Therefore, no dosage adjustment is considered to be necessary.
Patients with renal impairment
Relestat has not been studied in patients with renal impairment. Post-marketing safety data from the tablet formulation of epinastine hydrochloride (up to 20 mg once daily) indicate that there are no particular safety issues for patients with renal impairment. As such, no dosage adjustment is considered to be necessary.
Method of administration
Relestat is for topical ophthalmic use only.
To avoid contamination of the eye or eye drops, do not allow the dropper tip to come into contact with any surface.
If more than one topical ophthalmic medicinal product is being used, the different medicinal products should be administered at least 10 minutes apart.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Relestat is for topical ophthalmic use only and not for injection or oral use.
Excipients with known effect
Benzalkonium chloride
Benzalkonium chloride is commonly used as a preservative in ophthalmic products and has been reported rarely to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. Patients should be instructed to remove contact lenses before using this medicine and put them back 15 minutes afterwards.
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.
Phosphates
Relestat also contains phosphates. 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 (see section 4.8)
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
No drug-drug interactions are anticipated in humans since systemic concentrations of epinastine are extremely low following ocular dosing. In addition, epinastine is mainly excreted unchanged in humans indicating a low level of metabolism.
4.6. Fertility, pregnancy and lactation
Pregnancy
Data on a limited number (11) of exposed pregnancies indicate no adverse effects of epinastine on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development (see section 5.3).
Caution should be exercised when prescribing to pregnant women.
Breast-feeding
Epinastine is excreted in the breast milk of rats, but it is not known if epinastine is excreted in human milk. Due to the lack of experience, caution should be exercised when prescribing to breast-feeding women.
Fertility
There are no adequate data from the use of epinastine on fertility in humans.
4.7. Effects on ability to drive and use machines
Based on the pharmacodynamic profile, reported adverse reactions and specific psychometric studies, Relestat has no or negligible influence on the ability to drive and use machines.
If transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.
4.8. Undesirable effects
Summary of the safety profile
In clinical studies, the overall incidence of adverse reactions following Relestat was less than 10%. No serious adverse reactions occurred. Most were ocular and mild. The most common adverse reaction was burning sensation in eye (mostly mild); all other adverse reactions were uncommon.
Tabulated list of adverse reactions
Within each frequency grouping, adverse reactions are presented according to System Organ Class in order of decreased seriousness. The following terminologies have been used in order to classify the occurrence of undesirable effects: 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); not known (cannot be estimated from the available data).
The following adverse reactions have been reported with epinastine:
System Organ Class
Frequency
Adverse reaction
Immune system disorders
Not known
Hypersensitivity reaction including symptoms or signs of eye allergy and extra-ocular allergic reactions, including angioedema, skin rash and redness
Nervous system disorders
Uncommon
Headache
Eye disorders
Common
Burning sensation, eye irritation
Uncommon
Conjunctival/ocular hyperaemia, eye discharge, eye dryness, eye pruritus, visual disturbance
Not known
Increased lacrimation, eye pain, eye swelling, eyelid oedema
Respiratory, thoracic and mediastinal disorders
Uncommon
Asthma, nasal irritation, rhinitis
Gastrointestinal disorders
Uncommon
Dysgeusia
Paediatric population
Frequency, type and severity of adverse reaction in adolescents ≥ 12 years of age are expected to be the same as in adults.
There is limited experience in children aged 3-12 years regarding frequency, type and severity of adverse reactions.
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 (see section 4.4).
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:
Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
After instillation of 0.3% epinastine hydrochloride eye drops 3 times daily (corresponds to 9 times the recommended daily dose) reversible miosis, without influence on visual acuity or other ocular parameters, was observed.
The 5 ml bottle of Relestat contains 25 mg of epinastine hydrochloride. A tablet formulation is marketed at a once daily dose of up to 20 mg epinastine hydrochloride, as such, intoxication after oral ingestion of the ophthalmic formulation is not expected even if the whole content of the bottle is swallowed.
No case of overdose has been reported.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- RelestatEpinastini hydrochloridum · eye / ear / nose
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Relestat, 0.5 mg/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.