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.
Oxybuprocaine hydrochloride contains the active substance oxybuprocaine hydrochloride, a local anaesthetic, which is particularly suitable for numb the surface of the eye temporarily. Your doctor or eye specialist will use it:
• to examine your eye without it being painful,
• to measure the pressure inside your eye,
• to perform minor operations such as the removal of stitches and foreign bodies,
• for the fitting of contact lenses,
Oxybuprocaine hydrochloride is indicated for the treatment of adults, adolescents and children.
The medicinal product can only be used for a short period of time.
Do not use Oxybuprocaine hydrochloride • if you are allergic to oxybuprocaine hydrochloride or any of the other ingredients of this medicine (see section 6).
• If you are using at the same time as Oxybuprocaine hydrochloride other eye drops containing chlorhexidine acetate as a preservative.
Take special care • If you have had an allergic reaction to other local anaesthetics in the past. Inform your doctor or eye specialist.
• When your eye has been numbed it is important not to rub it and to keep it free of dust and bacterial contamination. Your doctor or eye specialist will make sure that your eye is properly protected.
• If you have an inflamed eye, as red eyes greatly increase the passage into the blood stream through the surface of the eyes.
Your eye drops are not intended for long term use. Frequent use of local anaesthetic in the eye over long periods of time may severely affect your eyesight.
Other medicines and Oxybuprocaine hydrochloride Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Oxybuprocaine hydrochloride is not compatible with:
• silver nitrate (bactericide);
• mercury salts (disinfectants);
• alkaline substances (e.g. detergents).
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
The use of oxybuprocaine hydrochloride during pregnancy and lactation has not been adequately studied. Your doctor will assess whether the benefits to you clearly outweigh the risks to the foetus/child before giving you Oxybuprocaine hydrochloride .
Driving and using machines Wait until the anaesthetic effect of Oxybuprocaine hydrochloride has worn off before driving vehicles or using machines.
Oxybuprocaine hydrochloride contains boric acid Do not administer to children under 2 years of age without medical advice, as this medicine contains boron and may impair fertility in the future, if it is used more frequently than medically advised.
Contact lenses Your doctor will ask you to remove your contact lenses prior to the administration of the drops. There is no information on the effect of this product on contact lenses. Therefore, do not wear your contact lenses until the effects of the drops have completely worn off.
Dosage The amount of anaesthetic used will vary, depending on the procedure decided by your doctor or eye specialist:
• One drop of solution is enough to allow your doctor or eye specialist to measure the pressure inside your eye.
• Two drops, one and a half minutes apart is enough to allow contact lenses to be fitted.
• Three drops at one and a half minute intervals is enough to allow minor operations to be performed.
Method of administration The doctor or eye specialist will put the drops in your eye for you. You may be asked to press on the inner corners of your eyelid for 3 minutes. This will help stop the solution draining into your nose and throat. This is especially advisable in children, the elderly and population at risk.
Your eye will remain numb for about one hour, depending on how many drops you received. Avoid touching the eye until the anaesthetic has worn off.
If you have other eye drops to instill, you should wait at least 15 minutes before administering them.
If you use more Oxybuprocaine hydrochloride than you should, an overdose is very unlikely to occur.
If you suddenly feel unwell after receiving the drops, tell your doctor or eye specialist or contact your nearest emergency department immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Oxybuprocaine Hydrochloride does not usually cause side effects, but allergic reactions (including anaphylactic shock have occasionally occurred.
The symptoms of anaphylaxis/anaphylactic shock (severe allergic reactions) are difficulty breathing or swallowing, swelling of the face, lips, throat or tongue and severe skin rash. You should inform your doctor immediately if you get any of these symptoms.
The symptoms of an allergic reaction are redness, swelling and itching of the eyes.
Oxybuprocaine Hydrochloride may sting when the drops are first put in and your vision may become blurred. Eye irritation may also occur. This will gradually wear off.
Other side effects
Not known: frequency cannot be estimated from the available data.
This medicine can affect the cornea (the transparent membrane covering the iris and the pupil of the eye), causing intense discomfort, pain, redness, sensitivity to light or loss of visual acuity (the clarity or sharpness of vision).
Red, swollen or itchy eyes, burning or tearing of the eyes, itchy eyelids, foreign body sensation may also occur.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.
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 after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not freeze.
For single use only.
After the first opening of the sachet: use the single-dose containers within 3 months.
After the first opening of the single-dose container: use immediately and discard the single-dose container even if partially used.
Do not use this medicine if you notice changes in the colour of the solution or the appearance of a sediment (visible solid particles).
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.
What Oxybuprocaine hydrochloride contains • The active substance is oxybuprocaine hydrochloride. Each ml of solution contains 4.0 mg of oxybuprocaine hydrochloride.
• The other ingredients are: boric acid, purified water.
What Oxybuprocaine hydrochloride looks like and contents of the pack Eye drops of 20 or 30 unit single-dose containers in neutral colour, divided in 2 or 3 strips of 10 containers, are contained in PET/Al/PE pouches (1 strip in each pouch) and then in a suitable box, together with the leaflet.
Each carton box contains 20 or 30 single-dose polyethylene containers containing 0.5 ml of solution.
Each single-dose container contains 12 drops.
Not all pack sizes may be marketed.
Marketing Authorisation Holder MARKETING AUTHORISATION HOLDER:
Alfa Intes Limited
Second Floor
150 Fleet Street
London
EC4A 2DQ
UK
DISTRIBUTOR
Penlan Pharmaceuticals Ltd
45-47 Monument Hill
Weybridge
KT13 8RN
UK
Manufacturer ALFA INTES Industria Terapeutica Splendore S.r.l.
Via F.lli Bandiera, 26
80026 Casoria (NA)
Italy
This leaflet was last revised in November 2025
Penlan Pharmaceuticals Ltd
Address
45-47 Monument Hill, Weybridge, KT13 8RN, UK
Telephone
+44 345 241 4330
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Oxybuprocaine hydrochloride 4 mg/ml eye drops, solution in single-dose container comes as drops containing 4 mg/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 Oxybuprocaine hydrochloride 4 mg/ml eye drops, solution in single-dose container is oxybuprocaine hydrochloride.
Medicines with the same active substance include: Minims Oxybuprocaine Hydrochloride 0.4% w/v. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Oxybuprocaine hydrochloride 4 mg/ml eye drops, solution in single-dose container, 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.
Oxybuprocaine hydrochloride 4 mg/ml eye drops is indicated in adults, adolescents and children as a topical ocular anaesthetic.
Adults (including the elderly) and children
One drop is sufficient when dropped into the conjunctival sac to anaesthetise the surface of the eye to allow tonometry after one minute. A further drop after 90 seconds provides adequate anaesthesia for the fitting of contact lenses. Three drops at 90 second intervals provides sufficient anaesthesia for a foreign body to be removed from the corneal epithelium or for incision of a meibomian cyst through the conjunctiva. Corneal sensitivity is normal again after about one hour.
Instil dropwise into the eye according to the recommended dosage. Each unit should be discarded after use.
The medicinal product can only be used for a short period of time.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Oxybuprocaine hydrochloride 4 mg/ml eye drops is incompatible with silver nitrate, mercury salts and alkaline substances.
Oxybuprocaine is incompatible with chlorhexidine acetate. Avoid co-administration with other ophthalmic agents containing chlorhexidine acetate as a preservative
This product should not be used in pregnancy or lactation, unless considered essential by the physician.
Patients should be advised not to drive or operate hazardous machinery until normal vision is restored.
Overdose following the recommended use is unlikely.
Ask anything about Oxybuprocaine hydrochloride 4 mg/ml eye drops, solution in single-dose container. 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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