Oxybuprocaine hydrochloride 4 mg/ml eye drops, solution in single-dose container

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Oxybuprocaine hydrochloride is and what it is used for
2. What you need to know before you use Oxybuprocaine hydrochloride
3. How to use Oxybuprocaine hydrochloride
4. Possible side effects
5. How to store Oxybuprocaine hydrochloride
6. Contents of the pack and other information

• 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.

• 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.

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).

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 .

Wait until the anaesthetic effect of Oxybuprocaine hydrochloride has worn off before driving vehicles or using machines.

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.

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.

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.

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 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.

• 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.

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.

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