Minims Oxybuprocaine Hydrochloride 0.4%w/v – patient leaflet, side effects, dosage

1. What Minims^TM Oxybuprocaine Hydr are used for

Minims^TM Oxybuprocaine Hydrochloride contains an anaesthe 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 stitch
• for the fitting of contact lenses,

This medicine is indicated for children, adults and the elderly.

2. Before you use your eye drops

Do not use these drops if

• you are allergic to the active substance (oxybuprocaine hy of this leaflet).
• you are using at the same time as Minims^TM Oxybuprocain acetate as a preservative.

Take special care

• If you have had an allergic reaction to other local anaesth

• When your eye has been numbed it is important not to ru

  Your doctor or eye specialist will make sure that your eye

  ochloride eye drops are and what they tic. It is used to numb the surface of the eye temporarily.

  es and foreign bodies, drochloride) or any of the other ingredients (refer to the end e Hydrochloride other eye drops containing chlorhexidine etics in the past. Inform your doctor or eye specialist. b it and to keep it free of dust and bacterial contamination. is properly protected.

• If you have an inflamed eye, as red eyes greatly increase the Your eye drops are not intended for long term use. Frequent u may severely affect your eyesight.

If you are pregnant, may be pregnant, or are breas

Tell your doctor or eye specialist, he/she may decide to use th Contact lenses

Your doctor will ask you to remove your contact lenses prior to the of this product on contact lenses. Therefore, do not wear your cont Driving and using machines

As with all eye drops, your vision may be blurred after putting using machines.

3. How to use your eye drops

The drops are in special single use “Minims” units, to treat bot Once opened, use immediately. Discard any unused portion. Dosage

The amount of anaesthetic used will vary, depending on the p

• One drop of solution is enough to allow your doctor or eye
• Two drops, one and a half minutes apart is enough to allo

• Three drops at one and a half minute intervals is enough t

  passage into the blood stream through the surface of the eyes. se of local anaesthetic in the eye over long periods of time tfeeding ese drops or to prescribe you an alternative.

  administration of the drops. There is no information on the effect act lenses until the effects of the drops have completely worn off.

  the drops in. Wait until your vision is clear before driving or h eyes if necessary.

  rocedure decided by your doctor or eye specialist: specialist to measure the pressure inside your eye. w contact lenses to be fitted.

  o allow minor operations to be performed.

P1UK01 77425

Read all this leaflet carefully before you start using your me

dicine. It contains a summary of the information available on your medicine. If you have any questions or are not sure a

bout anything, ask your doctor or pharmacist. Remember this medicine is for you. Do not giv

e it to someone else.

R & D

Bausch + Lomb ULOTKA PIL

Nazwa produktu

Product Name

Minims Oxybuprocaine Hydrochloride 0.4% DRP SOL 20 SDU

K

olor nadruku Co

lours

Kraj

Country (ISO)

UK

N S

r wykrojnika pec No

5338 revision F

Opracowane przez Designed by

Shelby Fleskes shelby.fleskes@bausch.com

K M

od Wytwórcy anufacturer cod

e

77425

2

Data Date

13.03.2024

K P

od farmaceutycz harmacode

ny

-

Kod wersji version code

P1UK01

I

O

nny kod ther code

77425 (Data Matrix)

minimum 9 pt

Wymiar ulotki IL size

P

160 x 240 mm

Krój czcionki Font used

Frutiger Neue LT W1G font family

G P

ramatura papier aper weight

u

60 g/m²

Komentarze Comments (Reason for the change)

-PMR_BNL-23-0165-A -Update B+L logo on carton and leaflet. Update o Aubenas address from the carton. Removal of Iri UK Only text on carton. Remove trademark state TM. Editorial updates to leaflet.

-Packing Site: Bausch & Lomb Aubenas

f Aubenas address in the leaflet. Removal of sh MA holder details from carton and leaflet. Add ments on carton and leaflet and replace R with

Akceptacja Techniczna Technical Approval

Akceptacja Działu ds. Rejestracji Regulatory Affairs

Dept. Approval

Method of administration

The doctor or eye specialist will put the drops in your eye for y eyelid for 3 minutes. This will help stop the solution draining i children, the elderly and population at risk.

Your eye will remain numb for about one hour, depending on the anaesthetic has worn off.

If you have other eye drops to instill, you should wait If you use more Minims^TM Oxybuprocaine Hydrochl to occur. If you suddenly feel unwell after receiving the drops, emergency department immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, althou Minims^TM Oxybuprocaine Hydrochloride may sting when the d irritation may also occur. This will gradually wear off. Other side effects

Not known: frequency cannot be estimated from the available Minims Oxybuprocaine Hydrochloride does not usually cause shock have occasionally occurred.

The symptoms of anaphylaxis/anaphylactic shock (severe alle P1UK01 77425

ou. You may be asked to press on the inner corners of your nto your nose and throat. This is especially advisable in how many drops you received. Avoid touching the eye until at least 15 minutes before administering them. oride than you should, an overdose is very unlikely tell your doctor or eye specialist or contact your nearest gh not everybody gets them.

rops are first put in and your vision may become blurred. Eye data.

side effects, but allergic reactions (including anaphylactic rgic reactions) are difficulty breathing or swallowing, swelling of the face, lips, throat or tongue and severe skin ras of these symptoms.

The symptoms of an allergic reaction are redness, swelling an This medicine can affect the cornea (the transparent membr intense discomfort, pain, redness, sensitivity to light or loss of Red, swollen or itchy eyes, burning or tearing of the eyes, itch Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist o this leaflet. You can also report side effects directly via: Yellow Card Scheme - Website: www.mhra.gov.uk/yellowcard or se By reporting side effects you can help provide more informati

5. How to store your eye drops

Keep out of the reach and sight of children.

Do not use the eye drops after the expiry date which is stated letters “EXP”. The expiry date refers to the last day of that mo original package to protect from light.

The drops are in special single use “Minims” units, to treat bo Discard any unused portion.

Medicines should not be disposed of via wastewater or house medicines no longer required. These measures will help to pr

6. Further information

h. You should inform your doctor immediately if you get any d itching of the eyes.

ane covering the iris and the pupil of the eye), causing visual acuity (the clarity or sharpness of vision). y eyelids, foreign body sensation may also occur.

r nurse. This includes any possible side effects not listed in arch for MHRA Yellow Card in the Google Play or Apple App Store. on on the safety of this medicine.

on the overwrap of each unit and on the carton after the nth. Do not store above 25°C. Do not freeze. Store in the th eyes if necessary. Once opened, use immediately.

hold waste. Ask your pharmacist how to dispose of otect the environment.

What do your eye drops contain

• The active ingredient oxybuprocaine hydrochloride. Each oxybuprocaine hydrochloride 0.4% w/v (2 mg).
• The other ingredients are hydrochloric acid (for pH adjust This medicine does not contain a preservative as it is a sterile Contents of the pack

Each carton contains 20 units.

Marketing Authorisation Holder:

Bausch & Lomb UK Ltd.

106 London Road, Kingston-upon-Thames, KT2 6TN - UK

L Z 5 0 F DATE OF PREPARATION: November 2023

unit contains approximately 0.5 ml eye drops solution of ment) and purified water.

single use unit.

Manufacturer:

aboratoire Chauvin one Industrielle de Ripotier

0 Avenue Jean Monnet

7200 Aubenas rance