Minims Tetracaine Hydrochloride 0.5%w/v eye drops solution – patient leaflet, side effects, dosage

1. What Minims^TM Tetracaine Hydrochloride eye dr

Minims^TM Tetracaine Hydrochloride contains a local anaesthetic. It is u use it to examine or treat your eye without it being painful. This medicine should be avoided in premature babies.

2. Before you use your eye drops

Do not use these drops if

• if you are allergic to the active substance (tetracaine) or any of th
• if you are allergic to other similar types of local anaesthetic.
• if you are taking medicines used to treat bacterial infection or dia
• in premature babies.

Take special care

Your eye drops are not intended for long term use. Frequent use of loc affect your eyesight.

Do you use any of these medicines?

• medicines called “sulphonamides” used to treat bacterial infectio If the answer to any of these questions is yes, tell your doctor or eye s

  ops are and what are they used for sed to numb the eye temporarily. Your doctor or eye specialist may e other ingredients (refer to the end of this leaflet).

  betes called “sulphonamides”.

  al anaesthetic in the eye over long periods of time may severely n or diabetes.

  pecialist.

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

Tell your doctor or eye specialist, he/she may decide to use these dro

Contact lenses

Your doctor will ask you to remove your contact lenses prior to the ad product on contact lenses. Therefore, do not wear your contact lenses

Driving and using machines

As with all eye drops, your vision may be blurred after putting the dro

3. How to use your eye drops

A doctor or eye specialist will use these eye drops to examine your eye. The drops are for single use only and provided in single use Minims uni Discard any unused portion.

Dosage

The usual dose is 1 drop of solution in one or both eyes. If necessary, your doctor or eye specialist will tell you to use more tha

Method of administration

The doctor or eye specialist will put the drops in your eye for you. He/she may ask you to press gently on the inner corner of your eyelid nose and throat. This is especially advisable in children, the elderly an He/she will then throw away the Minims unit, even if some solution r Your eye will remain numb, depending on how many drops you receiv

ps or to prescribe you an alternative.

ministration of the drops. There is no information on the effect of this until the effects of the drops have completely worn off.

ps in. Wait until your vision is clear before driving or using machines.

ts, to examine both eyes if necessary. Once opened, use immediately.

n one drop.

for 3 minutes. This will help stop the solution draining into your d population at risk.

emains.

ed. Avoid touching the eye until the anaesthetic has worn off.

Art.77407 P9UK01

Read all this leaflet carefully before you start using your medicine. I

t contains a summary of the information available on your medicine.

If you have any questions or are not sure about anything, ask your d

octor or pharmacist.

Remember this medicine is for you. Do not give it to someone else.

R&D

Bausch & Lomb

ULOTKA PIL

Nazwa produktu Product Name

Minims Tetracaine

Hydrochloride 0,5% and 1% w/v DRP SOL

Kolor nadruku C

olours

Kraj

Country (ISO)

United Kingdom (UK)

Nr wykrojnika Spec No

5338 revision F

Opracowane przez Designed by

5537

Kod Wytwórcy Manufacturer co

de

77407

2

Data Date

16.01.2024

czny

-

Kod wersji

Internal version code

P9UK01

Inny kod Other code

77407 (Data Matrix)

minimum 8 pt

Wymiar ulotki PIL size

160 x 240 mm

Krój czcionki Font used

Frutiger Neue LT W1G Condensed

Noto Sans

Condensed Bold

Gramatura papi Paper weight

eru

60 g/m²

Komentarze Comments (Reason for the change)

Update B+L logo on carton and leaflet, Update Aubenas address from the carton, Removal of I UK Only text on carton, Remove trademark stat TM, Editorial updates as annotated

PMR_BNL-23-0150-A Packing Site: Bausch & Lomb Aubenas - Natha

of Aubenas address in the leaflet, Removal of rish MA holder details from carton and leaflet, Add ements on carton and leaflet and replace R with

lie Clot (nathalie.clot@bausch.com)

Akceptacja Techniczna Technical Approval

Akceptacja Działu ds. Rejestracji Regulatory Affa

irs

Dept. Approval

Your doctor or eye specialist will make sure that your eye is properly

If you use more Minims^TM Tetracaine Hydrochloride than you sh unwell after receiving the drops, tell your doctor or eye specialist or c

4. Possible side effects

Minims^TM Tetracaine may sting or burn when the drops are first put in Occasionally, the skin around the eyes can become sore, superficial d surface of the eye) may also be observed after short-term application soreness around your eyes or blurred vision that is causing you a prob The cornea (the transparent membrane covering the surface of the eye) If any of the side effects gets serious, please seek immediate medical please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This incl effects directly via:

The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search f

5. How to store your eye drops

Art.77407 P9UK01

protected.

ould, an overdose is very unlikely to occur. If you suddenly feel ontact your nearest emergency department immediately.

and your vision may become blurred. This will gradually wear off. efect or swelling of cornea (the transparent membrane covering the of these eye-drops. If you find that you have itching, discomfort, lem, you should tell your doctor or pharmacist.

may be damaged by prolonged administration of anaesthetic eye drops. attention. If you notice any side effects not listed in this leaflet, udes any side effects not listed in this leaflet. You can also report side or MHRA Yellow Card in the Google Play or Apple App Store.

Keep out of the reach and sight of children.

Do not use the eye drops after the expiry date which is stated on the The expiry date refers to the last day of that month.

Do not store above 25°C. Do not freeze. Store in the original package The drops are for single use only and provided in single use Minims u immediately. Discard any unused portion.

Medicines should not be disposed of via wastewater or household wa required. These measures will help to protect the environment.

6. Further information

What do your eye drops contain

• The active ingredient is tetracaine hydrochloride. Each unit conta hydrochloride 0.5% w/v (2.5 mg) or 1% w/v (5 mg).
• The other ingredients are hydrochloric acid (for pH adjustment) a This medicine does not contain a preservative as it is a sterile single u

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

Manufacturer:

overwrap of each unit and on the carton after the letters “EXP”.

in order to protect from light.

nits, to examine both eyes if necessary. Once opened, use ste. Ask your pharmacist how to dispose of medicines no longer ins approximately 0.5 ml eye drops solution of tetracaine nd purified water.

se unit.

Laboratoire Chauvin

Zone Industrielle de Ripotier

50 Avenue Jean Monnet

07200 Aubenas

France

DATE OF PREPARATION: November 2023.