Minims Tropicamide 1%w/v – patient leaflet, side effects, dosage

1. What Minims™ Tropicamide eye drops are and what they

Minims™ Tropicamide contains a mydriatic and cycloplegic agent. It i lens. Your doctor or eye specialist may use it to examine your eye.

2. Before you use your eye drops

Do not use these drops if

• you are allergic to the active substance (tropicamide) or any of the
• you have history of closed angle glaucoma with your eyes likely to dev Consult your doctor for advice; use of this product may cause: - Increase in the pressure of your eye. You should have your eye pres Take special care

Ask yourself the following questions:

• Is this product to be used in a small child?
• Are your eyes red or inflamed?

If the answer to any of these questions is yes, tell your doctor or eye s If you are pregnant, may be pregnant, or are breastfeeding

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

Your doctor will ask you to remove your contact lenses prior to the ad

are used for s used to enlarge the pupil of your eye and temporarily paralyse the other ingredients (refer to the end of this leaflet).

elop sudden increased internal pressure when the pupil is enlarged sure checked before initiation of therapy, especially in elderly.

pecialist.

s or to prescribe you an alternative.

ministration of the drops. There is no information on the effect of this product on contact lenses. Therefore, do not wear your contact lenses Driving and using machines

Some people find bright light (such as daylight) uncomfortable for a few hours a drive.

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

3. How to use your eye drops

The drops are for single use only and provided in single use Minims u Discard any unused portion.

Dosage

• The normal adult dose is 1 drop followed by a second drop after an interval
• The dose for children will be decided by the doctor or eye specialist Method of administration

Make sure you follow these instructions carefully:

1. 1. Wash your hands.
2. 2. Use a mirror, this will help you to see what you are doing.
3. 3. Carefully dry your eyes using a tissue, and twist off the cap from th
4. 4. Pull your lower eyelid down gently, and then carefully place 1 or 2
5. 5. Close your eye and blink a few times to make sure your eye is cove
6. 6. Close the eyelids. It is advisable to press gently on the inner corner into your nose and throat. This is especially advisable in children, t
7. 7.

   Repeat steps 4, 5 and 6 for the other eye if necessary, then throw a

   until the effects of the drops have completely worn off.

   fter receiving Minims™ Tropicamide. This may make it difficult for you to n. Wait until your vision is clear before driving or using machines.

   nits, to treat both eyes if necessary. Once opened, use immediately.

   of 5 minutes. A further 1 drop may be instilled after 30 minutes, if required. .

   e Minims body of the unit.

   drops inside your lower eyelid.

   red by the liquid.

   of your eyelid for 3 minutes. This will help stop the solution draining he elderly and population at risk.

   way the Minims unit, even if some solution remains.

P9UK01 77419

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

ntains a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or p

harmacist.

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

Bausch + Lomb ULOTKA PIL

Nazwa produktu

Product Name

Minims Tropicamide 0.5% DRP 20 SDU

Kolor nadruku Colo

urs

Kraj

Country (ISO)

UK

Nr wykrojnika Spec No

5338 revision F

Opracowane przez Designed by

Chris Robinson chris.robinson@bausch.com

Kod Wytwórcy Manufacturer code

77419

2

Data Date

13.03.2024

y

-

Kod wersji version code

P9UK01

Inny kod Other code

77419 (Data Matrix)

minimum 8 pt

Wymiar ulotki PIL size

160 x 240 mm

Krój czcionki Font used

Frutiger Neue LT W1G Condensed

Franklin Gothic Cond Demi

Gramatura papieru Paper weight

60 g/m²

Komentarze Comments (Reason for the change)

Update B+L logo on carton and leaflet. Update of Aub address from the carton. Removal of Irish MA holder ton. Remove trademark statements on carton and lea PMR_BNL-23-0199-A Packing Site: Bausch & Lom

enas address in the leaflet. Removal of Aubenas details from carton and leaflet. Add UK Only text on car-flet and replace R with TM. Editorial updates to leaflet. b Aubenas, Nathalie Clot (nathalie.clot@bausch.com)

Akceptacja Techniczna Technical Approval

Akceptacja Działu ds. Rejestracji Regulatory Affairs

Dept. Approval

If you use more Minims™ Tropicamide than you should, an overdose is ver drops, tell your doctor or eye specialist or contact your nearest emerg

4. Possible side effects

The following side effects may occur:

• temporary stinging and blurred vision. This will gradually wear off.
• dry mouth. This is caused by the active substance being absorbed t medicine. This effect should wear off within a couple of hours. 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 inclu effects directly via:

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

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 on the o 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 units,

y unlikely to occur. If you suddenly feel unwell after receiving the ency department immediately.

hrough the tear duct and causing a common effect for this type of attention. If you notice any side effects not listed in this leaflet, des 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.

verwrap of each unit and on the carton after the letters “EXP”. The in order to protect from light.

to treat both eyes if necessary. Once opened, use 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 tropicamide. Each Minims unit contains ap (2.5 mg) or 1% w/v (5 mg).
• The other ingredients are sodium hydroxide and hydrochloric acid ( 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:

Laboratoire Chauvin

Zone Industrielle de Ripotier

50 Avenue Jean Monnet

07200 Aubenas

France

DATE OF PREPARATION: November 2023

ste. Ask your pharmacist how to dispose of medicines no longer proximately 0.5 ml eye drops solution of tropicamide 0.5% w/v for pH adjustment) and purified water.

se unit.

P9UK

01 77419

R

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