Omidria 10 mg / ml + 3 mg / ml concentrate for solution for Intraocular Irrigation – patient leaflet, side effects, dosage

1. What Omidria is and what it is used

for

Omidria is a medicine used during surgery o phenylephrine and ketorolac. Phenylephrine Ketorolac is a painkiller that belongs to the g drugs (NSAIDS); it also helps stop the pupil fr

n the eye. It contains the active substances acts to keep the pupil dilated (widened). roup called non-steroidal anti-inflammatory om contracting (getting smaller).

• Also tell your doctor if you are taking an op antihistamine. These medications, when ta change how effectively Omidria is able to d - One of the active substances in Omidria ca anaesthetics. Your doctor will know about t general anaesthesia, talk to your doctor ab

  ioid pain reliever or a non-drowsy ken at the same time as Omidria, can ilate (widen) your pupil for surgery. n react with several types of

Omidria is used in adults to rinse the eye dur the eye that focuses light passing through th known as intraocular lens replacement. The m (widened) during surgery and to reduce eye

ing surgery to implant a new lens (part of e pupil to allow you to see clearly). This is edicine is used to keep the pupil dilated pain after the procedure.

his. If your eye surgery will involve out this.

Pregnancy and breast-feeding

Label

Pa

ckage leaflet: Information for the user Omidria® 10 mg/mL +

If you are pregnant or breast-feeding, think y have a baby, ask your doctor for advice before

ou may be pregnant or are planning to taking this medicine.

2. What you need to know before you

use Omidria

3 mg/mL

concentrate for solution for intraocular irrigation phenylephrine/ketorolac

Do not use Omidria:

after folding

• if you are allergic to phenylephrine or keto medicine (listed in section 6);

  rolac or any of the other ingredients of this

  Omidria should not be used during pregnan you should be using suitable contraception b

  cy. If you are able to become pregnant, efore you are given Omidria.

Panel visible

• if you have an eye condition called narrow

  -angle glaucoma.

XXXXXXXXXXXXX

Omidria should not be used during breast-fe

eding.

Panel visible after folding

Warnings and precautions

Driving and using machines

Talk to your doctor, pharmacist or nurse befor - have heart disease;

e using Omidria if you:

mixup

This medicine has major influence on the abi vision may be affected, you should not drive cleared. This may be several hours up to abou medications your doctor may use during surg

lity to drive and use machines. As your or use machines until your vision has t a day, depending on other

code

• have raised blood pressure;

Label

• have overactive thyroid gland (hyperthyroi - are allergic to acetylsalicylic acid or other p anti-inflammatory drugs (NSAIDs); - have asthma.

  dism);

  ainkillers called non-steroidal

  ery.

3. How Omidria is used

Read all of this leaflet carefully bef because it contains important infor

ore you start using this medicine mation for you.

Omidria will be given to you in a hospital or c who is specialised in eye surgery.

linic by a qualified doctor or surgeon

•Keep this leaflet. You may need to read •If you have any further questions, ask y •If you get any side effects, talk to your any possible side effects not listed in th

it again.

If any of the above applies to you, please info Omidria is suitable for you.

rm your doctor. Your doctor will decide if

our doctor, pharmacist or nurse. doctor, pharmacist or nurse. This includes is leaflet. See section 4.

Omidria is used as a solution to rinse the eye replace the lens.

(irrigation solution) during surgery to

Children and adolescents

What is in this leaflet

Omidria should not be used in children and not been studied in these groups.

adolescents aged below 18 years as it has

If you are given more Omidria than you

should have been

1. 1.

   What Omidria is and what it is used fo 2. What you need to know before you us 3. How Omidria is used

   r

   Phenylephrine, one of the active substances blood pressure if too much is given and enou parts of the body. It may also cause headache abnormal rapid heart rhythm.

   of Omidria, may cause a rapid rise in gh passes into the blood to affect other , anxiety, nausea, vomiting, and

   e Omidria

   Other medicines and Omidria

   Tell your doctor or pharmacist if you are takin other medicines.

   g, have recently taken or might take any

2. 4. Possible side effects
3. 5. How Omidria is stored

Your doctor will monitor you for any sign them if necessary.

s or symptoms of side effects and will treat

If you have any further questions on the nurse.

use of this medicine, ask your doctor or

4. Possible side effects

Like all medicines, this medicine can cau them.

se side effects, although not everybody gets

Side effects listed below are typically mil resolve on their own without any long-te Side effects affecting the eye: Common side effects (may affect up to - eye pain;

d to moderate in intensity and usually rm effects.

1 in 10 people):

• inflammation of the front of the eye; - red eyes;

• swelling of the cornea (the clear layer - sensitivity to light.

  over the front of the eye);

Uncommon side effects (may affect u - eye discomfort;

p to 1 in 100 people):

• eye inflammation;
• eye irritation;
• eye redness;

• problems with the cornea such as scrat - dilated pupil;

  ches or dryness;

• blurred vision;

• reduction in sharpness of vision; - small, dark shapes moving in the field - itchy eyes;

  of vision;

• eyelid pain;

• sensation of foreign bodies in the eyes - glare;

  ;

• increased eye pressure.

Side effects affecting the body: Common side effects:

• ocular inflammation

The following information is intend

ed for healthcare professionals only:

To prepare Omidria for intraocular irrigation, concentrate for solution in 500 mL of standar

dilute 4.0 mL (the content of 1 vial) of Omidria d ophthalmological irrigation solution.

Uncommon side effects:

• Water for injection
• nausea;
• pain;
• headache.

Reporting of side effects

What Omidria looks like and contents o

f the pack

Clear, colourless to slightly yellow, sterile con irrigation.

centrate for solution for intraocular

If you get any side effects, talk to your doctor, possible side effects not listed in this leaflet. the Yellow Card Scheme at: www.mhra.gov.u in the Google Play or Apple App Store. By rep more information on the safety of this medic

pharmacist or nurse. This includes any You can also report side effects directly via k/yellowcard or search for MHRA Yellow Card orting side effects, you can help provide ine.

5. How Omidria is stored

Supplied in a single-use vial designed to del into 500 mL of irrigation solution for intraocu closed with a butyl rubber stopper and a poly

iver 4.0 mL of concentrate for solution lar use. Colourless 5 mL type 1 glass vial propylene flip-off cap.

Multipack contains 10 cartons, each carton co

ntains one single-use vial.

Keep this medicine out of the sight and reach

of children.

Do not use this medicine after the expiry date The expiry date refers to the last day of that m

which is stated on the carton after “EXP”. onth.

Do not store above 25 ˚C. Keep the vial in the

outer carton in order to protect from light.

Marketing Authorisation Holder

Rayner Pharmaceuticals Limited

10 Dominion Way,

Worthing,

West Sussex BN14 8AQ,

United Kingdom

Do not use if the solution is cloudy, or if it con The diluted solution is to be used within 6 ho

tains particles.

urs after dilution.

tel +44 (0) 1903 258 900 fax +44 (0) 1903 751 470 e-mail Pharma-ra@rayner.com

Do not throw away any medicines via wastew cist how to throw away medicines you no lon the environment.

ater or household waste. Ask your pharma-ger use. These measures will help protect

6. Contents of the pack and other infor

mation

Manufacturer

Manufacturing Packaging Farmaca (MPF) B.V Heerenveen, 8448CN, The Netherlands

., Neptunus 12,

What Omidria contains

The active substances are phenylephrine (as (as trometamol).

hydrochloride) and ketorolac

Each 4.0 mL vial of solution contains 40.6 mg phenylephrine and 11.5 mg (2.88 mg/mL) o

(10.2 mg/mL) of f ketorolac.

For any information about this medicine, ple Holder:

ase contact the Marketing Authorisation

This leaflet was last revised in March 2

024

The other ingredients are

• Citric acid monohydrate
• Sodium citrate dihydrate

• Sodium hydroxide (to adjust alkalinity l - Hydrochloric acid (to adjust acidity level

  evel)

  )

The following instructions must be adhered to: - The vial should be visually inspected for particu yellow concentrate for solution without visible p - Using aseptic technique, withdraw 4.0 mL of co needle.

• The bag/bottle must be visually inspected for p solution without visible particles should be use - No other medicinal products should be added t

  articulate matter. Only a clear, colourless d.

late matter. Only a clear, colourless to slightly articles should be used.

o the prepared irrigation solution.

ncentrate for solution using an appropriate sterile

Any unused medicinal product or waste material s local requirements.

hould be disposed of in accordance with

• 4.0 mL of concentrate for solution should be inj solution.

  ected into a 500 mL bag/bottle of irrigation

• The bag/bottle should be gently inverted in ord used within 6 hours of preparation.

  er to mix the solution. The solution should be