Rhokiinsa

Patient Information Leaflet

Rhokiinsa 200 micrograms/mL eye drops, solution

netarsudil
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Rhokiinsa is and what it is used for

Rhokiinsa contains an active substance called netarsudil. Netarsudil belongs to a group of
medicines known as "Rho-kinase inhibitors," which function by reducing the amount of
fluid inside the eye, thereby lowering eye pressure.
Rhokiinsa is indicated to reduce eye pressure in adults who suffer from an eye condition
known as glaucoma or who have elevated intraocular pressure. If eye pressure is too high, it may damage vision.

2. What you need to know before using Rhokiinsa

Do not use Rhokiinsa

• if you are allergic to netarsudil or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Do not use Rhokiinsa more than once a day, as this may lead to an increased risk of side effects.

Children and adolescents
Rhokiinsa must not be used in children and adolescents under 18 years of age, as it has only been studied in adults.
Other medicines and Rhokiinsa
Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines (see section 3 “How to use Rhokiinsa”).
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not use Rhokiinsa if you are pregnant or breastfeeding, unless your doctor specifically advises you to do so.
Driving and using machines
Rhokiinsa has a negligible effect on the ability to drive and use machines. You may experience blurred or abnormal vision immediately after using Rhokiinsa. Do not drive or operate machinery until these symptoms have resolved.
Rhokiinsa contains benzalkonium chloride
This medicine contains approximately 150 micrograms of benzalkonium chloride per mL of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. You must remove your contact lenses before using this medicine and reinsert them after 15 minutes (see section 3 “How to use Rhokiinsa”).
Benzalkonium chloride may also cause ocular irritation, particularly if you have dry eyes or corneal abnormalities (the transparent layer at the front of the eye). Consult your doctor if you experience abnormal eye sensitivity, ocular pain, or a stinging sensation after using this medicine.

3. How to use Rhokiinsa

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use Rhokiinsa only in the eye (ophthalmic use). Do not swallow or inject it.
The recommended dose is one drop into the affected eye or eyes once daily in the evening. Use the
medicine every day at approximately the same time.
Do not use more than one drop once daily in the affected eye(s).
Instructions for use

• Wash your hands before starting. Contact lenses must be removed before instilling Rhokiinsa (see section 2 "Rhokiinsa contains benzalkonium chloride").
• Do not touch the dropper tip with your fingers when opening or closing the bottle. This could contaminate the eye drops.
• Unscrew the bottle cap and place the cap on a clean surface. Keep holding the bottle, making sure the dropper tip does not come into contact with anything.
• Hold the bottle between your thumb and fingers, with the tip pointing downwards.
• Tilt your head backwards.
• Gently pull down the lower eyelid with a clean finger to create a "pocket" between the eyelid and the eye. The drop should be placed here (Figure 1).
• Bring the dropper tip close to the eye. Using a mirror may be helpful.
• Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip. This could contaminate the eye drops.
• Gently squeeze the bottle to release one drop of Rhokiinsa into the eye.
• Put only one drop into the eye each time. If the drop misses the eye, repeat the procedure.
• If you need to use the eye drops in both eyes, repeat the steps for the other eye while the bottle is open.
• Replace the cap to close the bottle.

If you are using other eye drops, wait at least five minutes after using them before using Rhokiinsa, due to the vasodilatory properties of netarsudil. If you are using ophthalmic ointments, these should be used last.
If you use more Rhokiinsa than you should
Rinse the eye with lukewarm water. Do not instill additional drops until the next scheduled regular dose.
If you forget to use Rhokiinsa
Continue with the next dose as scheduled. Do not use a double dose to make up for the missed dose.
If you stop using Rhokiinsa
Do not stop using Rhokiinsa without first talking to your doctor. If you stop using Rhokiinsa, your eye pressure will not be controlled, which could lead to vision loss.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following non-serious side effects have been observed with Rhokiinsa:

Very common side effects (may affect more than 1 in 10 people)

• Eye effects: eye redness; fine deposits in the front part of the eye (cornea verticillata); pain at the site where the drops were instilled

Common side effects (may affect up to 1 in 10 people)

• Eye effects: eye infection or inflammation; dry eye or minor disruptions in the liquid film on the eye surface (conjunctivitis, punctate keratitis); eye inflammation due to an allergic reaction or prominent blood vessels; eye discharge; watery eyes; eye pain; gritty sensation or feeling of having something in the eye; general eye redness shortly after instilling the drops; spots or patches of eye redness; eyelid itching; swelling around the eye; blurred vision and slightly reduced vision; light sensitivity; blurred vision
• General side effects: headache

Uncommon side effects (may affect up to 1 in 100 people)

• Eye effects: increased pressure of the fluid inside the eye; inflammation of the coloured part of the eye (iris); iris protrusion; small coloured spots on the eye surface; eyelash growth; eyelash loss (madarosis); eyelid dryness; abnormal outward turning of the lower eyelid; dry eye caused by inflammation of the eyelid glands; eyelid crusting; diabetic eye disease (diabetic retinopathy); excessive folds in the conjunctiva (conjunctivochalasis); blindness; blurred, double vision or vision with halos; cataract; eye allergy; vitreous eyes; fatigue
• General side effects: worsening of allergic symptoms; dizziness; nasal discomfort and pain
• Skin effects: skin redness or itching sensation; skin rash; inflammation of cartilage; skin abrasion

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system referred to in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rhokiinsa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the
bottle after Exp. The expiry date refers to the last day of that month.
Unopened bottles: store in the refrigerator (2 °C – 8 °C).
After opening the bottle: do not store at temperatures above 25 °C.
Do not use the bottle more than 4 weeks after first opening, to prevent infections, and use a new bottle.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rhokiinsa contains

• The active substance is netarsudil. Each mL of solution contains 200 micrograms of netarsudil (as mesylate).
• The other excipients are benzalkonium chloride (see section 2, "Rhokiinsa contains benzalkonium chloride"), mannitol, boric acid, sodium hydroxide (for pH adjustment) and water for injections.

Description of the appearance of Rhokiinsa and contents of the pack
Rhokiinsa 200 micrograms/mL eye drops, solution is a clear solution in a plastic bottle.
Each bottle contains 2.5 mL of medicinal product and each pack contains one bottle with a screw cap.

Marketing Authorization Holder
Santen Oy
Niittyhaankatu 20,
33720 Tampere,
Finland

Manufacturer
Santen Oy
Kelloportinkatu 1,
33100 Tampere,
Finland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Santen Oy Santen Oy
Tél/Tel: +32 (0) 24019172 Tel: +370 37 366628

България Luxembourg/Luxemburg
Santen Oy Santen Oy
Teл.: +40 21 528 0290 Tél/Tel: +352 (0) 27862006

Česká republika Magyarország
Santen Oy Santen Oy
Tel: +358 (0) 3 284 8111 Tel: +358 (0) 3 284 8111

Danmark Malta
Santen Oy Santen Oy
Tlf: +45 898 713 35 Tel: +358 (0) 3 284 8111

Deutschland Nederland
Santen GmbH Santen Oy
Tel: +49 (0) 3030809610 Tel: +31 (0) 207139206

Eesti Norge
Santen Oy Santen Oy
Tel: +372 5067559 Tlf: +47 21939612

Ελλάδα Österreich
Santen Oy Santen Oy
Τηλ: +358 (0) 3 284 8111 Tel: +43 (0) 720116199

España Polska
Santen Pharmaceutical Spain S.L. Santen Oy
Tel: +34 914 142 485 Tel.: +48(0) 221042096

France Portugal
Santen S.A.S. Santen Oy
Tél: +33 (0) 1 70 75 26 84 Tel: +351 308 805 912

Hrvatska România
Santen Oy Santen Oy
Tel: +358 (0) 3 284 8111 Tel: +358 (0) 3 284 8111

Ireland Slovenija
Santen Oy Santen Oy
Tel: +353 (0) 16950008 Tel: +358 (0) 3 284 8111

Ísland Slovenská republika
Santen Oy Santen Oy
Sími: +358 (0) 3 284 8111 Tel: +358 (0) 3 284 8111

Italia Suomi/Finland
Santen Italy S.r.l. Santen Oy
Tel: +39 0236009983 Puh/Tel: +358 (0) 974790211

Κύπρος Sverige
Santen Oy Santen Oy
Τηλ: +358 (0) 3 284 8111 Tel: +46 (0) 850598833

Latvija United Kingdom (Northern Ireland)
Santen Oy Santen Oy
Tel: +371 677 917 80 Tel: +353 (0) 169 500 08
(UK Tel: +44 (0) 345 075 4863)

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.