InfoCons Consumer Protection informs you – Rhokiinsa – Package Leaflet
Rhokiinsa – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Rhokiinsa, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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 further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Rhokiinsa is and what it is used for
Rhokiinsa contains an active substance called netarsudil. Netarsudil belongs to a group of medicines called “Rho kinase inhibitors”, which work to reduce the amount of fluid inside the eye and so lower its pressure.
Rhokiinsa is used to lower pressure in the eyes in adults who have an eye condition known as glaucoma or who have raised pressure in their eyes. If the pressu re in the eye is too high, it can damage your sight.
⚠️ 2. What you need to know before you use Rhokiinsa
Do not use Rhokiinsa
- if you are allergic to netarsudil or 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 you may experience more side effects.
Children and adolescents
Rhokiinsa should not be used in children and teenagers under 18 years of age as it has only been studied in adults.
Other medicines and Rhokiinsa
Tell 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 breast -feeding If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not use Rhokiinsa if you are pregnant or breastfeeding unless your doctor still recomme nds it.
20 Driving and using machines Rhokiinsa has negligible influence on the ability to drive and use machines. You may find that your vision is blurred or abnormal just after using Rhokiinsa. Do not drive or use machines until the symptoms are cleared.
Rhokiinsa contains benzalkonium chloride
This medicine contains approximately 150 micrograms benzalkonium chloride in each ml of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You sh ould remove contact lenses before using this medicine and put them back 15 minutes afterwards (see section 3 ‘How to use Rhokiinsa’).
Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
💊 3. How to use Rhokiinsa
Always use this medicine exactly as your doctor or pharmacist has told you. Check w ith your doctor or pharmacist if you are not sure.
Only use Rhokiinsa for your eyes (ocular use). Do not swallow or inject.
The recommended dose is one drop in the affected eye or eyes once a day in the evening. Use the medicine at around the same time each day.
Do not use more than one drop in the affected eye(s) once a day.
How to use
- Wash your hands before you start . Contact lenses should be removed prior to instillation of
Rhokiinsa (see section 2 ‘Rhokiinsa contains benzalkonium chloride’).
- Do not touch the dropper with your fingers when opening or closing the bottle. It could contaminate the drops.
- Twist off the bottle cap, and lie the cap on a clean surface on its side. Continue to hold the bottle, ensuring that the tip doesn’t come into contact with anything.
- Hold the bottle, pointing down, between your thumb and fingers.
- Tilt your head back.
- Pull down your lower eyelid with a clean finger to form a ‘pocket’ between the eyelid and your eye. The drop will go in here (Pic ture 1).
- Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
- Do not touch your eye, eyelid, surrounding areas or other surfaces with the dropper. It could contaminate the drops.
- Gently squeeze the bottle to release one drop of Rhokiinsa into your eye.
- Only put one drop into your eye each time. If a drop misses your eye, try again.
21 • If you need to use the drops in both eyes, repeat the steps for your other eye while you have the bottle open.
- Put back the bottle cap to close the bo ttle.
If you are using other eye drops , wait at least five minutes after using them and then use Rhokiinsa last due to netarsudil’s vasodilating properties. If you are using eye ointments, these should be used last.
If you use more Rhokiinsa than you should
Rinse your eye with warm water. Do not put in any more drops until it is time for your next regular dose.
If you forget to use Rhokiinsa
Continue with the next dose as planned. Do not use a double dose to make up for a forgotten dose.
If you stop using Rhokiinsa
Do not stop using Rhokiinsa without first speaking to your doctor. If you stop using Rhokiinsa the pressure in your eye will not be controlled which could lead to loss of sight.
If you have any further questions on the use of this medicine, ask 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)
- Effects in the eye:
Eye redness ; fine deposits on the front of the eye (corneal verticillata) Pain where the drops have been put in
Common side effects (may affect up to 1 in 10 people)
- Effec ts in the eye:
Infection or inflammation of the eye, dryness of the eye or small breaks in the film of liquid on the surface of the eye (conjunctivitis, punctate keratitis); eye inflammation caused by an allergic reaction or prominent blood vessels; Eye di scharge; eyes can become watery; Eye pain; feeling of grittiness or having something in the eye; general eye redness shortly after drops are put in; spots or patches of eye redness; Itchy eyelids; swelling around the eye; Clouding of the eye and vision may decrease somewhat; sensitive to light; blurred vision
- General side effects : Headache
Uncommon side effects (may affect up to 1 in 100 people)
- Effects in the eye:
Increased fluid pressure inside the eye; Inflammation of the coloured part of the eye (the iris); bulging of iris; small colored spots on the eye surface; Growth of eyelashes; loss of eyelashes (madarosis); Eyelid dryness; abnormal turning outward of the lower eyelid; eye dryness caused by inflammation of the glands of the eyelids; eyelid crusting; Eye disease related to diabetes; (diabetic retinopathy); Excess folds of the conjunctiva (conjunctivochalasis); Blindness; blurred, double and halo vision; cataracts; Eye allergy; Glassy eyes; tiredness
- General side effects :
22 Increased allergic symptoms; Dizziness; Nasal discomfort and pain;
- Effects on the skin: redness or itching of the skin; rash on skin; inflammation of the cartilage; picking of the skin
Reporting of side effects
If you get any side effects, talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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 which is stated on the carton and bottle label after “EXP”.
The expiry date refers to the last day of that month.
Unopened bottles: Store in a refrigerator (2°C – 8°C).
After opening the bottle: Do not store above 25°C.
Do not use the bottle 4 weeks after first opening to prevent infections and use a new bottle.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What Rhokiinsa contains
- The active substance is netarsudil. Each ml of solution contains 200 micrograms netarsudil (as mesylate).
- The other excipients are benzalkonium chloride (see section 2 under ‘Rhoki insa contains benzalkonium chloride’), mannitol, boric acid, sodium hydroxide (for pH adjustment) and water for injections.
What Rhokiinsa looks like and contents of the pack
Rhokiinsa 200 micrograms/ml eye drops, solution (eye drops) is a clear, liquid eye drop solution in a plastic bottle. Each bottle contains 2.5 ml of the medicine and each pack contains one bottle with a screw -cap.
Marketing Authorisation Holder
Santen Oy Niittyh aankatu 20, 33720 Tampere, Finland
Manufacturer
Santen Oy, Kelloportinkatu 1, 33100 Tampere, Finland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
23 België/Belgique/Belgien Santen Oy Tél/Tel : +32 (0) 24019172 Lietuva Santen Oy Tel: +370 37 366628 България Santen Oy Teл.: +40 21 528 0290 Luxembourg/Luxemburg Santen Oy Tél/Tel: +352 (0) 27862006 Česká republika Santen Oy Tel: + 358 (0) 3 284 8111 Magyarország Santen Oy Tel: + 358 (0) 3 284 8111 Danmark Santen Oy Tlf: + 45 898 713 35 Malta Santen Oy Tel: + 358 (0) 3 284 8111 Deutschland Santen GmbH Tel: +49 (0) 3030809610 Nederland Santen Oy Tel: +31 (0) 207139206 Eesti Santen Oy Tel: +372 5067559 Norge Santen Oy Tlf: +47 21939612 Ελλάδα Santen Oy Τηλ: + 358 (0) 3 284 8111 Österreich Santen Oy Tel: +43 (0) 720116199 España Santen Pharmaceutical Spain S.L.
Tel: + 34 914 142 485 Polska Santen Oy Tel.: +48(0) 221042096 France Santen S.A.S.
Tél: +33 (0) 1 70 75 26 84 Portugal Santen Oy Tel: + 351 308 805 912 Hrvatska Santen Oy Tel: + 358 (0) 3 284 8111 Ireland Santen Oy Tel: + 353 (0) 16950008 România Santen Oy Tel: + 358 (0) 3 284 8111 Slovenija Santen Oy Tel: + 358 (0) 3 284 8111 Ísland Santen Oy Sími: + 358 (0) 3 284 8111 Slovenská republika Santen Oy Tel: + 358 (0) 3 284 8111 Italia Santen Italy S.r.l .
Tel: +39 0236009983 Suomi/Finland Santen Oy Puh/Tel: +358 (0) 974790211 Κύπρος Santen Oy Τηλ: + 358 (0) 3 284 8111 Sverige Santen Oy Tel: +46 (0) 850598833 Latvija United Kingdom (Northern Ireland) 24 Santen Oy Tel: +371 677 917 80 Santen Oy Tel: +353 (0) 169 500 08 (UK Tel: + 44 (0) 345 075 4863)
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Rhokiinsa (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/19/1400).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.
