Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - rhokiinsa

Document Subject

Generated Narrative: MedicinalProductDefinition mp1dfe892dc67968025b224d593ef39db2

identifier: http://ema.europa.eu/identifier/EU/1/19/1400/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Rhokiinsa 200 micrograms/ml eye drops, solution.

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-1dfe892dc67968025b224d593ef39db2

identifier: http://ema.europa.eu/identifier/EU/1/19/1400/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - rhokiinsa

Attesters

What is in this leaflet

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

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 pressure in the eye is too high, it can damage your sight.

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.

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 unless your doctor still recommends it.

Driving and using 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 should remove contact lenses before using this medicine and put them back minutes afterwards.

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.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with 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.

How to use

Wash your hands before you start.

Do not touch the dropper with your fingers when opening or closing the bottle. It could infect 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 (Picture 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 infect 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.

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 bottle.

If you are using other eye drops, wait at least five minutes after using them and then use Rhokiinsa. 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.
Do not use more than one drop in the affected eye(s) once a day.

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.

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

The following 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 and pain where the drops have been put in

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

Effects 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; eye discharge; itchy eyelids; clouding of the eye and vision may decrease somewhat; 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; eye inflammation caused by an allergic reaction or prominent blood vessels; eyes can become watery, sensitive to light; swelling around the eye; 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; growth of eyelashes; eyelid dryness; eye disease related to diabetes; excess folds of the conjunctiva; blindness; blurred, double and halo vision; cataracts; abnormal turning outward of the lower eyelid; small colored spots on the eye surface; eye dryness caused by inflammation of the glands of the eyelids; eye allergy; eyelid crusting; glassy eyes; loss of eyelashes; tiredness

General side effects: Increased allergic symptoms; dizziness; blurred vision; nasal discomfort and pain; 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.

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 bottle and the carton 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. Throw away 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.

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 Rhokiinsa contains benzalkonium chloride ), mannitol, boric acid, sodium hydroxide and water for injections.

What Rhokiinsa looks like and contents of the pack Rhokiinsa 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 Niittyhaankatu 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:

Belgi /Belgique/Belgien Santen Oy T l/Tel: +32 (0) 24019Lietuva Santen Oy Tel: +370 37 366
Santen Oy Te .: +359 (0) 888 755 Luxembourg/Luxemburg Santen Oy T l/Tel: +352 (0) 27862 esk republika Santen Oy Tel: +358 (0) 3 284 8Magyarorsz g Santen Oy Tel: +358 (0) 3 284 8Danmark Malta Santen Oy
Tlf: +45 898 713 Santen Oy
Tel: +358 (0) 3 284 8Deutschland Santen GmbH
Tel: +49 (0) 3030809Nederland Santen Oy
Tel: +31 (0) 207139Eesti Santen Oy
Tel: +372 5067Norge Santen Oy Tlf: +47 21939
Santen Oy
: +358 (0) 3 284 8 sterreich Santen Oy Tel: +43 (0) 720116Espa a Santen Pharmaceutical Spain S.L. Tel: +34 914 142 Polska Santen Oy
Tel.: +48(0) 221042France
Santen S.A.S. T l: +33 (0) 1 70 75 26 Portugal Santen Oy Tel: +351 308 805 Hrvatska Santen Oy Tel: +358 (0) 3 284 8Ireland Santen Oy

Tel: +353 (0) 16950Rom nia Santen Oy
Tel: +358 (0) 3 284 8Slovenija Santen Oy Tel: +358 (0) 3 284 8 sland Santen Oy S mi: +358 (0) 3 284 8Slovensk republika Santen Oy
Tel: +358 (0) 3 284 8Italia Santen Italy S.r.l. Tel: +39 0236009Suomi/Finland Santen Oy Puh/Tel: +358 (0) 974790
Santen Oy
: +358 (0) 3 284 8Sverige Santen Oy
Tel: +46 (0) 850598Latvija Santen Oy
Tel: +371 677 917 United Kingdom (Northern Ireland) Santen Oy

Tel: +353 (0) 169 500 (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: