200 micrograms/ml eye drops,
netarsudil solution
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 by reducing the amount of fluid inside the eye and thus lowering its pressure.
Rhokiinsa is used to lower the pressure in the eyes of adults who have an eye disease called glaucoma or who have elevated pressure in the eyes. If the pressure in the eye is too high, your vision can be damaged.
What you need to know before using 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 cautions
- Do not use Rhokiinsa more than once a day, as this may give you more side effects.
Children and young people
Rhokiinsa should not be used in children and adolescents 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 taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
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 specifically recommends it.
Driving and using machines
Shortly after using Rhokiinsa, you may notice that your vision becomes blurred or abnormal. Do not drive or use machines until the symptoms have passed.
Rhokiinsa contains benzalkonium chloride
This medicine contains approximately 150 micrograms of benzalkonium chloride in each ml of solution.
Benzalkonium chloride can be absorbed by soft contact lenses and can change the color of contact lenses. Remove your contact lenses before using this medicine and wait 15 minutes before inserting them again.
Benzalkonium chloride can also irritate the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane in the front of the eye). If you experience an abnormal feeling in the eye or feel tingling or pain in the eye after using this medicine, consult a doctor.
How to use Rhokiinsa
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Rhokiinsa should only be used in the eyes ( ocular use). The drug must not be swallowed or injected.
The recommended dose is one drop in the affected eye or eyes once a day in the evening. Use the medicine at about the same time each day.
How to use it
- Wash your hands before you start.
- Do not touch the drip device with your fingers when opening or closing the bottle. This can contaminate the drops.
- Unscrew the bottle cap and place the cap on its side on a clean surface. Continue to hold the bottle while making sure that the drip tip does not touch anything.
- Hold the bottle, pointing down, between your thumb and fingers.
- Bend your head back.
- Pull down the lower eyelid with a clean finger until a “pocket” is formed between the eyelid and the eye. The drop should end up here (picture 1).
- Push the drip tip of the bottle towards the eye. Do this in front of a mirror if it makes it easier.
- Do not touch the eye or eyelid, surrounding areas, or other surfaces with the drip tip. This can contaminate the drops.
- Gently press on the bottle to release a drop of Rhokiinsa in the eye.
- Only one drop should be applied to the eye each time. If a drop misses the eye, try again.
- Repeat the steps for the other eye while the bottle is open if you need to use drops in both eyes.
- Replace the bottle cap to close the bottle.
If you use other eye drops, wait at least 5 minutes after using them, and only then use Rhokiinsa. If you use eye ointments, these should be used last.
If you use more Rhokiinsa than you should
Rinse the eye with lukewarm water. Do not take more drops until it is time for the 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 or eyes once a day.
If you stop using Rhokiinsa
Do not stop taking Rhokiinsa without first talking to your doctor. If you stop using Rhokiinsa, the pressure in your eye will not be kept under control, which could lead to vision loss.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been seen with Rhokiinsa:
Very common side effects (may affect more than 1 in 10 people)
- Effects in the eye: Eye redness; small deposits in the front of the eye and pain where the drops have been applied
Common side effects (may affect up to 1 in 10 people)
- Eye effects: Infection or inflammation of the eye; dry eyes or small damage to the liquid film on the surface of the eye; eye secretion; itchy eyelids; cloudiness of the eye and vision may decrease slightly; eye pain; a feeling of grit or of having something in the eye; general redness of the eyes shortly after application of the drops; reddening of the eyes as dots or spots; eye inflammation caused by an allergic reaction or prominent blood vessels; eyes may become watery, sensitive to light; swelling around the eye; dimsyn
- 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 colored part of the eye ( iris one); swollen iris; eyelash growth; dry eyelids; eye disease associated with diabetes; effect on the conjunctiva (the outer membrane of the eye and covers the inside of the eyelids); blindness; blurred vision, double vision, and halo effect (rings around a light source); cataract; abnormal outward turning of the lower eyelid; small colored dots/spots on the surface of the eye; dry eyes due to inflammation of the eyelid glands; eye allergy; crusting on the eyelids; watery eyes; loss of eyelashes; fatigue
- General side effects: Increased allergic symptoms; dizziness; dimsyn; discomfort and pain in the nose; redness or itching of the skin; rash on the skin; bronchitis; tingling in the skin
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 bottle and carton after “EXP” or “EXP”. The expiration date is the last day of the specified month.
Unopened bottles: Store in a refrigerator (2 ° C – 8 ° C).
After opening the bottle: Do not store it above 25 ° C.
Discard the bottle 4 weeks after it was first opened to prevent infection, and use a new bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance is netarsudil. Each ml of solution contains 200 micrograms of netarsudil (as mesylate).
- Other excipients are benzalkonium chloride (see section 2 under ‘Rhokiinsa contains benzalkonium chloride’), mannitol, boric acid, sodium hydroxide, and water for injections.
What the medicine looks like and the contents of the pack
Rhokiinsa is a clear eye drop solution in liquid form in a plastic bottle. Each bottle contains 2.5 ml of medicine and each pack contains a bottle with a screw cap.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Santen Oy
Niittyhaankatu 20,
33720 Tampere,
Finland
Manufacturer
Aerie Pharmaceuticals Ireland, Limited
Athlone Business and Technology Park,
Dublin Road,
Garrycastle,
Athlone, Co Westmeath,
N37 DW40,
Ireland
Contact the representative of the marketing authorization holder to find out more about this medicine: show
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