Roclanda - Latanoprost and netarsudil uses, dose and side effects

Roclanda contains the active substances latanoprost and netarsudil. Latanoprost belongs to a group of medicines called prostaglandin analogs. Netarsudil belongs to a group of medicines called Rho-kinase inhibitors. They work in different ways to reduce the amount of fluid in the eyes and thus lower the pressure.

Roclanda 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, vision can be damaged.

What you need to know before using Roclanda

Do not use Roclanda

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

Warnings and cautions

If you think any of the following may be true for you, talk to your doctor or pharmacist before using Roclanda:

You have dry eyes.
You have severe asthma or asthma that is not well controlled.
You have had or have an ongoing viral infection in your eye caused by the herpes simplex virus.

Do not use Roclanda more than once a day, as it may give you more side effects.

Children and young people

Roclanda should not be used in children or adolescents under 18 years of age, as it is not known if the medicine is safe and effective in this age group.

Other medicines and Roclanda

Roclanda can affect or be affected by other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially those containing another prostaglandin analog, such as latanoprost.

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 Roclanda if you are pregnant.

Driving and using machines

Shortly after using Roclanda, you may notice that your vision becomes blurred or abnormal. Do not drive or use machines until your vision problems have passed.

Roclanda contains benzalkonium chloride

This medicine contains benzalkonium chloride, which can be absorbed by soft contact lenses and discolor them. Remove the contact lenses before using the medicine and wait at least 15 minutes before re-inserting them.

Benzalkonium chloride can also be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using this medicine, consult a doctor.

How to use Roclanda

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Roclanda should only be used in the eyes ( ocular use).

The recommended dose is one drop in the affected eye once a day in the evening. Use the medicine at about the same time each day. Do not use this medicine more than once a day.

How to use the medicine

Wash your hands before you start.
Do not touch the drip tip with your fingers when opening or closing the bottle. This can contaminate the eye 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.
Move the drip tip 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 eye drops.
Gently press the bottle to release a drop of Roclanda into the eye.
Only one drop should be applied to the eye each time. If a drop misses the eye, try again.
After dosing, press a finger against the inner corner of the eye at the nose. Hold your finger for 1 minute and close your eyes at all times.
If you need to use drops in both eyes, repeat the steps for the other eye while the bottle is open.
Replace the bottle cap and close the bottle.
Put the bottle back in the carton to protect the eye drops from light until you need to use them again.

If you use other eye drops, wait at least 5 minutes after using them, and only then use Roclanda. If you use an eye ointment, use it last.

If you use more Roclanda than you should

Rinse the eye with lukewarm water. Do not take more drops, but wait until it is time for the next regular dose.

If you forget to use Roclanda

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 once a day.

If you stop using Roclanda

Do not stop taking Roclanda without talking to your doctor first. If you stop using Roclanda, the pressure in your eye will not be kept under control, which may lead to impaired vision/loss of vision.

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 Roclanda and other medicines containing latanoprost or netarsudil alone.

Very common (may affect more than 1 user in 10)
- Effects on the eye
  - Reddening of the eyes; small deposits in the front of the eye and pain where the drops have been applied; a gradually increasing amount of brown pigment in the colored part of the eye ( iris ) which gives a change in eye color; a gradual increase in eyelash color (darker), length, thickness, and number.
Common (may affect up to 1 in 10 people)
- Effects on the eye
  - Infection or inflammation of the eye; dry eyes or small damage to the liquid film on the surface of the eye; eye secretions; itchy eyelids; cloudiness of the eye and slight deterioration of vision; eye pain; a feeling of grit or of having something in the eye; general redness of the eyes shortly after application of the drops; redness of the eyes in the form of dots or spots; conjunctivitis (eye inflammation or prominent blood vessels) caused by an allergic reaction; watery eyes, increased sensitivity to light; swelling around the eye; crusting on the eyelids; dimsyn.
- General adverse reactions
  - Redness or itching of the skin on the face.
Uncommon (may affect up to 1 in 100 people)
- Effects on the eye
  - Increased fluid pressure inside the eye; inflammation of the colored part of the eye ( iris ); swollen iris; increased creasing of the clear membrane over the eye where it meets the lower eyelid; blindness, blurred vision, double vision or halo effect; blocked tear duct; small colored dots/spots on the surface of the eye; dry eyelids; dry eyes due to inflammation of the eyelid glands; eye allergy; shiny/glossy eyes; tired eyes; a numb or burning sensation in the eye; abnormal outward turning of the lower eyelid; loss of eyelashes, an eye disease associated with diabetes
- Side effects are in other parts of the body
  - Nasal congestion; nosebleeds; discomfort and pain in the nose; headache; dizziness; redness or itching of the skin; dry skin; thickening of the skin; muscle pain or cramps; joint pain; jaw pain; tingling in the skin; bronchitis; chest pain (angina); awareness of heartbeat (palpitations); asthma; shortness of breath ( dyspnoea ).
Rare side effects (may affect up to 1 in 1,000 people)
- Effects on the eye
  - Swelling or abrasions with damage to the eye surface; swelling around the eye (periorbital edema ); the eyelashes growing in the wrong direction or an extra row of eyelashes is formed; scarring on the surface of the eye; fluid-filled area within the colored part of the eye (iris cyst); skin reactions on the eyelids; darkening of the skin on the eyelids; viral infection of the eye caused by the herpes simplex virus ( HSV ).
- Side effects are in other parts of the body
  - Exacerbated asthma; severe itchy skin.
Very rare side effects (may affect up to 1 in 10,000 people)
- Effects on the eye
  - The eyes look sick (deepening of the eye socket).
- Side effects are in other parts of the body
  - Exacerbated angina in patients who also have heart disease.

How to store Roclanda

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 bottle: Store in a refrigerator (2 ° C – 8 ° C).

After opening the bottle: Do not store it above 25 ° C.

Store in the original package. Sensitive to light.

To prevent infection, discard the bottle 4 weeks after it was first opened and use a new bottle instead.

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 pack and other information

Content declaration

The active substances are latanoprost and netarsudil. Each ml of solution contains 50 micrograms of latanoprost and 200 micrograms netarsudil (as mesylate).
Other excipients are benzalkonium chloride (see section 2 under “Roclanda contains benzalkonium chloride”), mannitol, boric acid, sodium hydroxide (for pH adjustment), and water for injections.

What the medicine looks like and the contents of the pack

Roclanda eye drops are a clear solution 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

and