Roclanda 50 microgramos/ml + 200 microgramos/ml colirio en solucion

Prospect: information for the patient

Roclanda 50 micrograms/ml + 200 micrograms/ml eye drops in solution

latanoprost/netarsudil

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

Roclanda contains the active ingredients latanoprost and netarsudil. Latanoprost belongs to a group of medications called «prostaglandin analogs». Netarsudil belongs to a group of medications called «Rho kinase inhibitors». They act in different ways to reduce the amount of fluid inside the eye and thus decrease the pressure.

Roclanda is used to reduce eye pressure in adults who suffer from a eye disease called «glaucoma» or who present with ocular hypertension. If the pressure in the eye is too high, it can damage vision.

Do not use Roclanda:

• if you are allergic to latanoprost, netarsudil, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Roclanda if you think your case corresponds to any of the following situations:

• you have dry eye;
• you have severe or uncontrolled asthma;
• you have had or have a viral eye infection caused by the herpes simplex virus.

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

Children and adolescents

Roclanda should not be used in children and adolescents under 18 years of age, as its safety and efficacy in this age group are unknown.

Other medications and Roclanda

Roclanda may interact with other medications. Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, especially if it contains another prostaglandin analogue, such as latanoprost.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Do not use Roclanda if you are pregnant.

Driving and operating machinery

You may notice blurred or altered vision shortly after using Roclanda. Do not drive or operate machinery until the symptoms have disappeared.

Roclanda contains benzalkonium chloride

This medication contains benzalkonium chloride, which can be absorbed by soft contact lenses and may alter their color. Remove your contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases. Consult your doctor if you experience any unusual sensation, burning, or pain in your eye after using this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Roclanda should only be applied to the eyes (ophthalmic route).

The recommended dose is one drop in each affected eye once a day, in the evening. Use the medication at approximately the same time every day. Do not use more than once a day.

Method of use

• Wash your hands before using the medication.
• Do not touch the tip of the dropper with your fingers when opening or closing the bottle, as the eye drops could become infected.
• Twist off the cap of the bottle and set it aside on a clean surface. Continue to hold the bottle, ensuring the tip does not come into contact with anything.
• Hold the bottle, pointing downwards, between your thumb and the rest of your fingers.
• Tilt your head back.
• Pull down the lower eyelid with your clean finger to form a "pocket" between the eyelid and the eye. The drop will enter this pocket.
• Bring the tip of the dropper close to the eye. If it helps, you can do it in front of a mirror.
• Do not touch your eyes, eyelids, surrounding areas, or other surfaces with the tip of the dropper, as the eye drops could become infected.
• Gently press the bottle to instill one drop of Roclanda into the eye.
• Instill one drop in the eye each time. If the drop does not enter the eye, try again.
• Press with a finger the edge of the eye, next to the nose, for 1 minute. Keep the eye closed.
• If you need to use the eye drops in both eyes, repeat the steps in the other eye while the bottle is open.
• Replace the cap on the bottle to close it.
• Replace the bottle in the box to protect it from light until you need to use the eye drops again.

If you are using other eye drops, wait at least five minutes after using them and then use Roclanda. If you use ophthalmic ointments, you must use them last.

If you use more Roclanda than you should

Rinse your eyes with warm water. Do not apply more drops until the next scheduled dose.

If you forgot to use Roclanda

Continue with the next dose as scheduled. Do not use a double dose to compensate for the missed doses.

Do not use more than one drop once a day in the affected eye.

If you interrupt treatment with Roclanda

You should not interrupt treatment with Roclanda without first talking to your doctor. If you stop using Roclanda, intraocular pressure will not be controlled, which could cause vision loss.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

The following side effects have been observed with Roclanda and other medications containing latanoprost or netarsudil alone:

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

• Eye effects:

• Redness of the eye; fine deposits on the front of the eye and pain at the site of drop instillation; gradual brown pigmentation increase in the colored part of the eye (iris) causing eye color alteration; gradual increase in color (darkening), length, thickness, and number of eyelashes.

• Common (may affect up to 1 in 10 people)

• Eye effects:

• Eye infection or inflammation; dry eye or small breaks in the tear film on the surface of the eye; eye discharge; itchy eyelids; eye cloudiness and slight vision decrease; eye pain; sensation of sand or having a foreign body in the eye; general eye redness shortly after putting in the drops; eye spots or areas of redness; allergic conjunctivitis (inflammation of the eye or prominent blood vessels); watery eyes; swelling around the eye; crusts on the eyelid and blurry vision.

• General side effects:

• Redness or itchiness of the facial skin.

• Uncommon (may affect up to 1 in 100 people)

• Eye effects:

• Increased pressure inside the eye; iris inflammation; iris bulging; increased wrinkles on the transparent layer at the front of the eye, where it coincides with the lower eyelid; blindness; blurry vision, double vision, or halo vision; tear duct blockage; small colored spots on the surface of the eye; dry eyelids; dry eye caused by inflammation of the eyelid glands; eye allergy; shiny/ glassy eyes; tired eyes; numbness or burning in the eye; abnormal downward turning of the lower eyelid; eyelash loss and diabetic eye disease; increased sensitivity to light; skin discoloration of the eyelid.

• Side effects in other parts of the body:

• Nasal obstruction; nasal bleeding; nasal discomfort and pain; headache; dizziness; vomiting; redness or itchiness of the skin; dry skin; skin thickening; muscle pain or spasms or weakness; joint pain; jaw pain; skin itching; cartilage inflammation; chest pain (angina); feeling heartbeats (palpitations); asthma and difficulty breathing (dyspnea).

• Rare (may affect up to 1 in 1000 people)

• Eye effects:

• Swelling or itchiness causing damage to the surface of the eye; swelling around the eye (periorbital edema); eyelash growth deviation or growth of another row of eyelashes; surface of the eye scarring; accumulation of fluid in the colored part of the eye (iris cyst); skin reactions on the eyelids; skin darkening of the eyelids; viral eye infection caused by the herpes simplex virus.

• Side effects in other parts of the body:

• Asthma worsening; intense skin itchiness.

• Very rare (may affect up to 1 in 10,000 people)

• Eye effects:

• Appearance of sunken eyes (greater depth of the eye socket).

• Side effects in other parts of the body:

• Asthma worsening in patients with heart disease.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in Appendix V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle and the box after CAD. The expiration date is the last day of the month indicated.

Unopened bottle: store in refrigerator (between 2 °C and 8 °C).

Once the bottle is opened: do not store at a temperature above 25 °C.

Store in the original box to protect it from light.

To prevent infections, discard the bottle 4 weeks after opening it for the first time and use a new bottle.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and the medications you no longer need. In this way, you will help protect the environment.

Composition of Roclanda

• The active principles are latanoprost and netarsudil. Each milliliter of solution contains 50 micrograms of latanoprost and 200 micrograms of netarsudil (as mesylate).
• The other excipients are benzalkonium chloride (see "Roclanda contains benzalkonium chloride" in section 2), mannitol, boric acid, sodium hydroxide (for pH adjustment) and water for injection preparations.

Appearance of the product and contents of the container

Roclanda is a transparent liquid eye drop that is presented in a plastic bottle. Each bottle contains 2.5 ml of the medication and each package contains 1 or 3 bottles with a screw cap. Some package sizes may only be marketed.

Marketing authorization holder

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Finland

Responsible for manufacturing

Aerie Pharmaceuticals Ireland, Limited

Athlone Business and Technology Park, Dublin Road,

Garrycastle, Athlone, Co Westmeath, N37 DW40, Ireland

and

Santen Oy

Kelloportinkatu 1, 33100 Tampere, Finland

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

Detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu.