ROCLANDA 50 micrograms/ml + 200 micrograms/ml Eye Drops, Solution

Introduction

Package Leaflet: Information for the Patient

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

latanoprost/netarsudil

This medicinal product is subject to additional monitoring, which will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.

Contents of the pack

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

1. What is Roclanda and what is it used for

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

Roclanda is used to reduce eye pressure in adults with a condition called ‘glaucoma’ or who have high pressure in the eye. If the pressure in the eye is too high, it can damage your sight.

2. What you need to know before you use Roclanda

Do not use Roclanda:

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

Warnings and precautions

Tell your doctor or pharmacist before you start using Roclanda if you think any of the following apply to you:

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

Do not use Roclanda more than once a day, as this may increase the risk of side effects.

Children and adolescents

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

Other medicines and Roclanda

Roclanda may interact with other medicines. Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, especially if they contain another prostaglandin analogue, such as latanoprost.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Do not use Roclanda if you are pregnant.

Driving and using machines

You may notice blurred or altered vision just after using Roclanda. Do not drive or use machines until the symptoms have resolved.

Roclanda contains benzalkonium chloride

This medicine contains benzalkonium chloride, which may be absorbed by soft contact lenses and may change the colour of the contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before putting them back.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other diseases of the cornea (the transparent layer on the front of the eye). Tell your doctor if you feel any unusual sensation, itching or pain in the eye after using this medicine.

3. How to use Roclanda

Use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Roclanda is for use in the eyes only (ophthalmic use).

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

Method of administration

• Wash your hands before using the medicine.
• Do not touch the tip of the dropper with your fingers when opening or closing the bottle, as the eye drops may become contaminated.
• Remove the cap from the bottle and place it on a clean surface. Continue to hold the bottle, making sure the tip does not touch anything.
• Hold the bottle, pointing downwards, between your thumb and the other fingers.
• Tilt your head back.
• Pull down the lower eyelid to form a ‘pocket’ between the eyelid and the eye. The drop will go into this pocket.
• Bring the tip of the dropper close to the eye. If it helps, you can do this in front of a mirror.
• Do not touch the eyes, eyelids, or surrounding areas with the tip of the dropper, as the eye drops may become contaminated.
• Gently squeeze the bottle to release one drop of Roclanda into the eye.
• Release one drop at a time. If the drop does not go into the eye, try again.
• Press 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.
• Put the bottle back in the carton to protect it from light until you need to use the eye drops again.

If you are using other eye drops, wait at least 5 minutes after using them before using Roclanda. If you use eye ointments, you should use them last.

If you use more Roclanda than you should

Rinse your eyes with warm water. Do not put in any more drops until the next normal dose is due.

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 once a day in the affected eye.

If you stop using Roclanda

Do not stop using Roclanda without talking to your doctor first. If you stop using Roclanda, your eye pressure will not be controlled, which could lead to loss of vision.

If you have any other 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 side effects have been seen with Roclanda and with other medicines that contain latanoprost or netarsudil alone:

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

• Ocular effects:

• eye redness; fine deposits in the front of the eye and pain at the drop administration site; gradual increase in brown pigmentation of the coloured part of the eye (the iris) which may result in a change in eye colour; gradual increase in colour (darkening), length, thickness and number of eyelashes.

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

• Ocular effects:

• eye infection or inflammation; dry eye or small breaks in the tear film on the surface of the eye; eye discharge; eyelid itching; blurred vision and slight decrease in vision; eye pain; feeling of something in the eye; general redness of the eyes shortly after putting in the drops; red spots or areas of redness on the eye; allergic conjunctivitis (inflammation of the eye or prominent blood vessels); watery eyes; swelling around the eye; crusts on the eyelid and blurred vision.

• General side effects:

• redness or itching of the skin of the face.

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

• Ocular effects:

• increase in pressure of the fluid in the eye; inflammation of the coloured part of the eye (the iris); swelling of the iris; increase in wrinkles of the transparent layer on the front of the eye where it meets the lower eyelid; blindness; blurred vision, double vision or halo vision; blockage of the tear duct; small coloured spots on the surface of the eye; dryness of the eyelids; dry eye caused by inflammation of the glands in the eyelids; eye allergy; shiny eyes; tired eyes; numbness or burning in the eye; abnormal turning out of the lower eyelid; loss of eyelashes and diabetic eye disease; increased sensitivity to light; discolouration of the eyelid skin.

• General side effects:

• nose congestion; nosebleed; nasal discomfort and pain; headache; dizziness; vomiting; redness or itching of the skin; dry skin; thickening of the skin; muscle pain or spasms or weakness; joint pain; jaw pain; skin itching; inflammation of the cartilage; chest pain (angina); feeling your heartbeat (palpitations); asthma and difficulty breathing (dyspnoea).

• Rare (may affect up to 1 in 1,000 people)

• Ocular effects:

• swelling or itching that causes damage to the surface of the eye; swelling around the eye (periorbital oedema); misdirected growth of eyelashes or growth of an extra row of eyelashes; scarring of the surface of the eye; accumulation of fluid in the coloured part of the eye (iris cyst); skin reactions on the eyelids; darkening of the eyelid skin and viral infection of the eye caused by the herpes simplex virus.

• General side effects:

• worsening of asthma; intense itching of the skin.

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

• Ocular effects:

• appearance of sunken eyes (increased depth of the eye socket).

• General side effects:

• worsening of angina in patients with heart disease.

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. Storage of 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. The expiry date is the last day of the month shown.

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

Once the bottle is open: do not store above 25°C.

Store in the original carton to protect from light.

To avoid infections, discard the bottle 4 weeks after first opening 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. This will help to protect the environment.

6. Contents of the pack and other information

What Roclanda contains

• The active substances are latanoprost and netarsudil. Each ml of solution contains 50 micrograms of latanoprost and 200 micrograms of netarsudil (as mesilate).
• The other ingredients are benzalkonium chloride (see ‘Roclanda contains benzalkonium chloride’ in section 2), mannitol, boric acid, sodium hydroxide (for pH adjustment) and water for injections.

Appearance and packaging

Roclanda is a clear liquid eye drop solution. It comes in a plastic bottle. Each bottle contains 2.5 ml of the medicine and each pack contains 1 or 3 bottles with a screw cap. Not all pack sizes may be marketed.

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

Santen Oy

Kelloportinkatu 1, 33100 Tampere, Finland

For further information about this medicine, contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.