Roclanda
Italy
Table of Contents
Patient Information Leaflet
Roclanda 50 micrograms/mL + 200 micrograms/mL eye drops, solution
latanoprost + netarsudil
Please 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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it could be harmful.
- If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Roclanda is and what it is used for
- What you need to know before using Roclanda
- How to use Roclanda
- Possible side effects
- How to store Roclanda
- Contents of the pack and other information
1. What Roclanda is and what it is used for
Roclanda contains two 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". The two active substances work in different ways to reduce the amount of fluid inside the eye, thereby lowering the pressure.
Roclanda is indicated to reduce intraocular pressure in adults who have a medical eye condition known as glaucoma or who have elevated intraocular pressure. If too high, intraocular pressure can damage vision.
2. What you need to know before using Roclanda
Do not use Roclanda
- if you are allergic to latanoprost or netarsudil or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Roclanda if you think any of the following situations apply to you:
- if you suffer from dry eyes
- if you or your child suffer from eye problems (such as eye pain, irritation or inflammation, blurred vision)
- if you suffer from severe or poorly controlled asthma
- if you have had or are currently experiencing a viral eye infection caused by the herpes simplex virus
- if you wear contact lenses. You may still use Roclanda, but follow the instructions for contact lens wearers provided in section 3.
Do not use Roclanda more than once a day, as this may lead to an increased risk of side effects.
Inform your doctor if you experience a decrease in vision or eye pain during treatment with this medicine. This could be due to a type of swelling in the transparent outer layer of the eye (reticular epithelial corneal edema). This effect has been reported following administration of this medicine in patients with certain risk factors, including previous eye surgery. This usually improves after stopping the medicine.
Children and adolescents
Roclanda must not be used in children and adolescents under 18 years of age, as it is not known whether it is safe or effective in this age group.
Other medicines and Roclanda
Roclanda may interact with other medicines. Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, especially medicines containing another prostaglandin analogue such as latanoprost (see section 3 "How to use Roclanda").
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Do not use Roclanda if you are pregnant or breastfeeding.
Driving and using machines
Roclanda has a negligible effect on the ability to drive and use machines. You may experience blurred or abnormal vision immediately after using Roclanda. Do not drive or operate machinery until your vision returns to normal.
Roclanda contains benzalkonium chloride
This medicine contains benzalkonium chloride, which can be absorbed by soft contact lenses and may cause a change in their colour. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them (see section 3 "How to use Roclanda").
Benzalkonium chloride may also cause eye irritation, particularly if you have dry eyes or corneal disorders (the eye's most superficial transparent layer). Consult your doctor if you experience an abnormal sensation in the eyes or sharp or dull eye pain after using this medicine.
3. How to use Roclanda
Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use Roclanda only in the eye (ophthalmic use).
The recommended dose is one drop into the affected eye once daily in the evening. Use the medicine
every day at approximately the same time. Do not use it more than once a day.
Do not use more than one drop into the affected eye once daily.
Instructions for use
- Wash your hands before starting. Contact lenses must be removed before instilling latanoprost + netarsudil (see section 2 “Warnings and precautions”).
- Do not touch the dropper tip with your fingers when opening or closing the bottle. This could contaminate the eye drops.
- Unscrew the cap and place it on a clean surface. Keep holding the bottle, making sure the dropper tip does not come into contact with anything.
- Hold the bottle between your thumb and fingers, with the tip pointing downwards.
- Tilt your head backwards.
- Gently pull down the lower eyelid with a clean finger to create a “pocket” between the eyelid and the eye. The drop should be placed here.
- Bring the dropper tip close to the eye. Using a mirror may be helpful.
- Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip. This could contaminate the eye drops.
- Gently squeeze the bottle to release one drop of Roclanda into the eye.
- Apply only one drop into the eye each time. If the drop misses the eye, repeat the procedure.
- Press gently with your finger on the inner corner of the eye, near the nose. Keep pressing for one minute while keeping the eye closed.
- If you need to use the eye drops in both eyes, repeat the steps for the other eye while the bottle remains open.
- Replace the cap to close the bottle.
- Put the bottle back into the box to protect the eye drops from light until the next use.
If you are using other eye drops , wait at least five minutes after using them, then use Roclanda last, due to netarsudil’s ability to dilate blood vessels. If you are using an ophthalmic ointment, it should be used last.
If you use more Roclanda than you should
Rinse the eye with lukewarm water. Do not instill further drops until the next scheduled regular dose.
If you forget to use Roclanda
Continue with the next dose as scheduled. Do not use a double dose to make up for a missed dose.
If you stop using Roclanda
Do not stop using Roclanda without first discussing it with your doctor. If you stop using Roclanda, eye pressure will not be controlled, which could lead to vision loss.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
You can usually continue using the eye drops unless the side effects are serious. If you are concerned,
speak to your doctor or pharmacist. Do not stop using this eye drop without consulting your doctor.
The following side effects have been observed with Roclanda and other medicines containing latanoprost
and netarsudil used alone:
- Very common (may affect more than 1 in 10 people) or Eye effects:
- Redness of the eyes; fine deposits in the front part of the eye (cornea verticillata)
- Pain at the site where the drops were instilled
- Gradual increase in the amount of brown pigment in the coloured part of the eye (iris), leading to 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) or Eye effects:
- General redness of the eyes shortly after instilling the drops; spots or patches of redness in the eyes
- Eye infection or inflammation; conjunctivitis (inflammation of the eyes or prominent blood vessels) due to an allergic reaction; dry eye or small breaks in the liquid film on the surface of the eye (punctate keratitis)
- Eye discharge; watery eyes
- Itching of the eyelids; swelling around the eye; eyelid crusting
- Blurred vision and slightly reduced vision; blurred vision
- Eye pain; gritty sensation or feeling of having something in the eye or General side effects
- Redness or itching sensation of the facial skin
- Uncommon (may affect up to 1 in 100 people) or Eye effects:
- Increased pressure of the fluid inside the eye
- Inflammation of the coloured part of the eye (iris); protrusion of the iris
- Increased wrinkling of the transparent layer covering the eye where it meets the lower eyelid (conjunctivochalasis); small coloured spots on the eye surface; glassy/vitreous eyes; fatigue; numbness or burning sensation in the eye; increased sensitivity to light
- Eye allergy
- Blindness, double vision, or halos around vision
- Blockage of the tear duct; dry eyes caused by inflammation of the eyelid glands
- Abnormal outward turning of the lower eyelid; loss of eyelashes (madarosis); skin discolouration of the eyelids
- Eye disease related to diabetes (diabetic retinopathy) or Side effects in other parts of the body
- Stuffy nose; nosebleed; discomfort and pain in the nose
- Headache; dizziness; feeling unwell (nausea, vomiting)
- Redness or itching of the skin; dry skin; thickening of the skin; skin excoriation
- Muscle pain, spasm, or weakness; joint pain; jaw/mandible pain; cartilage inflammation
- Chest pain (angina); awareness of heartbeat (palpitations)
- Asthma; shortness of breath (dyspnea)
- Rare (may affect up to 1 in 1,000 people) or Eye effects:
- Swelling or scratching causing damage to the eye surface; swelling around the eye (periorbital edema); scar tissue formation on the eye surface
- Eyelash growth in the wrong direction or formation of an extra row of eyelashes
- Fluid-filled area in the coloured part of the eye (iris cyst)
- Skin reactions on the eyelids; darkening of the eyelid skin
- Viral eye infection caused by the herpes simplex virus (HSV) or Side effects in other parts of the body
- Worsening of asthma
- Severe itching of the skin
- Very rare (may affect up to 1 in 10,000 people) or Eye effects:
- Sunken eye (deepening of the eyelid groove) or Side effects in other parts of the body
- Worsening of angina in patients who also have heart disease
- Not known (frequency cannot be estimated from the available data) or Eye effects:
- Swelling of the outer transparent layer of the eye (epithelial reticular corneal edema)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects,
you can help provide more information on the safety of this medicine.
5. How to store Roclanda
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the carton and
bottle after Exp. The expiry date refers to the last day of that month.
Unopened vial: store in the refrigerator (2°C – 8°C).
After opening the vial: do not store above 25°C.
Keep in the original packaging to protect the medicine from light.
Do not use the vial more than 4 weeks after first opening to prevent infections; use a new vial.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.
6. Package contents 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 mesylate).
- The other components are benzalkonium chloride (see section 2, “Roclanda contains benzalkonium chloride”), mannitol (E 421), boric acid, sodium hydroxide (E 524) (for pH adjustment) and water for injections.
Description of the appearance of Roclanda and contents of the pack
Roclanda 50 micrograms/mL + 200 micrograms/mL ophthalmic solution (eye drops) is a clear solution in a plastic bottle. Each bottle contains 2.5 mL of medicinal product and each pack contains 1 or 3 bottles with screw caps. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Santen Oy
Niittyhaankatu 20, 33720 Tampere, Finland
Manufacturer
Santen Oy
Kelloportinkatu 1, 33100 Tampere, Finland
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Santen Oy Santen Oy
Tél/Tel: +32 (0) 24019172 Tel: +370 37 366628
България Luxembourg/Luxemburg
Santen Oy Santen Oy
Teл.: +40 21 528 0290 Tél/Tel: +352 (0) 27862006
Česká republika Magyarország
Santen Oy Santen Oy
Tel: +358 (0) 3 284 8111 Tel: +358 (0) 3 284 8111
Danmark Malta
Santen Oy Santen Oy
Tlf.: +45 898 713 35 Tel: +358 (0) 3 284 8111
Deutschland Nederland
Santen GmbH Santen Oy
Tel: +49 (0) 3030809610 Tel: +31 (0) 207139206
Eesti Norge
Santen Oy Santen Oy
Tel: +372 5067559 Tlf: +47 21939612
Ελλάδα Österreich
Santen Oy Santen Oy
Τηλ: +358 (0) 3 284 8111 Tel: +43 (0) 720116199
España Polska
Santen Pharmaceutical Spain S.L. Santen Oy
Tel: +34 914 142 485 Tel.: +48 (0) 221042096
France Portugal
Santen S.A.S. Santen Oy
Tél: +33 (0) 1 70 75 26 84 Tel: +351 308 805 912
Hrvatska România
Santen Oy Santen Oy
Tel: +358 (0) 3 284 8111 Tel: +358 (0) 3 284 8111
Ireland Slovenija
Santen Oy Santen Oy
Tel: +353 (0) 16950008 Tel: +358 (0) 3 284 8111
Ísland Slovenská republika
Santen Oy Santen Oy
Sími: +358 (0) 3 284 8111 Tel: +358 (0) 3 284 8111
Italia Suomi/Finland
Santen Italy S.r.l. Santen Oy
Tel: +39 0236009983 Puh/Tel: +358 (0) 974790211
Κύπρος Sverige
Santen Oy Santen Oy
Τηλ: +358 (0) 3 284 8111 Tel: +46 (0) 850598833
Latvija
Santen Oy
Tel: +371 677 917 80
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/