Roclanda

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Latanoprost, Netarsudil mesilate

Available from:

Santen Oy

ATC code:

S01EE

INN (International Name):

latanoprost / netarsudil

Therapeutic group:

Ophthalmologicals

Therapeutic area:

Glaucoma, Open-Angle; Ocular Hypertension

Therapeutic indications:

Roclanda is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction.

Product summary:

Revision: 4

Authorization status:

Authorised

Authorization date:

2021-01-07

Patient Information leaflet

23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROCLANDA 50 MICROGRAMS/ML + 200 MICROGRAMS/ML EYE DROPS, SOLUTION
latanoprost + netarsudil
This medicine is subject to additional monitoring. This 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.
WHAT IS IN THIS LEAFLET
1.
What Roclanda is and what it is used for
2.
What you need to know before you use Roclanda
3.
How to use Roclanda
4.
Possible side effects
5.
How to store Roclanda
6.
Contents of the pack and other information
1.
WHAT ROCLANDA IS AND WHAT IT IS USED FOR
Roclanda contains the active substances latanoprost and netarsudil.
Latanoprost belongs to a group of
medicines known as prostaglandin analogues. Netarsudil belongs to a
group of medicines called Rho
kinase inhibitors. They work in different ways to reduce the amount of
fluid, and so lower the
pressure, inside the eye.
Roclanda is used to lower pressure in the eyes in adults who have an
eye condition known as
glaucoma or who have raised pressure in their eyes. 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 or netarsudil or 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 foll

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Roclanda 50 micrograms/ml + 200 micrograms/ml eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 50 micrograms latanoprost and 200
micrograms netarsudil (as mesylate) .
Excipient(s) with known effect
Each ml of solution contains 200 micrograms benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution, pH 5 (approximately).
Osmolality: 280 mOsm/Kg.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Roclanda is indicated for the reduction of elevated intraocular
pressure (IOP) in adult patients with
primary open-angle glaucoma or ocular hypertension for whom
monotherapy with a prostaglandin or
netarsudil provides insufficient IOP reduction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Roclanda should only be initiated by an ophthalmologist
or a healthcare professional
qualified in ophthalmology.
Posology
_Use in adults, including the elderly _
The recommended dosage is one drop in the affected eye(s) once daily
in the evening. Patients should
not instil more than one drop in the affected eye(s) each day.
If one dose is missed, treatment should continue with the next dose in
the evening.
_Paediatric population _
The safety and efficacy of Roclanda in children below the age of 18
years have not been established.
No data are available._ _
3
Method of administration
For ocular use.
_ _
Data on potential interactions specific to latanoprost + netarsudil
are described in section 4.5. If
latanoprost + netarsudil is to be used concomitantly with other
topical ophthalmic medicinal products,
each medicinal product should be administered at least five minutes