Ikervis

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ciclosporin

Available from:

Santen Oy

ATC code:

S01XA18

INN (International Name):

ciclosporin

Therapeutic group:

Ophthalmologicals

Therapeutic area:

Corneal Diseases

Therapeutic indications:

Treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes.

Product summary:

Revision: 10

Authorization status:

Authorised

Authorization date:

2015-03-19

Patient Information leaflet

32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IKERVIS 1 MG/ML, EYE DROPS, EMULSION
ciclosporin
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 IKERVIS is and what it is used for
2.
What you need to know before you use IKERVIS
3.
How to use IKERVIS
4.
Possible side effects
5.
How to store IKERVIS
6.
Contents of the pack and other information
1.
WHAT IKERVIS IS AND WHAT IT IS USED FOR
IKERVIS contains the active substance, ciclosporin. Ciclosporin
belongs to a group of medicines
known as immunosuppressive agents that are used to reduce
inflammation.
IKERVIS is used to treat adults with severe keratitis (inflammation of
the cornea, the transparent layer
in the front part of the eye). It is used in those patients who have
dry eye disease, which has not
improved despite treatment with tear substitutes (artificial tears).
Talk to a doctor if you do not feel better or if you feel worse.
You should visit your doctor at least every 6 months to assess the
effect of IKERVIS.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IKERVIS
_ _
DO NOT USE IKERVIS
-
if you are allergic to ciclosporin or any of the other ingredients of
this medicine (listed in
section 6).
-
if you have had or have a cancer in or around your eye.
-
if you have an eye infection.
WARNINGS AND PRECAUTIONS
Only use IKERVIS for dropping in your eye(s).
Talk to your doctor or pharmacist before using IKERVIS
-
if you have previously had an eye infection by the herpes virus that
might have damaged the
transparent front part of th

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
IKERVIS 1 mg/mL eye drops, emulsion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of emulsion contains 1 mg of ciclosporin.
Excipient with known effect:
One mL of emulsion contains 0.05 mg cetalkonium chloride (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, emulsion.
Milky white emulsion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
Treatment of severe keratitis in adult patients with dry eye disease,
which has not improved despite
treatment with tear substitutes (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated by an ophthalmologist or a healthcare
professional qualified in
ophthalmology.
Posology
The recommended dose is one drop once daily to be applied to the
affected eye(s) at bedtime.
Response to treatment should be reassessed at least every 6 months.
If a dose is missed, treatment should be continued on the next day as
normal. Patients should be
advised not to instil more than one drop in the affected eye(s).
Special populations
_Elderly patients _
The elderly population has been studied in clinical studies. No dose
adjustment is required.
_ _
_Patients with renal or hepatic impairment _
The effect of ciclosporin has not been studied in patients with
hepatic or renal impairment. However,
no special considerations are needed in these populations.
3
_Paediatric population _
There is no relevant use of ciclosporin in children and adolescents
aged below 18 in the treatment of
severe keratitis in patients with dry eye disease, which has not
improved despite treatment with tear
substitutes.
Method of administration
Ocular use.
_Precautions to be taken before administering the medicinal product _
Patients should be instructed to first wash their hands.
Prior to administration, the single-dose container should be gently
shaken.
For single use only. Each single-dose container is sufficient to treat
both eyes. Any unused emulsion
shoul