DICLOFTIL 0.1 %

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

DICLOFENAC SODIUM

זמין מ:

BIOAVENIR LTD, ISRAEL

קוד ATC:

M02AA15

טופס פרצבטיות:

SOLUTION

הרכב:

DICLOFENAC SODIUM 0.1 %V/V

מסלול נתינה (של תרופות):

OCULAR

סוג מרשם:

Required

תוצרת:

FARMIGEA S.P.A., ITALY

קבוצה תרפויטית:

DICLOFENAC

איזור תרפויטי:

DICLOFENAC

סממני תרפויטית:

Post-operative inflammation following cataract extraction. Control of ocular pain and discomfort associated with corneal epithelial defects after laser excimer PRK or accidental trauma.

תאריך אישור:

2023-06-30

עלון מידע

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
DICLOFTIL 0.1% EYE DROPS
SINGLE DOSE CONTAINER
PRESERVATIVE-FREE
The active ingredient and its concentration:
Each 1 ml contains 1 mg diclofenac sodium.
Inactive ingredients and allergens: see section 2 "Important
information about
some of this medicine's ingredients" and section 6 "Additional
information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have any
further questions, consult your doctor or pharmacist.
This medicine has been prescribed for you to treat your illness. Do
not pass it
on to others. It may harm them, even if it seems to you that their
illness is
similar to yours.
The use of Dicloftil 0.1% is prohibited in children below 14 years of
age since
there are no sufficient efficacy and safety data available in this age
group.
1. WHAT IS THIS MEDICINE INTENDED FOR?
•
For the treatment of eye inflammation following cataract extraction
surgery.
•
Relief of ocular pain and discomfort associated with corneal
epithelial
defects following laser surgery or accidental trauma in the eye.
THERAPEUTIC GROUP:
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
2. BEFORE USING THIS MEDICINE:
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient (diclofenac
sodium), to
any of the other ingredients of this medicine (listed in section 6) or
to other
non-steroidal
anti-inflammatory
drugs
(aspirin
(acetylsalicylic
acid),
indomethacin etc.).
•
You have had an asthma attack, urticaria or acute rhinitis after
taking
aspirin (acetylsalicylic acid) or other prostaglandin-synthetase
inhibitor
drugs in the past.
•
You are under the age of 14.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
•
Do not wear soft contact lenses during treatment with this medicine.
Contact lenses should be removed before use of this medicine and
should
not be worn

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dicloftil 0.1% eye drops, solution – 30 single-dose containers 0.5
ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml contain
100 mg of diclofenac sodium (equal to 93.084 mg of diclofenac).
One ml of Dicloftil 0.1% eye drops
contains 1 mg of diclofenac sodium.
Excipient(s) with known effect(s): boric acid.
For a complete list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution in single-dose containers.
4.
CLINICAL INFORMATION
4.1 THERAPEUTIC INDICATIONS
• Post-operative inflammation following cataract extraction.
• Control of ocular pain and discomfort associated with corneal
epithelial defects after laser excimer PRK
surgery or accidental trauma.
4.2 POSOLOGY, DOSAGE AND METHOD OF ADMINISTRATION
ADULTS
A)
OCULAR SURGERY AND ITS COMPLICATIONS
Preoperatively, up to 1 drop 5 times during the 3 hours before
surgery.
Postoperatively, 1 drop 3 times on the day of surgery, followed by 1
drop 3 to 5 times daily for as long as
required. B) TREATMENT OF PAIN AND DISCOMFORT
One drop 4 to 6 hourly.
When pain is due to a surgical procedure (e.g. refractive surgery(.
Instill 1 drop, 30-60 minutes prior to
surgery, into the eye to be operated on. During the first 10 minutes
following surgery, instill 1-2 doses of 1
drop each, followed by 1 drop 4 times daily for 2 days.
ELDERLY:
There is no indication that dosage needs to be modified for the
elderly.
PAEDIATRIC USE:
Dicloftil 0.1% eye drops is not indicated for use in children.
Paediatric experience is limited to a few
published clinical studies in strabismus surgery.
The dispenser remains sterile until the original closure is broken.
Patients must be instructed to avoid
allowing the tip of the dispensing container to to contact the eye or
surrounding structures as this may
contaminate the solution.
If more than one medication needs to be instilled in the eye, an
interval of at least 5 minutes between
application of the different medicinal products must be allowed.
Following in