DURATEARS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LANOLIN; MINERAL OIL; PETROLATUM

Available from:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

ATC code:

S01XA

Pharmaceutical form:

OPHTALMIC OINTMENT

Composition:

MINERAL OIL 30 MG/G; LANOLIN 30 MG/G; PETROLATUM 1 G/G

Administration route:

OCULAR

Prescription type:

Not required

Manufactured by:

ALCON COUVREUR N.V., BELGIUM

Therapeutic group:

OTHER OPHTHALMOLOGICALS

Therapeutic indications:

Eye dryness.

Authorization date:

2023-01-31

Patient Information leaflet

The patient package insert in accordance with the
pharmacists’ regulations (preparations) – 1986
This medicine is dispensed without a doctor’s
Prescription
DURATEARS
Ocular Lubricating Ointment
Preservative Free
COMPOSITION:
Anhydrous liquid lanolin 30 mg/g
Mineral oil 30 mg/g
White petrolatum ad 1 g
READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE.
This leaflet contains concise information on the medicine. If you have
any
further questions, refer to the doctor or to the pharmacist.
You must use this medicine properly. Consult your pharmacist if you
need additional
information. You should refer to your doctor if the disease symptoms
worsens or do not
improve after 3 days.
1. WHAT IS THIS MEDICINE INTENDED FOR?
THERAPEUTIC ACTIVITY:
Lubricating ointment intended to prevent ocular dryness.
THERAPEUTIC GROUP: eye preparations.
2. BEFORE USING THE MEDICINE:
Do not use the medicine if:
•
You have a known sensitivity to any of the ingredients of the
medicine,
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
• If you are sensitive to any type of food or medicine,
inform the doctor before commencing treatment with this medicine.
• DURATEARS is intended for use in the eyes only.
• Do not wear contact lenses during treatment with this preparation.
• If you experience headache, eye pain or irritation of the eyes,
vision changes or
persistent redness in the eyes or if your condition worsens or
persists for more than
3 days – discontinue the treatment and refer to your doctor.
CHILDREN
The safety and efficacy of DURATEARS eye ointment in children has not
been determined.
IF YOU ARE TAKING, OR HAVE RECENTLY TAKEN, OTHER MEDICINES INCLUDING
NON-
PRESCRIPTION MEDICINES AND NUTRITIONAL SUPPLEMENTS, INFORM THE DOCTOR
OR
PHARMACIST.
• If you are using other eye preparations (for instance, drops), you
must wait at least 5
minutes between each application. Administer the eye ointment last.
USE OF THE MEDICINE AND FOOD:
Food and drink have no influence on the treatment.
PREGNANCY AND BRE

Summary of Product characteristics

1/4
1. NAME OF THE MEDICINAL PRODUCT
DURATEARS.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
This medicine contains no active substance.
Excipient with known effect: 1g eye ointment contains 30 mg lanoline
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye ointment
White to light yellow, translucent, homogeneous ointment
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Eye dryness
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
At night, before going to bed, apply a small amount of ointment into
the conjunctival sac or to the affected
spot.
_Pediatric population_
The safety and efficacy of DURATEARS eye ointment in children has not
been established.
Hepatic and Renal Disease
The safety and efficacy of DURATEARS eye ointment in subjects with
hepatic/renal disease has not been
established; however, no dosage modifications are expected to be
required for use in this population.
Method of administration x For ocular use.
x Remove contact lenses before using.
x Application of the ointment should be carried out under hygienic
conditions, avoiding any contact to
the tip of the tube. Close tube after every application.
x If a patient is receiving more than one topical ophthalmic drug, the
drugs should be administered at
least 5 minutes apart. Eye ointments should be administered last (see
section 4.5).
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For ocular use only. Not for injection or ingestion.
If patients experience headache, eye pain, vision changes, irritation
of the eyes, persistent redness, or if the
condition worsens or persists for more than 3 days, they are to
discontinue use and consult their doctor.
Contact lenses may not be worn during treatment with DURATEARS eye
ointment. Remove contact lenses
before using DURATEARS eye ointment.
DURATEARS eye ointment contains lanoline, which may cause local skin
reactions (e.g. contact dermatitis).
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER