Tears Naturale II Eye Drops Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DEXTRAN 70; HYPROMELLOSE

Available from:

Novartis Ireland Limited

ATC code:

S01XA20

INN (International Name):

DEXTRAN 70; HYPROMELLOSE

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

DEXTRAN 70 1 mg/ml; HYPROMELLOSE 3 mg/ml

Prescription type:

OTC

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Authorised

Patient Information leaflet

BASIC PATIENT LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. Nevertheless you
still need to use TEARS
NATURALE II carefully to get the best results from it.
•
_Keep this leaflet. You may need to read it again. _
•
_Ask your pharmacist if you need more information or advice. _
•
_You must see a doctor if your symptoms worsen or do not improve after
a number of days. _
CONTENTS OF THIS LEAFLET
1.
What TEARS NATURALE II is and what it is used for.
2.
What you should know before you use TEARS NATURALE II.
3.
How to use TEARS NATURALE II.
4.
Possible undesirable effects.
5.
How to store TEARS NATURALE II.
6.
Further information.
TEARS NATURALE II, eye drops, solution
-
The active substances are dextran 70 1.0 mg/ml and hypromellose 3.0
mg/ml.
-
The other ingredients are sodium chloride, potassium chloride, borax,
polyquaternium-1 solution,
concentrated hydrochloric acid and/or sodium hydroxide and purified
water to 1 ml.
MARKETING AUTHORISATION HOLDER
Novartis Ireland Limited
Vista Building,
Elm Park, Merrion Road,
Ballsbridge, Dublin 4,
Ireland.
MANUFACTURER
SA Alcon-Couvreur NV
Rijksweg 14 2870 Puurs
BELGIUM
MARKETING AUTHORISATION NUMBER
MA015/00101
1. WHAT TEARS NATURALE II IS AND WHAT IT IS USED FOR
TEARS NATURALE II eye drops, solution, is packed in a 5, 10 and 15 ml
droptainer.
1/4
TEARS NATURALE II is used against dryness of the eye.
TEARS NATURALE II is indicated for dry eyes, inadequate functioning of
the lacrimal glands and
instability of the lacrimal film.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE TEARS NATURALE II
DO NOT USE TEARS NATURALE II
-
if you are allergic to dextran 70, hypromellose or any of the other
ingredients of Tears Naturale II.
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH TEARS NATURALE II
-
If you experience headache, eye pain, changes in vision, irritation of
the
eyes, continued redness, or if the condition worsens or persists,
Tears Naturale II must be
discontinued and a doctor must b

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TEARS NATURALE II, eye drops, solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dextran 70 1,0 mg/ml – Hypromellose 3,0 mg/ml. For
excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
▪
Dry eyes syndrome
▪
Deficient tear secretion
▪
Instability of the lacrimal film
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
After cap is removed, if tamper evident snap collar is loose, remove
before using product.
Instill 1 or 2 drops in each eye as necessary.
4.3 CONTRAINDICATIONS
Hypersensitivity to dextran 70, hypromellose or to any of the
excipients of this preparation.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Patients should discontinue administration in case of persistent
irritation and consult a physician. If
patients experience headache, eye pain, vision changes, irritation of
the eyes, persistent
redness or if the condition worsens or persists, they are to
discontinue use and consult their
doctor.
TEARS NATURALE II is a sterile product. For topical use in the eye
only.
Page 1 of 6
Following measures are, after application of the eye drops, useful to
reduce systemic resorption:
-
Keep the eyelid closed for 2 minutes.
-
Close the lacrimal duct with the finger for 2 minutes.
4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Interactions of TEARS NATURALE II with other medicinal products have
not been specifically
evaluated. Based on the composition of this product, no clinically
relevant interactions have been
described.
In case of concomitant therapy with other topical ocular products, an
interval of at least 5 minutes
should be allowed between successive applications. Eye ointments
should be administered last.
4.6 FERTILITY, PREGNANCY AND LACTATION
Fertility
•
There is no adequate data regarding the impact of Dextran 70 /
Hypromellose Eye Drops on fertility.
All of the components are pharmacologically inert compounds or
generally classified