Tears Naturale eye drops, solution (Dextran 70 0.1% w/v, Hypromellose 0.3% w/v)

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Hypromellose; Dextran 70

Disponível em:

Alcon Laboratories Ireland Limited

Código ATC:

S01XA; S01XA20

DCI (Denominação Comum Internacional):

Hypromellose; Dextran 70

Dosagem:

percent volume/volume

Forma farmacêutica:

Eye drops, solution

Tipo de prescrição:

Product not subject to medical prescription

Área terapêutica:

Other ophthalmologicals; artificial tears and other indifferent preparations

Status de autorização:

Not marketed

Data de autorização:

1980-03-13

Folheto informativo - Bula

PACKAGE LEAFLET - INFORMATION FOR THE USER
TEARS NATURALE
® EYE DROPS, SOLUTION
(DEXTRAN 70 0.1 % W /V, HYPROMELLOSE 0.3 % W /V)
READ ALL OF THIS LEAFLET CAREFULLY because it contains important
information for you.
This medicine is available without a prescription. However, you still
need to use
TEARS NATURALE 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 CONTACT A DOCTOR if your symptoms worsen or do not improve
after 3 days
.

IF ANY OF THE SIDE EFFECTS GET SERIOUS, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET
1.
WHAT TEARS NATURALE IS AND WHAT IT IS USED FOR
2.
BEFORE YOU USE TEARS NATURALE
3.
HOW TO USE TEARS NATURALE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE TEARS NATURALE
6.
FURTHER INFORMATION
1
WHAT TEARS NATURALE IS AND WHAT IT IS USED FOR
TEARS NATURALE is a slightly viscous solution that acts as an
artificial tear.
IT IS USED TO TREAT dry eyes caused by a lack of tears in the eye(s).
Replacement of the missing natural tears with an artificial tear helps
to soothe and lubricate
your eyes and provide relief from irritation.
2
BEFORE YOU USE TEARS NATURALE
DO NOT USE
TEARS NATURALE
...
If you are ALLERGIC to dextran 70, hypromellose or any of the other
ingredients listed in section 6
If any of these apply, ask your doctor for advice.
TAKE SPECIAL CARE ...
Only use TEARS NATURALE in your eye(s).
You should stop using the product and should consult a doctor if any
of the following occur:

You experience headache, eye pain, vision changes, irritation of the
eyes, persistent
redness

Your eye condition gets worse

Your eye symptoms persist for more than 3 days.
THIS MEDICINE IS AVAILABLE WITHOUT A PRESCRIPTION. However, you still
need to use TEARS
NATURALE carefully to get the best results from it.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or might get pregnant, or if you are
breast-feeding a b

Características técnicas

Health Products Regulatory Authority
04 December 2019
CRN008JZL
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tears Naturale eye drops, solution (Dextran 70 0.1% w/v, Hypromellose
0.3% w/v)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dextran 70 0.1% w/v
Hypromellose 0.3% w/v
Also contains Benzalkonium Chloride Solution 0.01% w/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
A slightly viscous, clear and almost colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a lubricant and artificial tear in dry eye and other ocular
irritation syndromes associated with deficient tear or mucous
secretion.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, children and the elderly:
One or two drops as required or directed instilled into the
conjunctival sac.
METHOD OF ADMINISTRATION
For ocular use
Patients must not use this product if the solution becomes cloudy or
changes colour.
To avoid contamination, do not touch tip of container to any surface.
Replace cap after using.
Remove the loose collar from the cap when the bottle is first opened
to avoid eye injury.
4.3 CONTRAINDICATIONS
Hypersensitivity to dextran 70, hypromellose or to any of the
excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE

For ocular use only. Not for injection or ingestion.

Tears Naturale contains benzalkonium chloride which may cause eye
irritation and is known to discolour soft
contact lenses. Contact with soft contact lenses is to be avoided.
Patients should be advised to remove their
contact lenses prior to the application of Tears Naturale and wait at
least 15 minutes before reinsertion.

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 a doctor.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
If more than one topical ophthalmic medicinal product is bein