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TEARS NATURALE SINGLE DOSE EYE DROPS SOLUTION

Active substance(s): DEXTRAN 70 / HYPROMELLOSE / DEXTRAN 70 / HYPROMELLOSE / DEXTRAN 70 / HYPROMELLOSE

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427666

Package Leaflet – Information for the User

TEARS NATURALE® SINGLE DOSE eye drops, solution
Dextran, Hypromellose

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 Single Dose
is and what it is used for
2. Before you use TEARS NATURALE
Single Dose
3. H
 ow to use TEARS NATURALE
Single Dose

4. Possible side effects
5. How to store TEARS NATURALE
Single Dose
6. Further information

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1. WHAT TEARS NATURALE SINGLE DOSE 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 SINGLE DOSE
Do not use TEARS NATURALE ...

Driving and using machines

Take special care...

Using other medicines

I f 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.

You may experience blurred vision after using TEARS
NATURALE. Do not drive or use any machines
unless your vision is normal.

Pregnancy and breast-feeding

Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
If you are using more than one type of eye medicine,
the medicines must be used at least 5 minutes apart.
Eye ointments should be used last.

or breast-feeding.

Do not use the drops while wearing contact lenses.
Wait at least 15 minutes after use before putting your
lenses back in.

Only use TEARS NATURALE in your eye(s).
This medicine is available without a prescription.
However, you still need to use TEARS NATURALE
carefully to get the best results from it.
If you are pregnant or might get pregnant, or if you are
breast-feeding a baby, talk to your doctor before you
use TEARS NATURALE.
TEARS NATURALE can be used during pregnancy

Important Information if you wear
Contact Lenses

3. HOW TO USE TEARS NATURALE SINGLE DOSE
The usual dose

The usual dose is 1 or 2 drops in your eye(s) every one
to two hours as required to relieve the irritation.
Always use TEARS NATURALE exactly as recommended.
You should check with your doctor or pharmacist if you
are not sure.

If you experience eye pain, headaches, changes in
vision, persistent redness or irritation of your eyes, or if
your condition worsens or does not improve within
3 days, stop using TEARS NATURALE and consult a
doctor.

Continued over

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15/03/2017 10:31

The Maltings

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
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No
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Both
WO:
1591893
Comp. Description: Leaflet_Tears Naturale_LDSO_1 mg/ml + 3 mg/ml_GB

Production Site:
CTM:
Printing Colours:

Comp. Number New: 427666 GB
Comp. Number Old: 427665 GB
Format/Dimension: 178 x 274 mm
Tech. Drawing No.: 120401 v1

Technical Colours: Cutting

Recipharm
Martin, Rosalyn
Black

Minimum Font Size: 8.0pt
Font Type: Helvetica World, OCRB
Proof Number: 1
Braille:

15/03/2017

Rachel Smith

! P LE ASE TU R N OVE R P R I N T I N G O N !
5102845_1

HOW TO USE TEARS NATURALE SINGLE DOSE (continued)

How to use

Wash your hands before you start.

Open foil pouch and remove the
plastic vial (picture 1).
Twist off the cap of the plastic vial
(picture 2).

1

2

Hold the vial upside down.

Tilt your head back.

Pull down your lower eyelid with a
finger, until there is a ‘pocket’
between the eyelid and your eye.
The drop will go in here.

3

Bring the tip of the vial close to the eye. Do this in
front of a mirror if it helps.

Do not touch your eye or eyelid, surrounding

areas or other surfaces with the tip of the vial. It
could infect the drops.
Gently squeeze the vial so that one drop falls into the
gap between the eye and lower eyelid (picture 3).
Now release the lower eyelid and keep closed for
2 minutes.
If you use drops in both eyes, repeat the steps for
your other eye. Dispose of vial after use. Do not
keep to use again.

If a drop misses your eye, try again.
If you use more TEARS NATURALE than you
should do not worry as it will not cause you any
problems. If necessary TEARS NATURALE can be
washed out of your eye with warm water.

If you swallow TEARS NATURALE do not worry, it
will not harm you.
If you have any further questions on the use of
TEARS NATURALE, ask your doctor or pharmacist.

Like all medicines, TEARS NATURALE can cause side
effects, although not everybody gets them.

You may also experience effects in other areas of
your body including:
Uncommon: headache, discomfort (skin)
Not known: hypersensitivity

4. POSSIBLE SIDE EFFECTS

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 ou may experience some or all of the following
Y
effects in your eye(s):
Very common (affects more than 1 user in 10): blurred
vision
Common (affects 1 to 10 users in 100): dryness,
discomfort, abnormal sensation, feeling of something in
the eye, eyelid problem
Uncommon (affect 1 to 10 users in 1,000): sensitivity to
light, decreased sensation, redness, itching, irritation
Not known (cannot be estimated from the available data):
pain, swelling, discharge, eyelid redness or crusting,
increased tear production

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.

5. HOW TO STORE TEARS NATURALE SINGLE DOSE
Keep out of the reach and sight of children.
Do not freeze or store above 25°C.
Do not use the drops after the expiry date (marked
‘Exp’) on the sachet and the carton. The expiry date
refers to the last day of that month.
Once the pouch has been opened, any unused vials
should be stored in the opened pouch.

6. FURTHER INFORMATION

What TEARS NATURALE contains

 he active substances are dextran 70, 1 mg/ml and
T
hypromellose, 3 mg/ml.
The other ingredients are sodium chloride,

potassium chloride, calcium chloride, magnesium
chloride, zinc chloride, sodium hydrogen carbonate,
carbon dioxide (to adjust pH) and purified water.

Marketing authorisation holder:
Novartis Pharmaceuticals UK Limited
Frimley Business Park
Frimley, Camberley
Surrey, GU16 7SR,
United Kingdom

427666

Use all unopened vials within four days of opening
the pouch.
Dispose of the vial after use. Do not keep an open
vial to use again.
Medicines should not be disposed of via waste

water or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These
measures will help to protect the environment.

What TEARS NATURALE looks like and
contents of the pack

TEARS NATURALE is a clear, colourless eye drops,
solution supplied in a plastic single dose dispenser
containing 0.4 ml. Four vials are enclosed in a foil
overwrap. Each pack contains 28 vials.
The solution should not be used if it has changed
colour or become cloudy.
TEARS NATURALE is suitable for people who are
sensitive to preservatives.
Manufacturer:
SA Alcon-Couvreur NV
Rijksweg 14, B-2870 Puurs, Belgium.

This leaflet was last revised in 02/2017

© 2013, 2016 Novartis

427666_GB_p1_LFT.indd 2

15/03/2017 10:31

The Maltings

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
/
Both
WO:
1591893
Comp. Description: Leaflet_Tears Naturale_LDSO_1 mg/ml + 3 mg/ml_GB

Production Site:
CTM:
Printing Colours:

Comp. Number New: 427666 GB
Comp. Number Old: 427665 GB
Format/Dimension: 178 x 274 mm
Tech. Drawing No.: 120401 v1

Technical Colours: Cutting

Recipharm
Martin, Rosalyn
Black

Minimum Font Size: 8.0pt
Font Type: Helvetica World, OCRB
Proof Number: 1
Braille:

15/03/2017

Rachel Smith

! P LE ASE TU R N OVE R P R I N T I N G O N !
5102845_1

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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