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OCULOTECT 50MG/ML EYE DROPS SOLUTION IN SINGLE-DOSE CONTAINERS

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PACKAGE LEAFLET INFORMATION FOR THE USER

OCULOTECT
50 mg/ml eye drops, solution in single-dose containers
Povidone K25
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use
Oculotect 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.
• If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.

What Oculotect is and what it is used for
Before you use Oculotect
How to use Oculotect
Possible side effects
How to store Oculotect
Further information

1.WHAT OCULOTECT IS AND WHAT IT IS USED FOR
Oculotect contains the active substance povidone K25. Oculotect is an eye drop to
moisten and lubricate the eyes. It is used to relieve the symptoms of dry eyes.

2.BEFORE YOU USE OCULOTECT
Do not use Oculotect
If you are allergic (hypersensitive) to povidone K25 or any of the other ingredients of
Oculotect (please refer to section 6. Further information, What Oculotect contains). If
you think you may be allergic, do not use this medicine before talking to your doctor.
Take special care with Oculotect eye drops
If irritation of the dry eye persists or worsens, Oculotect eye drops should be
discontinued and a doctor should be consulted
Using other medicines
If you need to apply any other medicinal products to your eyes together with
Oculotect, you should wait at least 5 minutes between applying each product and
always apply Oculotect last.
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, think you might be, or are breast-feeding, ask your doctor or
pharmacist for advice before using any medicine.
Driving and using machines
Oculotect may cause blurred vision, If this happens to you, wait until this has cleared
before driving or operating machinery.

3.HOW TO USE OCULOTECT
Always use Oculotect exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The usual dose is one drop in the eye four times daily or as required.
One single-dose container contains enough solution to treat both eyes in one application.
Instructions for use
1.
2.
3.
4.
5.
6.

7.

8.

Wash your hands.
Remove one of the single-dose containers from the strip (Fig. 1).
Place the remaining single-dose containers back in the carton.
Open the single-dose container by twisting off the tip. Do not touch the tip after
opening the container as it may contaminate the solution (Fig 2).
Lean your head back (Fig. 3).
Pull down your lower eyelid with your finger and hold the container in your other
hand. The tip of the container should not come into contact with the eye as it may
cause injury to the eye. Squeeze the container so that one drop falls into the eye
(Fig 4).
Close your eyes and press the tip of one finger against the inner corner of the eye
for around 1-2 minutes. This will prevent the drop running through the tear duct
into your throat and most of the drop will remain in the eye (Fig 5). If necessary
repeat steps 5 to 7 with your other eye.
Discard the container after use.

Fig.1

Fig.2

Fig.3

Fig.4

Fig.5

If you have any further questions on the use of this product, ask your doctor or
pharmacist.

UK

23085307

4.POSSIBLE SIDE EFFECTS
Like all medicines, Oculotect can cause side effects, although not everybody gets them.
The following side effects have been reported:
Common (affecting between 1 and 10 in every 100 patients)
• slight, temporary burning or sticky sensation in the eye(s)
Very rare (affecting less than 1 in every 10,000 patients)
• irritation
• allergic reactions
Some patients experienced other side effects during the treatment with
Oculotect eye drops
• blurred vision
If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

5.HOW TO STORE OCULOTECT
Keep out of reach and sight of children.
Do not store above 25ºC.
Do not refrigerate or freeze.
Keep the container in the outer carton in order to protect from light.
The single-dose container is not sterile itself, but its contents are sterile until the
container is opened.
Once opened, the contents of the single dose container should be used immediately
and not saved.
Do not use Oculotect after the expiry date which is stated on the carton after EXP.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.

6.FURTHER INFORMATION
What Oculotect contains
The active substance is povidone K25. Each ml contains 50 mg povidone K25. The
other ingredients are boric acid, calcium chloride, potassium chloride, magnesium chloride,
sodium chloride, sodium lactate, sodium hydroxide, and water for injections.
The product does not contain any preservative.
What Oculotect looks like and contents of the pack
Oculotect is an almost colourless, clear aqueous solution. One single-dose container
contains 0.4 ml.
They are supplied in packs containing 20, 60 or 120 single-dose containers.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Novartis Pharmaceuticals UK Ltd, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR
Tel. 01276 698370
Manufacturer:
EXCELVISION
Rue de la Lombardière, 07100 Annonay, France.
This medicinal product is authorised in the Member States of the EEA under
the following names:
Denmark
Finland
Ireland
Italy
Portugal
Spain
Sweden
United Kingdom

Oculac (SDU)
Oculac (SDU)
Oculotect 50 mg/ml, eye drops solution (SDU)
Clarover monodose
Oculotect Unidoses
Oculotect 50 mg/ml colirio en solución en envase unidosis
Oculac
Oculotect Single Dose Unit`

This leaflet was last approved in 04/2010

UK

23085307

PACKAGE

LEA F LET INFOR MATION FOR THE USER

120 x 420 t ebmisio

OCULOTECT
50 mg/ml eye drops, solution in single-dose containers
Povidone K25

Read all of this leaflet carefully because it contains important information
for you.
This medicine is available without prescription. However, you still need to
use Oculotect 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.
• f any of the side effects gets serious, or if you notice any side effects not
I
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Oculotect is and what it is used for
2. Before you use Oculotect
3. How to use Oculotect
4. Possible side effects
5. How to store Oculotect
6. Further information

1. HAT OCULOTECT IS AND WHAT IT IS USED FOR
W
Oculotect contains the active substance povidone K25. Oculotect is an eye
drop to moisten and lubricate the eyes. It is used to relieve the symptoms
of dry eyes.

2. EFORE YOU USE OCULOTECT
B
Do not use Oculotect
If you are allergic (hypersensitive) to povidone K25 or any of the other
ingredients of Oculotect (please refer to section 6. Further information,
What Oculotect contains). If you think you may be allergic, do not use this
medicine before talking to your doctor.
Take special care with Oculotect eye drops
If irritation of the dry eye persists or worsens, Oculotect eye drops should
be discontinued and a doctor should be consulted.
Using other medicines
If you need to apply any other medicinal products to your eyes together
with Oculotect, you should wait at least 5 minutes between applying each
product and always apply Oculotect last.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, think you might be, or are breast-feeding, ask your
doctor or pharmacist for advice before using any medicine.
Driving and using machines
Oculotect may cause blurred vision, If this happens to you, wait until this
has cleared before driving or operating machinery.

3. OW TO USE OCULOTECT
H
Always use Oculotect exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
The usual dose is one drop in the eye four times daily or as required.
One single-dose container contains enough solution to treat both eyes in
one application.
Instructions for use
1. Wash your hands.
2. Remove one of the single-dose containers from the strip (Fig. 1).
3. Place the remaining single-dose containers back in the carton.
4.  pen the single-dose container by twisting off the tip. Do not touch the tip
O
after opening the container as it may contaminate the solution (Fig. 2).
5. Lean your head back (Fig. 3).
6. 
Pull down your lower eyelid with your finger and hold the container in
your other hand. The tip of the container should not come into contact
with the eye as it may cause injury to the eye. Squeeze the container so
that one drop falls into the eye (Fig. 4).
7. 
Close your eyes and press the tip of one finger against the inner corner
of the eye for around 1–2 minutes. This will prevent the drop running
through the tear duct into your throat and most of the drop will remain in
the eye (Fig. 5). If necessary repeat steps 5 to 7 with your other eye.
8. Discard the container after use.

Fig. 1

Fig. 2

Fig. 3

Fig. 4

Fig. 5

If you have any further questions on the use of this product, ask your
doctor or pharmacist.

UK

264702

4. P OSSIB LE SIDE EFFECTS
Like all medicines, Oculotect can cause side effects, although not everybody
gets them.
The following side effects have been reported:
Common (affecting between 1 and 10 in every 100 patients)
•  light, temporary burning or sticky sensation in the eye(s)
s
Very rare (affecting less than 1 in every 10,000 patients)
• irritation
• allergic reactions
Some patients experienced other side effects during the treatment with
Oculotect eye drops
• blurred vision
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5. OW TO STORE OCULOTECT
H
Keep out of reach and sight of children.
Do not store above 25ºC.
Do not refrigerate or freeze.
Keep the container in the outer carton in order to protect from light.
The single-dose container is not sterile itself, but its contents are sterile
until the container is opened.
Once opened, the contents of the single dose container should be used
immediately and not saved.
Do not use Oculotect after the expiry date which is stated on the carton
after EXP.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6. FURTHER INFOR MATION
What Oculotect contains
The active substance is povidone K25. Each ml contains 50 mg povidone
K25. The other ingredients are boric acid, calcium chloride, potassium
chloride, magnesium chloride, sodium chloride, sodium lactate, sodium
hydroxide, and water for injections.
The product does not contain any preservative.
What Oculotect looks like and contents of the pack
Oculotect is an almost colourless, clear aqueous solution. One single-dose
container contains 0.4 ml.
They are supplied in packs containing 20, 60 or 120 single-dose containers.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Novartis Pharmaceuticals UK Ltd, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR
Tel. 01276 698370
Manufacturer:
Laboratories Alcon, 23 Avenue Georges Ferrenbach,
F-68240, Kaysersberg, France.
This medicinal product is authorised in the Member States of the
EEA
under the following names:
Denmark
Oculac (SDU)
Finland
Oculac (SDU)
Ireland
Oculotect 50 mg/ml, eye drops solution (SDU)
Italy
Clarover monodose
Portugal
Oculotect Unidoses
Spain
Oculotect 50 mg/ml colirio en solución en envase unidosis
Sweden
Oculac
United Kingdom Oculotect Single Dose Unit`

This leaflet was last approved in 08/2011

UK

264702

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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