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OCULOTECT 50MG/ML SINGLE DOSE UNIT EYE DROPS

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Oculotect ® 50 mg/ml Single Dose Unit Eye Drops
(Povidone K25)
Your medicine is known as the above name but will be referred to as
Oculotect throughout this leaflet:
Patient Information Leaflet
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) 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) 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 One-Alpha
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.

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. 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. 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).
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.

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

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
 Do not use after the expiry date shown on the carton and container.
 Do not store above 25°C. Keep container in outer carton to protect from
light.
 Keep all medicines out of the reach and sight of children.
 This leaflet does not contain the complete information about Oculotect
eye drops.
 If you have any questions or are not sure of anything ask your doctor or
pharmacist who have access to additional information.
 If your doctor tells you to stop taking the Oculotect eye drops, please
take them back to the pharmacist for safe disposal. Only keep
Oculotect eye drops if your doctor tells you to.
 If Oculotect eye drops become discoloured or show signs of any
deterioration, you should seek the advice of your pharmacist.

6) Further information
What Oculotect contains
Each millilitre eye drops solution contain 50mg povidone K25 as the
active ingredient.
They also contain boric acid (E284), sodium chloride, sodium lactate,
potassium chloride, calcium chloride, magnesium chloride and water for
injection.

What Oculotect looks like and contents of the pack
Oculotect is an almost colourless, clear aqueous solution.
Oculotect eye drops comes in single dose unit each containing 0.4ml of
the eye drops.
Each carton contains 20 single dose units (4 strips of 5 single dose units).
PL 10383/1736

Oculotect ® 50 mg/ml Eye Drops Solution

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Who makes and repackages your medicine?
This product is manufactured by Novartis Farmaceutica, S.A. Gran Via de
les Corts Catalanes, Barcelona Spain. Procured from within the EU and
repackaged by the Product Licence holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue road, Northolt, Middlesex UB5 5QS
Leaflet date: 12.12.2012

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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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