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Oculotect

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. 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

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.

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.

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.

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.
  • 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.
  • 5. Lean your head back.
  • 6. Pull down your lower eyelid with your finger and hold the container in your other hand. Squeeze the container so that one drop falls into the eye.
  • 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. If necessary repeat steps 5 to 7 with your other eye.
  • 8. Discard the container after use.

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

Oculotect 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

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.

How To Store Oculotect

Keep out of reach and sight of children.

Do not store above 25?C. 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 must 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.

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 for pH adjustment, 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
Telephone number:01276 698370

Manufacturer

Excelvision
Rue de la Lombardiere
07100 Annonay
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 soluci?n en envase unidosis
Sweden: Oculac
United Kingdom: Oculotect Single Dose Unit

This leaflet was last approved in December 2009





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