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OPTREX INFECTED EYE DROPS - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - OPTREX INFECTED EYE DROPS

3. How to use Optrex Infected Eye Drops 4. Possible side effects


INFECTED EYE DROPS

Chloramphenicol

Package leaflet: Information for the patient


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Always use this medicine exactly as described in this leaflet oras your doctor or pharmacist has told you. Keep this leaflet. You might need to read it again.
  • Ask your doctor or pharmacist if you need more information or advice
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  • You must talk to your doctor or pharmacist if you do not feel better or feel worse after 2 days.

1. What Optrex Infected Eye Drops is and what itis used for 2. What you need to know before you use Optrex Infected Eye Drops

  • 3. How to use Optrex Infected Eye Drops

  • 4. Possible side effects

  • 5. How to store Optrex Infected Eye Drops

  • 6. Contents of the pack and other information

1. what optrex infected eye drops is and what it is used for

Optrex Infected Eye Drops contain an antibiotic called chloramphenicol. It is used to treat bacterial infections that affect the front surfaces of the eye.

The most common type of infection in this area is called acute bacterial conjunctivitis. When you have this condition, the white part of one or both of your eyes will be red and/or your eyelids will be red or swollen. There will be a sticky discharge, which can make the eye difficult to open in the morning and the eye may feel ‘gritty’ or ‘irritated’. Chloramphenicol eye drops are not suitable for treating eye infections that have spread to the deeper layers of the eye coverings or into the fluid within the eyeball. Antibiotic tablets or injections are needed to treat these deeper, more serious infections.

2. what you need to know before you use optrex infected eye drops

Optrex Infected Eye Drops are recommended for use in children aged 2 years and over, in adults and the elderly. A child below the age of2 years with an eye infection should see a doctor.

Do not use this product if you

  • areallergictochlo­ramphenicolora­nyoftheingredi­ents shown under section 6 ‘What is in the pack?’
  • have ever had problems with your blood (in particular very low numbers of blood cells)

during previous treatment with chloramphenicol

  • have bone-marrow depression or a family history of blood problems such as low white blood cell, red blood cell, or platelet counts
  • Do not use this product and seek advice from your doctor if your eyesight is affected (loss ofsight, reduced vision, blurred vision or halos around lights) you have pain within the eye
  • your eye has suffered a blow or other injury
  • your eye is inflamed and you have a rash on the scalp or face
  • the pupil of your eye looksunusual or your eye looks cloudy
  • your eyes are sensitive to light
  • you have (or think you have) a foreign body in your eye, which has not been removed
  • you have recently had an eye infection
  • you suffer from or have ever suffered from glaucoma or dry eye syndrome
  • youwearcontact lenses. If you wear contact lenses and your contact lens practitioner or doctor has advised you to use this product, do not wear your lenses during the course of treatment. Soft contact lenses should not be replaced for 24 hours after completing the treatment.
  • you are using any other eye drops or eye ointment
  • you have had eye surgery or laser treatment in the last

6 months.

Tell your pharmacist before using this product if you

  • are taking any other medicines
  • suffer from any other eye problems.

Taking other medicines

If you are taking bone marrow depressant drugs (drugs which decrease the activity of the bone marrow, causing low blood cell counts) such as azathioprine or are receiving chemotherapy, seek the advice of your pharmacist or your doctor before using this product.

Pregnancy and Breastfeeding

If you are pregnant, planning to become pregnant or breastfeeding speak to your doctor or pharmacist before using this product.

Driving and operating machinery

After using the drops, you may temporarily get blurred vision. Do not drive or operate machinery until your vision is clear. Ifin doubt, talk to your pharmacist or doctor.

Important information about some of the ingredients in Optrex Infected Eye Drops

Contains phenylmercuric nitrate which may cause allergic reactions.


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Applying the drops

To be used in the eye(s) only.

  • 1. Check the seal is not broken before first use.

  • 2. Wash and dry your hands.

  • 3. Remove the plastic cap from the eye drop tip.

  • 4. Tilt your head back while seated or lie down on your back.

  • 5. Gently pull the lower eyelid downwards and look up.

  • 6. Place the tip of the bottle close to your eye. Squeeze the bottle and let one drop fall into the space between the lower eyelid and the eye. Take care that the tip of the bottle does not touch your eye, the skin around your eye or your fingers.

  • 7. Close your eye for a moment.

  • 8. When both eyes are to be treated, repeat for the other eye

  • 9. Replace the cap straight away.



Whilst applying the drops, do not

  • breathe on or touch the dropper nozzle
  • touch the eyes or eyelids with the dropper nozzle
  • share your eye drops with anyone else.

For external use only.

Dose

Adults, children aged over 2 years, and elderly:

Apply one drop to the affected eye(s) every 2 hours for the first two days and 4 hourly thereafter. Use during waking hours only.

Length of treatment

The course of treatment is 5 days. Keep using these eye drops for 5 days. Do not stopjust because you feel better -this could make your condition worse.

If your symptoms donotimprove within 48 hours, consult your doctor. If your symptoms get worse, seek medical advice at once.

Do not use Optrex Infected Eye Drops for more than 5 days without consulting your doctor. Discard any remaining eye drops after the 5 day course of treatment. Do not use in children under 2 years of age.

If you take more medicine than you should:

Wash your eyes with plenty of water and speak to your doctor or pharmacist. Symptoms of local overdose may include eye irritation, pain, swelling, tears in the eye, sensitivity to light.

If you forget to use your drops

If you have only just missed adose and it is a long time before the next dose is due, put in the missed dose of drops straight away. If you missed the dose some time ago and itis nearly time for your next dose, just put in the next dose of drops at the right time. Never double up on a dose to make up for the one you have missed.


Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using the product and seek medical help immediately if you experience:

  • allergic reactions such as itching, rashes, fever, swelling, hives, wheezing, difficulty breathing, systemic inflammatory reactions and other.
  • changes in blood (anaemia) leading to severe tiredness or easy bruising.

Other side effects may include:

  • Discolouration or clouding of the eye surface (cornea) or lens due to the preservative.
  • The use of topical chloramphenicol may occasionally result in the overgrowth of other non susceptible organisms including fungi. If any new infection appears during treatment you should tell your doctor.
  • blurred vision, eye irritation or mild burning or stinging when you put the drops in.
  • irritation of the skin around the eyes, mercurialentis (brown discolouration of the lens) and atypical band keratopathy (appearance of calcium on the cornea). These may be due to the preservative in the drops called phenyl mercuric nitrate.

Reporting of sideeffects

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: orsearch for MHRAYellow Card in the Google PlayorApple App Store.


5. How to store Optrex Infected Eye Drops

Replace the cap securely after use. Store at 2°C to 8°C. This is the temperature of most domestic refrigerators. Keep this and all medicines out of the sight and reach of children. Do not use after the ‘use by’ date shown on the bottle. Discard any unused product within 28 days of opening. 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 protect the environment.

6. Contents of the packand other information

Each pack contains 10ml of the drops. The drops contain 0.5% w/v chloramphe­nicol, which is equivalent to 5mg of chloramphenicol per millilitre. They also contain purified water, boric acid, borax and phenylmercuric nitrate.

Further information

If you have any questions or are not sure about anything, ask your pharmacist or doctor. They can obtain more information about this medicine if needed.

Licence holder:Optrex­Limited, Slough, SL13UH, UK. Manufacturer: Reckitt BenckiserHealthcare International Ltd, Nottingham. NG902 DB.

Manufacturer: RB NLBrands B.V WTCSchipho­lAirport, g Schiphol Boulevard 207,1118 BH Schiphol, Netherlands o PL 00062/0051. g

Leaflet revised September 2021 °


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eCTD Optrex Infected Eye Drops 0.5% National


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Sources: Original (products.mhra.gov.uk)