Patient leaflet - Optrex Bloodshot eye drops

1. What Optrex Bloodshot Eye Drops is and what it is used for

Dusty, smoky atmospheres, eye strain and chlorine in swimming pools can make the eyesred.When the eyes are red it is because more blood than usual is flowing through the small blood vessels of the eye.

Optrex Bloodshot Eye Drops:

are mildly astringent to temporarily remove redness of the eye caused by minor eye irritation.
contain an active ingredient which restores the normal flow of blood to remove redness.

2. What you need to know before you use Optrex

Bloodshot Eye Drops

Optrex Bloodshot Eye Drops are recommended for adults and children over 12 years

Do not use this product if :

you are sensitive to Hamamelis water, naphazoline, or to any of the ingredients listed in Section 6. • you have glaucoma, other eye disease or have had eye surgery. • You have taken monamine oxidase inhibitors (MAOIs) in the last 14 days (medicine used to treat conditions such as depression).
•you are a child under12 yearsofage. Warnings and precautions
Talk toyourdoctor or pharmacist before using this medicineifyou have:
- high blood pressure
- depression
- heart disease
- diabetes
- thyroid disorders
- hardening and narrowing of blood vessels

Or experience eye pain or changes in your eyesight

Taking other medicines

If you are taking any other medicines you should speak to your doctor or pharmacist before using this product, particularly if you :

are taking digoxin, quinidine or tricyclic antidepressants
have taken monoamine oxidase inhibitors (MAOIs) within the last 14 days
are taking antihypertensive (high blood pressure) medication
are using any other eye treatments Pregnancy and Breastfeeding

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

Importantinformation aboutsome of the ingredients in Optrex Bloodshot Eye Drops

This medicine contains 0.0019 mg benzalkonium chloride ineach drop. Benzalkonium chloride may be absorbedby soft contact lenses and may changethe colour of the contact lenses.You should remove contact lenses before using this medicine and put themback 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

Driving and using machines

Do not drive or operate machinery if the vision is blurred.

3. How to use Optrex Bloodshot Eye Drops

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.
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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.

If anyone accidentally swallows the contents of the bottle seek medical advice.

Dose

Gently squeeze one or two drops into each eye. Repeat as necessary. Do not use more than four times in 24 hours.

Continued use may increase redness of the eye. Do not use the medicine if it changes colour or becomes cloudy. Ifyouhaveincreased redness of the eye or no improvement after 24 hours, stop taking the product andsee a doctor. If you take more medicine than you should:

Speak to your doctor or pharmacist immediately. Symptoms of overdose by mouth may include nausea, headache, low body temperature, bradicardia, sweating, drowsiness, coma, particularly in children. Using substantially more of Optrex Bloodshot Eye Drops than the recommended dose, for example if Optrex Bloodshot Eye Drops is accidentally swallowed, may lead to severe side effects affecting the heart and blood circulation. Symptoms may include: decreased heart rate (bradycardia), severe headache, nausea, vomiting, problems with breathing, increased heart rate (tachycardia), and chest pain. If you experience side effects, or in case of accidental intake/ingestion of an overdose of Optrex Bloodshot Eye Drops, seek immediate medical attention.

If you forget to take the medicine:

Take the next dose when needed. Do not take more than 4 doses in 24 hours.

4. Possible side effects

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 or rashes
pain in the eye or change in vision • stinging or irritation in the eye caused by using too many drops or using them too often

Other side effects may include:

Eye irritation, eye pain. Continued and excessive use may lead to increased redness of the eye and to developing of other eye conditions. • nausea
headache, dizziness

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 CardScheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. How to store Optrex Bloodshot Eye Drops

Keep all medicines out of the sight and reach of children.

Store below 25°C. Do not freeze. Do not use the drops after the expiry date (printed on the dropper bottle and carton).

You must throw away unused drops 28 days after first opening the bottle. The preservative can only keep them sterile in use for a limited time. Medicines should not be disposed of via waste water or household waste. Askyour pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Optrex Bloodshot Eye Drops contain the active ingredients Naphazoline and HamamelisVirginiana. These are present as Naphazoline

Hydrochloride PhEur 0.01% w/v and Distilled Witch Hazel BPC 12.5% v/v. Other ingredients are PurifiedWater, Glycerin, the preservative

Benzalkonium Chloride, Borax and Boric Acid (to balance the pH to help avoid stinging) and Disodium Edetate. The pack contains 10ml of the drops. Licence holder: Optrex Limited, Slough, SL1 3UH, UK.

Manufacturer: Tubilux Pharma, Via Costarica, 20/22. 00071 Pomezia (Roma) - Italia

PL 00062/0024.

Leaflet revised February 2024.

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