1.25 mg / ml + 3 mg / ml eye drops , solution
fluorescein sodium / oxybuprocaine hydrochloride
What Optax eye drops are and what they are used for
Optax eye drops contain the active substances oxibuprocaine and fluorescein. Oxibuprocaine is a topical anesthetic, used for short-term anesthesia of the eye surface. Fluorescein is a dye that facilitates the diagnosis of corneal damage. These eye drops are intended for diagnostic use. They are used in measuring eye pressure and examining corneal damage.
Fluorescein sodium and oxibuprocaine hydrochloride contained in Optax may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you get Optax eye drops
Optax eye drops should not be given:
- if you are allergic to oxibuprocaine, fluorescein or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to other local anesthetics in the para-aminobenzo group (a group of local anesthetics with a certain chemical structure) or if you are allergic to paraben additives.
Warnings and cautions
Remove contact lenses before receiving these drops, as the fluorescein in the medicine may discolor soft contact lenses. You can re-insert the contact lenses one hour after receiving this medicine.
Avoid rubbing your eye while the anesthetic is working.
You must contact your doctor immediately if you experience symptoms of a severe allergic/anaphylactic reaction (see section 4).
Other medicines and Optax eye drops
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. These eye drops may reduce the effect of sulfonamide medicines ( antibiotics used to treat infections ).
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
These eye drops can cause transient blurred vision. You should not drive motor vehicles or use machines until vision is normal again.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to administer Optax eye drops
This medicine is for eye use only. Optax is given by a doctor.
The usual dose for adults and children is 1-2 drops per eye. The surface of the eye is anesthetized within one minute to enable measurement of the eye pressure.
If several different medicines are used in the same eye, they should be applied at least 5 minutes apart.
If you take more Optax eye drops than you should
Overdose is unlikely, as the drops are used on the surface of the eye.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must contact a doctor immediately if you experience any of the following (symptoms of a severe allergic/anaphylactic reaction): facial swelling, rash, general itching, hives, chest tightness, difficulty breathing, chills, hot flashes, headache, general malaise, nausea, restlessness fast heart rate or low blood pressure.
Other possible side effects:
Common (may affect up to 1 in 10 people):
- eye irritation
- feeling of debris in the eye when the anesthetic effect has subsided
- superficial damage to the cornea (punctate keratitis) with repeated use
Rare (may affect up to 1 in 1,000 people):
- swelling of the eye (cornea)
- discoloration of the eye (cornea)
- inflammation of the iris
- slow heart rate
- low blood pressure
- dizziness
- nausea
Has been reported (occurs in an unknown number of users):
- transient blurred vision after application
How to store Optax eye drops
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
- Store in a refrigerator (2 ° C – 8 ° C).
- The shelf life of an opened bottle is 28 days when stored at a maximum of 25 o C.
- Store the bottle in the outer carton. Sensitive to light.
- 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.
Contents of the pack and other information
Content declaration
- The active substances are fluorescein sodium and oxybuprocaine hydrochloride. One ml of solution contains 1.25 mg of fluorescein sodium and 3 mg of oxybuprocaine hydrochloride.
- The other ingredients are chlorobutanol hemihydrate, sodium chloride, povidone and water for injections.
What the medicine looks like and contents of the pack
Eye drops, solution. Yellow (fluorescent), clear solution, practically free from particles.
White plastic bottle, yellow screw cap in plastic.
Pack size: 5 ml.
Marketing Authorisation Holder
Santen Oy
Niittyhaankatu 20
33720 Tampere
Finland
Manufacturer
Santen Oy
Kelloportinkatu 1
33100 Tampere
Finland