Active ingredients: Distilled water of Hamamelis Virginiana
OPTREX 130mg / ml Eye drops, solution
Why is Optrex used? What is it for?
WHAT IS IT
OPTREX Eye drops is an antiseptic, decongestant for the eyes.
WHY IT IS USED
OPTREX Collirio is useful in all cases where a decongestant and antiseptic (disinfectant) action is required at the ocular level (tired eyes, red also due to excessive exposure to external agents such as dust, light, wind, smoke, solar and snow glare. and in all those manifestations that are related to fatigue and irritative stimuli of the eyes).
Contraindications When Optrex should not be used
Hypersensitivity to product components or other closely related substances from a chemical point of view.
In subjects with glaucoma (a disease characterized by increased pressure inside the eye) or equally serious eye diseases.
Do not give to children under the age of three.
When OPTREX Eye drops can only be used after consulting your doctor
Although it has poor systemic absorption (only small quantities can reach the blood), the product should be used with caution:
- in subjects affected by:
- hypertension
- hyperthyroidism (condition of excessive functional activity of the thyroid gland)
- heart ailments
- hyperglycemia (diabetes);
- in subjects being treated with antidepressant drugs.
It is also advisable to consult your doctor if these disorders have occurred in the past.
What to do during pregnancy and breastfeeding.
OPTREX Eye drops can be used during pregnancy and breastfeeding
Precautions for use What you need to know before taking Optrex
This medicine contains benzalkonium chloride therefore may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reapplying.
The bleaching action against soft contact lenses is known.
Interactions Which drugs or foods may change the effect of Optrex
There are no known interactions of OPTREX Eye drops with other drugs.
In any case, if you are using other medicines, ask your doctor or pharmacist for advice.
Warnings It is important to know that:
OPTREX Collirio can cause, at the first application in very irritated eyes, a slight sense of burning, expression of the activity of the product. This sensation diminishes or disappears in subsequent applications. Infections, pus, foreign bodies in the eye, mechanical, chemical, heat damage require a doctor's consultation.
Dose, Method and Time of Administration How to use Optrex: Posology
How many
Warning: do not exceed the recommended doses without medical advice.
2-3 drops per eye 2-3 times a day.
Normally 2 or 3 drops per eye are sufficient to ensure rapid relief of eye fatigue and good relief of pain and discomfort deriving from irritation of eye congestion.
When and for how long
OPTREX Eye drops should be used for short periods of time. If the desired results are not obtained within 7 days, discontinue use of the product and consult your doctor.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Like
After washing your hands, tilt your head back and remove the outer part of the lower eyelid of the eye with your index finger to form a small bag where the drops should fall, in the quantity indicated. After administration, gently close the eye. Apply light pressure with the middle finger of the same hand on the inner corner of the eye, keeping it closed for a few seconds.
The bottle solution is sterile: this is why it is important that the nozzle never touches the eye and that it is carefully closed each time it is used.
Overdose What to do if you have taken an overdose of Optrex
In case of accidental ingestion / intake of an excessive dose of OPTREX Eye Drops, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Optrex
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. Hypersensitivity phenomena may rarely occur.
These side effects are usually transient. However, when they occur, it is advisable to consult your doctor or pharmacist.
It is important to inform your doctor or pharmacist of any undesirable effects not described in the package leaflet. Request and fill in the undesirable effects report form available at the pharmacy.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact and correctly stored packaging. Warning: do not use the medicine after the expiry date shown on the package.
Eye drops, solution: Store at a temperature not exceeding 25 ° C, use the medicine within 28 days of first opening the bottle
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children
COMPOSITION
1 ml of eye drops, solution contain:
Active ingredient: distilled water of Hamamelis Virginiana L. 130mg
Excipients: boric acid; glycerine; sodium borate; benzalkonium chloride; purified water
HOW IT LOOKS
OPTREX Eye drops, solution comes in the form of a white plastic bottle containing 10 ml of sterile solution
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
OPTREX 13%
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ocular bath: 100 ml of Ocular Bath contain: distilled water of Hamamelis Virginiana L. 13,0 g.
Eye drops: 100 ml of eye drops contain: distilled water of Hamamelis Virginiana L. 13.0 g.
03.0 PHARMACEUTICAL FORM
Eye bath: solution.
Eye drops: solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
In all cases in which it requires a decongestant and antiseptic action at the ocular level.
04.2 Posology and method of administration
Eye bath
1 to 3 applications of the liquid on each eye during the day. Do not exceed the recommended dose.
Rules for use
Clean the eyepiece before use. Fill it halfway, apply it against the eye kept well open, keep the head slightly tilted forward and give the head an oscillating movement in order to project the liquid well on the eye. Repeat the operation for the other eye, renewing the liquid. Never pour the contents of the eye cup back into the bottle after use. OPTREX Eye Bath can be used at room temperature or warmed. To warm the liquid, first immerse the eye cup in hot water for a few minutes and pour the liquid into it. OPTREX warms up on contact with the heated eye cup.
Eye drops
2 to 3 drops per eye 2-3 times a day. Do not exceed the recommended dose.
How to use
Normally two or three drops per eye are sufficient to ensure rapid relief of eye fatigue and good relief of pain and discomfort deriving from irritation of eye congestion. OPTREX eye drops can determine, at the first application in very irritated eyes, a slight sense of burning, expression of the curative activity of the product, irritation that diminishes or disappears in subsequent applications.
04.3 Contraindications
Hypersensitivity to the components or to other closely related substances from a chemical point of view. It should not be used by people with glaucoma or other serious eye diseases or in children under three years of age.
04.4 Special warnings and appropriate precautions for use
After a short treatment period, in any case not exceeding 7 days, if the desired results are not obtained, discontinue use of the product and consult your doctor in order to establish a suitable therapy.
Infections, pus, foreign bodies in the eye, mechanical, chemical, heat damage require medical attention.
Follow the recommended doses scrupulously.
The product, if accidentally ingested, or if used for a long period in excessive doses, can cause toxic phenomena. It should therefore be kept out of the reach and sight of children.
The product, although having poor systemic absorption, should be used with caution in patients suffering from hypertension, hyperthyroidism, cardiac disorders and hyperglycemia (diabetes) and in subjects undergoing treatment with antidepressant drugs. For all ophthalmic preparations containing benzalkonium chloride the use of contact lenses is not recommended while using the preparation. In the case of contact lens wearers wear the same only 15 minutes after applying the product.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interactions with other drugs.
04.6 Pregnancy and lactation
There is no contraindication to the use of the preparation during pregnancy and during lactation.
04.7 Effects on ability to drive and use machines
The use of the product does not interfere with the waking state of the subject.
04.8 Undesirable effects
Hypersensitivity phenomena may rarely occur. In this case it is necessary to interrupt the treatment and consult the doctor, so that, if necessary, a suitable therapy can be instituted. Report any undesirable effects to your doctor or pharmacist.
04.9 Overdose
There are no known symptoms of overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
OPTREX is a preparation based on Hamamelis Virginiana distilled water.
OPTREX acts by decongesting the eyelids and conjunctiva and develops a decongestant and slightly antiseptic activity at the level of the external structures of the eye.
OPTREX is useful in all cases of:
• redness and ocular congestion
• irritation of the lacrimal ducts, conjunctiva and eyelid (even if caused by external agents such as dust, smoke, etc.)
The product, after ocular application, has a poor systemic absorption.
05.2 Pharmacokinetic properties
...
05.3 Preclinical safety data
...
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Ocular bath
Boric acid; sodium borate; benzalkonium chloride; purified water.
Eye drops
Boric acid; glycerine; sodium borate; benzalkonium chloride; purified water.
06.2 Incompatibility
There are no known incompatibilities with other substances.
06.3 Period of validity
With intact packaging
Eye bath: 3 years.
Eye drops: 3 years.
After opening
Eye drops: use the product within 28 days of first opening the bottle
Eye bath: use the product within 3 months of first opening the bottle
06.4 Special precautions for storage
Ocular bath
No special storage precautions
Eye drops
Store at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
Ocular bath
110 ml bottle in colorless glass and high density polyethylene cap.
300 ml bottle in colorless glass and high density polyethylene cap.
Eye drops
10 ml bottle in white pigmented polyethylene.
06.6 Instructions for use and handling
See section 4.2.
07.0 MARKETING AUTHORIZATION HOLDER
Optrex Ltd - 103-105 Bath Road, Slough, Berkshire, SL1 3UH (UK)
Representative for Italy:
Reckitt Benckiser Healthcare (Italy) S.p.A. - Via Spadolini 7 - 20141 Milan
08.0 MARKETING AUTHORIZATION NUMBER
Eye bath
AIC n. 006451049 - Bottle 110 ml
AIC n. 006451052 - Bottle 300 ml
Eye drops
AIC n. 006451064 - Bottle 10 ml
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
18.10.1990
10.0 DATE OF REVISION OF THE TEXT
July 2006
