Medicines
Update of 20/01/2026
NÉOSYNÉPHRINE FAURE® 5 %
phenylephrine
Forms and presentations
Eye drops in solution at 5 % (clear, colourless to yellow): Bottle of 5 ml, with dropper.Composition
| per vial | |
| Phenylephrine (INN) hydrochloride
|
250 mg |
Excipient with known effect: thiomersal.
Indications
These eye drops are indicated to obtain:- a diagnostic mydriasis,
- a therapeutic mydriasis,
- pre-operative mydriasis.
Dosage and administration
Dosage1 drop of eye drops (approximately 40 µl) contains 2 mg of active substance (phenylephrine hydrochloride). The 5 ml bottle contains approximately 125 drops of eye drops.
- Adults:
- One instillation into the eye, to be repeated if necessary after 15-20 minutes, without exceeding three instillations.
- In elderly subjects, particular caution is necessary (see Warnings and Precautions for Use).
- Adolescents (12 to 18 years):
- One instillation into the eye, to be repeated if necessary after 15-20 minutes, without exceeding two instillations (see Warnings and Precautions for Use).
Method of administration:
As with all eye drops, carry out the following operations, in order:
- Wash hands thoroughly.
- Avoid touching the eye or eyelids with the tip of the bottle.
- To instil these eye drops, look upwards and gently pull the lower eyelid downwards.
- With the eye closed, carefully wipe away the excess, particularly from the cheek.
- Compress the inner corner of the eye for 1 minute after each instillation*.
- Recap the bottle carefully after use.
If concomitant treatment with another eye drop is used, space the instillations by 15 minutes.
Contraindications
- Child under 12 years.
- Hypersensitivity to the active substance or to any of the excipients listed in section Composition (notably thiomersal).
- In certain elderly subjects with severe arteriosclerotic, cardiovascular or cerebrovascular comorbidities.
- Risk of glaucoma due to angle closure.
- In combination with non-selective MAO inhibitors.
- In combination with other indirect sympathomimetics.
- In combination with alpha sympathomimetics (oral and/or nasal routes).
- During pregnancy and breastfeeding.
- In combination with selective MAO-A inhibitors.
- In combination with linezolid.
- In combination with dopaminergic and vasoconstrictor ergot alkaloids.
Warnings and precautions
NEOSYNEPHRINE 5 % FAURE, eye drops in solution, is reserved for adolescents (over 12 years) and adults.
Do not leave within the reach of children, as there is a risk of acute poisoning through accidental ingestion.
- As with any ophthalmic eye drop, phenylephrine passes into the general circulation.
- In order to avoid systemic effects induced by the passage of phenylephrine into the general circulation via the lacrimonasal routes, through the skin and through oral ingestion, the following measures should be taken:
- wipe off the excess eye drops running down the cheek in order to avoid any risk of ingestion (see Posology and Method of administration),
- close the eye and at the same time compress the inner corner of the eye for 1 minute after each instillation in order to occlude the lacrimal points.
- wipe off the excess eye drops running down the cheek in order to avoid any risk of ingestion (see Posology and Method of administration),
- The risk of toxicity is higher in adolescents and elderly subjects. In adolescents (12-18 years), the Neosynephrine concentration best suited to the patient's weight should be chosen.
- Due to the vasoconstrictive effect of phenylephrine, caution is required in patients with hyperthyroidism, arterial hypertension, coronary insufficiency, rhythm disorders or recent myocardial infarction, and in case of contraindication to the systemic use of pressor amines.
- In order to avoid overdose, repeated instillations should be avoided and the maximum recommended doses within a given time interval should not be exceeded (see Posology and Method of administration: Posology). Observe the recommended interval between instillations.
- In case of general anesthesia, possible associations, particularly with halogenated volatile anesthetics, must be taken into account. It is important that the anesthetist be informed of the administration of phenylephrine eye drops before or during the ophthalmologic procedure.
- Dark irides dilate less easily than light irides. In the case of dark irides, particular attention should be paid to the risk of overdose.
- Do not inject; the eye drops must not be administered by peri- or intraocular injection.
- Phenylephrine may trigger an acute glaucoma attack by mechanical obstruction of the aqueous humor outflow pathways in subjects with a narrow iridocorneal angle.
- In case of hypersensitivity, discontinue treatment, particularly in case of hypersensitivity to thiomersal.
- If the recommended doses (repeated instillations) are not respected, a rebound effect may occur.
- If concomitant treatment with another eye drop is used, space the instillations by 15 minutes.
- Due to the presence of phenylephrine, wearing soft hydrophilic contact lenses is not recommended during treatment.
- Athletes are advised that this eye drop contains an active substance (phenylephrine) that may induce a positive reaction in tests performed during anti-doping controls.
Interactions
Although administered locally, this medicine may cause systemic effects that should be taken into account.
Contraindicated combinations
+ non-selective MAOs
Paroxysmal hypertension, hyperpyrexia which may be fatal. Due to the duration of action of the MAOI, this interaction remains possible 15 days after discontinuation of the MAOI.
+ Other indirect sympathomimetics
Risk of vasoconstriction and/or hypertensive crises.
+ Alpha sympathomimetics (oral and/or nasal routes)
Risk of vasoconstriction and/or hypertensive surges.
Combinations not recommended
+ Dopaminergic ergot of rye alkaloids
Risk of vasoconstriction and/or hypertensive surges.
+ Vasoconstrictor ergot alkaloids of rye
Risk of vasoconstriction and/or hypertensive surges.
+ Selective MAO-A inhibitors
Risk of vasoconstriction and/or hypertensive surges.
+ Linezolid
Risk of vasoconstriction and/or hypertensive surges.
Associations requiring precautions for use
+ Halogenated volatile anaesthetics
Intraoperative hypertensive surge.
It is important that the anesthetist be informed of the administration of phenylephrine eye drops before or during the ophthalmologic procedure.
Fertility, pregnancy and breastfeeding
Pregnancy:There are no reliable data on teratogenesis in animals. In clinical practice, there are no specific data for ocular administration in pregnant women. In general, the results of epidemiological studies do not allow it to be established, in large numbers, that there is a malformative effect of phenylephrine after exposure (all routes combined) to 1er trimester of pregnancy.
However, given its potent vasoconstrictive properties, the use of phenylephrine by ocular route should only be considered if necessary during pregnancy. If administered, it is recommended to follow the rules previously mentioned for instillation.
Breastfeeding:
There are no data on the passage of phenylephrine into human milk. However, given the possible cardiovascular and neurological effects of vasoconstrictors, use of this medicinal product is not recommended during breast-feeding.
Driving and using machines
Instillation of this medicine causes troublesome mydriasis lasting a few hours. Consequently, after instillation, driving vehicles and/or using machines is not recommended for the entire duration of the visual disturbances.Adverse effects
Table of adverse reactions
The table below lists the adverse effects of NEOSYNEPHRINE 5 % FAURE, eye drops in solution. The following frequencies were used as the basis for evaluating adverse effects: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), frequency not known (cannot be estimated from the available data).
| Classification by medical discipline (System Organ Class, MedDRA) | Frequency not known |
| Nervous system disorders | Tremor, headache |
| Eye disorders | Troublesome mydriasis, photophobia
Risk of acute angle-closure glaucoma Possibility of eye irritation or transient eye stinging Possibility of allergic reactions: oedema of the eyelids, blepharitis, allergic conjunctivitis, superficial punctate keratitis, in particular due to the presence of thiomersal |
| Cardiac disorders | Tachycardia
Acute coronary syndrome, myocardial infarction, cardiac rhythm disorders |
| Vascular disorders | Pallor
Severe hypertension |
| Respiratory, thoracic and mediastinal disorders | Pulmonary oedema (particularly in the paediatric population) |
| Skin and subcutaneous tissue disorders | Contact eczema |
| Investigations | Increase in blood pressure |
Description of selected adverse reactions
Phenylephrine eye drops pass into the general circulation and can cause systemic effects, particularly in adolescents and elderly subjects (see Posology and Method of administrationWarnings and precautions), which should be taken into account:
- Elevated blood pressure, tachycardia.
- Tremor, pallor, headache.
- Risk of major accidents such as:
- Severe hypertension.
- Pulmonary oedema, acute coronary syndrome, myocardial infarction, cardiac rhythm disorders.
- Severe hypertension.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.
Overdose
2 situations are possible:- either through overdose during administration of the eye drops (particularly during repeated instillations),
- or due to accidental ingestion of a multidose bottle of eye drops, particularly by a child.
- Severe hypertension.
- Acute pulmonary oedema.
- Acute coronary syndrome, myocardial infarction.
- Ventricular rhythm disorders.
- Cerebrovascular accident.
- Convulsion.
- Coma.
The onset is generally rapid; treatment is symptomatic.
Management must be carried out in a specialist setting.
Pharmacodynamics
Pharmacotherapeutic class: Mydriatic, alpha sympathomimetic (ATC code: S01FB01 ; S: sensory organs).
At concentrations above 5 %, phenylephrine is a powerful mydriatic, resistant to opening of the anterior chamber, but with limited duration of action and without notable cycloplegic effect.
Phenylephrine has the properties and adverse effects of alpha 1 sympathomimetics.
It causes:- active mydriasis (within 15 to 60 minutes), which is the therapeutic effect sought in ophthalmology; the duration of the mydriasis obtained is a few hours (5 to 7 hours on average);
- vasoconstriction responsible for arterial hypertension and a decrease in cardiac output.
Pharmacokinetics
There are no relevant published data concerning the ocular bioavailability of phenylephrine.
It is extremely difficult to know what quantity of active ingredient reaches the eye. Only a small proportion of the volume of a drop reaches the anterior chamber of the eye for a local action. The remainder is rapidly drained through the nasolacrimal duct; this drainage promotes systemic passage, which is the cause of potentially serious adverse effects. It can be estimated that 90 % of the quantity of active ingredient that reaches the eye will pass into the general circulation.
Phenylephrine administered locally by the ocular route can pass into the general circulation by three routes: through the conjunctival vessels, through the anterior segment of the eye, and through the nasal and oropharyngeal mucosae. Phenylephrine then passes directly into the bloodstream without undergoing first-pass hepatic metabolism.
Ocular penetration depends on the state of the cornea. When the epithelium is altered, the barrier function of the cornea and local metabolic activity are reduced, which may generate greater absorption.
Storage conditions
- Shelf life before opening:
- 2 years.
No special precautions for storage.
- After opening:
- Store for a maximum of 15 days.
HANDLING/DISPOSAL INSTRUCTIONS
No special requirements for disposal.
Prescription, supply and reimbursement
| Marketing authorisation (AMM) | 3400932172085 (1979, SmPC rev 21.11.2025). |
| Price: | 2,11 euros (vial of 5 mL). |
| Reimbursed by Social Security at 65 %. Collective. | |
EUROPHTA Laboratories
2, rue du Gabian. MC 98000 Monaco
Tel: 00 377 97 77 72 72. Fax: 00 377 97 77 72 70
Source: VIDAL · Updated on 11/11/2026. This information does not replace advice from a healthcare professional.