OXYBUPROCAINE HYDROCHLORIDE THEA 1,6 mg/0,4 ml eye drops, single-dose container 20 unit PE/0,4 ml

VIDAL
Medicines
Update of the 19/03/2024

*OXYBUPROCAINE HYDROCHLORIDE THEA^®

Forms and presentations

Eye drops at 1,6 mg/0,4 ml:  Single-dose containers of 0,4 ml, boxes of 20 and 100.

Composition

	single-dose p
Oxybuprocaine (INN) hydrochloride	1,6 mg

Excipients: sodium chloride, sodium hydroxide, hydrochloric acid, water for injectable preparations.

Indications

Local anesthesia:

• Tonometry.
  
• Examinations using contact lens.
  
• Removal of superficial foreign bodies from the cornea and conjunctiva.
  
• Any procedure requiring local anesthesia of the cornea and conjunctiva.
  

Dosage and administration

1 to 2 drops of eye drops, one to two minutes before the examination or procedure.

Instill 1 to 2 drops of eye drops into the lower conjunctival sac of the affected eye(s), looking upward and gently pulling the lower eyelid downward. A single instillation is sufficient to ensure corneoconjunctival anesthesia of about ten minutes.

To obtain deeper or longer-lasting anesthesia, repeat the procedure 3 to 5 times at one-minute intervals.

Do not touch the eye or eyelids with the single-dose container.

After use, discard the single-dose container.

Method of administration:

Topical use.

For ocular instillation.

Contraindications

This medicine is contraindicated in cases of hypersensitivity to oxybuprocaine and other local anesthetics or to the excipients.

Warnings and precautions

Warnings:

Do not inject, do not swallow.

The eye drops must not be administered:

• by peri- or intraocular injection;
  
• in young children;
  
• concomitantly with any solution containing sodium hypochlorite (see Incompatibilities) due to total degradation of the active ingredient resulting in loss of efficacy of oxybuprocaine hydrochloride.
  

This eye drop solution must not be used repeatedly or for prolonged periods (in particular as an analgesic); likewise, it is imperative to comply with the recommended dosages because:

• Corneal opacifications and delayed wound healing may occur.
  
• Due to its local anaesthetic activity which relieves pain, the product may cause serious eye injuries, particularly to the cornea.
  

Precautions for use

• Due to the risk of alteration of the corneal epithelium, linked to the presence of a local anaesthetic, care must be taken to ensure that the eye drops do not penetrate into the anterior chamber of the eye.
  
• In ophthalmology, whether used alone or in combination, local anaesthetics all carry a risk of altering the corneal epithelium, even at low concentrations. It is imperative to always prefer general analgesics as analgesics instead.
  
• Athletes are advised that this product contains an active substance (local anaesthetic) that may cause a positive reaction in tests carried out during anti-doping controls.
  

Interactions

The data available to date do not suggest the existence of clinically significant interactions.

Fertility, pregnancy and breastfeeding

Pregnancy:

There is no reliable data on teratogenicity in animals.

In clinical practice, no particular malformative or foetotoxic effect has appeared to date. However, follow-up of pregnancies exposed to this medicine is insufficient to rule out any risk. Consequently, use of this medicine should be considered during pregnancy only if necessary.

Breastfeeding:

Due to the lack of data on the passage of this medicine into breast milk, use of this eye drop solution should only be considered if necessary and with breastfeeding suspended.

Driving and using machines

Patients with blurred vision must refrain from driving or using machinery for as long as visual disturbance persists.

Adverse effects

• Some cases of collapse with bradycardia have exceptionally been reported.
  
• A transient tingling sensation or irritation may occur on instillation.
  

Reporting of suspected adverse reactions:

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

Repeated and prolonged use exposes to a risk of serious eye injuries, particularly to the cornea.

Pharmacodynamics

Pharmacotherapeutic class: Local anaesthetic, ophthalmology (ATC code: S01HA02).

Local anaesthetic derived from para-aminobenzoic acid.

Pharmacokinetics

Rapid local anaesthetic action taking effect within one minute following instillation and lasting 5 to 10 minutes.

INCOMPATIBILITIES

The use of Oxybuprocaine Hydrochloride Théa 1,6 mg/0,4 ml, eye drops in single-dose container, is incompatible with the concomitant use of any solution containing sodium hypochlorite. Mixing these 2 solutions results in total degradation of oxybuprocaine hydrochloride molecules as well as the appearance of a coloured (brown) reaction.

Storage conditions

After use, discard the single-dose container.

HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.

Prescription, supply and reimbursement

LIST I

Medicinal product reserved for professional use by ophthalmologists.
Marketing authorisation (AMM)	3400936576865 (1993, SmPC rev 11.01.2019) 20 single-dose units.
	3400936576926 (1993, SmPC rev 11.01.2019) 100 single-dose units.

Collection.

THÉA PHARMA
37, rue Georges-Besse
63100 Clermont-Ferrand

http://www.theapharma.fr