Novesina

Package leaflet: Information for the patient

Novesina 4 mg/ml eye drops, solution

oxybuprocaine hydrochloride
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Novesina is and what it is used for
2. What you need to know before using Novesina
3. How to use Novesina
4. Possible side effects
5. How to store Novesina
6. Contents of the pack and other information

1. What Novesina is and what it is used for

Novesina contains the active substance oxybuprocaine hydrochloride, a local anaesthetic particularly suitable for producing surface anaesthesia on mucous membranes.
Novesina is used for:

• measuring intraocular pressure (tonometry using the Schiötz tonometer), contact lens fitting examinations
• removal of foreign bodies from the cornea
• preparation for intraocular injections (subconjunctival and retrobulbar)
• anterior chamber paracentesis for diagnostic purposes
• minor surgical procedures, for example pterygium (abnormal growth of the conjunctiva), chalazia (swelling and inflammation of the eyelid due to inflammation of tear glands), excision of small tumours.

2. What you need to know before using Novesina

Do not use Novesina

• if you are allergic to oxibuprocaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• in children under 2 years of age (see Novesina contains boric acid).

Warnings and precautions
Consult your doctor before using Novesina, especially if you have problems with:

• the liver
• the heart
• blood vessels. Novesina will be administered by your doctor only when strictly necessary. Do not use Novesina repeatedly, as it may cause damage to the cornea.

In corneal and conjunctival anaesthesia of the eye, Novesina 4 mg/ml eye drops do not cause
a burning sensation and thus avoid contraction of the eyelid muscles (blepharospasm).
Novesina is well tolerated by the corneal epithelium and does not cause

• pupil dilation (mydriasis)
• conjunctival redness (hyperaemia)
• allergic reactions
• epithelial lesions.

Other medicines and Novesina
Inform your doctor if you are currently taking, have recently taken, or might take any other medicines.
Novesina is not compatible with

• silver nitrate (bactericidal)
• mercury salts (disinfectants)
• alkaline substances (e.g. detergents).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.
The use of oxibuprocaine hydrochloride during pregnancy and breastfeeding has not been adequately studied.
Your doctor will assess whether the benefits to you clearly outweigh the risks to the fetus/infant before administering Novesina.

Driving and using machines
Wait until the anaesthetic effect of Novesina has worn off before driving or operating machinery.

Novesina contains boric acid
This medicine must not be administered to children under 2 years of age because it contains boron and may impair fertility in the future.

3. How to use Novesina

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Novesina 4 mg/ml eye drops, solution, should be administered by instilling the drops into the conjunctival sac, that is, inside the lower part of the eye.

• Measurement of intraocular pressure (tonometry) using the Schiötz tonometer, contact lens examinations
  The recommended dose is one or two drops, administered one minute before applying the tonometer.
• Removal of foreign bodies from the cornea, preparation for eye injections (subconjunctival and retrobulbar)
  The recommended dose is one drop 2–3 times within a 3-minute period.
• Paracentesis of the anterior chamber for diagnostic purposes, minor surgical procedures (pterygium, chalazia, excision of small tumours)
  The recommended dose is one drop every 30 seconds, repeated 5 to 10 times, with the addition of 1–2 drops of 1% adrenaline.

In case of application over large surfaces or repeated instillations, the maximum dose is 1.5 mg per kg of body weight; thus, for an adult weighing 70 kg, it corresponds to 100 mg of oxybuprocaine hydrochloride, equivalent to 25 ml of NOVESINA 4 mg/ml solution.

Use in children
Novesina is contraindicated in children under 2 years of age (see section 4. Contraindications).

If you use more Novesina than you should
In case of accidental ingestion of an excessive dose of Novesina or prolonged use of the medicine, contact your doctor immediately or go to the nearest hospital, as toxic effects may occur.
Symptoms may include:

• difficulty breathing
• seizures.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
When using Novesina, you may experience one or more of the following side effects:

• mild burning sensation immediately after instillation, which usually resolves quickly
• transient redness (hyperemia) of the conjunctiva
• allergic reactions of the conjunctiva
• allergic reactions of the eyelids and skin around the eyes
• corneal lesions: superficial lesions, erosions, intra-corneal inflammation (stromal infiltrates)
• cataract
• allergic phenomena following a second application.

Following absorption through damaged mucous membranes or skin, systemic effects involving the entire body may also occur:

• excitation of the central nervous system
• nausea
• vomiting
• depression of the cardiovascular system with pallor, sweating, hypotension
• disturbances in heart rhythm (arrhythmias)
• abnormal accumulation of hemoglobin in the blood (methemoglobinemia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Novesina

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Single-dose containers kept outside the protective pouch can be stored for up to 3 months.
After the first opening of the single-dose container, any remaining product should not be reused.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Novesina contains

• The active substance is ossibuprocaine hydrochloride. One ml of solution contains 4 mg of ossibuprocaine hydrochloride.
• The other components are boric acid, water for injections.

Description of the appearance of Novesina and contents of the package
Each package contains 30 single-dose containers made of polyethylene, each containing 0.5 ml of solution.
Marketing Authorization Holder
Laboratoires Théa - 12 rue Louis Blériot - 63017 Clermont-Ferrand (F)
Marketing Authorization Holder in Italy
THEA FARMA S.p.A. Via Tiziano, 32 – 20145 MILANO
Manufacturer
C.O.C. FARMACEUTICI S.r.l.
Via Modena, 15 - Sant’Agata Bolognese (BO)