Novain

Package Leaflet: Information for the User

Novain, 4 mg/mL, Eye Drops, Solution

Oxybuprocaine hydrochloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Novain and what is it used for

This medicine is a topical anesthetic for use in adults.
It is intended for local anesthesia of the eye surface during short ophthalmic procedures.

2. Important information before using Novain

When not to use Novain

• known hypersensitivity (allergy) to oxybuprocaine or any of the other ingredients of Novain (listed in section 6);
• known hypersensitivity (allergy) to other local anesthetics belonging to the same group of active substances (p-aminobenzoic acid).

Warnings and precautions

Special caution is required when using Novain

• If the patient wears contact lenses: they should remove the contact lenses before administration and wait until the anesthetic effect has completely worn off before reinserting them (see also section 3. How to use Novain).
• In patients with allergies, heart disease, asthma, hyperthyroidism, and liver disease, as well as in elderly patients.
• In case of eye inflammation, as the redness of the eye significantly increases blood flow through the eye surface.

Prolonged and repeated use

Novain is intended for short-term use only by a doctor. Repeated, uncontrolled use can lead to serious damage to the cornea. This also applies to prolonged use of the medicine.

Children and adolescents

The safety and efficacy of Novain in children and adolescents have not been established.

Novain and other medicines

Tell your doctor or pharmacist about all medicines and eye drops you are using or have recently used, as well as any medicines and eye drops you plan to use, including those obtained without a prescription.
Sulfonamides (contained in some antibiotics): The effectiveness of these antibiotics may be reduced.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Your doctor will decide whether you can use Novain.

Driving and using machines

This medicine may affect your ability to react and drive vehicles.
Using Novain may affect your vision and thus your ability to react in traffic and operate machines. Do not drive or operate tools or machines before the effect of the medicine has worn off.

3. How to use Novain

The recommended dose is 1 drop into the eye before examination or procedure; this dose may be repeated if necessary.
Method of administration
For use in the eye. (Administer a drop into the eye to be examined)
Your doctor or ophthalmologist will administer a drop into your eye. You may be asked to press the inner corners of your eyelid for 1-2 minutes. This will help prevent the solution from entering the nose and throat. This is especially recommended for elderly patients and those at risk.
The eye will remain numb for about an hour, depending on the number of drops administered. You should avoid touching the eye until the anesthetic effect has worn off.
If you need to use other eye drops, wait at least 15 minutes before administering them.
Overdose is very unlikely if you receive more Novain than recommended.
If you suddenly feel unwell after receiving the drop, tell your doctor or ophthalmologist or contact the nearest emergency department immediately.
Information for contact lens wearers
Remove your contact lenses before administering the drop and wait at least one hour after administration - until the anesthetic effect has completely worn off - before reinserting them. Failure to follow this advice may lead to corneal damage.

In case of overdose of Novain

Overdose: Poisoning caused by local anesthesia, especially when taken orally, may cause the following symptoms: muscle twitching, convulsions, low blood pressure, fainting, arrhythmias, cardiac arrest due to conduction disorders, respiratory paralysis.
In such cases, consult a doctor immediately.
Instructions for healthcare professionals
Information on overdose can be found at the end of the package leaflet.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek medical attention immediately if you experience any of the following symptoms of a severe allergic reaction/anaphylaxis: swelling, rash, itching, hives, difficulty breathing, chills, flushing, headache, general malaise, nausea, anxiety, rapid heartbeat, or low blood pressure (frequency not known).
Other side effects that may occur:
Common (may affect up to 1 in 10 people):
The most common side effect is local irritation. Other common side effects include temporary burning after administration and corneal damage with repeated use.
Uncommon (may affect up to 1 in 100 people):
Tremors, blurred vision, slow heartbeat, low blood pressure, dizziness.
Frequency not known (cannot be estimated from the available data):
Eye allergy, allergic conjunctivitis. Symptoms of eye allergy and allergic conjunctivitis may include itching, redness, and swelling of the eyelids, redness of the eyes, irritation, and tearing of the eyes, burning or stinging of the eyes, flakes, and crusts on the edge of the eyelashes, similar to dandruff, sensitivity to light.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Novain

This medicine does not require special storage conditions.
Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the month.
Shelf life after first opening the bottle: 28 days.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Novain contains

• The active substance is oxybuprocaine hydrochloride. Each mL contains 4 mg of oxybuprocaine hydrochloride
• The other ingredients are: boric acid, chlorhexidine digluconate, hydrochloric acid 1N (for pH adjustment), water for injections

What Novain looks like and contents of the pack

Novain, 4 mg/mL, eye drops, solution, is a clear, colorless solution for use in adults. Each carton contains one LDPE bottle of 10 mL.

Marketing authorization holder and manufacturer

AGEPHA Pharma s.r.o.,
Diaľničná cesta 5,
Senec 903 01,
Slovakia
Phone: +421 226 226 032
Fax: +421 245528069
Email: [email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet: October 2024

Information intended for healthcare professionals only:

Procedure in case of poisoning

Immediately initiate control of breathing and blood circulation (intubation and respirator), stimulate the circulatory system, and administer infusions (without adrenaline). In case of cardiac arrest, perform external cardiac massage and use electrostimulation. In case of convulsions, administer ultrashort-acting barbiturates or diazepam (do not administer long-acting barbiturates due to the risk of respiratory depression).