Benoxinate hydrochloride Intes

Package leaflet: Information for the patient

Benoxinato Cloridrato INTES 4 mg/ml eye drops, solution in single-dose container

Oxibuprocaine hydrochloride
Please read all of this leaflet carefully before using 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because 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 Benoxinato Cloridrato INTES is and what it is used for
2. What you need to know before using Benoxinato Cloridrato INTES
3. How to use Benoxinato Cloridrato INTES
4. Possible side effects
5. How to store Benoxinato Cloridrato INTES
6. Contents of the pack and other information

1. What Benoxinato Cloridrato INTES is and what it is used for

Benoxinato Cloridrato INTES contains the active substance oxibuprocaine hydrochloride, also known as
benoxinate hydrochloride, which belongs to the group of local anaesthetics. It acts by temporarily causing
loss of sensitivity in the area where it is applied, without inducing alterations in the state of consciousness (surface anaesthesia).
Benoxinato Cloridrato INTES is an eye drop solution used to facilitate certain eye examinations and procedures that
may be particularly uncomfortable in the absence of anaesthesia, such as:

• measurement of intraocular pressure (tonometry);
• examinations performed using diagnostic contact lenses;
• removal of foreign bodies from the eye surface;
• painful dressings;
• painful procedures (on the eyeball).

2. What you need to know before using Benoxinato Cloridrato INTES

Do not use Benoxinato Cloridrato INTES

• if you are allergic to oxibuprocaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Benoxinato Cloridrato INTES.
Avoid touching the eye and protect it from dust and any possible bacterial contamination for as long as the
anaesthetic effect lasts.
This medicine must be administered by a doctor, only when strictly necessary.
Avoid repeated and uncontrolled use of this medicine, as it may cause damage to the cornea.
Use this medicine with particular caution if you have liver problems (impaired liver function) or if you have
heart or circulatory problems (see section 4).
Accidental ingestion or use of high doses over prolonged periods may cause toxic effects.

Other medicines and Benoxinato Cloridrato INTES
Inform your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Pay particular attention and consult your doctor if you are taking medicines belonging to the class of
anticholinesterase agents, used to treat memory disorders or diseases such as Alzheimer's disease (anti-dementia medicines), as they may enhance the effect of this medicine.
Benoxinato Cloridrato INTES is incompatible with silver nitrate, mercury salts, and alkaline substances.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if strictly necessary and under direct medical supervision.

Driving and using machines
Do not drive or operate machinery requiring alertness until the effect of this medicine has worn off.

Benoxinato Cloridrato INTES in 0.5 ml single-dose containers contains boric acid
This medicine must not be administered to children under 2 years of age without medical advice, as it contains boron and may impair fertility in the future.

3. How to use Benoxinato Cloridrato INTES

This medicine will be administered to you by a doctor, only when strictly necessary.
The single-dose container must be opened by twisting the tab; after use, it must be discarded even if residual medicine remains.

Tonometry, diagnostic contact lens examinations
The recommended dose is one or two drops instilled into the conjunctival sac. Wait 1 minute before applying the tonometer or contact lens.

Removal of foreign bodies, painful dressings
The recommended dose is one drop instilled into the conjunctival sac, repeated 2 or 3 times within 3 minutes.

Painful procedures on the eyeball
The recommended dose is one drop instilled into the conjunctival sac every 30 seconds, repeated 5–10 times.

If you use more Benoxinato Cloridrato INTES than you should
This medicine will be administered by a doctor; therefore, it is unlikely that an excessive dose will be given. Avoid repeated use of this medicine, as allergic reactions (local or systemic sensitization phenomena) may occur, although rarely. If this happens, discontinue treatment immediately and contact your doctor, who will promptly initiate appropriate therapy.

In the case of more serious effects (systemic effects), immediate intervention is required to support respiration and blood circulation using techniques such as intubation, artificial ventilation, and administration of medicines that stimulate blood circulation.

If seizures occur, treatment includes the administration of specific medicines (short-acting barbiturates or diazepam).
Long-acting barbiturates should not be used, as they may worsen respiratory difficulties.

In case of accidental ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

• eye irritation, burning sensation, pain, eye redness (conjunctival hyperemia);
• allergic sensitization which may occur after the second application of the product.

In addition, absorption of the medicine through damaged skin and mucous membranes may cause:
Frequency not known (frequency cannot be estimated from the available data):

• central nervous system stimulation;
• nausea and vomiting;
• reduced heart and circulation activity (cardiocirculatory depression), associated with pale face, sweating, drowsiness and low blood pressure;
• changes in heart rhythm (arrhythmias);
• breathing difficulties (respiratory failure);
• systemic allergic reactions;
• methaemoglobinaemia (a blood disorder).

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

5. How to store Benoxinato Cloridrato INTES

Keep this medicine out of the 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.
Do not store above 25°C.
The single-dose containers must be stored in the original aluminium pouch. After first opening of the aluminium
pouch, use the medicine within 3 months. Discard the single-dose container after use, even if there is unused
residual medicine remaining.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Pack contents and other information

What Benoxinato Cloridrato INTES contains
The active substance is oxibuprocaine hydrochloride (benoxinate hydrochloride). 100 ml of solution contain 400 mg of oxibuprocaine hydrochloride.
The other components are boric acid, purified water.

Description of the appearance of Benoxinato Cloridrato INTES and pack contents
Pack containing 30 single-dose containers of 0.5 ml eye drops each.

Marketing Authorization Holder and Manufacturer
ALFA INTES Industria Terapeutica Splendore S.r.l.
Via F.lli Bandiera, 26
80026 Casoria (NA)
Italy

Patient Information Leaflet

Benoxinato Cloridrato INTES 4 mg/ml eye drops, solution

Oxibuprocaine hydrochloride
Please read this leaflet carefully before using 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Benoxinato Cloridrato INTES is and what it is used for

Benoxinato Cloridrato INTES contains the active substance oxibuprocaine hydrochloride, also known as
benoxinate hydrochloride, which belongs to the group of local anaesthetics that act by temporarily causing
loss of sensation in the area where they are applied, without inducing alterations in the state of consciousness (surface anaesthesia).
Benoxinato Cloridrato INTES is an eye drop solution used to facilitate certain eye examinations and procedures that may be particularly uncomfortable in the absence of anaesthesia, such as:

• measurement of intraocular pressure (tonometry);
• examinations performed using diagnostic contact lenses;
• removal of foreign bodies from the eye surface;
• painful dressings;
• painful procedures (procedures on the eyeball).

2. What you need to know before using Benoxinato Cloridrato INTES

Do not use Benoxinato Cloridrato INTES

• if you are allergic to oxibuprocaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Benoxinato Cloridrato INTES.
Do not touch the eye and protect it from dust and any possible bacterial contamination for as long as the anaesthetic effect lasts.
This medicine must be administered by a doctor, only when strictly necessary.
Avoid repeated and uncontrolled use of this medicine, as it may cause damage to the cornea.
Use this medicine with particular caution if you have liver problems (impaired liver function) or if you have heart or circulatory problems (see section 4).
Accidental ingestion or use of high doses over prolonged periods may cause toxic effects.

Other medicines and Benoxinato Cloridrato INTES
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Pay special attention and consult your doctor if you are taking medicines belonging to the anticholinesterase group, used to treat memory disorders or diseases such as Alzheimer’s disease (anti-dementia medicines), as they may enhance the effect of this medicine.
Benoxinato Cloridrato INTES is incompatible with silver nitrate, mercury salts, and alkaline substances.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, use this medicine only if strictly necessary and under direct medical supervision.

Driving and using machines
Do not drive or operate machinery requiring attention until the effect of this medicine has worn off.

Benoxinato Cloridrato INTES in 10 ml bottle contains benzalkonium chloride
This medicine in the multidose container (“10 ml bottle”) contains 0.1 mg of benzalkonium chloride per 1 ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience unusual sensations in the eye, such as burning or pain after using this medicine, speak to your doctor.

Benoxinato Cloridrato INTES in 10 ml bottle contains phosphates
This medicine in the multidose container (“10 ml bottle”) contains 9.34 mg of phosphate buffer per 1 ml. If you have severe damage to the outer transparent layer of the eye (the cornea), phosphates may, in very rare cases, cause cloudy corneal deposits due to calcium accumulation during treatment.

3. How to use Benoxinato Cloridrato INTES

This medicine will be administered by a doctor and only when strictly necessary.
Tonometry, diagnostic contact lens examinations
The recommended dose is one or two drops to be instilled into the conjunctival sac. Wait 1 minute before
applying the tonometer or contact lens.
Removal of foreign bodies, painful dressings
The recommended dose is one drop to be instilled into the conjunctival sac, repeated 2 or 3 times within
3 minutes.
Painful procedures on the eyeball
The recommended dose is one drop instilled into the conjunctival sac every 30 seconds, repeated 5–10 times.
If you wear contact lenses, remove them before applying the eye drops from the 10 ml bottle; you may reinsert
them after 15 minutes.
If you use more Benoxinato Cloridrato INTES than you should
This medicine will be administered by a doctor, so it is unlikely that you will receive an excessive dose. Avoid repeated use of this medicine, as allergic reactions (local or systemic sensitization phenomena) may occur, although rarely. If this happens, discontinue treatment immediately and contact your doctor, who will promptly establish an appropriate therapy.
In the case of more serious effects (systemic effects), immediate intervention is required to support respiration and blood circulation using techniques such as intubation, artificial respiration, and administration of medicines that stimulate blood circulation.
If seizures occur, treatment includes the administration of specific medicines (short-acting barbiturates or diazepam).
Long-acting barbiturates should not be used, as they may worsen respiratory difficulties.
In case of accidental ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you have any doubts 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 everyone experiences them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

• eye irritation, burning sensation, pain, eye redness (conjunctival hyperemia);
• allergic sensitization, which may occur after the second application of the product.

Additionally, absorption of the medicine through damaged skin or mucous membranes may cause:
Frequency not known (frequency cannot be estimated from the available data):

• central nervous system excitation;
• nausea and vomiting;
• reduced heart and circulation activity (cardiocirculatory depression) associated with pale face, sweating, drowsiness, and low blood pressure;
• changes in heart rhythm (arrhythmias);
• breathing difficulties (respiratory failure);
• systemic allergic reactions;
• methaemoglobinaemia (a blood disorder).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult 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 Benoxinato Cloridrato INTES

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Use the medicine within 28 days of first opening the multidose vial. After first opening,
store the vial at a temperature not exceeding 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Benoxinato Cloridrato INTES contains
Benoxinato Cloridrato INTES 10 ml bottle
The active substance is oxibuprocaine hydrochloride (benoxinate hydrochloride). 100 ml of solution contain 400 mg of oxibuprocaine hydrochloride.
The other components are potassium dihydrogen phosphate, sodium chloride, disodium phosphate dodecahydrate, benzalkonium chloride, purified water.
Description of the appearance of Benoxinato Cloridrato INTES and package contents
Pack containing one 10 ml bottle of eye drops.
Marketing Authorization Holder and Manufacturer
ALFA INTES Industria Terapeutica Splendore S.r.l.
Via F.lli Bandiera, 26
80026 Casoria (NA)
Italy