OJOSBEL EYE DROPS, 0.30 mg/0.08 ml Solution

Introduction

Package Leaflet: Information for the User

OJOSBEL EYE DROPS, 0.30 MG/0.08 ML Eye Solution

Naphazoline Hydrochloride and Witch Hazel Water

Read the package leaflet carefully because it contains important information for you.

This medication can be purchased without a prescription. However, to obtain the best results, it should be used properly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 3 days, consult your doctor.
• If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet:

1. What OJOSBEL is and what it is used for
2. Before using OJOSBEL
3. How to use OJOSBEL
4. Possible side effects
5. Storage of OJOSBEL
6. Additional information

1. What OJOSBEL is and what it is used for

OJOSBEL is an eye drop that is applied to the eyes and is effective in their hygiene and care; it belongs to a group of medications called sympathomimetics, which are used for their decongestant and antiseptic action.

OJOSBEL is indicated for the relief of symptoms of irritation in the eyes, congestion, allergic conjunctivitis (inflammation of the eye due to allergy), and redness caused by external agents (air, sun, dust, smoke, acids, etc.).

2. Before using OJOSBEL

Do not use OJOSBEL

• If you are allergic (hypersensitive) to naphazoline hydrochloride, witch hazel water, or any of the other components of OJOSBEL.
• If you have glaucoma (increased pressure inside the eye).
• Do not use OJOSBEL in children under 2 years of age.

Be careful with OJOSBEL

• If you suspect that you may have an injury or wound inside the eye.
• If you have an allergy or hypersensitivity to other sympathomimetic ophthalmic medications.
• If you have any of the following chronic diseases: angina pectoris, diabetes, arterial hypertension, hyperthyroidism, and coronary insufficiency.

Consult your doctor if any of the above circumstances occur or have occurred to you.

• Do not apply the drops immediately after administering another specific eye medication to avoid dragging the administered substance or interfering with its absorption.
• If there is no improvement after 3 days of treatment or if symptoms worsen when using the medication, consult your doctor.
• This medication may mask symptoms in patients with ophthalmological infections.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

OJOSBEL has not been shown to specifically interfere with other medications; however, its simultaneous use with IMAO-type antidepressants, maprotiline, or tricyclic antidepressants is not recommended.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

The safety of this medication during pregnancy and breastfeeding has not been fully established, so it should only be used if advised by your doctor.

Driving and using machines

OJOSBEL does not affect your ability to drive or operate machinery.

3. How to use OJOSBEL

Follow the administration instructions of OJOSBEL exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The normal dose is:

Adults and children over 2 years: apply one or two drops in each eye, three or four times every 24 hours. You can increase these doses if the discomfort requires it, observing the precautions and other warnings indicated in section 2 of this package leaflet.

Instructions for use

1. Separate the vial from the strip of vials.

2. Turn the cap of the vial until it comes off and the vial is open for use.

To correctly administer OJOSBEL, tilt your head back and with your index finger, separate the lower eyelid to form a kind of pouch. Let one or two drops fall into the pouch, never in the lacrimal (inner part of the eye), being careful not to touch the eye with the end of the vial.

Keep the eye closed for a few moments to facilitate the distribution of the administered liquid throughout the inside of the eye.

The application of OJOSBEL does not cause any discomfort; on the contrary, it immediately provides a feeling of coolness and well-being.

Act with caution. Avoid touching the end of the dropper vial with your hands or any object.

Each vial contains the necessary amount for one application in each eye (single-dose vial). If there is any remainder in the vial, discard it for reasons of sterility.

This medication is a solution for ophthalmic use and should not be ingested.

Use in children

OJOSBEL should not be administered to children under 2 years of age.

If you use more OJOSBEL than you should

Excessive application of OJOSBEL could lead to local disorders (irritation, burning). In the event of massive ingestion of the same, nervous manifestations may appear: headache, tremors, dizziness.

If you have used more OJOSBEL than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. If you go to a healthcare professional, bring the packaging and this package leaflet with you.

If you forget to use OJOSBEL

Do not use a double dose to make up for forgotten doses.

If you have any doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, OJOSBEL can cause side effects, although not everyone experiences them.

The side effects that may occur during the administration of this medication are as follows:

• Uncommon: blurred vision, dilation of the pupils, burning, itching, hepatic reactions, and conjunctivitis.
• In prolonged treatments and/or high doses (used in excess): eye irritation.
• Very rare: headaches, palpitations, nervousness, nausea, weakness, sweating.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of OJOSBEL

Keep out of the reach and sight of children.

Store in the original packaging to protect it from light.

Expiry date

Do not use OJOSBEL after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of OJOSBEL

• The active ingredients are naphazoline hydrochloride and witch hazel water.

Each ml of eye solution contains: 0.3 mg of naphazoline hydrochloride and 0.08 ml of witch hazel water.

• The other components are: boric acid, sodium borate, cetavlon, and purified water.

Appearance of the product and packaging content

Box with 10 single-dose vials of 0.5 ml of solution per vial. The vials are inside 1 aluminum bag.

Other presentations: dropper bottle with 8 ml of solution.

Marketing authorization holder and manufacturer

Marketing authorization holder:

DERMOFARM, S.A.U.

C/ Leonardo da Vinci 16-22

08191 Rubí (Barcelona) – Spain

Manufacturer:

C.O.C. FARMACEUTICI S.R.L.

Via Modena, 15

40019 Sant’Agata Bolognese – ITALY

This package leaflet was approved in July 2013

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.es/

Package Leaflet: Information for the User

OJOSBEL EYE DROPS, 0.30 MG/0.08 ML Eye Solution

Naphazoline Hydrochloride and Witch Hazel Water

Read the package leaflet carefully because it contains important information for you.

This medication can be purchased without a prescription. However, to obtain the best results, it should be used properly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 3 days, consult your doctor.
• If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet:

1. What OJOSBEL is and what it is used for
2. Before using OJOSBEL
3. How to use OJOSBEL
4. Possible side effects
5. Storage of OJOSBEL
6. Additional information

1. What OJOSBEL is and what it is used for

OJOSBEL is an eye drop that is applied to the eyes and is effective in their hygiene and care; it belongs to a group of medications called sympathomimetics, which are used for their decongestant and antiseptic action.

OJOSBEL is indicated for the relief of symptoms of irritation in the eyes, congestion, allergic conjunctivitis (inflammation of the eye due to allergy), and redness caused by external agents (air, sun, dust, smoke, acids, etc.).

1. Before using OJOSBEL

Do not use OJOSBEL

• If you are allergic (hypersensitive) to naphazoline hydrochloride, witch hazel water, or any of the other components of OJOSBEL.
• If you have glaucoma (increased pressure inside the eye).
• Do not use OJOSBEL in children under 2 years of age.

Be careful with OJOSBEL

• If you suspect that you may have an injury or wound inside the eye.
• If you have an allergy or hypersensitivity to other sympathomimetic ophthalmic medications.
• If you have any of the following chronic diseases: angina pectoris, diabetes, arterial hypertension, hyperthyroidism, and coronary insufficiency.

Consult your doctor if any of the above circumstances occur or have occurred to you.

• Do not apply the drops immediately after administering another specific eye medication to avoid dragging the administered substance or interfering with its absorption.
• If there is no improvement after 3 days of treatment or if symptoms worsen when using the medication, consult your doctor.
• This medication may mask symptoms in patients with ophthalmological infections.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

OJOSBEL has not been shown to specifically interfere with other medications; however, its simultaneous use with IMAO-type antidepressants, maprotiline, or tricyclic antidepressants is not recommended.

Pregnancy

Consult your doctor or pharmacist before using any medication.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

It is not known how OJOSBEL affects breastfeeding; therefore, it is recommended to suspend breastfeeding or avoid administering this medication during that period, unless the doctor indicates otherwise.

Driving and using machines

OJOSBEL does not affect your ability to drive or operate machinery.

1. How to use OJOSBEL

Follow the administration instructions of OJOSBEL exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The normal dose is:

Adults and children over 2 years: apply one or two drops in each eye, three or four times every 24 hours. You can increase these doses if the discomfort requires it, observing the precautions and other warnings indicated in section 2 of this package leaflet.

Instructions for use

To correctly administer OJOSBEL, tilt your head back and with your index finger, separate the lower eyelid to form a kind of pouch. Let one or two drops fall into the pouch, never in the lacrimal (inner part of the eye), being careful not to touch the eye with the end of the vial.

Keep the eye closed for a few moments to facilitate the distribution of the administered liquid throughout the inside of the eye.

The application of OJOSBEL does not cause any discomfort; on the contrary, it immediately provides a feeling of coolness and well-being.

Act with caution. Avoid touching the end of the dropper vial with your hands or any object.

This medication is a solution for ophthalmic use and should not be ingested.

Use in children

OJOSBEL should not be administered to children under 2 years of age.

If you use more OJOSBEL than you should

Excessive application of OJOSBEL could lead to local disorders (irritation, burning). In the event of massive ingestion of the same, nervous manifestations may appear: headache, tremors, dizziness.

If you have used more OJOSBEL than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. If you go to a healthcare professional, bring the packaging and this package leaflet with you.

If you forget to use OJOSBEL

Do not use a double dose to make up for forgotten doses.

If you have any doubts about the use of this product, ask your doctor or pharmacist.

1. Possible side effects

Like all medications, OJOSBEL can cause side effects, although not everyone experiences them.

The side effects that may occur during the administration of this medication are as follows:

• Uncommon: blurred vision, dilation of the pupils, burning, itching, hepatic reactions, and conjunctivitis.
• In prolonged treatments and/or high doses (used in excess): eye irritation.
• Very rare: headaches, palpitations, nervousness, nausea, weakness, sweating.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

1. Storage of OJOSBEL

Store in the original packaging to protect it from light.

Keep out of the reach and sight of children.

Expiry date

Do not use OJOSBEL after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Once the 8 ml packaging is opened, its validity period is 1 month.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

1. Additional information

Composition of OJOSBEL

• The active ingredients are naphazoline hydrochloride and witch hazel water.

Each ml of eye solution contains: 0.3 mg of naphazoline hydrochloride and 0.08 ml of witch hazel water.

• The other components are: boric acid, sodium borate, cetavlon, and purified water.

Appearance of the product and packaging content

Dropper bottle with 8 ml of solution.

Other presentations: box with 10 single-dose vials of 0.5 ml of solution per vial.

Marketing authorization holder and manufacturer

Marketing authorization holder:

DERMOFARM, S.A.U.

C/ Leonardo da Vinci 16-22

08191 Rubí (Barcelona) – Spain

Manufacturer:

C.O.C. FARMACEUTICI S.R.L.

Via Modena, 15

40019 Sant’Agata Bolognese – ITALY

This package leaflet was approved in July 2013

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.es/