Package Insert: Information for the User

OJOSBEL EYE DROPS, 0.30 mg/0.08 ml Eye Solution

Nafazolina Chlorhydrate and Hamamelis Water

Read this package insert carefully because it contains important information for you.

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

• Keep this package insert, 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 any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

1. What is OJOSBEL and for what it is used

2. Before using OJOSBEL

3. How to use OJOSBEL

4. Possible adverse effects

5. Storage of OJOSBEL

6. Additional information

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

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

Do not use OJOSBEL

• If you are allergic (hypersensitive) to naphazoline hydrochloride, to witch hazel water, or to 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 old.

Be especially careful with OJOSBEL

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

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

• Do not apply the drops immediately after administering another specific eye medication, to avoid carrying over the administered substance or interfering with its absorption.
• If no improvement is seen after 3 days of treatment or if symptoms worsen while using the medication, consult your doctor.
• This medication may mask symptoms in patients with ophthalmic 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 use is not recommended with MAOIs, maprotiline, or tricyclic antidepressants.

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 is recommended to use it only if advised by your doctor.

Driving and operating machinery

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

Follow exactly the administration instructions for OJOSBEL 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 needed, observing the precautions and warnings indicated in section 2 of this leaflet.

Usage Instructions

1st Separate the bottle from the strip of bottles.

2nd Turn the cap of the bottle until it comes loose and remains open for use.

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

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

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

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

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

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.

If you use more OJOSBEL than you should

An excessive application of OJOSBEL could lead to local disturbances (irritation, burning). In the event of a massive ingestion, nervous manifestations may appear: headache, tremors, dizziness.

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

If you forgot to use OJOSBEL

Do not use a double dose to compensate for the missed doses.

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

Like all medications, OJOSBEL may produce adverse effects, although not all people will experience them.

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

• Uncommon: blurred vision, pupil dilation, itching, burning, 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 any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Store in the original packaging to protect it from light.

Expiration Date

Do not use OJOSBEL after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point.Ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment.

Composition of OJOSBEL

• The active principles are naphazoline hydrochloride and hamamelis water.

Each ml of eye drop solution contains: 0.3 mg of naphazoline hydrochloride and 0.08 ml of hamamelis water.

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

Appearance of the product and contents of the package

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

Other presentations: dropper bottle with 8 ml of solution.

Holder of the marketing authorization and responsible for the manufacture

Holder of the marketing authorization:

DERMOFARM, S.A.U.

C/ Leonardo da Vinci 16-22

08191 Rubí(Barcelona) – Spain

Responsible for the Manufacture:

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

Via Modena, 15

40019 Sant’Agata Bolognese – ITALY

This leaflet was approved in July 2013

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/

Leaflet: information for the user

OJOSBEL EYE DROPS, 0.30 mg/0.08 ml Eye drop solution

Naphazoline Hydrochloride and Hamamelis Water

Read this leaflet carefully because it contains important information for you.

This medicine can be purchased without a prescription. However, to achieve the best results, it must be used properly.

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

1. What is OJOSBEL and what is it used for

2. Before using OJOSBEL

3. How to use OJOSBEL

4. Possible adverse effects

5. Storage of OJOSBEL

6. Additional information

1. WHAT IS OJOSBEL AND WHAT IS IT USED FOR

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

OJOSBEL is indicated for the relief of symptoms of eye irritation, 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, hamamelis water, or any of the other components of OJOSBEL.
• If you have glaucoma (increase in pressure within the eye).
• Do not use OJOSBEL in children under 2 years old.

Be careful with OJOSBEL

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

Consult your doctor if any of the above circumstances occur or if they have occurred at any time.

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

Use of other medicines

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

OJOSBEL has not been shown to interfere specifically with other medicines, however, it is not recommended to use it simultaneously with MAOI antidepressants, maprotiline, or tricyclic antidepressants.

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Lactation

Consult your doctor or pharmacist before using any medicine.

It is not known how the use of OJOSBEL affects lactation, so it is recommended to suspend breastfeeding or avoid administering this medicine during that period, unless the doctor indicates otherwise.

Driving and operating machinery

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

3. HOW TO USE OJOSBEL

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

The usual dose is:

Adults and children over 2 years old: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 leaflet.

Administration instructions

To properly 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 into the tear duct (inner part of the eye), being careful not to touch the eye with the end of the bottle.

Keep the eye closed for a few seconds to facilitate the distribution of the administered liquid throughout the interior of the eye.

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

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

This medicine is a solution for ocular use and should not be ingested.

Use in children

OJOSBEL should not be administered to children under 2 years old.

If you use more OJOSBEL than you should

Excessive application of OJOSBEL could lead to local disturbances (irritation, burning). In the event of a 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 Toxicological Information Service, phone 91 562 04 20 indicating the medicine and the amount used. If you visit a healthcare professional, bring the packaging and this leaflet with you.

If you forget to use OJOSBEL

Do not use a double dose to compensate for the missed doses.

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

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, OJOSBEL can cause adverse effects, although not all people will experience them.

The adverse effects that may occur during the administration of this medicine are the following:

• Uncommon: blurred vision, pupil dilation, itching, burning, 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 adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. STORAGE OF OJOSBEL

Store in the original packaging to protect it from light.

Keep out of the reach and sight of children.

Expiration date

Do not use OJOSBEL after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

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

Medicines should not be thrown away through the drains or in the trash. Deposit the packaging and the medicines that you do not need in the SIGRE point. Ask your pharmacist how to dispose of the packaging and the medicines that you do not need. In this way, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of OJOSBEL

• The active principles are naphazoline hydrochloride and hamamelis water.

Each ml of eye drop solution contains: 0.3 mg of naphazoline hydrochloride and 0.08 ml of hamamelis water.

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

Appearance of the product and contents of the package

Dropper bottle with 8 ml of solution.

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

Holder of the marketing authorization and responsible for the manufacture

Holder of the marketing authorization:

DERMOFARM, S.A.U.

C/ Leonardo da Vinci 16-22

08191 Rubí(Barcelona) – Spain

Responsible for the Manufacture:

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

Via Modena, 15

40019 Sant’Agata Bolognese – ITALY

This leaflet was approved in July 2013

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/