OPTISPRING 0.5 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Optispring0.5 mg/ml eye drops solution

Tetrizoline Hydrochloride

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 2 days of treatment.

Contents of the Package Leaflet

1. What Optispring is and what it is used for
2. What you need to know before using Optispring
3. How to use Optispring
4. Possible side effects
5. Storage of Optispring
6. Package Contents and Additional Information

1. What Optispring is and what it is used for

This medication belongs to the group of decongestant medications called sympathomimetics. It is an ophthalmic decongestant medication that contains tetrizoline as the active ingredient. Tetrizoline, when administered via the eye, produces local constriction of blood vessels, reducing eye congestion.

It is indicated for the temporary relief of mild eye irritation in adults and children over 6 years of age. You should consult a doctor if your condition worsens or does not improve after 2 days of treatment.

2. What you need to know before using Optispring

Do not use Optispring

• If you are allergic to tetrizoline or any of the other components of this medication (listed in section 6).
• If you have increased intraocular pressure (narrow-angle glaucoma).
• If you have heart disease or high blood pressure (hypertension).
• If you have a tumor in the adrenal glands (pheochromocytoma).
• If you have an overactive thyroid gland (hyperthyroidism).
• If you have diabetes controlled with insulin.
• If you are being treated with antidepressants of the monoamine oxidase inhibitor class or other blood pressure-increasing medications.
• If you have dry rhinitis.
• If you have inflammation of the cornea and conjunctiva (keratoconjunctivitis).
• In children under 2 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Optispring.

• If you have eye pain, headache, changes in vision, rapid appearance of floaters, redness, or continuous eye irritation, pain after exposure to light, or double vision. If this happens to you, or if the conditions worsen or persist, or if new symptoms appear, you should stop using the medication and consult a doctor.
• If you are over 65 years old.

When using this product, the pupils may temporarily dilate.

If you wear contact lenses, they should be removed before administering the medication (see warnings about excipients).

Excessive or continuous use of this product can cause increased eye redness.

To avoid contaminating the product, do not touch any surface with the tip of the container. Replace the cap after use. Do not use the product if the solution changes color or becomes cloudy.

Children and Adolescents

Do not use in children under 2 years of age.

Other Medications and Optispring

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Optispring should not be used if you are being treated with:

• Antidepressant medications that are monoamine oxidase inhibitors or
• Blood pressure-increasing medications.

And in particular, if you are using the following medication, it may be necessary to modify the dose of one of them:

• Tricyclic antidepressant medications.

Before administering any other eye medication, it is recommended to wait at least 5 minutes between administrations.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Using Machines

This medication has little or no influence on the ability to drive and use machines. In rare cases, the ability to drive and use machines may be impaired due to blurred vision or glare.

Optispring contains benzalkonium chloride.

This medication contains 0.2 mg of benzalkonium chloride per ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medication and wait 15 minutes before putting them back on.

Benzalkonium chloride can cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer of the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medication.

Optispring contains sodium.

This medication contains less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free".

3. How to use Optispring

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 6 years of age

Apply 1 or 2 drops in each eye 2 or 3 times a day as needed, up to a maximum of 4 times a day.

Children from 2 to 6 years of age

Use only under strict medical supervision.

How to use

This medication is administered via the eye.

Before application, wash your hands and dry your eyes.

Remove the cap by breaking the security ring. Tilt your head back. With your index finger, pull down the lower eyelid to separate it from the eyeball. Deposit the indicated dose in the eye, applying gentle pressure on the container. After application, it is advisable to blink gently for a few seconds to facilitate uniform distribution of the drops.

Do not rinse or clean the dropper, as it should not come into contact with anything, not even the eye. To avoid contagion, close the container immediately with its cap and keep it in a vertical position while not in use.

Each container can only be used by 1 person.

Use the medication only for minor eye irritations.

It should be used only until symptoms disappear and never for more than a week.

If your condition worsens or does not improve after 2 days of treatment, discontinue treatment and consult your doctor.

Use in Children

Do not use in children under 2 years of age. It is contraindicated.

Elderly Patients (over 65 years of age)

Consult your doctor or pharmacist before using this medication.

If you use more Optispring than you should

Excessive use or oral ingestion can lead to cardiovascular instability, central nervous system depression including somnolence and coma, and respiratory depression including apnea.

There is a risk, especially in neonates and children, due to absorption of the product, for example, due to ingestion.

The symptoms associated with overdose are dilation of the pupil, bluish discoloration of the skin and mucous membranes, vomiting, sedation, somnolence, stupor, drooling, nausea, fever, cramps, alteration of heart rhythm, cardiac arrest, increased blood pressure, pulmonary edema, respiratory and mental disorders.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Optispring

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

If you have any other doubts about using this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Common(may affect up to 1 in 10 patients): Eye irritation (pain, itching, burning), visual disturbances.

Uncommon(may affect up to 1 in 100 people): burning sensation in the ocular mucosa, dry eye, rebound redness (hyperemia), palpitations, headache, tremor, weakness, sweating, and increased blood pressure.

Rare(may affect up to 1 in 1,000 patients): blurred vision, irritation of the ocular conjunctiva, and dilation of the pupil (mydriasis).

Very Rare(may affect up to 1 in 10,000 people): reactions at the application site (including eye or periorbital burning, erythema, irritation, edema, pain, and itching).

Frequency Not Known(cannot be estimated from the available data): Increased lacrimation. Prolonged and frequent use can cause dry eye syndrome.

Reporting of Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Optispring

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the container after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Discard the product 30 days after opening the container.

Medications should not be disposed of via wastewater or household waste. Deposit the containers and medications you no longer need in the pharmacy's SIGRE Point. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Optispring

• The active ingredient is tetrizoline hydrochloride. Each ml of eye drops contains 0.5 mg of tetrizoline hydrochloride.
• The other components (excipients) are: boric acid (E-284), sodium borate, sodium chloride, disodium edetate, benzalkonium chloride, and purified water.

Appearance of the Product and Package Contents

Optispring 0.5 mg/ml eye drops solution is a clear solution presented in low-density polyethylene bottles with a high-density polyethylene cap, white in color, containing 10 ml of eye drops solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

FARMIGEA S.p.A.

Via G.B. Oliva, 8

56121 Pisa. ITALY

Date of the Last Revision of this Package Leaflet:May 2021

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.gob.es/