OPTISPRING 0.5 mg/ml EYE DROPS IN SINGLE-DOSE CONTAINERS

Introduction

Package Leaflet: Information for the User

Optispring0.5 mg/ml eye drops, solution in single-dose containers

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 is Optispring and what is it used for
2. What you need to know before starting to use Optispring
3. How to use Optispring
4. Possible side effects
5. Storage of Optispring
6. Contents of the pack and further information

1. What is Optispring and what is it 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 administered via the ocular route produces local vasoconstriction, reducing ocular congestion.

It is indicated for the temporary relief of mild ocular 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 starting to use Optispring

Do not useOptispring

• 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 insulin-controlled diabetes.
• If you are being treated with monoamine oxidase inhibitor antidepressants or blood pressure elevators.
• You have dry rhinitis.
• 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.

Especially:

• If you have eye pain, headache, changes in vision, rapid onset of floaters, redness, or persistent eye irritation, pain after exposure to light, or double vision. If this happens to you, or if your condition worsens or persists, or if new symptoms appear, you should stop using the medication and consult your doctor.
• If you are over 65 years of age.

When using this product, the pupils may temporarily dilate.

If you wear contact lenses, they should be removed before administering the medication.

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

To avoid contaminating the product, do not touch any surface with the tip of the container. 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

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medication.

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

• Monoamine oxidase inhibitor antidepressants.
• Blood pressure elevators.

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

• Tricyclic antidepressants.

Consult your doctor before administering any other medication via the ocular route. 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

Optispring in single-dose containers has little or no influence on the ability to drive and use machines. However, in rare cases, the ability to drive and use machines may be impaired due to blurred vision or glare.

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. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 6 years of age

Apply 1 or 2 drops to 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.

Children under 2 years of age

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

Elderly population (over 65 years of age)

Consult your doctor or pharmacist before using this medication.

How to use

This medication is administered via the ocular route.

Before application, wash your hands and dry your eyes.

The amount contained in the container is sufficient for a single use in both eyes.

Separate a single-dose container from the strip. Remove the closure device. Tilt your head back. With your index finger, pull the lower eyelid down to separate it from the eyeball and deposit the indicated dose into the eye, applying gentle pressure on the container.

After application, it is recommended to blink gently for a few seconds to facilitate uniform distribution of the drops.

Discard the container after each use.

It should only be used for minor eye irritations. If you do not obtain relief within 48 hours or if the redness increases or persists, discontinue use and consult your doctor.

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

If you use more Optispring than you should

Excessive use or oral ingestion may 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 changes.

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

Use this medication only if you notice the symptoms. If you do not have them, do not use it.

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

If you have any other doubts about the use of 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, stinging, burning), visual disturbances.

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

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

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

Frequency not known(cannot be estimated from available data): Increased lacrimation.

Prolonged and frequent use may 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 Medication Surveillance System for Human Use: 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 shown on the container after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Discard the container after each use.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Optispring

• The active ingredient is tetrizoline hydrochloride. Each ml of eye drops contains 0.5 mg of tetrizoline hydrochloride. Each single-dose container of 0.5 ml contains 0.25 mg of tetrizoline hydrochloride.
• The other components (excipients) are: boric acid (E-284), sodium borate, sodium chloride, and purified water.

Appearance of the product and contents of the pack

Optispring 0.5 mg/ml in single-dose containers is a clear solution eye drop that comes in single-dose containers of 0.5 ml of low-density polyethylene, which are inserted in a bag. Each container contains 10 single-dose ampoules.

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:March 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/