Label: information for the user

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

Tetrizolina Hidrocloruro

Read this label carefully before starting to use this medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this label or those indicated by your doctor or pharmacist.

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

This medication belongs to the group of decongestant medications known as sympathomimetics. It is an ophthalmic decongestant medication that contains tetrahydrozoline as the active ingredient. Tetrahydrozoline administered via the eye produces local vasoconstriction, reducing ocular congestion.

It is indicated for the temporary relief of mild ocular irritation in adults and children over 6 years old. Consult a doctor if symptoms worsen or do not improve after 2 days of treatment.

No 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 diabetes controlled with insulin.
• If you are being treated with antidepressants of the class of monoamine oxidase inhibitors or blood pressure elevators.
• If you have dry rinitis.
• If you have inflamed cornea and conjunctiva (keratoconjunctivitis).
• If you are under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Optispring.

And especially:

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

When using this product, the pupils may dilate temporarily.

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

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

To avoid product contamination, 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 old.

Other medicationsandOptispring

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

Optispring cannot be used if you are being treated with:

• Antidepressant monoamine oxidase inhibitors.
• Blood pressure elevators.

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

• Tricyclic antidepressants.

Consult your doctor before administering any other medication by eye drops; it is recommended to leave 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 operating machinery

Optispring in single-dose containers has little or no influence on the ability to drive and operate machinery. In rare cases, the ability to drive and operate machinery may be impaired due to blurred vision or dazzle.

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

Follow exactly the medication administration instructions contained in this leaflet or those 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 old

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 aged 2 to 6 years

Use only under strict medical supervision.

Children under 2 years old

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

Geriatric population (over 65 years old)

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 package is sufficient for a single use in both eyes.

Separate a single-use package from the strip. Remove the closure device. Lean your head back. With your index finger, lower the lower eyelid to separate it from the eyeball and deposit the indicated dose in the eye, applying gentle pressure on the package.

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

Dispose of the package after each use.

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

It should be used only until symptoms disappear and never for more than a 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 pupil dilation, blue discoloration of 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 alterations.

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

If you forgot to use Optispring

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

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

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

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

Rare(may affect up to 1 in 1,000 patients): Blurred vision, ocular 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 periocular burning, erythema, irritation, edema, pain, and pruritus).

Unknown Frequency(cannot be estimated from available data): Increased tear production.

Prolonged and frequent use may produce dry eye syndrome.

Reporting Adverse Effects

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

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

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

Do not store above 86°F (30°C).

Dispose of the packaging after each use.

Medications should not be thrown down the drain or in the trash. Deposit the packaging and unused medications at theSIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Optispring

• The active principle is tetrahydrozoline hydrochloride.Each milliliter of eye drops contains 0.5 mg of tetrahydrozoline hydrochloride. Each single-dose vial of 0.5 ml contains 0.25 mg of tetrahydrozoline 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 packaging

Optispring 0.5 mg/ml in single-dose vials isa clear solution eye drops that comes in single-dose vials of 0.5 ml of low-density polyethylene, which are introduced in a bag. Each vial contains 10 single-dose vials.

Holder of the marketing authorizationand responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

FARMIGEA S.p.A.

Via G.B. Oliva, 8 56121 Pisa. ITALY

Date of the last review of this leaflet:March 2021

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