Package Insert: Information for the User

Optispring0.5 mg/ml Eye Drop Solution

Tetrizolina Hydrochloride

Read this entire package insert carefully before you start using this medicine, because it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those given by your doctor or pharmacist.

• Keep this package insert, 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 package insert. 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 it worsens or does not improve after 2 days of treatment.

Do not use Optispring

• If you are allergic to tetrahydrozoline or any of the other ingredients 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 other blood pressure-elevating medications.
• If you have dry rinitis.
• If you have inflamed cornea and conjunctiva (keratoconjunctivitis).
• In children under 2 years.

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 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 (see warnings on excipients).

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

To avoid contamination of 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.

Other medications and Optispring

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 or
• Blood pressure-elevating medications.

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.

Before administering any other medication by eye drops, 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

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 reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer of the front of the eye). Consult your doctor if you feel a strange sensation, burning, 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”.

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.

How to use

This medication is administered via the ocular route.

Before application, wash your hands and dry your eyes.

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

Do not rinse or clean the dropper as it cannot come into contact with anything, not even the eye. To prevent contamination, close the container immediately with its cap and keep it in an upright position until it is not in use.

Each container can only be used by 1 person.

Use the medication only for small eye irritations.

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

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

Use in children

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

Older adults (over 65 years old)

Consult your doctor or pharmacist before using this medication.

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 newborns and children, due to absorption of the product, for example, due to ingestion.

The symptoms associated with overdose are pupil dilation, 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 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

Do not use a double dose to compensate for the 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.Reporting adverse effects can help provide more information about 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 product 30 days after having removed and opened the packaging.

Medications should not be thrown down the drains or in the trash. Deposit the packaging and medications you no longer need at theSIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Optispring

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible formanufacturing

FARMIGEA S.p.A.

Via G.B. Oliva, 8

56121 Pisa. ITALY

Date of the last review of this leaflet:May 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/