Vispring 500 microgram/ml eye drops in single-dose containers

Tetrizolina Hidrocloruro

Read this leaflet carefully before you start using this medicine because it contains important information for you.

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

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 48 hours.

1. What Vispring in single-dose containers is and for what it is used

2. What you need to know before starting to use Vispring in single-dose containers

3. How to use Vispring in single-dose containers

4. Possible side effects

5. Storage of Vispring in single-dose containers

6. Contents of the container and additional information

Vispring belongs to the group of medications known as ocular decongestants that act by producing ocular decongestion.

Vispring is indicated for the temporary symptomatic relief of mild conjunctival congestion in adults and children over 6 years old due to: smoke, wind, chlorinated water, light, and other irritating agents.

Do not use Vispring in single-dose containers if

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication 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 temporarily dilate.

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

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

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.

Use of Vispring in single-dose containers with other medications

Vispring cannot be used if you are being treated with:

• Antidepressant medications that inhibit monoamine oxidase or
• Blood pressure-elevating medications.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, and especially 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 administeringany 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 operating machinery

Vispring 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.

Follow exactly the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medication is administered via the ophthalmic route.

The recommended dose is:

Adults and children over 6 years: 1 or 2 drops in the affected eyes 2 or 3 times a day as needed, up to a maximum of 4 times a day.

Children 2 to 6 years: Use only under strict medical supervision.

The amount of Vispring in single-dose containers is sufficient for a single use in both eyes. Once a single-dose container is separated from the strip, and the closure device is removed, apply the drops to the eye by gently pressing the container. After application, it is advisable to blink gently for a few seconds to facilitate the uniform distribution of the drops.

Dispose of the container after each use.

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

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

If you use more Vispring in single-dose containers 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 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 Vispring in single-dose containers

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, Vispring may cause adverse effects, although not everyone 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 cause 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.

Do not store at a temperature above 25°C.

Keep out of 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.

Dispose of the container after each use.

Medicines should not be thrown into the drains or trash. Deposit the containers and medicines you no longer need at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Vispring in single-dose containers

- The active ingredient is tetrizoline hydrochloride. Each milliliter contains 500 micrograms of tetrizoline hydrochloride as the active ingredient. Each single-dose container of 0.5 ml contains 250 micrograms of tetrizoline hydrochloride

- The other components (excipients) are: boric acid (E-284), sodium borate, sodium chloride, and purified water.

Vispring in single-dose containers is a clear and colorless eye drop solution that is presented in single-dose containers of 0.5 ml. Each box contains 10 containers.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-Madrid

Spain

Responsible for manufacturingLABORATOIRE UNITHER

Rue De L Arquerie

Coutances, 50200

France

Last review date of this leaflet: November 2017

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