Vispring 500 micrograms/ml eye drops in single-dose container

Package leaflet: Information for the user

Introduction

Vispring 500 micrograms/ml eye drops solution in single-dose containers

Tetrahydrozoline Hydrochloride

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

Follow exactly the instructions for administration of the medicine 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 48 hours.

Leaflet contents

1. What Vispring in single-dose containers is and what it is used for
2. What you need to know before using Vispring in single-dose containers
3. How to use Vispring in single-dose containers
4. Possible adverse effects
5. How to store Vispring in single-dose containers
6. Contents of the pack and other information

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

Vispring belongs to a group of medicines called ophthalmic decongestants, which act by producing ocular decongestion.

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

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

Do not use Vispring in single-dose containers if

• You are allergic to tetrazoline or to any of the other ingredients of this medicine (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 of the adrenal glands (pheochromocytoma).
• You have an overactive thyroid gland (hyperthyroidism).
• You have insulin-controlled diabetes.
• You are being treated with antidepressants of the monoamine oxidase inhibitor class or other medications that increase blood pressure.
• You have dry rhinitis.
• You have inflammation of the cornea and the conjunctival membrane of the eye (keratoconjunctivitis).
• In children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine, and especially:

• If you experience eye pain, headache, changes in vision, sudden appearance of floating spots, persistent redness or irritation of the eye, pain after exposure to light, or double vision. If any of these occur, or if symptoms worsen or persist, or if new symptoms appear, you should stop using the medicine 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 must be removed prior to administering the drug.

Excessive or prolonged use of this product may lead to increased eye redness.

To avoid contamination of 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.

Using Vispring in single-dose containers with other medicines

Vispring cannot be used if you are being treated with:

• Antidepressant monoamine oxidase inhibitor medications or
• Medications that increase blood pressure.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, and especially if you are taking the following medicine, as it may be necessary to adjust the dose of one of them:

• Tricyclic antidepressant medications.

Consult your doctor before administering any other ophthalmic medication; it is recommended to wait at least 5 minutes between administrations.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Vispring in single-dose containers has minor or no effect on the ability to drive and use machinery. In rare cases, the ability to drive and use machinery may be impaired due to blurred vision or glare.

3. How to use Vispring in single-dose containers

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

This medicine is administered by ophthalmic route.

Recommended dose:

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

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

The amount of Vispring in single-dose containers is sufficient for a single application in both eyes. Once a single-dose container has been detached from the strip and the closure device removed, apply the drops by gently squeezing the container. After application, it is advisable to blink gently for a few seconds to help evenly distribute the drops.

Discard the container after each use.

This medicine should only be used for minor eye irritations. If no relief is obtained within 48 hours, or if redness increases or persists, discontinue use and consult your doctor.

It should be used only until symptoms disappear and never for longer than one 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 drowsiness and coma, and respiratory depression including apnea.

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

Symptoms associated with overdose include pupil dilation, bluish discoloration of the skin and mucous membranes, vomiting, sedation, drowsiness, stupor, drooling, nausea, fever, cramps, altered heart rhythm, cardiac arrest, increased blood pressure, pulmonary edema, and respiratory and mental disturbances.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91.562.04.20 (indicating the medicine and the amount ingested).

If you forget to use Vispring in single-dose containers

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

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

4. Possible adverse effects

Like all medicines, Vispring may cause adverse 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 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 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 itching).

Not known (frequency cannot be estimated from available data): Increased lacrimation.

Prolonged and frequent use may lead to dry eye syndrome.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vispring in single-dose containers.

Do not store at temperatures above 25°C.

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP.

The expiry date refers to the last day of the month indicated.

Discard the container after each use.

Medicines should not be disposed of via wastewater or household waste. Return unused containers and medicines to the Sigre Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vispring in single-dose containers

• The active substance is tetrizoline hydrochloride. Each ml contains 500 micrograms of tetrizoline hydrochloride as the active substance. Each 0.5 ml single-dose container 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 an eye drop solution that is clear and colourless, supplied in 0.5 ml single-dose containers. Each pack contains 10 containers.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

JNTL Consumer Health (Spain), S.L.

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

28033-Madrid

Spain

Manufacturer

LABORATOIRE UNITHER

Rue De L'Arquerie

Coutances, 50200

France

Date of the most recent review of this leaflet: November 2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es