VISPRING 0.5 mg/ml EYE DROPS SOLUTION

2. What you need to know before using Vispring

Do not use this medication if:

• You are allergic to tetrizoline hydrochloride or any of the other components of this medication (listed in section 6).
• You have narrow-angle glaucoma.
• In children under 2 years of age.

Warnings and precautions

Consult your doctor before using this medication if you have any of the following symptoms. You may still be able to use this medication, but before starting to use this medication, you must consult your doctor if you suffer from:

• severe cardiovascular diseases (e.g., coronary artery disease, high blood pressure, pheochromocytoma)
• benign prostatic hyperplasia
• metabolic disorders (e.g., hyperthyroidism, diabetes, disorders of red blood cell formation)
• dry rhinitis (chronic inflammation in the anterior region of the nose)
• dry keratoconjunctivitis (dryness of the conjunctiva and cornea)
• glaucoma (eye condition in which the optic nerve is damaged, which connects the eye to the brain).

If you do not improve within 48 hours or if the redness or irritation persists or worsens, or if you experience changes in vision or eye pain, stop using this medication and consult a doctor. Irritation or redness due to infection, a foreign body in the eye, or chemical corneal trauma also requires medical attention. If you experience headache, vision loss, vision disorders (e.g., appearance of floating spots or double vision), acute or unilateral intense eye redness, or pain when exposed to light, stop using the medication and consult a doctor, as it means you have a serious eye disease that this product will not help.

Be careful not to use more medication than you should and not to use it for a long time (i.e., more than 3-5 consecutive days), as it could worsen eye redness or nasal symptoms.

When using this product, your pupils may temporarily dilate.

Instructions for contact lens users

In general, contact lenses should not be used in the presence of eye diseases. If you use contact lenses, remove them before applying this medication and do not put them back on until 15 minutes after application.

Children

Children under 12 years of age should only use this medication with the help of an adult.

Children over 2 and under 6 years

This medication should only be used following the advice of a healthcare professional.

Children under 2 years

Do not use in children under 2 years of age.

Other medications and Vispring

Before using this medication, inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medication, especially other eye medications.

If you use antidepressant medications called monoamine oxidase inhibitors or "tricyclics," you should avoid using them with this medication, as it could cause an increase in your blood pressure.

Pregnancy, breastfeeding, and fertility

There are no adequate and well-controlled studies in pregnant and breastfeeding women for tetrizoline. 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

Pupil dilation and blurred vision may occur after using this medication. In these cases, do not drive or use machines until your vision has recovered.

Vispring contains phosphates

This medication contains 7.5 micrograms of phosphates in each drop. If you have severe corneal damage (the transparent layer of the front of the eye), treatment with phosphates, in very rare cases, can cause blurred vision due to calcium accumulation.

3. How to use Vispring

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Children from 6 years, adolescents, and adults:

Unless a doctor tells you otherwise, apply 1 or 2 drops to the affected eye(s) 2 to 3 times a day. Remove contact lenses beforehand (see "Instructions for contact lens users").

Children over 2 years and under 6 years:

In children from 2 to 6 years, this medication should only be used under the recommendation of a healthcare professional. If not indicated otherwise, the recommended dose is 1 drop in the affected eye(s) 2 to 3 times a day.

Children under 2 years:

Do not use in children under 2 years of age.

Method of administration:

This medication is indicated for ocular use (eye drops).

1. Before the first opening, remove the tamper-evident collar, which is around the neck of the container, following the perforations.
2. To open the child-resistant cap, press and unscrew it counterclockwise.
3. After opening the cap, the container should be placed upside down. Tilt your head slightly backward. Gently squeeze the bottle to apply 1 or 2 drops into the conjunctival sac. The tip of the bottle should not come into contact with anything other than the cap to avoid any contamination. Never touch the eye with the tip of the container.
4. After application, blink gently for several seconds to facilitate uniform distribution of the drops.
5. Close the cap by turning it clockwise until it is completely closed. Never touch the tip of the container. The container should be kept closed between applications.

Duration of treatment

This medication should be used for the shortest necessary time to relieve symptoms and no more than 5 consecutive days.

Repeated application should be done with caution, as prolonged use (even with brief breaks of a few days) or excessive use can cause chronic inflammation and/or conjunctival atrophy.

Continuous use may increase eye redness. If there is no improvement within 2 days or if the redness worsens or persists, discontinue use and consult a doctor.

If you use more Vispring than you should

When used in the eye, symptoms of overdose are unlikely. However, accidental ingestion can cause serious side effects or poisoning, especially in children.

Serious side effects may include, among others, cardiovascular instability, drowsiness, coma, hypothermia (decreased body temperature), bradycardia (slower heart rate), hypotension (low blood pressure) or hypertension (high blood pressure), shock-like states, apnea, circulatory disorders, vomiting, drooling, and other systemic effects such as miosis (excessive constriction of the pupil), lethargy (lack of energy), dryness of mucous membranes, and atypical chest pain, increased redness of ocular and nasal membranes.

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 Vispring

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone may experience them.

Rare (may affect up to 1 in 1,000 patients):

-Pupil dilation.

Very rare (may affect up to 1 in 10,000 people):

• Dryness of the conjunctiva with occlusion of the lacrimal puncta after prolonged use of tetrizoline.
• Tearing after prolonged use of tetrizoline.

Frequent (may affect up to 1 in 10 patients):

-Ocular irritation (pain, stinging, burning).

-Visual disturbances.

• Rebound hyperemia.
• Mucosal burning.
• Dryness of mucous membranes.

Unknown (frequency cannot be estimated from available data):

-Increased tearing.

• Ocular or periorbital burning, redness, irritation, swelling, pain, and itching.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects 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 Vispring

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the carton after EXP. The expiration date is the last day of the month indicated.

Store below 30°C.

Discard the product 6 weeks after opening the container.

Do not use this medication if you notice that the solution has changed color or has become cloudy.

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

6. Contents of the pack and further information

Composition of Vispring

• The active ingredient: 1 ml of eye drops contains 0.5 mg of tetrizoline hydrochloride.
• The other ingredients are: glycerol, hypromellose, macrogol 400, boric acid, disodium phosphate, sodium citrate, potassium chloride, magnesium chloride, sodium lactate, glycine, ascorbic acid, dextrose, poliquaternium 42, purified water.

Appearance of Vispring and contents of the pack

Vispring is a clear, colorless to slightly yellowish ocular solution, free of particles.

Vispring is available in 15 ml LDPE bottles with LDPE droppers and PP/HDPE child-resistant caps.

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

Manufacturer

JANSSEN PHARMACEUTICA N.V

Turnhoutseweg, 30

Beerse-Belgium

JOHNSON & JOHNSON GMBH

Johnson & Johnson Platz 2

41470 Neuss

Germany

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this package leaflet: November 2020

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