Package Insert: Information for the User

Vispring0.5mg/ml Eye Drops 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 of the medicine contained in this package insert or those indicated 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.

This medication contains the active ingredient tetrizoline hydrochloride. It belongs to a group of medicines called ocular decongestants (eye medication).

This medication is used to treat temporary eye redness caused by mild non-infectious irritations due, for example, to smoke, dust, wind, chlorinated water, light, or allergies in adults, adolescents, and children aged 2 years and above. Children over 2 years and under 6 years should be treated with this medication only under the recommendation of a healthcare professional.

Do not use this medication if:

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

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 have:

- severe cardiovascular diseases (e.g., coronary disease, high blood pressure, phaeochromocytoma)

- benign prostatic hyperplasia

- metabolic disorders (e.g., hyperthyroidism, diabetes, disorders of red blood cell pigment formation)

- dry rinitis (chronic inflammation in the anterior nasal region)

- dry keratoconjunctivitis (dryness of the conjunctiva and cornea)

- glaucoma (eye disease in which the optic nerve, which connects the eye to the brain, is damaged).

If you do not improve in 48 hours or if redness or irritation persist or worsen, or if you experience changes in vision or eye pain, stop using this medication and consult a doctor. Irritation or redness due to an infection, a foreign body in the eye, or a chemical corneal trauma also require a doctor's attention. If you experience headache, vision loss, vision disturbances (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 this means you have a serious eye disease with which this product will not help you.

Be careful not to use more medication than you should and do not 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 wear 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 old should only use this medication with the help of an adult.

Children over 2 and under 6 years old

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

Children under 2 years old

Do not use in children under 2 years old.

Other medications and Vispring

Before using this medication, inform your doctor or pharmacist if you are taking, have taken recently, or may have taken 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 this could cause an increase in your blood pressure.

Pregnancy, breastfeeding, and fertility

There are no adequate and well-controlled studies in pregnant women and lactating women for tetrahydrozoline. 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 may cause pupil dilation and blurred vision. In these cases, you should not drive or operate machinery until your vision has recovered.

Vispring contains phosphates

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

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

Children aged 6 years and above, adolescents and adults:

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

Children aged 2 to 6 years:

This medication should only be used under the recommendation of a healthcare professional in children aged 2 to 6 years. If not otherwise indicated, 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.

Method of administration:

This medication is indicated for use in the eye (ophthalmic route).

1. Before the first use, remove the tamper-evident seal, which is located around the neck of the container, following the perforations.
2. To open the child-resistant cap, press and twist it in the opposite direction to the clock hands.
3. After opening the cap, the container should be placed upside down. Lean your head slightly back. Gently squeeze the bottle to apply 1 or 2 drops in the conjunctival sac. The tip of the bottle should not come into contact with anything other than the cap to avoid any type of contamination. Never touch the eye with the tip of the container.
4. After application, blink gently several times to facilitate the uniform distribution of the drops.
5. Close the cap by twisting it in the direction of the clock hands 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 time necessary to relieve symptoms and not 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 may cause chronic inflammation and/or conjunctival atrophy.

Prolonged use may increase eye redness. If no improvement is seen in 2 days or if redness worsens or persists, discontinue use and consult your doctor.

If you use more Vispring than you should:

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

Severe side effects may include, among others, cardiovascular instability, somnolence, coma, hypothermia (decreased body temperature), bradycardia (slower heart rate), hypotension (low blood pressure) or hypertension (high blood pressure), shock-like states, apnea, circulatory disturbances, 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 Toxicological Information Service, phone 91.562.04.20 (indicating the medication and the amount ingested).

If you forgot to use Vispring:

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

Like all medications, this medication may produce adverse effects, although not all people 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 closure of tear ducts after prolonged use of tetrizoline.

- Watery eyes after prolonged use of tetrizoline.

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

- Eye irritation (pain, burning, stinging).

- Visual disturbances.

- Rebound hyperemia.

- Burning sensation of mucous membranes.

- Dryness of mucous membranes.

Unknown(frequency cannot be estimated from available data):

- Increased tear production.

- Burning sensation in the eyes or around the eyes, redness, irritation, swelling, pain, and itching.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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 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 box after CAD. The expiration date is the last day of the month indicated.

Store below 30° C.

Dispose of the product 6 weeks after having removed the label and opened the packaging.

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

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you do not need at the Sigre Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you do not need.This will help protect the environment.

Composition of Vispring

• The active principle: 1 ml of eye drops contains 0.5 mg of tetrizoline hydrochloride.
• The other components 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 container

Vispring is a transparent, colorless to slightly yellowish, particle-free eye drop solution.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of marketing authorization

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, 3rd floor

28033-MADRID

Responsible for manufacturing

JANSSEN PHARMACEUTICA N.V

Turnhoutseweg, 30

Beerse-Bélgica

JOHNSON & JOHNSON GMBH

Johnson & Johnson Platz 2

41470 Neuss

Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: November 2020

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