Visine Comfort

Package Leaflet: Information for the User

Visine Comfort, 0.5 mg/ml, eye drops, solution
Tetryzoline hydrochloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or further information, you should speak to your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If after 2 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Visine Comfort and what is it used for
• 2. Important information before using Visine Comfort
• 3. How to use Visine Comfort
• 4. Possible side effects
• 5. How to store Visine Comfort
• 6. Contents of the pack and other information

1. What is Visine Comfort and what is it used for

Visine Comfort contains the active substance tetryzoline hydrochloride. It belongs to a group of medicines used in ophthalmology to reduce redness.
Visine Comfort is used for the temporary relief of redness of the eye caused by minor, non-infectious irritations, such as those caused by smoke, dust, wind, chlorinated water, light, or allergies, in adults, adolescents, and children from 2 years of age (see section 2). In children over 2 years and under 6 years of age, Visine Comfort should only be used after consulting medical personnel.

2. Important information before using Visine Comfort

When not to use this medicine:

• if you are allergic to tetryzoline hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if you have narrow-angle glaucoma
• in children under 2 years of age.

Warnings and precautions

Before starting to use Visine Comfort, you should discuss it with your doctor if you have any of the following symptoms. It may still be possible to use Visine Comfort, but you should first discuss it with your doctor if you have:

• severe cardiovascular diseases (e.g., coronary artery disease, hypertension, pheochromocytoma),
• benign prostatic hyperplasia,
• metabolic disorders (e.g., hyperthyroidism, diabetes, disorders of red blood cell formation),
• dry nasal mucosa inflammation (chronic inflammatory condition in the anterior part of the nose),
• dry eye syndrome (dryness of the conjunctiva and cornea),
• glaucoma (eye disease in which the optic nerve is damaged, connecting the eye to the brain).

If there is no improvement within 48 hours, or if redness or irritation persists or worsens, or if changes in vision or eye pain occur, you should stop using the medicine and consult a doctor. Irritation or redness due to infection, the presence of a foreign body in the eye, or chemical damage to the cornea also requires consultation with a doctor. If you experience headache, loss of vision, visual disturbances (e.g., appearance of moving spots or double vision), severe acute or unilateral eye redness, or eye pain when exposed to light, you should stop using the medicine and consult a doctor, as this may indicate a serious eye disease for which this product is not effective.
You should be careful not to use a higher dose of this medicine than recommended and not to use it for too long (i.e., longer than 3-5 consecutive days), as this may cause increased eye redness or nasal symptoms.
During the use of this medicine, temporary pupil dilation may occur.
Instructions for contact lens wearers
Normally, you should not wear contact lenses in case of eye diseases. If you wear contact lenses, you should remove them before using the medicine and put them back on at least 15 minutes after instillation.

Children

Children under 12 years of age should use this medicine only with the help of an adult.
Children over 2 years and under 6 years of age
Visine Comfort should only be used after consulting medical personnel.
Children under 2 years of age
Do not use in children under 2 years of age.

Visine Comfort and other medicines

Before using this medicine, you should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, especially other ophthalmic medicines.
In the case of using antidepressant medicines called monoamine oxidase inhibitors or tricyclic antidepressants, you should avoid using them at the same time as Visine Comfort, as this may lead to increased blood pressure.
Do not use with other Visine medicines and/or medicines containing tetryzoline hydrochloride.

Pregnancy, breastfeeding, and fertility

There have been no adequate and well-controlled studies on the use of tetryzoline in pregnant and breastfeeding women. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

After using Visine Comfort, pupil dilation and blurred vision may occur. In such cases, you should not drive or operate machinery until your vision returns to normal.
Visine Comfort contains phosphates.
The medicine contains 7.5 µg of phosphates in each drop. In patients with severe damage to the transparent, anterior part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium accumulation during treatment.

3. How to use Visine Comfort

This medicine should always be used exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Children from 6 years of age, adolescents, and adults

Unless your doctor advises otherwise, you should instill 1 or 2 drops into the affected eye(s) 2 to 3 times a day. You should first remove your contact lenses (see "Instructions for contact lens wearers").

Children over 2 years and under 6 years of age

In children from 2 to 6 years of age, Visine Comfort should only be used after consulting medical personnel. If not otherwise indicated, the recommended dose is 1 drop into the affected eye(s) 2 to 3 times a day.

Children under 2 years of age

Do not use in children under 2 years of age.
Method of administration
Visine Comfort is intended for use in the eye.

• 1. Before the first opening, remove the protective cap from the neck of the bottle, along the perforation.
• 2. To open the child-resistant cap, press and turn it counterclockwise.
• 3. After opening the cap, turn the bottle upside down. Slightly tilt your head back. Gently squeeze the bottle to measure 1 or 2 drops into the conjunctival sac. To avoid contamination, the tip of the bottle should not come into contact with any objects other than the cap. Never touch the eye with the tip of the bottle.
• 4. After instillation, gently blink several times to facilitate even distribution of the drops.
• 5. Close the cap by turning it clockwise until it clicks. Never touch the tip of the bottle. Between uses, the bottle should be stored closed.

Duration of treatment
Visine Comfort should be used for the shortest time necessary to relieve symptoms, not longer than 5 consecutive days. You should be cautious when using it repeatedly, as prolonged (even with short breaks of several days) or excessive use may lead to chronic edema and/or conjunctival atrophy.
Continuous use may cause increased eye redness. If symptoms do not improve within 2 days, or if redness increases or persists, you should stop using the medicine and consult a doctor.

Using a higher dose of Visine Comfort than recommended

In the case of eye use, symptoms of overdose are unlikely. However, accidental ingestion may lead to serious side effects or poisoning, especially in children.
These serious side effects may include, among others, instability of the cardiovascular system, drowsiness, coma, hypothermia (decreased body temperature), bradycardia (slower heart rate), hypotension (low blood pressure) or hypertension (high blood pressure), shock-like state, apnea, circulatory disorders, vomiting, salivation, and other systemic effects, such as miosis (pupil constriction), lethargy (lack of energy), dryness of mucous membranes, and atypical chest pain, increased eye redness, and nasal mucosa redness.
In case of accidental ingestion of the medicine or suspected accidental ingestion by children, you should immediately contact a doctor or pharmacist.

Missing a dose of Visine Comfort

You should not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (affecting up to 1 in 1,000 people):

• pupil dilation

Very rare (affecting up to 1 in 10,000 people)

• dryness of the conjunctiva with closure of the lacrimal puncta after prolonged use of tetryzoline
• eye watering after prolonged use of tetryzoline

Common (affecting up to 1 in 10 people):

• eye irritation (pain, stinging, burning)
• reduced visual acuity
• reflex redness
• burning sensation of the mucous membranes
• dryness of the mucous membranes

Frequency not known (cannot be estimated from the available data):

• increased tearing
• burning of the eyes or around the eyes, redness, irritation, swelling, pain, itching

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Visine Comfort

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the month.
Store in a temperature below 30°C.
The medicine should be discarded 6 weeks after the first opening of the bottle.
Do not use this medicine if the solution changes color or becomes cloudy.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Visine Comfort contains

• Active substance: 1 ml of eye drops contains 0.5 mg of tetryzoline hydrochloride.
• Other ingredients are: glycerol, hypromellose, macrogol 400, boric acid, disodium phosphate, sodium citrate, potassium chloride, magnesium chloride hexahydrate, sodium (S)-lactate, solution, glycine, ascorbic acid, dextrose monohydrate, poliquaternium 42, solution, purified water.

What Visine Comfort looks like and contents of the pack

Visine Comfort is a clear, colorless or slightly yellowish solution for use in the eyes, not containing solid particles.
Visine Comfort is available in 15 ml bottles with LDPE dropper and child-resistant closure with PP/HDPE.
Outer packaging - cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:
McNeil Healthcare (Ireland) Limited
Block 5, High Street, Tallaght
Dublin 24
Ireland
Manufacturer:
Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse
Belgium
Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Germany

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

Germany
Visine Yxin Hydro
Bulgaria
Visine Novo
Croatia
Visiklear
Cyprus
Vispring Advance
Czech Republic
Visine Rapid
Estonia
Visine
Greece
Vispring Advance
Hungary
Visine Rapid
Latvia
Visine
Lithuania
Visine
Poland
Visine Comfort
Portugal
Visine
Romania
Visine Novo
Slovakia
Visine Rapid
Slovenia
Visiklear
Spain
Vispring