Visine Classic

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Visine Classic (Vispring), 0.5 mg/ml (0.05% w/v), eye drops, solution
Tetryzoline hydrochloride
Visine Classic and Vispring are different trade names for the same medicine.

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 2 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Visine Classic and what is it used for
• 2. Important information before using Visine Classic
• 3. How to use Visine Classic
• 4. Possible side effects
• 5. How to store Visine Classic
• 6. Package contents and other information

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

Visine Classic eye drops are indicated for the symptomatic treatment of conditions accompanied by swelling and conjunctival congestion, resulting from irritation, e.g. by smoke, dust, wind, chlorinated water, cosmetics, as well as in allergic inflammatory conditions, such as hay fever or pollen allergy.
The eye drops relieve accompanying symptoms, such as burning, itching, pain, excessive tearing, and irritation.

2. Important information before using Visine Classic

When not to use Visine Classic

• in patients with narrow-angle glaucoma,
• in children under 2 years of age.

Warnings and precautions

Before starting to use Visine Classic, the patient should discuss it with their doctor or pharmacist.
In case of eye pain, vision disturbances, persistence or worsening of irritation or conjunctival congestion, or if symptoms do not improve, worsen, or new symptoms appear, the use of the medicine should be discontinued and a doctor consulted.
Prolonged use or misuse of the medicine may cause worsening or recurrence of conjunctival congestion.
The use of the medicine may cause temporary blurred vision.
In patients with severe cardiovascular disorders (e.g. coronary artery disease, hypertension, pheochromocytoma) and/or metabolic disorders (e.g. diabetes, hyperthyroidism), treated with monoamine oxidase inhibitors (MAOIs) - also during the period up to 10 days after their administration - and other medicines that may increase blood pressure, as well as in patients with dry nose syndrome, keratitis, and glaucoma, the use of Visine Classic should be carried out after careful consideration of the potential benefits and risks.

Visine Classic and other medicines

In patients taking MAOI inhibitors and other medicines that may increase blood pressure, Visine Classic should be used after consulting a doctor.
A doctor should be consulted before using Visine Classic with other eye medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Due to possible systemic side effects, the use of Visine Classic in pregnant and breastfeeding women is only possible after careful consideration by the doctor of the risks and benefits associated with the treatment.
There are no data available on the passage of tetryzoline through the placental barrier and into breast milk.

Driving and using machines

The administration of Visine Classic may cause temporary blurred vision. In such cases, the patient should not drive or operate machines.

Visine Classic contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride per milliliter.
Contact between the medicine and contact lenses should be avoided.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Contact lenses should be removed before administration and not put back for at least 15 minutes.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, the patient should contact their doctor.

Visine Classic contains boric acid and sodium borate

The medicine should not be used in children under 2 years of age due to the boron content, which may cause fertility disorders.

3. How to use Visine Classic

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, a doctor or pharmacist should be consulted.

Children under 6 years of age

The medicine should not be used in children under 2 years of age. In children between 2 and 6 years of age, the use of the medicine should be under the supervision of a doctor.

Adults and children over 6 years of age

Unless otherwise directed by a doctor, 1 to 2 drops should be instilled into the affected eye, up to 3 times a day. Before administration, contact lenses should be removed and not put back for about 15 minutes after using the medicine.
The use of the medicine in children under 12 years of age should be under adult supervision.
The medicine should not be used for more than 2 days. Use for more than 2 days should only be under the supervision of a doctor.

Method of administration

To avoid contamination of the medicine, the tip of the applicator should not be touched to any surface.

• 1. Before administering the medicine, hands should be washed thoroughly.
• 2. The cap should be unscrewed.
• 3. The head should be tilted back and the lower eyelid pulled down to create a pocket between the eyelid and the eyeball.
• 4. The bottle should be gently squeezed and turned upside down. By reducing the pressure slightly, a little air should be let into the bottle. Thanks to the special applicator with a safe, rounded tip, even the slightest pressure will cause one drop to flow out. If the drop does not get into the eye, the next drop should be administered.
• 5. After administering the medicine, the inner corner of the eye should be gently pressed. This will prevent the medicine from entering the body.
• 6. If it is necessary to administer the medicine to the other eye as well, the above steps should be repeated.
• 7. After administration, the bottle should be screwed back on.

The medicine should be discarded if it changes color or becomes cloudy.

Using a higher dose of Visine Classic than recommended

Overdose symptoms are usually not related to the administration of Visine Classic to the eye. However, ingestion of the medicine may cause serious side effects. In case of ingestion of Visine Classic by an infant or small child, there is a risk of poisoning. Reported overdose symptoms include: nausea, vomiting, lethargy, tachycardia, slowed breathing, bradycardia, hypotension, sedation, drowsiness, pupil dilation, stupor, hypothermia, salivation, coma.
The medicine should be kept out of the reach of children. In case of ingestion, medical help should be sought immediately.

Missing a dose of Visine Classic

A double dose should not be used to make up for a missed dose.

4. Possible side effects

Like all medicines, Visine Classic can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined as follows:
Common (more than 1 in 100 people but less than 1 in 10 people): vision disturbances and eye irritation (pain, stinging, burning).
Very rare (less than 1 in 10,000 people): increased tearing, pupil dilation, and reactions at the application site, including eye or eyelid burning, redness, irritation, swelling, pain, and itching.
Frequency not known (cannot be estimated from the available data): feeling of dryness in the eye and headache.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Visine Classic

The medicine should not be stored at a temperature above 30°C.
The medicine should be kept out of sight and reach of children.
Visine Classic should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
The eye drops in the factory-sealed bottle are sterile. After 28 days from the first opening of the bottle, the medicine should be discarded, even if it has not been used up.
Medicines should not be disposed of via wastewater or household waste containers. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Visine Classic contains

• The active substance of the medicine is tetryzoline hydrochloride.
• The other ingredients are: sodium chloride, boric acid, disodium edetate, benzalkonium chloride, solution, sodium borate, purified water.

What Visine Classic looks like and what the pack contains

A 15 ml LDPE bottle with a dropper and cap in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Greece, the country of export:

Johnson & Johnson Hellas Consumer AE
Aigialeias & Epidavrou 4
15125 Marousi
Athens, Greece

Manufacturer:

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
2340 Beerse
Belgium

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Greece, the country of export:44533/9-5-2008
23905/20-12-2011
62892/15/15-03-2017
Parallel import authorization number:322/19

Date of leaflet approval: 11.04.2024

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