VISINE CLASSIC ACU PILIENI 0.05% 15ML

ATC code: S01GA02 

Active substances: Tetryzolini Hydrochloridum

Vendor, principal: Mcneil Consumer Healthcare,joh. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

VISINE CLASSIC 0.05% 15ML

Package leaflet: information for the user

Visine Classic 0.5 mg/ml eye drops

Tetryzoline hydrochloride

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

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist.
This inclused any possible side effects not listed in this leaflet.
-   You must talk to a doctor if you do not feel better or if you feel worse after two days.

What is in this leaflet

1.   What Visine Classic is and what it is used for
2.   What you need to know before you use Visine Classic
3.   How to use Visine Classic
4.   Possible side effects
5.   How to store Visine Classic
6.   Contents of the pack and other information

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

Temporary relief for patients suffering from non-infectious eye irritations in the case of chemosis and red eyes, which are caused by, for example, the wind, smoke, or chlorinated water.

2.   What you need to know before you use Visine Classic Do not use the medicine Visine Classic:

-   if you are allergic to tetryzoline or any of the other ingredients of this medicine (listed in section 6);
-   if you have narrow-angle glaucoma;
-   in children younger than 3 years of age.
In children aged 3-5, Visine Classic may only be used if prescribed by a doctor.

Warnings and precautions

Consult your doctor before using Visine Classic:
-   if you suffer from serious cardiovascular disorders (e.g. coronary heart disease, hypertension, phaeochromocytoma);
-   if you have benign prostatic hyperplasia;
-   if you are using monoamine oxidase inhibitors (MAOIs (certain medicines for depression) or other medications that potentially raise blood pressure;
-   if you are suffering from endocrine diseases (hyperthyroidism, diabetes, porphyria);
-   if you have dry inflammation of the nasal mucosa;
-   if you have dry inflammation of the cornea or conjunctiva ;
-   if you have open-angle glaucoma.
Long-term use or overdose of eye medication may cause conjunctival hyperaemia and reactive hyperaemia of nasal mucosa (Rhinitis medicamentosa).
Using this medicine may cause transient mydriasis (pupil dilation).
Note to contact lense users
As a rule, contact lenses should be removed in a case of an eye disorder. As an exception, so-called hard contact lenses may be worn but these contact lenses must also be removed before using Visine Classic. Contact lenses may be placed back 15 minutes after using the medicine.

Other medicines and Visine Classic

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Concomitant use of tetryzoline and MAOIs and tricyclic antidepressants may cause increased blood pressure due to vasoconstriction.

Pregnancy and breast-feeding

Visine Classic should not be used during pregnancy and breast-feeding.

Driving and using machines

In rare cases, blurred vision or mydriasis may cause impaired ability to operate machinery and drive a vehicle. The patient should find out the effect of the medicine before performing these activities.
Visine Classic contains benzalkonium chloride, which may cause eye irritation and discolouration of soft contact lenses. Remove contact lenses before using Visine Classic and wait 15 minutes before placing them back after administering the medicine.

3. How to use Visine Classic

Adults and children above the age of 6
Typically, one or two drops in each eye 2- 3 times a day. If necessary, treatment may be continued for up to 2 days.
You should stop using Visine Classic and consult your doctor if eye irritation or redness does not pass or worsens within 48 hours and if you are suffering from pain in the eye or change in vision. A prompt doctor’s consultation is essential if redness or irritation of the eyes is caused by a serious eye condition, such as infection, a foreign body in the eye, or chemical corneal injury. A prompt doctor’s consultation is also required if severe, acute eye redness in one side, severe pain in the eye and headache, impaired vision, or double vision occur or “spots swim before the eyes”.
Children aged 3-5 years
Use only as prescribed by a doctor.
In children younger than 12 years, it is advisable to administer the medicine with the help of a parent. Do not touch the tip of the dropper in order to prevent the contamination of the medicinal product.
After use, place the cap on the bottle.

If you use more Visine Classic than you should

In the case of an overdose, the active substance of Visine Classic is absorbed in the bloodstream, which may cause the occurrence of general side effects. Please consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common ≥ 1/100 to < 1/10): drug-induced redness of the eyes, burning sensation of the conjunctiva, dryness of the conjunctiva
Uncommon (> 1/1,000 to < 1/100): general effects (e.g. heart palpitations, headache, trembling, weakness, sweating, and increased blood pressure), abnormal heart rhythm, rapid heart rate, rapid and irregular heart rate, drug-induced slowing of the heart rate
Rare (> 1/10,000 to < 1/1,000): blurred vision, irritation of the conjunctiva
Very rare (> 1/10,000 to < 1/1,000; incl. side effects of unknown frequency): keratinisation of the tarsal conjunctiva along with blocked lacrimal duct and lacrimation, mydriasis (pupil dilation), administration site reactions (incl. burning sensation in or around the eye, redness of the skin, irritation, swelling, pain, and itching)

Reporting of 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. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Visine Classic

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 30 °C.
After the first opening of the bottle, the medicine should be used within 28 days.
Do not use this medicine if you notice a change in colour or blurriness of the liquid.
Avoid contact with contact lenses (see section 2 “Warnings and precautions”).
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help protect the environment.

6. Contents of the packand

other information

What Visine Classic contains

-   The active substance is tetryzoline. 1 ml contains 0.5 mg of tetryzoline hydrochloride.
-   The other ingredients are benzalkonium chloride, sodium chloride, boric acid, borax, disodium edetate, purified water.

What Visine Classic looks like and contents of the pack

Clear, colourless solution.
A 15 ml low-density polyethylene (LDPE) bottle with a low-density (LDPE) dropper, which has a threaded or childproof polypropylene cap with a polypropylene lining and a high-density polyethylene (HDPE) exterior.
Bottle contains: 15 ml of solution. The package contains 1 bottle.

Market Authorisation Holder and Manufacturer

Market Authorisation Holder:

McNeil Products Limited c/o Johnson & Johnson Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire, SL6 3UG, United Kingdom

Manufacturer:

Janssen Pharmaceutica N.V. Turnhoutseweg 30 2340 Beerse Belgium

The leaflet was last revised in September 2016