Naphcon

• Alcon Laboratories, Ophthalmic Div.

• Alcon, Inc.

• Cheshire Pharm. Systems

Naphazoline ophthalmic is for temporary relief of minor eye redness or discomfort caused by minor irritants.

You should not use naphazoline ophthalmic if you have narrow-angle glaucoma.

Stop using this medicine and call your doctor at once if you have ongoing or worsening eye redness, eye pain, vision changes, severe dizziness, or headache, buzzing in your ears, or feeling short of breath.

Since naphazoline ophthalmic is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

An overdose of naphazoline ophthalmic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Keep this medicine out of the reach of children. Certain eye medications can cause serious medical problems in a young child who accidentally sucks on or swallows medicine from the eye dropper.

Ask a doctor or pharmacist if it is safe for you to use naphazoline ophthalmic if you are also using any of the following drugs:

• an antidepressant--amitriptyline, clomipramine, desipramine, desvenlafaxine, doxepin, duloxetine, imipramine, maprotiline, milnacipran, nortriptyline, venlafaxine;

• ergot medicine--ergotamine, dihydroergotamine, ergonovine, methylergonovine; or

• an MAO inhibitor--furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine.

This list is not complete and other drugs may interact with naphazoline ophthalmic. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Naphazoline is used to relieve redness due to minor eye irritations, such as those caused by colds, dust, wind, smog, pollen, swimming, or wearing contact lenses.

Some of these preparations are available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use by infants and children is not recommended, since they are especially sensitive to the effects of naphazoline.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of naphazoline in the elderly with use in other age groups.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Type 2 diabetes mellitus or
• Heart disease or
• High blood pressure or
• Overactive thyroid—Use of ophthalmic naphazoline may make the condition worse

• Eye disease, infection, or injury—The symptoms of the condition may be confused with possible side effects of ophthalmic naphazoline

If eye pain or change in vision occurs or if redness or irritation of the eye continues, gets worse, or lasts for more than 72 hours, stop using the medicine and check with your doctor.

Instill one or two drops in the conjunctival sac(s) every three to four hours as needed.

Naphcon® FORTE (Naphazoline Hydrochloride Ophthalmic Solution USP), 0.1% is available in 15 mL in DROP-TAINER® dispenser.

NDC 0998-0079-15.

Storage: Store at 8° - 27°C (46° - 80°F).

Caution: Federal ( USA) law prohibits dispensing without prescription.

ALCON ( Puerto Rico) INC.
Humacao, Puerto Rico 00791 USA

Printed in USA

September 1996

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