NAPHCON-A are decongestant anti-allergic eye drops (contains pheniramine maleate, an anti-allergic medicine and naphazoline hydrochloride, a medicine that reduces swelling). It is used for treating the symptoms of eye irritation or swelling of the eye, caused by allergic eye disorders, in adults. NAPHCON-A is used over the counter for the temporary relief of redness and itching of the eyes.

Do not use NAPHCON-A

• If you are allergic to pheniramine maleate, naphazoline hydrochloride or any of the other ingredients of this medicine (listed in section 6).

• If you have narrow angle glaucoma (eye disease caused by an elevated pressure in the eye).

• If a risk exists that you may develop a closed-angle glaucoma.

• Do not administer NAPHCON-A to babies or young children aged 12 years or below.

Warnings and precautions

• Only use NAPHCON-A for dropping in your eyes.

• If the irritation persists or aggravates, interrupt the use of NAPHCON-A.

• Talk to your doctor or pharmacist before using NAPHCON-A:

- If you are being treated with monoamine oxidase inhibitors (MAOIs) (medicines to treat depression, Parkinson’s disease, …).

- If you are elderly.

- If you suffer from severe cardiovascular diseases, such as cardiac arrhythmia, a poorly controlled increased blood pressure or decreases in blood pressure related with postural changes. 2/6

- If you suffer from insulin dependent diabetes, hyperthyroidism (overactivity of the thyroid gland), prostatic hypertrophy (enlargement of the prostate), or history of urinary retention (urine remaining in the bladder).

• Avoid long-term or excessive use. This may cause you to have red or swollen eyes again. Do not use more of NAPHCON-A than the recommended dose and do not use it anymore after the symptoms have disappeared.

• Due to the presence of naphazoline in the formula, pupil dilation, increase in ocular pressure and systemic side effects such as headache, nausea, dizziness, heart disease (cardiopathy), high blood pressure (hypertension) and high blood sugar (hyperglycaemia) may occur as a result of absorption.

• The following systemic side effects have been reported with topical application of sympathomimetic drugs such as naphazoline: headache, blood pressure elevation, premature heart contractions (extrasystoles), racing heart (tachycardia), faintness and strokes (cerebrovascular accidents).

• If you wear contact lenses:

- Do not wear soft contact lenses while using NAPHCON-A.

- If you continue to wear contact lenses, remove them before using NAPHCON-A and wait at least 15 minutes before putting your lenses back in.

• Discontinue the use of NAPHCON-A prior to the use of anaesthetics. Anaesthetics (e.g. cyclopropane, halothane) may make you more susceptible to the effects of sympathomimetic drugs such as naphazoline.

• The use of NAPHCON-A in the eye may liberate pigment granules from the iris (coloured part of the eye), especially when used in high doses in elderly patients.

• If you are using other medicines, please also read the section “Other medicines and NAPHCONA”.

Consult your doctor if one of the above warnings is applicable to you or has been in the past. Talk to your doctor or pharmacist before using NAPHCON-A

Children

• Talk to your doctor or pharmacist before using NAPHCON-A in children, as they may be more susceptible to side effects from the medication.

• Do not use NAPHCON-A in children aged 12 years or younger as it may cause depression of the central nervous system in babies and children which may lead to coma and a significant drop in body temperature.

Other medicines and NAPHCON-A

Tell your doctor if you are using monoamine oxidase inhibitors (MAOIs) (medicines to treat depression, Parkinson’s disease, …). These medicines can cause in combination with NAPHCON-A a severe increase in blood pressure.

If you are using other eye preparations, wait at least 5 minutes between each application. If you also use an eye ointment, administer this last.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

NAPHCON-A with food and drink

Food and drink have no influence on your treatment.

Pregnancy, breast-feeding and fertility
Do not use NAPHCON-A if you are pregnant or breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
NAPHCON-A can cause the pupils to dilate briefly, which may impair your vision under strong lights. 3/6

If your vision becomes temporarily blurred after having used NAPHCON-A, do not drive or use machines until your vision has become clear again.

NAPHCON-A* Eye Drops, Solution contains benzalkonium chloride.A 

The preservative in NAPHCON-A (benzalkonium chloride) may cause eye irritation and discoloration of soft contact lenses. Avoid contact with soft contact lenses. Remove contact lenses before administration and wait at least 15 minutes before putting them back in.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

• 1 or 2 drops in the affected eye(s) every 3 to 4 hours (or less frequent) up to 4 times daily until the symptoms have disappeared.

• If the symptoms clear up, discontinue treatment. Avoid long-term or excessive use. This may cause you to have red or swollen eyes again. Do not continue treatment beyond the symptomatic period. Discontinue treatment and ask your doctor if you feel eye pain, change in vision or redness or irritation gets worse or lasts more than 72 hours.

After cap is removed, if tamper evident snap collar is loose, remove before using product

Use in children
• The safety and efficacy of NAPHCON-A in children aged between 0 and 18 years have not been established.

• Talk to your doctor or pharmacist before using NAPHCON-A in children, as they may be more susceptible to side effects from the medication.

• Do not administer NAPHCON-A to babies or young children aged 12 years or below as this may cause depression of the central nervous system which may lead to coma and a significant drop in body temperature.

Use in elderly patients

No dosage adjustment is required in elderly patients.

Use in patients with hepatic or renal impairment

No studies have been performed in patients with hepatic or renal failure

Instructions for use:

1. Wash your hands before using NAPHCON-A.

2. Sit down in front of a mirror, so that you can see what you are doing.

3. Twist off the bottle cap.

4. Make sure the dropper touches nothing else, as this may contaminate the contents.

5. Hold the bottle pointing down in one hand, between your thumb and middle finger.

6. Tilt your head back.

7. Pull down the lower eyelid of the affected eye with a finger of your other hand (Picture 1). 4/6

8. Bring the dropper close to your eye without touching it and gently press the base of the bottle with your index finger (Picture 2) so that 1 or 2 drops fall in the space between the eye and the lower eyelid.

9. Close your eye and press a finger into the corner of your eye next to your nose for 2 minutes (Picture 3). This will limit the quantity of medicine that ends up in your blood.

10. Repeat steps 5 through 9 for your other eye, if necessary. Close the bottle cap firmly.

If a drop misses your eye, try again.

If you are using other eye preparations, wait at least 5 minutes between each application. If you also use an eye ointment, administer this last.

Treatment duration:

If your doctor has prescribed NAPHCON-A to you, your doctor will tell you how long you should use it. Contact your doctor if your symptoms worsen or do not improve after a few days.

If you use more NAPHCON-A* Eye Drops, Solution than you should,

• If you have instilled more NAPHCON-A into your eye than necessary, you can rinse it out of your eye with lukewarm water. Do not put in any more drops until it is time for your next dose.

• If you have used more NAPHCON-A than you should or if you have accidentally swallowed NAPHCON-A, immediately seek advice from your doctor or pharmacist.

• In case of overdose or accidental ingestion, the following effects can be observed, especially in children: a decrease in body temperature, an abnormally slow heart rate, perspiring, drowsiness, dizziness, coma, fluctuations in blood pressure. Your doctor will take the decision if it is necessary to have the child admitted to the hospital

If you forget to use NAPHCON-A* Eye Drops, Solution, 

Administer the forgotten dose as soon as possible. However, do not use a double dose to make up for the missed dose. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

If you stop using NAPHCON-A

NAPHCON-A only treats the symptoms of eye irritation or swelling of the eye caused by allergic eye disorders. If the underlying condition persists, the symptoms may reappear when you stop the treatment with NAPHCON-A.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, NAPHCON-A can cause side effects, although not everybody gets them.

The following side effects have been seen during clinical trials and post-marketing experience with NAPHCON-A. The side effects have been grouped according to their frequency of occurrence: “very common”: affect more than 1 in 10 patients, “common”: 1 to 10 in 100 patients, “uncommon”: 1 to 10 in 1,000 patients, “rare”: 1 to 10 in 10,000 patients, “very rare”: less than 1 in 10,000 patients and “not known”: cannot be estimated from the available data.

• Eye disorders:

- Common: eye discomfort.

- Uncommon: eye surface inflammation – eye pain – eye swelling – eye redness.

- Not known: increase in pupil size – eye irritation – blurred vision – increased intraocular pressure.

• Reactions in other parts of your body:

- Not known: local allergic reactions.

Additional side effects in children

Excessive use of NAPHCON-A in babies and young children may cause serious reactions such as a fall in body temperature, drowsiness or other symptoms of depression of the central nervous system.

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. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Store below 25°C. Protect from light.

Do not use NAPHCON-A longer than 4 weeks after first opening.

Do not use NAPHCON-A after the expiry date which is stated on the label and carton after “EXP”. 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 you no longer use. These measures will help to protect the environment.