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HSA Approval

NAPHCON-A STERILE OPHTHALMIC SOLUTION

SIN04717P

NAPHCON-A STERILE OPHTHALMIC SOLUTION

NAPHCON-A STERILE OPHTHALMIC SOLUTION

June 13, 1990

ALCON PTE LTD

ALCON PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantALCON PTE LTD
Licence HolderALCON PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
General Sale List
HSA Singapore Classification

Formulation Information

SOLUTION

**3\. How to use NAPHCON-A Eye Drops, Solution** Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. - One or two drops topically in the eye(s) three to four times daily. - To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding area with the dropper tip of the bottle. The following measure is useful to limit the amount of medicine that will come into the blood after application of eye drops: - Keep the eyelid closed, while simultaneously applying gentle pressure to the lachrymal canal with a finger for at least 1 minute. **If a drop misses your eye,** try again. **If you use more NAPHCON-A Eye Drops, Solution than you should,** rinse it all out with warm water. Do not put in any more drops until it is time for your next regular dose. In case of severe overdose or accidental ingestion, immediately seek advice from your doctor, pharmacist or a poison control centre as serious reactions such as a fall in body temperature, drowsiness or other symptoms of depression of the central nervous system may occur (especially in children). Serious reactions affecting the cardiovascular system may also occur. **If you forget to use NAPHCON-A Eye Drops,** Solution continue with the next dose as planned. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use a double dose to make up. **If you are using other eye drop or eye ointment medicines,** leave at least 5 minutes between each medicine. Eye ointments should be administered last. **If you have any further questions on the use of this medicine, ask your doctor or pharmacist.**

OPHTHALMIC

Medical Information

**1\. What Naphcon-A Eye Drops, Solution is and what it is used for** NAPHCON-A Eye Drops, Solution is a - combination of an antihistamine, pheniramine maleate and a decongestant, naphazoline hydrochloride prepared as a sterile topical ophthalmic solution. **Each ml contains:** Actives: Naphazoline Hydrochloride 0.025 %, Pheniramine Maleate 0.3 %. Preservative: Benzalkonium Chloride 0.01 %. Boric Acid, Sodium Chloride, Sodium Borate, Disodium Edetate, Sodium Hydroxide and/or Hydrochloric Acid and Purified Water. NAPHCON-A Eye Drops, Solution is used for relief of ocular irritation and/or congestion or for the treatment of allergic or inflammatory ocular conditions.

**2\. What you need to know before you use Naphcon-A Eye Drops, Solution** **Do not use Naphcon-A Eye Drops, Solution:** - If you are allergic to naphazoline, pheniramine or any of the other ingredients of this medicine (listed in section 6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - If you have narrow angle glaucoma.

S01GA51

naphazoline, combinations

Manufacturer Information

ALCON PTE LTD

ALCON-COUVREUR NV

ALCON SINGAPORE MANUFACTURING PTE. LTD.

Active Ingredients

Pheniramine Maleate

3.0 mg/ml

Pheniramine

Naphazoline Hydrochloride

0.25 mg/ml

Naphazoline

Documents

Patient Information Leaflets

Naphcon-A Sterile Ophthalmic Solution PIL.pdf

Approved: January 19, 2018

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