INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ALBALON-A™ Liquifilm® sterile eye drops

SCHEDULING STATUS
S2

PROPRIETARY NAME
(and dosage form)

ALBALON-A™ Liquifilm® sterile eye drops

COMPOSITION
Each mL contains:
naphazoline hydrochloride 0,5 mg, antazoline phosphate 5,0 mg, Liquifilm (polyvinyl alcohol) 14,0 mg, benzalkonium chloride (preservative) 0,004%.

PHARMACOLOGICAL CLASSIFICATION
A/15.4/Ophthalmic preparations: Other.

PHARMACOLOGICAL ACTION
Albalon-A combines the effects of the anti-histamine, antazoline and the decongestant, naphazoline.

INDICATIONS
For relief of ocular irritation and/or congestion in allergic, inflammatory, or infectious ocular conditions.

CONTRA-INDICATIONS
Hypersensitivity to one or more of the components of this preparation. Should not be used in presence of narrow-angle glaucoma. Not for use in children, unless under medical advice.

WARNINGS
A severe hypertensive crisis may ensue in patients under MAO inhibitor medication from use of a sympathomimetic product.

DOSAGE AND DIRECTIONS FOR USE
One or two drops instilled in each eye every three or four hours or less frequently, as required to relieve symptoms.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
This preparation should be used only with caution in the presence of hypertension, cardiac irregularities, hyperglycemia (diabetes mellitus) or hyperthyroidism. 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.

It is not known whether naphazoline and/or antazoline can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Naphazoline and/or antazoline should be given to a pregnant woman only if clearly needed.

Nursing mothers: It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when naphazoline and/or antazoline is administered to a nursing woman.

Side-effects: Transient irritation may occur. Nausea and headache have been reported. Pupillary dilation, increase in intraocular pressure, systemic effects due to absorption (i.e. hypertension, cardiac irregularities and hyperglycemia). Drowsiness may be experienced in some patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Accidental ingestion (especially in children) may cause depression of the central nervous system with reduction in body temperature and symptoms of bradycardia, sweating, drowsiness and coma. Hypertension may be followed by rebound hypotension. Treatment is symptomatic and supportive.

IDENTIFICATION
A clear, colourless to slightly yellow solution.

PRESENTATION
Available in 15 mL plastic dropper bottles.

STORAGE INSTRUCTIONS
Store in a cool place below 25°C. Protect from light. Keep out of reach of children. Keep bottle tightly closed when not in use. Discard any unused portion 30 days after opening the bottle.

REGISTRATION NUMBER
P/15.4/254

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Allergan Pharmaceuticals (Pty) Ltd.
15th floor, North Towers
54 Siemert Road, NEW DOORNFONTEIN
JOHANNESBURG 2094
SOUTH AFRICA

DATE OF PUBLICATION OF THIS PACKAGE INSERT
March 1985 7137 SA 34P

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