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

Logo MINIMS* CYCLOPENTOLATE HYDROCHLORIDE 0,5%
MINIMS* CYCLOPENTOLATE HYDROCHLORIDE 1,0%

SCHEDULING STATUS:
Schedule 3

PROPRIETARY NAME:
(and dosage form)

MINIMS* CYCLOPENTOLATE HYDROCHLORIDE 0,5%
Eye Drops
MINIMS* CYCLOPENTOLATE HYDROCHLORIDE 1,0%
Eye Drops

COMPOSITION:
(per dispensing unit of 0,5 mL)
Cyclopentolate hydrochloride 2,5 mg (0,5% m/v)
Cyclopentolate hydrochloride 5,0 mg (1,0% m/v)

PHARMACOLOGICAL CLASSIFICATION:
A 15.4 Ophthalmic preparation: Other

PHARMACOLOGICAL ACTION:
Cyclopentolate hydrochloride is a parasympatholytic drug which paralyses the sphincter muscle of the iris, thus causing pupillary dilation; and also paralyses the ciliary muscle, thus causing paralysis of accommodation.

INDICATIONS:
Mydriasis and cycloplegia: iridocyclitis; applanation tonometry. The maximum effect is produced in 30 - 60 minutes after instillation of two drops of a 0,5% solution; recovery of accommodation occurs within 24 hours, but may be hastened if one or two drops of a 2% solution of pilocarpine nitrate are instilled.

CONTRA-INDICATIONS:
Cyclopentolate hydrochloride should not be administered to patients with narrow-angle glaucoma, or to those with a narrow angle between the iris and the cornea, since its use may increase intra-ocular pressure. Cyclopentolate hydrochloride should not be used in neonates except where on expert evaluation, the need is considered compelling.

DOSAGE AND DIRECTIONS FOR USE:
Adults and Children: To be used as directed by the ophthalmologist. For refraction, one drop of a 0,5% solution repeated after 5 minutes is usually sufficient, but deeply pigmented eye may require a 1% solution. For preventing or breaking down lenticular adhesions, one or two drops of a 0,5% solution are instilled and followed after six hours by one or two drops of a 2% solution of pilocarpine nitrate; this alternating treatment is repeated daily. In iritis or iridocyclitis one or two drops of a 0,5% solution are instilled every six to eight hours.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Dryness of the mouth and photophobia. Systemic effects arise from the parasympatholytic action; namely constipation, vomiting and giddiness, increased heart rate, depressant and stimulant action on the C.N.S. These are rarely seen on ocular administration.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Not applicable.

IDENTIFICATION:
Clear, colourless solution.

PRESENTATION:
Sterile, single-dose disposable eye drops in cartons of 10 units, each containing approximately 0,5 mL.

STORAGE INSTRUCTIONS:
Store in the refrigerator protected from strong light. DO NOT FREEZE.
Keep out of reach of children.

REGISTRATION NUMBERS:
C/15.4/48 –Cyclopentolate hydrochloride 0,5% Eye Drops.
C/15.4/49 –Cyclopentolate hydrochloride 1,0% Eye Drops.

NAME AND BUSINESS ADDRESS OF APPLICANT:
S & N Pharmaceuticals (Pty) Ltd
30 Gillitts Road
Pinetown 3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 26, 1970

* Trademark
9/67D        SNP 12/2

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