MYDRIACYL STERILE OPHTHALMIC SOLUTION 0.5%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

TROPICAMIDE

Available from:

ALCON PTE LTD

ATC code:

S01FA06

Dosage:

0.50%

Pharmaceutical form:

SOLUTION

Composition:

TROPICAMIDE 0.5%

Administration route:

OPHTHALMIC

Prescription type:

Prescription Only

Manufactured by:

ALCON-COUVREUR NV

Authorization status:

ACTIVE

Authorization date:

1990-06-25

Patient Information leaflet

34831-B
®
MYDRIACYL
®
(TROPICAMIDE 0.5 % AND 1.0 %)
OPHTHALMIC SOLUTION
DESCRIPTION :
Tropicamide is pharmacologically related to the parasympatholytic
(anticholinergic) group. It is a white 
crystalline solid melting at 96° to 96.5° C. It is slightly
soluble in water. Tropicamide is a synthetic compound
described chemically as Tropic acid-N-ethyl-N- (
γ-picolyl) amide.
ACTIONS :
A mydriatic-cycloplegic. Its action is remarkable in that maximum
mydriasis and cycloplegia are obtained
within 20 to 25 minutes following instillation in the eye. Complete
recovery occurs within 5 to 6 hours 
without the use of a miotic.
INDICATIONS :
For mydriasis and cycloplegia for diagnostic purposes. The 0.5 % is
recommended where mydriasis only
is desired. For cycloplegic effect in refractions, the
1.0 % solution is necessary.
CONTRALNDLCATIONS :
Contraindicated in narrow angle glaucoma.
WARNINGS :
For topical use only — NOT FOR INJECTION.
PRECAUTIONS :
As with any mydriatic, caution should be used when intraocular
pressure is high or unknown or when 
anterior chamber is shallow. In refractions where prolongation of
cycloplegia is desirable, one additional
drop only is recommended.
ADVERSE REACTIONS :
Transient stinging may occur when drops are instilled.
DOSAGE AND ADMINISTRATION :
For refraction, 1 or 2 drops of 1.0 % solution in eye(s) repeated in
5 minutes. If patient is not seen within 
20 to 30 minutes, an additional drop may be instilled to prolong
mydriatic effect. For examination of fun-
dus, 1 or 2 drops of 0.5 % solution, 15 or 20 minutes prior to
examination.
HOW SUPPLIED :
(0.5 % and 1.0 %) in 15 ml plastic Drop-Tainer
®
dispenser.
STORAGE :
Store at room temperature. Do not refrigerate or store at high
temperatures. Keep container tightly closed. 
Keep out of reach of children. Discard one month after opening.
1099
34831-B
A L C O N    B E L G I U M
PRODUKTNAAM :
CODE /LAND:
AFMETING :
AANTAL FILMEN :   
KLEUR :
INITIALEN/DATUM : 
Mydriacyl 0,5 % - 1 % 15 ml
34831-B

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
MYDRIACYL
*
0.5 % Sterile Ophthalmic Solution
MYDRIACYL
*
1.0 % Sterile Ophthalmic Solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
MYDRIACYL 0.5 % : 1 ml of solution contains 5 mg tropicamide [ Tropic
acid - N - ethyl - N - (
γ
- picolyl ) amide ).
MYDRIACYL 1.0 % : 1 ml of solution contains 10 mg tropicamide [ Tropic
acid - N - ethyl - N - (
γ
- picolyl ) amide ].
Preservative: 1 ml of solution contains 0.1 mg benzalkonium chloride
and 0.1 mg disodium edetate.
Tropicamide is a white crystalline solid melting at 96 ° to 96.5 °C.
It is slightly soluble in water.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MYDRIACYL Ophthalmic Solution contains tropicamide, which is
pharmacologically related to the parasympatholytic
(anticholinergic) group. It is a mydriatic and cycloplegic. MYDRIACYL
Ophthalmic Solution is indicated for mydriasis
and cycloplegia for diagnostic purposes.
The 0.5 % solution is recommended where mydriasis only is desired. For
cycloplegic effect in refractions, the 1.0 %
solution is necessary.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
• For examination of the fundus: 1 or 2 drops of the 0.5 % solution
in the eye(s), 15 or 20 minutes prior to
examination.
• For refraction: 1 or 2 drops of the 1.0 % solution in the eye(s)
repeated in 5 minutes. If the patient is not seen within
20 to 30 minutes, an additional drop may be instilled to prolong the
mydriatic effect.
Use in patients with hepatic or renal impairment
The safety and efficacy of MYDRIACYL Ophthalmic Solution in patients
with hepatic and renal impairment have not
been established.
METHOD OF ADMINISTRATION
For topical ophthalmic use only.
After cap is removed, if tamper evident snap collar is loose, remove
before using product.
Nasolacrimal occlusion or gently closing the eyelid after
administration is recommended. This may reduce the
systemic absorption of medicinal products administered via