MINIMS PHENYLEPHRINE HYDROCHLORIDE 10% 100mg/mL Eye Drops tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

phenylephrine hydrochloride, Quantity: 100 mg/mL

Available from:

Bausch & Lomb Australia Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: sodium metabisulfite; disodium edetate; purified water

Administration route:

Ophthalmic

Units in package:

20 X 0.5mL

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Phenylephrine is a directly acting sympathomimetic agent used topically in the eye as a mydriatic. Minims Phenylephrine Hydrochloride Eye Drops are indicated to dilate the pupil for diagnostic or therapeutic procedures.

Product summary:

Visual Identification: A clear, colourless solution, reasonably free from visible particulate matter; Container Type: Tube; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1991-10-30

Patient Information leaflet

MINIMS
® PHENYLEPHRINE
EYE DROPS
_Phenylephrine Hydrochloride Eye Drops_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minims
Phenylephrine Eye Drops, including
how to use the eye drops.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you using Minims
Phenylephrine Eye Drops against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MINIMS
PHENYLEPHRINE EYE
DROPS IS USED FOR
Minims Phenylephrine Eye Drops
belongs to a class of medicines called
sympathomimetic agents. It is used to
dilate (enlarge) the pupil of the
eye so that your doctor can examine
your eye(s). It is usually used at the
beginning of an eye examination.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED TO YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU USE
MINIMS PHENYLEPHRINE
EYE DROPS
_WHEN YOU MUST NOT USE IT_
DO NOT USE MINIMS PHENYLEPHRINE
EYE DROPS IF YOU HAVE AN ALLERGY
TO:
•
Any medicine containing
Phenylephrine
•
Any of the ingredients listed at
the end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
Shortness of breath
•
Wheezing or difficulty
breathing
•
Swelling of the face, lips,
tongue or other parts of the
body
•
Rash, itching or hives on the
skin
DO NOT USE THE 10% STRENGTH OF
MINIMS PHENYLEPHRINE EYE DROPS
IN CHILDREN OR THE ELDERLY.
Children and the elderly may be
more susceptible to the effects of
phenylephrine.
DO NOT USE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START USING THIS MEDICINE,
TALK TO

Summary of Product characteristics

Minims Phenylephrine PI-A20210127 v6
Page 1 of 7 AUSTRALIAN PRODUCT INFORMATION – MINIMS PHENYLEPHRINE
(PHENYLEPHRINE HYDROCHLORIDE) EYE DROPS
1
NAME OF THE MEDICINE
Phenylephrine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minims Phenylephrine Eye Drops containing phenylephrine hydrochloride
2.5% w/v (25 mg/mL)
or 10% w/v (100 mg/mL). No preservatives are contained in the
formulation.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
A single-use eye drops, solution.
Minims Phenylephrine are clear, colourless sterile solutions,
reasonable free from visible particulate
matter.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Phenylephrine is a directly acting sympathomimetic agent used
topically in the eye as a mydriatic.
Minims Phenylephrine Hydrochloride Eye Drops are indicated to dilate
the pupil for diagnostic or
therapeutic procedures.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The use of a drop of topical anaesthetic a few minutes before
instillation of Minims Phenylephrine
Eye Drops is recommended to prevent stinging.
Adults
Instil one drop topically to each eye. If necessary, this dose may be
repeated once only, at least one
hour after the first drop.
Children and the elderly
Instil one drop of the 2.5% solution topically to the eye. It is not
usually necessary to exceed this dose.
The use of phenylephrine 10% is contraindicated in children (see
Sections 4.3 Contraindications and
4.4 Special warnings and precautions for use – Paediatric use) and
the elderly because of the
increased risks of systemic toxicity.
Systemic absorption of phenylephrine may be reduced by compressing the
lacrimal sac at the medial
canthus for a minute during and following the instillation of the
drops. (This blocks the passage of
Minims Phenylephrine PI-A20210127 v6
Page 2 of 7
the drops via the naso-lacrimal duct to the wide absorptive area of
the nasal and pharyngeal mucosa.
It is especially advisable in children.)
Each Minims Phenylephrine Eye Drops unit should be discard