Minims Phenylephrine Hydrochloride

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Phenylephrine hydrochloride 10%;  ;  

Inapatikana kutoka:

Bausch & Lomb (NZ) Ltd

INN (Jina la Kimataifa):

Phenylephrine hydrochloride 10%

Kipimo:

10 %

Dawa fomu:

Eye drops, solution

Tungo:

Active: Phenylephrine hydrochloride 10%     Excipient: Disodium edetate dihydrate Sodium metabisulfite Water for injection

Vitengo katika mfuko:

Single use dropper, 0.5mL, 20 dose units

Darasa:

Prescription

Dawa ya aina:

Prescription

Viwandani na:

Siegfried PharmaChemikalien Minden GmbH

Bidhaa muhtasari:

Package - Contents - Shelf Life: Single use dropper, 0.5mL - 20 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Idhini ya tarehe:

1988-12-01

Taarifa za kipeperushi

MINIMS
®
PHENYLEPHRINE EYE DROPS
1
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 US

Tabia za bidhaa

NEW ZEALAND DATA SHEET
1
MINIMS Phenylephrine Hydrochloride, eye drops solution 2.5%
MINIMS Phenylephrine Hydrochloride, eye drops solution 10%
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL unit contains 12.5 mg or 50 mg Phenylephrine
hydrochloride.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Clear, colourless, single-use sterile eye drops.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Phenylephrine is a directly acting sympathomimetic agent used
topically in the eye as
a
mydriatic. It may be indicated to dilate the pupil in diagnostic or
therapeutic
procedures.
4.2
Dose and method of administration
Adults:
Apply one drop to each eye.
If necessary, this dose may be repeated once only, at
least
one hour after the first drop.
N.B.
The use of a drop of topical anaesthetic a few minutes before
instillation of
phenylephrine is recommended to prevent stinging.
Children and the elderly:
The use of phenylephrine 10% solution is contraindicated in these
groups because of
the
increased risks of systemic toxicity (see Section 4.3
Contraindications).
Phenylephrine 10% solution is contraindicated in children aged below
12 years.
There are no data in children aged 12 to 18 years. Phenylephrine 10%
solution is not
recommended in these patients.
Apply one drop of the 2.5% w/v solution topically to the eye. It is
not usually
necessary to
exceed this dose.
4.3
Contraindications
Patients with cardiac disease, hypertension, aneurysms,
thyrotoxicosis, long-
standing
insulin dependent diabetes mellitus and tachycardia.
Patients
on
monoamine
oxidase
inhibitors,
tricyclic
anti-depressants
and
anti-
hypertensive agents (including beta-blockers).
Patients with closed angle glaucoma (unless previously treated with
iridectomy) and
patients with a narrow angle prone to glaucoma precipitated by
mydriatics.
Phenylephrine 10% solution is contraindicated in children aged below
12 years and
NEW ZEALAND DATA SHEET
elderly.
Hypersensitivity to phenylephrine or any component of the preparation.
4.4
Special warnin