Minims Tropicamide

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Tropicamide 1%{relative};  

Dostupno od:

Bausch & Lomb (NZ) Ltd

INN (International ime):

Tropicamide 1% w/v

Doziranje:

1% w/v

Farmaceutski oblik:

Eye drops, solution

Sastav:

Active: Tropicamide 1%{relative}   Excipient: Hydrochloric acid Purified water Sodium hydroxide

Jedinice u paketu:

Single use dropper, 20 x 0.5mL, 10 mL

Razred:

Prescription

Tip recepta:

Prescription

Proizveden od:

Uquifa Mexico SA de CV

Terapijske indikacije:

Latest Regulatory Activity

Proizvod sažetak:

Package - Contents - Shelf Life: Single use dropper, 20 x 0.5mL - 10 mL - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Datum autorizacije:

1981-09-24

Uputa o lijeku

MINIMS
® TROPICAMIDE
_Tropicamide Eye Drops _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minims
Tropicamide, 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
Tropicamide 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
TROPICAMIDE IS USED
FOR
Minims Tropicamide belongs to a
class of medicines called
antimuscarinic agents. It is used to
enlarge the pupil of the eye and to
temporarily paralyse the lens so that
your doctor can examine your eye. 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
TROPICAMIDE
_WHEN YOU MUST NOT USE IT _
DO NOT USE MINIMS TROPICAMIDE IF
YOU HAVE AN ALLERGY TO:
*
any medicine containing
tropicamide
*
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 MINIMS TROPICAMIDE IF
YOU HAVE NARROW ANGLE GLAUCOMA
(HIGH PRESSURE IN THE EYE).
Tropicamide can increase the
pressure in the eye.
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 YOUR DOCTOR.
_BEFORE YOU START TO USE IT _
TELL YOUR DOCTOR IF YOU HAVE HAD AN
ALLERGY TO ANY OTHER MEDICINES,
FOOD

Svojstava lijeka

NEW ZEALAND DATA SHEET
1
MINIMS Tropicamide, eye drops solution 0.5% w/v
MINIMS Tropicamide, eye drops solution 1% w/v
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL unit contains 2.5 mg or 5 mg of Tropicamide.
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
As a topical mydriatic and cycloplegic.
4.2
Dose and method of administration
Adults (including the elderly):
1 drop followed by a second drop after an interval of 5 minutes. A
further 1drop may
be instilled after 30 minutes, if required.
Children:
At the discretion of the physician.
4.3
Contraindications
Do not use in patients with a known hypersensitivity to tropicamide.
Tropicamide
is
contraindicated
in
narrow
angle
glaucoma
and
in
eyes
where
the
filtration
angle
is
narrow,
as
an
acute
attack
of
angle
closure
glaucoma
may
be
precipitated.
4.4
Special warnings and precautions for use
Use with caution in an inflamed eye, as hyperaemia greatly increases
the rate of
systemic absorption through the conjunctiva.
Care should be exercised in small children.
Systemic absorption 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 the drops via the naso-lacrimal duct to the wide absorptive
area of the nasal
and pharyngeal mucosa. It is especially advisable in children.)
4.5
Interaction with other medicaments and other forms of interaction
None known.
NEW ZEALAND DATA SHEET
4.6
Fertility, pregnancy and lactation
There is no evidence as to the drug's safety in human pregnancy, nor
is there evidence
from animal work that it is free from hazard. This product should only
be used in
pregnancy if considered essential by the physician.
4.7
Effects on ability to drive and use machines
Patient warning: Patients who receive a mydriatic may suffer from
photophobia and this
may impair their ability to drive under certain circumstances.
4.8
Undesi