MINIMS TROPICAMIDE 1.0% W/V EYE DROPS SOLUTION

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

TROPICAMIDE

Saatavilla:

Bausch & Lomb UK Limited

ATC-koodi:

S01FA06

INN (Kansainvälinen yleisnimi):

TROPICAMIDE

Annos:

1.0 % %w/v

Lääkemuoto:

Eye Drops Solution

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

tropicamide

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1987-11-01

Pakkausseloste

MINIMS® TROPICAMIDE 0.5% W/V
MINIMS® TROPICAMIDE 1% W/V
EYE DROPS, SOLUTION
TROPICAMIDE
IN THIS LEAFLET:
1. What Minims® Tropicamide eye drops are and what they are used for
2. Before you use your eye drops
3. How to use your eye drops
4. Possible side effects
5. How to store your eye drops
6. Further information
1.
WHAT MINIMS® TROPICAMIDE EYE DROPS ARE AND WHAT THEY ARE USED FOR
Minims® Tropicamide contains a mydriatic and cycloplegic agent. It is
used to enlarge the pupil of your eye and temporarily paralyse the
lens. Your doctor or eye specialist may use it to examine your eye.
2.
BEFORE YOU USE YOUR EYE DROPS
DO NOT USE THESE DROPS IF
•
you are allergic to the active substance (tropicamide) or any of the
other ingredients (refer to the end of this leaflet).
•
you have history of closed angle glaucoma with your eyes likely to
develop sudden increased internal pressure when the pupil is enlarged
Consult your doctor for advice; use of this product may cause:
-
Increase in the pressure of your eye. You should have your eye
pressure checked before initiation of therapy, especially in elderly.
TAKE SPECIAL CARE
Ask yourself the following questions:
•
Is this product to be used in a small child?
•
Are your eyes red or inflamed?
If the answer to any of these questions is yes, tell your doctor or
eye specialist.
IF YOU ARE PREGNANT, MAY BE PREGNANT, OR ARE BREASTFEEDING
Tell your doctor or eye specialist, he/she may decide to use these
drops or to prescribe you an alternative.
CONTACT LENSES
Your doctor will ask you to remove your contact lenses prior to the
administration of the drops. There is no information on the effect of
this
product on contact lenses. Therefore, do not wear your contact lenses
until the effects of the drops have completely worn off.
DRIVING AND USING MACHINES
Some people find bright light (such as daylight) uncomfortable for a
few hours after receiving Minims® Tropicamide. This may make it
difficult for you to drive.
As with all eye drops, your vision may be blurred after putting

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Tropicamide 1% w/v Eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution contains 1.0% w/v tropicamide. Each unit (0.5ml) contains
5mg tropicamide.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution. (eye drops)
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a topical mydriatic and cycloplegic.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults (including the elderly):_
1 drop followed by a second drop after an interval of 5 minutes. A
further 1 drop 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, or 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 on 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
drops via the naso-lacrimal duct to the wide
absorptive area of the nasal and pharyngeal mucosa. It is especially
advisable in children.)
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