IOPIDINE 1%w/v Eye Drops, Solution

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Apraclonidine hydrochloride

Commercializzato da:

Novartis Ireland Limited

Codice ATC:

S01EA; S01EA03

INN (Nome Internazionale):

Apraclonidine hydrochloride

Dosaggio:

1 percent weight/volume

Forma farmaceutica:

Eye drops, solution

Tipo di ricetta:

Product subject to prescription which may not be renewed (A)

Area terapeutica:

Sympathomimetics in glaucoma therapy1); apraclonidine

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

1996-05-21

Foglio illustrativo

1
PACKAGE LEAFLET : INFORMATION FOR THE USER
IOPIDINE 1%W/V
EYE DROPS SOLUTION
(APRACLONIDINE HYDROCHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet
1.
What IOPIDINE is and what it is used for
2.
Before you are given IOPIDINE
3.
How IOPIDINE is given to you
4.
Possible side effects
5.
How IOPIDINE is stored
6.
Further information
IOPIDINE EYE DROPS WILL BE PUT IN BY YOUR DOCTOR. THIS LEAFLET IS
PROVIDED TO GIVE YOU
INFORMATION ON YOUR MEDICINE.
1.
WHAT IOPIDINE IS AND WHAT IT IS USED FOR
IOPIDINE eye drops contain apraclonidine which is used to control or
prevent the pressure in the eye
increasing after laser surgery.
2.
BEFORE YOU ARE GIVEN IOPIDINE
This medicine may not be suitable for you. If it is not suitable your
doctor may want to give you
another medicine so it is important you check all of the points below:
IOPIDINE WILL NOT BE USED
*
in children (this medicine is not for anyone under the age of 18);
** If you are
ALLERGIC
to clonidine, apraclonidine or any of the ingredients listed in the
“
OTHER
INGREDIENTS
” section of this leaflet (section 6)
*
if you have a history of any severe or unstable and uncontrolled heart
disease (including chest
pain, angina, heart attacks or heart failure);
*
if you are currently taking monoamine oxidase inhibitor
antidepressants
If you think any of the above conditions apply to you or if you are
not sure, talk to your doctor first.
SPECIAL CARE WILL BE TAKEN USING IOPIDINE.
ASK YOUR DOCTOR FOR ADVICE IF:
*
YOU SUFFER FROM, OR ARE TAKING MEDICATION FOR:
-
heart disease (including chest pain, angina, heart attacks or heart
failure;
-
high blood pressure;
-
circulatory problems (including stroke, Raynaud’s disease or
Buerger’s disease);
-
vasovagal attacks (fainting

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
IOPIDINE 1%w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Apraclonidine 1% w/v (10mg/ml)
(as hydrochloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
IOPIDINE 1% is a pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IOPIDINE 1% is indicated to control or prevent post surgical
elevations in intraocular pressure that occur in
patients after anterior segment laser surgery. (Clinical trials have
been conducted in trabeculoplasty, iridotomy and
capsulotomy).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical ophthalmic use only.
ADULTS (INCLUDING THE ELDERLY):
One drop of IOPIDINE 1% should be instilled into the eye scheduled for
operation one hour before initiating anterior
segment laser surgery.
A second drop should be instilled into the same eye immediately upon
completion of the laser
surgical procedure.
If for any reason, the drop of IOPIDINE 1% does not remain in the eye,
repeat the dose by placing another drop in the
eye.
Nasolacrimal occlusion or gently closing the eyelid after instillation
is recommended. This may reduce the systemic
absorption of medications administered via the ocular route and result
in a decrease in systemic side effects.
There are no special precautions for administration to the elderly.
PAEDIATRIC POPULATION
Safety and effectiveness of IOPIDINE in children have not been
established and therefore IOPIDINE 1% is not
recommended for use in children.
If more than one ophthalmic medicinal product is being used, the
medicines must be administered at least 5 minutes
apart. Eye ointments should be administered last.
4.3 CONTRAINDICATIONS
In patients with a history of severe or unstable and uncontrolled
cardiovascular disease.
For use in children,
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