IOPIDINE 1%w/v Eye Drops, Solution

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Apraclonidine hydrochloride

Verfügbar ab:

Essential Pharma Limited

ATC-Code:

S01EA; S01EA03

INN (Internationale Bezeichnung):

Apraclonidine hydrochloride

Darreichungsform:

Eye drops, solution

Therapiebereich:

Sympathomimetics in glaucoma therapy1); apraclonidine

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

1996-05-21

Gebrauchsinformation

1 Iop5mgpermlED-PL-IE-MT-2
PACKAGE LEAFLET - INFORMATION FOR THE USER
IOPIDINE
®
5 MG/ML EYE DROPS, SOLUTION
APRACLONIDINE (AS HYDROCHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
●
KEEP THIS LEAFLET.
You may need to read it again.
●
IF YOU HAVE ANY FURTHER QUESTIONS
, ask your doctor or your pharmacist.
●
This medicine has been prescribed for you only.
DO NOT PASS IT ON TO OTHERS.
It may harm
them, even if their signs of illness are the same as yours.
●
IF YOU GET ANY SIDE EFFECTS
talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT IOPIDINE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IOPIDINE
3.
HOW TO USE IOPIDINE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE IOPIDINE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT IOPIDINE IS AND WHAT IT IS USED FOR
IOPIDINE
5mg/ml Eye drops, solution contain apraclonidine (as hydrochloride) as
the active
substance.
IOPIDINE
belongs to a group of medicines known as alpha agonists.
IT IS USED IN THE TREATMENT
OF
chronic glaucoma in people who are already receiving other
medicines to treat this disease.
In these people, IOPIDINE helps to reduce the fluid pressure in the
eye and can delay the
need for pressure relieving eye surgery.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE IOPIDINE
DO NOT USE IOPIDINE:
●
if you have a history of
SEVERE
or unstable
HEART DISEASE
or
CIRCULATORY PROBLEMS.
●
if you are
ALLERGIC
to apraclonidine, clonidine or any of the other ingredients of this
medicine listed in section 6
●
if you are currently taking monoamine oxidase inhibitors
antidepressants or tricycylic
antidepressants
●
if you are currently taking medicines of the class of sympathomimetics
that are taken either
orally or via injection
●
in
CHILDREN
Ask your doctor for advice.
WARNINGS AND PRECAUTIONS
2 Iop5mgpermlED-PL-IE-MT-2
TAKE SPECIAL CARE:
●
Only use IOPIDINE for dr

Fachinformation

Health Products Regulatory Authority
04 November 2022
CRN00CVV1
Page 1 of 6
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.
In patients receiving monoamine oxidase inhibitor therapy, systemic
sympathomimetic agents, tricyclic antidepress