Iopidine 5 mg/ml Eye Drops, Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Apraclonidine hydrochloride

Available from:

Essential Pharma Limited

ATC code:

S01EA; S01EA03

INN (International Name):

Apraclonidine hydrochloride

Pharmaceutical form:

Eye drops, solution

Therapeutic area:

Sympathomimetics in glaucoma therapy1); apraclonidine

Authorization status:

Marketed

Authorization date:

1995-04-21

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
04 November 2022
CRN00CVV1
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Iopidine 5 mg/ml Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains Apraclonidine 5 mg (as hydrochloride).
Excipient(s) with known effect
1 ml of solution contains 0.1 mg benzalkonium chloride
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
A colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IOPIDINE 5 mg/ml is indicated for short‑term adjunctive therapy of
chronic glaucoma in patients on maximally tolerated
medical therapy who require additional intraocular pressure (IOP)
reduction to delay laser treatment or glaucoma surgery.
The IOP lowering efficacy of IOPIDINE diminishes over time in most
patients. Although some patients have received successful
treatment with IOPIDINE for longer periods, the benefit for most
patients is less than one month.
The addition of IOPIDINE to patients already using two aqueous
suppressing drugs (i.e. beta‑blockers plus carbonic anhydrase
inhibitor) as part of their maximally tolerated medical therapy may
not provide additional benefit. This is because IOPIDINE is
an aqueous suppressing drug and the addition of a third aqueous
suppressant may not significantly reduce IOP.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One drop of IOPIDINE should be instilled into the affected eye(s)
three times per day (t.i.d.). Since IOPIDINE will be used with
other ocular glaucoma therapies, an approximate five minute interval
between instillation of each medication should be
observed to prevent washout of the previous dose. Eye ointments should
be administered last. If, for any reason, the drop of
IOPIDINE does not remain in the eye, then the patient should repeat
the dose by placing another drop in the eye. The
maximum recommended duration of therapy is one month due to loss of
effect over time (tachyphylaxis). However, some
patie