Iopidine 5mg/ml Eye Drops Solution

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Tersedia dari:

Essential Pharma Ltd (Malta) Vision Exchange Building, Triq it-Territorjals, Zone Central Business District Birkirkara, CBD 1070, Malta

Kode ATC:

S01EA03

INN (Nama Internasional):

Apraclonidine 5 mg/ml

Bentuk farmasi:

EYE DROPS, SOLUTION

Komposisi:

Apraclonidine 5 mg/ml

Jenis Resep:

POM

Area terapi:

OPHTHALMOLOGICALS

Status otorisasi:

Authorised

Tanggal Otorisasi:

2018-09-26

Selebaran informasi

1
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
TAKE SPECIAL CARE:
●
Only use IOPIDINE for dropping in your eye(s).
●
IOPIDINE may not contin

Karakteristik produk

1
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 patients may benefit from treatment with IOPIDINE for longer
periods.
There ar