IOPIDINE 1 %w/v Eye Drops Solution

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

APRACLONIDINE HYDROCHLORIDE

Доступна з:

Novartis Pharmaceuticals UK Ltd

Код атс:

S01EA03

ІПН (Міжнародна Ім'я):

APRACLONIDINE HYDROCHLORIDE

Дозування:

1 %w/v

Фармацевтична форма:

Eye Drops Solution

Тип рецепту:

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

Терапевтична области:

Sympathomimetics in glaucoma therapy

Статус Авторизація:

Authorised

Дата Авторизація:

2017-05-05

інформаційний буклет

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.
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.
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.
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
listedin 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
TAKE SPECIAL CARE:
•
Only use IOPIDINE for dropping in your eye(s).
2
•
IOPIDINE may not continue to control your eye pressure after you

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
IOPIDINE 1%w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains Apraclonidine 5 mg (as hydrochloride).
Excipients 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
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
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 are no special precautions for administration to the elderly.
_Paediatric Population_
The safety and efficacy of IOPIDINE in children has not been
established. No data are available.
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.
4.3 CONTRAINDICATIONS
Method of administration
For ocular use only.
After cap is removed, if tamper evident snap collar is loose, remove
before using product.
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