Iopidine 5mg/ml eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Apraclonidine hydrochloride

Available from:

Essential Pharma Ltd

ATC code:

S01EA03

INN (International Name):

Apraclonidine hydrochloride

Dosage:

5mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11080200; GTIN: 5015664011793

Patient Information leaflet

IOPIDINE
®
5 mg/ml eye drops, solution
Apraclonidine (as hydrochloride)
Package Leaflet - Information for the User
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.
1. What IOPIDINE is and what it is
used for
2. Before you use IOPIDINE
3. How to use IOPIDINE
4. Possible side effects
5. How to store IOPIDINE
6. Further information
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 ingredients 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 under 12 years of age.
Ask your doctor for advice.
Take special care...
• Only use IOPIDINE for dropping in your eye(s).
• IOPIDINE may not continue to control your eye
pressure after you have used them for a period of
time. Your doctor will examine you often while you
are using IOPIDINE to see whether the eye drops
are still working for you.
• As IOPIDINE decreases the pressure in your
eye(s), you should have your eye pressure
checked regularly to ensure that the pressure in
your eye(s) remains under control.
If you have a history of, or are taking medicine
to treat, any of the following:
• Any heart disease (including angina, heart
attacks or heart failure)
• High blood pressure or other circulatory
problems (including stroke, Raynaud’s disease
and fainting spells)
• Kidney or liver problems
• Depression
• Parkinson’s disease
• Diabetes or low blood sugar. IOPIDINE may
hide the signs and symptoms of a sudden
reduction in blood sugar such as a fast hear

Summary of Product characteristics

OBJECT 1
IOPIDINE 5MG/ML EYE DROPS, SOLUTION
Summary of Product Characteristics Updated 07-Jun-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
IOPIDINE 5mg/ml 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.
A colourless to pale yellow solution.
4. Clinical particulars
4.1 Therapeutic indications
IOPIDINE 5mg/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)