Optizolin is indicated for use as a topical ocular decongestant and vasoconstrictor for relief from
irritant conjunctivitis; allergic or inflammatory conditions of the conjunctiva.

Optizolin is to be used only as eye drops. Instill 1-2 drops into the affected eye (s) up to 4 times daily;
in acute cases 1 drop every three hours or as directed by the physician.
Instructions for using eye drops
 Unscrew the cap from the bottle, check the dropper is clean.
 Pull your lower eyelid gently down, and then carefully instil 1-2 drop inside the lower eyelid,
in the corner closest to the nose.
 Release the lower eyelid, and blink a few times to make sure the eye is covered by the liquid.
 Repeat the procedure for your other eye.
 When you have finished, replace the protective cap tightly to prevent spilling or spoilage.

If you know that you have had a reaction to any of its ingredients or to any of the excipients listed in section 6.1.  If you have a condition called narrow angle glaucoma.  Soft contact lenses  If you are taking furazolidone or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days.

Like other topically applied ophthalmic drugs, Optizolin may be absorbed systemically
and occasionally cause systemic sympathomimetic effects such as hypertension,
nervousness, nausea, dizziness, headache, insomnia, palpitation, tachycardia, and
arrhythmia. Optizolin should be used with caution in elderly patients with severe
cardiovascular disease, including arrhythmia, poorly controlled hypertension, or diabetes.
Use with caution in the presence of hypertension, cardiac irregularities, hyperthyroidism
diabetes mellitus or phaeochromocytomas.
Optizolin should also be used with caution in patients with conditions causing urinary
retention such as prostatic hypertrophy and should also be used in caution in patients who
are currently receiving other sympathomimetic drugs Not suitable for patients suffering
from dry eyes without first seeking medical advice. Rebound hyperaemia may follow
prolonged frequent use. Optizolin should not be used without supervision over a long
period of time.
If the symptoms do not improve after 2 days, medical advice should be sought to rule out
the possibility of a bacterial infection. Inflammation arising from infection should receive
appropriate anti-bacterial therapy.
Eye drops are not for injection. They should never be injected subconjunctivally, nor
should they be directly introduced into the anterior chamber of the eye.

Sympathomimetic agents may cause a hypertensive crisis if used during treatment with
MAOls. Concomitant use with MAOIs is therefore contraindicated (see section
CONTRAINDICATIONS).
Sedating anti-histamines can enhance the sedating effects of CNS depressants including
alcohol, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics.
They also have an additive anti-muscarinic action with other ant muscarinic drugs, such as
atropine and some antidepressants (both tricyclic and MAOIs). As systemic absorption of
Antazoline is possible, caution should be exercised when using Optizolin concomitantly
with these medicinal products

In line with common practice, the use of medication during pregnancy is not recommended unless
considered essential.
It is not known whether the active ingredients are distributed in human milk. It should therefore not
be administered to nursing mothers or breast feeding should be interrupted for 48 hours after
administration.

All eye drops can cause a short term blurring of vision when first used so you should wait until
your eyes are clear before driving or using machines.

Like all medicines, Optizolin can cause side effects, although not everybody gets them.
Sometimes people notice that the drops make their eyes sting. Very occasionally people have noticed
that their red eyes get worse, or that they have blurred vision, headache, drowsiness or enlarged
pupils. Allergic reactions have been reported causing rash, swelling and itching of the eye area and
eye irritation. Certain sensitive people have experienced changes in heart beat rhythm, raised blood
pressure, sleeplessness, nausea, pallor and sweating. These effects are often mild. If they are severe or
last for more than a few days, or if you notice anything else not mentioned here, please go and see
your doctor.

To report any side effect(s):
Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662.
Call NPC at +966-11-2038222,
Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Other GCC States:
Please contact the relevant competent authority.

 

It is unlikely to cause you any harm. If you have placed too many drops in your eye(s), wash
your eyes with clean water. Put your next dose at the usual time. It should not be used for
more than 7 consecutive days without talking to your doctor or pharmacist, as this may cause
the itching, redness and/or swelling of the eyes or eyelids returns. Using too much
Optizolin™, or using it for too long, or too often, can cause serious side effects, especially in
children.
 If you accidentally swallow the eye drops consult a doctor

Optizolin is a combination of a long acting vasoconstrictor, Tetrahydrozoline HCl and an
Antihistamine, Antazoline HCl. ATC Code: R01AC04
Optizolin is a sterile solution which combines the properties of an antiallergic and decongestant. The
antihistamine Antazoline exerts antiallergic activity by competitive reversible blockade of the
H1 receptor sites on tissues, It reduces the effects of the histamine released in the tissue by
counteracting the increase in vascular permeability and expansion of the capillaries. Tetrahydrozoline
hydrochloride is a sympathomimetic agent with alpha adrenergic activity and is useful as a conjunctival decongestant. It acts as a local vasoconstrictor reducing the swelling and congestion in
the mucous membranes of the conjunctiva.

No formal studies have been conducted.

There are no other clinically relevant preclinical safety data in addition to those mentioned in other
sections of the SmPC.

Benzalkonium Chloride
Sodium Chloride
Hydroxypropylmethylcellulose
Hydrochloric acid 1N (QS to adj. pH)
Water for Injection

Not Applicable.

Unopening: 2 Years After First opining: Discard after 30 days of opening

Do not store above 30°C.
Keep out of the reach and sight of children.

10 ml of Optizolin Ophthalmic Solution filled in LDPE opaque bottles, LDPE nozzle with HDPE Cap
and packed in carton with PIL.

No special requirements.