For temporary relief of redness of the eye due to minor eye irritations.

Adults, children over 12 years and the elderly:
Gently squeeze one to two drops into the corner of each eye. No more than 4 times daily.
Children under 12 years:
Not recommended.
Method of Administration
For topical application to the eye.

Hypersensitivity to hamamelis water, naphazoline, or to any of the excipients listed in section 6.1. This product is contraindicated in persons suffering from closed-angle glaucoma. Do not take if you are suffering from serious eye disease or have had previous eye surgery. Do not use while taking monoamine oxidase inhibitors or within 14 days of stopping this medication (see section 4.5).

Not to be used by contact lens wearers whilst wearing lenses.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact
lenses. You should remove contact lenses before using this medicine and put them back 15 minutes
afterwards.
If you are being treated for high blood pressure, depression, heart disease, arteriosclerosis, diabetes or
increased thyroid activity consult your doctor before using the drops as naphazoline may exacerbate
vasoconstriction. For the same reason this product should not be used as a long term ocular irrigant.
Discard any eye drops remaining 28 days after opening the container.
Continued use of this product may increase redness of the eye.

Use of naphazoline in the eye may liberate pigment granules from the iris, especially when given in high
doses to elderly patients.
Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the
tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the
cornea may be compromised. Patients should be monitored in case of prolonged use.
If you experience eye pain, changes in vision or continued redness of the eye, or if the condition worsens or
persists for more than 24 hours consult a doctor.
If the solution changes colour or becomes cloudy do not use.

May interact with other topically applied autonomic drugs used in the treatment of glaucoma. May interact
with monoamine oxidase inhibitors and should not be used by patients receiving such treatment or within 14
days of ceasing therapy. May reverse the antihypertensive action of drugs used in the treatment of
hypertension. There may be an increased risk of arrhythmias in patients receiving cardiac glycosides,
quinidine or tricyclic antidepressants.

Pregnancy
Although the safety of Riazolin Red Eyes Eye Drops during pregnancy has not been established, it is
unlikely that sufficient of the active ingredients will reach the foetus to be harmful.
Breast Feeding
Although the safety of Riazolin Red Eyes Eye Drops during lactation has not been established, it is unlikely
that sufficient of the active ingredients will reach the breast-fed infant to be harmful.
Fertility
No known effects.

Do not drive or operate machinery if vision is blurred. Topical hamamelis water and naphazoline have no or
negligible other influence on the ability to drive and use machines

Adverse events which have been associated with hamamelis water and naphazoline hydrochloride are given
below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10);
Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1000); Very rare (<
1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping,
adverse events are presented in order of decreasing seriousness.

 

System Organ Class	Frequency	Adverse Events
Immune System Disorders	Not known	Hypersensitivity
Nervous System Disorders	Not known	Headache, dizziness
Eye Disorders	Not known	Eye irritation, eye pain, ocular hyperaemia1
Gastrointestinal Disorders	Not known	Nausea

Description of Selected Adverse Reactions
Following long term use a rebound secondary hyperaemia may occur

To report any side effects
- National Pharmacovigilance and Drug Safety Center (NPC)
o Fax: +966-11-205-7662
o To call the executive management of vigilance and crisis management: +966-11-2038222 ext.: 2353
– 2356 – 2317 – 2354 – 2334 – 2340
o Toll-free: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc
 

Symptoms
If applied in excessive quantities to the eye, it may give rise to irritation and stinging.
Excessive or long-term use of this product may result in allergic conjunctivitis, allergic blepharitis or
rebound conjunctival hyperaemia. Prolonged use may also lead to epithelial xerosis which can exacerbate
symptoms of irritation, pain and dryness experienced in allergic conjunctivitis.
Indiscriminate use of decongestants, such as naphazoline, in an irritated eye can induce papillary dilation and
precipitate angle-closure glaucoma in eyes that have narrow anterior chamber angles.
Overdosage by mouth may cause nausea, headache, depression of the central nervous system with marked
reduction of body temperature and symptoms of bradycardia, sweating, drowsiness and coma, particularly in
children. In addition, may cause hypertension followed by rebound hypotension.
There are no or limited data on overdose of topical hamamelis water, but risks are negligible.
Management
Treatment of adverse effects should be symptomatic and supportive

Pharmacotherapeutic group: Sensory Organs; Ophthalmologicals; Decongestants and Antiallergics;
Sympathomimetics Used as Decongestants.
ATC Code: S01GA51
Naphazoline is a sympathomimetic amine with pronounced alpha adrenergic activity and as a consequence
has vasoconstrictor activity.
Distilled witch hazel has astringent properties.

Although there are no specific pharmacokinetic properties for this product, systematic absorption of
naphazoline may take place following topical application.

There are no preclinical safety data of relevance to the consumer.

Sodium Chloride
Benzalkonium chloride solution
Water for injection

None known.

Unopened: 36 months. Opened: 1 month.

Store below 30°C.

15ml white LDPE bottle with polyethylene dropper insert and white polythylene cap having white
polyethylene plifer proof.

Do not use if the solution changes colour or becomes cloudy.