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OPTREX BLOODSHOT EYE DROPS

Active substance(s): HAMAMELIS WATER / NAPHAZOLINE HYDROCHLORIDE / HAMAMELIS WATER / NAPHAZOLINE HYDROCHLORIDE / HAMAMELIS WATER / NAPHAZOLINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Optrex Bloodshot Eye Drops

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Actives
Hamamelis water*
Naphazoline hydrochloride

BPC
EP

12.5% v/v
0.01% w/v

(*Synonyms. Distilled witch hazel, Witch hazel)

3.

PHARMACEUTICAL FORM
Eye drops

4.

CLINICAL PARTICULARS

4.1.

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

4.2.

Posology and Method of Administration
For topical application to the eye.
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.

4.3.

Contra-Indications

Hypersensitivity to any of the ingredients. Persons suffering from glaucoma,
serious eye diseases or who have had previous eye surgery.

4.4.

Special Warnings and Special Precautions for Use
Not to be used by contact lens wearers whilst wearing lenses.
If you are being treated for high blood pressure, depression, heart disease,
diabetes or increased thyroid activity consult your doctor before using the
drops.
Discard any eye drops remaining 28 days after opening the container.
Continued use of this product may increase redness of the eye.
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 you have any eye disease, suffer from glaucoma or have had eye surgery, do
not use this product except under the advice and supervision of a doctor.
If the solution changes colour or becomes cloudy do not use.

4.5.

Interaction with other Medicinal Products and other Forms of Interaction
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.

4.6.

Pregnancy and Lactation
Although the safety of Optrex Red Eyes Eye Drops during pregnancy and
lactation has not been established, it is unlikely that sufficient of the active
ingredients will reach the foetus or the breast-fed infant to be harmful.

4.7.

Effects on Ability to Drive and Use Machines
Not applicable.

4.8.

Undesirable Effects
Transient irritation and stinging may occur. Following long term use a
rebound secondary hyperaemia may occur.

4.9.

Overdose
If applied in excessive quantities to the eye, it may give rise to irritation and
stinging. 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. Treatment of adverse effects should be symptomatic and
supportive.

5.

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic Properties
Naphazoline is a sympathomimetic amine with pronounced alpha adrenergic
activity and as a consequence has vasoconstrictor activity.
Distilled witch hazel has astringent properties.

5.2.

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

5.3.

Pre-clinical Safety Data
There are no preclinical safety data of relevance to the consumer.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Glycerin
Boric acid
Borax
Disodium edetate
Benzalkonium chloride
Purified water

6.2.

Incompatibilities
Not applicable.

6.3.

Shelf-Life
a) Unopened:
b) After first opening:

6.4.

24 months.
28 days.

Special Precautions for Storage
Store below 25°C.
Do not freeze.

6.5.

Nature and Contents of Container
A pigmented high density/low density polythene bottle having a polythene
plug and wadless high density polyethylene tamper evident cap. Pack size is
10ml.

6.6.

Instructions for Use, Handling and Disposal
None.

7.

MARKETING AUTHORISATION HOLDER
Optrex Limited

103-105 Bath Road
Slough
SL1 3UH

8.

MARKETING AUTHORISATION NUMBER(S)
PL 00062/0024

9.
DATE OF FIRST AUTHORISATION / RENEWAL OF
AUTHORISATION
11 April 1978 / 08 July 1997

10

DATE OF REVISION OF THE TEXT
05/06/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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