Optrex Bloodshot eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hamamelis water; Naphazoline hydrochloride

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

n/a

INN (International Name):

Hamamelis water; Naphazoline hydrochloride

Dosage:

125microlitre/1ml ; 100microgram/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11040200; GTIN: 0000050483488

Patient Information leaflet

CUSTOMER INFO:
Minimum Point Size =
250
BLOODSHOT EYE DROPS
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_Naphazoline Hydrochloride_
_Hamamelis Virginiana_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described
in this leaflet or as your doctor or pharmacist
has told you.
• Keep this leaflet. You might need to read it again.
• Ask your doctor or pharmacist if you need
more information or advice
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.
• You must talk to your doctor or pharmacist if
you do not feel better or feel worse after 2 days.
1. What Optrex Bloodshot Eye Drops is and
what it is used for
2. What you need to know before you use
Optrex Bloodshot Eye Drops
3. How to use Optrex Bloodshot Eye Drops
4. Possible side effects
5. How to store Optrex Bloodshot Eye Drops
6. Contents of the pack and other information
1. WHAT OPTREX BLOODSHOT EYE DROPS
IS AND WHAT IT IS USED FOR
Dusty, smoky atmospheres, eye strain and chlorine
in swimming pools can make the eyes red.
When the eyes are red it is because more
blood than usual is flowing through the small
blood vessels of the eye.
Optrex Bloodshot Eye Drops:
• are mildly astringent to temporarily
remove redness of the eye caused by
minor eye irritation.
• contain an active ingredient which restores
the normal flow of blood to remove redness.
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE OPTREX BLOODSHOT EYE DROPS
Optrex Bloodshot Eye Drops are
recommended for ADULTS and CHILDREN
OVER 12 YEARS
DO NOT USE THIS PRODUCT IF :
• you are sensitive to Hamamelis water,
naphazoline, or to any of the ingredients
listed in Section 6.
• you have GLAUCOMA, OTHER EYE DISEASE or
have had EYE SURGERY.
• You have taken monamine oxidase
inhibitors (MAOIs) in the last 14 days
(medicine used to treat conditions such as
depression).
WARNINGS AND PRECAUTIONS
Talk t

Summary of Product characteristics

OBJECT 1
OPTREX BLOODSHOT EYE DROPS
Summary of Product Characteristics Updated 22-Jan-2021 | Reckitt
Benckiser Healthcare (UK) Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Optrex Bloodshot Eye Drops
2. Qualitative and quantitative composition
Actives
Hamamelis water*
BPC
12.5% v/v
Naphazoline hydrochloride
EP
0.01% w/v
_(*Synonyms. Distilled witch hazel, Witch hazel)_
Excipients with known effect: Benzalkonium chloride
For full list of excipients, see Section 6.1.
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
POSOLOGY
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.
4.3 Contraindications
Hypersensitivity to hamamelis water, n