MINIMS ROSE BENGAL 1.0 %w/v Eye Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ROSE BENGAL

Available from:

Chauvin Pharmaceuticals Limited

INN (International Name):

ROSE BENGAL

Dosage:

1.0 %w/v

Pharmaceutical form:

Eye Drops Solution

Authorization status:

Withdrawn

Authorization date:

2008-01-01

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minims Rose Bengal
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1% w/v solution of rose bengal
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Single-use, sterile eye drops solution.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
As a diagnostic stain.
Rose bengal solution stains degenerated conjunctival and
corneal epithelial cells. It is particularly useful in 
demonstrating these changes in Sjögren’s syndrome, where lack
of tears has caused damage.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
_Adults (including the elderly) and Children:_
One or two drops, as required.
4.3 CONTRAINDICATIONS
Rose bengal can produce severe stinging in dry eyes,
where it should be used with care.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Rose bengal should not be instilled into the eye when
the patient is wearing contact lenses.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 
None known.
4.6 PREGNANCY AND LACTATION
The use of rose bengal over the last 15 years has not shown
any adverse effects. In the absence of any teratology 
studies, however, rose bengal is not recommended in pregnancy
unless the therapeutic benefit exceeds the potential 
risk.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 12/10/2005_
_CRN 2015555_
_page number: 1_
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
May cause transient blurring of vision on instillation. Warn
patients not to drive or operate hazardous machinery until 
vision is clear.
4.8 UNDESIRABLE EFFECTS
Rose bengal may discolour the eye lids and/or conjunctiva.
4.9 OVERDOSE
As Minims are single-dose units, overdose is unlikely to occur.
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
Not