Hypromellose Eye Drops BPC 0.3%

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HYPROMELLOSE

Available from:

Macarthys Laboratories Limited Bampton Road, Harold Hill, Romford Essex, RM3 8UG, United Kingdom

ATC code:

S01KA02

INN (International Name):

HYPROMELLOSE 3 mg/ml

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

HYPROMELLOSE 3 mg/ml

Prescription type:

OTC

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Withdrawn

Authorization date:

2007-07-09

Summary of Product characteristics

 
Page 1 of 3 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Hypromellose Eye Drops BPC 0.3% 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Hypromellose BP (4500) 

3. PHARMACEUTICAL 
FORM 

Eye drops, Solution 

4. 
CLINICAL PARTICULARS 

4.1. THERAPEUTIC 
INDICATIONS 

To provide tear-like lubrication for the symptomatic relief of
dry eyes and eye irritation 
associated with deficient tear production. 

As an ocular lubricant for artificial eyes. 

4.2. 
POSOLOGY AND METHOD OF ADMINISTRATION 

Adults, children and the elderly 

The dose depends on the need for lubrication.  Usually one or two
drops to each eye three 
times daily or as prescribed. 

4.3. CONTRA-INDICATIONS 

Hypersensitivity to any component. 
Contains benzalkonium chloride, soft contact should not be worn. 

4.4. 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

If irritation persists or worsens, or headache, eye pain,
vision changes or continuous redness 
occur, discontinue use and consult a physician. 

Pharmacogenetic problems 

None known. 

4.5. 
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF
INTERACTION 

None known. 

Page 2 of 3 
4.6. 
PREGNANCY AND LACTATION 

There is insufficient evidence of safety in pregnancy and this
product should, therefore, only 
be used in pregnancy if it is considered essential by the
physician. 

4.7. 
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 

May cause transient mild stinging or temporary blurring
of vision. 
Do not drive or operate machinery unless vision is clear. 

4.8. UNDESIRABLE 
EFFECTS 

May cause transient mild stinging or temporary blurring of
vision. 

4.9. OVERDOSE 

Not applicable. 

5. 
PHARMACOLOGICAL PROPERTIES 

5.1. PHARMACODYNAMIC 
PROPERTIES 

This product is a sterile, isotonic, buffered solution of
Hypromellose.  It is used a