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Brolene 0.15% W/W Eye Ointment

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Brolene 0.15% w/w Eye Ointment

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Dibrompropamidine isetionate 0.15% w/w.

3.    PHARMACEUTICAL FORM

Ointment.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

Dibrompropamidine isetionate is an aromatic diamidine which is active against Gram-positive non-spore forming organisms, but less active against Gram-negative bacteria and spore forming organisms. It also has antifungal properties. It may be used topically for the treatment of minor eye infections such as conjunctivitis and blepharitis.

4.2.    Posology and Method of Administration

Adults, elderly persons and children: for the treatment of minor eye infections.

Apply topically once or twice daily. Medical advice should be obtained if there has been no significant improvement after two days.

4.3.    Contra-Indications

Hypersensitivity to dibrompropamidine or any component of the preparation.

4.4.    Special Warnings and Special Precautions For Use

If vision is disturbed or symptoms become worse during therapy, discontinue use and consult a physician.

If there is no significant improvement after two days’ therapy, discontinue use and consult a physician.

The eye ointment is unsuitable for use with hard contact lenses.

4.5.    Interaction with other Medicinal Products and other Forms of Interaction

None known.

4.6.    Pregnancy and Lactation

Safety of use in pregnancy and lactation has not been established. Use during pregnancy and lactation only if considered essential by a physician.

4.7.    Effects on Ability to Drive and Use Machines

Eye ointment will cause blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery unless vision is clear.

4.8.    Undesirable Effects

Hypersensitivity may occur, in which case treatment should be discontinued immediately.

4.9 Overdose

Topical overdose not applicable. Oral ingestion of a full 5g tube is unlikely to cause any toxic effects.

PHARMACOLOGICAL PROPERTIES

5.


5.1. Pharmacodynamic Properties

Dibrompropamidine is a member of the aromatic diamidine group of compounds which possess bacteriostatic properties against a wide range of fungi and bacteria. These diamidines exert antibacterial action against pyrogenic cocci, antibiotic resistant staphylococci and some Gram-negative bacilli. The activity of the diamidines is retained in the presence of organic matter such as pus and blood.

5.2. Pharmacokinetic Properties

No data available.

5.3. Pre-clinical Safety Data

No relevant data.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Paraffin, white soft Paraffin, liquid Wool fat Phenylethanol Water, purified

6.2. Incompatibilities

None known.

6.3


Shelf life

24 months. Use within 4 weeks of first opening

6.4. Special Precautions for Storage

Store below 25°C.

6.5. Nature and Content of Container

Printed, internally lacquered aluminium collapsible tubes with screw capped nozzle fitted with a polythene cap containing 5g ointment.

6.6. Instructions for Use, Handling and Disposal

No relevant instructions.

7 MARKETING AUTHORISATION HOLDER

Aventis Pharma Limited

Trading as Aventis Pharma or Rhone-Poulenc Rorer

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Or trading as:

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

8.    MARKETING AUTHORISATION NUMBER(S)

PL 04425/0198

9.    DATE OF FIRST AUTHORISATION / RENEWAL OF THE

AUTHORISATION

22 July 2002

10


DATE OF REVISION OF THE TEXT

24/02/2012