SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Cicatrin Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

NEOMYCIN SULPHATE EP 330,000 units per gram BACITRACIN ZINC BP    25,000 units per gram

GLYCINE BP    1.0%    w/w

L-CYSTEINE    0.2%    w/w

DL-THREONINE USP    0.1%    w/w

3    PHARMACEUTICAL FORM

Cream

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Topical broad-spectrum antibacterial. Superficial bacterial infection of the skin, such as

impetigo, varicose ulcers, pressure sores, trophic ulcers and burns.

4.2 Posology and method of administration

Administration and dosage in adults

Before use, the area for application should be cleaned gently. Debris such as pus or crusts should be removed from the affected area.

A thin film of the cream should be applied to the affected area up to three times/day, depending on the clinical condition. Treatment should not be continued for more than seven days without medical supervision (see Precautions and Warnings).

Dosage in children

Cicatrin Cream is suitable for use in children (2 years and over) at the same dose as adults. A possibility of increased absorption exists in very young children, thus Cicatrin Cream is not recommended for use in neonates and infants (< 2 years) (see 4.3 Contra-indications and 4.4 Special Warnings and Special Precautions for Use).

Dosage in the elderly

No specific studies have been carried out in the elderly however, Cicatrin cream is suitable for use in the elderly. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulphate may occur (See dosage in Renal Impairment and Precautions and Warnings).

Dosage in renal impairment

Dosage should be reduced in patients with reduced renal function (see Precautions and Warnings).

Route of Administration Topical

4.3 Contraindications

The use of Cicatrin Cream is contra-indicated in patients who have demonstrated allergic hypersensitivity to the product or any of its constituents, or to cross-sensitising substances such as framycetin, kanamycin, gentamicin and other related antibiotics.

Due to known ototoxic and nephrotoxic potential of neomycin sulphate, the use of Cicatrin Cream in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption could occur.

A possibility of increased absorption exists in very young children, therefore Cicatrin Cream is not recommended for use in neonates and infants (up to 2 years). In neonates and infants, absorption by immature skin may be enhanced, and renal function may be immature.

The presence of pre-existing nerve deafness is a contra-indication to the use of Cicatrin Cream in circumstances in which significant systemic absorption could occur.

Cicatrin Cream should not be applied to the eyes

4.4 Special warnings and precautions for use

Caution should be exercised so that the recommended dosage is not exceeded (see Dosage and Administration and Contra-indications).

Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity (and exacerbate existing partial nerve deafness); both neomycin sulphate and bacitracin zinc have nephrotoxic potential.

After a treatment course, administration should not be repeated for at least three months.

In neonates and infants, absorption by immature skin may be enhanced and renal function may be immature (see Contra-indications).

In renal impairment the plasma clearance of neomycin is reduced, this is associated with an

increased risk of ototoxicity; therefore, a reduction in dose should be made that relates to

the degree of renal impairment.

As with other antibacterial preparations, prolonged use may result in overgrowth by non-susceptible organisms, including fungi.

Concurrent administration of other aminoglycosides is not recommended.

4.5 Interaction with other medicinal products and other forms of interaction

Following significant systemic absorption, neomycin sulphate can intensify and prolong the respiratory depressant effect of neuromuscular blocking agents.

Pregnancy

There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy and lactation, therefore the use of Cicatrin is not recommended.

Lactation

No information is available regarding the excretion of the active ingredients in human milk.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

The incidence of allergic hypersensitivity to neomycin sulphate in the general population is low. However, there is an increased incidence of sensitivity to neomycin in certain selected groups of patients in dermatological practice, particularly those with venous stasis eczema and ulceration.

Allergic hypersensitivity to neomycin following topical application may manifest itself as a reddening and scaling of the affected skin, as an eczematous exacerbation of the lesion, or as a failure of the lesion to heal.

Allergic hypersensitivity following topical application of bacitracin zinc has been reported but is rare.

Anaphylactic reactions following the topical administration of bacitracin zinc have been reported but are rare.

4.9 Overdose

Symptoms and signs

No specific symptoms or signs have been associated with excessive use of Cicatrin Cream. However, consideration should be given to significant systemic absorption (see Precautions and Warnings).

Management

Use of the product should be stopped and the patient's general status, hearing acuity, renal and neuromuscular functions should be monitored. Blood levels of neomycin sulphate and bacitracin zinc should be determined, and haemodialysis may reduce the serum level of neomycin sulphate.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Not available.

5.2    Pharmacokinetic properties

Not applicable.

5.3    Preclinical safety data

A.    Mutagenicity

There is insufficient information available to determine whether the active ingredients have mutagenic potential.

B.    Carcinogenicity

There is insufficient information available to determine whether the active ingredients have carcinogenic potential.

C.    Teratogenicity

There is insufficient information available to determine whether the active ingredients have teratogenic potential.

Neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of foetal ototoxicity.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sorbitan Trioleate Wool Alcohols Macrogol (4) Lauryl Ether Liquid Paraffin Polysorbate 85 Hard Paraffin White Soft Paraffin

6.2 Incompatibilities

CICATRIN Cream should not be diluted.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Store below 25 °C.

6.5 Nature and contents of container

Internally lacquered aluminium collapsible tubes with polypropylene screw caps.

Pack Size: 15g and 30g

6.6 Special precautions for disposal

No special instructions.

7 MARKETING AUTHORISATION HOLDER

The Wellcome Foundation Ltd

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as

GlaxoSmithKline UK Stockley Park West Uxbridge

Middlesex UB11 1BT

8    MARKETING AUTHORISATION NUMBER(S)

PL 00003/5082R

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

10/12/2008

10 DATE OF REVISION OF THE TEXT

08/01/2013