It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

ADVANZ Pharma

ADVANZ Pharma

Summary of Product Characteristics last updated on medicines.ie: 6/12/2013

Genticin Eye/Ear Drops Solution

1. NAME OF THE MEDICINAL PRODUCT

Genticin1 0.3% w/v Eye/Ear Drops, Solution.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Gentamicin Sulphate equivalent to 0.3% w/v gentamicin base.

Excipients: also conatins benzalkonium chloride 0.02% w/v.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Eye/Ear drops, solution.

A clear, colourless liquid.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Genticin eye/ear drops are indicated:

1. For the treatment of superficial eye and ear infections caused by organisms sensitive to gentamicin.

2. For prophylaxis against infection in trauma of the eye or ear.

4.2 Posology and method of administration

Adults, including the elderly and children

Eyes: 1 or 2 drops should be instilled in the affected eye up to six times a day, or more frequently if required. (Severe infections may require 1 or 2 drops every fifteen to twenty minutes initially, reducing the frequency of instillation gradually as the infection is controlled).

Ears: The area should be cleaned and 2 - 3 drops instilled in the affected ear three to four times a day and at night, or more frequently if required.

4.3 Contraindications

Hypersensitivity to gentamicin or to any of the ingredients. Known or suspected perforation of the ear drum is a contraindication to use in otitis externa only.

4.4 Special warnings and precautions for use

Long-term continuous topical therapy should be avoided. Prolonged use may lead to skin sensitisation and the emergence of resistant organisms. Cross sensitivity with other aminoglycoside antibiotics may occur.

In severe infections, topical use of gentamicin should be supplemented with appropriate systemic antibiotic treatment.

Gentamicin may cause irreversible partial or total deafness when given systemically or when applied topically to open wounds or damaged skin. This effect is dose-related and is enhanced by renal and/or hepatic impairment and is more likely in the elderly.

Topical application of aminoglycoside antibiotics into the middle ear carries a theoretical risk of causing hearing loss due to ototoxicity. The benefits of gentamicin therapy should be considered against the risk of infection itself causing hearing loss.

Contact lenses should be removed during the period of treatment of ocular infections.

For ocular use: Benzalkonium chloride may cause eye irritation. Avoid contact with soft lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses.

For ear use: benzalkonium chloride is an irritant and may cause skin reactions.

4.5 Interaction with other medicinal products and other forms of interaction

Concurrent use with other potentially nephrotoxic or ototoxic drugs should be avoided unless considered essential by the physician.

4.6 Fertility, pregnancy and lactation

Safety for use in pregnancy and lactation has not been established. Gentamicin should only be used in pregnancy or lactation when considered essential by the physician, after careful assessment of the potential risks and benefits.

4.7 Effects on ability to drive and use machines

Patients should be advised that the use of Genticin in the eye may cause transient blurring of vision. If affected, patients should not drive or operate machinery until vision has cleared.

4.8 Undesirable effects

Irritation, burning, stinging, itching and dermatitis may occur. In the event of irritation, sensitisation or super-infection, treatment should be discontinued and appropriate therapy instituted.

Very rarely, cases of dizziness, tinnitus, hypersensitivity and allergic reaction have been reported.

Gentamicin may cause nephrotoxicity when given systemically. However, it is likely that systemic absorption following topical administration does not constitute a comparable risk.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions preferably through the online reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via 'freepost', in addition to the traditional post-paid 'yellow card' option.

FREEPOST

Pharmacovigilance Section

Irish Medicines Board

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

4.9 Overdose

The oral ingestion of the contents of one bottle is unlikely to cause any significant adverse effect.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Gentamicin is a bactericidal antibiotic which acts by inhibiting protein synthesis.

5.2 Pharmacokinetic properties

Topical application of gentamicin can result in some systemic absorption. Treatment of large areas can result in plasma concentrations of up to 1µg/ml.

> 90% Gentamicin is excreted in the urine by glomerular filtration.

< 10% is bound to plasma protein.

T½ = 2 - 3 hours in individuals with normal kidney function, but can be increased in cases of renal insufficiency.

5.3 Preclinical safety data

Not relevant.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzalkonium chloride

Borax (E285)

Sodium chloride

Water, purified

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years. Discard contents 4 weeks after opening.

6.4 Special precautions for storage

Do not store above 25°C. Do not freeze.

6.5 Nature and contents of container

10ml opaque LDPE bottles with closures comprising polythene plug droppers and HDPE tamper evident caps.

6.6 Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORISATION HOLDER

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

8. MARKETING AUTHORISATION NUMBER(S)

PA 1142/13/2

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorization: 20 April 1995

Date of last renewal: 20 April 2010

10. DATE OF REVISION OF THE TEXT

September 2013

1 CRN 2123018; 22/07/2013

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.