MEDICAL AND COSMETIC PRODUCTS COMPANY (M.C.P.C.) P.O. Box 442, Riyadh 11411 3rd Industrial Zone Riyadh, Exit 14 Kingdom of Saudi Arabia.

RIYADH PHARMA

COMPOSITION: Sterile Eye /Ear Drops: Each ml contains Gentamicin Sulphate (Ph Eur) equivalent to 3 mg of Gentamicin, Benzalkonium Chloride Solution 0.2 mg (preservative) Other excipients: sodium chloride, sodium phosphate, disodium phosphate dihydrate, disodium edetate and water for injection.

CLINICAL PHARMACOLOGY: Gentamicin, an aminoglycoside, is bactericidal against a wide variety of pathogenic gram-negative and some gram-positive bacteria. It acts by inhibiting protein synthesis.

PHARMACOKINETIC PROPETIES: Gentamicin is not readily absorbed from the gastro-intestinal tract. Gentamicin is 70-85% bound to plasma albumin following administration and is excreted 90% unchanged in urine. The half-life for its elimination in normal patients is 2 to 3 hours. Effective plasma concentration is 4 - 8ug/ml The volume of distribution ( VD) is 0.3 1/kg The elimination rate constant is; 0.02 Hr- ' for anuric patients* 0.30 H(' normal * Therefore in those with anuria care must be exercised.

INDICATIONS: GENTACIN is indicated in the topical treatment of infections caused by susceptible bacteria of the external structures of the eyes and their adnexa, such as conjunctivitis, keratitis and keratoconjunctivitis, corneal ulcers, blepharitis and blepharoconjunctivitis, acute melbomianitis and dacryocystitis. Also to be used for the prevention of ocular infection after removal of a corneal or conjunctival foreign body following trauma due to physical or chemical agents and before and after ocular surgery. GENTACIN may also be used for the topical treatment of otitis externa caused by susceptible bacteria.

CONTRAINDICATIONS: Gentamicin is contraindicated in patients with known hypersensitivity to any of its components. It is also contraindicated in patients with disrupted tympanic membranes. Evidence exists that gentamicin may cause neuromuscular blockade and is therefore contra-indicated in myasthenia gravis and related conditions.

INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION: - Potent diuretics such as ethacrynic acid and frusemide are believed to enhance any risk of ototoxicity

whilst amphotericin B, cisplatin and cyclosporine and cephalosporins are potential enhancers of nephrotoxicity.

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

- Neuromuscular blockade and respiratory paralysis have been reported in patients from the administration of aminoglycosides to patients who have received curare-type muscle relaxants during anaesthesia.

MEDICAL AND COSMETIC PRODUCTS COMPANY (M.C.P.C.) P.O. Box 442, Riyadh 11411 3rd Industrial Zone Riyadh, Exit 14 Kingdom of Saudi Arabia.

RIYADH PHARMA

PRECAUTIONS: When Gentamicin is used locally in the ear, potential eighth cranial nerve toxicity should be considered. Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible microorganisms and fungi. If this occurs or if irritation or hypersensitivity to Gentamicin develops, discontinue the use and institute appropriate therapy. To avoid contamination and cross-infection, avoid the use of the same bottle of medication for the treatment of otic and ocular infections. This effect is dose-related and is enhanced by renal an/or hepatic impairment and is more likely in the elderly. Irreversible toxic effects may result from direct contact of gentamicin with the middle and inner ear. The benefits of gentamicin therapy should be considered against the risk of infection itself causing hearing loss. Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have been occurred in patients receiving systemic gentamicin therapy. Although these effects have not been reported following topical otic use of gentamicin, caution is advised when used concomitantly with systemic aminoglycosides.

EFFECTS ON ABILITY TO DRIVE AND USING MACHINES: Patients should be advised that the use of gentamicin in the eye may cause transient blurring of vision. If affected, patients should not drive or operate machinery until vision has cleared.

WARNING: The product should not be used while wearing contact lenses, contact lens wearers should remove the contact lenses before the instillation and replace them 15 minutes after the instillation.

ADVERSE REACTIONS: 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.

OVREDOSE: Haemodialysis and peritoneal dialysis will aid the removal from blood but the former is probably more efficient. Calcium salts given intravenously have been used to counter the neuromuscular blockade caused by gentamicin.

USE DURING PREGNANCY AND LACTATION: Safety in pregnant women has not been established. Caution should be exercised when Gentamicin is administered to a nursing woman, since it is unknown whether the components excreted in human milk.

DOSAGE: Eye Drops: Instill 1 or 2 drops into the affected eye(s) every 4 hours. In severe infections, dosage may be increased to as much as 2 drops once every hour. Ear Drops: Thoroughly clean the ear canal of debris. The initial dosage is 3 or 4 drops 2-4 times a day. The patient should lie with the affected ear turned upward; instill the solution and remain in this position for several minutes to insure penetration of the medication into the ear canal. STORAGE: Store below 25 °C. Once the pack has been opened, the contents should be used within 1 month. Do not use the drug after the expiry date printed on the package.

PRESENTATION: Sterile Eye/Ear Drops: 8 ml or 10 ml dropper bottle.

MEDICAL AND COSMETIC PRODUCTS COMPANY (M.C.P.C.) P.O. Box 442, Riyadh 11411 3 rd Industrial Zone Riyadh, Exit 14 Kingdom of Saudi Arabia.

RIYADH PHARMA

Marketing Authorisation Holder and Manufacturer Medical and Cosmetic Products Company Ltd. (Riyadh Pharma) P.O.Box 442, Riyadh 11411 Fax: +966 11 265 0505 Email: contact©riyadhpharma.com For any information about this medicinal product, please contact the local representative of marketing authorisation holder: Saudi Arabia Marketing department Riyadh Tel: +966 11 265 0111 Email: marketing©riyadhpharma.com

For External Use Only

To Report Any Side Effect(s) or Quality Problems:

National Pharmacovigilance Center (NPC)— o Fax :+966-11-205-7662 o E-mail: npc.drug@sfda.gov.sa o website: www.sfda.gov .sainpc

This is a medicament

• A medicament is a product, which affects your health, and its consumption contrary to instructions is dangerous for you.

• Follow strictly the doctor's prescription, the method of use and the instructions of the pharmacist who sold the medicament.

• The doctor and the pharmacist are experts in medicine, its benefits and risks.

• Do not by yourself interrupt the period of treatment prescribed for you. • Do not repeat the same prescription without consulting your doctor.

Keep medicaments out of the reach of children Council of Arab Health Ministers

Union of Arab Pharmacists

Manufactured by RIYADH PHARMA Medical and Cosmetic Products Co. Ltd. Riyadh, Saudi Arabia.

GENTACIN is a trademark