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 COMPOSITION: Sterile Sterile Eye /Ear Drops: Each ml contains Ciprofloxacin Hydrochloride (USP) equivalent to Ciprofloxacin 3 mg, Benzalkonium Chloride Solution (BP) 0.2 mg (preservative) and excipients. Sterile Eye Ointment: Each g contains Ciprofloxacin Hydrochloride (USP) equivalent to Ciprofloxacin 3 mg, Benzalkonium Chloride Solution (BP) 0.2 mg (preservative) and excipients. CLINICAL PHARMACOLOGY: Ciprofloxacin is a broad spectrum antibacterial agent against ocular and otic infections. Ciprofloxacin acts by inhibiting the sub unit of DNA gyrase which is essential in the reproduction of bacterial DNA. INDICATIONS: CIPROCIN is indicated for the treatment of corneal ulcers and superficial infections of the eye caused by strains susceptible to Ciprofloxacin. CIPROCIN is indicated also in the ear for chronic otitis externa. CONTRAINDICATIONS: Hypersensitivity to Ciprofloxacin or any component of the drug. It is also contraindicated in patients with disrupted tympanic membranes. PRECAUTIONS: • Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction. To avoid contamination and cross infection, avoid the use of the same bottle of medication for treatment of otic and ocular infections. • It is not recommended for children under 1 year. • When using Ciprocin eye drops/ointment one should take into account the risk of a rhinopharyngeal passage which can contribute to the occurrence and the diffusion of bacterial resistance. • Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including ciprofloxacin, particularly in elderly patients and in those treated concurrently with corticosteroids. Therefore treatment with Ciprocin Eye drops/Ointment should be discontinued at the first sign of tendon inflammation. • During therapy, soft contact lenses should not be worn. • Ciprocin Eye drops contains benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses. • Contact lens wear is not recommended during treatment of an ocular infection. Therefore, patients should be advised not to wear contact lenses during treatment with Ciprocin eye drops/ointment 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: Transient local burning, itching, conjunctival hyperaemia, lid margin crusting; taste disturbance; corneal staining, keratitis, lid oedema, lacrimation, photophobia; nausea and visual disturbances. USE DURING PREGNANCY, LACTATION & FERTILITY: Pregnancy: There are no adequate data from the use of Ciprocin in pregnant women. Animal studies do not indicate direct harmful effects with respect to reproductive toxicity. Systemic exposure to ciprofloxacin after topical use is expected to be low. As a precautionary measure, it is preferable to avoid the use of Ciprocin during pregnancy, unless the therapeutic benefit is expected to outweigh the potential risk to the fetus. Lactation: Orally administered ciprofloxacin has been found in human breast milk. It is unknown whether ciprofloxacin is excreted to human milk following topical ocular or otic administration. Caution should be exercised when Ciprocin is administered to a nursing woman. Fertility: Studies have not been performed to evaluate the effect of topical administration of Ciprocin on fertility