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CYKLOKAPRON®Patient Counseling Information (tranexamic acid)

17 PATIENT COUNSELING INFORMATION

Thromboembolic Risk

Inform patients that CYKLOKAPRON may increase the risk of venous and arterial thrombosis or thromboembolism and to contact their healthcare provider for any signs or symptoms suggestive of thromboembolism.

Advise patients using hormonal contraception that combined use with CYKLOKAPRON may increase the risk for thromboembolic adverse reactions and to use effective alternative (nonhormonal) contraception during therapy with CYKLOKAPRON [see Warnings and Precautions (5.1), Drug Interactions (7.1), Use in Specific Populations (8.3)].

Seizures

Inform patients that CYKLOKAPRON may cause seizures and to contact their healthcare provider for any signs or symptoms suggestive of seizures [see Warnings and Precautions (5.2)].

Hypersensitivity Reactions

Inform patients that CYKLOKAPRON may cause hypersensitivity reactions and to contact their healthcare provider for any signs or symptoms of hypersensitivity reactions [see Warnings and Precautions (5.3)].

Visual Disturbances

Inform patients that CYKLOKAPRON can cause visual disturbance and that they should report any eye symptoms or change in their vision to their healthcare provider and to follow-up with an ophthalmologist for a complete ophthalmologic evaluation, including dilated retinal examination of the retina [see Warnings and Precautions (5.4)].

Risk of Driving and Operating Machinery

Inform patients that CYKLOKAPRON may cause dizziness, and that the patient should be cautioned about driving, operating machinery, or performing hazardous tasks while taking CYKLOKAPRON [see Warnings and Precautions (5.5)].

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