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ETC / RX - Erectile dysfunction - Re-zoom

COMPOSITION:
Each film coated tablet contains:
Active ingredient:
Tadalafil (as tadalafil granule 8%)…….20mg
Excipients: Flowlac 100, microcrystalline cellulose, talc, magnesium stearate, opadry II white and iron oxide yellow.


DESCRIPTION OF PRODUCT:
Film coated tablet, yellow color.


INDICATIONS:
– RE-ZOOM is indicated for the treatment of erectile dysfunction.


ADMINISTRATION AND DOSAGE:
– Adults:
The recommended starting dose is RE-ZOOM 10 mg, taken 30 minutes to 12 hours prior to anticipated sexual activity and without regard to food.
The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once daily.
Hepatic impairment: In patient with mild or moderate hepatic impairment receiving as-needed therapy the maximum dosage of tadalafil should not exceed 10 mg once daily. Use of tadalafil is not recommended in patients with severe hepatic impairment.
Renal impairment: Dosage adjustment is not necessary in patients with mild renal impairment (creatinine clearance of 51-80 mL/minutes) receiving tadalafil in an as needed or once daily basis.
In patients moderate renal impairment (creatinine clearance of 31-50 mL/minutes), the recommended initial tadalafil dose is 5 mg administered no more frequently than once daily and maximum recommended dosage is 10 mg administered no more frequently than once every 48 hours. In patients severe renal impairment (creatinine clearance of less than 30 mL/minutes), including those undergoing hemodialysis, the maximum recommended dosage is 5 mg administered no more frequently than once every 72 hours.
In patients with diabetes: Dosage adjustment is not necessary in patients with diabetes.
– It is not recommended in children under 18 years of age.


CONTRAINDICATIONS:
RE-ZOOM is contraindicated in patients:
– With a known hypersensitivity to any of the ingredients of this product.
– Who are using any form of organic nitrate, either regularly and/or intermittently.
– Taking any alpha-adrenergic antagonist.
– With left ventricular outflow obstruction (aortic stenosis and idiopathic hypertrophic subaortic stenosis).
– The safety and efficacy for use in the following groups of patients were not established, therefore, RE-ZOOM is not recommended in these group until further information is available:
With a myocardial infarction within the last 90 days.
With unstable angina or angina occurring during sexual intercourse.
With greater heart failure in the last 6 months.
With uncontrolled arrhythmias, hypotension (< 90.50 mmHg), or uncontrolled hypertension (>170/100 mmHg).
With a stroke within the last 6 months.
With known hereditary degenerative retinal disorders.


WARNINGS AND PRECAUTIONS:
– It is necessary to consider the cardiovascular status of their patients, since there may be a degree of cardiac risk associated with sexual activity.
– The safety and efficacy of combinations of RE-ZOOM and other treatments for erectile dysfunction  have not been studied. Therefore, the use of such combinations is not recommended.
– Use with caution in patients with renal, hepatic impairment and anatomical deformation of the penis.
Pregnancy and lactation: Tadalafil is not indicated for in pregnancy and lactation. Please consult in your physician before use this medicine.
Effects on ability to drive and use machines: Be careful when driving a motor vehicle or operating machinery.


SIDE EFFECTS:
Common, ADR > 1/100:
– Headache, indigestion, dizziness, flushing, nasal congestion, back pain/myalgia.
Uncommon, 1/1000 < ADR < 1/100:
– Devotional eyes, sore eyes and conjunctivitis in congestive.
In case of an unexpected reaction, consult your physician.


INTERACTIONS:
– Drugs that inhibit CYP3A4 (eg., itraconazole, ketoconazole,…) can increase Tadalafil exposure (AUC).
– When concomitant administration, tadalafil may increase the effect of hypotension of calcium channel blockers, ace inhibitors, beta-blockers and diuretics.


OVERDOSE AND TREATMENT:
– The most common symptoms are headache, heartburn, back pain, muscle aches, runny nose, and flushing.
– In case of overdose, standard supportive measure should be adopted, as required. Haemodialysis  contributes negligibly to tadalafil elimination.


PRESENTATION:
– Box of 1 blister x 2 film coated tablets.
– Box of 2 blister x 2 film coated tablets.


STORAGE:
Store at temperature below 30°C, protect from light.


SHELF-LIFE:
36 months from manufacturing date. Do not use after expiry date.