Osolam Tablet 5 mg (Tadalafil)

Adult dose

Do not crush this medicine. Take one tablet whole. For oral use. 1. Erectile dysfunction Use in adult men For patients who expect to use tadalafil frequently (at least 2 times per week), the recommended dose is up to 5mg once daily, taken at about the same time each day. The suitability of continued daily dosing should be reassessed periodically. 2. Once-daily use for benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at about the same time each day. 3. Once-daily use for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at about the same time each day, regardless of the timing of sexual activity. 4. Special populations ● Use in elderly men No dosage adjustments are required in elderly patients. ● Use in men with renal impairment - Erectile dysfunction No dose adjustment is required in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See sections 3.2) and 12.2) Pharmacokinetic properties under Precautions for use]. - Benign prostatic hyperplasia No dose adjustment is required in patients with mild renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See sections 3.3) and 12.2) Pharmacokinetic properties under Precautions for use]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, if prescribing this medicine, the physician should carefully assess the individual benefit/risk. (See section 12. <Special populations>) ● Use in men with diabetes No dose adjustment is required in patients with diabetes.

Child dose

● Use in children and adolescents This medicine should not be used in persons under 18 years of age.

This medication is used for the treatment of erectile dysfunction and benign prostatic hyperplasia. Before using this medication, a thorough diagnosis and evaluation by a physician are necessary, especially if there are heart diseases or blood pressure issues. Because it may put a strain on the heart during sexual activity, patients with cardiovascular diseases or a history of recent myocardial infarction, angina, heart failure, or stroke should not use this medication. This medication may cause prolonged erections lasting more than 4 hours or painful erections; if such symptoms occur, immediate medical assistance should be sought. Significant drops in blood pressure can occur when taken with nitrates or NO donors, so this medication must not be used if those medications are being taken. Dosing adjustments or cautious use is required in patients with severe kidney or liver impairment or when used concomitantly with certain antihypertensives. This medication contains lactose, thus caution is advised for individuals with lactose intolerance. It is not to be administered to pregnant or nursing women or to children. Side effects such as headaches, dyspepsia, myalgia, flushing, dizziness, and others may occur during treatment; rarely, serious cardiovascular adverse reactions or visual and auditory disturbances have been reported. Caution is advised when driving or operating machinery until individual responses to the medication are determined. In case of overdose, immediate contact with a medical institution is required to receive appropriate treatment. This medication should be kept out of reach of children and stored in its original packaging.

• Headache
• indigestion
• lower back pain
• muscle pain
• congestion
• flushing
• limb pain
• nasopharyngitis
• upper respiratory infection
• cough

This medication may be sensitive to air and humidity; therefore, it should be stored in a tightly sealed container. The recommended storage temperature is between 1 degree and 30 degrees Celsius at room temperature.

Appearance

Yellow film-coated tablets in the shape of rounded triangles

Package unit

30 tablets (10 tablets/PTP x 3)