Tadalafil Tablet Package Insert

Warning:
1. This product is available in 10 mg and 20 mg strengths and is not indicated for patients requiring doses of 2.5 mg or 5 mg.
2. This product must not be split before use.
【Drug Name】
Generic Name: Tadalafil Tablets
English Name: Tadalafil Tablets
Pinyin: Tadalafei Pian
【Ingredients】
The active ingredient of this product is tadalafil.
Chemical name: 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl, (6R,12aR)-pyrazino
[1'2':1,6]Pyrido[3,4-b]indole-1,4-dione

Excipients: microcrystalline cellulose, lactose, hydroxypropyl cellulose, croscarmellose sodium, sodium lauryl sulfate, and stearic acid.
Magnesium, film-coated premix (enteric-coated).
【Characteristics】
This product is a pale yellow to yellow, oval-shaped film-coated tablet; upon removal of the coating, it appears white or off-white.
【Indications】
Treatment of erectile dysfunction (ED).
【Specifications】
(1) 10 mg (2) 20 mg
【Usage and Dosage】

Tadalafil tablets can be taken with or without food.
Do not break the tadalafil tablet; this product must be taken whole.
Erectile Dysfunction
Take tadalafil tablets as needed.
• For most patients, the recommended starting dose of tadalafil tablets taken on an as-needed basis is 10 mg, to be taken prior to sexual activity.
• Depending on individual efficacy and tolerability, the dose may be increased to 20 mg or decreased to 5 mg. For most patients, the recommended maximum dosing frequency is once daily.
• Compared with placebo, on-demand tadalafil tablets can improve erectile function for up to 36 hours. Therefore, this factor should be taken into account when advising patients on the optimal dosing regimen for tadalafil.
Take tadalafil tablets once daily.
• The recommended starting dose of tadalafil tablets is 2.5 mg once daily, to be taken at approximately the same time each day, without requiring
Consider when to engage in sexual activity.
• Depending on individual efficacy and tolerability, the once-daily dose of tadalafil tablets may be increased to 5 mg. The appropriate treatment regimen should be selected by carefully weighing the risks and benefits based on the patient’s specific clinical circumstances.

Medication for Special Populations
Renal impairment
Take tadalafil tablets as needed.
• Creatinine clearance of 30–50 mL/min: The recommended starting dose is 5 mg, administered no more than once daily, with a maximum dose of 10 mg, not to exceed once every 48 hours. For creatinine clearance <30 mL/min or in patients undergoing hemodialysis: the maximum dose is 5 mg, not to exceed once every 72 hours (see “Precautions”).
Take tadalafil tablets once daily.
Erectile Dysfunction
• Creatinine clearance <30 mL/min or on hemodialysis: Once-daily tadalafil tablets are not recommended (see [Precautions]).
Erectile Dysfunction Combined with Benign Prostatic Hyperplasia
• Creatinine clearance of 30–50 mL/min: No data are available for the Chinese population.
• Creatinine clearance <30 mL/min or on hemodialysis: Once-daily tadalafil tablets are not recommended (see [Precautions]).
Liver damage
Take tadalafil tablets as needed.
• Mild or moderate hepatic impairment (Child-Pugh class A or B): The dose of tadalafil tablets should not exceed 10 mg once daily. Extensive evaluation of once-daily tadalafil administration in patients with hepatic impairment has not yet been conducted; therefore, caution is advised.
• Severe (Child-Pugh Class C): Tadalafil tablets are not recommended (see [Precautions]).

Take tadalafil tablets once daily.
• Mild or moderate hepatic impairment (Child-Pugh class A or B): Tadalafil tablets taken once daily have not yet been extensively evaluated in patients with liver impairment. Therefore, caution is advised when prescribing tadalafil once daily to such patients.
• Severe (Child-Pugh Class C): Tadalafil tablets are not recommended (see [Precautions]).
Elderly people
No dose adjustment is required for patients aged >65 years.
Combination therapy
Nitrate medications
Concomitant use with any nitrate-containing medications is strictly prohibited (see [Contraindications]).
Alpha-adrenergic receptor antagonist
ED—When tadalafil tablets are used in combination with α-adrenergic antagonists, patients receiving α-adrenergic antagonist therapy should be stabilized first before initiating tadalafil therapy, and treatment should be started at the recommended minimum dose (see “Precautions” and “Drug Interactions”).
BPH—Combined use of tadalafil tablets and α-adrenergic antagonists for the treatment of benign prostatic hyperplasia is not recommended. (See “Precautions” and “Drug Interactions.”)
CYP3A4 (Cytochrome P450 3A4) inhibitor
Take tadalafil tablets as needed.
For patients who are concurrently taking strong CYP3A4 inhibitors, such as ketoconazole or ritonavir, the maximum recommended dose of tadalafil tablets is 10 mg, not to exceed once every 72 hours (see “Precautions” and “Drug Interactions”).
Take tadalafil tablets once daily.
For patients who are concurrently taking strong CYP3A4 inhibitors, such as ketoconazole or ritonavir, the recommended dose is no more than 2.5 mg (see “Precautions” and “Drug Interactions”).

[Storage]
Seal tightly and store at room temperature (10–30°C). Keep the medication out of reach of children.
【Packaging】
Polyvinyl chloride solid medicinal hard blisters and pharmaceutical aluminum foil packaging.
10 mg: 7 tablets per blister, 1 blister per box; 7 tablets per blister, 2 blisters per box; 7 tablets per blister, 3 blisters per box.
20 mg: 3 tablets per blister, 1 blister per box; 3 tablets per blister, 2 blisters per box; 6 tablets per blister, 2 blisters per box; 6 tablets per blister, 3 blisters per box.
【Shelf Life】
24 months
[Implementation Standard]
National Medical Products Administration Drug Registration Standard YBH30512025
[Approval Number]
(1) National Drug Approval Number H20256171 (10 mg)
(2) National Drug Approval Number H20256170 (20 mg)
[Marketing Authorization Holder]
Name: Guangdong Bidi Pharmaceutical Co., Ltd.
Registered Address: No. 66, Bidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
Postal code: 529331
Telephone numbers: 0750-2789348 (product inquiries) and 2763089 (quality inquiries).
400-8899-328 (National Service Hotline)

Fax number: 0750-2789285
Website: http://www.pdpharm.com
【Manufacturing Enterprise】
Company Name: Guangdong Bidi Pharmaceutical Co., Ltd.
Production Address: No. 66, Bidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
Postal code: 529331
Telephone numbers: 0750-2789348 (product inquiries) and 2763089 (quality inquiries).
400-8899-328 (National Service Hotline)
Fax number: 0750-2789285
Website: http://www.pdpharm.com