New Sigra Oral Dissolving Film 20mg (Tadalafil)

Adult dose

For oral administration. The recommended dose of this medicine is 10mg, taken with or without food before anticipated sexual activity. Patients who do not achieve sufficient effect with tadalafil 10mg may try 20 mg. This medicine may be taken starting at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Immediately after removing this medicine from its individual packaging, place it on the tongue and allow it to dissolve; take it without water. Long-term safety following extended daily dosing has not been established, and since the effect of this medicine usually lasts for more than one day, continuous daily administration of this medicine is strongly discouraged. [See section 1. Warnings and section 11.1) Pharmacodynamic properties] No dosage adjustment is necessary in elderly patients. No dosage adjustment is necessary in patients with mild to moderate renal impairment. The maximum recommended dose in patients with severe renal impairment is 10mg. [See section 11.2) Pharmacokinetic properties]. The recommended dose is 10mg, taken with or without food before anticipated sexual activity. Since clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited, the physician should carefully assess the individual benefit/risk when prescribing it. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See section 3. Patients Requiring Caution and section 11.2) Pharmacokinetic properties]. No dosage adjustment is necessary in patients with diabetes.

Child dose

Do not use in persons under 18 years of age.

This drug is used for the treatment of erectile dysfunction, and a doctor's diagnosis and physical examination must be done before use. Sexual activity may put a strain on the heart, so patients with cardiovascular disease should exercise caution, and if heart-related symptoms occur during sexual activity, they should stop immediately and inform a doctor. If an erection lasts longer than 4 hours, medical help should be sought immediately as untreated cases can result in penile tissue damage or loss of erectile function. This medication should not be taken with nitrate medications due to the risk of severe blood pressure drop. Patients who have recently experienced myocardial infarction, angina pectoris, or stroke, or those with uncontrolled hypertension should not use this drug. It is also contraindicated for individuals with hereditary retinal diseases or hypersensitivity to this drug. The use of this drug in combination with other erectile dysfunction treatments is not recommended due to unproven safety and efficacy. Patients with penile deformities or certain blood disorders should use this drug cautiously. Those with severe kidney or liver dysfunction may require dosage adjustments, and caution is needed due to increased risk of side effects when used with certain medications. This drug may cause side effects such as headaches, dyspepsia, back pain, muscle pain, flushing, and pain in limbs, and most are mild or temporary. Rarely, serious side effects including cardiovascular adverse reactions, vision or hearing loss, and skin rashes have been reported, and if any symptoms occur, immediate consultation with a doctor is necessary. Caution is advised when taken with alcohol due to the potential for blood pressure drops or dizziness. It is not to be used by pregnant or breastfeeding women, children, or neonates. There is generally no significant effect on driving or operating machinery, but dizziness may occur in some individuals. In case of overdose, immediate medical attention is required as the drug is not effectively removed by dialysis. This medication should be kept out of the reach of children and maintained in its original packaging.

• Headache
• dyspepsia
• low back pain
• myalgia
• congestion
• flushing
• limb pain
• nasopharyngitis
• upper respiratory tract infection
• cough

This drug should be stored in a tightly closed container to protect it from air and moisture. In addition, when storing the medication, it is advisable to avoid extremely hot or cold places and to keep it at room temperature, between 1 degree and 30 degrees.

Appearance

White square oral dissolving film

Package unit

10 pieces (1 piece/pack X 10)/case