Zyrelis Oral Dissolving Film 20mg (Tadalafil)

Adult dose

Use in adult men The recommended dose of this medicine is 10mg, taken with or without food before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This medicine may be taken at least 30 minutes before sexual activity. The maximum recommended frequency of use is once daily. Immediately after removing this medicine from its individual package, place it on the tongue and allow it to dissolve; take it without water. Long-term safety after extended daily dosing has not been established, and because the effect of this medicine usually lasts longer than one day, continuous daily use of this medicine is strongly discouraged. [See sections 1. Warnings and 11.1) Pharmacodynamic properties] Use in elderly men No dosage adjustment is required in elderly patients. Use in men with renal impairment No dosage adjustment is required 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]. Use in men with hepatic impairment 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 administration of doses higher than 10mg to patients with hepatic impairment. [See sections 3. Use with caution in the following patients and 11.2) Pharmacokinetic properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Child dose

Do not use in persons under 18 years of age.

This medication is used for treating erectile dysfunction, and a doctor must carefully review the patient's medical history and physical condition before prescribing it. Sexual intercourse can put a strain on the heart, so individuals with cardiovascular diseases should exercise particular caution. This drug can cause an erection lasting more than 4 hours; if this occurs, immediate consultation with a healthcare professional is necessary. Taking it with nitrate compounds or NO donors can dangerously lower blood pressure, so it should not be taken together. Patients who have recently had cardiovascular issues, such as a heart attack, stroke, or unstable angina, should not use this medication. Individuals with certain eye conditions or known hypersensitivity to this drug should also not use it. The safety of using this drug in combination with other erectile dysfunction medications has not been established, so it is recommended not to combine them. Patients with severely impaired kidney or liver function should use this drug cautiously, and co-administration with blood pressure medications like alpha-blockers may lead to symptoms of hypotension. Common side effects of this drug include headache, dyspepsia, back pain, muscle pain, flushing, and limb pain. Rarely, serious side effects such as heart-related issues, vision or hearing loss may occur, and immediate medical attention should be sought if symptoms develop. Caution is advised when taking this medication with alcohol, as it can intensify hypotension and dizziness. It is not to be used by pregnant or nursing women or children. There is no special effect when driving or operating machinery, but it is advisable to monitor individual symptoms carefully. In case of overdose, immediate and appropriate medical treatment should be sought, and this medication cannot be removed by dialysis. Store this medication out of reach of children and in its original packaging for safety.

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

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature to preserve its efficacy and safety.

Appearance

Yellow rectangular oral dissolving film

Package unit

10 sheets/pack