Medication info
SENIT EN Oral Dissolving Film 20 mg (Tadalafil)

SENIT EN Oral Dissolving Film 20 mg (Tadalafil)

Prescription medicationOral
Ingredient · strength
Tadalafil›20mg / 1 sheet
Manufacturer / importer
Dongkwang Pharmaceutical Co., Ltd.
Appearance
Yellow rectangular oral dissolving film.
Packaging
10 pieces (1 piece/package × 10) / box
Approval status
Active

MFDS item code 201502266 · Approved 2015.04.15

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
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 a sufficient effect, 20 mg may be tried. This medicine may be taken 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 after extended daily dosing has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration of this medicine is strongly discouraged. [See Sections 1. Warnings and 11.1) Pharmacodynamic properties] Use in elderly men Dose adjustments are not required in elderly patients. Use in men with renal impairment Dose adjustment is not 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, if prescribing it, the physician should carefully assess the individual benefit/risk. There are no data on administering doses greater 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 Dose adjustment is not required in patients with diabetes.
Child dose
Persons under 18 years of age: This medicine should not be used.

Ingredients

Manufacturer
Dongkwang Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used to treat erectile dysfunction. It requires sexual stimulation for the therapeutic effect, which manifests when sexual stimulation occurs. Also, please remember that this medication is not intended for use by women. It helps improve erectile dysfunction and maintain a healthy sex life.

How to take

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 a sufficient effect, 20 mg may be tried. This medicine may be taken 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 after extended daily dosing has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration of this medicine is strongly discouraged. [See Sections 1. Warnings and 11.1) Pharmacodynamic properties] Use in elderly men Dose adjustments are not required in elderly patients. Use in men with renal impairment Dose adjustment is not 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, if prescribing it, the physician should carefully assess the individual benefit/risk. There are no data on administering doses greater 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 Dose adjustment is not required in patients with diabetes.

Child dose

Persons under 18 years of age: This medicine should not be used.

Precautions

This medication is used to treat erectile dysfunction and should only be taken after a proper diagnosis and physical examination by a physician. Sexual activity can put a strain on the heart, so cardiovascular status must be checked before taking this medication. If an erection lasts for more than 4 hours, immediate medical attention is required; without treatment, this may lead to penile tissue damage and loss of erectile function. This medication should not be used with nitrate drugs as it may cause dangerously low blood pressure; therefore, patients taking nitrate medications should avoid this drug. Patients with cardiovascular diseases such as myocardial infarction, angina, heart failure, and stroke should use this medication with caution or avoid it altogether. Patients with hereditary retinal diseases or specific visual impairments should not use this medication. This medication should not be used in conjunction with other erectile dysfunction treatments, and patients who have experienced vision loss due to certain eye conditions should not take it. Patients with penile deformities or specific blood disorders should use this medication cautiously, and careful consideration is necessary for those with significantly impaired kidney or liver functions. Co-administration with specific antihypertensive agents or antifungals may increase the risk of side effects, so consultation with healthcare professionals is advised. This medication is not intended for women, children, or infants. If sudden vision loss or hearing reduction occurs during use, discontinue immediately and consult a physician. Caution is advised when taking this medication with alcohol as it may cause blood pressure reduction or dizziness. In case of overdose, visit a medical institution for appropriate treatment, and blood dialysis is not effective for removing this medication. Store in a place out of reach of children and keep the original packaging.

Side effects

  • Headache
  • indigestion
  • back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
Show 77 more
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • urinary tract infection
  • gastroenteritis
  • hypertension
  • dizziness
  • hives
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • vision loss
  • priapism
  • vascular edema
  • myocardial infarction
  • sudden cardiac death
  • stroke
  • chest pain
  • palpitations
  • ventricular arrhythmia
  • tachycardia
  • increased blood urea nitrogen
  • eye congestion
  • increased SGPT
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • dry mouth
  • heartburn
  • gastrointestinal disease
  • drowsiness
  • increased white blood cell count
  • thrombocytopenia
  • anxiety
  • sleep disturbances
  • decreased hemoglobin
  • eye pain
  • chest pain
  • joint pain
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorder
  • pain in external genitalia
  • erythema
  • itching
  • penile disorder
  • tinnitus
  • nasal bleeding
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • allergic reaction
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin
  • chills
  • skeletal pain

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. The appropriate storage temperature is room temperature between 1°C and 30°C. This storage method helps maintain the medication's efficacy and prevents degradation.

Appearance and packaging

Appearance

Yellow rectangular oral dissolving film.

Package unit

10 pieces (1 piece/package × 10) / box

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.