Medication info

Withergood Oral Disintegrating Film 10 mg (Tadalafil)

Prescription medicationOral
Ingredient · strength
Tadalafil›10mg / 1 sheet
Manufacturer / importer
Withus Pharmaceutical Co., Ltd.
Appearance
Rectangular yellow oral disintegrating film
Packaging
2 films/package [1 film/foil X 2], 10 films/package [1 film/foil X 10]
Approval status
Active

MFDS item code 202107094 · Approved 2021.10.25

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 (tadalafil) 10mg does not provide 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 package, place it on the tongue and allow it to dissolve; take without water. Long-term safety after extended daily dosing has not been established, and because the effect of this medicine usually lasts more than one day, continuous daily administration of this medicine is strongly not recommended. [See sections 1. Warnings and 11.1) Pharmacodynamic properties] Use in elderly men No dosage adjustments are necessary in elderly patients. Use in men with renal impairment No dose 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]. Use in men with hepatic impairment The recommended dose is 10mg, taken with or without food before anticipated sexual activity. Clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited; if prescribing, the physician should carefully assess the individual benefit/risk. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See sections 3. Patients requiring caution and 11.2) Pharmacokinetic properties]. Use in men with diabetes No dose adjustment is necessary in patients with diabetes.
Child dose
Under 18 years of age: Do not use this medicine in persons under 18 years of age.

Ingredients

Manufacturer
Withus Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used for the treatment of erectile dysfunction, and sexual stimulation is necessary for it to take effect. This drug aims to improve erectile function in men and is not intended for use in women. It can help those who are struggling with erectile dysfunction.

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 (tadalafil) 10mg does not provide 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 package, place it on the tongue and allow it to dissolve; take without water. Long-term safety after extended daily dosing has not been established, and because the effect of this medicine usually lasts more than one day, continuous daily administration of this medicine is strongly not recommended. [See sections 1. Warnings and 11.1) Pharmacodynamic properties] Use in elderly men No dosage adjustments are necessary in elderly patients. Use in men with renal impairment No dose 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]. Use in men with hepatic impairment The recommended dose is 10mg, taken with or without food before anticipated sexual activity. Clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited; if prescribing, the physician should carefully assess the individual benefit/risk. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See sections 3. Patients requiring caution and 11.2) Pharmacokinetic properties]. Use in men with diabetes No dose adjustment is necessary in patients with diabetes.

Child dose

Under 18 years of age: Do not use this medicine in persons under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction, and a doctor's diagnosis and physical examination are necessary before administration. Patients with a history of heart disease, recent myocardial infarction, angina, heart failure, or stroke should not take this medication. As sexual activity itself can put stress on the heart, it is essential to ensure that the cardiovascular condition is stable. While taking this medication, do not use nitrates or NO donors together, as it can cause a dangerous drop in blood pressure. Additionally, if an erection lasts longer than 4 hours or is accompanied by pain, seek medical assistance immediately. Those with penile deformities or certain blood disorders, patients with severe kidney or liver impairment, and patients taking certain alpha blockers should use this medication cautiously. This drug is not for use in women, children, or infants, and its safety during pregnancy has not been established. After taking this medication, side effects such as headache, dyspepsia, back pain, muscle pain, flushing, dizziness, etc., may occur. Rarely, cardiac-related adverse reactions or loss of vision and hearing have been reported, so if these symptoms occur, discontinue use immediately and consult a physician. Caution is advised when taking this medication with alcohol, as it can increase the risk of lowering blood pressure and dizziness. In case of overdose, standard treatment should be applied, and blood dialysis does not significantly affect the excretion of this drug. When storing, keep it out of reach of children and maintain its original packaging.

Side effects

  • Headache
  • indigestion
  • lower back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
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  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • urinary tract infection
  • gastroenteritis
  • hypertension
  • dizziness
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizures
  • transient global amnesia
  • visual field defects
  • retinal vein occlusion
  • retinal artery occlusion
  • vision loss
  • sudden hearing loss or reduction
  • tinnitus
  • angioedema
  • myocardial infarction
  • sudden cardiac death
  • stroke
  • chest pain
  • palpitations
  • ventricular arrhythmias
  • 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 disorders
  • drowsiness
  • increased white blood cell count
  • thrombocytopenia
  • anxiety
  • sleep disorders
  • 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 dysfunction
  • next-day syndrome
  • myocardial infarction
  • ear ringing
  • nasal bleeding
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reactions
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin
  • ineffective
  • chills
  • skeletal pain

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

Storage

This medication should be stored in a closed container to protect it from air and light, and it is safest to store it at room temperature between 1°C and 30°C. Storing it this way helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

Rectangular yellow oral disintegrating film

Package unit

2 films/package [1 film/foil X 2], 10 films/package [1 film/foil X 10]

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.

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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.