Medication info
Bu-kwang Tadalafil Tablet 20mg

Bu-kwang Tadalafil Tablet 20mg

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›20mg / 1 tablet
Manufacturer / importer
Bu-kwang Pharmaceutical Co., Ltd.
Appearance
Yellow, oblong film-coated tablet
Packaging
4 tablets/PTP
Approval status
Active

MFDS item code 201501708 · Approved 2015.03.31

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 before anticipated sexual activity, with or without food. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This medicine may be administered at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Long-term safety after prolonged daily dosing has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration is strongly discouraged. [See section 1. Warnings and section 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 of this medicine is 10mg, taken before anticipated sexual activity, with or without food. Clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited; therefore, if prescribing it, the physician should carefully assess the benefit/risk for each individual patient. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See section 3. Administer with caution in the following patients and section 11.2) Pharmacokinetic Properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.
Child dose
Use in children and adolescents This medicine should not be used in persons under 18 years of age.

Ingredients

Manufacturer
Bu-kwang 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. However, sexual stimulation is required to achieve the effects of the drug, and this medication is not indicated for use by women. Therefore, it can be helpful for male patients who are troubled by erectile dysfunction.

How to take

Adult dose

Use in adult men The recommended dose of this medicine is 10mg, taken before anticipated sexual activity, with or without food. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This medicine may be administered at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Long-term safety after prolonged daily dosing has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration is strongly discouraged. [See section 1. Warnings and section 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 of this medicine is 10mg, taken before anticipated sexual activity, with or without food. Clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited; therefore, if prescribing it, the physician should carefully assess the benefit/risk for each individual patient. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See section 3. Administer with caution in the following patients and section 11.2) Pharmacokinetic Properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Child dose

Use in children and adolescents This medicine should not be used in persons under 18 years of age.

Precautions

This medication is used to treat erectile dysfunction, and before using it, a physician must thoroughly check the patient's medical history and physical condition. In particular, patients with cardiovascular disease should only use this medication after sufficiently evaluating their cardiovascular status as sexual activity may put strain on the heart. Rarely, an erection that lasts longer than 4 hours may occur, in which case immediate medical attention should be sought, as untreated cases may lead to penile tissue damage or permanent erectile dysfunction. Patients taking nitrate compounds or NO donors must avoid using this medication together as it can dangerously lower blood pressure. Patients who have had recent cardiovascular events such as myocardial infarction, unstable angina, or stroke should not take this medication. Additionally, it is contraindicated for patients with certain hereditary retinal diseases or allergies to any components of this medication. The safety of taking this medication in conjunction with other erectile dysfunction treatments has not been established, and thus it is not recommended. Patients with severely impaired kidney or liver function should use this medication with caution, and it is essential to consult with healthcare providers when taking it with some blood pressure medications as symptoms of hypotension may occur. During treatment with this medication, side effects such as headache, dyspepsia, back pain, myalgia, flushing, limb pain, nasopharyngitis, upper respiratory infection, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, insomnia, paresthesia, drowsiness, vertigo, itching, rash, sweating, blurred vision, color vision abnormalities, conjunctivitis, eye pain, increased tear production, eyelid swelling, sudden decrease or loss of hearing, tinnitus, increased erections, or spontaneous penile erections may occur, but they are usually mild and improve over time. Rarely, cardiovascular abnormalities, changes in vision or hearing, priapism, and allergic reactions have been reported, so if symptoms are severe or sudden changes in vision or hearing occur, immediate contact with medical personnel is advised. This medication is not to be used by women, children, or pregnant individuals, and although it typically does not significantly affect driving or operating machinery, individual responses should be confirmed. In the case of overdose, standard treatment should be administered, and blood dialysis does not significantly impact the elimination of this medication from the body.

Side effects

  • headache
  • dyspepsia
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
Show 112 more
  • diarrhea
  • urinary tract infection
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • gastroenteritis
  • hypertension
  • angina
  • chest pain
  • hypotension
  • myocardial infarction
  • orthostatic hypotension
  • palpitations
  • syncope
  • tachycardia
  • abnormal liver function test results
  • dry mouth
  • dysphagia
  • esophagitis
  • gastritis
  • elevated GGTP
  • loose stools
  • nausea
  • epigastric pain
  • vomiting
  • gastroesophageal reflux
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory disturbance
  • insomnia
  • paraesthesia
  • drowsiness
  • vertigo
  • renal impairment
  • dyspnea
  • epistaxis
  • pharyngitis
  • pruritus
  • rash
  • sweating
  • blurred vision
  • color vision abnormalities
  • conjunctivitis
  • eye pain
  • increased tear production
  • eyelid edema
  • sudden hearing loss
  • hearing loss
  • tinnitus
  • increased erection
  • spontaneous penile erection
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • angioedema
  • abnormal electrocardiogram
  • primary bradycardia
  • increased blood urea nitrogen
  • chest tightness
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • renal colic
  • heartburn
  • drowsiness
  • leukocytosis
  • thrombocytopenia
  • anxiety
  • sleep disorder
  • decreased hemoglobin
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • elevated bilirubin
  • ejaculation disorder
  • pain in external genitalia
  • erythema
  • penile dysfunction
  • myocardial infarction
  • tinnitus
  • epistaxis
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial edema
  • fever
  • elevated SGOT
  • increased hemoglobin
  • chills
  • skeletal pain

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

Storage

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a temperature between 1 degree and 30 degrees Celsius during storage.

Appearance and packaging

Appearance

Yellow, oblong film-coated tablet

Package unit

4 tablets/PTP

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.