Medication info

K-Pill 10mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›10mg / 1 tablet
Manufacturer / importer
KS Pharmaceutical Co., Ltd.
Appearance
Film-coated tablet in a yellow, rounded triangular shape with a dividing line
Packaging
8 tablets/box [(8 tablets/PTP)*1]
Approval status
Active

MFDS item code 202106106 · Approved 2021.08.23

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
For oral administration. 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 dosing frequency is once daily. 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 is strongly discouraged. [See section 1. Warnings and section 11.1) Pharmacodynamic properties] Use in older men No dosage adjustment is required in older patients. Use in men with renal impairment No dose 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 product is 10mg, taken with or without food before anticipated sexual activity. Clinical data on the safety of this product in patients with severe hepatic impairment (Child-Pugh Class C) are limited; therefore, 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 section 3. Use with caution in the following patients and section 11.2) Pharmacokinetic properties]. Use in men with diabetes No dose adjustment is required in patients with diabetes.
Child dose
This product should not be used in persons under 18 years of age.

Ingredients

Manufacturer
KS Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used to treat erectile dysfunction. However, sexual stimulation must be present to achieve the effect. It should not be used in women. This drug helps improve erectile function and assists in normal sexual activity.

How to take

Adult dose

For oral administration. 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 dosing frequency is once daily. 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 is strongly discouraged. [See section 1. Warnings and section 11.1) Pharmacodynamic properties] Use in older men No dosage adjustment is required in older patients. Use in men with renal impairment No dose 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 product is 10mg, taken with or without food before anticipated sexual activity. Clinical data on the safety of this product in patients with severe hepatic impairment (Child-Pugh Class C) are limited; therefore, 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 section 3. Use with caution in the following patients and section 11.2) Pharmacokinetic properties]. Use in men with diabetes No dose adjustment is required in patients with diabetes.

Child dose

This product should not be used in persons under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction, and a doctor must thoroughly evaluate the patient's health status before prescribing. Patients with heart disease or risk factors for cardiovascular disease should take it cautiously, considering the potential cardiac stress during sexual activity. This drug may rarely cause priapism lasting more than 4 hours or pain associated with prolonged erections. If these symptoms occur, immediate medical attention is required. If untreated, this can lead to penile tissue damage and permanent erectile dysfunction. Patients taking nitrate medications or NO donors should never use this drug together, as it may cause dangerously low blood pressure. Furthermore, patients who have recently experienced significant cardiovascular diseases such as myocardial infarction, unstable angina, heart failure, or stroke should also refrain from using this medication. This medication contains lactose, so caution is advised for patients with lactose intolerance, and those with a history of hypersensitivity to this drug or its ingredients should avoid use. Combination with other erectile dysfunction treatments is not recommended due to unverified safety and efficacy. Patients with severe renal or liver impairment, those with difficult-to-control blood pressure, or those taking certain antihypertensive medications (alpha-blockers) should use this drug with caution, as dosage adjustments may be necessary. Common side effects include headaches, dyspepsia, back pain, muscle pain, flushing, limb pain, dizziness, diarrhea, cough, nasopharyngitis, upper respiratory tract infections, gastroesophageal reflux disease, abdominal pain, gastritis, facial edema, itchiness, abnormal sensation, visual disturbances, palpitations, vomiting, nausea, fatigue, decreased hemoglobin, drowsiness, insomnia, thrombocytopenia, anxiety, muscle weakness, pain, peripheral edema, angina, chest pain, hypotension, orthostatic hypotension, fainting, and hematuria. This drug is not to be used by women, children, or pregnant women. It has minimal effects on driving or operating machinery; however, caution should be observed after confirming individual responses. In case of overdose, standard medical treatment should be obtained as blood dialysis is not effective in eliminating this drug. Store this medication in its original packaging out of reach of children and do not transfer to any other container.

Side effects

  • Prolonged erection
  • priapism
  • headache
  • dyspepsia
  • back pain
  • myalgia
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
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  • upper respiratory tract infection
  • cough
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • urinary tract infection
  • gastritis
  • hypertension
  • angina
  • chest pain
  • hypotension
  • myocardial infarction
  • orthostatic hypotension
  • palpitations
  • syncope
  • tachycardia
  • abnormal liver function test results
  • dry mouth
  • dysphagia
  • esophagitis
  • gastritis
  • increased GGTP
  • loose stools
  • nausea
  • epigastric pain
  • vomiting
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory loss
  • insomnia
  • paresthesia
  • drowsiness
  • vertigo
  • renal impairment
  • dyspnea
  • epistaxis
  • pharyngitis
  • pruritus
  • rash
  • sweating
  • blurred vision
  • color vision deficiency
  • conjunctivitis
  • eye pain
  • increased tear production
  • eyelid edema
  • sudden hearing loss or decrease
  • tinnitus
  • increased erection
  • spontaneous penile erection
  • urticaria
  • Stevens-Johnson syndrome
  • epidermolytic dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • angioedema
  • ECG abnormalities
  • primary bradycardia
  • increased blood urea nitrogen
  • conjunctival injection
  • increased SGPT
  • chest tightness
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • renal colic
  • heartburn
  • gastrointestinal diseases
  • drowsiness
  • increased white blood cell count
  • thrombocytopenia
  • anxiety
  • sleep disturbance
  • decreased hemoglobin
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eyes
  • abdominal cramping
  • increased bilirubin
  • ejaculation disorder
  • pain in external genitalia
  • erythema
  • penile dysfunction
  • myocardial infarction
  • tinnitus
  • epistaxis
  • nasal dryness
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial edema
  • fever
  • increased SGOT
  • increased hemoglobin
  • no effect
  • chills
  • skeletal pain

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

Storage

Store this medication in a tightly sealed container to protect it from air and moisture. It is recommended to maintain the storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Film-coated tablet in a yellow, rounded triangular shape with a dividing line

Package unit

8 tablets/box [(8 tablets/PTP)*1]

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.