Medication info
Tadalafil 10 mg Tablets (Tadalafil)

Tadalafil 10 mg Tablets (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›10mg / 1 tablet
Manufacturer / importer
Yuhan Corporation
Appearance
Pink almond-shaped film-coated tablets
Packaging
4 tablets (1 tablet/PTP packaging x 4)
Approval status
Active

MFDS item code 201501998 · Approved 2015.04.13

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
Use in adult men The recommended dose of this drug 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 drug may be taken at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Long-term safety following extended daily dosing has not been established, and because the effect of this drug 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 adjustments are necessary in elderly patients. Use in men with renal impairment No dosage 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 of this drug is 10mg, taken with or without food before anticipated sexual activity. Clinical data on the safety of this drug 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 administration of doses greater than 10mg to patients with hepatic impairment. [See Section 3. Patients Requiring Caution and Section 11.2) Pharmacokinetic properties]. Use in men with diabetes No dosage adjustment is necessary in patients with diabetes.
Child dose
This medicine should not be used in people under 18 years of age.

Ingredients

Manufacturer
Yuhan Corporation

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used to treat erectile dysfunction and requires sexual stimulation to take effect. It mainly helps improve erectile function in men and is not suitable for women. Therefore, it is effective in improving the symptoms of erectile dysfunction in men.

How to take

Adult dose

Use in adult men The recommended dose of this drug 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 drug may be taken at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Long-term safety following extended daily dosing has not been established, and because the effect of this drug 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 adjustments are necessary in elderly patients. Use in men with renal impairment No dosage 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 of this drug is 10mg, taken with or without food before anticipated sexual activity. Clinical data on the safety of this drug 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 administration of doses greater than 10mg to patients with hepatic impairment. [See Section 3. Patients Requiring Caution and Section 11.2) Pharmacokinetic properties]. Use in men with diabetes No dosage adjustment is necessary in patients with diabetes.

Child dose

This medicine should not be used in people under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction, and it is essential to confirm the underlying causes through a doctor's diagnosis and physical examination before taking it. Sexual activity may put strain on the heart; thus, patients with cardiovascular diseases should be particularly cautious and should immediately stop sexual activity and consult a doctor if symptoms arise. This medication may rarely cause erections lasting longer than 4 hours (priapism), and in such cases, immediate medical assistance is required, as untreated cases may lead to tissue damage of the penis and permanent loss of erectile function. Taking this medication with nitrates or nitric oxide donors can dangerously lower blood pressure; therefore, patients on these medications should not use this drug. Administration is prohibited in patients who have recently experienced significant cardiovascular diseases such as myocardial infarction, acute cardiac arrest, unstable angina, or stroke. This medication may affect sperm formation, so consultation with a doctor regarding reproductive function is necessary during long-term use. Patients with anatomical abnormalities of the penis or certain blood disorders should use this medication cautiously, and those with severely impaired kidney or liver function should also take precautions. This medication should not be used in conjunction with other erectile dysfunction treatments, and patients with lactose intolerance should avoid it. In clinical trials and post-marketing research, common side effects reported include headache, dyspepsia, low back pain, myalgia, flushing, limb pain, rhinitis, upper respiratory tract infections, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, diarrhea, itching, thrombocytopenia, insomnia, drowsiness, light-headedness, vomiting, nausea, fatigue, decreased hemoglobin, decreased platelets, increased hemoglobin, chestburn, increased blood urea nitrogen, decreased hemoglobin, kidney pain, neck stiffness, arthralgia, muscle cramps, hiccup, sleep disturbances, Sudden vision or hearing changes should lead to immediate discontinuation and medical attention. Taking this medication with alcohol may result in hypotension and dizziness, so caution is advised. Other drug interactions may occur during use, so it's essential to inform the doctor, especially if taking antibiotics, antifungals, antivirals, or antihypertensives. This medication is not intended for use in women, children, or neonates, and safety during pregnancy has not been established. There are no specific effects on driving or operating machinery, though caution is needed as dizziness may occur in some individuals. In case of overdose, immediate medical attention should be sought, and dialysis is not effective for the elimination of this medication.

Side effects

  • Headache
  • dyspepsia
  • low 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
  • angina pectoris
  • 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
  • nosebleed
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • color vision abnormality
  • conjunctivitis
  • eye pain
  • increased tear secretion
  • eyelid swelling
  • sudden hearing loss or decrease
  • tinnitus
  • increased erection
  • spontaneous penile erection
  • hives
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • angioedema
  • electrocardiogram abnormality
  • primary bradycardia
  • increased blood urea nitrogen
  • eye congestion
  • increased SGPT
  • chest pressure sensation
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • renal colic
  • heartburn
  • gastrointestinal disorders
  • drowsiness
  • increased white blood cell count
  • thrombocytopenia
  • anxiety
  • sleep disorders
  • decreased hemoglobin
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorders
  • pain in external genitalia
  • erythema
  • penile disorders
  • ear ringing
  • nosebleed
  • nasal dryness
  • increased serum creatinine
  • hiccups
  • asthenia
  • abdominal discomfort
  • abdominal pain
  • allergic reactions
  • 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 should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the drug's effectiveness.

Appearance and packaging

Appearance

Pink almond-shaped film-coated tablets

Package unit

4 tablets (1 tablet/PTP packaging x 4)

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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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.