Medication info
Ajax Tablet 20 mg (Tadalafil)

Ajax Tablet 20 mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›20mg / 1 tablet
Manufacturer / importer
Hyundai Pharmaceutical Co., Ltd.
Appearance
Film-coated tablet in yellow color, rounded triangular shape with a score line
Packaging
8 tablets (8 tablets/PTP*1)
Approval status
Active

MFDS item code 201508516 · Approved 2015.12.30

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 sufficient effect, 20 mg may be tried. This medicine may be administered starting 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 medicine usually lasts for more than one day, continuous daily administration of this medicine is strongly discouraged. [See section 1. Warnings and section 11.1) Pharmacodynamic properties] Use in elderly men Dose adjustments are not required in elderly 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. Since clinical data on the safety of this product in patients with severe hepatic impairment (Child-Pugh Class C) are limited, if it is prescribed, 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. Cautions for use in the following patients and section 11.2) Pharmacokinetic properties]. Use in men with diabetes Dose adjustment is not required in patients with diabetes.
Child dose
Under 18 years of age: This product should not be used.

Ingredients

Manufacturer
Hyundai 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 for effectiveness, and it is not intended for use in women. It helps improve erectile function in men.

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 sufficient effect, 20 mg may be tried. This medicine may be administered starting 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 medicine usually lasts for more than one day, continuous daily administration of this medicine is strongly discouraged. [See section 1. Warnings and section 11.1) Pharmacodynamic properties] Use in elderly men Dose adjustments are not required in elderly 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. Since clinical data on the safety of this product in patients with severe hepatic impairment (Child-Pugh Class C) are limited, if it is prescribed, 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. Cautions for use in the following patients and section 11.2) Pharmacokinetic properties]. Use in men with diabetes Dose adjustment is not required in patients with diabetes.

Child dose

Under 18 years of age: This product should not be used.

Precautions

This medication is used for the treatment of erectile dysfunction and it is essential to identify the underlying cause of erectile dysfunction through a doctor's diagnosis and physical examination before use. Patients with heart conditions or poor cardiovascular health should consult a doctor before taking this medication, as it may put stress on the heart during sexual activity. If an erection lasts longer than 4 hours after taking this medication, seek medical attention immediately to prevent penile tissue damage or permanent erectile dysfunction. Patients taking nitrate medications or those containing nitrates should not use this medication together, as it may dangerously lower blood pressure. Patients with a history of cardiovascular disease, such as myocardial infarction, acute heart failure, unstable angina, heart failure, or stroke, should not use this medication, as its safety has not been established in these patients. Patients with penile deformities or certain blood disorders, severe renal or liver impairment should use this medication cautiously and strictly follow the doctor's instructions. This medication is not recommended to be taken in conjunction with other erectile dysfunction treatments, and patients with lactose intolerance should also avoid it. Side effects such as headaches, dyspepsia, back pain, muscle pain, flushing, limb pain, dizziness, diarrhea, nasopharyngitis, upper respiratory infections, cough, abdominal pain, gastroesophageal reflux disease, itching, rash, sweating, chest pressure, vomiting, nausea, fatigue, reduced hemoglobin, drowsiness, insomnia, abnormal sensations, facial edema, thrombocytopenia, anxiety, sleep disturbances, increased hemoglobin, dry mouth, hiccups, kidney pain, dry mouth, and heartburn may appear, most of which are mild or temporary. Serious adverse effects such as sudden vision or hearing loss have been rarely reported, so if such symptoms occur, immediately discontinue use and consult medical personnel. Caution is advised when using alcohol, as it may cause blood pressure dropping or dizziness; it is recommended to assess drug response before driving or operating machinery. In case of overdose, general supportive therapy is required, and blood dialysis is not effective for removing this medication. This medication should not be used in children, women, pregnant or nursing mothers, and must be stored out of reach of children.

Side effects

  • Priapism
  • headache
  • indigestion
  • back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
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  • cough
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • urinary tract infection
  • gastroenteritis
  • 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
  • gastroesophageal reflux
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory loss
  • insomnia
  • paresthesia
  • drowsiness
  • dizziness
  • kidney impairment
  • dyspnea
  • nasal bleeding
  • pharyngitis
  • itching
  • 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
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • angioedema
  • electrocardiogram abnormalities
  • primary bradycardia
  • increased blood urea nitrogen
  • conjunctival injection
  • increased SGPT
  • chest pressure sensation
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • heartburn
  • gastrointestinal disease
  • drowsiness
  • leukocytosis
  • thrombocytopenia
  • anxiety
  • sleep disorders
  • decreased hemoglobin
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • xerophthalmia
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorder
  • pain in the external genitalia
  • erythema
  • penile disorders
  • sequel
  • myocardial infarction
  • tinnitus
  • nasal bleeding
  • dry nose
  • increased blood creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial edema
  • 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 protect it from air and moisture. It is recommended to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

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

Package unit

8 tablets (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.

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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.