Medication info
Heros 20mg (Tadalafil)

Heros 20mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›20mg
Manufacturer / importer
Vivozon Pharmaceutical Co., Ltd.
Appearance
(Domestic) Yellow triangular film-coated tablet, (Export) Yellow oval film-coated tablet
Packaging
4 tablets/PTP (2 tablets × 2)
Approval status
Active

MFDS item code 201501612 · Approved 2015.03.26

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
The recommended dose of this medicine is 10mg, taken regardless of meals 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 administered 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 of this medicine is strongly discouraged. [See Sections 1. Warnings and 11.1) Pharmacodynamic properties] No dosage adjustment is required in elderly patients. 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]. The recommended dose of this medicine is 10mg, taken regardless of meals before anticipated sexual activity. Because clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited, the physician should carefully assess the individual benefit/risk when prescribing it. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See Sections 3. Use with caution in the following patients and 11.2) Pharmacokinetic properties]. No dosage adjustment is required in patients with diabetes.
Child dose
Should not be used in people under 18 years of age.

Ingredients

Manufacturer
Vivozon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is effective for the treatment of erectile dysfunction and works when sexual stimulation occurs. Additionally, this medication is intended for the treatment of erectile dysfunction in males and is not suitable for females.

How to take

Adult dose

The recommended dose of this medicine is 10mg, taken regardless of meals 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 administered 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 of this medicine is strongly discouraged. [See Sections 1. Warnings and 11.1) Pharmacodynamic properties] No dosage adjustment is required in elderly patients. 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]. The recommended dose of this medicine is 10mg, taken regardless of meals before anticipated sexual activity. Because clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited, the physician should carefully assess the individual benefit/risk when prescribing it. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See Sections 3. Use with caution in the following patients and 11.2) Pharmacokinetic properties]. No dosage adjustment is required in patients with diabetes.

Child dose

Should not be used in people under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction, and before use, it is essential to confirm the underlying cause through medical history and physical examination. Sexual activity can put strain on the heart, so patients with cardiovascular diseases should use it only after evaluation by a physician. If an erection lasts more than 4 hours, immediate medical assistance should be sought, as untreated prolonged erection can lead to penile tissue damage and loss of erectile ability. This medication should not be used in patients taking nitrate medications or NO donors, as it can dangerously lower blood pressure. It should not be administered to patients who have recently experienced severe cardiovascular diseases such as heart attack, cardiac arrest, unstable angina, or stroke. This medication may affect sperm production in some animal studies; however, it has not shown significant issues in clinical studies involving humans. Patients at high risk for cardiovascular disease need special caution when using this medication and should be administered under appropriate medical supervision. Co-administration with antihypertensive medications or alpha-blockers may cause symptoms of hypotension, so patients taking such medications should consult their physician. This medication contains lactose, and patients with lactose intolerance should not take it. It is not recommended to use this medication with other erectile dysfunction treatments. While using this medication, side effects such as headaches, dyspepsia, back pain, muscle pain, flushing, limb pain, rhinitis, upper respiratory infections, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, generalized muscle weakness, facial swelling, fatigue, pain, peripheral edema, angina, chest pain, hypotension, orthostatic hypotension, palpitations, syncope, tachycardia, abnormal liver function test results, dry mouth, dysphagia, esophagitis, gastritis, increased GGTP, loose stools, and nausea may occur, most of which are mild or transient. Rarely, serious cardiovascular adverse reactions or loss of vision and hearing have been reported; therefore, if any abnormal symptoms occur, immediate reporting to medical staff is necessary. This medication is not intended for use in women, children, or neonates, and its safety in pregnant women has not been established. It does not significantly affect driving or operating machinery, but caution should be exercised as dizziness may occur in some individuals. In case of overdose, standard supportive treatment should be provided, and blood dialysis does not significantly affect the removal of this medication.

Side effects

  • Prolonged erection
  • priapism
  • headache
  • indigestion
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
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  • upper respiratory infection
  • cough
  • 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
  • upper abdominal pain
  • vomiting
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory impairment
  • insomnia
  • paresthesia
  • drowsiness
  • vertigo
  • renal impairment
  • shortness of breath
  • nasal bleeding
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • color vision deficiency
  • conjunctivitis
  • eye pain
  • increased tear secretion
  • eyelid swelling
  • sudden hearing loss or reduction
  • 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
  • decreased vision
  • angioedema
  • electrocardiogram abnormalities
  • primary tachycardia
  • facial swelling
  • fatigue
  • pain
  • peripheral edema
  • increased blood urea nitrogen
  • decreased hemoglobin
  • thrombocytopenia
  • chest tightness
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • neck stiffness
  • urethral pain
  • renal pain
  • heartburn
  • drowsiness
  • leukocytosis
  • anxiety
  • sleep disturbances
  • conjunctival injection
  • increased SGPT
  • chest pain
  • arthralgia
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorder
  • pain in external genitalia
  • erythema
  • penile dysfunction
  • ear ringing
  • nasal bleeding
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • 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 can be sensitive to air and moisture, so it must be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. Proper storage will help maintain the drug's effectiveness and stability for a longer period.

Appearance and packaging

Appearance

(Domestic) Yellow triangular film-coated tablet, (Export) Yellow oval film-coated tablet

Package unit

4 tablets/PTP (2 tablets × 2)

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.