Medication info
Heros Tablet 5mg (Tadalafil)

Heros Tablet 5mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›5mg
Manufacturer / importer
Vivozon Pharmaceutical Co., Ltd.
Appearance
(Domestic) Yellow round film-coated tablet, (Export) Yellow round film-coated tablet
Packaging
28 tablets/PTP (7 tablets × 4)
Approval status
Active

MFDS item code 201501610 · Approved 2015.03.26

Summary

Main use
Treatment of erectile dysfunction, benign prostatic hyperplasia, and symptoms when both conditions are present
Who takes it
Adults · Children
Adult dose
Do not crush this medication. Swallow one tablet whole. For oral use. 1. Erectile dysfunction Use in adult men For patients who are expected to use tadalafil frequently (at least 2 times per week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. The appropriateness of continuous daily dosing should be reassessed periodically. 2. Once-daily use for benign prostatic hyperplasia The recommended dose of this medication for once-daily use is 5mg, taken at approximately the same time every day. 3. Once-daily use for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this medication for once-daily use is 5mg, taken at approximately the same time every day, regardless of the timing of sexual activity. 4. Special populations ● Use in older men Dose adjustments are not required in older patients. ● Use in men with renal impairment - Erectile dysfunction No dose adjustment is required in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment.[See Precautions for Use 3.2) and Pharmacokinetic Properties 11.2)]. - Benign prostatic hyperplasia No dose adjustment is required in patients with mild renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See Precautions for Use 3.3) and Pharmacokinetic Properties 11.2)]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, if prescribing this medication, the physician should carefully assess the benefit/risk for each individual.(See section 11.<Special Populations>) ● Use in men with diabetes Dose adjustment is not required in patients with diabetes.
Child dose
● Use in children and adolescents This medication should not be used in persons under 18 years of age.

Ingredients

Manufacturer
Vivozon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction, benign prostatic hyperplasia, and symptoms when both conditions are present

  • Signs and symptoms of erectile dysfunction and benign prostatic hyperplasia
View approved original text

This medication is used for the treatment of erectile dysfunction and requires sexual stimulation to be effective. It is not intended for use in women. Additionally, it helps alleviate the signs and symptoms associated with benign prostatic hyperplasia. Notably, it is effective in improving both symptoms in men who have both erectile dysfunction and benign prostatic hyperplasia at the same time. Thus, this medication is used for the treatment of erectile dysfunction and benign prostatic hyperplasia in men.

How to take

Adult dose

Do not crush this medication. Swallow one tablet whole. For oral use. 1. Erectile dysfunction Use in adult men For patients who are expected to use tadalafil frequently (at least 2 times per week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. The appropriateness of continuous daily dosing should be reassessed periodically. 2. Once-daily use for benign prostatic hyperplasia The recommended dose of this medication for once-daily use is 5mg, taken at approximately the same time every day. 3. Once-daily use for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this medication for once-daily use is 5mg, taken at approximately the same time every day, regardless of the timing of sexual activity. 4. Special populations ● Use in older men Dose adjustments are not required in older patients. ● Use in men with renal impairment - Erectile dysfunction No dose adjustment is required in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment.[See Precautions for Use 3.2) and Pharmacokinetic Properties 11.2)]. - Benign prostatic hyperplasia No dose adjustment is required in patients with mild renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See Precautions for Use 3.3) and Pharmacokinetic Properties 11.2)]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, if prescribing this medication, the physician should carefully assess the benefit/risk for each individual.(See section 11.<Special Populations>) ● Use in men with diabetes Dose adjustment is not required in patients with diabetes.

Child dose

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

Precautions

This medication is used to treat erectile dysfunction and benign prostatic hyperplasia. Before taking this medication, a correct diagnosis of the causes of erectile dysfunction or prostate enlargement should be made, and appropriate treatment options should be assessed by a physician. Sexual activity may put strain on the heart, so patients with heart disease should confirm their cardiovascular status before taking this medication. If any cardiac-related symptoms occur during or after sexual activity, sexual activity should be stopped immediately and a doctor should be notified. Rarely, an erection lasting more than 4 hours can occur after taking this medication; in such cases, immediate medical assistance should be obtained. If prolonged erection is not treated, damage to the penile tissue and permanent loss of erectile function may occur. If taking this medication with nitrate medications or nitric oxide donors, blood pressure may drop too low, so those taking such medications should inform their doctor. Patients who have recently experienced cardiovascular diseases such as myocardial infarction, unstable angina, heart failure, or stroke should not take this medication. The use of this medication is also prohibited in cases of genetic retinal diseases or specific allergies. The combination of this medication with other erectile dysfunction treatments is not recommended due to unproven safety and efficacy. Patients with severe kidney or liver dysfunction should be cautious when taking this medication, and dosage adjustments may be necessary. Patients taking alpha-blockers or antihypertensives should consult their doctor as the risk of excessively low blood pressure may arise. Side effects of this medication may include headache, dyspepsia, back pain, muscle pain, flushing, and limb pain, most of which are mild or transient. Rarely, cardiac-related adverse reactions or vision and hearing problems have been reported, so it is important to inform a doctor of any unusual symptoms. This medication is not for use in women, children, or infants, and its safety during pregnancy has not been established. Care should be taken when consuming alcohol while taking this medication as it may exacerbate blood pressure lowering and dizziness. In case of overdose, it is essential to visit a medical facility for appropriate treatment, as blood dialysis has little effect on the excretion of this medication. This medication should be kept out of reach of children and it is recommended to maintain its original packaging conditions. There is no special effect on driving or operating machinery, but dizziness may occur in some individuals, so caution is advised.

Side effects

  • Headache
  • indigestion
  • lumbar pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
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  • diarrhea
  • urinary tract infection
  • gastroesophageal reflux disease
  • abdominal pain
  • dizziness
  • hypertension
  • priapism
  • increased blood urea nitrogen
  • tachycardia
  • palpitations
  • conjunctival congestion
  • increased SGPT
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • dry mouth
  • heartburn
  • gastrointestinal disease
  • drowsiness
  • increased white blood cell count
  • decreased platelet count
  • decreased hemoglobin
  • eye pain
  • chest pain
  • joint pain
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramping
  • increased bilirubin
  • ejaculation disorder
  • pain in external genitalia
  • erythema
  • itching
  • penile disorder
  • myocardial infarction
  • tinnitus
  • nosebleed
  • dry nose
  • increased serum creatinine
  • hiccups
  • asthenia
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • decreased vision
  • angioedema
  • myocardial infarction
  • sudden cardiac death
  • stroke
  • chest pain
  • palpitations
  • ventricular arrhythmia
  • tachycardia
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • decreased vision
  • angioedema
  • sudden hearing reduction or loss
  • tinnitus
  • priapism
  • angioedema

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is also best to avoid storage in overly hot or cold places and to keep it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

(Domestic) Yellow round film-coated tablet, (Export) Yellow round film-coated tablet

Package unit

28 tablets/PTP (7 tablets × 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.

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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.