Medication info
Sunka Tablet 5 mg (Tadalafil)

Sunka Tablet 5 mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›5mg / 1 tablet
Manufacturer / importer
Aju Pharmaceuticals Co., Ltd.
Appearance
Yellow round shaped film-coated tablet
Packaging
28 tablets (7 tablets/PTP×4)
Approval status
Active

MFDS item code 201501675 · Approved 2015.03.30

Summary

Main use
Treatment of erectile dysfunction, benign prostatic hyperplasia, and symptoms associated with both conditions
Who takes it
Adults · Children
Adult dose
Do not crush this medicine. Swallow one tablet whole. For oral administration. 1. Erectile dysfunction Use in adult men For patients who anticipate frequent use of tadalafil (at least 2 times per week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. The suitability of continuous daily dosing should be reassessed periodically. 2. Once-daily use for benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time each day. 3. Once-daily use for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time each day, regardless of the timing of sexual activity. 4. Special populations ● Use in elderly men Dose adjustment is not required in elderly patients. ● Use in men with renal impairment - Erectile dysfunction Dose adjustment is not required in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended in patients with severe renal impairment.[See sections 3.2) and 11.2) Pharmacokinetic properties of Precautions for use]. - Benign prostatic hyperplasia Dose adjustment is not required in patients with mild renal impairment. Once-daily tadalafil is not recommended in patients with severe renal impairment. [See sections 3.3) and 11.2) Pharmacokinetic properties of Precautions for use]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, if prescribing this medicine, the physician should carefully assess the individual benefit/risk. (See section 11. <Special populations>) ● Use in men with diabetes Dose adjustment is not required in patients with diabetes.
Child dose
This medicine should not be used in people under 18 years of age.

Ingredients

Manufacturer
Aju Pharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction, benign prostatic hyperplasia, and symptoms associated with both conditions

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

This drug is primarily used to treat erectile dysfunction in men and requires sexual stimulation to be effective. It is not used for women. Additionally, it is used to alleviate symptoms and signs of benign prostatic hyperplasia. In particular, it helps improve the symptoms of men who have both erectile dysfunction and benign prostatic hyperplasia. Thus, this drug is useful in enhancing male sexual function and prostate health.

How to take

Adult dose

Do not crush this medicine. Swallow one tablet whole. For oral administration. 1. Erectile dysfunction Use in adult men For patients who anticipate frequent use of tadalafil (at least 2 times per week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. The suitability of continuous daily dosing should be reassessed periodically. 2. Once-daily use for benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time each day. 3. Once-daily use for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time each day, regardless of the timing of sexual activity. 4. Special populations ● Use in elderly men Dose adjustment is not required in elderly patients. ● Use in men with renal impairment - Erectile dysfunction Dose adjustment is not required in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended in patients with severe renal impairment.[See sections 3.2) and 11.2) Pharmacokinetic properties of Precautions for use]. - Benign prostatic hyperplasia Dose adjustment is not required in patients with mild renal impairment. Once-daily tadalafil is not recommended in patients with severe renal impairment. [See sections 3.3) and 11.2) Pharmacokinetic properties of Precautions for use]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, if prescribing this medicine, the physician should carefully assess the individual benefit/risk. (See section 11. <Special populations>) ● Use in men with diabetes Dose adjustment is not required in patients with diabetes.

Child dose

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

Precautions

This drug is used for the treatment of erectile dysfunction and benign prostatic hyperplasia and requires proper medical evaluation before use. Patients with heart disease or poor cardiovascular conditions should consult their doctor before engaging in sexual activity, and if cardiovascular symptoms occur during sexual activity, they should stop immediately and inform their doctor. If an erection lasts longer than 4 hours after taking this drug, immediate medical attention is needed, as untreated conditions could lead to penile tissue damage or loss of erection ability. Furthermore, using this drug with nitrate medications or NO donors can excessively lower blood pressure, so they should not be taken together. It is contraindicated for patients who have recently had cardiovascular diseases such as myocardial infarction, stroke, unstable angina, or heart failure, or patients with uncontrolled hypertension or hypotension, certain retinal diseases, and patients allergic to any component of this drug. Patients with penile deformities or certain blood disorders should use this drug cautiously, and those with severely impaired kidney or liver function should also take precautions. When taken with alpha-blockers or antihypertensives, blood pressure lowering may be intensified, so consultation with a doctor is necessary. This drug should not be used by women, children, or infants, and its safety during pregnancy has not been confirmed. It has minimal impact on driving or operating machinery, but it is advisable to check one's own condition after taking it. In the case of overdose, standard treatment should be received, and dialysis does not significantly affect the excretion of this drug. Store it in its original container out of reach of children. During the use of this drug, side effects such as headache, dyspepsia, back pain, muscle pain, nasal congestion, flushing, limb pain, nasopharyngitis, upper respiratory infection, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, hypertension, dizziness, itching, rash, sweating, chest burning, facial swelling, abnormal sensations, drowsiness, vertigo, hemolysis, anxiety, sleep disturbances, dry mouth, hiccups, asthenia, abdominal discomfort, thrombocytopenia, hemoglobin increase, facial flushing, facial swelling, and auditory disturbances (tinnitus) may occur. If unusual symptoms occur, immediate consultation with medical personnel is necessary. This drug may interact with various medications, so if other medications are being taken, it is essential to inform the doctor or pharmacist, especially regarding strong CYP3A4 inhibitors, nitrate medications, alpha-blockers, antihypertensives, and alcohol use.

Side effects

  • Headache
  • indigestion
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory tract infection
  • cough
Show 70 more
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • priapism
  • increased blood urea nitrogen
  • tachycardia
  • palpitations
  • eye congestion
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • dry mouth
  • heartburn
  • gastrointestinal disorders
  • 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 eyes
  • abdominal cramping
  • increased bilirubin
  • ejaculation dysfunction
  • pain in external genitalia
  • erythema
  • itching
  • penile dysfunction
  • myocardial infarction
  • tinnitus
  • nasal bleeding
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • 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
  • angioedema
  • sudden hearing loss or decrease
  • tinnitus
  • increased erection
  • spontaneous penile erection

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

Storage

This drug may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature. This helps to safely maintain the effectiveness of the medication for an extended period.

Appearance and packaging

Appearance

Yellow round shaped film-coated tablet

Package unit

28 tablets (7 tablets/PTP×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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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.