Medication info
Ipaledong 5mg (Tadalafil)

Ipaledong 5mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›5mg / 1 tablet
Manufacturer / importer
Huons Co., Ltd.
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201505843 · Approved 2015.08.20

Summary

Main use
Treatment of symptoms of erectile dysfunction, benign prostatic hyperplasia, and concomitant erectile dysfunction and benign prostatic hyperplasia
Who takes it
Adults · Children
Adult dose
Do not crush this medicine. Take one tablet whole. For oral administration. 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 once-daily dosing should be reassessed periodically. 2. Once-daily regimen 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 regimen 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 older men No dosage adjustments are 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 in patients with severe renal impairment. [See Precautions for Use, 3.2) and section 11.2) Pharmacokinetic Properties]. - Benign prostatic hyperplasia No dose adjustment is required in patients with mild renal impairment. Once-daily tadalafil is not recommended in patients with severe renal impairment. [See Precautions for Use, 3.3) and section 11.2) Pharmacokinetic Properties]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, if prescribing it, the physician should carefully assess the individual benefit/risk. (See section 11. <Special Populations>) ● Use in men with diabetes No dose adjustment is required in patients with diabetes.
Child dose
This medicine should not be used in persons under 18 years of age.

Ingredients

Manufacturer
Huons Co., Ltd.

Efficacy & effects

Treatment of symptoms of erectile dysfunction, benign prostatic hyperplasia, and concomitant erectile dysfunction and benign prostatic hyperplasia

  • Erectile dysfunction
  • signs and symptoms of benign prostatic hyperplasia
  • and erectile dysfunction and benign prostatic hyperplasia in men.
View approved original text

This medication is used for the treatment of erectile dysfunction and requires sexual stimulation to be effective. It is not for use in women. It also helps alleviate the signs and symptoms of benign prostatic hyperplasia. It is particularly effective in treating both erectile dysfunction and benign prostatic hyperplasia in men who experience both conditions. Therefore, this medication is used to improve the symptoms of erectile dysfunction and prostatic hyperplasia in men.

How to take

Adult dose

Do not crush this medicine. Take one tablet whole. For oral administration. 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 once-daily dosing should be reassessed periodically. 2. Once-daily regimen 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 regimen 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 older men No dosage adjustments are 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 in patients with severe renal impairment. [See Precautions for Use, 3.2) and section 11.2) Pharmacokinetic Properties]. - Benign prostatic hyperplasia No dose adjustment is required in patients with mild renal impairment. Once-daily tadalafil is not recommended in patients with severe renal impairment. [See Precautions for Use, 3.3) and section 11.2) Pharmacokinetic Properties]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, if prescribing it, the physician should carefully assess the individual benefit/risk. (See section 11. <Special Populations>) ● Use in men with diabetes No dose adjustment is required in patients with diabetes.

Child dose

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

Precautions

This medication is used for the treatment of erectile dysfunction and benign prostatic hyperplasia, and appropriate medical evaluation is required before use. Especially patients with heart disease or those at high cardiovascular risk must thoroughly consult their doctor about their heart condition before sexual activity and medication usage. This medication requires immediate medical assistance if an erection lasts longer than 4 hours, as untreated can lead to penile tissue damage and loss of potency. Additionally, patients taking nitrate preparations or NO donors must not use this medication as it can dangerously lower blood pressure. Patients with a history of cardiovascular diseases such as myocardial infarction, angina, or stroke should not receive this medication, and certain heart disease patients are prohibited from use. This medication may affect sperm production, so individuals taking it for an extended period should consult their physician regarding this aspect. Caution is needed when taken with alpha blockers or antihypertensives as blood pressure may decrease excessively. This medication contains lactose, so it should not be taken by those with lactose intolerance. If sudden vision loss, hearing impairment, prolonged erection, or cardiovascular symptoms occur, discontinue use immediately and consult healthcare personnel. It is not to be used in pregnant women or children, and although no special effects have been reported while driving or operating machinery, individual differences may apply. In case of overdose, standard emergency treatment should be administered, and blood dialysis does not significantly affect the excretion of this medication. Store in a place out of reach of children and maintain the original packaging.

Side effects

  • Headache
  • dyspepsia
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
Show 78 more
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • urinary tract infection
  • gastroenteritis
  • upper abdominal pain
  • nausea
  • vomiting
  • joint pain
  • muscle spasms
  • color vision changes
  • diarrhea
  • priapism
  • elevated blood urea nitrogen
  • tachycardia
  • palpitations
  • eye congestion
  • elevated SGPT
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • dry mouth
  • heartburn
  • drowsiness
  • leukocytosis
  • thrombocytopenia
  • decreased hemoglobin
  • eye pain
  • chest pain
  • joint pain
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • increased bilirubin
  • sexual dysfunction
  • pain in external genitalia
  • erythema
  • itching
  • penile disorders
  • myocardial infarction
  • tinnitus
  • epistaxis
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • allergic reactions
  • facial edema
  • fever
  • elevated SGOT
  • increased hemoglobin
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizures
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • angioedema
  • angioedema
  • sudden hearing loss or reduction
  • tinnitus
  • increased erection
  • spontaneous penile erection

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is best to keep the storage temperature between 1 degree and 30 degrees Celsius. This way, the effectiveness of the medication can be preserved for a longer time.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)

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.