Medication info
Gugujeong 10mg (Tadalafil)

Gugujeong 10mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›10mg
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
Light yellow-orange oval film-coated tablet
Packaging
8 tablets/box [8 tablets/PTP x 1]
Approval status
Active

MFDS item code 201405692 · Approved 2014.12.02

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
For oral administration. Use in adult men The recommended dose of this medicine is 10mg, taken before anticipated sexual activity, with or without food. For patients who do not achieve a sufficient effect with tadalafil 10mg, 20 mg may be tried. This medicine may be taken 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] Use in elderly men Dose adjustments are not required in elderly patients. Use in men with renal impairment Dose adjustment is not 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 tadalafil tablets is 10mg, taken before anticipated sexual activity, with or without food. Clinical data on the safety of tadalafil tablets in patients with severe hepatic impairment (Child-Pugh Class C) are limited; therefore, if prescribing, the physician should carefully assess the individual benefit/risk. There are no data on administration of doses higher than 10mg to patients with hepatic impairment. [See Sections 3. Use with Caution in the Following Patients and 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: Tadalafil tablets should not be used in persons under 18 years of age.

Ingredients

Manufacturer
Hanmi Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

Tadalafil tablets are used for the treatment of erectile dysfunction and act effectively when there is sexual stimulation. This medication helps improve male erectile function and assists in sexual life. It is not for use in women, therefore caution is required when taken. Tadalafil tablets help improve the symptoms of erectile dysfunction.

How to take

Adult dose

For oral administration. Use in adult men The recommended dose of this medicine is 10mg, taken before anticipated sexual activity, with or without food. For patients who do not achieve a sufficient effect with tadalafil 10mg, 20 mg may be tried. This medicine may be taken 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] Use in elderly men Dose adjustments are not required in elderly patients. Use in men with renal impairment Dose adjustment is not 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 tadalafil tablets is 10mg, taken before anticipated sexual activity, with or without food. Clinical data on the safety of tadalafil tablets in patients with severe hepatic impairment (Child-Pugh Class C) are limited; therefore, if prescribing, the physician should carefully assess the individual benefit/risk. There are no data on administration of doses higher than 10mg to patients with hepatic impairment. [See Sections 3. Use with Caution in the Following Patients and 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: Tadalafil tablets should not be used in persons under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction and must be taken only after confirmation of the underlying cause through a doctor's diagnosis and physical examination. Patients with cardiovascular disease need to be cautious as it may increase the burden on the heart during sexual activity; if cardiovascular symptoms arise during sexual activity, they should stop immediately and consult a doctor. Rarely, this medication may cause an erection lasting more than 4 hours (priapism), in which case immediate medical attention is required, as untreated cases may lead to penile tissue damage and loss of erectile function. Taking it simultaneously with nitrate compounds or nitric oxide donors may lead to a significant drop in blood pressure, so patients on these medications should not use this product. Patients with a history of serious cardiovascular diseases such as myocardial infarction, unstable angina, ventricular arrhythmia, or stroke should not take this drug, and sexual activity itself is not recommended for these patients. This drug may cause changes in sperm count or concentration in some patients, but there is no clinically significant impact, and there is no change in sperm motility or morphology. Patients with specific heart diseases, such as left ventricular outflow obstruction, may be sensitive to the vasodilatory effects of this medication and should use it cautiously. This medication is contraindicated in patients taking organic nitrates, those at high cardiovascular risk, patients with certain liver and kidney impairments, genetic retinal disease patients, and those with hypersensitivity. Combining it with other erectile dysfunction treatments is not recommended as safety and efficacy have not been established, and patients with lactose intolerance should avoid taking it. This medication may lead to a more significant drop in blood pressure when used with alpha-blockers; therefore, co-administration should be avoided or used with extreme caution. Common side effects may include headache, dyspepsia, back pain, myalgia, flushing, limb pain, dizziness, rhinitis, upper respiratory infection, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, hypertension, itching, decreased hemoglobin, drowsiness, insomnia, paraesthesia, thrombocytopenia, increased blood urea nitrogen, fatigue, vomiting, nausea, facial swelling, heartburn, epistaxis, conjunctivitis, eye pain, increased tear production, eyelid swelling, and auditory disturbances. Rarely reported serious adverse reactions include hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, difficulty in breathing or shortness of breath, asthma attacks, respiratory difficulties with cough and fever, yellowing of skin or eyes (jaundice), feeling very lethargic, sudden and severe headache, thunderclap headache, seizures, mental confusion, visual disturbances, paralysis, and urination issues. Taking this medication with alcohol can increase the risk of lower blood pressure and dizziness, so caution is required. In case of overdose, standard treatment should be provided; dialysis does not significantly affect the elimination of this medication. This medication is not for use in children, women, or newborns, and its safety in pregnant women has not been established. It does not greatly affect the ability to drive or operate machinery, but it is safe to perform such activities after checking individual response. This drug can be taken regardless of meals, and it is important to consult with a doctor about one’s health condition and all medications being taken before and after use.

Side effects

  • prolonged erection
  • priapism
  • headache
  • indigestion
  • 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
  • dizziness
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • decreased vision
  • decreased hearing
  • tinnitus
  • angioedema
  • myocardial infarction
  • sudden cardiac death
  • stroke
  • chest pain
  • palpitations
  • ventricular arrhythmia
  • tachycardia
  • hypotension
  • orthostatic hypotension
  • syncope
  • increased blood urea nitrogen
  • eye congestion
  • increased SGPT
  • chest pressure sensation
  • 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
  • anxiety
  • sleep disorders
  • decreased hemoglobin
  • eye pain
  • chest pain
  • joint pain
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • increased bilirubin
  • ejaculatory dysfunction
  • pain in external genitalia
  • erythema
  • itching
  • penile disorder
  • nasal dryness
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin
  • no effect
  • 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 prevent exposure to air or moisture and should be kept at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the effectiveness of the drug and ensure safe usage.

Appearance and packaging

Appearance

Light yellow-orange oval film-coated tablet

Package unit

8 tablets/box [8 tablets/PTP x 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.