Medication info
Gugujeong 20 mg (Tadalafil)

Gugujeong 20 mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›20mg / 1 tablet
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
Bright yellow-orange oval film-coated tablet
Packaging
8 tablets/box [4 tablets/PTPX2]
Approval status
Active

MFDS item code 201405693 · 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
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 effective medications for the treatment of erectile dysfunction, and they work only with sexual stimulation. In other words, this medicine helps achieve an erection only when there is sexual arousal. Moreover, tadalafil is developed specifically for use in men and is not to be used by women. Therefore, it is a suitable medication for men who wish to improve erectile dysfunction symptoms.

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

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

Precautions

This medication is for the treatment of erectile dysfunction; prior to use, a doctor's diagnosis and physical examination should confirm the underlying cause. Sexual intercourse may put a strain on the heart, so patients with cardiovascular diseases should exercise particular caution, and any symptoms should be reported to a doctor immediately. If an erection lasts longer than 4 hours or is accompanied by pain, immediate medical assistance should be sought; untreated, this can lead to penile tissue damage and loss of erectile function. This medication should not be used with nitrate medications, as it can dangerously lower blood pressure; patients taking nitrates must not use this medication. Patients with a history of serious cardiovascular conditions, such as myocardial infarction, cardiac arrest, unstable angina, or stroke, should not take this medication, and it should be ensured that there is no such history. This medication has shown some effects on sperm production in certain animal studies, but no significant effects were observed in clinical research. Patients with conditions that can affect erectile function, such as penile deformities or blood disorders, should use this medication cautiously. Patients with severe renal or liver dysfunction may require dosage adjustments or should not take this medication. Caution is needed when combined with alpha-blockers or strong CYP3A4 inhibitors, and consultation with a doctor is advised before use. This medication is not to be used by women, children, or neonates. If sudden vision loss, hearing loss, priapism, or cardiovascular symptoms occur during use, the medication should be immediately discontinued, and medical attention should be sought. Caution should also be exercised when consuming alcohol, as it may cause low blood pressure or dizziness. In cases of overdose, standard emergency treatment should be applied, as it is not removed through dialysis. This medication should be kept out of reach of children and preferably stored in its original packaging. It has little effect on driving or machine operation, but dizziness may occur for some individuals, so caution is advised.

Side effects

Headache, indigestion, lower back pain, muscle pain, congestion, flushing, limb pain, nasopharyngitis, upper respiratory infection, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, urinary tract infection, gastroenteritis, hypertension, adverse reactions related to benign prostatic hyperplasia, dizziness, sensory impairment, insomnia, paresthesia, drowsiness, vertigo, kidney impairment, dyspnea, epistaxis, pharyngitis, itching, rash, sweating, blurred vision, color vision deficiency, conjunctivitis, eye pain, increased tear secretion, eyelid swelling, sudden decrease or loss of hearing, tinnitus, increased erection, spontaneous penile erection, priapism, urticaria, Stevens-Johnson syndrome, exfoliative dermatitis, migraine, seizures and seizure recurrence, transient global amnesia, visual field defect, retinal vein occlusion, retinal artery occlusion, permanent vision loss, angioedema, myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, ventricular arrhythmia, tachycardia, increased blood urea nitrogen, decreased hemoglobin, thrombocytopenia, dry mouth, dysphagia, esophagitis, gastritis, increased GGTP, loose stools, nausea, upper abdominal pain, vomiting, hemorrhoidal bleeding, rectal bleeding, arthralgia, neck pain, dizziness, myasthenia, facial swelling, fatigue, pain, peripheral edema, angina, hypotension, orthostatic hypotension, syncope, hyperventilation, eye hemorrhage, eyelid swelling, conjunctival hemorrhage, dry eyes, abdominal cramps, increased bilirubin, ejaculation disorders, pain in external genitalia, erythema, penile disorders, nasal dryness, increased serum creatinine, hiccups, weakness, abdominal discomfort, abdominal pain, allergic reactions, facial swelling, fever, increased SGOT, increased hemoglobin, skeletal pain, chills

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

Storage

This medication may be sensitive to air and moisture; it should be stored in a tightly sealed container. Additionally, it should be kept at room temperature between 1°C and 30°C, avoiding extreme heat or cold. Proper storage will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Bright yellow-orange oval film-coated tablet

Package unit

8 tablets/box [4 tablets/PTPX2]

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.