Medication info
Uresco Tablet 0.5/5 mg (Dutasteride, Tadalafil)

Uresco Tablet 0.5/5 mg (Dutasteride, Tadalafil)

Prescription medicationTablet
Ingredient · strength
Dutasteride›0.5mg / 1 tabletTadalafil›5mg / 1 tablet
Manufacturer / importer
Dongguk Pharmaceutical Co., Ltd.
Appearance
White oblong tablet
Packaging
30 tablets/box [10PTPx3]
Approval status
Active

MFDS item code 202500172 · Approved 2025.01.23

Summary

Main use
Treatment of symptoms of moderate to severe benign prostatic hyperplasia
Who uses it
Adults · Children
Adult dosage
Adults: The recommended dose is 1 tablet once daily (dutasteride 0.5mg and tadalafil 5mg), taken orally. This medicine may be taken with or without food. Swallow the tablet whole at approximately the same time each day. Use in elderly men: No dose adjustment is necessary in elderly patients. Use in men with renal impairment: No dose adjustment is necessary in patients with mild renal impairment. This medicine is not recommended for patients with severe renal impairment. Use in men with hepatic impairment: The recommended dose of this medicine in patients with hepatic impairment has not been established.
Children's dosage
Do not use in children under 18 years of age.

Ingredients

Manufacturer
Dongguk Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of symptoms of moderate to severe benign prostatic hyperplasia

  • Symptoms of benign prostatic hyperplasia
View approved original text

This medication is used to treat symptoms of benign prostatic hyperplasia that are categorized as moderate to severe. It helps relieve various uncomfortable symptoms such as urinary obstruction, frequent urination, and nocturia caused by prostate enlargement, thereby improving the quality of life for patients.

Dosage and Administration

Adult dosage

Adults: The recommended dose is 1 tablet once daily (dutasteride 0.5mg and tadalafil 5mg), taken orally. This medicine may be taken with or without food. Swallow the tablet whole at approximately the same time each day. Use in elderly men: No dose adjustment is necessary in elderly patients. Use in men with renal impairment: No dose adjustment is necessary in patients with mild renal impairment. This medicine is not recommended for patients with severe renal impairment. Use in men with hepatic impairment: The recommended dose of this medicine in patients with hepatic impairment has not been established.

Children's dosage

Do not use in children under 18 years of age.

Precautions

This medication should never be handled or taken by women, especially those who are pregnant or may become pregnant, as the dutasteride component can be absorbed through the skin and pose a risk of deformities to a male fetus. Children should also be kept from contact with this medication, and in the event of contact, they should wash immediately with soap and water. This medication is for the treatment of benign prostatic hyperplasia only, and medical professionals must evaluate the patient's heart condition and prostate health before administration. Patients with cardiovascular disease or those who have recently experienced a myocardial infarction or stroke should not take this medication. Due to cardiac risks associated with sexual activity, if cardiac symptoms occur during sexual activity, one should stop immediately and seek medical attention. The tadalafil component in this medication can rarely cause an erection lasting longer than 4 hours, accompanied by pain (priapism), and if this occurs, immediate medical assistance should be sought. Additionally, it should never be taken with nitrate compounds or NO donors as it can dangerously lower blood pressure. Patients with impaired liver or kidney function should use this medication cautiously, as it may affect drug metabolism and excretion and may require dosage adjustment. This medication may interact with various drugs; therefore, especially if taking CYP3A4 inhibitors, alpha-blockers, or antihypertensive agents, one should consult a doctor. During the use of this medication, regular prostate cancer screenings and PSA level tests should be conducted, and any unusual symptoms should be reported to a healthcare professional immediately. Possible side effects include headache, dyspepsia, muscle pain, dizziness, erectile dysfunction, decreased libido, etc., and rarely serious cardiovascular adverse reactions or visual and hearing impairments may occur. This medication is not to be used in children under the age of 18, and elderly patients should be monitored closely. In case of overdose, one should visit a medical facility immediately for appropriate treatment, as blood dialysis may not be effective for drug clearance. Finally, this medication should be stored out of reach of children and kept in its original packaging for safety.

Side effects

COVID-19, headache, dizziness, muscle pain, joint pain, indigestion, palpitations, hyperlipidemia, pruritus, liver abscess, acute sinusitis, bronchitis, impetigo, herpes zoster, athlete's foot, nasopharyngitis, pharyngitis, periodontitis, chronic inflammatory demyelinating polyneuropathy, sensory loss, polyneuropathy, neuropathy, facial paralysis, sensory abnormalities, back pain, neck pain, osteoarthritis, muscle weakness, arthropathy, plantar fasciitis, limb pain, intervertebral disc disorder of the spine, gastroesophageal reflux disease, colitis, inguinal hernia, irritable bowel syndrome, abdominal distension, epigastric pain, dysphagia, nausea, gastritis, diverticulosis, voice disorders, nasal congestion, dyspnea, varicose veins, hypertension, flushing, heat sensation flushing, cataract, dry eyes, diabetic retinopathy, retinal crystals, star-shaped vitreous opacity, capsular opacification, blepharitis, gout, chest discomfort, death, chest pain, urticaria, rash, hair loss, bladder mass, urge incontinence, urgency, gynecomastia in males, breast mass, breast pain, prostatic cyst, decreased hemoglobin, increased triglycerides in the blood, recurrent liver cancer, non-sinusoidal papilloma, colonic-rectal adenoma, cholecystitis, hepatitis, fatty liver disease, gallbladder disorder, peri-implant fracture, eye contusion, cartilage damage, ear pain, depression, Type I bipolar disorder, mixed anxiety and depressive disorder, cataract surgery, erectile dysfunction, decreased libido, ejaculation disorder, gynecomastia, testicular pain, testicular swelling, heart failure, headache, epigastric pain, muscle pain, low back pain, nasopharyngitis, diarrhea, limb pain, dizziness, gastroesophageal reflux, nausea, vomiting, joint pain, muscle cramps, myasthenia, facial swelling, fatigue, pain, peripheral edema, angina, chest pain, hypotension, myocardial infarction, orthostatic hypotension, palpitation, syncope, tachycardia, abnormal liver function test results, dry mouth, dysphagia, esophagitis, elevated GGTP, loose stool, vomiting, hemorrhoidal bleeding, rectal bleeding, sensory loss, insomnia, paresthesia, drowsiness, dizziness, renal impairment, dyspnea, epistaxis, pharyngitis, itching, rash, sweating, blurred vision, color vision abnormality, conjunctivitis, eye pain, increased tear production, eyelid swelling, sudden hearing loss or decrease, tinnitus, increased erection, spontaneous penile erection, priapism, angioedema, migraine, seizure, transient global amnesia, visual field defect, retinal vein occlusion, retinal artery occlusion, permanent vision loss, urticaria, Stevens-Johnson syndrome, exfoliative dermatitis, angioedema, insomnia, congestion, abdominal pain, diarrhea, epigastric discomfort, fever, chills, dry mouth, constipation, cramps, facial dystonia, vomiting, colorectal polyp, weakness, deep vein thrombosis, chills, musculoskeletal pain

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. A storage temperature of between 1 to 30 degrees Celsius is recommended.

Appearance and packaging

Appearance

White oblong tablet

Package unit

30 tablets/box [10PTPx3]

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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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.