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

Eurogard Tablet 0.5/5 mg (Dutasteride, Tadalafil)

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

MFDS item code 202500182 · 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. No dose adjustment is necessary in elderly patients. No dose adjustment is necessary in patients with mild renal impairment. This medicine is not recommended for patients with severe renal 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
Donggu Bio 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 moderate to severe symptoms of benign prostatic hyperplasia. It primarily alleviates symptoms such as difficulty in urination, sensations of incomplete bladder emptying, and increased frequency of urination, thereby improving bladder function issues related to prostate enlargement. This helps reduce discomfort felt in daily life and assists in enhancing overall urinary function.

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. No dose adjustment is necessary in elderly patients. No dose adjustment is necessary in patients with mild renal impairment. This medicine is not recommended for patients with severe renal 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 must not be handled by women, particularly those who are pregnant or may become pregnant, as the Dutasteride component can be absorbed through the skin and pose a risk of fetal deformities in male fetuses. Additionally, care should be taken to avoid contact with individuals under the age of 18. If contact occurs, immediate washing with soap and water is necessary. This medication is used for the treatment of benign prostatic hyperplasia, and appropriate medical evaluation is required prior to administration. It is essential to confirm the patient's cardiovascular condition, especially in cases where there are cardiac risks associated with sexual activity. The Tadalafil component can rarely cause an erection lasting more than 4 hours (priapism), and immediate medical assistance should be sought if this occurs. Failure to treat may result in damage to penile tissue and loss of erectile function. Taking this medication in conjunction with nitrates or NO donors (e.g., nitroglycerin) may cause excessive drops in blood pressure, thus patients taking these medications should not use this drug. Patients with significant cardiovascular conditions such as myocardial infarction, angina, or stroke, or who have experienced these conditions recently should also avoid using this medication. This drug must be used cautiously in patients with impaired liver or kidney function, and is particularly not recommended for patients with severe renal impairment. Moreover, co-administration with alpha-blockers or antihypertensive agents may lead to excessively low blood pressure; thus, careful administration according to a physician's guidance is necessary. This medication may cause various side effects due to the presence of Dutasteride and Tadalafil. Common side effects include headache, dyspepsia, muscle pain, dizziness, erectile dysfunction, and decreased libido; rare reports have included allergic reactions, vision impairment, hearing loss, and priapism. Dutasteride may affect the risk assessment for prostate cancer, so regular PSA testing and prostate examinations should be performed. During the use of this medication, blood donation should be avoided, and there is also a prohibition on blood donation for a certain period after discontinuation. Pregnant or nursing women should not use this drug, and particularly women must not take this medication at all. This medication is not approved for use in individuals under 18 years of age. In case of overdose, there is no specific antidote; symptoms should prompt immediate medical attention and treatment. Finally, this medication should be kept out of reach of children, and it is safer to maintain it in its original packaging.

Side effects

COVID-19, headache, dizziness, muscle pain, joint pain, indigestion, palpitations, hyperlipidemia, pruritus, liver abscess, acute sinusitis, bronchitis, impetigo, shingles, athlete's foot, nasopharyngitis, pharyngolaryngitis, periodontitis, chronic inflammatory demyelinating polyneuropathy, sensory loss, polyneuropathy, neuropathy, facial paralysis, altered sensation, back pain, neck pain, osteoarthritis, muscle weakness, joint disease, plantar fasciitis, limb pain, intervertebral disc disorder, gastroesophageal reflux disease, colitis, inguinal hernia, irritable bowel syndrome, abdominal distension, epigastric pain, dysphagia, nausea, gastritis, diverticulosis, voice disorder, nasal congestion, dyspnea, varicose veins, hypertension, flushing, heat sensation flushing, cataract, dry eyes, diabetic retinopathy, retinal detachment, star-shaped vitreous degeneration, posterior capsule opacification, blepharitis, gout, chest discomfort, death, chest pain, urticaria, rash, hair loss, bladder mass, urge urinary incontinence, urgency, gynecomastia in males, breast mass, breast pain, prostatic cyst, decreased hemoglobin, increased serum triglycerides, recurrent liver cancer, non-sinusoidal papilloma, colonic and rectal adenoma, cholecystitis, hepatitis, fatty liver disease, gallbladder dysfunction, periprosthetic fracture, eye contusion, cartilage damage, ear pain, depression, type I bipolar disorder, mixed anxiety and depressive disorder, cataract surgery, erectile dysfunction, decreased libido, ejaculatory disorder, gynecomastia, testicular pain, testicular swelling, myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, ventricular arrhythmia, tachycardia, headache, epigastric pain, muscle pain, low back pain, nasopharyngitis, diarrhea, limb pain, dizziness, gastroesophageal reflux, epigastric pain, nausea, vomiting, joint pain, muscle cramps, myasthenia, facial edema, fatigue, pain, peripheral edema, angina pectoris, chest pain, hypotension, myocardial infarction, orthostatic hypotension, palpitations, syncope, tachycardia, abnormal liver function test results, dry mouth, dysphagia, esophagitis, increased GGTP, loose stools, nausea, epigastric pain, vomiting, gastroesophageal reflux, hemorrhoidal bleeding, rectal bleeding, joint pain, neck pain, dizziness, sensory loss, insomnia, paresthesia, drowsiness, vertigo, renal impairment, dyspnea, epistaxis, pharyngitis, itching, rash, sweating, blurred vision, color vision disturbances, conjunctivitis, eye pain, increased tear secretion, eyelid swelling, sudden hearing loss or reduction, tinnitus, increased penile erection, spontaneous penile erection, priapism, angioedema, electrocardiogram abnormalities, primary sinus bradycardia, facial flushing, limb discomfort, facial edema, decreased semen, flushing, insomnia, abdominal pain, diarrhea, discomfort in the epigastrium, allergy, fever, congestion, xerostomia, constipation, cramps, hemifacial spasm, vomiting, colonic polyps, weakness, deep vein thrombosis, chills, gastroesophageal reflux, hemorrhoids, pain, pneumonia, pulmonary embolism, lung cancer, thromboembolic stroke, chills, skeletal 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 prevent air or moisture from entering. It is advisable to store it in a temperature range between 1 to 30 degrees Celsius, avoid extreme heat or cold.

Appearance and packaging

Appearance

White rectangular 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.