Medication info
Europebig Tablet 5 mg (Tadalafil)

Europebig Tablet 5 mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›5mg / 1 tablet
Manufacturer / importer
Jungheon Pharm. Co., Ltd.
Appearance
Yellow, rounded triangular film-coated tablet
Packaging
30 tablets/box[((10 tablets/PTP)X3)]
Approval status
Active

MFDS item code 202107433 · Approved 2021.11.11

Summary

Main use
Treatment of erectile dysfunction, benign prostatic hyperplasia, and symptoms associated with both conditions
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 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 daily dosing should be reassessed periodically. 2. Once-daily dosing 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 dosing 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 elderly men Dose adjustments are not required in elderly patients. ● Use in men with renal impairment - Erectile dysfunction Dose adjustment is not 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, sections 3.2) and 11.2) Pharmacokinetic properties]. - Benign prostatic hyperplasia Dose adjustment is not required in patients with mild renal impairment. Once-daily tadalafil is not recommended in patients with severe renal impairment. [See Precautions for Use, sections 3.3) and 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 this medicine, the physician should carefully assess the individual benefit/risk. (See section 11. <Special populations>.) ● Use in men with diabetes Dose adjustment is not required in patients with diabetes.
Child dose
Under 18 years of age: This medicine should not be used in people under 18 years of age.

Ingredients

Manufacturer
Jungheon Pharm. Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction, benign prostatic hyperplasia, and symptoms associated with both conditions

  • Erectile dysfunction
  • signs of benign prostatic hyperplasia
  • symptoms of benign prostatic hyperplasia
View approved original text

This medication is effective for the treatment of erectile dysfunction and works when there is sexual stimulation. It also helps relieve the signs and symptoms of benign prostatic hyperplasia. It is specifically used in men who experience both erectile dysfunction and benign prostatic hyperplasia for the treatment of these two conditions. However, this medication is not suitable for women. Therefore, it is used for improvement of erectile dysfunction and prostatic enlargement 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 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 daily dosing should be reassessed periodically. 2. Once-daily dosing 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 dosing 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 elderly men Dose adjustments are not required in elderly patients. ● Use in men with renal impairment - Erectile dysfunction Dose adjustment is not 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, sections 3.2) and 11.2) Pharmacokinetic properties]. - Benign prostatic hyperplasia Dose adjustment is not required in patients with mild renal impairment. Once-daily tadalafil is not recommended in patients with severe renal impairment. [See Precautions for Use, sections 3.3) and 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 this medicine, the physician should carefully assess the individual benefit/risk. (See section 11. <Special populations>.) ● Use in men with diabetes Dose adjustment is not required in patients with diabetes.

Child dose

Under 18 years of age: This medicine should not be used in people under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction and benign prostatic hyperplasia, and a proper medical evaluation is required before use. Patients with heart disease or unstable cardiovascular conditions should consult a doctor before taking this medication, and if cardiovascular symptoms occur during sexual activity, discontinue use immediately and inform a physician. If an erection lasts longer than 4 hours, seek medical help immediately as delay in treatment may lead to tissue damage and loss of the ability to achieve an erection. Taking this medication with nitrates or NO donors can cause dangerously low blood pressure, so patients using these medications should not take this drug. Patients who have experienced serious cardiovascular conditions such as myocardial infarction, stroke, or unstable angina recently should also avoid this medication. Additionally, patients with hereditary retinal disorders or hypersensitivity to any components of this medication, or those using other erectile dysfunction treatments, should not use it. Caution should be exercised in patients with severe renal or hepatic impairment, those with difficulty controlling blood pressure, and those taking alpha-blockers or potent CYP3A4 inhibitors, as dose adjustments may be necessary. Pregnant and breastfeeding women and children should not use this medication. During treatment, adverse effects such as headache, dyspepsia, back pain, myalgia, flushing, nasal congestion, peripheral pain, pharyngitis, upper respiratory infection, cough, diarrhea, abdominal pain, dizziness, diarrhea, pain in the abdomen, increased blood urea nitrogen, tachycardia, palpitations, vomiting, nausea, fatigue, cervical stiffness, urethral pain, renal pain, dry mouth, heartburn, gastrointestinal disorders, drowsiness, increased white blood cell count, thrombocytopenia, anxiety, sleep disorders, eye pain, chest pain, and joint pain may occur. Caution is advised as combining this medication with alcohol can increase blood pressure drops and dizziness. In case of overdose, visit a medical facility immediately for appropriate treatment. Store this medication out of reach of children and preferably in its original packaging.

Side effects

  • Headache
  • indigestion
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory tract infection
  • cough
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  • diarrhea
  • urinary tract infection
  • gastroesophageal reflux disease
  • abdominal pain
  • dizziness
  • hypertension
  • priapism
  • increased blood urea nitrogen
  • tachycardia
  • palpitations
  • eye congestion
  • increased SGPT
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • dry mouth
  • heartburn
  • gastrointestinal disorders
  • drowsiness
  • increased white blood cell count
  • decreased platelets
  • anxiety
  • sleep disturbances
  • decreased hemoglobin
  • eye pain
  • chest pain
  • joint pain
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eyes
  • abdominal cramps
  • increased bilirubin
  • ejaculation dysfunction
  • pain in external genitalia
  • erythema
  • itching
  • penile disorders
  • myocardial infarction
  • tinnitus
  • nosebleeds
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reactions
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin
  • hives
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • 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 should be stored in a tightly closed container to prevent air or moisture from entering, and it is safe to store at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the efficacy of the medication and prevent degradation.

Appearance and packaging

Appearance

Yellow, rounded triangular film-coated tablet

Package unit

30 tablets/box[((10 tablets/PTP)X3)]

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.