Medication info
Bultium Tablet 5 mg (Tadalafil)

Bultium Tablet 5 mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›5mg / 1 tablet
Manufacturer / importer
(Co., Ltd.) Seoul Pharma
Appearance
Yellow oval film-coated tablet
Packaging
30 tablets (10 tablets/ PTP * 3)
Approval status
Active

MFDS item code 201503139 · Approved 2015.05.26

Summary

Main use
Treatment of symptoms of erectile dysfunction, benign prostatic hyperplasia, or 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 twice a week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. The appropriateness of continuous daily treatment should be reassessed periodically. 2. Once-daily regimen 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 regimen 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 No dosage adjustments are required in elderly patients. ● Use in men with renal impairment - Erectile dysfunction No dose adjustment is required in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See Precautions for Use 3.2) and Pharmacokinetic Properties 11.2).] - Benign prostatic hyperplasia No dose adjustment is required in patients with mild renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See Precautions for Use 3.3) and Pharmacokinetic Properties 11.2).] ● 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 No dose adjustment is required in patients with diabetes.
Child dose
Do not use in people under 18 years of age.

Ingredients

Manufacturer
(Co., Ltd.) Seoul Pharma

Efficacy & effects

Treatment of symptoms of erectile dysfunction, benign prostatic hyperplasia, or both conditions

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

This medication is used for the treatment of erectile dysfunction and requires sexual stimulation for effect. It is also not indicated for use in women. It is effective in improving the signs and symptoms of benign prostatic hyperplasia. When erectile dysfunction and benign prostatic hyperplasia occur together in men, this medication is used to treat both conditions simultaneously. In summary, this medication helps improve the symptoms of erectile dysfunction and benign prostatic hyperplasia, thereby enhancing the quality of life.

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 twice a week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. The appropriateness of continuous daily treatment should be reassessed periodically. 2. Once-daily regimen 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 regimen 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 No dosage adjustments are required in elderly patients. ● Use in men with renal impairment - Erectile dysfunction No dose adjustment is required in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See Precautions for Use 3.2) and Pharmacokinetic Properties 11.2).] - Benign prostatic hyperplasia No dose adjustment is required in patients with mild renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See Precautions for Use 3.3) and Pharmacokinetic Properties 11.2).] ● 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 No dose adjustment is required in patients with diabetes.

Child dose

Do not use in people under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction and benign prostatic hyperplasia, and an appropriate medical evaluation is required before use. Sexual activity may put a strain on the heart; therefore, cardiovascular status must be evaluated. If an erection lasts longer than 4 hours, seek medical help immediately, as untreated conditions may cause damage to penile tissue. This medication should not be used in conjunction with nitrates as it can cause a dangerously low blood pressure. It is not prescribed for patients who have recently experienced cardiovascular conditions such as myocardial infarction, angina, or stroke. Patients with hereditary retinal diseases or specific lactose metabolism disorders should also not use this medication. Using it with other erectile dysfunction medications has not been proven safe and is not recommended. Patients with severely impaired kidney or liver function, as well as those taking alpha-blockers or certain antihypertensives, should use it cautiously. Adverse effects such as headaches, dyspepsia, back pain, myalgia, flushing, limb pain, nasopharyngitis, upper respiratory infection, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, itching, facial swelling, paresthesia, visual impairment, palpitations, dry mouth, dysphagia, gastritis, diarrhea, nausea, abdominal pain, vomiting, hemorrhoidal bleeding, rectal bleeding, arthralgia, neck pain, insomnia, drowsiness, dizziness, kidney disorders, shortness of breath, and nasal bleeding may occur and are generally mild. Severe cardiovascular adverse reactions and visual and auditory disorders have been reported; if symptoms occur, consult a healthcare professional immediately. It should not be used in pregnant or breastfeeding women, or children. Although use does not generally affect driving or machine operation, it is advisable to monitor individual responses. In cases of overdose, standard treatment should be provided, and blood dialysis does not significantly help in the elimination of this medication. When storing, keep it out of reach of children and maintain it in its original packaging to ensure safety.

Side effects

  • Headache
  • dyspepsia
  • low back pain
  • myalgia
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory tract infection
  • cough
Show 118 more
  • diarrhea
  • urinary tract infection
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • priapism
  • increased blood urea nitrogen
  • tachycardia
  • palpitations
  • conjunctival injection
  • increased SGPT
  • chest pressure
  • 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
  • arthralgia
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • increased bilirubin
  • sexual dysfunction
  • pain in external genitalia
  • erythema
  • itching
  • penile disorder
  • myocardial infarction
  • tinnitus
  • epistaxis
  • nasal dryness
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • allergic reaction
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • sudden hearing loss or decrease
  • tinnitus
  • angioedema
  • fatigue
  • pain
  • peripheral edema
  • angina
  • chest pain
  • hypotension
  • myocardial infarction
  • orthostatic hypotension
  • palpitations
  • syncope
  • tachycardia
  • abnormal liver function test results
  • dry mouth
  • dysphagia
  • esophagitis
  • gastritis
  • increased GGTP
  • loose stools
  • nausea
  • epigastric pain
  • vomiting
  • gastroesophageal reflux
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • dizziness
  • sensory impairment
  • insomnia
  • paresthesia
  • drowsiness
  • vertigo
  • renal impairment
  • dyspnea
  • epistaxis
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • color vision deficiency
  • conjunctivitis
  • eye pain
  • increased tear secretion
  • eyelid swelling
  • sudden hearing loss
  • spontaneous penile erection
  • increased erection

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 air or moisture from entering. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius to safely preserve the medication's effectiveness.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets (10 tablets/ PTP * 3)

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.