Medication info
Jetrafil 5mg (Tadalafil)

Jetrafil 5mg (Tadalafil)

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

MFDS item code 201506289 · Approved 2015.08.31

Summary

Main use
Treatment of symptoms of erectile dysfunction, benign prostatic hyperplasia, or both conditions when they coexist
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 who are expected to use tadalafil frequently (at least 2 times a week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. The suitability of continuous daily dosing should be reassessed periodically. 2. Once-daily use 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 use 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 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 The once-daily dose has not been evaluated in patients with hepatic impairment. Therefore, when prescribing, 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
● Use in children and adolescents This medicine should not be used in people under 18 years of age.

Ingredients

Manufacturer
CMG Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is primarily effective for the treatment of erectile dysfunction when there is sexual stimulation and is not intended for use in women. It also helps alleviate various symptoms caused by benign prostatic hyperplasia. Additionally, male patients with both erectile dysfunction and benign prostatic hyperplasia can improve both conditions with this medication. Therefore, this medication is used to treat symptoms related to erectile dysfunction and prostatic hypertrophy.

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 who are expected to use tadalafil frequently (at least 2 times a week), the recommended dose is up to 5mg once daily, taken at approximately the same time each day. The suitability of continuous daily dosing should be reassessed periodically. 2. Once-daily use 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 use 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 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 The once-daily dose has not been evaluated in patients with hepatic impairment. Therefore, when prescribing, 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

● Use in children and adolescents 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. Before using this medication, patients must receive a doctor's evaluation, including an assessment of their overall health status concerning their heart condition. Sexual activity may put stress on the heart; therefore, it should only be used after consulting with a physician in cases of cardiovascular disease. If an erection lasts longer than 4 hours, immediate medical attention is required; delayed treatment may lead to tissue damage in the penis and loss of erectile function. This medication should not be used in conjunction with nitrates due to the risk of excessive blood pressure drop; patients currently taking nitrates should not use this medication. Patients with a history of cardiovascular diseases such as myocardial infarction, angina, or stroke should not use this medication; particularly, those who have recently experienced a myocardial infarction or stroke are contraindicated. Patients with genetic retinal disease or specific lactose intolerances should also avoid this medication. It is not recommended to combine with other erectile dysfunction treatments, and patients with severe kidney or liver dysfunction should use it cautiously. Patients taking alpha-blockers or antihypertensives should discuss with their doctors due to the potential for blood pressure reduction. This medication may cause side effects such as headaches, dyspepsia, back pain, myalgia, flushing, limb pain, dizziness, cough, diarrhea, nasopharyngitis, upper respiratory infections, gastroesophageal reflux disease, abdominal pain, itching, rash, sweating, eye pain, increased tear production, eyelid edema, tinnitus, spontaneous erections, increased blood pressure, decreased hemoglobin, thrombocytopenia, drowsiness, insomnia, paresthesia, sensory loss, vertigo, dry mouth, dysphagia, gastritis, and vomiting. If sudden vision loss or hearing decrease occurs during use, stop using the medication immediately and seek medical attention. This medication is not intended for use in pregnant or breastfeeding women or in children. Caution is advised when driving or operating machinery due to potential dizziness.

Side effects

  • headache
  • dyspepsia
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • rhinitis
  • upper respiratory tract infection
  • cough
Show 79 more
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • urinary tract infection
  • gastritis
  • upper abdominal pain
  • nausea
  • vomiting
  • arthralgia
  • muscle cramps
  • hypertension
  • increased blood urea nitrogen
  • tachycardia
  • palpitations
  • eye congestion
  • increased SGPT
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • renal 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
  • ejaculatory dysfunction
  • pain in external genitalia
  • erythema
  • itching
  • penile dysfunction
  • myocardial infarction
  • tinnitus
  • epistaxis
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • allergic reaction
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin
  • priapism
  • vascular edema
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizures
  • transient global amnesia
  • visual field deficits
  • retinal vein occlusion
  • retinal artery occlusion
  • reduced vision
  • decreased or loss of hearing
  • tinnitus
  • increased erection
  • spontaneous penile erection

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

Storage

Store this medication in a tightly sealed container to protect it from air and humidity. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage can maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets (10 tablets/PTP packaging x 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.