Medication info

Tara Tablet 20 mg (Tadalafil)

Prescription medicationApproval withdrawn
Ingredient · strength
Tadalafil›Strength being verified
Manufacturer / importer
RP Bio Co., Ltd.
Appearance
Yellow, film-coated tablet in a triangular shape with rounded corners and a score line.
Packaging
8 tablets (8 tablets/PTP*1)
Approval status
Approval withdrawn

MFDS item code 201503597 · Approved 2015.06.04

This product's status changed to Approval withdrawn on 2023.03.15. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of erectile dysfunction
Who uses it
Adults · Children
Adult dosage
Use in adult men The recommended dose of this medicine is 10mg, taken before anticipated sexual activity, regardless of meals. For patients who do not achieve a sufficient effect with tadalafil 10mg, 20 mg may be tried. This medicine may be administered at least 30 minutes before sexual activity. The maximum recommended frequency is once daily. Long-term safety after extended daily dosing has not been established, and because the effects of this medicine usually last for more than one day, continuous daily administration is strongly discouraged. [See section 1. Warnings and 11.1) Pharmacodynamic Properties] Use in elderly men No dosage adjustments are required in elderly patients. Use in men with renal impairment No dosage adjustment is required in patients with mild to moderate renal impairment. The maximum recommended dose for patients with severe renal impairment is 10mg. [See 11.2) Pharmacokinetic Properties]. Use in men with hepatic impairment The recommended dose of this product is 10mg, taken before anticipated sexual activity, regardless of meals. Since clinical data on the safety of this product in patients with severe hepatic impairment (Child-Pugh Class C) are limited, the physician should carefully assess the individual benefit/risk when prescribing it. There are no data on administration of doses higher than 10mg to patients with hepatic impairment. [See section 3. Use with Caution in the Following Patients and 11.2) Pharmacokinetic Properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.
Children's dosage
This medicine should not be used in persons under 18 years of age.

Ingredients

Manufacturer
RP Bio Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used to treat erectile dysfunction, which is a male sexual dysfunction. Please remember that sexual stimulation is necessary for this product to be effective. Additionally, this medication is not intended for use by females, thus it is suitable for men. It helps improve erectile dysfunction and restore confidence.

Dosage and Administration

Adult dosage

Use in adult men The recommended dose of this medicine is 10mg, taken before anticipated sexual activity, regardless of meals. For patients who do not achieve a sufficient effect with tadalafil 10mg, 20 mg may be tried. This medicine may be administered at least 30 minutes before sexual activity. The maximum recommended frequency is once daily. Long-term safety after extended daily dosing has not been established, and because the effects of this medicine usually last for more than one day, continuous daily administration is strongly discouraged. [See section 1. Warnings and 11.1) Pharmacodynamic Properties] Use in elderly men No dosage adjustments are required in elderly patients. Use in men with renal impairment No dosage adjustment is required in patients with mild to moderate renal impairment. The maximum recommended dose for patients with severe renal impairment is 10mg. [See 11.2) Pharmacokinetic Properties]. Use in men with hepatic impairment The recommended dose of this product is 10mg, taken before anticipated sexual activity, regardless of meals. Since clinical data on the safety of this product in patients with severe hepatic impairment (Child-Pugh Class C) are limited, the physician should carefully assess the individual benefit/risk when prescribing it. There are no data on administration of doses higher than 10mg to patients with hepatic impairment. [See section 3. Use with Caution in the Following Patients and 11.2) Pharmacokinetic Properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Children's dosage

This medicine should not be used in persons under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction, and before use, a physician must verify the underlying causes through the patient's medical history and physical examination. Sexual activity can place stress on the heart, so it is essential to assess the stability of cardiovascular conditions. If an erection lasts longer than four hours after taking this medication, seek medical assistance immediately, as failure to treat may result in penile tissue damage and loss of erectile function. Concurrent use with nitrate medications or NO donors can cause dangerously low blood pressure, so these medications should not be taken before or after taking this drug. Patients with recent myocardial infarction, unstable angina, heart failure, uncontrolled hypertension or hypotension, serious arrhythmias, or a history of stroke should not use this medication. Patients with genetic retinal diseases or allergies to this medication's components should also refrain from use. The safety and efficacy of using this drug in conjunction with other erectile dysfunction treatments have not been established, and therefore such combination is not recommended. Patients with severe renal or liver impairment require caution when taking this medication, and co-administration with alpha-blockers may cause symptoms of low blood pressure, so it is advisable to avoid this combination. This medication may have side effects such as headache, dyspepsia, back pain, myalgia, facial flushing, and more serious adverse cardiovascular reactions or vision and hearing loss have been reported rarely. If sudden loss of vision or hearing occurs during use, discontinue immediately and seek medical attention. Caution is advised when consuming with alcohol as it may exacerbate blood pressure lowering and dizziness. This medication should not be used in pregnant women or children, and caution should be exercised when driving or operating machinery after confirming individual response. In overdose cases, standard treatment should be initiated, and hemodialysis has little effect on this medication's elimination. This product should be stored out of the reach of children, and it is advisable to maintain the original packaging.

Side effects

  • Priapism
  • prolonged erection
  • headache
  • dyspepsia
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
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  • upper respiratory infection
  • cough
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • urinary tract infection
  • gastritis
  • hypertension
  • 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
  • upper abdominal pain
  • vomiting
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory loss
  • insomnia
  • paresthesia
  • drowsiness
  • vertigo
  • renal impairment
  • dyspnea
  • epistaxis
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • color vision anomaly
  • conjunctivitis
  • eye pain
  • increased tear production
  • eyelid swelling
  • sudden hearing loss
  • hearing loss
  • tinnitus
  • increased erection
  • spontaneous penile erection
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • angioedema
  • electrocardiogram abnormalities
  • primary bradycardia
  • increased blood urea nitrogen
  • ocular congestion
  • increased SGPT
  • chest pressure sensation
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • heartburn
  • gastrointestinal diseases
  • drowsiness
  • increased white blood cell count
  • thrombocytopenia
  • anxiety
  • sleep disorders
  • decreased hemoglobin
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • xerophthalmia
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorder
  • external genital pain
  • erythema
  • itching
  • penile disorder
  • myocardial infarction
  • ear ringing
  • epistaxis
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin
  • chills
  • skeletal pain

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 infiltration. Additionally, it is important to store the medicine at room temperature between 1 degree and 30 degrees Celsius. This helps to maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Yellow, film-coated tablet in a triangular shape with rounded corners and a score line.

Package unit

8 tablets (8 tablets/PTP*1)

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

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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.