Medication info

Garesasan 10 mg (Tadalafil)

Prescription medicationOral
Ingredient · strength
Tadalafil›10mg / 1 packet
Manufacturer / importer
Anguk Pharmaceutical Co., Ltd.
Appearance
White or light yellow powder
Packaging
450 mg/pack x 10
Approval status
Active

MFDS item code 201505612 · Approved 2015.08.13

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
For oral administration. Use in adult men The recommended dose of this medicine is 10mg, taken with or without food before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide an adequate effect, 20mg may be tried. This medicine may be taken at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Long-term safety after extended daily dosing has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration is strongly not recommended. [See sections 1. Warnings and 11.1) Pharmacodynamic properties] Use in elderly men No dosage adjustment is 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 in patients with severe renal impairment is 10mg. [See section 11.2) Pharmacokinetic properties]. Use in men with hepatic impairment The recommended dose is 10mg, taken with or without food before anticipated sexual activity. Since clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited, if it is prescribed, the physician should carefully assess the individual benefit/risk. There are no data on administration of doses higher than 10mg to patients with hepatic impairment. [See sections 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.
Child dose
People under 18 years of age: This medicine should not be used.

Ingredients

Manufacturer
Anguk Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used for the treatment of erectile dysfunction. Sexual stimulation is required for the effect, and it is suitable only for men. It is not recommended for use in women.

How to take

Adult dose

For oral administration. Use in adult men The recommended dose of this medicine is 10mg, taken with or without food before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide an adequate effect, 20mg may be tried. This medicine may be taken at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Long-term safety after extended daily dosing has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration is strongly not recommended. [See sections 1. Warnings and 11.1) Pharmacodynamic properties] Use in elderly men No dosage adjustment is 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 in patients with severe renal impairment is 10mg. [See section 11.2) Pharmacokinetic properties]. Use in men with hepatic impairment The recommended dose is 10mg, taken with or without food before anticipated sexual activity. Since clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited, if it is prescribed, the physician should carefully assess the individual benefit/risk. There are no data on administration of doses higher than 10mg to patients with hepatic impairment. [See sections 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.

Child dose

People under 18 years of age: This medicine should not be used.

Precautions

This medication is used for the treatment of erectile dysfunction. Before taking it, a doctor must thoroughly evaluate the patient's health status, especially cardiac and vascular conditions. Sexual activity can put a strain on the heart, so its use may be risky for patients with cardiovascular diseases. If chest pain, palpitations, or dizziness occur during or after sexual activity, sexual activity should be stopped immediately and medical attention sought. If an erection lasts longer than 4 hours after taking this medication, immediate medical attention is required to prevent damage to the penile tissue. This drug should not be used in conjunction with nitrates, as it can cause a dangerous drop in blood pressure; patients taking nitrates should not use this medication. Patients with serious cardiovascular issues such as myocardial infarction, angina, heart failure, or stroke are also prohibited from taking this medication. Additionally, it should not be used in cases of inherited retinal diseases or specific ophthalmic diseases. It is not recommended to use this medication in combination with other erectile dysfunction treatments, as safety has not been established. Patients with severe kidney or liver impairment should be particularly careful when using this medication, and dosage adjustments may be necessary. Drug interactions may occur if taken in conjunction with alpha-blockers, certain antifungals, or antibiotics; patients must inform their doctor of all medications they are taking. This medication should not be used in women, children, or newborns. Common side effects during use include dizziness, headache, dyspepsia, back pain, myalgia, flushing, limb pain, dizziness, diarrhea, nasopharyngitis, upper respiratory infection, cough, gastroesophageal reflux disease, abdominal pain, facial flushing, itching, paresthesia, visual disturbances, palpitations, vomiting, nausea, fatigue, neck stiffness, urethral pain, renal pain, dry mouth, heartburn, gastrointestinal disorders, drowsiness, leukocytosis, thrombocytopenia, anxiety, sleep disturbance, eye pain, chest pain, joint pain. While under this medication, if sudden vision loss or hearing loss occurs, it should be stopped immediately and medical attention sought. In case of overdose, immediate medical attention is required, and dialysis is not effective for the removal of this medication. This medication should be stored out of reach of children and kept in its original packaging for safety. It does not significantly affect driving or machinery operation, but caution is advised as dizziness may occur in some individuals.

Side effects

  • Priapism
  • headache
  • dyspepsia
  • back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
Show 119 more
  • cough
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • urinary tract infection
  • gastroenteritis
  • 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
  • gastroesophageal reflux
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory loss
  • insomnia
  • paresthesia
  • drowsiness
  • vertigo
  • renal impairment
  • dyspnea
  • nasal bleeding
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • color vision abnormalities
  • conjunctivitis
  • eye pain
  • increased tear secretion
  • eyelid swelling
  • sudden hearing loss or decrease
  • tinnitus
  • increased erection
  • spontaneous penile erection
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizures
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • angioedema
  • ECG abnormalities
  • primary bradycardia
  • increased blood urea nitrogen
  • eye congestion
  • increased SGPT
  • chest pressure
  • 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
  • ocular bleeding
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eyes
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorders
  • pain in external genitalia
  • erythema
  • itching
  • penile dysfunction
  • proctalgia
  • myocardial infarction
  • ear ringing
  • nasal bleeding
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin
  • no effect
  • chills
  • skeletal pain

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

Storage

This medication should be stored in a closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White or light yellow powder

Package unit

450 mg/pack x 10

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.