Medication info
Gugu Chewable Tablet 10 mg (Tadalafil)

Gugu Chewable Tablet 10 mg (Tadalafil)

Prescription medicationChewable TabletOral
Ingredient · strength
Tadalafil›10mg / 1 tablet
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
Light yellow chewable round tablet
Packaging
8 tablets (8 tablets/PTPX1)/carton
Approval status
Active

MFDS item code 201501892 · Approved 2015.04.08

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
The recommended dose of this drug is 10mg. Chew and take it regardless of meals before anticipated sexual activity. For patients who do not achieve a sufficient effect with tadalafil 10mg, 20 mg may be tried. This drug may be taken at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Long-term safety after prolonged daily dosing has not been established, and because the effect of this drug usually lasts for more than a day, continuous daily administration is strongly discouraged. [See section 1. Warnings and section 11.1) Pharmacodynamic properties] No dosage adjustment is required in elderly patients. 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]. The recommended dose of this drug is 10mg, taken regardless of meals before anticipated sexual activity. Since clinical data on the safety of this drug in patients with severe hepatic impairment (Child-Pugh Class C) are limited, if prescribing it, the physician should carefully assess the individual benefit/risk. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See section 3. Use with caution in the following patients and section 11.2) Pharmacokinetic properties]. No dosage adjustment is required in patients with diabetes.
Child dose
Should not be used in persons under 18 years of age.

Ingredients

Manufacturer
Hanmi Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used to treat erectile dysfunction. Sexual stimulation is necessary to obtain an effect, and it should not be used by women. It helps improve sexual function and contributes to a healthy lifestyle.

How to take

Adult dose

The recommended dose of this drug is 10mg. Chew and take it regardless of meals before anticipated sexual activity. For patients who do not achieve a sufficient effect with tadalafil 10mg, 20 mg may be tried. This drug may be taken at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Long-term safety after prolonged daily dosing has not been established, and because the effect of this drug usually lasts for more than a day, continuous daily administration is strongly discouraged. [See section 1. Warnings and section 11.1) Pharmacodynamic properties] No dosage adjustment is required in elderly patients. 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]. The recommended dose of this drug is 10mg, taken regardless of meals before anticipated sexual activity. Since clinical data on the safety of this drug in patients with severe hepatic impairment (Child-Pugh Class C) are limited, if prescribing it, the physician should carefully assess the individual benefit/risk. There are no data on administering doses higher than 10mg to patients with hepatic impairment. [See section 3. Use with caution in the following patients and section 11.2) Pharmacokinetic properties]. No dosage adjustment is required in patients with diabetes.

Child dose

Should not be used in persons under 18 years of age.

Precautions

This medication is used to treat erectile dysfunction, and before taking it, the underlying cause must be confirmed through a doctor's diagnosis and physical examination. Patients with heart disease or cardiovascular risk should consult a doctor before use as sexual activity may strain the heart. This medication can rarely cause an erection that lasts longer than 4 hours, which is an urgent situation requiring immediate medical attention. Taking this medication with nitrates that lower blood pressure can be dangerous, so nitrates should not be taken while using this medication. Patients who have recently experienced cardiovascular diseases such as myocardial infarction, angina, or stroke, or patients with severe hypertension or hypotension should not take this medication. Patients with certain genetic retinal diseases should not use this medication, and those with hypersensitivity to the drug should also avoid its use. Combining with other erectile dysfunction medications is not recommended as safety and efficacy have not been established. Patients with penile deformities or certain blood disorders should use this medication with caution, and patients with severely impaired kidney or liver function should also be careful. Taking this medication with some antihypertensive agents may cause blood pressure to drop too low, so it should be taken after consulting with a doctor. This medication may cause side effects such as headaches, indigestion, muscle pain, flushing, etc., and serious cardiovascular adverse reactions or visual and auditory disturbances have been reported rarely. If sudden loss of vision or hearing occurs during use, discontinue the medication immediately and consult healthcare professionals. Taking this medication with alcohol may cause low blood pressure and dizziness, so caution is advised. In case of overdose, standard emergency treatment should be received, and hemodialysis is not very helpful in removing this drug. This medication is not to be used in children, women, or pregnant women, and it should be stored in a secure place out of the reach of children. It does not significantly affect driving or operating machinery, but it is recommended to check one's condition after taking it.

Side effects

  • Prolonged erection
  • priapism
  • 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
  • gastroenteritis
  • hypertension
  • angina
  • chest pain
  • hypotension
  • myocardial infarction
  • orthostatic hypotension
  • palpitations
  • syncope
  • tachycardia
  • weakness
  • facial edema
  • fatigue
  • pain
  • peripheral edema
  • abnormal liver function test values
  • dry mouth
  • dysphagia
  • esophagitis
  • gastritis
  • increased GGTP
  • loose stools
  • nausea
  • upper abdominal pain
  • vomiting
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory impairment
  • insomnia
  • paresthesia
  • drowsiness
  • vertigo
  • renal impairment
  • dyspnea
  • epistaxis
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • color vision abnormality
  • conjunctivitis
  • eye pain
  • increased tear secretion
  • eyelid edema
  • sudden decrease or loss of hearing
  • tinnitus
  • increased erection
  • spontaneous penile erection
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field loss
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • angioedema
  • electrocardiogram abnormalities
  • primary bradycardia
  • increased blood urea nitrogen
  • decreased hemoglobin
  • thrombocytopenia
  • chest pressure
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • heartburn
  • drowsiness
  • increased white blood cell count
  • anxiety
  • sleep disturbance
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorder
  • pain in external genitalia
  • erythema
  • penile disorders
  • myocardial infarction
  • ear ringing
  • epistaxis
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial swelling
  • fever
  • increased hemoglobin
  • chills
  • skeletal pain

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the medication's effectiveness over time.

Appearance and packaging

Appearance

Light yellow chewable round tablet

Package unit

8 tablets (8 tablets/PTPX1)/carton

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.