Medication info
Tadalafil Oral Film 20 mg

Tadalafil Oral Film 20 mg

Prescription medicationOral
Ingredient · strength
Tadalafil›20mg / 1 sheet
Manufacturer / importer
CMG Pharmaceutical Co., Ltd.
Appearance
White rectangular oral dissolving film
Packaging
10 sheets/case
Approval status
Active

MFDS item code 201504230 · Approved 2015.06.30

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
Use in adult men The recommended dose is 10mg, taken regardless of meals before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This drug may be taken at least 30 minutes before sexual activity. The maximum recommended frequency is once daily. Immediately after removing this drug from its individual package, place it on the tongue and allow it to dissolve; take it without water. Long-term safety following extended daily dosing has not been established, and because the effect of this drug usually lasts for more than one day, continuous daily administration is strongly discouraged. [See section 1, Warnings, and section 11.1) Pharmacodynamic properties] Use in older men Dose adjustments are not required in older patients. Use in men with renal impairment No dose 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 regardless of meals before anticipated sexual activity. Because clinical data on the safety of this drug 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 greater than 10mg to patients with hepatic impairment. [See section 3, Patients Requiring Caution, and section 11.2) Pharmacokinetic properties]. Use in men with diabetes No dose adjustment is required in patients with diabetes.
Child dose
Do not use in persons under 18 years of age.

Ingredients

Manufacturer
CMG 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. Please be aware that sexual stimulation is necessary for the medication to take effect. Additionally, this medication is not intended for use in women.

How to take

Adult dose

Use in adult men The recommended dose is 10mg, taken regardless of meals before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This drug may be taken at least 30 minutes before sexual activity. The maximum recommended frequency is once daily. Immediately after removing this drug from its individual package, place it on the tongue and allow it to dissolve; take it without water. Long-term safety following extended daily dosing has not been established, and because the effect of this drug usually lasts for more than one day, continuous daily administration is strongly discouraged. [See section 1, Warnings, and section 11.1) Pharmacodynamic properties] Use in older men Dose adjustments are not required in older patients. Use in men with renal impairment No dose 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 regardless of meals before anticipated sexual activity. Because clinical data on the safety of this drug 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 greater than 10mg to patients with hepatic impairment. [See section 3, Patients Requiring Caution, and section 11.2) Pharmacokinetic properties]. Use in men with diabetes No dose adjustment is required in patients with diabetes.

Child dose

Do not use in persons under 18 years of age.

Precautions

This medication is for the treatment of erectile dysfunction, and before use, a thorough evaluation of the patient's condition must be conducted through a physician's diagnosis and physical examination. Sexual activity can place stress on the heart, so patients with cardiovascular diseases should be especially cautious, and if any heart-related symptoms occur during sexual activity, it should be stopped immediately and a healthcare professional consulted. This medication can rarely cause an erection lasting more than 4 hours (priapism); if the erection lasts longer than 4 hours, immediate medical assistance must be sought. Taking this medication with drugs that lower blood pressure, such as nitrates or nitric oxide donors, can lead to a risk of excessive blood pressure drop, so such medications should be avoided while taking this drug. Patients with a history of cardiovascular diseases such as heart attack, angina, or stroke should not use this medication safely; those allergic to the drug or with specific eye diseases should also avoid it. Patients with severely impaired kidney or liver function, those who have difficulty controlling blood pressure, and those taking certain antihypertensives also have a risk of hypotension, so this medication should be used cautiously under a physician's directives. This medication may cause side effects such as headaches, indigestion, back pain, muscle pain, facial flushing, etc., most of which are mild or temporary, but if symptoms are severe, consultation with a healthcare professional is recommended. There may rarely be issues with vision or hearing, so if sudden vision loss or hearing reduction occurs, the medication should be stopped immediately, and medical advice should be sought. It is not to be used in pregnant women or children, and caution should be taken when driving or operating machinery after confirming personal reactions. In case of overdose, standard emergency treatment should be received, and blood dialysis does not significantly affect the elimination of this medication. Keep the medication out of reach of children, and it is advisable to maintain it in its original packaging.

Side effects

  • Headache
  • dyspepsia
  • lower back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
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  • 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 tests
  • dry mouth
  • dysphagia
  • esophagitis
  • gastritis
  • increased GGTP
  • loose stools
  • nausea
  • epigastric pain
  • vomiting
  • gastroesophageal reflux
  • 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 defect
  • conjunctivitis
  • eye pain
  • increased tear secretion
  • eyelid swelling
  • sudden hearing decrease or loss
  • 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
  • increased blood urea nitrogen
  • chest tightness
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • renal colic
  • heartburn
  • gastrointestinal disease
  • drowsiness
  • leukocytosis
  • thrombocytopenia
  • 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
  • penile disorder
  • ear ringing
  • epistaxis
  • nasal dryness
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial edema
  • fever
  • increased SGOT
  • 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 humidity, so it should be stored in a sealed container. The recommended storage temperature is between 1 and 30 degrees Celsius. Storing it this way can help maintain its efficacy.

Appearance and packaging

Appearance

White rectangular oral dissolving film

Package unit

10 sheets/case

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.