Medication info

Starafil Oral Dissolving Film 20 mg (Tadalafil)

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

MFDS item code 201507480 · Approved 2015.10.30

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
Use in adult men The recommended dose of this medicine is 10mg, taken with or without food before anticipated sexual activity. For patients who do not achieve an adequate effect with tadalafil 10mg, 20 mg may be tried. This medicine may be taken at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Immediately after removing this medicine from its individual package, place it on the tongue and allow it to dissolve; take it without water. 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 of this medicine is strongly discouraged. [See sections 1. Warnings and 11.1) Pharmacodynamic properties] Use in elderly men Dosage adjustments are not 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. Clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited; therefore, 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 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
This medicine should not be used by anyone under 18 years of age.

Ingredients

Manufacturer
(Co., Ltd. ) PharmGen Science

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used for the treatment of erectile dysfunction, and sexual stimulation is necessary to achieve its effect. Please also note that this medication is not intended for use by women. It helps improve erectile dysfunction symptoms in men.

How to take

Adult dose

Use in adult men The recommended dose of this medicine is 10mg, taken with or without food before anticipated sexual activity. For patients who do not achieve an adequate effect with tadalafil 10mg, 20 mg may be tried. This medicine may be taken at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Immediately after removing this medicine from its individual package, place it on the tongue and allow it to dissolve; take it without water. 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 of this medicine is strongly discouraged. [See sections 1. Warnings and 11.1) Pharmacodynamic properties] Use in elderly men Dosage adjustments are not 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. Clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited; therefore, 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 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

This medicine should not be used by anyone under 18 years of age.

Precautions

This medication is indicated for the treatment of erectile dysfunction, and the underlying cause should be identified through medical history and physical examination before taking it. Sexual activity can put a strain on the heart, so patients with unstable cardiovascular conditions should consult a doctor before taking this medication. If an erection lasts more than 4 hours after taking this medication, seek immediate medical assistance, as failure to treat may result in penile tissue damage or loss of erectile function. Taking this medication in conjunction with nitrates or NO donors can dangerously lower blood pressure; therefore, such medications should not be used while taking this medication. Patients with cardiovascular diseases such as myocardial infarction, stroke, or unstable angina should avoid taking this medication or do so with extreme caution, especially if these conditions have occurred recently. Patients with penile deformities, certain blood disorders, severely impaired kidney or liver function, or those taking certain medications should use this medication cautiously. The safety and efficacy of this medication have not been established when used in conjunction with other erectile dysfunction treatments, so co-administration is not recommended. Common side effects may include headaches, indigestion, back pain, muscle pain, flushing, and nasal congestion, while serious cardiovascular adverse reactions or vision and hearing loss have been reported rarely. This medication should not be used by women, children, or infants, and its safety in pregnant women has not been established. Caution should be exercised as combining this medication with alcohol may cause low blood pressure or dizziness. This medication is known not to significantly affect driving or machine operation; however, dizziness may occur in some individuals, so caution is necessary. In case of overdose, immediate medical attention is required, as blood dialysis does not significantly affect the elimination of this medication from the body. Store this medication in a place out of reach of children and keep it in its original packaging to maintain its condition.

Side effects

  • Headache
  • dyspepsia
  • low back pain
  • muscular pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
Show 119 more
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • urinary tract infection
  • gastroenteritis
  • hypertension
  • angina
  • chest pain
  • hypotension
  • myocardial infarction
  • orthostatic hypotension
  • palpitations
  • syncope
  • tachycardia
  • muscle weakness
  • facial edema
  • fatigue
  • pain
  • peripheral edema
  • 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
  • dizziness
  • kidney dysfunction
  • respiratory distress
  • epistaxis
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • color vision deficiency
  • conjunctivitis
  • eye pain
  • increased tear secretion
  • eyelid edema
  • sudden decrease or loss of hearing
  • tinnitus
  • increased erections
  • spontaneous penile erection
  • priapism
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizures
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • decreased vision
  • angioedema
  • abnormal ECG
  • primary tachycardia
  • increased blood urea nitrogen
  • eye congestion
  • increased SGPT
  • chest pressure sensation
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • renal pain
  • heartburn
  • gastrointestinal disorders
  • drowsiness
  • increased white blood cell count
  • thrombocytopenia
  • anxiety
  • sleep disorders
  • decreased hemoglobin
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • eye bleeding
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramping
  • increased bilirubin
  • ejaculation disorder
  • pain in external genitalia
  • erythema
  • 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 may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. Proper storage will help retain the medication's efficacy and safety for a longer period.

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.