Medication info

Cialafil Oral Film 20 mg (Tadalafil)

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

MFDS item code 201804693 · Approved 2018.11.27

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 in whom tadalafil 10mg does not produce a sufficient effect, 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 without water. Long-term safety following extended daily dosing has not been established, and because the effect of this medicine usually lasts for more than a day, continuous daily administration of this medicine is strongly discouraged. [See Sections 1. Warnings and 11.1) Pharmacodynamic Properties] Use in elderly men Dose adjustment is not required in elderly 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 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 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 Dose adjustment is not required in patients with diabetes.
Child dose
Do not use in people under 18 years of age.

Ingredients

Manufacturer
iWorld 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. However, sexual stimulation is required to achieve effectiveness, and it is not indicated for women. Patients should consider this point when using the medication, as it will help in improving erectile dysfunction.

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 in whom tadalafil 10mg does not produce a sufficient effect, 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 without water. Long-term safety following extended daily dosing has not been established, and because the effect of this medicine usually lasts for more than a day, continuous daily administration of this medicine is strongly discouraged. [See Sections 1. Warnings and 11.1) Pharmacodynamic Properties] Use in elderly men Dose adjustment is not required in elderly 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 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 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 Dose adjustment is not required in patients with diabetes.

Child dose

Do not use in people under 18 years of age.

Precautions

This medication is prescribed for the treatment of erectile dysfunction, and a doctor's diagnosis and physical examination must be conducted to identify any underlying causes before use. Sexual activity can put a strain on the heart, so patients with cardiovascular disease must have their heart condition thoroughly evaluated before taking this medication. If an erection lasts longer than 4 hours after taking this medication, immediate medical attention must be sought, as untreated cases can lead to penile tissue damage and permanent erectile dysfunction. This medication should not be used in conjunction with nitrates, as there is a risk of excessive hypotension; patients taking nitrates should not use this medication. Use of this medication is contraindicated in patients with severe cardiovascular diseases such as myocardial infarction, unstable angina, heart failure, or stroke. It should also not be taken by individuals with hereditary retinal disease or hypersensitivity to any component of the product. Combining it with other erectile dysfunction medications is not recommended due to unverified safety and efficacy. Patients with penile deformities or certain blood disorders should use this medication cautiously, and those with severe renal or liver impairment also require special attention. When taken with some antihypertensive medications or alpha-blockers, blood pressure reduction may become more severe, so consultation with a physician is necessary. The most common side effects of this medication include headaches, dyspepsia, back pain, muscle pain, flushing, etc., and most are mild or transient. Rarely, serious cardiovascular adverse reactions, vision loss, hearing reduction, allergic reactions, etc., have been reported; if any abnormal symptoms occur, it is essential to inform a physician immediately. It is not recommended for use in pregnant or breastfeeding women, children, or infants. This medication does not significantly affect driving or operating machinery, but dizziness may occur, so it is advisable to check your state after taking it. In case of overdose, standard treatment should be followed, as hemodialysis has little impact on the excretion of this medication. When storing this medication, keep it out of reach of children and maintain it in its original packaging.

Side effects

  • Priapism
  • headache
  • dyspepsia
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
Show 120 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
  • muscle weakness
  • facial edema
  • fatigue
  • pain
  • peripheral edema
  • abnormal liver function test results
  • dry mouth
  • dysphagia
  • esophagitis
  • gastritis
  • elevated GGTP
  • loose stools
  • nausea
  • epigastric pain
  • vomiting
  • gastroesophageal reflux
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory loss
  • insomnia
  • paresthesia
  • drowsiness
  • vertigo
  • kidney impairment
  • dyspnea
  • epistaxis
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • color vision disturbance
  • conjunctivitis
  • eye pain
  • increased tear production
  • eyelid edema
  • sudden decrease or loss of hearing
  • tinnitus
  • increase in erection
  • spontaneous penile erection
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizures and recurrence of seizures
  • 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
  • elevated SGPT
  • chest pressure sensation
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • heartburn
  • 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 cramps
  • increased bilirubin
  • ejaculation disorder
  • pain in external genitalia
  • erythema
  • itching
  • penile dysfunction
  • myocardial infarction
  • ear ringing
  • epistaxis
  • nasal dryness
  • 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 must be stored in a tightly sealed container. It is important to keep the storage temperature between 1 and 30 degrees Celsius to safely maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

White rectangular oral film

Package unit

10 films/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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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.