Medication info

Cialong Oral Dissolving Film 20mg (Tadalafil)

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

MFDS item code 201805151 · Approved 2018.12.18

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
Use in adult men The recommended dose of this product is 10mg, taken with or without food before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This product may be taken at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Immediately after removing this product from its individual package, place it on the tongue and allow it to dissolve without water. Long-term safety after extended daily dosing has not been established, and because the effect of this product generally lasts for more than one day, continuous daily administration is strongly discouraged. [See section 1, Warnings, and section 12.1) Pharmacodynamic Properties] Use in older men Dosage adjustments are not required in older 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 12.2) 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 product 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, Patients Requiring Caution, and section 12.2) Pharmacokinetic Properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.
Child dose
This product should not be used in persons under 18 years of age.

Ingredients

Manufacturer
Daewon 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 and requires sexual stimulation to work effectively. Additionally, this medication is not indicated for use by women. It may help men who are experiencing difficulties with erectile dysfunction.

How to take

Adult dose

Use in adult men The recommended dose of this product is 10mg, taken with or without food before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This product may be taken at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Immediately after removing this product from its individual package, place it on the tongue and allow it to dissolve without water. Long-term safety after extended daily dosing has not been established, and because the effect of this product generally lasts for more than one day, continuous daily administration is strongly discouraged. [See section 1, Warnings, and section 12.1) Pharmacodynamic Properties] Use in older men Dosage adjustments are not required in older 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 12.2) 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 product 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, Patients Requiring Caution, and section 12.2) Pharmacokinetic Properties]. Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Child dose

This product should not be used in persons under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction; it is necessary to confirm the underlying cause through the patient's medical history and physical examination before use. Patients with cardiovascular disease may experience additional strain on the heart during sexual activity, thus it is essential to consult with a physician to adequately evaluate heart conditions before taking this medication. Seek immediate medical assistance if an erection lasts longer than 4 hours, as untreated prolonged erections can lead to penile tissue damage and permanent loss of erectile ability. This medication can cause dangerous drops in blood pressure when taken with nitrate medications, so patients taking nitrates should not use this drug. Patients with severe cardiovascular diseases such as myocardial infarction, acute cardiac arrest, unstable angina, ventricular arrhythmia, or those who have recently experienced any of these should also avoid this medication. Patients with hereditary retinal diseases or hypersensitivity to any ingredient in this medication should also refrain from taking it. Combining this medication with other erectile dysfunction treatments is not recommended due to unproven safety and efficacy. Patients with penile deformities or certain blood disorders should use this medication with caution and those with severe kidney or liver dysfunction should consult a physician before use. There may be an increased risk of side effects when using this medication alongside alpha-blockers or potent CYP3A4 inhibitors. Possible side effects include headaches, dyspepsia, back pain, muscle aches, nasal congestion, flushing, limb pain, pharyngitis, upper respiratory infection, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, facial flushing, itching, facial swelling, paresthesia, visual disturbances, palpitations, vomiting, nausea, fatigue, drowsiness, leukocytosis, thrombocytopenia, anxiety, sleep disturbances, reduced hemoglobin, eye pain, chest pain, joint pain, hyperventilation, nasal bleeding, dry nose, hiccups, and others. This medication is not to be used in women, children, or neonates, and its safety for pregnant women has not been established. It has minimal effects on driving or operating machinery, but caution should be exercised after assessing individual responses. In case of overdose, seek immediate medical attention as blood dialysis is not significantly effective in removing this medication. This medication should be kept out of the reach of children and should ideally be stored in its original packaging.

Side effects

  • Headache
  • dyspepsia
  • low back pain
  • muscle pain
  • nasal congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
Show 131 more
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • gastroenteritis
  • hypertension
  • dizziness
  • urinary tract infection
  • gastroesophageal reflux disease
  • hypertension
  • angina
  • chest pain
  • hypotension
  • myocardial infarction
  • orthostatic hypotension
  • palpitations
  • syncope
  • tachycardia
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • vision loss
  • hearing loss
  • deafness
  • tinnitus
  • persistent erection
  • angioedema
  • abnormal electrocardiogram
  • primary tachycardia
  • myasthenia
  • facial edema
  • fatigue
  • pain
  • peripheral edema
  • abnormal liver function tests
  • dry mouth
  • dysphagia
  • esophagitis
  • gastritis
  • increased GGTP
  • loose stools
  • nausea
  • upper abdominal pain
  • vomiting
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory loss
  • insomnia
  • dysesthesia
  • drowsiness
  • dizziness
  • renal impairment
  • respiratory distress
  • nasal bleeding
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • conjunctivitis
  • eye pain
  • increased tear production
  • eyelid swelling
  • sudden hearing loss
  • loss
  • penile enlargement
  • spontaneous penile erection
  • chills
  • skeletal pain
  • facial flushing
  • itching
  • dysesthesia
  • visual impairment
  • palpitations
  • facial edema
  • dizziness
  • abdominal pain
  • increased blood urea nitrogen
  • eye redness
  • increased SGPT
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • heartburn
  • gastrointestinal disease
  • drowsiness
  • leukocytosis
  • thrombocytopenia
  • anxiety
  • sleep disturbance
  • decreased hemoglobin
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eyes
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorder
  • pain in external genitalia
  • erythema
  • penile disorder
  • myocardial infarction
  • tinnitus
  • nasal bleeding
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It should be stored at room temperature between 1°C and 30°C, away from extremely hot or cold conditions.

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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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.