Medication info
Centrip Oral Disintegrating Film 10mg (Tadalafil)

Centrip Oral Disintegrating Film 10mg (Tadalafil)

Prescription medicationOral
Ingredient · strength
Tadalafil›10mg / 1 sheet
Manufacturer / importer
CL Pharm Co., Ltd.
Appearance
Yellow rectangular oral disintegrating film
Packaging
1 film/package, 5 packages/box, 10 packages/box
Approval status
Active

MFDS item code 201501976 · Approved 2015.04.10

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
Use in adult men The recommended dose of this drug 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 drug may be taken at least 30 minutes before sexual activity. The maximum recommended dosing 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 elderly men No dosage adjustments are necessary in elderly patients. Use in men with renal impairment No dosage adjustment is necessary 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 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 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 dosage adjustment is necessary in patients with diabetes.
Child dose
Should not be used in persons under 18 years of age.

Ingredients

Manufacturer
CL Pharm 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, it is important to note that sexual stimulation is required to see the effects of this medication. Additionally, this medication is only suitable for the treatment of erectile dysfunction in men and should not be used in women. Therefore, it may help improve sexual function.

How to take

Adult dose

Use in adult men The recommended dose of this drug 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 drug may be taken at least 30 minutes before sexual activity. The maximum recommended dosing 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 elderly men No dosage adjustments are necessary in elderly patients. Use in men with renal impairment No dosage adjustment is necessary 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 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 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 dosage adjustment is necessary in patients with diabetes.

Child dose

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

Precautions

This medication is used as a treatment for erectile dysfunction, and the underlying cause must be confirmed through medical history and a physical examination before taking it. Since sexual activity can put strain on the heart, patients with cardiovascular diseases should use it with caution after consulting with a doctor. An erection lasting more than 4 hours is a serious side effect, and immediate medical assistance should be sought, as untreated cases may result in permanent damage. This medication should not be taken with nitrate drugs or nitric oxide donors, as it can cause a dangerously low blood pressure. Patients currently taking such medications should avoid using this drug. Patients with serious cardiovascular diseases such as myocardial infarction, stroke, or unstable angina should not take this medication, and those with cardiovascular risk factors should exercise caution as well. This drug may affect sperm production, so it is advisable to consult a doctor regarding reproductive health with long-term use. Patients with specific heart conditions or hereditary retinal diseases should avoid using this medication, and it is not recommended to combine with other erectile dysfunction treatments. Patients with penile deformities or blood disorders should carefully use this medication. Patients with severely impaired liver or kidney function must consult a doctor regarding dosage adjustment or use. When combined with alpha-blockers or potent CYP3A4 inhibitors, there may be an increased risk of side effects, so caution is advised. This medication is not to be used by women, children, or infants. It does not significantly affect driving or operation of machinery, but caution is advised as some may experience dizziness. In cases of overdose, standard treatment should be administered, and dialysis may not be very effective in removing this drug from the body. This medication should be kept out of reach of children and stored in its original packaging. While taking this medication, side effects such as headache, dyspepsia, back pain, muscle pain, flushing, limb pain, dizziness, diarrhea, upper respiratory infection, gastroesophageal reflux disease, abdominal pain, nasopharyngitis, gastritis, hypertension, cough, facial flushing, itching, facial swelling, paresthesia, visual disturbances, palpitations, vomiting, nausea, fatigue, neck stiffness, urethral pain, kidney pain, dry mouth, heartburn, gastrointestinal disorders, drowsiness, elevated white blood cell count, thrombocytopenia, anxiety, and sleep disturbances may occur. If severe symptoms arise, immediate consultation with a doctor is needed. If sudden vision loss or hearing reduction occurs, discontinue use immediately and seek medical attention.

Side effects

  • Headache
  • dyspepsia
  • low back pain
  • myalgia
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
Show 108 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
  • abnormal liver function test results
  • 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 deficiency
  • conjunctivitis
  • eye pain
  • increased tear production
  • eyelid edema
  • sudden hearing decrease or loss
  • tinnitus
  • increased erections
  • spontaneous penile erection
  • priapism
  • angioedema
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field deficit
  • retinal vein occlusion
  • retinal artery occlusion
  • decreased vision
  • increased blood urea nitrogen
  • chest pressure
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • renal colic
  • heartburn
  • 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
  • ejaculation disorders
  • pain in external genitalia
  • erythema
  • penile disorders
  • tinnitus
  • 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 should be stored in a tightly closed container to protect it from air and moisture, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the medication’s efficacy over time.

Appearance and packaging

Appearance

Yellow rectangular oral disintegrating film

Package unit

1 film/package, 5 packages/box, 10 packages/box

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.