Medication info
Cialtame 20mg (Tadalafil)

Cialtame 20mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›20mg / 1 tablet
Manufacturer / importer
Daewoong Bio Co., Ltd.
Appearance
Yellow film-coated tablets in a triangular shape with rounded corners and a score line
Packaging
8 tablets (8 tablets/PTP × 1)
Approval status
Active

MFDS item code 201901043 · Approved 2019.02.20

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 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 medicine may be taken at least 30 minutes before sexual activity. The maximum recommended frequency of administration is once daily. Long-term safety following extended daily dosing has not been established, and since 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 No dosage adjustments are 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 of this product is 10mg, taken regardless of meals before anticipated sexual activity. Since 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 greater 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 in persons under 18 years of age.

Ingredients

Manufacturer
Daewoong Bio 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 be effective. Please note that this medication is not to be used by women. It is designed to assist patients who are experiencing difficulties with erectile dysfunction.

How to take

Adult dose

Use in adult men The recommended dose of this medicine 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 medicine may be taken at least 30 minutes before sexual activity. The maximum recommended frequency of administration is once daily. Long-term safety following extended daily dosing has not been established, and since 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 No dosage adjustments are 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 of this product is 10mg, taken regardless of meals before anticipated sexual activity. Since 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 greater 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 in persons under 18 years of age.

Precautions

This medication is for the treatment of erectile dysfunction, and a medical diagnosis and physical examination must be conducted to identify the underlying cause before use. Sexual activity may strain the heart, so patients with cardiovascular diseases should have their heart condition thoroughly evaluated before taking this medication. If an erection lasts for more than 4 hours after taking this medication, immediate medical attention should be sought as ignoring this condition may lead to penile tissue damage or loss of erectile function. Taking this medication with nitrates (blood pressure-lowering agents) or NO donors may cause a dangerous drop in blood pressure; therefore, patients taking these medications should not use this product. Patients who have recently experienced serious cardiovascular diseases like myocardial infarction, unstable angina, heart failure, or stroke should not take this medication. Patients with hereditary retinal diseases or certain ophthalmic conditions are also advised against using this medication. Combining with other erectile dysfunction treatments is not recommended due to safety uncertainties. Patients with severely impaired kidney or liver function should be cautious when using this medication and consult a physician if liver function is severely compromised. Some antihypertensives may interact with this medication, potentially resulting in excessive blood pressure lowering; thus, patients on blood pressure medication must consult with a physician. This medication may cause side effects such as headache, dyspepsia, back pain, muscle pain, flushing, and others, most of which are mild or moderate. If sudden vision loss or hearing loss occurs during use, discontinue and seek medical advice immediately. This medication should not be used by women who are pregnant or breastfeeding, or by children and adolescents. This medication does not significantly affect driving or machine operation, but it is advisable to assess one’s own reactions after use. In case of overdose, standard medical treatment should be administered; blood dialysis does not effectively eliminate this medication. Store out of reach of children and maintain its original packaging. This medication is metabolized by certain enzymes and may interact with other drugs, so inform your doctor or pharmacist of any other medications being taken. When taken with alcohol, there may be a risk of low blood pressure or dizziness, so caution is advised.

Side effects

  • headache
  • dyspepsia
  • low back pain
  • muscle pain
  • nasal congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory tract infection
  • cough
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  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • gastroenteritis
  • hypertension
  • urinary tract infection
  • upper abdominal pain
  • nausea
  • vomiting
  • joint pain
  • muscle spasm
  • color vision changes
  • priapism
  • elevated blood urea nitrogen
  • tachycardia
  • palpitations
  • eye congestion
  • increased SGPT
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • dry mouth
  • heartburn
  • gastrointestinal disease
  • drowsiness
  • increased leukocyte count
  • decreased platelet count
  • anxiety
  • sleep disorders
  • decreased hemoglobin
  • eye pain
  • chest pain
  • joint pain
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramping
  • increased bilirubin
  • erectile dysfunction
  • pain in external genitals
  • erythema
  • itching
  • penile dysfunction
  • myocardial infarction
  • tinnitus
  • nosebleeds
  • dry nose
  • increased serum creatinine
  • hiccups
  • fatigue
  • abdominal discomfort
  • allergic reactions
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin
  • hives
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizures
  • transient global amnesia
  • visual field loss
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • angioedema
  • angioedema
  • sudden decrease or loss of hearing
  • tinnitus
  • increased erection
  • spontaneous penile erection

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

Storage

Store this medication in a tightly sealed container to protect it from air and moisture. It is also preferable to keep it at room temperature, between 1 to 30 degrees Celsius, avoiding overly hot or cold places.

Appearance and packaging

Appearance

Yellow film-coated tablets in a triangular shape with rounded corners and a score line

Package unit

8 tablets (8 tablets/PTP × 1)

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.

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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.