Medication info
Cial 5 mg (Tadalafil)

Cial 5 mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›5mg / 1 tablet
Manufacturer / importer
Unimed Pharmaceutical Co., Ltd.
Appearance
Pale yellow, drop-shaped film-coated tablets
Packaging
28 tablets (14 tablets/PTP*2)
Approval status
Active

MFDS item code 201604178 · Approved 2016.07.06

Summary

Main use
Treatment of erectile dysfunction, benign prostatic hyperplasia, and symptoms when both conditions are present
Who takes it
Adults · Children
Adult dose
Do not crush this medicine. Take one tablet whole. For oral administration. 1. Erectile dysfunction Use in adult men For patients who expect to use tadalafil frequently (at least 2 times a week), the recommended dose is up to 5mg once daily, preferably at approximately the same time each day. The suitability of continuous daily dosing should be reassessed periodically. 2. Once-daily regimen for benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time each day. 3. Once-daily regimen for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time each day, regardless of the timing of sexual activity. 4. Special populations ● Use in elderly men No dosage adjustment is required in elderly patients. ● Use in men with renal impairment - Erectile dysfunction No dosage adjustment is required in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See sections 3.2) and 11.2) Pharmacokinetic properties under Precautions for Use]. - Benign prostatic hyperplasia No dosage adjustment is required in patients with mild renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See sections 3.3) and 11.2) Pharmacokinetic properties under Precautions for Use]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, if prescribing this medicine, the physician should carefully assess the benefit/risk for each patient. (See section 11. <Special Populations>.) ● Use in men with diabetes No dosage adjustment is required in patients with diabetes.
Child dose
Persons under 18 years of age: This medicine should not be used in persons under 18 years of age.

Ingredients

Manufacturer
Unimed Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction, benign prostatic hyperplasia, and symptoms when both conditions are present

  • Erectile dysfunction
  • signs and symptoms of benign prostatic hyperplasia
View approved original text

This medication is mainly used to treat erectile dysfunction in men. Sexual stimulation is necessary to improve erectile dysfunction and it is not suitable for women. Additionally, this medication helps relieve symptoms and signs of benign prostatic hyperplasia. It is effective for men experiencing symptoms of both erectile dysfunction and benign prostatic hyperplasia simultaneously. Therefore, it is widely used to improve these symptoms in men.

How to take

Adult dose

Do not crush this medicine. Take one tablet whole. For oral administration. 1. Erectile dysfunction Use in adult men For patients who expect to use tadalafil frequently (at least 2 times a week), the recommended dose is up to 5mg once daily, preferably at approximately the same time each day. The suitability of continuous daily dosing should be reassessed periodically. 2. Once-daily regimen for benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time each day. 3. Once-daily regimen for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this medicine for once-daily use is 5mg, taken at approximately the same time each day, regardless of the timing of sexual activity. 4. Special populations ● Use in elderly men No dosage adjustment is required in elderly patients. ● Use in men with renal impairment - Erectile dysfunction No dosage adjustment is required in patients with mild to moderate renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See sections 3.2) and 11.2) Pharmacokinetic properties under Precautions for Use]. - Benign prostatic hyperplasia No dosage adjustment is required in patients with mild renal impairment. Once-daily tadalafil is not recommended for patients with severe renal impairment. [See sections 3.3) and 11.2) Pharmacokinetic properties under Precautions for Use]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, if prescribing this medicine, the physician should carefully assess the benefit/risk for each patient. (See section 11. <Special Populations>.) ● Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Child dose

Persons under 18 years of age: This medicine should not be used in persons under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction and benign prostatic hyperplasia, and appropriate medical evaluation is required before use. Patients with heart disease or unstable cardiovascular conditions must consult a physician before using this medication. If cardiovascular symptoms appear during or after sexual activity, immediately cease sexual activity and seek medical attention. An erection lasting longer than 4 hours can be a serious condition; immediate medical help is necessary, as untreated cases may lead to penile tissue damage and permanent erectile dysfunction. Co-administration with nitrate compounds or NO donors can result in a sudden drop in blood pressure, so these medications should not be taken while using this medication. Patients who have recently experienced severe cardiovascular diseases such as myocardial infarction, angina, or stroke must not use this medication. Patients with genetic retinal diseases or certain allergies should also refrain from using this medication. Combining this medication with other erectile dysfunction treatments is not recommended as safety and efficacy have not been established. Patients with severely impaired kidney or liver function should use this medication with caution and be aware of potential blood pressure drops when combined with alpha-blockers or antihypertensive agents. While taking this medication, side effects may include headaches, dyspepsia, low back pain, myalgia, nasal congestion, flushing, limb pain, nasopharyngitis, upper respiratory infections, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, facial swelling, itching, drowsiness, visual disturbances, color vision abnormalities, conjunctivitis, eye pain, increased tear production, eyelid swelling, sudden hearing decrease or loss, tinnitus, increased erections, spontaneous penile erections, fatigue. Serious side effects reported include cardiovascular abnormalities, vision or hearing loss, and priapism; therefore, if any abnormal symptoms appear, notify a doctor immediately. Pregnant or breastfeeding women and children should not use this medication. It does not significantly affect driving or operating machinery; however, caution is advised if dizziness occurs. In cases of overdose, appropriate treatment should be provided based on symptoms; this medication is not readily removed by dialysis. This medication should be kept out of reach of children, and it is advisable to maintain it in its original packaging.

Side effects

  • Headache
  • indigestion
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
Show 73 more
  • diarrhea
  • urinary tract infection
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • priapism
  • increased blood urea nitrogen
  • tachycardia
  • palpitations
  • conjunctival injection
  • increased SGPT
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • dry mouth
  • heartburn
  • gastrointestinal disease
  • drowsiness
  • increased white blood cell count
  • decreased platelet count
  • decreased hemoglobin
  • eye pain
  • chest pain
  • joint pain
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorder
  • pain in external genitalia
  • erythema
  • itching
  • penile disorder
  • myocardial infarction
  • tinnitus
  • epistaxis
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial swelling
  • fever
  • increased SGOT
  • increased hemoglobin
  • hives
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • angioedema
  • angioedema
  • sudden hearing loss
  • hearing loss
  • tinnitus
  • increased erection
  • spontaneous penile erection

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, avoid storing the medication in excessively hot or cold environments, and store it at a temperature between 1 and 30 degrees Celsius, which is normal room temperature.

Appearance and packaging

Appearance

Pale yellow, drop-shaped film-coated tablets

Package unit

28 tablets (14 tablets/PTP*2)

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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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.