Medication info
Cialtam 5 mg (Tadalafil)

Cialtam 5 mg (Tadalafil)

Prescription medicationTabletOral
Ingredient · strength
Tadalafil›5mg / 1 tablet
Manufacturer / importer
Daewoong Bio Co., Ltd.
Appearance
Yellow, rounded triangular film-coated tablet
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201901044 · Approved 2019.02.20

Summary

Main use
Treatment of symptoms of erectile dysfunction, benign prostatic hyperplasia, or both conditions concurrently
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 are expected 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 appropriateness of continuous once-daily dosing should be reassessed periodically. 2. Once-daily dosing 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 dosing 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 adjustments are 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 it, the physician should carefully assess the individual benefit/risk. (See section 11. <Special Populations>) ● Use in men with diabetes No dosage adjustment is required in patients with diabetes.
Child dose
Under 18 years of age: This medicine should not be used.

Ingredients

Manufacturer
Daewoong Bio Co., Ltd.

Efficacy & effects

Treatment of symptoms of erectile dysfunction, benign prostatic hyperplasia, or both conditions concurrently

  • Signs and symptoms of erectile dysfunction
  • benign prostatic hyperplasia
View approved original text

This medication is effective in treating erectile dysfunction primarily when sexual stimulation occurs. It is also used to alleviate signs and symptoms resulting from benign prostatic hyperplasia. This medication can be beneficial for men who have both erectile dysfunction and benign prostatic hyperplasia. However, it is not suitable for women and is used to improve specific conditions in men. Overall, this medication effectively treats symptoms of erectile dysfunction and prostatic hyperplasia 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 are expected 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 appropriateness of continuous once-daily dosing should be reassessed periodically. 2. Once-daily dosing 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 dosing 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 adjustments are 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 it, the physician should carefully assess the individual benefit/risk. (See section 11. <Special Populations>) ● Use in men with diabetes No dosage adjustment is required in patients with diabetes.

Child dose

Under 18 years of age: This medicine should not be used.

Precautions

This medication is used to treat erectile dysfunction and benign prostatic hyperplasia, and proper evaluation and diagnosis by a physician must be conducted prior to use. Sexual activity can strain the heart; therefore, patients with cardiovascular diseases should exercise particular caution and must stop immediately and inform their doctor if cardiovascular symptoms arise during or after sexual activity. If an erection lasts more than 4 hours while taking this medication, seek immediate medical assistance, as untreated conditions can lead to penile tissue damage and permanent erectile dysfunction. Co-administration with nitrates or NO donors can result in dangerously low blood pressure; therefore, patients taking such medications should not use this drug. Patients with a history of cardiovascular diseases such as myocardial infarction, angina, or stroke should use this medication with caution or it may be contraindicated. This medication may affect sperm count and concentration in some patients, so consulting a physician about reproductive health is advisable. Patients with penile deformities or certain blood disorders, as well as those with severe kidney or liver dysfunction, should use this medication carefully, as there is an increased risk of blood pressure lowering when combined with other antihypertensive medications. This medication is not recommended to be taken with other erectile dysfunction treatments, and patients with lactose intolerance should also avoid it. If symptoms such as sudden vision loss, hearing reduction, persistent erection, severe headache, dizziness occur, immediate medical attention is required. This drug is not intended for use in women, newborns, or children, and its safety in pregnant women has not been established. Caution should be exercised if this medication is taken in conjunction with alcohol, as it may exacerbate blood pressure lowering and dizziness. In case of overdose, standard treatment should be followed, and blood dialysis does not significantly affect the elimination of this medication. This drug should be kept out of reach of children and it is recommended to maintain it in its original packaging.

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
  • urinary tract infection
  • gastroenteritis
  • hypertension
  • dizziness
  • color vision changes
  • priapism
  • angioedema
  • urticaria
  • Stevens-Johnson syndrome
  • epidermal necrolysis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • vision reduction
  • sudden hearing loss or decrease
  • tinnitus
  • angioedema
  • myocardial infarction
  • sudden cardiac death
  • stroke
  • chest pain
  • palpitations
  • ventricular arrhythmia
  • tachycardia
  • angina
  • hypotension
  • orthostatic hypotension
  • syncope
  • hypochromic anemia
  • thrombocytopenia
  • xerostomia
  • dysphagia
  • esophagitis
  • gastritis
  • increased GGTP
  • loose stools
  • nausea
  • upper abdominal pain
  • vomiting
  • gastroesophageal reflux
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • dizziness
  • sensory loss
  • insomnia
  • paresthesia
  • drowsiness
  • vertigo
  • kidney disorders
  • dyspnea
  • epistaxis
  • pharyngitis
  • itching
  • rash
  • sweating
  • blurred vision
  • conjunctivitis
  • eye pain
  • increased tear secretion
  • eyelid swelling
  • increased erection
  • spontaneous penile erection
  • myasthenia
  • facial edema
  • fatigue
  • pain
  • peripheral edema
  • abdominal pain
  • increased blood urea nitrogen
  • eye redness
  • increased SGPT
  • chest pressure
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • rigidity
  • urethral pain
  • renal colic
  • heartburn
  • drowsiness
  • leukocytosis
  • anxiety
  • sleep disorders
  • 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
  • dysgeusia
  • myocardial infarction
  • tinnitus
  • 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 can be sensitive to air and moisture and must be stored in a tightly closed container. It is important to maintain storage temperatures between 1 degrees and 30 degrees Celsius. Proper storage will help retain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Yellow, rounded triangular film-coated tablet

Package unit

30 tablets (10 tablets/PTP X 3)

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.