Medication info

Tadalafil Oral Film 5 mg

Prescription medicationOral
Ingredient · strength
Tadalafil›5mg / 1 sheet
Manufacturer / importer
CMG Pharmaceutical Co., Ltd.
Appearance
White square oral film
Packaging
1 film x 30 pieces/case
Approval status
Active

MFDS item code 201700517 · Approved 2017.01.31

Summary

Main use
Treatment of symptoms of erectile dysfunction, benign prostatic hyperplasia, or both conditions when present together
Who takes it
Adults · Children
Adult dose
1. Erectile dysfunction Use in adult men For patients who are expected to use tadalafil frequently (at least twice a week), the recommended dose is up to 5 mg once daily, taken at approximately the same time each day. Immediately after removing this drug from its individual package, place it on the tongue and allow it to dissolve; take without water. The appropriateness of continuous daily dosing should be reassessed periodically. 2. Once-daily use for benign prostatic hyperplasia The recommended dose of this drug for once-daily use is 5 mg, taken at approximately the same time each day. 3. Once-daily use for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this drug for once-daily use is 5 mg, 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 Precautions for Use, sections 3.2) and 11.2) Pharmacokinetic Properties]. - 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 Precautions for Use, sections 3.3) and 11.2) Pharmacokinetic Properties]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, if prescribing this drug, 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
● Use in children and adolescents Persons under 18 years of age: This drug should not be used in persons under 18 years of age.

Ingredients

Manufacturer
CMG Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of symptoms of erectile dysfunction, benign prostatic hyperplasia, or both conditions when present together

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

This medication is primarily used to treat erectile dysfunction in men. However, sexual stimulation is necessary for the effect to occur, and it is not suitable for women. It also helps alleviate the symptoms and signs of benign prostatic hyperplasia. It is used to treat symptoms in men who suffer from both erectile dysfunction and benign prostatic hyperplasia simultaneously. Therefore, this drug acts effectively on the symptoms of erectile dysfunction and benign prostatic hyperplasia in men.

How to take

Adult dose

1. Erectile dysfunction Use in adult men For patients who are expected to use tadalafil frequently (at least twice a week), the recommended dose is up to 5 mg once daily, taken at approximately the same time each day. Immediately after removing this drug from its individual package, place it on the tongue and allow it to dissolve; take without water. The appropriateness of continuous daily dosing should be reassessed periodically. 2. Once-daily use for benign prostatic hyperplasia The recommended dose of this drug for once-daily use is 5 mg, taken at approximately the same time each day. 3. Once-daily use for erectile dysfunction and benign prostatic hyperplasia The recommended dose of this drug for once-daily use is 5 mg, 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 Precautions for Use, sections 3.2) and 11.2) Pharmacokinetic Properties]. - 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 Precautions for Use, sections 3.3) and 11.2) Pharmacokinetic Properties]. ● Use in men with hepatic impairment Once-daily dosing has not been evaluated in patients with hepatic impairment. Therefore, if prescribing this drug, 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

● Use in children and adolescents Persons under 18 years of age: This drug should not be used in persons under 18 years of age.

Precautions

This drug is used for the treatment of erectile dysfunction and benign prostatic hyperplasia, and appropriate diagnosis and evaluation by a specialist are required before use. Patients with heart disease or high cardiovascular risk should use this medication cautiously, considering the heart burden due to sexual activity, and should stop immediately and consult a doctor if any heart-related symptoms occur during sexual activity. This drug may cause an erection lasting longer than 4 hours, especially if accompanied by pain (priapism). In such cases, immediate medical attention is required. Patients taking nitrate compounds or nitric oxide donors must not use this drug, as it may dangerously lower blood pressure. Patients who have recently experienced myocardial infarction, unstable angina, heart failure, or stroke, as well as those with uncontrolled high blood pressure or low blood pressure, should not use this drug. Patients with hereditary retinal diseases or allergies to this drug or its ingredients should not use it either. It is not recommended to use this drug in combination with other erectile dysfunction treatments since safety and efficacy have not been established. Patients with severely impaired kidney or liver function may require dosage adjustments and should use this drug with caution. When used with alpha blockers or antihypertensives, there may be a significant decrease in blood pressure, thus requiring consultation with a doctor for adjustments. Common side effects of this drug include headache, dyspepsia, back pain, muscle pain, flushing, etc., and most are mild or moderate and improve over time. Rarely, severe cardiovascular adverse reactions, vision impairment, and hearing loss have been reported. If any unusual symptoms occur, immediate consultation with medical staff is required. The use of this drug is prohibited in women who are pregnant or breastfeeding and in children. Caution is advised if consuming alcohol with this medication, as it may lead to decreased blood pressure or dizziness. In the case of overdose, immediate visit to a medical institution for appropriate treatment is necessary, and it is not removed through dialysis. This drug should be kept out of reach of children and stored in its original packaging.

Side effects

  • Headache
  • indigestion
  • back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory tract infection
  • cough
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  • diarrhea
  • urinary tract infection
  • gastroesophageal reflux disease
  • abdominal pain
  • dizziness
  • hypertension
  • orthostatic hypotension
  • palpitations
  • tachycardia
  • angina
  • chest pain
  • myocardial infarction
  • ventricular arrhythmia
  • syncope
  • increased blood urea nitrogen
  • decreased hemoglobin
  • thrombocytopenia
  • itching
  • rash
  • sweating
  • blurred vision
  • color vision abnormalities
  • conjunctivitis
  • eye pain
  • increased tear secretion
  • eyelid edema
  • sudden hearing loss or decrease
  • tinnitus
  • increased erection
  • spontaneous penile erection
  • priapism
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizures
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • angioedema
  • myasthenia
  • facial edema
  • fatigue
  • pain
  • peripheral edema
  • dry mouth
  • dysphagia
  • esophagitis
  • gastritis
  • increased GGTP
  • loose stools
  • nausea
  • epigastric pain
  • vomiting
  • gastroesophageal reflux
  • hemorrhoidal bleeding
  • rectal bleeding
  • arthralgia
  • neck pain
  • sensory impairment
  • insomnia
  • paresthesia
  • drowsiness
  • vertigo
  • renal impairment
  • dyspnea
  • epistaxis
  • pharyngitis
  • limb discomfort
  • decreased semen
  • dizziness
  • abdominal pain
  • increased hemoglobin
  • chest pressure
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • heartburn
  • gastrointestinal disease
  • drowsiness
  • increased white blood cell count
  • anxiety
  • sleep disorder
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorder
  • pain in external genitalia
  • erythema
  • penile dysfunction
  • following symptoms
  • ringing in the ears
  • epistaxis
  • nasal dryness
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • abdominal pain
  • allergic reaction
  • facial edema
  • fever
  • increased SGOT
  • increased hemoglobin
  • chills
  • skeletal pain

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

Storage

This drug may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. It is important to maintain storage temperature between 1 degree and 30 degrees Celsius room temperature.

Appearance and packaging

Appearance

White square oral film

Package unit

1 film x 30 pieces/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.

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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.