Medication info
Selle Oral Dispersible Film 20mg (Tadalafil)

Selle Oral Dispersible Film 20mg (Tadalafil)

Prescription medicationOral
Ingredient · strength
Tadalafil›20mg / 1 sheet
Manufacturer / importer
Daehwa Pharmaceutical Co., Ltd.
Appearance
White square oral dispersible film
Packaging
1 piece/pack x 10
Approval status
Active

MFDS item code 201504302 · Approved 2015.06.30

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 with or without food before anticipated sexual activity. Patients who do not achieve sufficient effect with tadalafil 10mg may try 20 mg. This medicine may be taken starting at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Immediately after removing this medicine from its individual packaging, 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 since the effect of this medicine usually lasts for more than one day, continuous daily administration of this medicine is strongly discouraged. [See section 1. Warnings and section 11.1) Pharmacodynamic properties] Use in elderly men No dosage adjustment is 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. Since clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited, the physician should carefully assess the individual benefit/risk when prescribing it. There are no data on administering doses higher 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
Do not use in persons under 18 years of age.

Ingredients

Manufacturer
Daehwa Pharmaceutical 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 necessary to achieve an effect. Furthermore, it is not used for women, and it is solely applicable for the improvement of male erectile function. This medication is effective in assisting the improvement of sexual function.

How to take

Adult dose

Use in adult men The recommended dose of this medicine is 10mg, taken with or without food before anticipated sexual activity. Patients who do not achieve sufficient effect with tadalafil 10mg may try 20 mg. This medicine may be taken starting at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Immediately after removing this medicine from its individual packaging, 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 since the effect of this medicine usually lasts for more than one day, continuous daily administration of this medicine is strongly discouraged. [See section 1. Warnings and section 11.1) Pharmacodynamic properties] Use in elderly men No dosage adjustment is 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. Since clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited, the physician should carefully assess the individual benefit/risk when prescribing it. There are no data on administering doses higher 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

Do not use in persons under 18 years of age.

Precautions

This medication is used for the treatment of erectile dysfunction and should only be taken after a doctor’s diagnosis and physical examination. There can be cardiac burden during sexual activity, so patients with cardiovascular diseases should be particularly cautious. If an erection lasts more than 4 hours, immediate medical attention should be sought, as neglecting this can result in penile tissue damage and permanent loss of erectile function. Patients taking nitrate preparations or NO donors should avoid this medication as it may cause dangerously low blood pressure. Patients who have had recent cardiovascular diseases such as myocardial infarction, angina, or stroke should not use this medication. Patients with hereditary retinal disorders or allergies to this medication's ingredients are also prohibited from taking it. It is not recommended to use this medication in conjunction with other erectile dysfunction treatments as safety and efficacy have not been established. Patients with anatomical abnormalities in the penis, or certain blood disorders should be particularly cautious when using this medication. Patients with severely impaired kidney or liver function should consult a doctor before taking this medication. Caution is needed as some antihypertensives may result in low blood pressure when used in combination. Common side effects after taking this medication may include headaches, indigestion, back pain, muscle pain, congestion, flushing, limb pain, nasopharyngitis, upper respiratory tract infections, cough, diarrhea, gastroesophageal reflux disease, abdominal pain, dizziness, drowsiness, lightheadedness, itching, rash, sweating, facial flushing, abnormal sensations, vision impairment, palpitations, dry mouth, facial swelling, increased blood pressure, decreased hemoglobin, increased white blood cell count, decreased platelet count, anxiety, sleep disorders, eye pain, eyelid swelling, and increased tear secretion. Rarely, serious side effects such as cardiovascular abnormalities, vision changes, hearing problems, and priapism have been reported, so immediate medical consultation should be sought in case of any abnormal symptoms. This medication is not for use in women, children, or newborns, and its safety during pregnancy has not been established. While this medication does not significantly affect driving or machinery operation, caution is advised if dizziness occurs. In case of overdose, immediate medical attention should be sought, and blood dialysis is not effective for the removal of this medication. This medication should be kept out of reach of children and it is advisable to maintain it in its original packaging.

Side effects

  • Headache
  • dyspepsia
  • low back pain
  • muscle pain
  • congestion
  • flush
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
Show 76 more
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • urinary tract infection
  • gastroenteritis
  • hypertension
  • dizziness
  • hives
  • Steven-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizures
  • transient global amnesia
  • visual defects
  • 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 arrhythmias
  • tachycardia
  • increased blood urea nitrogen
  • ocular hyperemia
  • increased SGPT
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • dry mouth
  • heartburn
  • drowsiness
  • leukocytosis
  • thrombocytopenia
  • anxiety
  • sleep disorders
  • decreased hemoglobin
  • eye pain
  • chest pain
  • arthralgia
  • hyperventilation
  • ocular hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eye syndrome
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorder
  • pain in external genitalia
  • erythema
  • itching
  • penile disorder
  • 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 may be sensitive to air and moisture, so it should be stored in a sealed container. The appropriate storage temperature is between 1 to 30 degrees Celsius. By storing it this way, the medication's efficacy can be maintained for a longer period.

Appearance and packaging

Appearance

White square oral dispersible film

Package unit

1 piece/pack x 10

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.