Medication info
Selle Oral Dissolving Film 10 mg (Tadalafil)

Selle Oral Dissolving Film 10 mg (Tadalafil)

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

MFDS item code 201504301 · Approved 2015.06.30

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
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] No dosage adjustment is necessary in elderly patients. 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]. 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]. 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 and requires sexual stimulation to be effective. It is manufactured for the improvement of erectile dysfunction in men and is not indicated for women. Therefore, taking it exactly as directed by a doctor can help improve erectile function.

How to take

Adult dose

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] No dosage adjustment is necessary in elderly patients. 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]. 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]. 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 for the treatment of erectile dysfunction and requires a precise diagnosis and physical examination by a physician before use. As sexual activity can place a strain on the heart, patients with cardiovascular disease should use this medication cautiously after consulting with a doctor. Rarely, an erection lasting more than 4 hours may occur, which can lead to penile tissue damage and the loss of erectile function, so immediate medical assistance should be sought. It should not be taken with nitrate compounds or NO donors due to the risk of significantly lowering blood pressure. It is not safe for patients with a history of cardiovascular diseases such as myocardial infarction, angina, or stroke. Long-term use may affect sperm production, so consultation with a doctor is necessary when taken for an extended period. Patients with left ventricular outflow obstruction may be sensitive to the vasodilatory effects of this medication. This medication must not be administered to patients taking organic nitrate preparations regularly or intermittently. Severe patients with heart diseases or recent myocardial infarction, unstable angina, heart failure, uncontrolled arrhythmias or hypertension should not use this medication. Patients with hereditary retinal diseases should also avoid using this drug. Concomitant use with other erectile dysfunction treatments is not recommended as safety has not been established. Caution is necessary for patients with penile deformities or certain blood disorders, and patients with severely impaired kidney or liver function should also be careful. Combining with alpha blockers or certain antifungal, antiviral agents may alter drug concentration and increase the risk of side effects, thus consulting a physician is necessary. This medication should not be used by women, children, or infants. Common side effects include dizziness, headache, dyspepsia, myalgia, flushing, limb pain, facial flushing, dizziness, diarrhea, nasopharyngitis, upper respiratory tract infections, cough, gastroesophageal reflux disease, abdominal pain, gastritis, hypertension, dizziness, arthralgia, throat pain, insomnia, paresthesia, drowsiness, lightheadedness, renal impairment, dyspnea, epistaxis, pharyngitis, itching, rash, sweating, blurred vision, color vision abnormalities, conjunctivitis, ocular pain, and increased tear secretion. Sudden loss of vision or hearing should prompt immediate cessation of the medication and medical evaluation. In cases of overdose, standard emergency treatment should be administered, and dialysis is not effective. This medication should be kept out of the reach of children and stored in its original packaging.

Side effects

  • headache
  • dyspepsia
  • low back pain
  • muscle pain
  • nasal congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
Show 78 more
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • hypertension
  • dizziness
  • urinary tract infection
  • gastritis
  • hypertension
  • angina
  • chest pain
  • hypotension
  • myocardial infarction
  • orthostatic hypotension
  • palpitations
  • syncope
  • tachycardia
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizures
  • transient global amnesia
  • visual field loss
  • retinal vein occlusion
  • retinal artery occlusion
  • vision loss
  • sudden hearing loss or decrease
  • tinnitus
  • increased libido
  • spontaneous penile erection
  • angioedema
  • increased blood urea nitrogen
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • renal pain
  • dry mouth
  • heartburn
  • gastrointestinal disorders
  • drowsiness
  • increased white blood cell count
  • thrombocytopenia
  • anxiety
  • sleep disorders
  • decreased hemoglobin
  • eye pain
  • chest pain
  • joint pain
  • hyperventilation
  • eye hemorrhage
  • eyelid swelling
  • conjunctival hemorrhage
  • dry eyes
  • abdominal cramps
  • increased bilirubin
  • ejaculation disorder
  • pain in external reproductive organs
  • erythema
  • itching
  • penile dysfunction
  • myocardial ischemia
  • ringing in the ears
  • nosebleed
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • allergic reaction
  • facial swelling
  • fever
  • increased hemoglobin
  • chills
  • skeletal pain

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

Storage

This medication should be kept in a tightly sealed container to prevent air or moisture from entering, and preferably stored at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy for a prolonged period.

Appearance and packaging

Appearance

White square oral dissolving film

Package unit

1 piece/box 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.