Medication info
SendoM Oral Dissolving Film 10 mg (Tadalafil)

SendoM Oral Dissolving Film 10 mg (Tadalafil)

Prescription medicationOral
Ingredient · strength
Tadalafil›10mg / 1 sheet
Manufacturer / importer
Jongkundang Co., Ltd.
Appearance
White rectangular oral dissolving film
Packaging
10 sheets/case
Approval status
Active

MFDS item code 201502238 · Approved 2015.04.15

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 before anticipated sexual activity, regardless of meals. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This medicine may be taken at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Remove this medicine from its individual package and place it on the tongue immediately, allow it to dissolve, and take it without water. Long-term safety following prolonged daily dosing has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration of this medicine is strongly not recommended. [See section 1. Warnings and section 11.1) Pharmacodynamic Properties] Use in elderly men No dosage adjustments are required in elderly patients. Use in men with renal impairment No dosage adjustment is required 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 before anticipated sexual activity, regardless of meals. Clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited; therefore, if prescribing this medicine, the physician should carefully assess the individual benefit/risk. There are no data on administration of 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 required in patients with diabetes.
Child dose
This medicine should not be used in persons under 18 years of age.

Ingredients

Manufacturer
Jongkundang Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used for the treatment of erectile dysfunction. It shows its effects in the presence of sexual stimulation and helps improve male erectile function. However, it should not be used by females and must be taken according to the specified indications.

How to take

Adult dose

Use in adult men The recommended dose of this medicine is 10mg, taken before anticipated sexual activity, regardless of meals. For patients in whom tadalafil 10mg does not provide an adequate effect, 20 mg may be tried. This medicine may be taken at least 30 minutes before sexual activity. The maximum recommended dosing frequency is once daily. Remove this medicine from its individual package and place it on the tongue immediately, allow it to dissolve, and take it without water. Long-term safety following prolonged daily dosing has not been established, and because the effect of this medicine usually lasts for more than one day, continuous daily administration of this medicine is strongly not recommended. [See section 1. Warnings and section 11.1) Pharmacodynamic Properties] Use in elderly men No dosage adjustments are required in elderly patients. Use in men with renal impairment No dosage adjustment is required 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 before anticipated sexual activity, regardless of meals. Clinical data on the safety of this medicine in patients with severe hepatic impairment (Child-Pugh Class C) are limited; therefore, if prescribing this medicine, the physician should carefully assess the individual benefit/risk. There are no data on administration of 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 required in patients with diabetes.

Child dose

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

Precautions

This drug is used as a treatment for erectile dysfunction, and before use, a doctor must thoroughly assess the patient's overall health and cardiovascular condition. Sexual activity may impose a burden on the heart; therefore, patients with cardiovascular disease should exercise particular caution and immediately stop sexual activity and consult a doctor if any heart-related symptoms occur. If an erection lasts more than 4 hours, it may be an emergency, so immediate medical assistance is required to avoid permanent damage. This drug should not be used by patients taking nitrate preparations, as it can cause a dangerously low blood pressure. Patients with significant cardiovascular diseases such as myocardial infarction, stroke, or unstable angina, or those with a recent history of such conditions should not take this medication. Patients with hereditary retinal diseases or allergies to this drug's components should avoid administration, and it is not recommended to combine it with other erectile dysfunction treatments. Patients with penile deformities, certain blood disorders, or severe kidney or liver dysfunction should use this medication with caution. Especially, there is a heightened risk of side effects when taken in conjunction with alpha blockers or strong CYP3A4 inhibitors. Common side effects include headaches, dyspepsia, back pain, myalgia, flushing, and limb pain; serious cardiovascular adverse reactions or loss of vision and hearing have been reported, though rarely. If any sudden changes in vision or hearing occur while taking this medication, immediately discontinue use and consult the healthcare provider. This drug is not for use in women, children, or pregnant individuals, and caution should be exercised when driving or operating machinery to assess individual reactions. In case of overdose, standard emergency treatments should be administered, and blood dialysis is ineffective in eliminating this medication. Store this drug in its original packaging, away from the reach of children, ensuring it is tightly sealed to prevent exposure to air or moisture.

Side effects

  • Headache
  • indigestion
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasal pharyngitis
  • upper respiratory infection
  • cough
Show 68 more
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • gastritis
  • hypertension
  • dizziness
  • priapism
  • increased blood urea nitrogen
  • tachycardia
  • palpitations
  • eye congestion
  • increased SGPT
  • chest pressure
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • renal 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 cramping
  • increased bilirubin
  • ejaculation disorder
  • pain in the external genitalia
  • erythema
  • itching
  • penile disorder
  • myocardial infarction
  • tinnitus
  • nosebleed
  • dry nose
  • increased serum creatinine
  • hiccups
  • weakness
  • abdominal discomfort
  • allergic reaction
  • facial edema
  • 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
  • sudden hearing loss or decrease
  • tinnitus
  • angioedema

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

Storage

This medication must be stored in a tightly sealed container to prevent air or moisture ingress. It is safest to store it at room temperature between 1 to 30 degrees Celsius. Avoid extremely hot or cold locations.

Appearance and packaging

Appearance

White rectangular oral dissolving film

Package unit

10 sheets/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.