Medication info

Senit En Oral Dissolving Film 10mg (Tadalafil)

Prescription medicationOralApproval withdrawn
Ingredient · strength
Tadalafil›10mg / 1 sheet
Manufacturer / importer
DongKwang Pharmaceutical Co., Ltd.
Appearance
Yellow rectangular oral dissolving film
Packaging
10 pieces (1 piece/package × 10)/box
Approval status
Approval withdrawn

MFDS item code 201502265 · Approved 2015.04.15

This product's status changed to Approval withdrawn on 2024.03.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults · Children
Adult dose
Directions for use: For oral administration. Use in adult men The recommended dose of this medicine is 10mg, taken with or without food before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide a sufficient 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. 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 after extended 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 discouraged. [See Sections 1. Warnings and 11.1) Pharmacodynamic properties] Use in elderly men Dose adjustments are not required in elderly patients. Use in men with renal impairment Dose adjustment is not 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 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, if prescribing it, the physician should carefully assess the individual benefit/risk. There are no data on administering doses greater than 10mg to patients with hepatic impairment. [See Sections 3. Use with caution in the following patients and 11.2) Pharmacokinetic properties]. Use in men with diabetes Dose adjustment is not required in patients with diabetes.
Child dose
This medicine should not be used in persons under 18 years of age.

Ingredients

Manufacturer
DongKwang 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. Moreover, this medication is not used for females. It is utilized as a treatment for men experiencing difficulties with erectile dysfunction.

How to take

Adult dose

Directions for use: For oral administration. Use in adult men The recommended dose of this medicine is 10mg, taken with or without food before anticipated sexual activity. For patients in whom tadalafil 10mg does not provide a sufficient 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. 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 after extended 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 discouraged. [See Sections 1. Warnings and 11.1) Pharmacodynamic properties] Use in elderly men Dose adjustments are not required in elderly patients. Use in men with renal impairment Dose adjustment is not 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 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, if prescribing it, the physician should carefully assess the individual benefit/risk. There are no data on administering doses greater than 10mg to patients with hepatic impairment. [See Sections 3. Use with caution in the following patients and 11.2) Pharmacokinetic properties]. Use in men with diabetes Dose adjustment is not required in patients with diabetes.

Child dose

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

Precautions

This medication is used for the treatment of erectile dysfunction, and prior to use, a doctor must thoroughly assess the patient's cardiovascular status and medical history. Sexual activity may put stress on the heart, hence patients with heart conditions should be particularly cautious. If an erection lasts longer than 4 hours after taking the medication, immediate medical assistance is required, as it may cause damage to the penile tissue if left untreated. This medication should not be taken together with nitrate medications, as it can cause a dangerous drop in blood pressure; patients taking nitrate medications should not use this drug. Patients with a history of cardiovascular disease such as myocardial infarction, stroke, or angina must consult a doctor before using this medication, and it is prohibited for those who have recently suffered a myocardial infarction or stroke. Patients with hereditary retinal disorders or those allergic to any components of this medication should not take it. The combined use with other erectile dysfunction treatments is not recommended, as safety has not been established. Patients with penile deformities or specific blood disorders should use it with caution, and patients with significantly impaired kidney or liver function require caution as well. This medication may cause symptoms of hypotension when combined with certain antihypertensives; therefore, patients taking alpha-blockers should consult their physician. Side effects may include headaches, dyspepsia, back pain, muscle pain, nasal congestion, flushing, limb pain, dizziness, diarrhea, cough, upper respiratory infections, pharyngitis, gastroenteritis, abdominal pain, vomiting, nausea, fatigue, drowsiness, insomnia, abnormal sensations, sensory loss, lightheadedness, facial swelling, itching, hemoglobin decrease, anxiety, thrombocytopenia, hemoglobin increase, leukocytosis, rash, facial flushing, facial swelling, itching, angioedema, and rash. Serious cardiovascular adverse reactions, as well as vision and hearing disorders have been reported rarely; hence, if sudden vision loss or hearing impairment occurs, immediately stop taking the medication and inform a healthcare professional. This medication should not be used by women, children, or infants. When taking, caution is advised as consuming alcohol may exacerbate side effects such as blood pressure drops. In case of overdose, standard supportive treatment should be given, as dialysis does not help in removing the drug from the body. Store the medication out of reach of children and it is advisable to maintain it in its original packaging.

Side effects

  • Headache
  • indigestion
  • low back pain
  • muscle pain
  • congestion
  • flushing
  • limb pain
  • nasopharyngitis
  • upper respiratory infection
  • cough
Show 84 more
  • diarrhea
  • gastroesophageal reflux disease
  • abdominal pain
  • gastroenteritis
  • hypertension
  • dizziness
  • urinary tract infection
  • gastroesophageal reflux disease
  • hypertension
  • dizziness
  • urticaria
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • migraine
  • seizure
  • transient global amnesia
  • visual field defect
  • retinal vein occlusion
  • retinal artery occlusion
  • permanent vision loss
  • sudden decrease or loss of hearing
  • tinnitus
  • increased erections
  • spontaneous penile erection
  • angioedema
  • myocardial infarction
  • sudden cardiac death
  • stroke
  • chest pain
  • palpitations
  • ventricular arrhythmia
  • tachycardia
  • increased blood urea nitrogen
  • eye congestion
  • increased SGPT
  • chest pressure sensation
  • vomiting
  • nausea
  • increased alkaline phosphatase
  • fatigue
  • neck stiffness
  • urethral pain
  • kidney pain
  • dry mouth
  • heartburn
  • gastrointestinal disorders
  • drowsiness
  • leukocytosis
  • 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 disorders
  • pain in external genitalia
  • erythema
  • itching
  • penile disorders
  • next symptom
  • 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 should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius. This will help preserve the efficacy and safety of the medication.

Appearance and packaging

Appearance

Yellow rectangular oral dissolving film

Package unit

10 pieces (1 piece/package × 10)/box

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.