Medication info
Please Oral Melting Film 100 Milligrams (Sildenafil)

Please Oral Melting Film 100 Milligrams (Sildenafil)

Prescription medicationOral
Ingredient · strength
Sildenafil›100mg
Manufacturer / importer
CTC Bio Co., Ltd.
Appearance
A rectangular oral melting film of blue or light blue color
Packaging
For domestic use - 1 film/package, For domestic use - 10 films/box [1 film/package x 10], For export - 1 film/package, For export - 2 films/box [1 film/package x 2], For export - 4 films/box [1 film/package x 4], For export - 5 films/box [1 film/package x 5], For export - 6 films/box [1 film/package x 6], For export - 10 films/box [1 film/package x 10], For export - 20 films/box [1 film/package x 20], For export - 25 films/box [1 film/package
Approval status
Active

MFDS item code 201309277 · Approved 2013.09.11

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults
Adult dose
Administer the recommended dose of 25 ∼ 50 mg of sildenafil orally once daily approximately 1 hour before sexual activity; in some cases, it may be administered 4 hours to 30 minutes before sexual activity. The dose may be increased or decreased according to efficacy and tolerability. Immediately after removing this drug from its individual package, place it on the tongue and allow it to dissolve; it may be taken with or without water. For the following patients, adjust the initial dose to 25 mg because sildenafil plasma concentrations may increase: - Age 65 years or older (AUC increased by 40 %) - Hepatic impairment (cirrhosis: 80 %) - Severe renal impairment (creatinine clearance 30 mL/min or less: 100 %) - Concomitant use with CYP3A4 inhibitors (ketoconazole, itraconazole, erythromycin (182 %), etc., and saquinavir (210 %)); increased blood concentrations may increase efficacy and the incidence of adverse reactions. - For patients receiving concomitant ritonavir, do not exceed 25 mg as the maximum single dose during 48 hours.

Ingredients

Manufacturer
CTC Bio Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medication is used for the treatment of erectile dysfunction.

How to take

Adult dose

Administer the recommended dose of 25 ∼ 50 mg of sildenafil orally once daily approximately 1 hour before sexual activity; in some cases, it may be administered 4 hours to 30 minutes before sexual activity. The dose may be increased or decreased according to efficacy and tolerability. Immediately after removing this drug from its individual package, place it on the tongue and allow it to dissolve; it may be taken with or without water. For the following patients, adjust the initial dose to 25 mg because sildenafil plasma concentrations may increase: - Age 65 years or older (AUC increased by 40 %) - Hepatic impairment (cirrhosis: 80 %) - Severe renal impairment (creatinine clearance 30 mL/min or less: 100 %) - Concomitant use with CYP3A4 inhibitors (ketoconazole, itraconazole, erythromycin (182 %), etc., and saquinavir (210 %)); increased blood concentrations may increase efficacy and the incidence of adverse reactions. - For patients receiving concomitant ritonavir, do not exceed 25 mg as the maximum single dose during 48 hours.

Precautions

This medication can be dangerous if taken with nitrates or NO donors, which lower blood pressure, so a physician must confirm patients are not taking such medications before prescribing this drug. Patients with heart disease must undergo a thorough examination of cardiovascular status before taking this medication, and if there is a risk to the heart, sexual activity is not recommended, and this drug should not be used. This medication can dilate blood vessels and temporarily lower blood pressure; thus, particularly in patients with cardiovascular conditions, the potential for adverse reactions should be carefully considered. Patients who have experienced serious heart problems or strokes, cerebral hemorrhages within the last six months, low blood pressure, uncontrolled high blood pressure, or those with pigmentary retinopathy should not use this medication. If an erection lasts more than 4 hours or is accompanied by pain, medical attention should be sought immediately, as untreated cases can lead to permanent damage. This medication may have a sensitive effect on patients with impaired blood pressure control or certain cardiac valve diseases, and caution is advised. Taking this medication with certain drugs like Ritonavir can significantly increase its blood concentration and raise the risk of side effects, so dosage adjustment is necessary for patients taking such medications. Patients who have hypersensitivity to this medication, are taking organic nitrates, are advised against sexual activity due to cardiovascular diseases, have severe liver failure, or are children under 18 and women should not use this medication. Additionally, patients with anatomical penile deformities, bleeding disorders, elderly age, severe renal or liver failure, or diabetic retinopathy should use this medication cautiously and start at a lower dose if necessary. Common side effects when taking this medication include headaches, facial flushing, dyspepsia, nasal congestion, dizziness, visual disturbances, etc.; if these symptoms persist or worsen, one should consult a physician. Severe cardiovascular events can occur during or immediately after sexual activity, thus patients with cardiovascular risk factors should exercise particular caution. Dizziness or visual disturbances may occur when driving or operating machinery; therefore, one should check how they respond after taking this medication before engaging in such activities. This medication should not be used in conjunction with other erectile dysfunction treatments, and it does not provide protection against sexually transmitted diseases, so necessary precautions should be taken concurrently. In cases of overdose, appropriate treatment should be provided based on symptoms, as renal dialysis does not effectively eliminate this medication, requiring special management. Keep out of reach of children, and be cautious about transferring to other containers as it can compromise quality.

Side effects

  • Headache
  • flushing
  • rhinitis
  • hypersensitivity reaction
  • dizziness
  • drowsiness
  • seizures
  • seizure recurrence
  • syncope
  • blurred vision
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  • visual impairment
  • cyanopsia
  • eye pain
  • glare
  • photopsia
  • chromatopsia
  • eye congestion
  • brightening of vision
  • eye swelling
  • eye edema
  • dry eye
  • eye fatigue
  • halo effect
  • xanthopsia
  • erythropsia
  • eye disorders
  • conjunctival hyperemia
  • eye irritation
  • abnormal sensations in the eyes
  • eyelid swelling
  • tachycardia
  • palpitations
  • facial flushing
  • flushing
  • hypotension
  • nasal congestion
  • epistaxis
  • sinus congestion
  • throat tightness
  • nasal dryness
  • nasal edema
  • nausea
  • dyspepsia
  • gastroesophageal reflux disease
  • vomiting
  • upper abdominal pain
  • dry mouth
  • oral sensory decrease
  • rash
  • myalgia
  • limb pain
  • priapism
  • increased erection
  • feeling of heat
  • irritability
  • increased heart rate
  • urinary tract infection
  • diarrhea
  • migraine
  • confusion
  • weakness
  • memory impairment
  • neurosensitivity
  • insomnia
  • abnormal dreams
  • decreased reflex function
  • sensory disturbance
  • asthma
  • shortness of breath
  • laryngitis
  • pharyngitis
  • sinusitis
  • bronchitis
  • increased sputum
  • increased coughing
  • urticaria
  • herpes simplex
  • itching
  • sweating
  • skin ulcer
  • contact dermatitis
  • exfoliative dermatitis
  • sudden hearing loss
  • hearing impairment
  • tinnitus
  • eye pain
  • ear pain
  • ocular hemorrhage
  • cataract
  • dry eye syndrome
  • cystitis
  • nocturia
  • frequency of urination
  • chest enlargement
  • urinary incontinence
  • ejaculation disorder
  • genital edema
  • sexual hypersensitivity
  • migraine
  • confusion
  • nausea
  • hiccups
  • dry mouth
  • abdominal pain
  • dysphagia
  • gastric ulcer
  • gastrointestinal disorder
  • abdominal distension
  • vision disturbance
  • diplopia
  • dry eye syndrome
  • tachycardia
  • vasodilation
  • hypotension
  • rhinitis
  • nasal congestion
  • shortness of breath
  • upper respiratory tract infection
  • elevated AST
  • elevated ALT
  • anxiety
  • insomnia
  • drowsiness
  • penile disorder
  • painful urination
  • polyuria
  • glaucoma
  • overflow incontinence
  • gastric cancer
  • seborrhea
  • myocardial infarction
  • hypotension
  • syncope
  • tachycardia
  • vasodilation
  • tension hyperactivity
  • headache
  • confusion
  • dizziness
  • drowsiness
  • vomiting
  • dry mouth
  • myalgia
  • eye congestion
  • visual abnormalities
  • anxiety disorder
  • hematuria
  • epistaxis
  • hypersensitivity reaction
  • diplopia
  • transient visual loss
  • retinal detachment
  • nasal bleeding
  • eye edema
  • prolonged erection
  • facial flushing
  • infection
  • distal pain
  • hepatitis
  • virus
  • penile pain
  • hematuria
  • retinal vascular disease
  • bleeding
  • transient visual loss
  • retinal detachment
  • nasal bleeding
  • eye edema
  • prolonged erection

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, avoid extremely hot or cold places, and it is best stored at a temperature between 1°C to 30°C.

Appearance and packaging

Appearance

A rectangular oral melting film of blue or light blue color

Package unit

For domestic use - 1 film/package, For domestic use - 10 films/box [1 film/package x 10], For export - 1 film/package, For export - 2 films/box [1 film/package x 2], For export - 4 films/box [1 film/package x 4], For export - 5 films/box [1 film/package x 5], For export - 6 films/box [1 film/package x 6], For export - 10 films/box [1 film/package x 10], For export - 20 films/box [1 film/package x 20], For export - 25 films/box [1 film/package

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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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.