Medication info
Pal Pal Chewable Tablet 25 mg (Sildenafil)

Pal Pal Chewable Tablet 25 mg (Sildenafil)

Prescription medicationChewable TabletOral
Ingredient · strength
Sildenafil›25mg / 1 tablet
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
Light blue chewable round tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 201205260 · Approved 2012.05.31

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults
Adult dose
The recommended dose is 25 ∼ 50 mg of sildenafil once daily, chewed approximately 1 hour before sexual activity. In some cases, it may be chewed 4 hours to 30 minutes before sexual activity. The dose may be increased or decreased depending on efficacy and tolerability. The initial dose should be adjusted to 25 mg in the following patients, as sildenafil plasma concentrations may be increased: - Age 65 years or older (AUC increased by 40 %) - Hepatic impairment (cirrhosis: 80 %) - Severe renal impairment (creatinine clearance of 30 mL/min or less: 100 %) - Concomitant use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin (182 %), and saquinavir (210 %)): Increased blood concentrations may increase efficacy and the incidence of adverse reactions. - In patients receiving concomitant ritonavir, do not exceed a maximum single dose of 25 mg over 48 hours.

Ingredients

Manufacturer
Hanmi 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. Patients can benefit from improved erectile function through this drug. It is convenient to take, as it can be easily dissolved in the mouth in the form of an oral dissolving film. It is available in various formulations, including chewable tablets, allowing patients to choose according to their convenience. This drug effectively improves symptoms of erectile dysfunction and helps enhance the quality of sexual life.

How to take

Adult dose

The recommended dose is 25 ∼ 50 mg of sildenafil once daily, chewed approximately 1 hour before sexual activity. In some cases, it may be chewed 4 hours to 30 minutes before sexual activity. The dose may be increased or decreased depending on efficacy and tolerability. The initial dose should be adjusted to 25 mg in the following patients, as sildenafil plasma concentrations may be increased: - Age 65 years or older (AUC increased by 40 %) - Hepatic impairment (cirrhosis: 80 %) - Severe renal impairment (creatinine clearance of 30 mL/min or less: 100 %) - Concomitant use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin (182 %), and saquinavir (210 %)): Increased blood concentrations may increase efficacy and the incidence of adverse reactions. - In patients receiving concomitant ritonavir, do not exceed a maximum single dose of 25 mg over 48 hours.

Precautions

This drug can dilate blood vessels and lower blood pressure, so there is a risk of excessively lowering blood pressure when taken with nitrate drugs or NO donors. In patients with cardiovascular diseases, sexual activity can put a strain on the heart, so these patients should evaluate their heart condition before using this drug. Patients with very low or high blood pressure, heart failure, arrhythmias, or certain diseases such as pigmentary retinopathy should consult a physician before using this drug. If an erection lasts longer than 4 hours, immediate medical attention should be sought, as untreated cases may lead to penile tissue damage or loss of erectile capability. The drug may have elevated blood levels in the elderly or patients with impaired liver or kidney function, so dosage adjustment may be necessary. If sudden vision loss or hearing loss occurs during the use of this drug, it should be discontinued immediately and a doctor should be consulted. The risk of side effects may increase when this drug is used in combination with other erectile dysfunction treatments or certain cardiovascular drugs, so any medications being taken must be reported. Pregnant women, children under 18, and women should not use this drug. Caution is advised when driving or operating machinery, as dizziness or visual disturbances may occur. This drug should only be used for the treatment of erectile dysfunction and does not have any effect on preventing sexually transmitted diseases. Overdose may intensify symptoms such as headaches, flushing, dizziness, and indigestion, so prescribed dosages must be adhered to. Keep out of reach of children and do not transfer to other containers.

Side effects

  • Headache
  • flushing
  • rhinitis
  • hypersensitivity reactions
  • dizziness
  • drowsiness
  • seizures
  • seizure recurrence
  • syncope
  • blurred vision
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  • visual impairment
  • cyanopsia
  • eye pain
  • photophobia
  • phosphenes
  • chromatic vision disturbances
  • eye redness
  • vision brightening
  • eye swelling
  • eyelid swelling
  • tachycardia
  • palpitations
  • facial flushing
  • flushing
  • hypotension
  • nasal congestion
  • epistaxis
  • sinus congestion
  • throat tightness
  • dry nose
  • nasal edema
  • nausea
  • dyspepsia
  • gastroesophageal reflux disease
  • vomiting
  • upper abdominal pain
  • dry mouth
  • oral sensory impairment
  • rash
  • myalgia
  • limb pain
  • priapism
  • increased erections
  • feeling hot
  • irritability
  • increased heart rate
  • urinary tract infection
  • diarrhea
  • migraine
  • confusion
  • weakness
  • memory impairment
  • nervousness
  • insomnia
  • unusual dreams
  • decreased reflex function
  • sensory decline
  • 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 loss
  • tinnitus
  • ocular pain
  • ear pain
  • ocular hemorrhage
  • cataract
  • dry eye syndrome
  • cystitis
  • nocturia
  • frequency
  • chest enlargement
  • urinary incontinence
  • ejaculation disorders
  • genital edema
  • sexual hypersensitivity
  • migraine
  • confusion
  • prolonged erection
  • hematuria
  • epistaxis
  • facial flushing
  • infection
  • distal pain
  • hepatitis
  • virus
  • penile dysfunction
  • painful urination
  • polyuria
  • glaucoma
  • enuresis
  • gastric cancer
  • seborrhea
  • myocardial infarction
  • hypotension
  • syncope
  • tachycardia
  • vasodilation
  • hypertension
  • palpitations
  • arrhythmia
  • incomplete right bundle branch block
  • hypertonia
  • confusion
  • nausea
  • vomiting
  • dry mouth
  • myalgia
  • rhinitis
  • nasal bleeding
  • nasal congestion
  • shortness of breath
  • upper respiratory infection
  • arthralgia
  • abdominal pain
  • rash
  • itching
  • dry skin
  • decreased hematocrit
  • decreased white blood cell count
  • increased eosinophils
  • increased lymphocytes
  • decreased red blood cell count
  • increased red blood cell count
  • decreased hemoglobin
  • increased hematocrit
  • decreased lymphocytes
  • ocular congestion
  • nasal bleeding
  • priapism
  • decreased vision
  • increased intraocular pressure
  • retinal vascular disease
  • bleeding
  • anxiety
  • transient visual loss
  • retinal detachment
  • nasal bleeding
  • ocular edema
  • prolonged erection
  • facial swelling
  • chest pain
  • sensory abnormalities
  • fatigue
  • sweating
  • erythema
  • myalgia

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

Storage

This drug must be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is best stored at room temperature between 1 degrees and 30 degrees Celsius.

Appearance and packaging

Appearance

Light blue chewable round tablet

Package unit

30 tablets/box [10 tablets/PTP x 3]

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.