Medication info

Neobiasel 50mg (Sildenafil)

Prescription medicationOral
Ingredient · strength
Sildenafil›50mg / 1 packet
Manufacturer / importer
Kolon Pharma Co., Ltd.
Appearance
This medication is a white to pale yellow granule.
Packaging
10 sachets/case
Approval status
Active

MFDS item code 201203072 · Approved 2012.04.20

Summary

Main use
Treatment of erectile dysfunction
Who takes it
Adults
Adult dose
For sildenafil, the recommended dose is 25 ∼ 50 mg orally once daily approximately 1 hour before sexual activity; in some cases, it may be administered from 4 hours to 30 minutes before sexual activity. The dose may be increased or decreased according to efficacy and tolerability. In the following patients, adjust the initial dose to 25 mg because sildenafil plasma concentrations may be increased: - Age 65 years and 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 (such as 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 25 mg as a maximum single dose during a 48-hour period.

Ingredients

Manufacturer
Kolon Pharma Co., Ltd.

Efficacy & effects

Treatment of erectile dysfunction

  • Erectile dysfunction
View approved original text

This medicine is used for the treatment of erectile dysfunction. Patients can improve erectile dysfunction symptoms and maintain a normal sexual life through this medication.

How to take

Adult dose

For sildenafil, the recommended dose is 25 ∼ 50 mg orally once daily approximately 1 hour before sexual activity; in some cases, it may be administered from 4 hours to 30 minutes before sexual activity. The dose may be increased or decreased according to efficacy and tolerability. In the following patients, adjust the initial dose to 25 mg because sildenafil plasma concentrations may be increased: - Age 65 years and 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 (such as 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 25 mg as a maximum single dose during a 48-hour period.

Precautions

This medication should not be taken with nitrate medications or nitric oxide donors, as it may cause an excessive decrease in blood pressure, so the doctor must thoroughly check the patient's medication history. Patients with heart disease should have their heart condition thoroughly examined before taking this medication, and sexual activity that could put a strain on the heart is not recommended. This medication works by dilating blood vessels, which may temporarily lower blood pressure, so caution is especially necessary for patients with cardiovascular diseases. Patients with heart rhythm issues, heart failure, unstable angina, low blood pressure, or high blood pressure as well as those with certain retinal diseases should use this medication cautiously. If an erection lasts longer than 4 hours, medical attention should be sought immediately, as failure to treat can lead to damage to the penile tissue. Patients with impaired blood pressure control or specific heart diseases may be sensitive to this medication, so caution is advised. Taking certain antiviral drugs can significantly increase the blood concentration of this medication, raising the risk of side effects, so dose adjustment is necessary. The artificial sweetener aspartame included in this medication should not be administered to patients with phenylketonuria. Patients who are allergic to this medication or its components, take nitrate medications regularly, or have cardiovascular diseases where sexual activity is not recommended should not use this medication. This medication is also not used in patients with severe liver or kidney diseases, children under 18 years old, and women. It should be used with caution in patients with anatomical abnormalities of the penis, blood diseases, bleeding tendencies, elderly patients, or those with impaired liver or kidney function. During treatment, side effects such as headaches, facial flushing, indigestion, nasal congestion, dizziness, visual disturbances, rashes, nausea, vomiting, diarrhea, muscle pain, limb pain, dryness of the eyes, conjunctival hyperemia, eye fatigue, eye pain, photophobia, conjunctivitis, hematuria, prolonged erection, increased erection, palpitations, tachycardia, flushing, hypotension, nasal congestion, nosebleeds, rhinitis, throat tightness, and dry mouth may occur, and if symptoms are severe, the doctor should be consulted. This medication may cause dizziness or visual disturbances when driving or operating machinery, so caution is necessary. When combined with alpha-blockers or certain antihypertensive medications, it may excessively lower blood pressure, necessitating adjustments in dosing intervals, and it must be discussed with a doctor before use. Women who are pregnant or breastfeeding should not use this medication, and it is not intended for women. In case of overdose, side effects may be worsened, so the prescribed dosage should be adhered to, and if an overdose occurs, medical attention should be sought immediately.

Side effects

  • Headache
  • flushing
  • rhinitis
  • hypersensitivity reactions
  • dizziness
  • drowsiness
  • seizures
  • seizure recurrence
  • syncope
  • blurriness
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  • visual impairment
  • cyanopsia
  • eye pain
  • photophobia
  • phosphenes
  • chromatopsia
  • eye congestion
  • brightening of vision
  • eye swelling
  • eyelid edema
  • tachycardia
  • palpitations
  • facial flushing
  • flushing
  • hypotension
  • nasal congestion
  • nosebleed
  • sinus congestion
  • throat discomfort
  • nasal dryness
  • nasal edema
  • nausea
  • dyspepsia
  • gastroesophageal reflux disease
  • vomiting
  • upper abdominal pain
  • dry mouth
  • oral sensory loss
  • rash
  • myalgia
  • limb pain
  • priapism
  • increased erection
  • feeling of warmth
  • irritability
  • increased heart rate
  • urinary tract infection
  • diarrhea
  • rash
  • angina
  • heart block
  • migraine
  • orthostatic hypotension
  • myocardial ischemia
  • cerebral thrombosis
  • cardiac arrest
  • heart failure
  • abnormal ECG
  • cardiomyopathy
  • vasodilation
  • glossitis
  • colitis
  • dysphagia
  • gastritis
  • gastroenteritis
  • esophagitis
  • stomatitis
  • liver function abnormalities
  • rectal bleeding
  • gingivitis
  • anemia
  • leukopenia
  • thirst
  • edema
  • gout
  • unstable diabetes
  • hyperglycemia
  • peripheral edema
  • hyperuricemia
  • hypoglycemia
  • hypernatremia
  • arthritis
  • arthropathy
  • tendon rupture
  • tenosynovitis
  • bone pain
  • myasthenia
  • synovitis
  • ataxia
  • tension hyperactivity
  • neuralgia
  • neuropathy
  • paresthesia
  • tremor
  • depression
  • insomnia
  • dream abnormalities
  • reflex function reduction
  • sensory decline
  • asthma
  • dyspnea
  • laryngitis
  • pharyngitis
  • sinusitis
  • bronchitis
  • increased sputum
  • increased cough
  • urticaria
  • herpes simplex
  • itching
  • sweating
  • skin ulcer
  • contact dermatitis
  • exfoliative dermatitis
  • sudden hearing loss
  • hearing impairment
  • mydriasis
  • conjunctivitis
  • photophobia
  • tinnitus
  • eye pain
  • ear pain
  • retinal hemorrhage
  • cataract
  • dry eye syndrome
  • cystitis
  • nocturia
  • frequent urination
  • chest enlargement
  • urinary incontinence
  • ejaculation disorder
  • genital swelling
  • hyperesthesia
  • systemic heat sensation
  • hiccups
  • red lips
  • gastric ulcer
  • gastroesophageal reflux
  • gastrointestinal disorders
  • increased non-protein nitrogen
  • migraine
  • confusion
  • diarrhea
  • hiccups
  • thirst
  • abdominal pain
  • dysphagia
  • gastric ulcer
  • gastroesophageal reflux
  • gastrointestinal disorders
  • visual disturbances
  • diplopia
  • dry eye syndrome
  • tachycardia
  • vasodilation
  • hypotension
  • rhinitis
  • nasal congestion
  • dyspnea
  • upper respiratory infection
  • elevated AST
  • elevated ALT
  • anxiety
  • insomnia
  • myoclonus
  • persistent erection
  • genitourinary pain
  • facial flushing
  • infection
  • distal pain
  • hepatitis
  • virus
  • penile dysfunction
  • painful urination
  • polyuria
  • glaucoma
  • overflow incontinence
  • gastric adenocarcinoma
  • seborrhea

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering, ideally at room temperatures between 1 degree and 30 degrees Celsius. This will help maintain the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

This medication is a white to pale yellow granule.

Package unit

10 sachets/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.

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.