Medication info
Sildenafil 50 mg Tablets (Sildenafil Citrate)

Sildenafil 50 mg Tablets (Sildenafil Citrate)

Prescription medicationTablet경구
Ingredient · strength
Sildenafil Citrate›70.23mg / 1 tablet
Manufacturer / importer
신일제약(주)
Appearance
Green triangular film-coated tablet with rounded edges and a score line
Packaging
8 tablets/box (8 tablets/PTP) × 1, 24 tablets/box (8 tablets/PTP) × 3, 40 tablets/box (8 tablets/PTP) × 5
Approval status
Active

MFDS item code 202400774 · Approved 2024.04.05

Summary

Main use
Improvement of Erectile Dysfunction
Who takes it
Adults
Adult dose
As sildenafil, the recommended dosage is 25 to 50 mg taken orally about 1 hour before sexual activity, once daily. Depending on the situation, it can be taken from 4 hours to 30 minutes before sexual activity. Dosage may be adjusted according to efficacy and tolerance. For specific patients (aged 65 and older, liver impairment, severe kidney impairment, co-administration of CYP3A4 inhibitors, co-administration of ritonavir) the starting dose should be adjusted to 25 mg.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Improvement of Erectile Dysfunction

  • Erectile Dysfunction
View approved original text

This medication is used for the treatment of erectile dysfunction. It is available in various forms (tablets, orally disintegrating films, oral dissolving films, orally disintegrating tablets, chewable tablets, powders) designed to dissolve quickly in the mouth for rapid effect, allowing for convenient administration by patients. This medication helps improve erectile function by increasing blood flow.

How to take

Adult dose

As sildenafil, the recommended dosage is 25 to 50 mg taken orally about 1 hour before sexual activity, once daily. Depending on the situation, it can be taken from 4 hours to 30 minutes before sexual activity. Dosage may be adjusted according to efficacy and tolerance. For specific patients (aged 65 and older, liver impairment, severe kidney impairment, co-administration of CYP3A4 inhibitors, co-administration of ritonavir) the starting dose should be adjusted to 25 mg.

Precautions

This medication should not be taken with nitrate drugs or NO donors, as it can cause dangerously low blood pressure in such cases. Patients taking these medications must avoid this drug. Patients with heart disease or those at high risk of cardiovascular issues should consult a doctor before using this medication to assess heart condition. Since sexual activity itself can put stress on the heart, use of this medication is not advisable for patients with poor cardiovascular health. This medication can dilate blood vessels and temporarily lower blood pressure, so caution is needed for patients with unstable blood pressure or cardiovascular diseases. Particularly patients who have experienced serious heart problems or stroke within the last 6 months, those with low blood pressure or uncontrolled high blood pressure, and those with specific eye diseases should not take this medication. If an erection lasts longer than 4 hours after taking this medication, immediate medical attention is required, as untreated prolonged erection can lead to penile tissue damage and permanent erectile dysfunction. When used with certain other medications, particularly some antivirals or antifungals, the blood concentration of this medication can significantly increase, necessitating dosage adjustment. This medication contains the artificial sweetener aspartame, so it should not be taken by patients with certain genetic disorders such as phenylketonuria. Women who are pregnant or breastfeeding should not use this medication, and it is also not recommended for children under 18 years of age. Possible side effects when taking this medication include headache, facial flushing, dyspepsia, dizziness, visual disturbances, among others, so caution is advised. When driving or operating machinery, caution is needed as this medication may cause blurred vision or dizziness. This medication should not be used with other erectile dysfunction treatments, and the safety and efficacy of concurrent use have not been established. Drug interactions should be monitored, especially if taking blood pressure medications, alpha blockers, or CYP3A4 inhibitors, and consultation with a doctor is advised prior to use. Overdose may lead to intensified side effects, so the prescribed dosage must be adhered to, and immediate consultation with healthcare personnel is necessary if unusual symptoms occur. Keep this medication out of the reach of children and do not transfer it to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain of oral/eye mucosa, difficulty or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Headache, flushing, dyspepsia, nasal congestion, urinary tract infection, dizziness, drowsiness, rash, visual disturbances (temporary color vision abnormalities, increased light sensitivity, blurred vision), nausea, vomiting, diarrhea, dry mouth, sensory abnormalities in the eyes, eye fatigue, dry eyes, conjunctival congestion, eye redness, ocular pain, facial flushing, palpitations, tachycardia, hypotension, nasal congestion, throat tightness, sinus congestion, muscle pain, limb pain, genital pain, hematuria,

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain storage temperatures between 1°C and 30°C at room temperature. This will help preserve the medication's effectiveness and safety for a longer period.

Appearance and packaging

Appearance

Green triangular film-coated tablet with rounded edges and a score line

Package unit

8 tablets/box (8 tablets/PTP) × 1, 24 tablets/box (8 tablets/PTP) × 3, 40 tablets/box (8 tablets/PTP) × 5

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.