SNAFI 20/MG 4/FC TAB

Indications

Approved Uses

Erectile Dysfunction (ED), Benign Prostatic Hyperplasia (BPH), Pulmonary Arterial Hypertension (PAH).

Dosage & Administration

Dosing by Condition

Erectile dysfunction (as‑needed): 10 mg prior to sexual activity; may decrease to 5 mg or increase to 20 mg based on efficacy/tolerability; max 20 mg per dose, once daily. Erectile dysfunction (once daily): 2.5 mg once daily, may increase to 5 mg once daily. BPH (with or without ED): 5 mg once daily. Pulmonary arterial hypertension: 40 mg once daily (given as 20 mg twice daily or 40 mg once daily per product labeling; commonly 40 mg once daily total).

Initial Dose

10mg taken prior to anticipated sexual activity (on-demand); or 2.5mg once daily for daily dosing regimen

Maintenance Dose

10-20mg as needed (on-demand ED); 5mg once daily (daily ED/BPH); 40mg once daily (PAH

Maximum Dose

20mg as needed prior to sexual activity (ED); 5mg once daily (ED/BPH); 40mg once daily (PAH

Children's Dosage

Not approved for children.

Dose Adjustment Notes

Renal impairment (ED as‑needed): CrCl 30-50 mL/min: max 10 mg every 48 hours; CrCl <30 mL/min or on hemodialysis: max 5 mg every 72 hours. Hepatic impairment: mild-moderate (Child‑Pugh A/B): max 10 mg once daily (as‑needed); severe (Child‑Pugh C): not recommended. With potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): for as‑needed use, do not exceed 10 mg every 72 hours; for once‑daily use, maximum 2.5 mg daily.

How to Take

Swallow the film‑coated tablet whole with water; may be taken with or without food. For erectile dysfunction (as‑needed), take prior to anticipated sexual activity (commonly at least 30 minutes before). Do not take more than 1 dose in 24 hours.

Side Effects

Common Side Effects

Headache, Flushing, Dyspepsia, Nasal congestion, Back pain, Myalgia, Nasopharyngitis, Dizziness

Side Effect Frequency

Common: headache, dyspepsia, back pain, myalgia, flushing, nasal congestion. Other reported effects include dizziness and limb pain; rare but serious events include hypotension/syncope, priapism, NAION/sudden vision loss, and sudden hearing loss.

Safety & Warnings

Contraindications

Contraindicated with: (1) concomitant use of any organic nitrate (regular or intermittent) or nitric oxide donors; (2) concomitant use of soluble guanylate cyclase stimulators (e.g., riociguat); (3) known hypersensitivity to tadalafil or any excipient. Not absolute contraindications but generally avoid/use only after specialist cardiovascular assessment: recent MI/stroke, unstable angina, severe hypotension, uncontrolled hypertension, or other conditions where sexual activity is inadvisable; hereditary retinal disorders/retinitis pigmentosa are a precaution (avoid if advised). Severe hepatic impairment: use not recommended (often treated as a practical contraindication).

Warnings & Precautions

Key warnings/precautions: assess cardiovascular status and avoid use when sexual activity is inadvisable; strict avoidance with nitrates/riociguat; risk of symptomatic hypotension (caution with alpha-blockers/antihypertensives and volume depletion); priapism risk (seek urgent care if >4 hours; higher risk with anatomical penile deformity or predisposition); discontinue and seek care for sudden vision loss (NAION) or sudden hearing loss; caution in patients with bleeding disorders or active peptic ulcer due to limited data; counsel on alcohol-related hypotension; product is prescription-only per SFDA data.

Age Restriction

Not approved under 18 years

Driving Warning

Dizziness may occur; use caution when driving or operating machinery

Drug Interactions

Drug Interactions

Major interactions: (1) Nitrates-contraindicated (profound hypotension); (2) Riociguat-contraindicated (additive hypotension); (3) Alpha-blockers-additive hypotension (use caution; ensure stable alpha-blocker therapy and start tadalafil at lowest dose); (4) Antihypertensives-additive BP lowering (monitor); (5) Alcohol (substantial amounts)-increased risk of symptomatic hypotension; (6) Strong CYP3A4 inhibitors (e.g., ketoconazole/itraconazole, ritonavir/cobicistat, clarithromycin)-increase tadalafil exposure (dose limitation/avoid high doses); (7) Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin)-reduce exposure/efficacy.

Interaction Severity

MAJOR/Contraindicated: nitrates (including recreational nitrites) and riociguat. MODERATE/Clinically significant: potent CYP3A4 inhibitors (↑ tadalafil exposure-dose limits required), alpha‑blockers and other antihypertensives (additive hypotension risk). CYP3A4 inducers (e.g., rifampin) may reduce efficacy. Alcohol: may increase hypotension/dizziness (counsel moderation).

Food Interaction

No clinically significant food interaction; may be taken with or without food.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children.

Elderly

Standard adult dosing; no dose adjustment required based on age alone, but renal function should be considered as it may be reduced in elderly patients

Kidney Impairment

As-needed ED dosing: CrCl 30-50 mL/min: 5 mg initially, maximum 10 mg no more frequently than every 48 hours; CrCl <30 mL/min or on hemodialysis: maximum 5 mg no more frequently than every 72 hours. Once-daily ED dosing: CrCl 30-50 mL/min: consider 2.5 mg daily (may increase to 5 mg based on response); CrCl <30 mL/min or on hemodialysis: once-daily use not recommended.

Liver Impairment

Mild to moderate hepatic impairment (Child-Pugh A or B): for as-needed ED use, maximum 10 mg once daily; once-daily regimens should be used cautiously (often not recommended depending on indication). Severe hepatic impairment (Child-Pugh C): use not recommended (avoid).

Storage & Patient Advice

Missed Dose

As‑needed ED: not applicable (take only when needed). Once‑daily regimens (ED daily/BPH/PAH): take as soon as remembered the same day; if close to the next dose, skip the missed dose-do not double.

Stopping the Medicine

Safe to stop anytime - no tapering required

Overdose

Overdose: symptoms are typically an exaggeration of pharmacologic effects (e.g., headache, flushing, dizziness, hypotension, dyspepsia, back pain/myalgia, visual symptoms); management is supportive/symptomatic with monitoring of hemodynamics, and hemodialysis is unlikely to be beneficial due to high protein binding; no specific antidote.

Patient Counseling

Take exactly as prescribed: as‑needed dosing before sexual activity or once daily at the same time each day (if on daily therapy). Do not use with nitrates or riociguat; tell your clinician about all BP medicines/alpha‑blockers and CYP3A4 inhibitors. Seek urgent care for chest pain after use (do not take nitrates), erection >4 hours, or sudden vision/hearing loss; limit excessive alcohol to reduce dizziness/low BP.

Monitoring Requirements

No routine laboratory monitoring is required; clinically monitor blood pressure and symptoms of hypotension (especially with antihypertensives/alpha‑blockers), and monitor for vision/hearing changes and priapism risk symptoms.

Pharmacology

Mechanism of Action

Selective PDE5 inhibition increases cGMP by reducing its breakdown, causing smooth‑muscle relaxation and vasodilation in the corpus cavernosum (and also pulmonary/prostatic vasculature), facilitating erection with sexual stimulation and lowering pulmonary vascular resistance in PAH.

Onset of Action

30-60 minutes.

Duration of Effect

Up to 36 hours.

Half-Life

17.5 hours.

Bioavailability

Absolute oral bioavailability has not been determined; food does not produce a clinically meaningful effect on exposure.

Metabolism

Hepatic metabolism primarily via CYP3A4 to metabolites (predominantly inactive), followed by conjugation.

Excretion

Fecal (approximately 61%) and renal (approximately 36%).

Protein Binding

94%.

Product Information

Available Dosage Forms

Film‑coated tablet (oral).

Composition per Dose

Each film-coated tablet: Tadalafil 20mg

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Mechanism

PDE5 Inhibitor

Onset Time

30-60 minutes

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.