TADALANDRO 20 MG (TADALAFIL) – 4 FILM-COATED TABLETS

Active Ingredient: Tadalafil 20 mg
Dosage Form: Film-coated tablets
Pack Size: 4 tablets
Therapeutic Category: Phosphodiesterase Type 5 (PDE5) inhibitor.

Product Overview

Tadalandro 20 mg contains tadalafil, a selective phosphodiesterase type 5 (PDE5) inhibitor used primarily for the treatment of erectile dysfunction (ED) in adult men.

It works by enhancing the natural erectile response to sexual stimulation through increased blood flow to the penile tissues. By inhibiting the PDE5 enzyme, tadalafil helps maintain higher levels of cyclic guanosine monophosphate (cGMP), promoting relaxation of smooth muscles in penile blood vessels and facilitating an erection.

Tadalafil is known for its relatively long duration of action, with effects that may last up to 36 hours after administration. However, sexual stimulation is still required for an erection to occur.

Active Ingredient and Mechanism of Action

Tadalafil 20 mg

Tadalafil selectively inhibits the phosphodiesterase type 5 (PDE5) enzyme, which is responsible for breaking down cGMP in smooth muscle cells.

Its mechanism of action involves:

• Inhibits PDE5: Prevents the breakdown of cyclic guanosine monophosphate (cGMP).
• Enhances Blood Flow: Increases cGMP availability, promoting relaxation of smooth muscles in the corpus cavernosum.
• Supports Erectile Function: Improves penile blood flow in response to sexual stimulation.
• Prolonged Duration of Action: Has a relatively long elimination half-life of approximately 17.5 hours, allowing an erectile response to be facilitated for up to 36 hours.

Important: Tadalafil does not independently cause an erection and does not increase sexual desire. Sexual stimulation is necessary for its therapeutic effect.

Indications and Benefits

Tadalafil 20 mg is primarily indicated for the treatment of erectile dysfunction in adult men.

Main therapeutic benefits include:

1. Management of Erectile Dysfunction: Helps men achieve and maintain an erection sufficient for satisfactory sexual activity.
2. Improved Erectile Response: Enhances the natural physiological response to sexual stimulation by increasing blood flow to penile tissues.
3. Long Duration of Action: Provides an extended therapeutic window of up to 36 hours, offering greater flexibility in sexual activity.
4. Improved Sexual Confidence: Successful treatment may help improve sexual satisfaction and confidence.
5. Convenient On-Demand Treatment: The 20 mg strength is generally used when needed rather than as a routine daily dose.

Clinical evidence: Tadalafil has demonstrated significant improvements in erectile function in randomized clinical trials, including improvements in successful intercourse attempts and erectile-function questionnaire scores.

Dosage and Administration

Important: Tadalafil dosage should be individualized according to the patient's medical condition, response to treatment, tolerability, and concomitant medications.

For Erectile Dysfunction (On-Demand Use):

• Recommended starting dose: 10 mg taken before anticipated sexual activity.
• Dose adjustment: May be increased to 20 mg or reduced to 5 mg depending on efficacy and tolerability.
• Maximum recommended dose: 20 mg once daily.
• Timing: Take at least 30 minutes before anticipated sexual activity.
• Duration of action: May remain effective for up to 36 hours.

Method of Administration:

• Take orally with a glass of water.
• May be taken with or without food.
• Sexual stimulation is required for the medicine to work.
• Do not take more than one dose within 24 hours.
• Avoid excessive alcohol consumption because it may increase the risk of dizziness and low blood pressure.

Important: Tadalandro 20 mg is generally intended for on-demand use. It should not automatically be used as a daily treatment. Daily tadalafil therapy for erectile dysfunction or benign prostatic hyperplasia generally uses lower strengths, such as 2.5 mg or 5 mg.

The appropriate dose may require adjustment in patients with renal or hepatic impairment or those taking interacting medications.

Possible Side Effects

Tadalafil is generally well tolerated when used appropriately. However, some patients may experience adverse effects.

Common Side Effects:

• Headache.
• Facial flushing.
• Indigestion (dyspepsia).
• Nasal congestion.
• Back pain.
• Muscle aches (myalgia).
• Pain in the limbs.
• Dizziness.

Less Common but Serious Side Effects:

• Sudden decrease or loss of vision.
• Sudden decrease or loss of hearing.
• Severe hypotension (low blood pressure).
• Allergic reactions.
• Priapism (prolonged erection lasting more than 4 hours).

Priapism: An erection lasting more than 4 hours requires immediate emergency medical attention to prevent permanent damage to penile tissues.

Sudden vision loss, hearing loss, chest pain, or severe allergic reactions also require immediate medical evaluation.

Warnings and Precautions

• Cardiovascular Disease: Patients with underlying heart conditions should undergo medical assessment before treatment. Sexual activity may carry additional cardiovascular risks in certain patients.
• Nitrate Interaction: Tadalafil must never be used with organic nitrates because the combination can cause a dangerous drop in blood pressure.
• Blood Pressure: Use caution in patients with hypotension or uncontrolled hypertension.
• Alcohol Consumption: Excessive alcohol intake may increase the risk of dizziness, orthostatic hypotension, and fainting.
• Renal Impairment: Dose adjustment may be required in patients with impaired kidney function. Severe renal impairment requires particular caution.
• Hepatic Impairment: Patients with liver dysfunction should be medically evaluated before use.
• Eye Disorders: Patients with a history of non-arteritic anterior ischemic optic neuropathy (NAION) require special assessment.
• Prolonged Erection: Patients should seek emergency medical attention if an erection lasts longer than 4 hours.
• Other Erectile Dysfunction Treatments: Avoid combining tadalafil with other PDE5 inhibitors unless specifically directed by a specialist.

►Critical Emergency Precaution: If chest pain occurs after taking tadalafil, seek emergency medical attention and inform healthcare professionals about the last tadalafil dose. Nitrates should not be administered within 48 hours of tadalafil use unless considered medically necessary in a life-threatening situation under close medical supervision.

Contraindications

Tadalafil is contraindicated in patients with:

• Known hypersensitivity to tadalafil or any of its excipients.
• Concomitant use of organic nitrates, including nitroglycerin and isosorbide preparations.
• Concomitant use of guanylate cyclase stimulators, such as riociguat.
• Certain cardiovascular conditions in which sexual activity is medically inadvisable.
• Previous non-arteritic anterior ischemic optic neuropathy (NAION) with associated vision loss, according to applicable product labeling.

Drug Interactions

Important drug interactions include:

• Organic Nitrates: Such as nitroglycerin, isosorbide mononitrate, and isosorbide dinitrate. Concomitant use is contraindicated.
• Alpha-Blockers: Such as doxazosin and tamsulosin. May increase the risk of symptomatic hypotension.
• Antihypertensive Medicines: Concomitant use may enhance blood-pressure-lowering effects.
• CYP3A4 Inhibitors: Such as ketoconazole, itraconazole, clarithromycin, and ritonavir. These may increase tadalafil concentrations.
• CYP3A4 Inducers: Such as rifampicin, carbamazepine, and phenytoin. These may decrease tadalafil exposure.
• Riociguat: Concomitant use is contraindicated because of the risk of significant hypotension.
• Other PDE5 Inhibitors: Combining tadalafil with sildenafil or other PDE5 inhibitors is generally not recommended.

Patients should inform their healthcare professional about all prescription medicines, OTC products, and supplements they are taking before starting treatment.

Storage Conditions

• Store at room temperature according to the original package instructions.
• Protect from excessive heat and moisture.
• Keep in the original packaging until use.
• Keep out of reach of children.
• Do not use after the expiry date.

References

1. European Medicines Agency (EMA). Cialis (Tadalafil) – European Public Assessment Report and Summary of Product Characteristics. Includes pharmacological properties, indications, dosage, contraindications, and safety information. EMA official product information.
2. U.S. Food and Drug Administration (FDA) / DailyMed. Tadalafil Tablets – Full Prescribing Information. Includes dosage recommendations, adverse reactions, warnings, contraindications, and drug interactions. Official prescribing information.
3. National Health Service (NHS). Tadalafil – Uses, dosage, side effects, precautions, and interactions. NHS medicine guide.
4. Health Products Regulatory Authority (HPRA), Ireland. Tadalafil 20 mg Film-Coated Tablets – Summary of Product Characteristics. Official product information.
5. National Library of Medicine (NIH/PubMed). Clinical evidence and research concerning tadalafil efficacy and safety in erectile dysfunction. Tadalafil clinical studies.

Patient Disclaimer

This product description is intended for educational and informational purposes only. Tadalandro 20 mg (tadalafil) is a prescription medicine that should be used under the supervision of a qualified healthcare professional. It is not suitable for everyone, particularly patients taking nitrate medications or those with certain cardiovascular conditions. Do not exceed the prescribed dose or combine it with other erectile dysfunction treatments without medical advice. Seek immediate medical attention for chest pain, sudden vision or hearing loss, or an erection lasting more than 4 hours. This product is not intended to diagnose, treat, cure, or prevent any disease without appropriate medical supervision.