BUY TADALAFIL C20 (CIALIS) (20 MG/TAB. – 10 TABS)

MAIN PRODUCT DESCRIPTION

Tadalafil C20 is an oral tablet containing 20 mg of tadalafil, a phosphodiesterase type-5 (PDE-5) inhibitor. According to the supplied product information, tadalafil is indicated for the treatment of erectile dysfunction (ED) and the signs and symptoms of benign prostatic hyperplasia (BPH).

Tadalafil works by influencing the nitric oxide–cyclic guanosine monophosphate (NO-cGMP) signalling pathway. This pathway has an important role in the physiological response involved in penile erection. During sexual stimulation, nitric oxide is released in erectile tissue, increasing cGMP concentrations. cGMP promotes relaxation of smooth muscle and increased blood flow.

PDE-5 is responsible for the breakdown of cGMP. By inhibiting PDE-5, tadalafil allows cGMP activity to remain elevated for longer, supporting the erectile response when sexual stimulation occurs.

PRODUCT SPECIFICATIONS

• Product: Tadalafil C20
• Brand reference: Cialis
• Strength: 20 mg per tablet
• Active Ingredient: Tadalafil
• Dosage Form: Tablet
• Route: Oral
• Pack Size: 10 tablets
• Molecular Formula: C22H19N3O4*
• Molecular Weight: 389.404 g/mol
• CAS Number: 171596-29-5
• Market Status: Prescription
• Company: Hilma Biocare

PHARMACOLOGICAL CLASS

Tadalafil belongs to the PDE-5 inhibitor class. Unlike androgenic medicines or anabolic steroids, tadalafil does not act by increasing testosterone or directly stimulating androgen receptors.

Its pharmacological effect is associated with inhibition of PDE-5 and enhancement of cGMP-mediated smooth-muscle relaxation in tissues where the nitric oxide pathway is active.

ERECTILE DYSFUNCTION

The supplied information identifies tadalafil for the treatment of erectile dysfunction. Tadalafil does not independently create sexual desire or produce an erection without sexual stimulation. Instead, it supports the normal physiological mechanism required for erection when sexual stimulation is present.

The supplied product information states that tadalafil taken as needed can improve erectile function for up to 36 hours following dosing. This does not mean that an erection lasts for 36 hours; rather, the medicine may remain capable of supporting erectile function during this period when sexual stimulation occurs.

BENIGN PROSTATIC HYPERPLASIA

The supplied information also identifies tadalafil for the treatment of the signs and symptoms associated with benign prostatic hyperplasia (BPH).

BPH can cause urinary symptoms associated with enlargement of the prostate. Before starting tadalafil for BPH, the supplied source recommends considering other urological conditions that may produce similar symptoms.

DOSAGE AND ADMINISTRATION

According to the supplied product information, the recommended starting dose for tadalafil used as needed in most patients is 10 mg before anticipated sexual activity. Depending on efficacy and tolerability, the dose may be reduced to 5 mg or increased to 20 mg.

The source states that the maximum recommended frequency for as-needed treatment is once per day in most patients.

Because this product is supplied as a 20 mg tablet, the appropriate dose should be determined by a qualified healthcare professional. Patients should not take more than prescribed or combine tadalafil with other erectile-dysfunction medicines without medical advice.

FOOD AND ADMINISTRATION

The supplied information states that tadalafil may be taken with or without food.

Unlike some medicines whose absorption is substantially affected by meals, tadalafil does not require administration on an empty stomach according to the supplied information.

IMPORTANT CARDIOVASCULAR SAFETY INFORMATION

One of the most important safety considerations with tadalafil is its interaction with organic nitrates.

Tadalafil is contraindicated in patients using any form of organic nitrate because the combination can significantly increase the blood-pressure-lowering effects of both substances. This can result in dangerous hypotension.

Tadalafil should also be used with caution in patients taking alpha-blockers or antihypertensive medicines, because additive blood-pressure-lowering effects may occur.

Patients whose cardiovascular status makes sexual activity inadvisable should not use tadalafil without appropriate medical evaluation.

ALCOHOL

The supplied information states that tadalafil and alcohol can both act as mild vasodilators. Substantial alcohol consumption together with tadalafil may therefore increase the likelihood of orthostatic symptoms such as dizziness, increased heart rate and decreased standing blood pressure.

Patients should discuss alcohol consumption with their healthcare professional where appropriate.

WARNINGS

Patients should seek emergency medical attention if an erection lasts longer than 4 hours, because prolonged erection (priapism) can cause tissue damage.

The supplied information also instructs patients to stop tadalafil and seek medical care if they experience:

• Sudden loss of vision in one or both eyes
• Sudden decrease or loss of hearing

Sudden visual loss may be associated with non-arteritic anterior ischaemic optic neuropathy (NAION), while sudden hearing loss requires prompt medical assessment.

ADVERSE REACTIONS

The supplied information identifies several common adverse reactions associated with tadalafil:

• Headache
• Dyspepsia
• Back pain
• Myalgia
• Nasal congestion
• Flushing
• Pain in the limbs

Other reported reactions include gastroesophageal reflux disease, upper abdominal pain, nausea, vomiting, arthralgia and muscle spasm.

The source states that back pain and myalgia may occur approximately 12–24 hours after dosing and generally resolve within a limited period. Severe back pain is reported less frequently.

Patients should speak with a healthcare professional if adverse reactions are persistent, severe or unexpected.

RENAL AND HEPATIC IMPAIRMENT

The supplied clinical pharmacology information describes changes in tadalafil exposure in patients with renal impairment. Exposure can increase substantially in patients with reduced creatinine clearance and in patients with end-stage renal disease undergoing haemodialysis.

For hepatic impairment, the supplied information states that tadalafil exposure following a 10 mg dose in patients with mild or moderate hepatic impairment was comparable with exposure in healthy subjects. Data for higher doses and severe hepatic impairment are limited.

Because the 20 mg tablet represents the upper end of the as-needed dosing range described in the source, patients with renal or hepatic impairment should receive individual medical assessment before treatment.

DRUG INTERACTIONS

Tadalafil is predominantly metabolised by CYP3A4. Medicines that strongly inhibit CYP3A4 may increase tadalafil exposure.

The supplied information specifically discusses:

• Ketoconazole, which substantially increased tadalafil exposure in a pharmacokinetic study.
• Ritonavir, which increased tadalafil exposure.
• Other CYP3A4 inhibitors, including erythromycin, itraconazole and grapefruit juice, which may also increase exposure.
• Rifampin, a CYP3A4 inducer, which reduced tadalafil exposure.

The supplied source also discusses interactions with antacids, H2 antagonists, warfarin, aspirin and digoxin.

SPECIFIC POPULATIONS

The supplied clinical-trial information reports no overall difference in efficacy or safety between older and younger participants in the referenced ED and BPH studies.

However, treatment decisions in older patients should still take into account cardiovascular health, kidney function, liver function and concurrent medicines.

OVERDOSAGE

The supplied information states that single doses up to 500 mg were studied in healthy subjects and multiple daily doses up to 100 mg were studied in patients, with adverse events similar to those observed at lower exposure levels.

Tadalafil overdose should nevertheless be treated as a medical concern. Supportive treatment may be required, and haemodialysis contributes negligibly to tadalafil elimination according to the supplied information.

Do not intentionally exceed the prescribed dose. Seek medical attention if overdose is suspected or unwanted symptoms develop.

REGULATORY AND PHARMACEUTICAL INFORMATION

The supplied product data identifies Tadalafil C20 as a prescription product manufactured by Hilma Biocare. No independent regulatory verification for this specific 20 mg presentation has been supplied here.

Accordingly, the product should not be described as officially EU-authorised, prescription-free or legally saleable in every European country unless the relevant national regulatory status has been verified.

IMPORTANT PHARMACEUTICAL DISCLAIMER

This product contains tadalafil, a pharmacologically active PDE-5 inhibitor. The information above is based on the product data supplied and does not replace official prescribing information or professional medical advice.

Patients should consult a qualified healthcare professional before using tadalafil, particularly if they have cardiovascular disease, kidney or liver impairment, or take nitrates, alpha-blockers, antihypertensives or other medicines that may interact with tadalafil.