Diamonrecta 5 mg 30 tablets
Eva Pharma
Eva Pharma
Composition
Each film-coated tablet contains
Active ingredient
Tadalafil 5 mg.
Inactive ingredients
Hydroxypropyl cellulose, lactose monohydrate, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate, Opadry yellow coating.
Description
Diamonrecta is indicated for the treatment of erectile dysfunction and symptoms of benign prostatic hyperplasia (BPH) in adult men.
Tadalafil, the active substance, is a selective phosphodiesterase type 5 (PDE5) inhibitor that increases cGMP levels, leading to smooth muscle relaxation and enhanced blood flow to the corpus cavernosum.
In BPH, it improves vascular perfusion and reduces smooth muscle tone in the prostate and bladder.
Indications for Use
- Erectile dysfunction in adult men (with sexual stimulation required).
- Treatment of the signs and symptoms of benign prostatic hyperplasia (5 mg only).
Dosage and Administration
- Erectile dysfunction: 10 mg taken at least 30 minutes before anticipated sexual activity; may be increased to 20 mg.
- For regular use (≥ twice weekly): 5 mg once daily at the same time of day.
- Benign prostatic hyperplasia: 5 mg once daily, with or without food.
- In renal or hepatic impairment, use with caution; daily dosing not recommended in severe impairment.
- For oral use, tablets should be swallowed with water.
Contraindications
- Hypersensitivity to tadalafil or any excipients.
- Concomitant use with organic nitrates, nitric oxide donors, or guanylate cyclase stimulators (e.g., riociguat).
- Recent myocardial infarction or stroke (within 6 months).
- Severe heart failure, unstable angina.
- Hypotension (<90/50 mmHg) or uncontrolled hypertension.
- Loss of vision due to non-arteritic anterior ischemic optic neuropathy (NAION).
Precautions
- Assess cardiovascular risk before initiating treatment.
- Use with caution in patients with cardiac, hepatic, or renal disorders, diabetes, penile anatomical deformation, or predisposition to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).
- Avoid concomitant use with potent CYP3A4 inhibitors (ritonavir, ketoconazole, itraconazole, erythromycin).
- Patients should seek immediate medical attention if they experience sudden vision or hearing loss or prolonged erection lasting more than 4 hours.
Side Effects
Very common - headache, dyspepsia.
Common - back pain, myalgia, flushing, nasal congestion.
Uncommon - dizziness, nausea, hypotension, palpitations, rash.
Rare - hypersensitivity reactions, angioedema, visual or auditory disturbances, priapism.
Pregnancy and Lactation
Not indicated for use in women.
Storage Conditions
Store below 30 °C in a dry place, out of reach of children.
Packaging
Carton box containing 3 blisters, each with 10 film-coated tablets and a package insert.