HappiLong Special Precautions





SB Pharma
Full Prescribing Info
Special Precautions
Before treatment with HappiLong: A medical history and physical examination should be undertaken to diagnose erectile dysfunction or benign prostatic hyperplasia and determine potential underlying cause, before pharmacological treatment is considered.
Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure and as such potentiates the hypotensive effect of nitrates.
The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment. It is not known if HappiLong is effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy.
Cardiovascular: Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischaemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/or in clinical trials. Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitely determine whether these events are related directly to these risk factors, to HappiLong, to sexual activity, or to a combination of these or other factors.
Tadalafil (2.5 mg* and 5 mg): In patients receiving concomitant antihypertensive medicinal products, tadalafil may induce a blood pressure decrease. When initiating daily treatment with tadalafil, appropriate clinical considerations should be given to a possible dose adjustment of the antihypertensive therapy.
In patients who are taking alpha1 blockers, concomitant administration of HappiLong may lead to symptomatic hypotension in some patients. The combination of tadalafil and doxazosin is not recommended.
Vision: Visual defects and cases of NAION have been reported in connection with the intake of HappiLong and other PDE5 inhibitors. The patient should be advised that in case of sudden visual defect, he should stop taking HappiLong and consult a physician immediately.
Renal and hepatic impairment: Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of HappiLong is not recommended in patients with severe renal impairment.
There is limited clinical data on the safety of single-dose administration of HappiLong in patients with severe hepatic insufficiency (Child-Pugh class C). Once-a-day administration either for the treatment of erectile dysfunction or benign prostatic hyperplasia has not been evaluated in patients with hepatic insufficiency. If HappiLong is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Priapism and anatomical deformation of the penis: Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
HappiLong, should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease) or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma, or leukaemia).
Use with CYP3A4 inhibitors: Caution should be exercised when prescribing HappiLong to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin), as increased tadalafil exposure (AUC) has been observed if the medicinal products are combined.
HappiLong and other treatments for erectile dysfunction: The safety and efficacy of combinations of HappiLong and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. The patients should be informed not to take HappiLong in such combinations.
Lactose: HappiLong contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
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