HappiLong

HappiLong

tadalafil

Manufacturer:

Samjin

Distributor:

SB Pharma
Full Prescribing Info
Contents
Tadalafil.
Indications/Uses
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required.
HappiLong is not indicated for use by women.
Dosage/Direction for Use
Posology: Erectile dysfunction in adult men: In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food. In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. It may be taken at least 30 minutes prior to sexual activity.
The maximum dose frequency is once per day.
Tadalafil 10 mg and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.
In patients who anticipate a frequent use of HappiLong (i.e., at least twice weekly) a once daily regimen with the lowest doses of HappiLong might be considered suitable, based on patient choice and the physician's judgement.
In these patient, the recommended dose is 5 mg taken once a day at approximately the same time of day. The dose may be decreased to 2.5 mg* once a day on individual tolerability.
The appropriateness of continued use of the daily regimen should be reassessed periodically.
Special Populations: Elderly Men: Dose adjustments are not required in elderly patients.
Men with Renal Impairment: Dose adjustments are not required in patients with mild to moderate renal impairment. For patients with severe renal impairment, 10 mg is the maximum recommended dose for on-demand treatment.
Once-a-day dosing of 2.5 mg* or 5 mg tadalafil for the treatment of erectile dysfunction is not recommended in patients with severe renal impairment.
Men with Hepatic Impairment: For the treatment of erectile dysfunction using on-demand HappiLong the recommended dose of HappiLong is 10 mg taken prior to anticipated sexual activity and with or without food. There is limited clinical data on the safety of HappiLong in patients with severe hepatic impairment (Child-Pugh class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available data about the administration of doses higher than 10 mg of tadalafil to patients with hepatic impairment. Once-a-day dosing of HappiLong for the treatment of erectile dysfunction has not been evaluated in patients with hepatic impairment; therefore if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Men with Diabetes: Dose adjustments are not required in diabetic patients.
Paediatric population: There is no relevant use of HappiLong in the paediatric population with regard to the treatment of erectile dysfunction.
Method of administration: HappiLong is available as 20 mg film-coated tablet for oral use.
* HappiLong 2.5 mg Tablet is not available.
Contraindications
Hypersensitivity to the active substance.
In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of HappiLong to patients who are using any form of organic nitrate is contraindicated.
HappiLong, must not be used in men with cardiac disease for whom sexual activity is inadvisable.
Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.
The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated: Patients with myocardial infarction within the last 90 days.
Patients with unstable angina or angina occurring during sexual intercourse.
Patients with New York Heart Association class 2 or greater heart failure in the last 6 months.
Patients with uncontrolled arrhythmias, hypotension (<90/50 mmHg), or uncontrolled hypertension.
Patients with a stroke within the last 6 months.
HappiLong is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
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.
Storage
Store below 30°C.
MIMS Class
Drugs for Erectile Dysfunction & Ejaculatory Disorders
ATC Classification
G04BE08 - tadalafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
FC tab 20 mg x 4's.
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