Tadalafil STELLA 2.5 mg

Rx

Indications

• Used in the treatment of erectile dysfunction in adult males. Tadalafil is effective only in the presence of adequate sexual stimulation

Dosage

• The usual daily dose is 10 mg at least 30 minutes before sexual intercourse, may be increased to 20 mg. The maximum dose is frequency is once per day.
• Doses of 10 mg and 20 mg are 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 tadalafil (at least twice weekly), a once daily regimen with the lowest doses might be considered suitable. The recommended dose is 5 mg taken once a day and at approximately the same time every day, may be decreased to 2.5 mg once a day.
• The appropriateness of continued use of daily regimen should be reassessed periodically.
• Elderly patients, patients with mild to moderate renal impairment, patients with diabetes: Dose adjustment is not required.
• Patients with severe renal impairment: 10 mg is the maximum recommended dose. Once-a-day dosing of 2.5 or 5 mg is not recommended.
• Patients with hepatic impairment: The recommended dose is 10 mg taken prior to anticipated sexual activity. There are no available data about administration of doses > 10 mg of tadalafil. Once-a-day dosing of tadalafil has not been evaluated.
• Paediatric population: There is no relevant use in paediatric population.

Usage

• Administered orally, without regard to meals.

• Known hypersensitivity to tadalafil or any ingredient in the formulation.
• Patients receiving nitrates.
• Patients with cardiac disease for whom sexual activity is inadvisable.
• Patients with visual impairment for monocular due to non-arteritic anterior ischaemic optic neuropathy.
• Patients with uncontrolled arrhythmias, hypotension (< 90/50 mmHg), or uncontrolled hypertension.
• Patients with a stroke within the last 6 months.
• Patients with a myocardial infarction within the last 90 days.
• Patients with unstable angina or angina occurring during sexual intercourse.
• Patients with unstable angina or angina occurring during sexual intercourse.
• Patients with class 2 or greater heart failure in the last 6 months.
• Concomitant use of PDE5 inhibitors, including tadalafil with guanylat cyclase inducer, e.g. riociugat

Common

• Headache, flushing, nasal congestion, dyspepsia, gastro-oesophageal reflux, back pain, myalgia, pain in extremity.

• Prior initiating treatment with tadalafil for benign prostatic hyperplasia patients should be examined to ruled out the presence of carcinoma of the prostate and assessed for cardiovascular conditions.
• It is necessary to assess the cardiovascular status of the patient prior to initiating tadalafil therapy. Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported.
• Use of tadalafil currently is not recommended in patients with hereditary degenerative retinal disorders, including retinitis pigmentosa.
• Use with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, Peyronie’s disease) and with conditions that may predispose to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia).
• Combined use of tadalafil and other therapies for erectile dysfunction currently is not recommended.
• Tadalafil STELLA 2.5 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• The drug is not indicated for use in children, neonates and women.
• Patients should be aware of how they react to tadalafil before driving or operating machinery.