Tadalafil Stella 5mg (3 blisters x 10 tablets/box)

Indications

• Treatment of erectile dysfunction in adult males. Tadalafil is effective only in the presence of adequate sexual stimulation.
• Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.

Contraindications

• 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 a previous history of non-arteritic anterior ischaemic optic neuropathy.
• Patients with uncontrolled arrhythmias, uncontrolled hypertension.
• Patients with a stroke within the last 6 months.
• Patients with a myocardial infarction within the last 90 days.

Compositon/Ingredients

Dosage and administration

Erectile dysfunction in adult males

• 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, may be decreased to 2.5 mg once a day.
• The appropriateness of continued use of daily regimen should be reassessed periodically.

Benign prostatic hyperplasia in adult males

• The recommended dose is 5 mg, taken at approximately the same time every day.

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.

Paediatric population

• There is no relevant use in paediatric population.

Precaution

• Prior initiating treatment with tadalafil for benign prostatic hyperplasia patients should be examined to rule 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 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.

Storage

Store at temperature below 30°C, protect from light.