Therapeutic Group:
Urogenital

Presentation:
Dilafil 5 mg Tablet: Each film-coated tablet contains Tadalafil USP 5 mg.

Pharmacology:
Tadalafil, when sexual stimulation causes the local release of nitric oxide in the corpus cavernosum, activates the enzyme guanylyl cyclase, resulting in increased levels of cGMP. The increased cGMP levels produce smooth muscle relaxation and increased blood flow into the penile tissues, thereby producing an erection. PDE-5 degrades cGMP in the corpus cavernosum, while inhibition of PDE-5 by Tadalafil maintains increased levels of cGMP. Tadalafil has no effect on penile blood flow in the absence of sexual stimulation.

Indications:
Tadalafil is indicated for the treatment of erectile dysfunction (ED) and for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Dosage & Administration:

Erectile Dysfunction – For Use as Needed:
The recommended starting dose for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.

For Once Daily Use:
The recommended starting dose for once-daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. The Dilafil dose for once-daily use may be increased to 5 mg, based on individual efficacy and tolerability.

Patients with BPH or with ED and BPH:
The recommended dose of Dilafil for once-daily use is 5 mg, taken at approximately the same time every day.

Contraindications:
Administration of Tadalafil to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, Tadalafil was shown to potentiate the hypotensive effect of nitrates.

Hypersensitivity Reactions:
Tadalafil is contraindicated in patients with a known serious hypersensitivity to Tadalafil.

Side Effects:
Gastrointestinal side effects such as nausea, vomiting, diarrhoea, flatulence, loose stool and minor abdominal cramps may occur.

Warning & Precaution:
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 identification of appropriate treatment following an appropriate medical assessment.

It is not known if Tadalafil 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 definitively determine whether these events are related directly to these risk factors, to Tadalafil, to sexual activity, or to a combination of these or other factors.

Drug Interactions:
Interaction studies were conducted with 10 mg and/or 20 mg Tadalafil, as indicated in the product information. With regard to those interaction studies where only the 10 mg Tadalafil dose was used, clinically relevant interactions at higher doses cannot be completely ruled out.

Use in Pregnancy & Lactation:
Tadalafil is not indicated for use by women. There are limited data from the use of Tadalafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of Tadalafil during pregnancy.

Available pharmacodynamic/toxicological data in animals have shown excretion of Tadalafil in milk. A risk to the suckling child cannot be excluded. Tadalafil should not be used during breast feeding.

Overdose:
Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required.

Storage:
Store below 30°C, protected from light and moisture. Store in a dry and cool place. Keep out of reach of children.

Commercial Packaging:
Dilafil 5 mg Tablet: Each box contains 20 tablets in Alu-Alu blister pack.