Contraindications:

• Co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form
• Hypersensitivity to the active substance or to any of the excipients
• Co-administration with guanylate cyclase stimulators, such as riociguat
• Men for whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure)
• 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
• Not indicated for use by women
   

The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension, recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa.

Dosage and administration:

For oral use. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once per day. Should be taken approximately one hour before sexual activity.

Special precautions for storage: This medicine does not require any special storage conditions but it is best to store in the original foil and box protected from moisture below 30 °C.

Nature and contents of container: PVC/aluminium foil blisters. Pack of 4 tablets. Each unit-box contains one blister with four (4) film-coated tablets along with package insert.

Shelf life: 3 years

Manufacturer: Troge Medical GMBH, Germany.

See also: http://www.trogemedical.de/