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Avialis is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Avialis has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. Avialis contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Avialis works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Avialis will not help you if you do not have erectile dysfunction. It is important to note that Avialis does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction. How to use Avialis tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food. The recommended starting dose is one 10 mg tablet before sexual activity. However, you have been given the dose of one 20mg tablet as your doctor has decided that the recommended dose of 10mg is too weak. You may take a Avialis tablet at least 30 minutes before sexual activity. Avialis may still be effective up to 36 hours after taking the tablet. Do not take Avialis more than once a day. Avialis 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use. Warnings and precautions Do not take Avialis if you: Are allergic to tadalafil or any of the other ingredients of Avialis Are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Avialis has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor. Have serious heart disease or recently had a heart attack within the last 90 days. Recently had a stroke within the last 6 months. Have low blood pressure or uncontrolled high blood pressure. Ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”. Are taking riociguat. This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors, such as Avialis, have been shown to increase the hypotensive effects of Avialis. If you are taking riociguat or are unsure tell your doctor. Warnings and precautions Talk to your doctor before taking Avialis. Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor. Before taking the tablets, tell your doctor if you have: Sickle cell anaemia (an abnormality of red blood cells). Multiple myeloma (cancer of the bone marrow). Leukaemia (cancer of the blood cells). Any deformation of your penis. A serious liver problem. A severe kidney problem. Side Effects Like all medicines, Avialis can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature. If you experience any of the following side effects stop using the medicine and seek medical help immediately: Allergic reactions including rashes (frequency uncommon). Chest pain - do not use nitrates but seek immediate medical assistance (frequency uncommon). Priapism, a prolonged and possibly painful erection after taking Avialis (frequency rare). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately. Sudden loss of vision (frequency rare). Other side effects have been reported: Common (seen in 1 to 10 in every 100 patients) Headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion, and indigestion. Storage Information Store below 30ºC. Drug Interactions Tell your doctor or pharmacist if you are already taking: An alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia). Other medicines to treat high blood pressure. Riociguat. A 5alpha reductase inhibitor (used to treat benign prostatic hyperplasia). Medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment of aids or HIV infection. Phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines). Rifampicin, erythromycin , clarithromycin or itraconazole. Other treatments for erectile dysfunction. Ingredients The active substance is tadalafil. The other ingredients are: lactose monohydrate, croscarmellose sodium, Sodium lauryl sulphate, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate and Opadry yellow 32K220033. Specifications Avialis 20 mg is a yellow film-coated tablet.