
Tyra® 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. Tyra® has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. Tyra® contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Tyra® 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. Tyra® will not help you if you do not have erectile dysfunction. It is important to note that Tyra® 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 Tyra® 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 before sexual activity. However, you have been given the dose of one 20 mg tablet as your doctor has decided that the recommended dose of 10 mg is too weak. You may take a Tyra® tablet at least 30 minutes before sexual activity. Tyra® may still be effective up to 36 hours after taking the tablet. Do not take Tyra® more than once a day. Tadalafil 10 mg and 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 Tyra® tablets if you: Are allergic to tadalafil or any of the other ingredients of this medicine. 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”). Tadalafil 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”. Take special care with Tyra® Talk to your doctor before taking Tyra®. 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. It is not known if Tyra® is effective in patients who have had: pelvic surgery. removal of all or part of the prostate gland in which nerves of the prostate are cut (radical nonnerve-sparing prostatectomy). If you experience sudden decrease or loss of vision, stop taking Tyra® and contact your doctor immediately. Side Effects 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). prolonged and possibly painful erection after taking Tyra® (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, indigestion and reflux. Storage Information Store below 30°C in the original package. Drug Interactions Tell your doctor if you are taking, have recently taken or might take any other medicines. Do not take Tyra® if you are already taking nitrates. Some medicines may be affected by Tyra® or they may affect how well Tyra® will work. 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. A 5- alpha 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 Tyra® 20 film-coated tablets: Each tablet contains 20 mg tadalafil. Other ingredients are lactose, croscarmellose sodium, sodium laurilsulphate, hypromellose, microcrystalline cellulose, magnesium stearate, iron oxide yellow (E172), triacetin, titanium dioxide.
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