Product Details

What you need to know before you take Spedra Do not take Spedra: • If you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6) • If you are taking “nitrate” medicines for chest pain (angina), such as amyl nitrite or glyceryl trinitrate. Spedra can increase the effects of these medicines and severely lower your blood pressure • If you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir 2 • If you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin • If you have a serious cardiac problem • If you have had a stroke or heart attack in the last 6 months • If you have low blood pressure or high blood pressure not controlled by medicines • If you have chest pain (angina) or you get chest pain during sexual intercourse • If you have a serious liver or kidney problem • If you have loss of vision in one eye due to not enough blood getting to your eye (non-arteritic ischemic optic neuropathy [NAION]) • If certain serious eye problems run in your family (such as retinitis pigmentosa). • If you are taking riociguat. This medicine 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 have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor. Do not take Spedra if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Spedra.

Warnings and precautions Talk to your doctor or pharmacist before taking Spedra: • If you have heart trouble. It may be risky for you to have sexual intercourse • If you suffer from priapism, that is a persistent erection lasting 4 hours or more. This can happen in men with conditions like sickle cell disease, multiple myeloma or leukaemia. • If you have a physical condition that affects the shape of your penis (such as angulation, Peyronie’s disease or cavernosal fibrosis) • If you have any bleeding disorder or active peptic ulceration. If any of the above apply to you talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure. Problems with your sight or hearing Some men taking medicines like Spedra have had problems with their sight and hearing – see “Serious side effects” in section 4 for more details. It is not known if these problems are related directly to Spedra, other diseases that you may have or a combination of factors. If you experience sudden decrease or loss of vision or your vision is distorted or dimmed while you are taking Spedra, stop taking Spedra and contact your doctor immediately. Children and adolescents Spedra should not be taken by children and adolescents under 18 years of age. Other medicines and Spedra Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Spedra can affect the way some other medicines work. Also some other medicines can affect the way Spedra works. In particular, tell your doctor and do not take Spedra if you are taking “nitrate” medicines for chest pain (angina) such as amyl nitrite or glyceryl trinitrate. Spedra has been shown to increase the effects of these medicines and severely lower your blood pressure. Also do not take Spedra if you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir or if you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin (see beginning of section 2 under ‘Do not take Spedra’). Tell your doctor or pharmacist if you are taking any of the following medicines: • so called “alpha-blockers” – for prostate problems or for lowering your high blood pressure • medicines for an irregular heartbeat (“arrhythmia”) such as quinidine, procainamide, amiodarone or sotalol • antibiotics for infections such as erythromycin • phenobarbital or primidone – for epilepsy • carbamazepine – for epilepsy, to stabilise your mood or for certain types of pain • other medicines that may reduce the breakdown of Spedra in the body (‘moderate CYP3A4 inhibitors’) including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil. • riociguat Do not use Spedra together with other treatments for erectile dysfunction such as sildenafil, tadalafil or vardenafil. If any of the above apply to you talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure. Spedra with drink and alcohol Grapefruit juice can increase exposure to the medicine and should be avoided within 24 hours prior to taking Spedra. Drinking alcohol at the same time as taking Spedra may increase your heart rate and lower your blood pressure. You may feel dizzy (especially when standing), have a headache or feel your heart beating in your chest (palpitations). Drinking alcohol may also decrease your ability to get an erection.

Fertility There was no effect on sperm movement or structure after single 200 mg oral doses of avanafil in healthy volunteers. The repeated oral administration of avanafil 100 mg over a period of 26 weeks to healthy volunteers and adult males with mild erectile dysfunction was not associated with any untoward effects on sperm concentration, count, motility, or morphology. Driving and using machines Spedra can make you feel dizzy or affect your vision. If this happens, do not drive, cycle, use tools or machines