1. What this product is and what it is used for Lovera 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. Lovera has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity. Lovera contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Lovera 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. Lovera will not help you if you do not have erectile dysfunction. It is important to note that Lovera 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. Lovera 5 mg is used to treat adult men with urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is when the prostate gland gets bigger with age. Symptoms include difficulty in starting to pass water, a feeling of not completely emptying the bladder and a more frequent need to pass water even at night. Lovera improves blood flow to, and relaxes the muscles of, the prostate and bladder which may reduce symptoms of benign prostatic hyperplasia. Lovera has been shown to improve these urinary symptoms as early as 1-2 weeks after starting treatment. 2. What you need to know before you use this product Do not take Lovera - If you are allergic (hypersensitive) to tadalafil or any of the other ingredients of Lovera (listed in section 6). - If you 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”). Lovera has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor. - If you have serious heart disease or have had a recent heart attack within the last 90 days. - If you have had a recent stroke within the last 6 months. - If you have low blood pressure or uncontrolled high blood pressure. - If you have ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”. - If you 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 Lovera, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor. Take special care with Lovera Talk to your doctor before taking Lovera. 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. The following are reasons why Lovera may also not be suitable for you. If any of them apply to you, talk to your doctor before you take the medicine: - You have sickle cell anaemia (an abnormality of red blood cells). - You have multiple myeloma (cancer of the bone marrow). - You have leukaemia (cancer of the blood cells). - You have any deformation of your penis. - You have a serious liver problem. - You have a severe kidney problem It is not known if Lovera 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 Lovera and contact your doctor immediately. Lovera is not intended for use by women. Children and adolescents Lovera is not intended for use by children and adolescents under the age of 18. Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription, because they might interact. Do not take Lovera if you are already taking nitrates. Some medicines may be affected by Lovera or they may affect how well Lovera 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. - Riociguat. - 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. Taking Lovera with food and drink Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Lovera will work and should be taken with caution. Talk to your doctor for further information. Fertility When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility. Driving and using machines Some men taking Lovera in clinical studies have reported dizziness. Check carefully how you react to the medicines before driving or using any machines. Important information about some of the ingredients of Lovera Lovera contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. How to use this product. Always take Lovera exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Lovera tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food. For Lovera 5 mg film-coated tablets: For the treatment of erectile dysfunction The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day. Do not take Lovera more than once a day. When taken once a day Lovera 5 mg allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day. Once a day dosing of Lovera 5 mg may be useful to men who anticipate having sexual activity two or more times per week. It is important to note that Lovera 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. Drinking alcohol may affect your ability to get an erection. For the treatment benign prostatic hyperplasia The dose is one 5 mg tablet taken once a day at approximately the same time of the day. If you have benign prostatic hyperplasia and erectile dysfunction, the dose remains one 5 mg tablet taken once a day. Do not take Lovera more than once a day. For Lovera 10 and 20 mg film-coated tablets: The recommended starting dose is one 10 mg tablet before sexual activity. If the effect of this dose is too weak your doctor may increase the dose to 20 mg. You may take a Lovera tablet at least 30 minutes before sexual activity. Lovera may still be effective up to 36 hours after taking the tablet. Do not take Lovera more than once a day. Lovera 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use. It is important to note that Lovera 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. Drinking alcohol may affect your ability to get an erection. Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Lovera, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up. If you take more Lovera than you should Contact your doctor. You may experience side effects described in section 4. If you forget to take Lovera Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet. You should not take Lovera more than once a day. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Lovera 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). - Prolonged and possibly painful erection after taking Lovera (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. Uncommon (seen in 1 to 10 in every 1,000 patients) - Dizziness, stomach ache, blurred vision, eye pain, increased sweating, difficulty in breathing, penile bleeding, presence of blood in semen and/or urine, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds and ringing in the ears. Rare (seen in 1 to 10 in every 10,000 patients) - Fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing and hives (itchy red welts on the surface of the skin). Heart attack and stroke have also been reported rarely in men taking Lovera. Most of these men had known heart problems before taking this medicine. Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported. Some additional rare side effects have been reported in men taking Lovera that were not seen in clinical trials. These include: - Migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death. The side effects dizziness and diarrhoea have been reported more frequently in men over 75 years of age taking Lovera. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store this product Keep out of the reach and sight of children. Do not use Lovera after the expiry date stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture. Store below 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.