155 mm 20 mm 135 mm Package leaflet: Information for the User Aronix® 50 mg Film-Coated Tablets STOP TAKING Aronix and seek medical attention IMMEDIATELY if you experience any of the Sildenafil 40 mm following SERIOUS side effects: Read all of this leaflet carefully before you start taking this medicine because it contains important • chest pains: this occurs uncommonly. information for you. If this occurs before, during or after intercourse get Always take this medicine exactly as described in this leaflet or as your pharmacist has told you. in a semi-sitting position and try to relax. • Keep this leaflet. You may need to read it again. Do NOT use nitrates to treat your chest pain • Ask your pharmacist if you need more information or advice. • a persistent and sometimes painful erection • If you get any side effects, talk to your pharmacist or doctor. This includes any possible side effects not listed lasting longer than 4 hours: this occurs rarely in this leaflet. See section 4. • a sudden decrease or loss of vision: this occurs • If you have taken Aronix as directed and were NOT able to get or keep an erection hard enough for rarely satisfactory sex, you should talk to your pharmacist or doctor. • an allergic reaction: this occurs uncommonly. Symptoms include sudden wheeziness, difficulty What is in this leaflet Children and adolescents breathing or dizziness, swelling of the eyelids, 40 mm face, lips or throat 1. What Aronix is and what it is used for This medicine should not be given to children and • serious skin reactions such as Stevens-Johnson 2. What you need to know before you take Aronix adolescents under the age of 18 years. Syndrome (SJS) and Toxic Epidermal Syndrome 3. How to take Aronix (TEN): this occurs rarely. Symptoms may include 4. Possible side effects Other medicines and Aronix Tell your pharmacist or doctor if you are taking, have severe peeling and swelling of the skin, blistering 5. How to store Aronix of the mouth, genitals and around the eyes, fever 6. Contents of the pack and other information recently taken or might take any other medicines. Some medicines may be affected by Aronix or they • seizures or fits: this occurs rarely. may affect how well Aronix will work. 1. What Aronix is and what it is used for Other side effects that have been reported: Nitrate medicines: Do NOT take Aronix if you are Very common (may affect more than 1 in 10 people): Aronix is a treatment for adult men (aged 18 years taking nitrate medicines (such as glyceryl headache. and older) with erectile dysfunction (also known as trinitrate, isosorbide mononitrate, isosorbide impotence). This is when a man cannot get or keep an dinitrate) or nitric oxide donors (such as amyl Common (may affect up to 1 in 10 people): erection hard enough for satisfactory sexual activity. nitrite (“poppers”), nicorandil or sodium 40 mm • nausea, indigestion, stuffy nose, dizziness nitroprusside). • facial flushing, hot flush (symptoms include a Erections depend on many things, including proper These are often used for the relief of chest pain sudden feeling of heat in your upper body) blood flow to the penis. If blood cannot flow (angina pectoris), or heart failure. • colour tinge to vision, blurred vision, visual adequately to the penis, it can cause erectile Using Aronix with any of these medicines may lead to disturbance dysfunction. Erectile dysfunction is a common problem a dangerous fall in blood pressure. and can affect men differently. Some men cannot get Uncommon (may affect up to 1 in 100 people): an erection, other men can get an erection but it may Do not take Aronix if you are taking a medicine called • vomiting, upper abdominal pain, not be hard enough for sex, or they may lose their riociguat (or other medicines of a group called gastro-oesophageal reflux disease (also known as erection before or during sex. guanylate cyclase stimulators), used to treat acid reflux with symptoms including heartburn) Aronix contains the active ingredient sildenafil. pulmonary arterial hypertension (i.e. high blood • skin rash, pain in the arms or legs, nosebleed, It belongs to a group of medicines called pressure in the lungs) and chronic thromboembolic feeling hot, feeling tired phosphodiesterase type 5 (PDE5) inhibitors. pulmonary hypertension (i.e. high blood pressure in • eye irritation, bloodshot eyes/red eyes, eye pain, It works by relaxing the blood vessels in your penis, the lungs due to blood clots). 40 mm seeing flashes of light, visual brightness, light sensitivity, watery eyes allowing blood to flow into your penis when you get In addition, do not take Aronix if you are taking a sexually excited and causing an erection. • pounding heartbeat, rapid heartbeat medicine called ritonavir, for the treatment for HIV • high blood pressure Aronix will only help you to get an erection if you are infection. sexually excited (stimulated). • low blood pressure (symptoms include dizziness, Tell your pharmacist or doctor before using Aronix if fainting, blurred vision, nausea and tiredness) • muscle pain, feeling sleepy, reduced sense of 2. What you need to know before you you are taking: • any other treatment for erectile dysfunction touch, vertigo, ringing in the ears take Aronix • alpha-blockers such as alfuzosin, doxazosin or • dry mouth, blocked or stuffy sinuses, inflammation tamsulosin, which are medicines used to treat of the lining of the nose (symptoms include runny Do not take Aronix if you: urinary problems due to an enlarged prostate nose, sneezing and stuffy nose) • do not have an erection problem, as this medicine (benign prostatic hyperplasia) or occasionally high • presence of blood in urine will not provide any benefit to you blood pressure, as Aronix may not be suitable for 40 mm Rare (may affect up to 1 in 1,000 people): • take any medicines called nitrates or nitric you • fainting, dry nose, swelling of the inside of the oxide donors, (such as glyceryl trinitrate, • medicines that may affect the way Aronix works nose, feeling irritable and sudden decrease or loss isosorbide mononitrate, isosorbide dinitrate for the such as: of hearing relief of chest pain, or heart failure or amyl nitrite - protease inhibitors (saquinavir) to treat HIV • stroke, heart attack, irregular heartbeat, temporary also known as “poppers”, nicorandil or sodium infections decreased blood flow to parts of the brain nitroprusside), as the combination may lead to a - the heartburn treatment cimetidine • feeling of tightening of the throat, numb mouth dangerous fall in blood pressure - medicines to treat fungal infections called • bleeding at the back of the eye, double vision, • are allergic to sildenafil or any of the other itraconazole or ketoconazole, and an antibiotic reduced sharpness of vision, abnormal sensation ingredients of this medicine (listed in section 6) called erythromycin. in the eye, swelling of the eye or eyelid, small • take riociguat or other medicines of a group called Aronix may not be suitable for you. Ask your particles or spots in your vision, seeing halos guanylate cyclase stimulators. This medicine is pharmacist or doctor about a 25 mg tablet which around lights, dilation of the pupil of the eye, used to treat pulmonary arterial hypertension may be more suitable for you. discolouration of the white of the eye (i.e. high blood pressure in the lungs) and chronic 40 mm • penile bleeding, presence of blood in semen. thromboembolic pulmonary hypertension (i.e. high Aronix with food and drink blood pressure in the lungs due to blood clots). Aronix can be taken with or without food. When this Cases of unstable angina (a heart condition) and • take ritonavir for the treatment of HIV infection medicine is taken after a high-fat meal, it may take a sudden death have been reported rarely. Of note, • have been advised by your doctor to avoid sexual little longer to start working. Do not take Aronix with most, but not all, of the men who experienced these activity because of a problem with your heart or grapefruit or grapefruit juice, because this can affect side effects had heart problems before taking this blood vessels, such as a recent heart attack or how the medicine works. medicine. It is not possible to determine whether these stroke (within the last 6 months), unstable angina Drinking excessive alcohol can temporarily reduce events were directly related to this medicine. or severe cardiac failure your ability to get an erection. To get the maximum • have ever had loss of vision because of damage to benefit from your medicine, you are advised not to Reporting of side effects the optic nerve [such as non-arteritic anterior drink large amounts of alcohol before sexual activity. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not ischaemic optic neuropathy (NAION)] or have an Pregnancy, breastfeeding and fertility inherited eye disease (such as retinitis listed in this leaflet. You can also report side effects This medicine should not be used by women. 40 mm pigmentosa) directly via the Yellow Card Scheme website • have low blood pressure (which can cause Driving and using machines www.mhra.gov.uk/yellowcard or search for MHRA symptoms such as tiredness, dizziness, Aronix can cause dizziness and can affect your vision. Yellow Card in the Google Play or Apple App Store. lightheadedness, feeling sick, clammy skin, Do not drive or use machines if you suffer from these By reporting side effects you can help provide more depression, loss of consciousness, or blurry vision) side effects after taking this medicine. information on the safety of this medicine. or high blood pressure that is not controlled • have a severe liver problem Important information about some of the 5.