® LEVITRA 5 (La·vee·trah) ® LEVITRA 10 (La·vee·trah) ® LEVITRA 20 (La·vee·trah) vardenafil Consumer Medicine Information (CMI) WHAT IS IN THIS • nicorandil Levitra will only work if you are • sodium nitroprusside LEAFLET sexually aroused. It will not • isosorbide mononitrate This leaflet answers some increase your sex drive. • isosorbide dinitrate common questions about Levitra. • amyl nitrite (also known as It does not contain all the Levitra is not addictive. ‘poppers’, ‘amyl’ or ‘rush’) available information. It does not take the place of talking to your Ask your doctor if you have any Do not take Levitra if you are doctor or pharmacist. questions about why this taking: medicine has been prescribed • HIV protease inhibitors, All medicines have risks and for you. medicines used to treat HIV benefits. Your doctor has weighed Your doctor may have prescribed infection. Examples of HIV the risks of you taking Levitra it for another reason. protease inhibitors are against the benefits they expect it cobicistat, indinavir or will have for you. ritonavir. BEFORE YOU TAKE • Riociguat, used to treat a disease called pulmonary If you have any concerns about LEVITRA taking this medicine, ask your arterial hypertension. doctor or pharmacist. When you must not take it Because sexual activity may Do not take Levitra if you have place a strain on your heart, Keep this leaflet with the an allergy to: your doctor will need to check medicine. • any medicine containing whether you are fit enough to You may need to read it again. vardenafil hydrochloride have sexual intercourse. trihydrate • any of the ingredients listed at WHAT LEVITRA IS the end of this leaflet Do not take Levitra if you have: • unstable angina (chest pain) USED FOR • hypotension (low blood Some of the symptoms of an pressure) This medicine is used to treat allergic reaction may include: • uncontrolled hypertension (high erectile dysfunction. • shortness of breath blood pressure) • wheezing or difficulty • uncontrolled arrhythmia Erectile dysfunction, also known breathing (irregular heart beat) as impotence in adult males, is the • swelling of the face, lips, • ever had a condition involving inability to obtain and/or maintain tongue or other parts of the loss of vision due to damage to a hard erect penis sufficient for body the optic nerve from sexual activity. • rash, itching or hives on the insufficient blood supply skin known as non-arteritic anterior Levitra tablet contains the active optic neuropathy (NAION) ingredient vardenafil which works Do not take Levitra if you are • hereditary degenerative retinal by relaxing the blood vessels in the taking nitrate medicines which disorders (such as retinitis penis when you are sexually include: pigmentosa) aroused. This allows blood to flow • glyceryl trinitrate (also called • severe liver problems into the penis, allowing you to get nitroglycerine) an erection. Levitra 5 10 & 20 CMI 1 • severe kidney problems • sickle cell anaemia Dabigatran is an example for these requiring dialysis • bleeding disorders medicines. • been diagnosed with a disease • active stomach ulcer called pulmonary arterial • liver problems You may need to use different hypertension amounts of your medicine, or you If you have not told your doctor may need to take different Do not take Levitra if you have, or pharmacist about any of the medicines. Your doctor will be or have had, any of the following above, tell them before you start able to advise you. conditions within the previous 6 taking Levitra. months: Talk to your doctor if you are • myocardial infarction (heart Taking other medicines taking certain medicines for attack) arrhythmia, including quinidine, Tell your doctor or pharmacist if • stroke procainamide, amiodarone and you are taking any other • cardiac ischaemia sotalol. medicines, including those that • serious arrhythmia (irregular Levitra should not be used with heart beat) you buy without a prescription these medicines. from your pharmacy, Do not give Levitra to children, supermarket or health food Levitra tablets may be used adolescents or women. shop. together with an alpha-blocker if you are on stable alpha-blocker Some medicines may be affected Do not take this medicine after therapy. If your doctor by Levitra or vice versa. These the expiry date printed on the recommends this, they will start medicines include: pack or if the packaging is torn your Levitra treatment with a • nitrates, medicines for angina, or shows signs of tampering. lower dose. or nitric oxide donors, such as If it has expired or is damaged, amyl nitrite. Taking these return it to your pharmacist for Concomitant use of Levitra with medicines with Levitra could disposal. The EXPIRY date is alpha-blockers may contribute to seriously affect your blood marked on the strip of tablets as dizziness or fainting. pressure well as on the label of the carton. • For example, 11 18 refers to the cobicistat, ritonavir or Your doctor or pharmacist will eleventh month of 2018. indinavir, medicines for HIV also have a more complete list of • ketoconazole and itraconazole, medicines to be careful with or If you are not sure whether you used to treat fungal infections avoid while taking Levitra. should start taking this • erythromycin, clarithromycin medicine, talk to your doctor. and gatifloxacin, which are Ask your doctor or pharmacist, antibiotics if you are not sure if you are Before you start to take it • alpha-blockers, medicines used taking any of these medicines. to treat an enlarged prostate or Tell your doctor if you have high blood pressure. Examples allergies to any other medicines, of alpha-blockers are HOW TO TAKE foods, preservatives or dyes. terazosin, alfuzosin, tamsulosin and prazosin LEVITRA Tell your doctor if you have or • Riociguat, a type of medicine have had any of the following Follow all directions given to used to treat high blood you by your doctor or medical conditions: pressure in the arteries • any heart or blood vessel pharmacist carefully. carrying blood from your heart problems to your lungs • They may differ from the leukaemia (cancer of the blood • other treatments for erectile cells) information contained in this dysfunction leaflet. • multiple myeloma (a cancer of the bone marrow) Levitra might increase the amount Swallow the tablet whole with • any disease or deformity of of some medicines in your blood water. Levitra can be taken with your penis (sensitive P-gp substrates). or without food. • low or high blood pressure Levitra 5 10 & 20 CMI 2 If you do not understand the If you take too much instructions on the box, ask your (overdose) Please also be aware that you doctor or pharmacist for help. may have to take treatments like Immediately telephone your Levitra a few times before you doctor, or the Poisons get the best response. How much to take Information Centre (telephone If you’re still not getting a Your doctor or pharmacist will tell in Australia 13 11 26, in New response, speak to your doctor. you how much and how often you Zealand 0800 POISON or 0800 should take Levitra. Follow the 764 766), or go to the accident directions given to you by your and emergency department at Things you must not do doctor or pharmacist carefully. your nearest hospital, if you Do not use the recreational drug They may differ from the think you or anyone else may amyl nitrite (sometimes called information contained in this have taken too much Levitra. ‘poppers’, ‘amyl’ or ‘rush’) leaflet. Do this even if there are no signs while you are taking Levitra. of discomfort or poisoning. The dose ranges from 5 mg to Do not take Levitra if you are 20 mg. Your doctor will You may need urgent medical taking HIV protease inhibitors, determine the correct dose for you attention. medicines used to treat HIV depending on your condition, infection. other medicines and response. Do not take more than one dose WHILE YOU ARE Do not take Levitra if you are of Levitra a day. taking Riociguat, used to treat USING LEVITRA pulmonary arterial When to take it Things you must do hypertension. Sexual stimulation is required Tell all the doctors, dentists and for a natural response to If you get an angina attack pharmacists who are treating treatment with Levitra. whilst taking Levitra, do not you that you are taking Levitra. take nitrate medicines to relieve Take your dose of Levitra 25 to If you are about to start taking the pain. Tell your doctor 60 minutes before you wish to any new medicines, especially immediately or contact your have sex. nitrates or some medicines to nearest emergency department. treat HIV, e.g. cobicistat, Make sure that your doctor knows Levitra may work as soon as 15 indinavir or ritonavir, tell your you are taking Levitra tablets. minutes and as long as 4-5 hours doctor or pharmacist that you after taking it. The amount of time are taking Levitra. Do not take more than one dose it takes to start working varies of Levitra a day. If Levitra does from person to person. Stop taking Levitra and tell your not help you get an erection, or if doctor if you notice a sudden your erection does not last long If you are also taking an alpha- decrease or loss of hearing. enough to complete sexual blocker other than tamsulosin or Ringing of the ears and dizziness intercourse, tell your doctor. alfuzosin, allow at least 6 hours may also occur. between the time you take it and Do not give your Levitra tablets the time you take your Levitra Stop taking Levitra and tell your to anyone else, even if they have tablet (see Taking other doctor if you notice a sudden loss the same condition as you. medicines). Tamsulosin can be in vision.