APO-PRAZOSIN TABLETS Contains the active ingredient prazosin hydrochloride Consumer Medicine Information

What is in this leaflet • problems, such as benign medicines called quinazolines, prostatic hyperplasia (BPH) in or any of the ingredients listed Read this leaflet carefully before men waiting for prostate surgery at the end of this leaflet. taking your medicine. • Raynaud's disease, where the Symptoms of an allergic reaction Ask your doctor or pharmacist if fingers become white and very may include: cough, shortness of you do not understand anything or painful when cold breath, wheezing or difficulty are worried about taking your • certain types of . breathing; swelling of the face, lips, tongue, throat or other parts medicine. Ask your doctor if you have any of the body; rash, itching or hives This leaflet answers some common questions about why this medicine on the skin; fainting; or hay questions about prazosin. has been prescribed for you. Your fever-like symptoms. It does not contain all the available doctor may have prescribed this If you think you are having an information. medicine for another reason. allergic reaction, do not take This medicine is available only with It does not take the place of talking to any more of the medicine and a doctor's prescription your doctor or pharmacist. contact your doctor immediately or go to the The information in this leaflet was How it works last updated on the date listed on the Accident and Emergency last page. Some more recent Prazosin works by relaxing the department at the nearest information on the medicine may be muscles in the walls of blood vessels hospital. available. Speak to your pharmacist and making it easier for blood to • The expiry date (EXP) printed or doctor to obtain the most up to flow. They also relax the muscles in on the pack has passed. the prostate gland and increase the date information on the medicine. • The packaging is torn, shows flow of urine. All medicines have risks and signs of tampering or it does not benefits. Your doctor has weighed When use to treat high blood look quite right. the risks of you using this medicine pressure or heart failure, prazosin is against the benefits they expect it often used together with other Before you start to take it will have for you. medicines. Before you start taking this There is no known evidence to show Keep this leaflet with the medicine. medicine, tell your doctor if: that this medicine is addictive. You may want to read it again. 1. You have allergies to: Use in children • any other medicines There is not enough information to • any other substances, such as What this medicine is recommend the use of this medicine foods, preservatives or dyes. used for in children. 2. You have or have had any medical conditions, especially the The name of your medicine is Apo- following: Prazosin. It contains the active Before you take this • heart problems such as heart ingredient, prazosin (as prazosin medicine failure or angina or recent heart hydrochloride). attack When you must not take it • kidney or liver problems. It is used to treat: Do not take this medicine if: 3. You are currently pregnant or • high blood pressure • You are hypersensitive to or plan to become pregnant. () have had an allergic reaction to prazosin or to related

APO-PRAZOSIN TABLETS 1 Do not take this medicine whilst How to take this How to take it pregnant until you and your medicine Swallow the tablets with a glass of doctor have discussed the risks water. and benefits involved. Follow carefully all directions given The tablets can be broken in half, if 4. You are currently breastfeeding to you by your doctor. your doctor has prescribed this. or plan to breastfeed. Their instructions may be different to Prazosin may appear in breast the information in this leaflet. When to take it milk. Do not take this medicine Take this medicine at the same time whilst breastfeeding until you and How much to take each day. Taking this medicine at the your doctor have discussed the Your doctor will tell you how much same time each day will have the risks and benefits involved. of this medicine you should take. best effect and will also help you 5. You are planning to have This will depend on your condition remember when to take it. cataract surgery. and whether you are taking any other Take your very first dose last thing at If you are taking or have medicines. night, just before going to bed. Be previously taken prazosin, then Do not stop taking your medicine or very careful if you need to get up the eye surgeon needs to be aware change your dosage without first during the night, because you may of this so he can be extra careful checking with your doctor, feel dizzy and could fall. to avoid complications during the Prazosin is usually started at a low If your doctor increases your dose, operation. dose of 0.5 mg (half a 1mg tablet). take the first of that increased dose 6. You are planning to have surgery Your doctor may gradually increase last thing at night. Again, be or an anaesthetic. this dose as required. Starting with a especially careful if you have to get 7. You are currently receiving or are low dose reduces the risk of too great up in the night. planning to receive dental a drop in your blood pressure which It does not matter if you take it treatment. can make you dizzy, light-headed or before, with or after food. faint. 8. You are taking or are planning to take any other medicines. This Hypertension (high blood How long to take it for includes vitamins and pressure): Prazosin helps control your condition supplements that are available The usual starting dose is 0.5 mg but does not cure it. Therefore, you from your pharmacy, supermarket twice a day, increasing to 1 mg two must take your medicine every day. or health food shop. or three times a day. Your doctor If you are taking prazosin for high may increase this up to 20 mg a day, blood pressure, heart failure or Taking other medicines taken as divided doses. Raynaud's disease, you may need to Some medicines may interact with Heart failure: take it for a long time. prazosin. These include: The usual starting dose is 0.5 mg If you are taking prazosin for prostate • medicines used to lower blood increasing to 4 mg a day, divided into problems, you will only have to take pressure or for other heart three or four doses. This may be it until your operation. conditions increased by your doctor up to 20 mg Continue taking your medicine for as • fluid tablets (diuretics), also used a day, taken in divided doses. long as your doctor tells you. to lower blood pressure Raynaud's disease: Make sure you have enough to last • medicines to treat impotence The usual starting dose is 0.5 mg over weekends and holidays. (erectile dysfunction). twice a day. Your doctor may If you are taking any of these, you increase this up to 1 mg or 2 mg If you forget to take it twice a day. may need a different dose or you If it is almost time for your next dose may need to take different medicines. Benign prostatic hyperplasia (within 3 hours), skip the dose you Your doctor and pharmacist can tell (BPH): missed and take your next dose when you if you are taking any of these The usual starting dose is 0.5 mg you are meant to. medicines. They may also have more twice a day. Your doctor may Otherwise, take it as soon as you information on medicines to be increase this gradually up to a remember, and then go back to careful with or avoid while taking maximum of 2 mg twice a day. taking your medicine as you would prazosin. normally. Other medicines not listed above may also interact with prazosin.

APO-PRAZOSIN TABLETS 2 Do not take a double dose to make These symptoms can be dangerous, • Stop taking your medicine, or up for missed doses. especially in people aged 65 years or change the dosage, without first This may increase the chance of you older with heart or blood vessel checking with your doctor. getting an unwanted side effect. disease. Things to be careful of If you miss two doses or more, you If you feel dizzy or light-headed, lie will need to restart at a low dose and down so that you do not faint, then Be careful driving or operating build up again gradually to your sit for a few moments before machinery until you know how usual dose. standing to prevent the dizziness prazosin affects you. from returning. Make sure the area Prazosin may cause dizziness, light- Ask your doctor how to do this. around you is clear so that you do not headedness or fainting in some If you are not sure what to do, ask injure yourself if you fall. people, especially after the first dose your doctor or pharmacist. If these symptoms continue, tell your or a dose increase. Blurred vision or If you have trouble remembering to doctor. drowsiness may also occur. Make take your medicine, ask your A change in your dose may be sure you know how you react to pharmacist for some hints to help you needed. prazosin before you drive a car, remember. operate machinery, or do anything See your doctor immediately if you else that could be dangerous if you experience painful erections or if If you take too much are dizzy, light-headed or not alert. your erection continues for longer (overdose) If this occurs do not drive. than four hours. Immediately telephone your doctor Limit the amount of you Tell your doctor that you are taking or the National Poisons drink while taking prazosin. this medicine if: Information Centre (0800 POISON Combining prazosin with alcohol can • you are about to be started on any or 0800 764 766) for advice or go to make you more dizzy or light- new medicine Accident and Emergency at the headed. nearest hospital, if you think that • you are pregnant or are planning Make sure you drink enough water in you or anyone else may have taken to become pregnant hot weather, during exercise and too much prazosin. • you are breastfeeding or are when you have to stand for long Do this even if there are no signs of planning to breast-feed periods of time, while you are taking discomfort or poisoning. • you are about to have any blood prazosin. This is because dizziness, You may need urgent medical tests or urine tests light-headedness and fainting are attention. more likely to occur in these • you are going to have surgery situations. If you take too much prazosin, you or an anaesthetic or are going may feel lightheaded, dizzy, have a into hospital. You are about to If you continue to feel unwell, tell fast or irregular heartbeat, or you have eye surgery (for example your doctor. may faint. cataract surgery) Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Side effects While you are taking Go to your doctor regularly for a Tell your doctor as soon as possible this medicine check-up. if you do not feel well while you are Tell any other doctors, dentists, and Things you must do taking prazosin or if you have any pharmacists who are treating you that questions or concerns. Get up slowly after you have been you are taking this medicine. Do not be alarmed by the following sitting or lying down. list of side effects. You may not Prazosin can cause dizziness, light- Things you must not do experience any of them. All headedness and fainting, particularly Do not: medicines can have side effects. if you get up too quickly. This effect Sometimes they are serious, but most • Give this medicine to anyone is more likely to occur if you have else, even if their symptoms seem of the time they are not. just started prazosin, if the dose has similar to yours. If you are 65 years or older, you just been increased or you have should be especially careful while started taking another blood pressure • Take your medicine to treat any taking prazosin. Report any side medicine as well. other condition unless your effects promptly to your doctor. doctor tells you to.

APO-PRAZOSIN TABLETS 3 Tell your doctor if you notice any • chest pain Disposal of the following: • fainting or passing out If your doctor or pharmacist tells • nausea, vomiting, feeling sick • hallucinations (seeing, hearing or you to stop taking this medicine or • dry mouth feeling things that aren't there) it has passed its expiry date, ask your pharmacist what to do with • constipation or diarrhoea Other side effects not listed above any medicine that is left over. • weakness, lack of energy may occur in some patients. • headache Allergic reactions • drowsiness If you think you are having an Product description • pain or fever allergic reaction to prazosin, do not • hair loss or thinning take any more of this medicine and What it looks like tell your doctor immediately or go • poor bladder control to the Accident and Emergency Apo-Prazosin 1mg tablets: White, • impotence department at your nearest capsule-shaped tablets, flat-faced, • painful joints hospital. bevelled edge tablet. Scored & • ringing in the ears (tinnitus) Symptoms of an allergic reaction engraved APO P1 on one side, other • stuffy nose may include some or all of the side plain. following: • problems getting to sleep • cough, , Apo-Prazosin 2mg tablets: White, • breast enlargement wheezing or difficulty breathing round, biconvex tablet. Scored & Tell your doctor immediately if • swelling of the face, lips, tongue, engraved APO over P2 on one side, you notice any of the following: throat or other parts of the body other side plain. These may be serious side effects and • rash, itching or hives on the skin you may need medical attention: Apo-Prazosin 5mg tablets: White, • fainting • dizziness, spinning sensation or diamond-shaped, biconvex tablet. light-headedness when standing • hay fever-like symptoms. Scored & engraved APO over P5 on up one side, other side plain. • fast or pounding heart beat Available in blister packs of 100, • skin problems such as rash, Storage and disposal itching or hives 500, 1000 tablets and bottles of 100, 500 and 1000 tablets. • blurred vision or painful or red Storage eyes Keep your medicine in its original Not all strengths, pack types and/or • painful, continual erection packaging until it is time to take it. pack sizes may be available. • tingling or numbness in the hands If you take your medicine out of its or feet original packaging it may not keep Ingredients • swelling of the hands, feet or well. Active Ingredient: ankles Keep your medicine in a cool dry • feelings of nervousness or place where the temperature will stay Each tablet contains either 1mg, 2mg depression below 25°C. Protect it from light. and 5mg of prazosin hydrochloride. If you experience any of the Do not store your medicine, or any This medicine also contains the following, stop taking your other medicine, in the bathroom or following inactive ingredients: medicine and contact your doctor near a sink. Do not leave it on a • Croscarmellose sodium immediately or go to the Accident window sill or in the car. • Magnesium stearate and Emergency department at Heat and dampness can destroy some • Microcrystalline cellulose your nearest hospital. medicines. • Polysorbate 80 NF These are very serious side effects Keep it where children cannot • Lactose monohydrate and you may need urgent medical reach it. attention or hospitalisation A locked cupboard at least one-and- Colouring for 1mg: • sharp pain in the stomach or back a-half metres above the ground is a • Quinoline yellow • fast or slow heart beat good place to store medicines. • Sunset yellow

APO-PRAZOSIN TABLETS 4

This medicine is glucose free but contains lactose.

Sponsor Apotex NZ Ltd 32 Hillside Road Wairau Valley, Auckland 0627

Telephone: (09) 444 2073 Fax: (09) 444 2951 E-mail: [email protected]

APO and APOTEX are registered trademarks of Apotex Inc

This leaflet was last updated in: November 2018

APO-PRAZOSIN TABLETS 5