1.3 : SmPC, Labelling and Package Leaflet : Package Leaflet Page : 1

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1 1.3.1 : Package Leaflet Page : 1 PACKAGE LEAFLET: INFORMATION FOR THE USER <product name> * - 4mg tablets Doxazosin mesylate, equivalent to 4mg doxazosin per tablet. Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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. In this leaflet: 1. What Doxazosin is and what it is used for 2. Before you take Doxazosin 3. How to take Doxazosin 4. Possible side effects 5. How to store Doxazosin 6. Further information 1. WHAT DOXAZOSIN IS AND WHAT IT IS USED FOR Doxazosin belongs to the group known as vasodilators. These substances cause the blood vessel to widen, which reduces the blood pressure. Doxazosin can also reduce tension in the muscle tissues of the prostate and the urinary tract. To be used for: - elevated blood pressure; - treating the symptoms of an enlarged prostate. 2. BEFORE YOU TAKE DOXAZOSIN Do not use Doxazosin if you are allergic (hypersensitive) to Doxazosin, other medicines from the same group (known as quinazolines, such as e.g. prazosin and terazosin) or any of the other constituents of the tablets (see also section 6 Further information ); if you have severely reduced kidney function; if you are unable to produce urine (anuria); if you are unable to hold your urine or faeces (incontinence). If Doxazosin has been prescribed for you for an enlarged prostate, you should not use this medication: if you suffer from (or have suffered from) blood pressure that is too low, or dizziness when standing up from a lying or sitting position; if blood has been accumulating in the upper part of the urinary tract; if you have chronic inflammation of the urinary tract; if you have bladder stones. Take special care with Doxazosin at the start of treatment or when the dosage is increased. The likelihood of your blood pressure dropping too fast is greatest then. You may observe this as dizziness or more rarely

2 1.3.1 : Package Leaflet Page : 2 fainting when changing position. To reduce the risk of this happening, your doctor will check your blood pressure thoroughly at the start of treatment and when the dosage is increased. The chance of your blood pressure dropping too rapidly at the start of the treatment is greater in the following cases: if you are following a strict low-salt diet or are using diuretics; when Doxazosin is given to elderly people; if you have reduced kidney function or reduced liver function. In any of the above cases, you should therefore avoid situations at the start of treatment in which dizziness or faintness could cause injury. You should also be particularly careful: if you suffer from particular serious heart diseases such as e.g. severely reduced cardiac function or a restrictive and painful sensation in the chest (angina pectoris). This is because too rapid or excessive lowering of the blood pressure can exacerbate these complaints; if you suffer from certain rare hereditary conditions such as hypersensitivity to galactose, a deficiency of what is known as Lapp lactase or a glucose-galactose uptake problem; if you have a nervous system condition as a result of diabetes. if you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used Doxazosin. This is because Doxazosin may cause complications during the surgery which can be managed if your speicalist is prepared in advance. It is not recommended for paediatric use. Taking other medicines Inform your doctor or your pharmacist if you are using (or have recently used) other medicines. This also applies for other medicines that are available without prescription. Note: the following comments can also be applicable to the use of medicines some time ago or in the near future. You may be more familiar with the medicines mentioned in this leaflet under a different name, often the brand name. This leaflet only refers to the active compound in the medicine, or the group of medicines, and not the brand name! You should therefore always look closely at the packaging or the information leaflet to see what the active compound is in the medicines you are using. An interaction means that the medicines or substances can affect the way each other works or the side effects when both are being taken at the same time. Interactions can arise when Doxazosin is used concomitantly with: other medicines against elevated blood pressure; nitrates (medicines for heart problems) such as nitroglycerine and isosorbide nitrate: these can exacerbate the hypotensive effect; medicines that dilate the blood vessels: these can exacerbate the hypotensive effect; certain painkillers for rheumatism (known as non-steroidal anti-inflammatory drugs) such as naproxen, ibuprofen or any other anti-inflamatory painkiller: these can reduce the hypotensive effect; what are known as sympathicomimetics (substances that have a stimulatory effect on a particular part of the nervous system) such as dopamine, ephedrine, metaraminol, epinephrine and phenylephrine: these can reduce the hypotensive effect; medications that could also possibly affect the liver metabolism, e.g. cimetidine (a medicine for stomach problems); certain medicines for erectile problems such as sildenafil, tadalafil and vardenafil: these can exacerbate the hypotensive effect. Pregnancy and breast-feeding

3 1.3.1 : Package Leaflet Page : 3 There is insufficient data known about use during human pregnancy to make any judgements regarding the possible dangers. Animal tests did not demonstrate any harmful effects. This medicine should only be used during pregnancy if a physician decides that the benefits for the mother outweigh the possible risk for the foetus. Doxazosin is secreted in the mother s milk. Doxazosin should therefore not be used while breast-feeding. Consult your doctor or your pharmacist before taking medicines. Driving and using machines Doxazosin has a negative influence on the ability to drive and use machines, particulary at the beginning of the treatment. Doxazosin can sometimes cause dizziness or fainting. In such an event, you should exercise care during activities that require attentiveness, such as using the roads, operating machinery and working at heights. If you are unsure whether Doxazosin is having a negative effect on your ability to drive, discuss this with your doctor. 3. HOW TO TAKE DOXAZOSIN Follow your doctor s advice closely when taking Doxazosin. You should check with your doctor or pharmacist if you are unsure. The usual dose is: HIGH BLOOD PRESSURE The initial dose is 1mg daily (= 24 hours) in a single dose. After 1 to 2 weeks, the dose is generally increased to 2mg in a single daily dose (= 24 hours). This dose is also retained for 1 to 2 weeks. If necessary, the dosage can be further increased to 4, 8 or 16mg per day, until the desired reduction in blood pressure is achieved. The maximum daily dose is 16mg. An initial dose should preferably be taken before going to bed; this means that any dizziness you may experience is less of a problem. ENLARGED PROSTATE The initial dose is 1mg daily (= 24 hours) in a single dose on days 1 to 8. A 2mg tablet is taken on days 8 to 14. If the effect is insufficient after 1 to 2 weeks, then the dose can be increased to 4mg per day. In some cases the dose may be increased up to the maximum of 8mg per day (= 24 hours). The tablets should be taken as a single dose each day (= 24 hours). The tablets must be taken with plenty of water (± a whole glassful). If your physician has prescribed you a dose of 1mg doxazosine per day, you should break a 2mg tablet into two halves and use one half. If you take more Doxazosin than you should If you have taken more than the prescribed dose, you should consult your doctor and/or pharmacist immediately. If you feel extremely dizzy or think you might faint, you should lie down immediately with your head down. If you forget to take Doxazosin If you have forgotten to take a tablet, then skip it and take the next tablet at the usual time. You should check with your doctor or pharmacist if you are unsure. Do not take a double dose to make up for a forgotten tablet. When you stop taking Doxazosin If you suddenly stop taking Doxazosin, the complaints you suffered prior to the start of treatment may recur. It is therefore better not to stop taking this medication suddenly. Your doctor will decrease the dosage gradually. You should always check with your doctor or pharmacist if you are unsure.

4 1.3.1 : Package Leaflet Page : 4 If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Doxazosin can cause side effects, although not everybody gets them. Side effects may occur: very commonly: in more than 10% of patients commonly: in more than 1% but less than 10% uncommonly: in more than 0.1% but less than 1% rarely: in more than 0.01% but less than 0.1% very rarely: in less than 0.01% of patients The following side effects may arise when Doxazosin is used: Blood Rare: changes in the blood (lack of white blood cells associated with increased susceptibility to infections and unanticipated bleeding or bruising) Nutrition and metabolism Uncommon: insufficient potassium in the blood (hypokalaemia, which can in severe cases manifest itself as muscular cramps or muscular weakness and fatigue), thirst, gout Rare: too low a level of sugar in the blood, associated with hunger, perspiration, dizziness, palpitations of the heart Psychiatric disorders Common: delayed ejaculation, listlessness, feeling unwell (malaise) Uncommon: bad dreams, reduced memory, being emotionally volatile Nervous system Common: muscular cramps Rare: (severe) depression, excitement, restlessness, stimulation of the senses with no cause Eyes Common: difficulty seeing Uncommon: watery eyes, problems with intense lighting Rare: blurred vision, conjunctivitis Ears (and labyrinth) Uncommon: ringing noises Heart Common: palpitations of the heart, fluid accumulation Uncommon: rapid heart rate (tachycardia), irregularity of the heartbeat, restrictive and painful sensation in the chest (angina pectoris), myocardial infarction Blood vessels Common: dizziness, wooziness Uncommon: low blood pressure when changing position, tingling or cramping pains in arms or legs (peripheral ischemia) Rare: problems in the blood vessels in the brain (cerebrovascular problems). Respiratory tract Common: laboured breathing, blocked nose

5 1.3.1 : Package Leaflet Page : 5 Uncommon: nosebleed, coughing, sore throat, dyspnoea due to cramps in the muscles of the respiratory tract (bronchospasm) Rare: dyspnoea due to accumulation of fluid in the larynx Gastrointestinal tract Common: constipation, metabolic disorders with symptoms such as a bloated feeling in the upper abdomen, pain in the abdomen, belching, nausea, acid indigestion (dyspepsia) Uncommon: reduced or increased appetite Rare: stomach pains, diarrhoea, vomiting Liver (and gall) Rare: jaundice, inflammation of the liver Skin Uncommon: hair loss Rare: rashes, bruising under the skin (purpura), itching, perspiration Skeletal muscle system Uncommon: trembling, stiffness, pain, swollen joints, weakness Kidneys and urinary tract Common: the need to urinate frequently, increased production of urine Uncommon: inability to hold urine and/or faeces (incontinence), difficulty or pain when urinating, disorders during urinating Reproductive system Rare: impotence, persistent erections without sexual stimulus General Common: fatigue, nausea, weakness, headaches, pain in the chest, drowsiness Uncommon: fluid accumulation in the body, a swollen or red face, fainting, fever/trembling, paleness, changes to the sense of taste, temporary loss of consciousness Rare: reduced body temperature in elderly patients, changes to the sense of taste In the beginning of treatment, low blood pressure (when changing position) can occur and can lead to dizziness and wooziness, in rare cases temporary loss of consciousness can occur, particularly at high doses. This can also occur if treatment is continued after a short interruption. If any of the side effects become serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE <PRODUCT NAME> * Keep out of the reach and sight of children. Store below 30 C. Do not use <product name> * after the date given on the packaging after the text Do not use after or exp.. The first two digits indicate the month; the subsequent digits give the year. 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.

6 1.3.1 : Package Leaflet Page : 6 6. FURTHER INFORMATION What <product name> * contains The active ingredient is doxazosin mesylate. One tablet of <product name> * contains doxazosin mesylate equivalent to 4mg doxazosin. The other constituents are microcrystalline cellulose, anhydrous lactose, sodium starch glycolate (type A), magnesium stearate, sodium lauryl sulphate and colloidal anhydrous silica. What <product name> * looks like and contents of the pack <product name> * : a long, white tablet with a break groove on one side and the inscription D4 on the other. The tablets are packaged in a PVC/PVDC-aluminium press-through strip. <All pack sizes for this pharmaceutical form and strength> ** Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder <MAH> * Manufacturer <manufacturer> *** <product name> * has been registered under number RVG For any information about this medicine, please contact the local representative of the Marketing Autorisation Holder: <name and addres MAH> This leaflet was last approved in 18/11/2007 * See application form, annex 6.19 for the proposed (invented) names and marketing authorisation holders in the concened member states. ** See application form, section for the pack sizes. *** See application form, section and for the proposed manufacturers and release sites.