DOXAZOSIN 1MG TABLETS
Active substance: DOXAZOSIN MESYLATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Doxadura 1mg, 2mg and 4mg Tablets
Doxazosin Mesilate
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 get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Doxadura Tablets are and what they are used for 2. Before you take Doxadura Tablets 3. How to take Doxadura Tablets 4. Possible side-effects 5. How to store Doxadura Tablets 6. Further information 1. What Doxadura Tablets are and what they are used for The active ingredient in your tablets, doxazosin, belongs to a group of medicines known as alpha-1 antagonists. Doxadura is used to treat the following conditions: - High blood pressure. If left uncontrolled, high blood pressure can increase the risk of heart disease or stroke. Doxadura works by widening your blood vessels making it easier for your heart to pump blood through them. This helps to lower raised blood pressure and reduce the risk of heart disease. 2. Before you take Doxadura Tablets Do not take Doxadura Tablets - if you have ever suffered an allergic reaction to the active ingredient, doxazosin, or any of the other ingredients listed at the end of the leaflet. Allergic reactions may be, for example, itching, reddening of the skin or difficulty breathing - if you know that you are sensitive to quinazolines (e.g. prazosin, terazosin). Quinazolines is the chemical family of medicines to which doxazosin belongs. - if you are breast-feeding - if you have any form of obstruction of the digestive tract - if you have a history of blood pressure dropping on standing - if you suffer from an enlarged prostate gland - if you have a problem with your bladder or passing urine - if you are under 16 years of age. Take special care with Doxadura Tablets - if you have liver problems - if you have a heart condition - if you have a disorder of the blood vessels of the brain - if you have a tendency to fainting or dizziness (hypotension) - if you suffer from accumulation of fluid on the lungs. Before surgery and anaesthesia (even at the dentist), you should tell the doctor or dentist that you are taking Doxadura Tablets. 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 Doxadura Tablets. This is because Doxadura Tablets may cause complications during the surgery which can be managed if your specialist is prepared in advance. Taking other medicines Tell your doctor if you are already taking any of the following: - Non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen - Other medicines used in the treatment of high blood pressure, e.g. ramipril, bisoprolol, nifedipine, tamsulosin - Oestrogens (female hormones) - Dopamine, ephedrine, adrenaline, metaraminol, methoxamine, phenylephrine (medicines used for the treatment of heart problems) - Drugs called monoamine oxidase inhibitors (MAOI's) used to treat depression - Drugs used for the treatment of erection problems (PDE-5 inhibitors, e.g. sildenafil (viagra), tadalafil, vardenafil). Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or lightheadedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking drugs for erection problems (impotence) with alpha-blockers such as Doxadura. In order to reduce the likelihood of these symptoms occurring, you should be on a regular daily dose of your alphablocker before you start drugs for erection problems. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Doxadura with food and drink Doxadura can be taken with or after food. Pregnancy and breast-feeding Do not take Doxadura if you are pregnant, trying to become pregnant or if you are breast-feeding. Speak to your doctor first. Driving and using machines Doxadura may influence your ability to drive and use machines. If you feel dizzy or light-headed, you must not drive or operate machinery. Be especially careful when you take your first dose or if your dose is increased. Also be careful if you are starting to take your medicine again after not having taken it for some time. Important information about the ingredients of Doxadura Tablets Doxadura tablets contain 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. Doxadura 2 and 4mg tablets also contain the colouring agent sunset yellow FCF (E110). This ingredient may cause allergic reactions. 3. How to take Doxadura Tablets You must keep taking your Doxadura Tablets exactly as your doctor has told you. The directions should be given on the label. You should check with your doctor or pharmacist if you are not sure. Adults and the elderly Doxadura is taken once daily. The dose is adjusted according to your blood pressure decrease and your response to Doxadura. The initial dose is 1mg once daily. Thereafter the dose will be gradually increased (e.g. 2, 4 or 8mg daily) for up to four weeks. The maximum daily dose of Doxadura is 16mg. Doxadura can be taken in the morning or the evening. It is best to take your tablets at about the same time each day with a drink of water. Children Doxadura should not be used in children under 16 years of age. If you take more Doxadura Tablets than you should If you take too many tablets you should lie down on your back with your feet higher than your head. The most likely symptoms of overdose would be a feeling of light-headedness or dizziness due to a fall in blood pressure. If you have any of these symptoms you should tell your doctor or pharmacist or go to your accident and emergency department immediately. If you forget to take Doxadura Tablets If you miss a dose, do not worry. Simply take the next days tablet when it is due. Do not take a double dose to make up for a forgotten tablet. If you stop taking Doxadura Tablets Keep taking your tablets until your doctor tells you to stop.
Please read the back of this leaflet.
*Trademark
4. Possible side-effects Like all medicines, Doxadura can cause sideeffects, although not everybody gets them. The evaluation of the side-effects is based on the following frequencies: Not known: Frequency cannot be estimated from the available data In less than 1 in 10,000 patients treated, including single reports In less than 1 in 1,000, but more than 1 in 10,000 patients treated In less than 1 in 100, but more than 1 in 1,000 patients treated In less than 1 in 10, but more than 1 in 100 patients treated In more than 1 in 10 patients treated
Very rare:
Rare:
Uncommon:
Common:
Very common:
If you experience any of the following very rare or uncommon unwanted effects you should tell your doctor immediately: - slow heartbeat - bronchial spasms (wheezing and tightness in the chest) - raised red patches on the skin - increased passing of urine - excessive urination at night - changes in the number of cells in the blood, which may result in easy bleeding - blurred vision - jaundice (yellowing of the skin) - hepatitis (inflammation of the liver) - blocked bile flow (yellowing of the skin, clay or white coloured faeces, stomach pain) - abnormal liver function tests - development of breasts in males - painful persistent erection in males. Uncommon side-effects include: - ringing or noise in the ears - increased appetite - wind - being sick - gastroenteritis (upset stomach) - delayed or difficult passage of faeces - pain - muscle cramps - muscle weakness - gout (painful inflammation of the joints) - painful joints - trembling or shaking - reduced sense of touch - fainting - stroke (sudden loss of consciousness) - nosebleed - a feeling of irregular heartbeat - angina pectoris (sudden brief attacks of pain in the centre of the chest) - heart attack - facial swelling - loss of hair - skin rash - purple rash caused by bleeding under the skin - pain when passing urine or a change to the frequency of urination - urinary incontinence (leakage of urine) - increased volume of urine passed - blood in the urine - hot flushes (redness of the face) - allergic drug reaction - weight increase - abnormal liver function tests - agitation - depression - erection problems. Other side-effects whose frequency is not known include: - little or no semen ejaculated at sexual climax in males; cloudy urine following sexual climax - altered sense of taste or loss of taste - Intraoperative Floppy Iris Syndrome (leads to problems in cataract surgery). However you should tell your doctor if any of the following common symptoms are severe or become troublesome: - vertigo (a feeling of dizziness or spinning) - mouth dryness - stomach pain - diarrhoea (upset stomach) - feeling sick or being sick - indigestion (difficulty digesting food and a burning sensation at top of stomach) - malaise (feeling unwell) - flu-like symptoms
oedema (swelling) fatigue weakness painful muscles and back pain headache dizziness postural dizziness (dizziness as a result of getting up from a sitting or lying position) - drowsiness - insomnia (inability to sleep) - sensation of prickling or tingling on the skin with unknown cause - cough - difficulty in breathing - bronchitis - nasal stuffiness and/or runny nose - infection in the lungs, windpipe or urinary tract - heart palpitations - increased heart rate - chest pain - itching - cystitis - inability to pass urine - low blood pressure - anorexia (loss of appetite) - nervousness. If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store Doxadura Tablets Keep out of the reach and sight of children. Do not use Doxadura Tablets after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of the month. Store below 25C. 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 protect the environment. 6. Further information What Doxadura Tablets contain The active substance is doxazosin mesilate. The other ingredients are microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, magnesium stearate, sodium lauryl sulphate and colloidal silicon dioxide. Sunset yellow FCF (E110) is an additional ingredient present in the 2mg and 4mg tablets. What Doxadura Tablets look like and the contents of the pack Doxadura 1mg tablets are white to off-white biconvex uncoated tablets, scored with a division mark and embossed with DZS1 on one side. Doxadura 2mg tablets are light orange to pink biconvex uncoated tablets, scored with a division mark and embossed with DZS2 on one side. Doxadura 4mg tablets are light orange to pink biconvex uncoated tablets, scored with a division mark and embossed with DZS4 on one side. They are supplied in cartons of 28 or 56 tablets in foil blister strips.
-
POM
PL 06831/0091 PL 06831/0092 PL 06831/0093 Doxadura 1mg Tablets Doxadura 2mg Tablets Doxadura 4mg Tablets
Marketing Authorisation Holder: Genus Pharmaceuticals Park View House, 65 London Road, Newbury Berkshire RG14 1JN, UK. Manufacturer: Synthon BV Microweg 22, 6545 CM Nijmegen The Netherlands. Synthon Hispania SL Castello 1, Poligono Las Salinas 08830 Sant Boi de Llobregat, Spain. Distributed by: Discovery Pharmaceuticals The Old Vicarage, Market Place Castle Donington, Derbyshire DE74 2JB, UK. This leaflet was last approved in June 2011.
xxxxxxx xxxx
*Trademark
Doxadura 1mg, 2mg and 4mg Tablets
Doxazosin Mesilate
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 get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Doxadura Tablets are and what they are used for 2. Before you take Doxadura Tablets 3. How to take Doxadura Tablets 4. Possible side-effects 5. How to store Doxadura Tablets 6. Further information 1. What Doxadura Tablets are and what they are used for The active ingredient in your tablets, doxazosin, belongs to a group of medicines known as alpha-1 antagonists. Doxadura is used to treat the following conditions: - High blood pressure. If left uncontrolled, high blood pressure can increase the risk of heart disease or stroke. Doxadura works by widening your blood vessels making it easier for your heart to pump blood through them. This helps to lower raised blood pressure and reduce the risk of heart disease. 2. Before you take Doxadura Tablets Do not take Doxadura Tablets - if you have ever suffered an allergic reaction to the active ingredient, doxazosin, or any of the other ingredients listed at the end of the leaflet. Allergic reactions may be, for example, itching, reddening of the skin or difficulty breathing - if you know that you are sensitive to quinazolines (e.g. prazosin, terazosin). Quinazolines is the chemical family of medicines to which doxazosin belongs. - if you are breast-feeding - if you have any form of obstruction of the digestive tract - if you have a history of blood pressure dropping on standing - if you suffer from an enlarged prostate gland - if you have a problem with your bladder or passing urine - if you are under 16 years of age. Take special care with Doxadura Tablets - if you have liver problems - if you have a heart condition - if you have a disorder of the blood vessels of the brain - if you have a tendency to fainting or dizziness (hypotension) - if you suffer from accumulation of fluid on the lungs. Before surgery and anaesthesia (even at the dentist), you should tell the doctor or dentist that you are taking Doxadura Tablets. 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 Doxadura Tablets. This is because Doxadura Tablets may cause complications during the surgery which can be managed if your specialist is prepared in advance. Taking other medicines Tell your doctor if you are already taking any of the following: - Non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen - Other medicines used in the treatment of high blood pressure, e.g. ramipril, bisoprolol, nifedipine, tamsulosin - Oestrogens (female hormones) - Dopamine, ephedrine, adrenaline, metaraminol, methoxamine, phenylephrine (medicines used for the treatment of heart problems) - Drugs called monoamine oxidase inhibitors (MAOI's) used to treat depression - Drugs used for the treatment of erection problems (PDE-5 inhibitors, e.g. sildenafil (viagra), tadalafil, vardenafil). Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or lightheadedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking drugs for erection problems (impotence) with alpha-blockers such as Doxadura. In order to reduce the likelihood of these symptoms occurring, you should be on a regular daily dose of your alphablocker before you start drugs for erection problems. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Doxadura with food and drink Doxadura can be taken with or after food. Pregnancy and breast-feeding Do not take Doxadura if you are pregnant, trying to become pregnant or if you are breast-feeding. Speak to your doctor first. Driving and using machines Doxadura may influence your ability to drive and use machines. If you feel dizzy or light-headed, you must not drive or operate machinery. Be especially careful when you take your first dose or if your dose is increased. Also be careful if you are starting to take your medicine again after not having taken it for some time. Important information about the ingredients of Doxadura Tablets Doxadura tablets contain 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. Doxadura 2 and 4mg tablets also contain the colouring agent sunset yellow FCF (E110). This ingredient may cause allergic reactions. 3. How to take Doxadura Tablets You must keep taking your Doxadura Tablets exactly as your doctor has told you. The directions should be given on the label. You should check with your doctor or pharmacist if you are not sure. Adults and the elderly Doxadura is taken once daily. The dose is adjusted according to your blood pressure decrease and your response to Doxadura. The initial dose is 1mg once daily. Thereafter the dose will be gradually increased (e.g. 2, 4 or 8mg daily) for up to four weeks. The maximum daily dose of Doxadura is 16mg. Doxadura can be taken in the morning or the evening. It is best to take your tablets at about the same time each day with a drink of water. Children Doxadura should not be used in children under 16 years of age. If you take more Doxadura Tablets than you should If you take too many tablets you should lie down on your back with your feet higher than your head. The most likely symptoms of overdose would be a feeling of light-headedness or dizziness due to a fall in blood pressure. If you have any of these symptoms you should tell your doctor or pharmacist or go to your accident and emergency department immediately. If you forget to take Doxadura Tablets If you miss a dose, do not worry. Simply take the next days tablet when it is due. Do not take a double dose to make up for a forgotten tablet. If you stop taking Doxadura Tablets Keep taking your tablets until your doctor tells you to stop.
Please read the back of this leaflet.
*Trademark
4. Possible side-effects Like all medicines, Doxadura can cause sideeffects, although not everybody gets them. The evaluation of the side-effects is based on the following frequencies: Not known: Frequency cannot be estimated from the available data In less than 1 in 10,000 patients treated, including single reports In less than 1 in 1,000, but more than 1 in 10,000 patients treated In less than 1 in 100, but more than 1 in 1,000 patients treated In less than 1 in 10, but more than 1 in 100 patients treated In more than 1 in 10 patients treated
Very rare:
Rare:
Uncommon:
Common:
Very common:
If you experience any of the following very rare or uncommon unwanted effects you should tell your doctor immediately: - slow heartbeat - bronchial spasms (wheezing and tightness in the chest) - raised red patches on the skin - increased passing of urine - excessive urination at night - changes in the number of cells in the blood, which may result in easy bleeding - blurred vision - jaundice (yellowing of the skin) - hepatitis (inflammation of the liver) - blocked bile flow (yellowing of the skin, clay or white coloured faeces, stomach pain) - abnormal liver function tests - development of breasts in males - painful persistent erection in males. Uncommon side-effects include: - ringing or noise in the ears - increased appetite - wind - being sick - gastroenteritis (upset stomach) - delayed or difficult passage of faeces - pain - muscle cramps - muscle weakness - gout (painful inflammation of the joints) - painful joints - trembling or shaking - reduced sense of touch - fainting - stroke (sudden loss of consciousness) - nosebleed - a feeling of irregular heartbeat - angina pectoris (sudden brief attacks of pain in the centre of the chest) - heart attack - facial swelling - loss of hair - skin rash - purple rash caused by bleeding under the skin - pain when passing urine or a change to the frequency of urination - urinary incontinence (leakage of urine) - increased volume of urine passed - blood in the urine - hot flushes (redness of the face) - allergic drug reaction - weight increase - abnormal liver function tests - agitation - depression - erection problems. Other side-effects whose frequency is not known include: - little or no semen ejaculated at sexual climax in males; cloudy urine following sexual climax - altered sense of taste or loss of taste - Intraoperative Floppy Iris Syndrome (leads to problems in cataract surgery). However you should tell your doctor if any of the following common symptoms are severe or become troublesome: - vertigo (a feeling of dizziness or spinning) - mouth dryness - stomach pain - diarrhoea (upset stomach) - feeling sick or being sick - indigestion (difficulty digesting food and a burning sensation at top of stomach) - malaise (feeling unwell) - flu-like symptoms
oedema (swelling) fatigue weakness painful muscles and back pain headache dizziness postural dizziness (dizziness as a result of getting up from a sitting or lying position) - drowsiness - insomnia (inability to sleep) - sensation of prickling or tingling on the skin with unknown cause - cough - difficulty in breathing - bronchitis - nasal stuffiness and/or runny nose - infection in the lungs, windpipe or urinary tract - heart palpitations - increased heart rate - chest pain - itching - cystitis - inability to pass urine - low blood pressure - anorexia (loss of appetite) - nervousness. If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store Doxadura Tablets Keep out of the reach and sight of children. Do not use Doxadura Tablets after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of the month. Store below 25C. 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 protect the environment. 6. Further information What Doxadura Tablets contain The active substance is doxazosin mesilate. The other ingredients are microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, magnesium stearate, sodium lauryl sulphate and colloidal silicon dioxide. Sunset yellow FCF (E110) is an additional ingredient present in the 2mg and 4mg tablets. What Doxadura Tablets look like and the contents of the pack Doxadura 1mg tablets are white to off-white biconvex uncoated tablets, scored with a division mark and embossed with DZS1 on one side. Doxadura 2mg tablets are light orange to pink biconvex uncoated tablets, scored with a division mark and embossed with DZS2 on one side. Doxadura 4mg tablets are light orange to pink biconvex uncoated tablets, scored with a division mark and embossed with DZS4 on one side. They are supplied in cartons of 28 or 56 tablets in foil blister strips.
-
POM
PL 06831/0091 PL 06831/0092 PL 06831/0093 Doxadura 1mg Tablets Doxadura 2mg Tablets Doxadura 4mg Tablets
Marketing Authorisation Holder: Genus Pharmaceuticals Park View House, 65 London Road, Newbury Berkshire RG14 1JN, UK. Manufacturer: Synthon BV Microweg 22, 6545 CM Nijmegen The Netherlands. Synthon Hispania SL Castello 1, Poligono Las Salinas 08830 Sant Boi de Llobregat, Spain. Distributed by: Discovery Pharmaceuticals The Old Vicarage, Market Place Castle Donington, Derbyshire DE74 2JB, UK. This leaflet was last approved in June 2011.
xxxxxxx xxxx
*Trademark
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
