Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Doxazosin mesilate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for CARDURA XL contains the active substance doxazosin mesilate and is one of a group of medicines called alpha-blockers. It is used to treat high blood pressure, or the symptoms caused by enlargement of the prostate gland in men. CARDURA XL can be used to treat high blood pressure (hypertension), by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure. In patients with an enlarged prostate gland, CARDURA XL is taken to treat poor and/or frequent passing of urine. This is common in patients with an enlarged prostate gland. CARDURA XL works by relaxing muscle around the bladder exit and prostate gland so urine is passed more easily.
e CARDURA XL Do not take CARDURA XL: •
If you are allergic to doxazosin, other quinazolines (e.g. prazosin or terazosin), or to any of the other ingredients of this medicine (listed in section 6). This may have been itching, reddening of the skin or difficulty in breathing.
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•
If you have any form of obstruction of the digestive tract
•
If you have an enlarged prostate gland (benign prostatic hyperplasia) and have low blood pressure
•
If you have a history of a condition known as 'orthostatic hypotension' which is a form of low blood pressure that causes you to feel dizzy or light-headed when you stand up from sitting or lying down
•
If you have an enlarged prostate gland with one of the following: any kind of congestion or blockage in your urinary tract, a longstanding infection of the urinary tract or you have bladder stones
•
If you have overflow incontinence (you do not feel the urge to urinate), or anuria (your body is not producing any urine) with or without kidney problems.
Warnings and precautions Talk to your doctor or pharmacist before taking CARDURA XL as it may not be suitable for you: •
If you are pregnant or trying to become pregnant
•
If you have liver disease
•
If you have heart disease
•
If you are also taking other medicines
If you are undergoing eye surgery because of cataract (cloudiness of the lens of the eye), please inform your eye specialist before the operation that you are using or have previously used CARDURA XL. This is because CARDURA XL may cause complications during the surgery which can be managed if your specialist is prepared in advance. If any of these apply to you speak to your doctor before taking this medicine. When you start to take CARDURA XL you may experience faintness or dizziness caused by low blood pressure, when getting up from sitting or lying down. If you feel faint or dizzy, you should sit or lie down until you feel better and avoid situations where you might fall or hurt yourself. Your doctor may want to measure your blood pressure regularly at the start of therapy to reduce the possibility of these effects happening. Persistent painful erections may occur very rarely. If this happens you should contact a doctor immediately. Before starting treatment with CARDURA XL your doctor may perform tests to rule out other conditions such as prostate cancer that may cause the same symptoms as benign prostatic hyperplasia. Children and adolescents CARDURA XL is not recommended for use in children or adolescents below 18 years as safety and efficacy have not yet been established. Benign prostate hyperplasia is not relevant in children.
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Other medicines and CARDURA XL Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. There are some medicines that may interact with CARDURA XL. Ask your doctor or pharmacist before use if you are taking any of these medicines as they may change the effect of CARDURA XL: •
Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking medicines called PDE-5 inhibitors for the treatment of erectile dysfunction (impotence) with alpha-blockers e.g. sildenafil, tadalafil, vardenafil (please see Section "Warnings and precautions"). In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha blocker before you start drugs for erectile dysfunction.
•
Cardura XL may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure such as terazosin and prazosin. Medicines to treat bacterial or fungal infections, e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole. Medicines used in the treatment of HIV e.g. indinavir, nelfinavir, ritonavir, saquinavir. Nefazodone, a medicine used to treat depression.
• • •
CARDURA XL with food and drink See section 3 How to take CARDURA XL Pregnancy, breast-feeding and fertility Pregnancy The safety of using CARDURA XL during pregnancy has not been established. If you are pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Breast-feeding Small amounts of doxazosin, the active substance of CARDURA XL, can get into your breast milk. You should not use CARDURA XL during breast-feeding unless your doctor advises you to do so. Driving and using machines Take care if you drive or operate machinery. Your tablets may affect your ability to drive or operate machinery safely, particularly when you first start to take them. They may make you feel weak or dizzy. If affected, do not drive or operate machinery and contact your doctor immediately. Information about the ingredients of CARDURA XL This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
3. How to take CARDURA XL Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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CARDURA XL is a prolonged release tablet. The medicine is contained within a non-absorbable shell that has been specially designed to slowly release the medicine. Once swallowed, doxazosin is slowly released into the body from the tablet, until the tablet is empty. Since the empty tablet is eliminated from the body in bowel movements, you may occasionally observe in the stools, something that looks like a tablet. This is to be expected and you should not be concerned.
your medicine
4. Possible side effects Like all medicines, this medicine can cause side effects although not everybody gets them. STOP taking CARDURA XL and call an ambulance immediately if you experience any of the following:
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• • • • • •
Chest pain, angina (uncommon: may affect up to 1 in 100 people) Irregular heartbeat (very rare: may affect up to 1 in 10,000 people) Skin rash or itching (especially the whole body) (uncommon: may affect up to 1 in 100 people) Yellowing of the skin or the eyes (jaundice) (very rare: may affect up to 1 in 10,000 people) Low numbers of white blood cells or blood platelets, which may result in bruising or easy bleeding (very rare: may affect up to 1 in 10,000 people) Persistent painful erection of the penis. Seek urgent medical advice (very rare: may affect up to 1 in 10,000 people)
The following events have been reported in patients being treated with CARDURA XL. If any of these
get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. Common side effects: may affect up to 1 in 10 people
blockage of the digestive tract
Very Rare side effects: may affect up to 1 in 10,000 people
• • • • • • • •
agitation, nervousness tiredness, generally feeling unwell aggravated wheezing muscle cramps, muscle weakness blurred vision flushing disorder in passing urine, needing to pass urine at night, increased volume of urine passed, increased production of urine causing an increase in the number of times of passing urine discomfort or enlargement of the breasts in men
Not known: frequency cannot be estimated from the available data
CARDURA XL Keep this medicine out of the sight and reach of children. Do not use CARDURA XL after the expiry date which is stated on carton and blister after EXP. The expiry date refers to the last day of that month. Do not store above 30°C. Store in the original package. The tablets should be whole to work effectively, if you notice any defects (such as broken tablets) consult your pharmacist immediately. Do not throw away any medicines via wastewater or household waste. Ask you pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What CARDURA XL contains The active substance is doxazosin. Each tablet contains either 4.85mg doxazosin mesilate equivalent to 4mg doxazosin or 9.70mg doxazosin mesilate equivalent to 8mg doxazosin within a shell that has been specially designed to slowly release the drug. The other ingredients are: polyethylene oxide, sodium chloride (see section 2 "Information about the ingredients of CARDURA XL"), hypromellose, red ferric oxide (E172), titanium dioxide (E171), magnesium stearate, cellulose acetate, Macrogol, pharmaceutical glaze, black iron oxide (E172), ammonium hydroxide and propylene glycol. What CARDURA XL looks like and contents of the pack CARDURA XL tablets are white film coated, round, biconvex shaped with a hole in one side and marked CXL 4 for the 4mg and CXL 8 for the 8mg.
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They are available in strengths of 4mg and 8mg prolonged release tablets and in packs of 28 or 30 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Viatris Products Limited, Station Close, Potters Bar, EN6 1TL, United Kingdom. Manufacturer Pfizer Manufacturing Deutschland GmbH, Mooswaldallee 1, 79108 Freiburg Im Breisgau, Germany or Klocke Verpackungs-Service GmbH, Max-Becker-Strasse 6, 76356 Weingarten (Baden), Germany This leaflet was last revised in 01/2026.
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Cardura XL 4mg tablet comes as tablet containing 4mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Cardura XL 4mg tablet is doxazosin mesilate.
Medicines with the same active substance, strength and form include: Doxadura 4mg Tablets, Doxadura XL 4mg Prolonged Release Tablets, Doxazosin 4mg tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Cardura XL 4mg tablet, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Hypertension: Cardura XL is indicated for the treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. In patients inadequately controlled on single antihypertensive therapy, Cardura XL may be used in combination with a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an angiotensin-converting enzyme inhibitor.
Benign prostatic hyperplasia: Cardura XL is indicated for the treatment of urinary outflow obstruction and symptoms associated with benign prostatic hyperplasia (BPH).
Cardura XL may be used in BPH patients who are either hypertensive or normotensive. While the blood pressure changes in normotensive patients with BPH are not usually clinically significant, patients with hypertension and BPH have had both conditions effectively treated with doxazosin monotherapy.
Posology
Hypertension and benign prostatic hyperplasia: The initial dose of Cardura XL is 4mg once daily. Over 50% of patients with mild to moderate severity hypertension will be controlled on Cardura XL 4mg once daily. Optimal effect of Cardura XL may take up to 4 weeks. If necessary, the dosage may be increased following this period to 8mg once daily according to patient response.
The maximum recommended dose of Cardura XL is 8mg once daily.
Paediatric population: The safety and efficacy of Cardura XL in children and adolescents have not been established.
Elderly patients: Normal adult dosage.
Hepatic/Renal impairment
Patients with renal impairment: Since there is no change in pharmacokinetics in patients with impaired renal function the usual adult dose of Cardura XL is recommended. Doxazosin is not dialysable.
Patients with hepatic impairment: As with any drug wholly metabolised by the liver, Cardura XL should be administered with caution to patients with evidence of impaired hepatic function (see section 4.4 and 5.2).
Method of administration
Cardura XL can be taken with or without food.
The tablets should be swallowed whole with a sufficient amount of liquid. Patients should not chew, divide or crush the tablets (see section 4.4).
Cardura XL is contraindicated in:
1) Patients with known hypersensitivity to doxazosin, quinazolines or to any of the excipients listed in section 6.1.
2) Patients with a history of orthostatic hypotension.
3) Patients with benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones.
4) Patients with a history of gastro-intestinal obstruction, oesophageal obstruction, or any degree of decreased lumen diameter of the gastro-intestinal tract.
5) Patients with hypotension (For benign prostatic hyperplasia indication only)
Doxazosin is contraindicated as monotherapy in patients with either overflow bladder or anuria with or without progressive renal insufficiency.
Information to be given to the Patient:
Patients should be informed that Cardura XL tablets should be swallowed whole. Patients should not chew, divide or crush the tablets (see section 4.2).
In Cardura XL, the active compound is surrounded by an inert, non-absorbable shell that has been specially designed to control the release of the drug over a prolonged period. After transit through the gastrointestinal tract, the empty tablet shell is excreted. Patients should be advised that they should not be concerned if they occasionally observe remains in their stools that look like a tablet.
Abnormally short transit times through the gastrointestinal tract (e.g. following surgical resection) could result in incomplete absorption. In view of the long half life of doxazosin the clinical significance of this is unclear.
Postural hypotension / syncope:
Initiation of therapy –
In relation with the alpha-blocking properties of doxazosin, patients may experience postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness (syncope), particularly with the commencement of therapy. Therefore, it is prudent medical practice to monitor blood pressure on initiation of therapy to minimise the potential for postural effects.
When instituting therapy with any effective alpha-blocker, the patient should be advised how to avoid symptoms resulting from postural hypotension and what measures to take should they develop. The patient should be cautioned to avoid situations where injury could result should dizziness or weakness occur during the initiation of Cardura XL therapy.
Use in patients with acute cardiac conditions:
As with any other vasodilatory anti-hypertensive agent it is prudent medical practice to advise caution when administering doxazosin to patients with the following acute cardiac conditions:
- pulmonary oedema due to aortic or mitral stenosis
- high-output cardiac failure
- right-sided heart failure due to pulmonary embolism or pericardial effusion
- left ventricular heart failure with low filling pressure.
Use in patients with hepatic impairment:
As with any drug wholly metabolised by the liver, Cardura XL should be administered with particular caution to patients with evidence of impaired hepatic function (see sections 4.2 and 5.2). Since there is no clinical experience in patients with severe hepatic impairment use in these patients is not recommended.
Use with PDE-5 Inhibitors:
Concomitant administration of doxazosin with phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, and vardenafil) should be done with caution as both drugs have vasodilating effects and may lead to symptomatic hypotension in some patients. To reduce the risk of orthostatic hypotension it is recommended to initiate the treatment with phosphodiesterase-5-inhibitors only if the patient is hemodynamically stabilized on alpha-blocker therapy. Furthermore, it is recommended to initiate phosphodiesterase-5-inhibitor treatment with the lowest possible dose and to respect a 6-hour time interval from intake of doxazosin. No studies have been conducted with doxazosin prolonged release formulations.
Use in patients undergoing cataract surgery:
The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural complications during the cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.
Screening for Prostate Cancer:
Carcinoma of the prostate causes many of the symptoms associated with BHP and the two disorders can co-exist. Carcinoma of the prostate should therefore be ruled out prior to commencing therapy with doxazosin for treatment with BPH symptoms.
Priapism:
Prolonged erections and priapism have been reported with alpha-1 blockers including doxazosin in post marketing experience. If priapism is not treated immediately, it could result in penile tissue damage and permanent loss of potency, therefore the patient should seek immediate medical assistance.
Excipient information:
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium free'.
Phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil)
Concomitant administration of doxazosin with a PDE-5 inhibitor may lead to symptomatic hypotension in some patients (see section 4.4). No studies have been conducted with doxazosin prolonged-release formulations.
Doxazosin is highly bound to plasma proteins (98%). In vitro data in human plasma indicates that doxazosin has no effect on protein binding of the drugs tested (digoxin, phenytoin, warfarin or indomethacin).
In vitro studies suggest that doxazosin is a substrate of cytochrome P450 3A4 (CYP 3A4). Caution should be exercised when concomitantly administering doxazosin with a strong CYP 3A4 inhibitor, such as clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole (see section 5.2).
Conventional doxazosin has been administered without any adverse drug interactions in clinical experience with thiazide diuretics, frusemide, beta-blocking agents, non-steroidal anti-inflammatory drugs, antibiotics, oral hypoglycaemic drugs, uricosuric agents, or anticoagulants. However, data from formal drug/drug interaction studies are not present.
Doxazosin potentiates the blood pressure lowering activity of other alpha-blockers and other antihypertensives.
In an open-label, randomized, placebo-controlled trial in 22 healthy male volunteers, the administration of a single 1 mg dose of doxazosin on day 1 of a four-day regimen of oral cimetidine (400 mg twice daily) resulted in a 10% increase in mean AUC of doxazosin, and no statistically significant changes in mean Cmax and mean half-life of doxazosin. The 10% increase in the mean AUC for doxazosin with cimetidine is within intersubject variation (27%) of the mean AUC for doxazosin with placebo.
For the hypertension indication:
Pregnancy
As there are no adequate and well-controlled studies in pregnant women, the safety of Cardura XL during pregnancy has not yet been established. Accordingly, during pregnancy, Cardura XL should be used only when, in the opinion of the physician, the potential benefit outweighs the potential risk.
Although no teratogenic effects were seen in animal testing, reduced foetal survival was observed in animals at extremely high doses (see section 5.3).
Breast-feeding
The excretion of doxazosin in breast milk was demonstrated to be very low (with the relative infant dose less than 1%) however human data is very limited. A risk to the newborn or infant cannot be excluded and therefore doxazosin should be used only when in the opinion of the physician, the potential benefit outweighs the potential risk.
For the benign prostatic hyperplasia indication:
This section is not applicable
The ability to drive or use machinery may be impaired, especially when initiating therapy.
In clinical trials, the most common reactions associated with Cardura XL therapy were of a postural type (rarely associated with fainting) or non-specific.
The following undesirable effects have been observed and reported during treatment with Cardura XL with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), Not know (cannot be estimated from the available data).
System Organ Class
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1,000 to <1/100)
Rare
(≥1/10,000 to <1/1,000
Very Rare
(<1/10,000)
Unknown
Infections and infestations
Respiratory tract infection, urinary tract infection
Blood and the lymphatic system disorders
Leukopenia, thrombocytopenia
Immune system disorders
Allergic drug reaction
Metabolism and nutrition disorders
Anorexia, gout, increased appetite
Psychiatric disorders
Anxiety, depression, insomnia
Agitation, nervousness
Nervous system disorders
Dizziness, headache, somnolence
Cerebrovascular accident, hypoesthesia, syncope, tremor
Dizziness postural, paresthesia
Eye disorders
Blurred vision
Intraoperative floppy iris syndrome (see section 4.4)
Ear and labyrinth disorders
Vertigo
Tinnitus
Cardiac disorders
Palpitation, tachycardia
Angina pectoris, myocardial infarction
Bradycardia, cardiac arrhythmias
Vascular disorders
Hypotension, postural hypotension
Flush
Respiratory, thoracic and mediastinal disorders
Bronchitis, cough, dyspnoea, rhinitis
Epistaxis
Bronchospasm
Gastrointestinal disorders
Abdominal pain, dyspepsia, dry mouth, nausea
Constipation, diarrhoea, flatulence, vomiting, gastroenteritis
Gastrointestinal obstruction
Hepato-biliary disorders
Abnormal liver function tests
Cholestasis, hepatitis, jaundice
Skin and subcutaneous tissue disorders
Pruritus
Skin rash
Alopecia, purpura, urticaria
Musculoskeletal, connective tissue and bone disorders
Back pain, myalgia
Arthralgia
Muscle cramps, muscle weakness
Renal and urinary disorders
Cystitis, urinary incontinence
Dysuria, hematuria, micturition frequency
Micturition disorder, nocturia, polyuria, increased diuresis
Reproductive system and breast disorders
Impotence
Gynecomastia, priapism
Retrograde ejaculation
General disorders and administration site conditions
Asthenia, chest pain, influenza-like symptoms, peripheral edema
Pain, facial oedema
Fatigue, malaise
Investigations
Weight increase
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Should overdosage lead to hypotension, the patient should be immediately placed in a supine, head down position. Other supportive measures should be performed if thought appropriate in individual cases. Since doxazosin is highly protein bound, dialysis is not indicated.
Ask anything about Cardura XL 4mg tablet. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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