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
Doxazosin with food and drink Please refer to section 3.
Doxazosin 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. Doxazosin 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, doxazosin is taken to treat poor and/or frequent passing of urine. This is common in patients with an enlarged prostate gland. Doxazosin works by relaxing muscle around the bladder exit and prostate gland so urine is passed more easily.
e Doxazosin Do not take Doxazosin
Pregnancy, breast-feeding and fertility Breast-feeding Small amounts of doxazosin can get into your breast milk. You should not use doxazosin during breast-feeding unless your doctor advises you to do so. Pregnancy The safety of using doxazosin during pregnancy has not been established. If you are pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 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 you are affected, do not drive or operate machinery and contact your doctor immediately. Doxazosin contains 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. Doxazosin tablet contains Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'
Doxazosin Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist or nurse if you are not sure.
Children and adolescents Doxazosin 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.
Black
Other medicines and Doxazosin 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 Doxazosin. Ask your doctor or pharmacist before use if you are taking any of these medicines as they may change the effect of Doxazosin.
If you forget to take Doxazosin Do not worry. If you forget to take a tablet, leave that dose out completely. Then go on as before. Do not take a double dose to make up for a forgotten tablet.
A/s 210 x 420 mm
Packaging Development
Product Name
Component
Item Code
Doxazosin
Leaflet
P1540348
06.10.2025 & 9:15 AM Reviewed / Approved by
Customer / Country
Version No.
Reason Of Issue
Milpharm_Unit-3
01
Revision
Team Leader
Ramesh P
Dimensions
Initiator
Jaya Durga
210 x 420 mm
Artist:
Additional Information :
Date & Time
No. of Colours : 01
2D Code 40348
Supersede Item Code: P1537069
Sign / Date
Like all medicines, this medicine can cause side effects, although not everybody gets them. STOP taking Doxazosin and call an ambulance immediately if you experience any of the following:
Not known :frequency cannot be estimated from available data
Doxazosin Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister, label, bottle and carton after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage condition. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment
What Doxazosin contains
P1540348
Doxazosin 8 mg tablets comes as tablet containing 8mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Doxazosin 8 mg tablets is doxazosin mesilate.
Medicines with the same active substance, strength and form include: Cardura XL 8mg tablet. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Doxazosin 8 mg tablets, 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: Doxazosin 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, doxazosin may be used in combination with a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an angiotensin-converting enzyme inhibitor.
Benign Prostatic Hyperplasia:
Doxazosin is indicated for the treatment of urinary outflow obstruction and symptoms associated with benign prostatic hyperplasia (BPH). Doxazosin may be used in BPH patients who are either hypertensive or normotensive.
Posology:
Doxazosin may be administered in the morning or the evening.
Hypertension:
Doxazosin is used in a once daily regimen: the initial dose is 1mg, to minimise the potential for postural hypotension and/or syncope (see section 4.4). Dosage may then be increased to 2mg after an additional one or two weeks of therapy and thereafter, if necessary to 4mg. The majority of patients who respond to Doxazosin will do so at a dose of 4mg or less. Dosage can be further increased if necessary to 8mg or the maximum recommended dose of 16mg.
Benign prostatic hyperplasia:
The recommended initial dosage of Doxazosin is 1mg given once daily to minimise the potential for postural hypotension and/or syncope (see section 4.4). Depending on the individual patient's urodynamics and BPH symptomatology dosage may then be increased to 2mg and thereafter to 4mg and up to the maximum recommended dose of 8mg. The recommended titration interval is 1-2 weeks. The usual recommended dose is 2-4mg daily.
Paediatric population:
The safety and efficacy of Doxazosin in children and adolescents have not been established.
Elderly patients:
Normal adult dosage.
Hepatic/Renal impairment
Patients with renal impairment:
Sincethere is no change in pharmacokinetics in patients with impaired renal function, the usual adult dose of doxazosin is recommended.
Doxazosin is not dialyzable.
Patients with hepatic impairment:
There are only limited data in patients with liver impairment and on the effect of drugs known to influence hepatic metabolism (e.g. cimetidine). As with any drug wholly metabolised by the liver, Doxazosin should be administered with caution to patients with evidence of impaired liver function (see section 4.4 and section 5.2).
Method of administration
Oral administration.
Doxazosin is contraindicated in:
• Hypersensitivity to the active substance or other types of quinazolines (e.g. prazosin, terazosin, doxazosin), or to any of the excipients listed in section 6.1.
• Patients with a history of orthostatic hypotension
• Patients with benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones
• 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.
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 (see section 4.2). 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 doxazosin 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 hepatically impaired patients:
As with any drug wholly metabolised by the liver, doxazosin should be administered with particular caution to patients with evidence of impaired hepatic function (see section 4.2). 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.
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.
Screening for Prostate Cancer:
Carcinoma of the prostate causes many of the symptoms associated with BPH and the two disorders can co-exist. Carcinoma of the prostate should therefore be ruled out prior to commencing therapy with doxazosin for treatment of BPH symptoms.
Doxazosin contains lactose monohydrate
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Doxazosintablet contains Sodium
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)
Conventional doxazosin has been administered without any adverse drug interaction in clinical experience with thiazide diuretics, furosemide, 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.
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).
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 doxazosin during pregnancy has not yet been established. Accordingly, during pregnancy, doxazosin should be used only when, in the opinion of 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.
Hypertension: In clinical trials involving patients with hypertension, the most common reactions associated with doxazosin therapy were of a postural type (rarely associated with fainting) or non-specific.
Benign prostatic hyperplasia: Experience in controlled clinical trials in BPH indicates a similar adverse event profile to that seen in hypertension.
The following undesirable effects have been observed and reported during treatment with Doxazosin 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) and not known (cannot be estimated from the available data).
System Organ Class
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 known
(frequency cannot be estimated from the available data)
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
Gout, increased appetite, anorexia,
Psychiatric disorders
Agitation, depression, anxiety, insomnia, nervousness,
Nervous system disorders
Somnolence dizziness, headache
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
Hot flushes
Respiratory, thoracic and mediastinal disorders
Bronchitis, cough, dyspnea, rhinitis,
Epistaxis,
Bronchospasm,
Gastrointestinal disorders
Abdominal pain, dyspepsia, dry mouth, nausea
Constipation, flatulence, vomiting, gastroenteritis diarrhoea
Hepato-biliary disorders
Abnormal liver function tests,
Cholestasis, hepatitis, jaundice
Skin and subcutaneous tissue disorders
Pruritus
Skin rash
Urticaria, alopecia, purpura
Musculoskeletal, connective tissue and bone disorders
Back pain, myalgia
Arthralgia
Muscle cramps, muscle weakness,
Renal and urinary disorders
Cystitis, urinary incontinence
Dysuria, micturition frequency, hematuria,
Polyuria
Increased diuresis, micturition disorder, nocturia,
Reproductive system and breast disorders
Impotence
Gynecomastia, priapism
Retrograde ejaculation
General disorders and administration site conditions
Asthenia, chest pain, influenza-like symptoms, peripheral oedema
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 national reporting system listed in Yellow Card Scheme Website: 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 may be appropriate in individual cases.
If this measure is inadequate, shock should first be treated with volume expanders. If necessary, vasopressor should then be used. Renal function should be monitored and supported as needed.
Since doxazosin is highly protein bound, dialysis is not indicated.
Ask anything about Doxazosin 8 mg tablets. 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.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.