Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Doxadura XL 4mg Prolonged Release Tablets
⚠ This medicine appears to have been discontinued
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.
What it is and what it is used for
for
Product Title: Doxadura XL 4mg prolonged-release tablets
Pack Size: 28s Mat.No:
92795841909_PIL
Dimensions: 160mm x 420mm Keyline Reference: Barcode: Verified
Pharmacode:
FPO
Datamatrix: Reason for Change: Update to excipient warnings.
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Proof Number: 1 Date: 09.09.2019 Operator: GKE Artwork Number: 1070858 CRN: 16356
Suffix: A
Local Authority submission required: Yes Approved by: Date:
Issued by:
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What you need to know before you take it
e Doxadura XL Do not take Doxadura XL
- if you are allergic to doxazosin, to quinazolines (e.g. prazosin, terazosin) which is the chemical family of medicines to which doxazosin belongs, or any of the other ingredients of this medicine (in section 6). Allergic reactions may be, for example, itching, reddening of the skin or difficulty breathing
- if you have low blood pressure (hypotension) or have had a fall in blood pressure on standing up which caused dizziness, light-headedness or fainting (orthostatic hypotension)
- if you have or have had any formof obstruction of the digestive tract
- if you have benign prostatic hyperplasia (BPH) and additionally suffer from a blockage of your upper urinary tract, chronic urinary infections or bladder stones
- if you have an overflowing bladder, almost no productionof urine(anuria) or if your kidneys fail to function properly (progressive renal insufficiency)
- if you are breast-feeding. Warnings and precautions Talk to your doctor or pharmacist before taking Doxadura XL
- if you suffer from liver disease
- if you have suffered acute heart disease such as heart failure
- dizziness, weakness andinrareoccasions fainting may occur, especially when you first start taking this medicine. You should therefore be careful in the beginning of treatment, and avoid situations that could lead to injury if these symptoms occur. Your physicians will advise you what to do in the event of postural hypotensive symptoms (a decrease in blood pressure with symptoms when changing positions, e.g. from lying down or sitting to standing). You should not be concerned if occasionally you observe remains in the stools that look like a tablet. This is because Doxadura XL has a non-absorbable coating that is designed to control the release of the medicine over a prolonged period. If you are undergoing eye surgery because of a cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used Doxadura XL. This is because Doxadura XL may cause complications during the surgery, which can be managed if your specialist is prepared in advance.
Other medicines and Doxadura XL Please tell your doctor or pharmacist if you are taking, have recently taken or might take any 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
- Oestrogens (female hormones)
- Dopamine, ephedrine, adrenaline, metaraminol, methoxamine, phenylephrine (medicines called sympathomimetics used e.g. for the treatment of heart problems, low blood pressure, asthma, or congestion of the nose)
- Doxazosin and the so-called phosphodiesterase5 inhibitors (e.g. sildenafil, tadalafil or 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 pressureuponsittingorstandingupquickly.Certain patients have experienced these symptoms when taking drugs for erectile dysfunction (impotence) with alpha-blockers. 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. Furthermore, it is recommended to respect a 6-hour time interval from intake of doxazosin and phosphodiesterase-5 inhibitors. Doxadura XL with food and drink Doxadura XL can be taken with or without food. Pregnancy and breast-feeding If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice. Do not take Doxadura XL if you are breast-feeding.
- If you are pregnant do not take this medicine without consulting your doctor first. The safety of this medicine in pregnancy is not sufficiently established. Driving and using machines Doxadura XL may cause dizziness or tiredness. If you feel tired, 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. Doxadura XL contains sodium This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially 'sodiumfree'.
How to take it
Doxadura XL Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Dosage The dose of Doxadura XL is the same whether you are taking it for high blood pressure or to treat the symptoms of BPH. The usual dose is one tablet (4mg) each day.Your doctor may increase your dose to the maximum recommended dose of two tablets each day. Choose any time of the day that is convenient for you and take your tablets at this time each day. The tablets must be swallowed whole with a sufficient amount of water. Do not chew, divide or crush the tablets. Doxadura XL releases the active substance slowly throughout the day. For the treatment of high blood pressure, Doxadura XL can be used as single therapy, or in combination with other blood pressure-lowering medications (e.g. diuretics, water tablets). Please read the back of this leaflet. *Trademark
92795841909
FPO
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The active substance in your tablets, doxazosin, belongs to a group of medicines known as alpha-1 antagonists. Doxadura XL 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 XL 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.
- Symptoms of benign prostatic hyperplasia (BPH). This condition causes enlargement of the prostate gland, which is just underneath the bladder in men. This makes it difficult to pass urine. Doxadura XL works by relaxing muscle around the bladder exit and prostate gland, making it easier to pass urine.
Children and adolescents Doxadura XL is not recommended for use in children or adolescents below18 years as safety and efficacy have not been established.
It may take up to four weeks to reach the optimal blood pressure-lowering effect of Doxadura XL. Because high blood pressure is treated in order to prevent problems from arising, you may have no symptoms at all while taking Doxadura XL. Even if this is so and you feel well, you should not stop taking your medication unless instructed to by your doctor. Don't change the dose or stop taking the tablets without first checking with your doctor. If you take more Doxadura XL 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 the nearest casualty department immediately. If you forget to take Doxadura XL If you miss a dose, do not worry. Simply take the next day's tablet when it is due. Do not take a double dose to make up for a forgotten tablet. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side-effects
Product Title: Doxadura XL 4mg prolonged-release tablets
Pack Size: 28s Mat.No:
92795841909_PIL
Dimensions: 160mm x 420mm Keyline Reference: Barcode: Verified
Pharmacode: Datamatrix: Reason for Change: Update to excipient warnings.
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Black
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Other side effects
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Proof Number: 1 Date: 09.09.2019 Operator: GKE Artwork Number: 1070858 CRN: 16356
Suffix: A
Local Authority submission required: Yes Approved by: Date:
Issued by:
Like all medicines, this medicine can cause sideeffects, although not everybody gets them. STOP taking Doxadura XL and call an ambulance immediately if you experience any of the following:
- Heart attack (uncommon)
- Weakness of arms, legs or problems speaking which may be symptoms of a stroke (uncommon)
- Swelling of the face, tongue or throat which may betheresult of anallergic reactiontothis medicine (uncommon) Tell your doctor immediately if you experience any of the following symptoms after taking Doxadura XL:
- Chest pain (common), angina (uncommon)
- Shortness of breath, difficulty breathing, wheezing (very rare)
- Increased (common), decreased or irregular heartbeat (very rare)
- Feeling your heartbeat (palpitations) (common)
- Skin rash or itching (especially the whole body) (common)
- Fainting (uncommon)
- Yellowing of the skin or the eyes (jaundice) (very rare)
- Low numbers of white blood cells or blood platelets, which may result in bruising or easy bleeding (very rare)
Date:
Common (may affect up to 1 in 10 people):
- respiratory tract infection
- dizziness, headache, drowsiness
- loss of balance
- low blood pressure and low blood pressure as a result of getting up from a sitting or lying position (postural hypotension)
- inflammation of the air passages within the lungs, cough, shortage of breath, nasal stuffiness and/or runny nose
- abdominal pain, indigestion, dry mouth, feeling sick (nausea)
- back pain, painful muscles
- inflammation of the bladder (cystitis), urinary incontinence
- general weakness, influenza-like symptoms. Uncommon (may affect up to 1 in 100 people):
- loss of appetite, gout, increased appetite
- anxiety, emotional instability (depression), sleeplessness (insomnia)
- reduced sense of touch or sensation, tremor, ringing or noise in the ears (tinnitus)
- nosebleed
- constipation, diarrhoea, flatulence, being sick (vomiting), inflammation of the gastrointestinal tract
- abnormal liver function test
- joint pain
- painful or difficult urination, presence of red blood cells in the urine (haematuria), frequent desire to urinate
- abnormal accumulation of fluid beneath the skin causing swelling of the face (facial oedema)
- difficulty to develop an erection (impotence)
- pain
- weight increase. Very Rare (may affect up to 1 in 10,000 people):
- reduced numbers of red cells
- dizziness postural
- restlessness, nervousness
- pins and needles
- blurred vision
- flushing
- blocked flow of bile (cholestasis), inflammation of the liver (hepatitis)
- hair loss (alopecia), rash caused by bleeding under the skin (purpura), hives
- muscle cramps, muscle weakness
- urination disorder, frequent urinating during the night, increased volume of urine passed
- temporary enlargement of the breasts (gynaecomastia)
- persistent painful erection of the penis. Seek urgent medical advice.
- feeling tired (fatigue), malaise Not known (frequency cannot be estimated from available data):
- intraoperative floppy iris syndrome
- taste disturbances
- retrograde ejaculation. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report
Possible side effects
directly 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. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Doxadura XL 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 carton, and blister after Exp. The expiry date refers to the last day of the month. This medicinal product does not require any special storage conditions. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Doxadura XL contains The active substance is doxazosin. One prolongedrelease tablet contains 4mg doxazosin (as mesilate). The other ingredients are
- polyethylene oxide, microcrystalline cellulose, povidone, butyl-hydroxytoluene (E321), all-racα-Tocopherol, colloidal anhydrous silica, sodium stearyl fumarate, methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30%, macrogol, and titanium dioxide (E171). What Doxadura XL looks like and contents of the pack The tablets are white, round, biconvex tablets with "DL" embossed on one side. Your medicine is available in PVC/PVDC/aluminium blister packs: Cartons with 10, 20, 28, 30, 50, 56, 60, 90, 98, 100, 140 (10 x 14) prolonged-release tablets. Calendar packs of 28 and 98 prolonged-release tablets Unit dose pack of 50 x 1 prolonged-release tablets Not all pack sizes may be marketed POM PL 06831/0171
Doxadura XL 4mg prolonged-release tablets
Marketing Authorisation Holder and Manufacturer: Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK. This medicinal product is authorised in the Member States of the EEA under the following names: Estonia Doxalfa Latvia Doxalfa 4 mg ilgstošās darbības tabletes Lithuania Doxalfa The Netherlands Doxazosine retard CF Spain DOXAZOSINA NEO STADA Sweden Doxastad Great Britain Doxadura XL This leaflet was last revised in September 2019
*Trademark
92795841909
Frequently asked questions about Doxadura XL 4mg Prolonged Release Tablets
How do I take Doxadura XL 4mg Prolonged Release Tablets?
Doxadura XL 4mg Prolonged Release Tablets 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.
What is the active substance in Doxadura XL 4mg Prolonged Release Tablets?
The active substance in Doxadura XL 4mg Prolonged Release Tablets is doxazosin mesilate.
Are there equivalent medicines to Doxadura XL 4mg Prolonged Release Tablets?
Medicines with the same active substance, strength and form include: Cardura XL 4mg tablet, Doxadura 4mg Tablets, Doxazosin 4mg tablets. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Doxadura XL 4mg Prolonged Release Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Doxadura XL 4mg Prolonged Release Tablets without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: doxazosin mesilate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Essential hypertension.
Symptomatic treatment of benign prostatic hyperplasia.
4.2. Posology and method of administration
Posology
The maximum recommended dose is 8 mg doxazosin once daily.
Essential hypertension
Adults
Most patients treated with Doxadura XL 4 mg prolonged release tablets once daily achieve control of blood pressure. It may take up to four weeks to reach optimal effect. If necessary, the dose can thereafter be increased to 8 mg once daily depending on the clinical response.
Doxadura XL 4 mg prolonged release tablets can be used as monotherapy or in combination with another medicinal product e.g. a thiazide diuretic, a beta-adrenoceptor blocking agent, a calcium antagonist or an ACE-inhibitor if either of them alone does not provide sufficient effect.
Symptomatic treatment of benign prostatic hyperplasia
Adults
Recommended dose is 4 mg once daily. Depending on clinical response, the dosage may be increased to 8 mg doxazosin once daily.
Doxazosin may be used in benign prostatic hyperplasia patients who are either hypertensive or normotensive, as the blood pressure reduction in normotensive patients is generally slight. Patients should be closely monitored in the initial phase of the treatment due to the risk of postural adverse events.
Special populations
Elderly
Same dosage recommendations as for adults.
Renal impairment
Since there is no change in pharmacokinetics in patients with impaired renal function and since there are no signs that doxazosin aggravates existing renal impairment, normal dose can generally be used in these patients.
Hepatic impairment
Doxazosin should be administered with caution in patients with signs of minor to moderate hepatic impairment. Since no clinical experience from patients with severe hepatic insufficiency exists, use in these patients is not recommended (see section 4.4).
Paediatric population
The safety and efficacy of doxazosin in children and adolescents have not been established.
Method of administration
Doxadura XL 4 mg prolonged-release tablets can be taken with or without food. The tablets should be swallowed whole with a sufficient amount of liquid. The patient should not chew, divide or crush the tablet.
4.3. Contraindications
Doxazosin is contraindicated
• in patients with hypersensitivity to the active substance, other types of quinazolines (e.g. prazosin, terazosin) or to any of the excipients listed in section 6.1
• in patients with a history of orthostatic hypotension
• in patients with benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones
• in patients with a history of gastro-intestinal obstruction, oesophageal obstruction, or any degree of decreased lumen diameter of the gastro-intestinal tract
• in during lactation (see section 4.6) (for the hypertension indication only)
• in patients with hypotension (for the benign prostatic hyperplasia indication only)
Doxazosin is contraindicated as monotherapy in patients with either overflow bladder, or anuria with or without progressive renal insufficiency.
4.4. Special warnings and precautions for use
Information to be given to the patient:
Patients should be informed that doxazosin tablets should be swallowed whole. Patients should not chew, divide or crush the tablets.
For some prolonged-release formulations the active compound is surrounded by an inert, non-absorbable coating that is 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 not to 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.
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. The patient should be cautioned to avoid situations where injury could result should dizziness or weakness occur during the initiation of doxazosin therapy.
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
• heart failure at high output
• right-sided heart failure due to pulmonary embolism or pericardial effusion
• left ventricular heart failure with low filling pressure
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. 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 haemodynamically 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.
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.
Laboratory data
Doxazosin may influence the plasma renin activity and urinary excretion of vanillylmandelic acid. This should be considered when analysing laboratory data.
Excipients
This medicinal product contains less than 1mmol sodium (23mg) per tablet, that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
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.
Most (98 %) of plasma doxazosin is protein bound. In vitro data in human plasma indicate that doxazosin has no effect on protein binding of digoxin, warfarin, phenytoin or indometacin.
Conventional doxazosin has been administered without any adverse drug interaction in clinical experience with thiazide diuretics, furosemide, beta-blockers, non-steroidal anti-inflammatory drugs, antibiotics, oral hypoglycaemic drugs, uricosuric agents, and 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, randomised, 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.
Non-steroidal antirheumatics or oestrogens may reduce the antihypertensive effect of doxazosin.
Sympathomimetics may reduce the antihypertensive effect of doxazosin; doxazosin may reduce blood pressure and vascular reactions to dopamine, ephedrine, epinephrine, metaraminol, methoxamine and phenylephrine.
There are no studies available concerning interactions with agents influencing hepatic metabolism.
4.6. Fertility, pregnancy and lactation
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 been established. Accordingly, during pregnancy, doxazosin should be used only if the potential benefit outweighs the 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).
Breastfeeding
Doxazosin is contraindicated during lactation as the drug accumulates in milk of lactating rats and there is no information about the excretion of the drug into the milk of lactating women.
Alternatively, mothers should stop breastfeeding when treatment with doxazosin is necessary (see section 5.3).
For the benign prostatic hyperplasia indication:
This section is not applicable.
4.7. Effects on ability to drive and use machines
The ability to engage in activities such as operating machinery or operating a motor vehicle may be impaired, especially when initiating therapy.
4.8. Undesirable effects
Frequencies used are as follows: 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 (cannot be estimated from the available data).
MedDRA
System Organ Class
Frequency
Undesirable Effects
Infections and infestations
Common
Respiratory tract infection, urinary tract infection
Blood and lymphatic system disorders
Very rare
Leukopenia, thrombocytopenia
Immune system disorders
Uncommon
Allergic drug reaction
Metabolism and nutrition disorders
Uncommon
Anorexia, gout, increased appetite
Psychiatric disorders
Uncommon
Very rare
Anxiety, depression, insomnia
Agitation, nervousness
Nervous system disorders
Common
Uncommon
Very rare
Dizziness, headache, somnolence
Cerebrovascular accident, hypoesthesia, syncope, tremor
Dizziness postural, paraesthesia
Eye disorders
Very rare
Not known
Blurred vision
Intraoperative floppy iris syndrome (see section 4.4)
Ear and labyrinth disorders
Common
Uncommon
Vertigo
Tinnitus
Cardiac disorders
Common
Uncommon
Very rare
Palpitation, tachycardia
Angina pectoris, myocardial infarction
Bradycardia, cardiac arrhythmias
Vascular disorders
Common
Very rare
Hypotension, postural hypotension
Flush
Respiratory, thoracic and mediastinal disorders
Common
Uncommon
Very rare
Bronchitis, cough, dyspnoea, rhinitis
Epistaxis
Bronchospasm
Gastrointestinal disorders
Common
Uncommon
Not known
Abdominal pain, dyspepsia, dry mouth, nausea
Constipation, diarrhoea, flatulence, vomiting, gastroenteritis
Taste disturbances
Hepatobiliary disorders
Uncommon
Very rare
Abnormal liver function tests
Cholestasis, hepatitis, jaundice
Skin and subcutaneous tissue disorders
Common
Uncommon
Very rare
Pruritus
Skin rash
Alopecia, purpura, urticaria
Musculoskeletal and connective tissue disorders
Common
Uncommon
Very rare
Back pain, myalgia
Arthralgia
Muscle cramps, muscle weakness
Renal and urinary disorders
Common
Uncommon
Very rare
Cystitis, urinary incontinence
Dysuria, haematuria, micturition frequency
Micturition disorder, nocturia, polyuria, increased diuresis
Reproductive system and breast disorders
Uncommon
Very rare
Not known
Impotence
Gynaecomastia, priapism
Retrograde ejaculation
General disorders and administration site conditions
Common
Uncommon
Very rare
Asthenia, chest pain, influenza-like symptoms, peripheral oedema
Pain, facial oedema
Fatigue, malaise
Investigations
Uncommon
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.
4.9. Overdose
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.
Toxicity
There is limited data on the effect of overdoses. Syncope occurred in a fasting adult who had taken doxazosin 16 mg. A 13-year-old experienced moderate intoxication following a maximum dose of doxazosin 40 mg.
Symptoms
Headache, dizziness, unconsciousness, syncope, dyspnoea, hypotension, palpitations, tachycardia, arrhythmia. Nausea, vomiting. Possibly hypoglycaemia, hypokalaemia.
Treatment
Ventricle emptying and charcoal if required. In cases of hypotension: lower the head position, provide intravenous fluids and if needed vasopressors (for instance noradrenaline or ephedrine). Provide symptomatic treatment as needed.
💬 Ask about this leaflet
Ask anything about Doxadura XL 4mg Prolonged Release 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.