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.
Xatral XL 10mg 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 Alfuzosin hydrochloride 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 The name of your tablets is Xatral XL. This belongs to a group of medicines called alpha-blockers. Xatral XL can be used to treat the symptoms of Benign Prostatic Hyperplasia. This is when the prostate gland enlarges (hyperplasia) but the growth is not cancerous (it is benign). It can cause problems in passing water (urine). This happens mainly in older men.
- The prostate gland lies underneath the bladder. It surrounds the urethra. This is the tube that takes your water to the outside of the body.
- If the prostate gets bigger, it presses on the urethra making it smaller. This makes it difficult to pass water.
- Your tablets work by relaxing the prostate gland muscle. This allows the urethra to get bigger and so makes it easier to pass water. In a few patients with benign prostatic hyperplasia, the prostate gland gets so big that it stops the flow of urine completely. This is called Acute Urinary Retention.
- This is very painful and you may need a short stay in hospital
- A thin, flexible tube (catheter) is passed into the bladder. This drains the water and relieves the pain.
- During this time, Xatral XL may be used to help the water to flow again. This has only been shown to help in men aged over 65. 1
What you need to know before you take it
e Xatral XL Do not take Xatral XL if: × You are allergic (hypersensitive) to alfuzosin or any of the other ingredients of this medicine (listed in section 6). × You are taking another alpha-blocker. See section below on 'Other medicines and Xatral XL'. × You have something called orthostatic hypotension. This is a drop in blood pressure which usually happens when you stand up. It can make you feel dizzy, light-headed or faint when you stand or sit up quickly. × You have liver problems. × You are taking Ritonavir alone or in combination with ombitasvir/paritaprevir, lopinavir, nirmatrelvir. See section "Other medicines and Xatral XL" below. If you are not sure if any of these apply to you do not take and talk to your doctor.
Take special care with Xatral XL Check with your doctor or pharmacist before taking your medicine if: You have chest pain (angina). You have a condition where your kidneys are hardly working at all. You have heart problems, or if your heart suddenly stopped pumping efficiently (acute cardiac failure) You have hereditary problems with the way your heart beats (congenital QTc prolongation)
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Other medicines and Xatral XL Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. This is because Xatral XL can affect the way some other medicines work. Some medicines can also have an effect on the way that Xatral XL works. Do not take Xatral XL if you are taking:
- Other alpha-blockers such as doxazosin, indoramin, prazosin, terazosin, tamsulosin, or phenoxybenzamine.
- Ritonavir (a medicine used for treatment of Chronic Hepatitis C infection) alone or as a combination drug of ombitasvir/paritaprevir. These medicines will lead to more quantity of alfuzosin in blood due to decrease of liver function to remove alfuzosin from the body. Check withh your doctor or pharmacist before taking your medicine if:
- In the past, you have had a large fall in blood pressure while taking an alpha- blocker (this could include previous use of alfuzosin. See paragraph immediately above for examples of other alpha- blockers).
- You are taking a medicine for high blood pressure, as you may get dizzy, weak or start sweating within a few hours of taking this medicine. If this happens, lie down until the symptoms have completely gone.
Tell your doctor as he or she may decide to change the dose of your medicine.
- You are taking medicines for chest pain (angina)
- You are taking medicines for fungal infections (such as itraconazole).
- You are taking medicines for HIV (such as ritonavir).
- You are taking medicines for bacterial infections (such as clarithromycin, telithromycin).
- You are taking medicines for treatment of depression (such as nefazodone).
- You are taking ketoconazole tablets (used to treat Cushing's syndrome – when the body produces an excess of cortisol). Operations and tests while taking Xatral XL
- If you are going to have an operation on the eye because of cataract (cloudiness of the eye), tell your eye specialist you are using or have used Xatral XL in the past. This is because Xatral XL may cause complications during your operation. This can be managed if your eye specialist knows before carrying out the operation.
- If you are being treated for high blood pressure, your doctor should measure your blood pressure regularly, especially at the start of treatment.
- If you are going to have an operation that needs a general anaesthetic, tell your doctor you are taking Xatral XL before the operation. Your doctor may decide to stop you having Xatral XL 24 hours before the operation. This is because it can be dangerous as it can lower your blood pressure. 2
Xatral XL with food and drink
- Take Xatral XL after a meal.
- You may feel dizzy and weak while taking Xatral XL. If this happens do not drink any alcohol.
You may feel dizzy and weak while taking Xatral XL. If this happens do not drive or operate any tools or machines. Xatral XL contains: Hydrogenated castor oil: This can cause stomach upset and diarrhoea.
How to take it
Xatral XL Always take this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
- Swallow your tablets whole with plenty of water.
- Do not break, crush or chew your tablets. This can affect the release of your medicine into the body.
- Take this medicine after a meal. Benign Prosthatic Hyperplasia The usual dose is one Xatral XL tablet once a day. Acute Urinary Retention
- Xatral XL will be given to you by your doctor on the day you have the catheter inserted.
- You should continue taking Xatral XL once a day.
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You are over 65. This is due to the increased sensitivity to develop hypotension and related adverse reactions in elderly patients. You ever get painful erections of the penis, unrelated to sexual activity that will not go away, before or during treatment.
If you take more Xatral XL than you should Contact your local hospital Accident and Emergency department straight away. Tell the doctor how many tablets you have taken. Lie down as much as possible to help stop the side effects. Do not try to drive to the hospital yourself. If you forget to take Xatral XL Do not take a double dose to make up for a forgotten tablet. If you stop taking Xatral XL Keep taking your tablets, even if your symptoms improve. Only stop if your doctor tells you to. The symptoms are better controlled if you continue taking the same dose of this medicine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects Like all medicines, this medicine can cause
Possible side effects
, although not everybody gets them. These side effects are most likely to happen at the start of treatment. Chest pain (angina) Normally, this only happens if you have had angina before. If you get chest pain stop taking your tablets and contact a doctor or go to a hospital immediately. This happens in less than 1 in 10,000 people.
Allergic reactions You could notice symptoms of angioedema, such as a red and lumpy skin rash, swelling (on the eyelids, face, lips, mouth and tongue), difficulty in breathing or swallowing. These are symptoms of an allergic reaction. If this happens, stop taking your tablets and contact a doctor or go to a hospital immediately. This happens in less than 1 in 10,000 people.
- Water retention (may cause swollen arms or legs).
- Runny nose, itching, sneezing, and stuffy nose.
- General feeling of being unwell.
- Problems with your vision.
Painful erection of the penis (priapism) If you get painful erections of the penis, unrelated to sexual activity, that will not go away stop taking your tablets and contact a doctor or go to a hospital immediately. Frequency not known.
Other side effects (frequency not known) which may occur are:
- Liver problems. Signs may include yellowing of your skin or the whites of your eyes.
- If you are having an operation on your eyes because of cataracts (where the lens of the eye is cloudy) and are already taking or have taken Xatral XL in the past, the pupil may dilate poorly and the iris (the coloured part of the eye) may become floppy during the procedure. This only happens during the operation and it is important for the eye specialist to be aware of this as the operation may need to be carried out differently (see section 'Take special care with Xatral XL').
- You may get more infections than usual. This could be caused by a decrease in the number of white blood cells (neutropenia).
- Being sick (vomiting).
- Increased risk of bleeding (including nose bleeds and/or bleeding gums) and bruising. This could be a blood problem called 'thrombocytopenia' which is a reduced number of platelets in the blood.
Other side effects include: Common (affects less than 1 in 10 people)
- Feeling dizzy or faint
- Headache.
- Feeling sick (nausea).
- Stomach pain.
- Weakness or tiredness. Uncommon (affects less than 1 in 100 people)
- Feeling dizzy, lightheaded, or faint when you stand or sit up quickly (postural hypotension).
- Fast heartbeat (tachycardia) and palpitations (pounding in the chest and uneven heartbeat).
- Chest Pain.
- Drowsiness.
- Diarrhoea.
- Dry mouth.
- Rash and itching.
- Flushes. 3
Very rare side effects (affects less than 1 in 10,000 people)
- Itchy, lumpy rash also called hives or nettle rash (urticaria).
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- You should stop taking Xatral XL the day after the catheter is removed (3-4 days in total).
How to store it
Xatral 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. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. 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.
Contents of the pack and other information
What Xatral XL contains
- The active substance is 10mg alfuzosin hydrochloride.
- The other ingredients are ethyl cellulose, hydrogenated castor oil, hypromellose, yellow ferric oxide (E172), magnesium stearate, microcrystalline cellulose,
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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 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.
povidone, colloidal hydrated silica and mannitol. What Xatral XL looks like and contents of the pack Round biconvex, three layer tablets: one white layer between two yellow layers. Your prolonged release tablets are available in packs of 10, 30, 50, 100 and 500 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK Tel: 0800 035 2525 Email: [email protected] Manufacturer Sanofi Winthrop Industrie 30-36 avenue Gustave Eiffel 37000 Tours France This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in September 2024 © Sanofi 2001 – 2024
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Frequently asked questions about Xatral XL 10mg prolonged release tablets
How do I take Xatral XL 10mg prolonged release tablets?
Xatral XL 10mg prolonged release tablets comes as tablet containing 10mg. 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 Xatral XL 10mg prolonged release tablets?
The active substance in Xatral XL 10mg prolonged release tablets is alfuzosin hydrochloride.
Are there equivalent medicines to Xatral XL 10mg prolonged release tablets?
Medicines with the same active substance, strength and form include: Besavar XL 10mg Tablets, Vasran XL 10 mg prolonged-release tablets, Zochek 10 mg Prolonged Release 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 Xatral XL 10mg 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 Xatral XL 10mg 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: alfuzosin hydrochloride
- 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
Xatral XL is indicated in the treatment of the functional symptoms of benign prostatic hypertrophy (BPH).
For information on use in acute urinary retention (AUR) related to BPH see sections 4.2 and 5.1.
4.2. Posology and method of administration
Xatral XL should be swallowed whole (see section 4.4).
BPH: The recommended dose is one 10mg tablet to be taken once daily after a meal.
AUR: In patients 65 years and older, one 10 mg tablet daily after a meal to be taken from the first day of catheterisation. The treatment should be administered for 3-4 days, 2-3 days during catheterisation and 1 day after its removal. In this indication no benefit has been established in patients under 65 years of age or if treatment is extended beyond 4 days.
Paediatric Population
Efficacy of Xatral XL has not been demonstrated in children aged 2 to 16 years (see section 5.1). Therefore Xatral XL is not indicated for use in the paediatric population.
4.3. Contraindications
• Hypersensitivity to the active substance or to any of the excipients (see Section 6.1 List of excipients);
• history of orthostatic hypotension;
• combination with other alpha-1 receptor blockers;
• concomitant administration with ritonavir alone or in combination with ombitasvir/paritaprevir, lopinavir and nirmatrelvir (see Section 4.5);
• hepatic insufficiency.
4.4. Special warnings and precautions for use
As with all alpha-1-blockers in some subjects, in particular patients receiving antihypertensive medications or nitrates, postural hypotension with or without symptoms (dizziness, fatigue, sweating) may develop within a few hours following administration. In such cases, the patient should lie down until the symptoms have completely disappeared.
These effects are transient, occur at the beginning of treatment and do not usually prevent the continuation of treatment. Pronounced drop in blood pressure has been reported in post-marketing surveillance in patient with pre-existing risk factors (such as underlying cardiac diseases and/or concomitant treatment with anti-hypertensive medication, see section 4.8). The risk of developing hypotension and related adverse reactions may be greater in elderly patients. The patient should be warned of the possible occurrence of such events.
As with all alpha1-receptor blockers, alfuzosin should be used with caution in patients with acute cardiac failure.
Care should be taken when Xatral XL is administered to patients who have had a pronounced hypotensive response to another alpha-1-blocker.
Treatment should be initiated gradually in patients with hypersensitivity to alpha-1-blockers. Xatral XL should be administered carefully to patients being treated with antihypertensive medication or nitrates (see section 4.5). Blood pressure should be monitored regularly, especially at the beginning of treatment.
Patients with congenital QTc prolongation, with a known history of acquired QTc prolongation or who are taking drugs known to increase the QTc interval should be evaluated before and during the administration of alfuzosin.
Concomitant use of alfuzosin and potent CYP3A4 inhibitors (such as itraconazole, ketoconazole, protease inhibitors, clarithromycin, telithromycin and nefazodone) should be avoided (see section 4.5). Alfuzosin should not be used concomitantly with CYP3A4 inhibitors that are known to increase the QTc interval (e.g. itraconazole and clarithromycin) and a temporary interruption of alfuzosin treatment is recommended if treatment with such medicinal products is initiated.
Prolonged erections and priapism have been reported with alpha-1 blockers including alfuzosin 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 (see section 4.8).
In coronary patients, the specific treatment for coronary insufficiency should be continued. If angina pectoris reappears or worsens Xatral XL should be discontinued.
As there are no clinical safety data available in patients with severe renal impairment (creatinine clearance < 30ml/min), alfuzosin 10 mg prolonged released tablets should not be administered to this patient group.
Patients should be warned that the tablet should be swallowed whole. Any other mode of administration, such as crunching, crushing, chewing, grinding or pounding to powder should be prohibited. These actions may lead to inappropriate release and absorption of the drug and therefore possible early adverse reactions.
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 alpha-1-blockers. Although the risk of this event with alfuzosin appears very low, ophthalmic surgeons should be informed in advance of cataract surgery of current or past use of alpha-1-blockers, as IFIS may lead to increased procedural complications. The ophthalmologists should be prepared for possible modifications to their surgical technique.
Alfuzosin 10 mg prolonged release tablets contain hydrogenated castor oil which may cause stomach upset and diarrhoea.
4.5. Interaction with other medicinal products and other forms of interaction
Combinations contra-indicated:
• Alpha-1-receptor blockers (see Section 4.3 Contraindications).
Concomitant use not recommended:
• potent CYP3A4 inhibitors such as itraconazole, ketoconazole, protease inhibitors (e.g. ritonavir), clarithromycin, telithromycin and nefazodone since alfuzosin blood levels may be increased (see section 4.4).
Combinations to be taken into account:
• Antihypertensive drugs (see Section 4.4 Special warnings and precautions for use);
• nitrates (see Section 4.4 Special warnings and precautions for use);
Repeated 200 mg daily dosing of ketoconazole, for seven days resulted in a 2.1-fold increase in Cmax and a 2.5-fold increase in exposure of alfuzosin 10 mg when administered as a single dose under fed conditions (high fat meal). Other parameters such as tmax and t1/2 were not modified.
Cmax and AUC of alfuzosin 10 mg, when administered as a single dose under fed conditions, increased 2.3-fold and 3.0-fold, respectively following 8-day repeated 400 mg ketoconazole daily dosing (see Section 5.2 Pharmacokinetic properties).
The administration of general anaesthetics to patients receiving Xatral XL could cause profound hypotension. It is recommended that the tablets be withdrawn 24 hours before surgery.
Other forms of interaction
No pharmacodynamic or pharmacokinetic interaction has been observed in healthy volunteers between alfuzosin and the following drugs: warfarin, digoxin, hydrochlorothiazide and atenolol.
4.6. Pregnancy and lactation
Due to the type of indication this section is not applicable
4.7. Effects on ability to drive and use machines
There are no data available on the effect on driving vehicles.
Adverse reactions such as vertigo, dizziness and asthenia may occur essentially at the beginning of treatment. This has to be taken into account when driving vehicles and operating machinery.
4.8. Undesirable effects
Classification of expected 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 known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
System Organ Class
Frequency
Preferred Term
Nervous system disorders
Common
Faintness/dizziness
Headache
Uncommon
Syncope
Vertigo
Malaise
Drowsiness
Eye disorders
Uncommon
Vision abnormal
Not known
Intraoperative floppy iris syndrome (see section 4.4)
Cardiac disorders
Uncommon
Tachycardia
Palpitations
Hypotension (postural)
Very rare
New onset, aggravation or recurrence of angina pectoris in patients with pre-existing coronary artery disease. (see section 4.4.)
Not known
Atrial fibrillation
Vascular disorders
Uncommon
Hypotension (postural)
Flushing
Blood and lymphatic system disorders
Not known
Neutropenia
Thrombocytopenia
Respiratory, thoracic and mediastinal disorders
Uncommon
Rhinitis
Gastro-intestinal disorders
Common
Nausea
Abdominal pain
Uncommon
Diarrhoea
Dry mouth
Vomiting
Not known
Vomiting
Hepatobiliary disorders
Not known
Hepatocellular injury
Cholestatic liver disease.
Skin and subcutaneous tissue disorders
Uncommon
Rash
Pruritus
Very rare
Urticaria
Angioedema
Reproductive system and breast disorders
Not known
Priaprism
General disorders and administration site conditions
Common
Asthenia
Uncommon
Flushes
Oedema
Chest Pain
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 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
In case of overdosage, the patient should be hospitalised, kept in the supine position, and conventional treatment of hypotension should take place.
In case of significant hypotension, the appropriate corrective treatment may be a vasoconstrictor that acts directly on vascular muscle fibres.
Alfuzosin is not dialysable because of its high degree of protein binding.
💬 Ask about this leaflet
Ask anything about Xatral XL 10mg 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.