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 Alfuzosin hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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The name of your medicine is Besavar XL 10mg Tablets (called Besavar XL throughout this leaflet). Besavar XL contains a medicine called alfuzosin hydrochloride. This belongs to a group of medicines called alpha-blockers. Besavar 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.
e Besavar XL Do not take Besavar XL and tell your doctor if you:
Besavar XL Always take Besavar XL exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Taking this medicine
reading
Package leaflet: Information for the user
Like all medicines, Besavar XL can cause side effects, although not everybody gets them. These side effects are most likely to happen at the start of treatment.
Besavar XL
What Besavar XL 10mg Tablets contain Each tablet contains 10mg of alfuzosin hydrochloride as the active substance. The other ingredients are ethyl cellulose, hydrogenated castor oil, hypromellose, yellow ferric oxide (E172), magnesium stearate, microcrystalline cellulose, povidone, colloidal hydrated silica and mannitol. What Besavar XL looks like and contents of the pack Besavar XL 10mg Tablets are round, biconvex, three layer tablets: one white layer between two yellow layers. They are supplied in blister packs of 30 tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom Manufacturer: Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, 37000 Tours, France or Zentiva k.s. U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic This leaflet was last revised in December 2025
ZV/744 42
Besavar XL 10mg 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.
The active substance in Besavar XL 10mg Tablets is alfuzosin hydrochloride.
Medicines with the same active substance, strength and form include: Vasran XL 10 mg prolonged-release tablets, Xatral XL 10mg prolonged release tablets, Zochek 10 mg Prolonged Release Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Besavar XL 10mg 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.
Besavar 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.
Besavar XL tablets should be swallowed whole.
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 alfuzosin has not been demonstrated in children aged 2 to 16 years (see section 5.1). Therefore, alfuzosin is not indicated for use in the paediatric population.
• Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
• 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.
Warnings
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 patients 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 Besavar 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. Besavar 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).
Precautions
In coronary patients, the specific treatment for coronary insufficiency should be continued. If angina pectoris reappears or worsens Besavar XL should be discontinued.
As there are no clinical safety data available in patients with severe renal impairment (creatinine clearance < 30ml/min), Besavar XL 10mg 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.
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.
Excipients
Besavar XL 10mg tablets contain hydrogenated castor oil which may cause stomach upset and diarrhoea.
Combinations contra-indicated:
• Alpha-1-receptor blockers (see section 4.3).
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).
• Nitrates (see section 4.4).
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).
The administration of general anaesthetics to patients receiving Besavar XL 10mg Tablets 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.
Due to the type of indication this section is not applicable.
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.
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).
• 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
• Eye disorders
Uncommon: vision abnormal
Not known: intraoperative floppy iris syndrome (see section 4.4)
• General disorders and administration site conditions
Common: asthenia
Uncommon: flushes, oedema, chest pain
• Gastro-intestinal disorders
Common: nausea, abdominal pain
Uncommon: diarrhoea, dry mouth
Not known: vomiting
• Hepatobiliary disorders
Not known: hepatocellular injury, cholestatic liver disease
• Nervous system disorders
Common: faintness/dizziness, headache
Uncommon: syncope, vertigo, malaise, drowsiness
• Reproductive system and breast disorders
Not known: priapism
• Respiratory, thoracic and mediastinal disorders
Uncommon: rhinitis
• Skin and subcutaneous tissue disorders
Uncommon: rash, pruritus
Very rare: urticaria, angioedema
• Vascular disorders
Uncommon: hypotension (postural), flushing
• Blood and lymphatic system disorders
Not known: neutropenia, thrombocytopenia
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.
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 anything about Besavar XL 10mg 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.
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