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.
for
Alfuzosin is a medicine in the form of a tablet that must be taken via the mouth. Alfuzosin belongs to a group of medicines, for prostate diseases, called alpha-1blockers. It promotes relaxation of the muscle tissue in the prostate and urethra, allowing urine to flow out of the bladder more easily. Alfuzosin is used to treat the symptoms of Benign Prostate Hyperplasia. Benign Prostate Hyperplasia The prostate gland lies underneath the bladder. The urethra goes through the prostate to the outside of the body. In addition to glandular tissue (for the production of prostatic fluid), muscle tissue is also present in the prostate. This muscle tissue is also present in the urethra. In Benign Prostate Hyperplasia, this muscle tissue in the prostate and urethra tenses, causing the urethra to narrow. This makes it more difficult for the urine to flow out of the bladder causing lower urinary tract complaints. Acute Urinary Retention 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, alfuzosin may be used to help the water to flow again.
V025
2.
e Vasran XL 10 mg prolonged release tablets
Do not take Vasran XL 10 mg prolonged release tablets –
if you are allergic to alfuzosin or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, throat, or tongue. if you have had in the past, a drop in blood pressure when sitting or standing up. if you are already taking another alpha-1-blocker. if you have liver problems.
Warnings and precautions Talk to your doctor or pharmacist before taking Vasran XL 10 mg prolonged release tablets: –
–
–
You have a condition of the coronary arteries. Any treatment of reduced blood supply to the heart muscle should be continued. If symptoms of chest pain (angina pectoris) recur or worsen. The use of Vasran XL 10 mg prolonged release tablets should be discontinued. 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). If you are elderly, if you have an increased sensitivity to alpha-1 blockers or if you are being treated for high blood pressure. If a fall in blood pressure occurs when sitting or standing up in the first hours after taking the tablet. This effect can possibly occur with symptoms such as: dizziness, tiredness or sweating. In such a case you must lie down until the symptoms have completely disappeared. These symptoms are usually transient and may occur at the beginning of treatment. As a rule, treatment can be continued. If you have an eye surgery for cataract (cloudiness of the lens) planned, tell your eye specialist before the surgery that you are using or have used Vasran XL 10 mg prolonged release tablets. This is because Vasran XL 10 mg prolonged release tablets may cause complications during your operation which can be managed if your eye specialist is aware of this information before carrying out the operation. You continue to have a prolonged erection of the penis without being sexually aroused. This is a serious condition that can lead to permanent impotence if not treated properly.
Consult your doctor if one of the above warnings apply to you, or has done in the past. Children Alfuzosin is not to be used in children.
V025
Other medicines and Vasran XL 10 mg prolonged release tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also applies to medicines that you can obtain without a prescription. Some medicines may affect each other's actions or may not be used at the same time for other reasons. Do not use Vasran XL 10 mg prolonged release tablets if:
Take Vasran XL 10 mg prolonged release tablets just after a meal. Drinking alcohol may increase the unpleasant effects of alfuzosin. You may feel dizzy and weak while taking Vasran XL 10 mg prolonged release tablets. If this happens do not drink any alcohol.
Pregnancy and breast-feeding Not applicable. Vasran XL 10 mg prolonged release tablets is only prescribed for men. Driving and using machines No known data are available on the effect on the ability to drive or use machines. Complaints such as dizziness or general weakness may occur. This should be taken into account when driving vehicles or using machines. Vasran XL 10 mg prolonged release tablets contain lactose.
V025
This medicine 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. 3.
Vasran XL 10 mg prolonged release tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. For oral use. Benign Prostate Hyperplasia The usual dose is one tablet per day. Acute Urinary Retention Vasran XL 10 mg prolonged release tablet will be given to you by your doctor on the day you have the catheter inserted. You should continue taking Vasran XL 10 mg prolonged release tablet once a day. Take one tablet of Vasran XL 10 mg prolonged release tablet after the evening meal. Take the tablet with plenty of fluid (for instance a glass of water). The prolongedrelease tablet should not be ground, chewed or divided. Taking the tablet at the same time every day provides the best effect. It also helps you to remember when to take the tablet. Elderly (over 65 years) and patients with kidney problems Your dose does not need to be adjusted for mild to moderate kidney problems whereas it is not given by your doctor in case if you have severe kidney problems. Patients with liver problems Vasran XL 10 mg prolonged release tablet should not be used in patients with liver problems. However in mild to moderate liver problems other products containing low dose of alfuzosin can be used according to the appropriate dosage regimen. Your doctor will inform you about this. Use in children and adolescents The efficacy of Vasran XL 10 mg prolonged release tablet has not been established in children aged 2 to 16 years. Therefore Vasran XL 10 mg prolonged release tablet is not indicated for children and adolescents (2 to 16 years old). If you take more Vasran XL 10 mg prolonged release tablets than you should If you take too much Vasran XL 10 mg prolonged release tablets, contact your doctor or pharmacist immediately. If you forget to take Vasran XL 10 mg prolonged release tablets You may forget to take a tablet. In that case it is not necessary to take the forgotten tablet. You can continue to take the prescribed dose the next day.
V025
Do not take a double dose to make up for a forgotten tablet. If you stop taking Vasran XL 10 mg prolonged release tablets You should not interrupt or stop taking Vasran XL 10 mg prolonged release tablets without speaking to your doctor first. Take your tablets as directed and for as long as directed. Do not stop taking them even if you feel better, as otherwise the symptoms may return. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects: If any of the following happen, stop taking Vasran XL 10 mg prolonged release tablets and tell your doctor immediately or go to your nearest hospital emergency department: Very rare: (may affect up to 1 in 10,000 people) •
Rapid swelling of the eyelids, face, lips, mouth and tongue, difficulty in breathing or swallowing, rashes, hives and itching. These are symptoms of a very serious allergic reaction (the medical term for these symptoms is angioedema).
•
Feeling of tightness, heaviness, discomfort, or crushing pain that is felt behind the breastbone and may spread to the arms, neck and jaw (these may be manifestations of angina). Normally, this only happens if you have had angina before.
•
Not known (frequency cannot be estimated from the available data): Prolonged and painful erection of the penis, unrelated to sexual activity (these may be due to a medical condition called priapism).
Other side effects: Common (may affect up to 1 in 10 people): • • • • • • • •
feeling sick (nausea) stomach pain dryness of mouth weakness or tiredness feeling unwell (malaise) headache feeling dizzy or faint full body weakness (asthenia)
Uncommon (may affect up to 1 in 100 people):
V025
• • • • •
•
• • • • • • • •
loose stools (diarrhea) problems with your vision fast heart beat (tachycardia) fast or irregular heart beat (palpitations) sudden loss of consciousness (syncope) a drop in blood pressure caused, for example, by rising quickly from a sitting or lying position, sometimes accompanied by dizziness (orthostatic hypotension) getting warm, blushing (flushing) runny or blocked nose, sneezing, facial pressure or pain (rhinitis) skin rash itching water retention (may cause swollen arms or legs) chest pain drowsiness Sensation of spinning or whirling when you are not actually moving (vertigo).
Very rare (may affect up to 1 in 10,000 people): • •
damage or injury to the liver caused by a drug or chemical (liver toxicity) itchy, lumpy rash also called hives or nettle rash (urticaria).
Not known (frequency cannot be estimated from the available data):
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
V025
information on the safety of this medicine. 5.
Vasran XL 10 mg prolonged release tablets
Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month. 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. 6.
What Vasran XL 10 mg prolonged release tablets contain
V025
Terapia S.A. Str. Fabricii Nr. 124 Cluj-Napoca 400 632 Romania Please contact the marketing authorisation holder if you require more information about this medicine. This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: France ALFUZOSINE CRISTERS PHARMA LP 10 mg comprimés à libération prolongée Italy Profuzo Netherlands Alfuzosine HCl SUN 10 mg tabletten, tabletten met verlengde afgifte Poland Alfabax United Kingdom (Northern Ireland) Vasran XL 10 mg Prolonged-release Tablets This leaflet was last revised in November 2023.
V025
Vasran XL 10 mg 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.
The active substance in Vasran XL 10 mg prolonged-release tablets is alfuzosin hydrochloride.
Medicines with the same active substance, strength and form include: Besavar XL 10mg 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 Vasran XL 10 mg 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.
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.
Treatment of moderate to severe functional symptoms of benign prostate hyperplasia (BPH).
As an adjunct therapy in connection with catheterisation in acute urinary retention (AUR) related to BPH.
Posology
BPH: The recommended dose is one Alfuzosin 10 mg prolonged-release tablet to be taken once daily after the evening meal.
AUR: One 10 mg tablet daily after a meal to be taken from the first day of catheterisation and continued beyond catheter removal unless there is a relapse of acute urinary retention or disease progression.
Elderly (over 65 years) and patients with renal impairment
Based on pharmacokinetic and clinical safety data, older people and patients with renal insufficiency (creatinine clearance ≥30 ml/min) can be treated with the usual dose. Due to lacking clinical safety data.
Alfuzosin 10 mg should not be given to patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.4).
Hepatic insufficiency:
Alfuzosin, given as 10 mg prolonged-release tablets are contraindicated in patients with hepatic insufficiency. Preparations containing a low dose of alfuzosin hydrochloride might be used in patients with mild to moderate hepatic insufficiency as instructed in the corresponding product information.
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 paediatric population.
Method of administration
For oral use.
The tablet should be swallowed whole with sufficient amount of fluid (e.g. a glass of water). The prolonged-release tablets must not be crushed, chewed or divided (see section 4.4).
- Hypersensitivity to the active substance or to any one of the excipients listed in section 6.1
- History of orthostatic hypotension
- Combination with other alpha-1 receptor blockers
- Hepatic insufficiency.
The patient should be examined before commencement of therapy with alfuzosin to exclude the presence of other conditions that can produce similar symptoms to those of BPH. Before starting and regularly during treatment, examination with rectal touch and, if necessary, prostate specific antigen (PSA) should take place.
Care should be taken when alfuzosin is administered to patients who have had a pronounced hypotensive response to another alpha-1-receptor blocker.
Alfuzosin should be given with caution to patients who are being treated with antihypertensive medications or nitrates.
Blood pressure should be monitored at the start 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). Elderly patients (especially the patient over 75 years of age) and patients receiving medication for cardiovascular disease are at the greatest risk of (orthostatic) hypotension. Blood pressure should be carefully monitored in these patients. In some subjects postural hypotension with or without symptoms (dizziness, fatigue, sweating) may develop within a few hours following administration. In such cases the patient should rest lying down until the symptoms have completely disappeared. These effects are transient, occur at the start of the treatment and usually do not require the treatment to be stopped. The patient should be warned that these symptoms may possibly occur.
In coronary patients the specific treatment for coronary insufficiency should be continued. If angina pectoris recurs the treatment with alfuzosin should be discontinued.
As with all alpha-1-receptor blockers alfuzosin should be used with caution in patients with acute cardiac failure.
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.
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.
Like other alpha-1-receptor blockers, alfuzosin is associated with priapism. If not treated properly, this side effect may lead to permanent tissue damage (including necrosis and/or gangrene) and impotence. If priapism occurs, the patient should seek immediate medical assistance to determine the severity of the side effect and the need for observation and/or treatment.
Use with PDE-5 inhibitors: Concomitant use of alfuzosin with a phosphodiesterase-5 inhibitor (e.g. sildenafil, tadalfil and vardenafil) may cause symptomatic hypotension in some patients (see section 4.5).
To reduce the risk of developing orthostatic hypotension, patients should be stabilized on alpha-blocker therapy before initiating therapy with a phosphodiesterase-5 inhibitor. In addition, it is recommended to start treatment with a phosphodiesterase-5 inhibitor at the lowest possible dose.
Patients should be warned that the tablet should be swallowed whole. Other methods of administration such as crunching, crushing, grinding, pounding to powder or chewing the tablets should be prohibited. These actions may lead to inappropriate release and absorption of the drug with the risk of early side effects.
As there are no clinical safety data available in patients with severe renal impairment (creatinine clearance < 30ml/min), Alfuzosin 10 mg prolonged-release tablets should not be administered to this patient group.
This product contains lactose. Patients with rare hereditary conditions such as galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
General anaesthetics: administration of general anaesthetics to a patient using alfuzosin may lead to profound hypotension. It is recommended that the tablets be withdrawn 24 hours before surgery.
Combinations contra-indicated:
- Concomitant use with alpha-1-receptor blockers (see section 4.3 Contraindications)
Concomitant use not recommended:
- potent CYP3A4 inhibitors such as itraconazole, ketoconazole, voriconazole, posaconazole, protese inhibitors (such as bocéprévir, nelfinavir, ritonavir and telaprevir), clarithromycin, erythromycin,telithromycin, cobicistat and nefazodone since alfuzosin blood levels may be increased (see section 4.4).
Combinations subject to precautions for use:
- patients being treated with alfuzosin must be haemodynamically stable before treatment with a phosphodiesterase-5 inhibitor (sildenafil, tadalafil, vardenafil) is initiated.
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)
- dapoxetine (due to the increase of undesirable effects, such as dizziness or syncope).
The dose recommendation should be taken into account due to the possibility of hypotension (See section 4.4).
Repeated 200 mg daily dosing of the potent CYP3A4 inhibitor ketoconazole, for 7 days resulted in an increase in Cmax (2.11-fold) and AUClast (2.46-fold) of alfuzosin when administered as a single dose under fed conditions. Other parameters such as tmax and t1/2 were not modified.
Repeated 400mg daily dosing of Ketoconazole for 8 days increased the Cmax of alfuzosin by 2.3-fold and AUClast and AUC of alfuzosin by 3.2-fold and 3.0-fold respectively (see Section 5.2).
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.
Not applicable.
There are no data available on the effect on driving vehicles or using machines.
Undesirable effects such as vertigo, dizziness and asthenia can occur particularly at the start of the treatment. This should be taken into account when driving vehicles or using machines.
The frequency of the adverse reactions listed below are defined using the following classification:
very common (≥1/10); common (>1/100 to <1/10); uncommon (>1/1000 to ≤1/100); rare (>1/10 000 to ≤1/1000); very rare (≤1/10 000), not known (cannot be estimated from the available data)
System Organ Class
Frequency
Common
Uncommon
Very rare
Not Known (cannot be estimated from the available data)
Blood and lymphatic system disorders
Neutropenia, Thrombocytopenia
Nervous system disorders
Weakness, malaise, headache, faintness/dizziness
Drowsiness, vertigo
Eye disorders
Vision abnormal
Intraoperative floppy iris syndrome (See section 4.4)
Cardiac disorders
Tachycardia, palpitations, syncope
New onset, aggravation or recurrence of angina pectoris in patients with pre-existing coronary artery disease (see section 4.4)
Atrial fibrillation
Vascular disorders
Hypotension (postural), flushing
Respiratory, thoracic and mediastinal disorders
Rhinitis
Gastrointestinal disorders
Nausea, abdominal pain, dry mouth
Diarrhoea
Vomiting
Hepatobiliary disorders
Hepatotoxicity
Hepatocellular injury, cholestatic liver disease.
Skin and subcutaneous tissue disorders
rash, pruritus
Urticaria, angio-oedema
Reproductive system and breast disorders
Priapism
General disorders and administration site conditions
Asthenia
Oedema, chest pain (see section 4.4)
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.
In case of overdose, the patient should be admitted to hospital, kept in supine position, and conventional treatment for hypotension should take place.
In case of significant hypotension, the appropriate corrective treatment may be a vasoconstrictor that acts directly on the vascular muscle fibres.
Alfuzosin is not easily dialysed due to the strong degree of protein binding.
Gastric flushing is possible, followed by administration of activated charcoal and a laxative.
Ask anything about Vasran XL 10 mg 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.
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.