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 belongs to a group of medicines called alpha-blockers, medicines for problems with urination in the case of prostate disorders. Use for:
e Alfuzosin HCl Do not use Alfuzosin HCl
if you have a condition which affects the coronary arteries (any treatment of a reduction in the supply of blood to the cardiac muscle should be continued); if symptoms of pain in the chest (angina pectoris) recur or become worse, the use of alfuzosin should be stopped. if you are known to have an abnormality of electrocardiogram (ECG), called "QT prolongation" if you belong to one of the following patient groups:
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Other medicines and Alfuzosin HCl Note: the following comments can also apply to the use of medicines some time ago or in the near future. The medicines mentioned in this section might be known to you by another name, often the trade name. In this section, only the name of the active substance or the category of active substances of the medicine is mentioned and not the trade name. For this reason, you should always take a good look at the packaging or the package insert to see what is the active substance of the medicine you are using. Interaction means that medicines will have a bearing on each other's effect and/or side effects when used together. Interaction can occur when these tablets are used with:
Alfuzosin HCl Always use Alfuzosin HCl exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Use in children Alfuzosin HCl is not recommended for children. Dosage and method of use The recommended dose is one 2.5 mg tablet three times a day. Your doctor may increase this to four times a day if needed. In patients with poor kidney function: The usual dose is two 2.5 mg tablets daily. Take the first tablet in the evening.
A/s: 150 x 350 mm
Packaging Development
Product Name
Component
Item Code
Date & Time
Alfuzosin HCl 2,5 mg
Leaflet
P1540043
06.10.2025 & 9.00 AM Reviewed / Approved by
Customer / Country
Version No.
Reason Of Issue
APL_Milpharm_Unit-3
01
Revision
No. of Colours : 01
Team Leader
Ramesh P
Dimensions
Initiator
Jaya Durga
150 x 350 mm
Artist:
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P1540043
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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if you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used Alfuzosin HCl . This is because Alfuzosin HCl may cause complications during the surgery which can be managed if your specialist is prepared in advance if you are incontinent (unable to hold urine). You are over 65. This is due to the increased risk of developing 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.
40043
Additional Information : Supersede Item Code: P1526578
Sign / Date
Adults over 65, patients taking other medicines for high blood pressure, or patients with poor kidney function: The initial dose is one 2.5 mg tablet twice a day (morning and evening). If you are starting the treatment, it is best if you take the first tablet before you go to bed. If you notice that Alfuzosin HCl has too strong or too weak an effect, consult your doctor or pharmacist. How long will the treatment last? Your doctor or pharmacist will tell you how long you should use Alfuzosin HCl. Alfuzosin HCl is prescribed for a fairly long period of time. If you use more Alfuzosin HCl than you should If you (or someone else) have taken too much Alfuzosin HCl, or you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. If you have taken too much Alfuzosin HCl, you might suffer from low blood pressure. Lie down as much as possible, as this will help minimise the side effects. If you forget to use Alfuzosin HCl If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten tablet. Take your next dose at the usual time. If you stop using Alfuzosin HCl If you have any further questions on the use of this product, ask your doctor or pharmacist.
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Reporting side effects If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme. Website: 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. 5.
You should see your doctor immediately if you experience the following symptoms: Swollen face, tongue or throat; difficulty in swallowing; difficulty in breathing and hives (these symptoms occur in less than 1 in 10,000 persons treated). The following side effects have been reported at the approximate frequencies shown: Common (may affect up to 1 in 10 people):
Like all medicines, this medicine can cause side effects, although not everybody gets them.
if you are undergoing eye surgery because of cataract (cloudiness of the lens) and are using or have previously used Alfuzosin HCl, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure. This only occurs during the operation and it is important for the eye specialist to be aware of this possibility as the operation may need to be performed differently. abnormal heart rhythm (Atrial fibrillation) abnormal, often painful, persistent erection of the penis unrelated to sexual activity (priapism). being sick (vomiting)
Alfuzosin HCl
Keep this medicine out of the sight and reach of children. Do not use Alfuzosin HCl after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of the month. This medicine 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. 6.
What Alfuzosin HCl contains
P1540043
In patients with liver problems: The usual dose is one 2.5 mg tablet daily. Your doctor may increase this to one 2.5 mg tablet twice a day (in the morning and evening).
Alfuzosin HCl 2.5 mg film-coated tablets comes as tablet containing 2.5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Alfuzosin HCl 2.5 mg film-coated tablets is alfuzosin hydrochloride.
Medicines with the same active substance, strength and form include: Alfuzosin Hydrochloride 2.5mg Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Alfuzosin HCl 2.5 mg film-coated 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 the functional symptoms of benign prostatic hyperplasia (BPH).
Posology
Adults
The usual dose is one tablet three times daily. The dose may be increased to a maximum of 4 tablets (10 mg) per day depending on the clinical response.
Elderly and treated hypertensive patients
As a routine precaution when prescribing alfuzosin to elderly patients (aged over 65 years) and the treated hypertensive patient, the initial dose should be 1 tablet in the morning and 1 tablet in the evening.
Renal impairment
In patients with renal insufficiency, as a precaution, it is recommended that the dosing be started at Alfuzosin HCl 2.5mg twice daily adjusted according to clinical response.
Hepatic impairment
In patients with mild to moderate hepatic insufficiency, it is recommended that therapy should commence with a single dose of Alfuzosin HCl 2.5 mg Tablets/day to be increased to Alfuzosin HCl 2.5 mg Tablets twice daily according to clinical response.
Alfuzosin HCl 2.5 mg tablets are contraindicated in patients with severe hepatic insufficiency (see section 4.3).
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
Alfuzosin HCl 2.5 mg film-coated tablets should be swallowed whole. The first dose should be given just before bedtime.
- Hypersensitivity to the active substance alfuzosin, another quinazolines (eg: terazosine, doxazosine) or to any of the excipients.
- History of orthostatic hypotension.
- Combination with other alfa1-blockers and / or dopamine receptor agonists.
- Severe hepatic insufficiency
Blood pressure should be monitored at the start of treatment. A reduction in blood pressure may arise in individual cases.
Alfuzosin HCl should be given with caution to patients who are on antihypertensive medication or nitrates.
In some subjects postural hypotension may develop, with or without symptom (dizziness, fatigue, sweating) within a few hours following administration. These effects are transient, occur in 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). The risk of developing hypotension and related adverse reactions may be greater in elderly patients (see section 4.8). The patient should be warned of the possible occurrence of such events.
In cases of orthostatic hypotension the patient should lie or sit down until the symptoms have disappeared.
Care should be taken when alfuzosin is administered to patients who have had a pronounced hypotensive response to another alpha-1-blocker.
In coronary patients, the specific treatment for coronary insufficiency should be continued. If angina pectoris reappears or worsens, alfuzosin should be discontinued.
As with all alpha-1-blockers, alfuzosin should be used with caution in patients with acute cardiac failure.
- lung oedema due to mitral or tricuspidal stenosis,
- high output cardiac failure,
- cardiac failure due to pulmonary embolism or pericardial effusion
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
The patient should be examined prior to treatment with alfuzosin to exclude other conditions, which may cause the same symptoms as benign prostatic hyperplasia. A digital rectal examination should be performed prior to treatment and regularly during treatment. A prostate specific antigen (PSA) test should also be carried out if required.
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.
Alfuzosin, like other alpha adrenergic antagonist, has been associated with priapism (persistent painful penile erection unrelated to sexual activity; see section 4.8). Because this condition can lead to permanent impotence if not properly treated, patients should be advised to seek immediate assistance in the event of an erection that persists longer than 4 hours.
Alfuzosin should not be used in patients suffering from incontinence due to overflow, anuria or prolonged renal insufficiency.
Alfuzosin HCl contains lactose
Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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.
Alfuzosin HCl Contains sodium:
This medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially 'sodium-free.'
Combinations contra-indicated:
- Alpha1-receptor blockers (see section 4.3).
Concomitant use not recommended:
- Potent CYP3A4 inhibitors such as itraconazole, ketoconazole, protease inhibitors, 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)
The administration of general anaesthetics to patients receiving Alfuzosin HCl 2.5mg film-coated tablets could cause profound hypotension. It is recommended that Alfuzosin HCl 2.5mg Tablets be withdrawn 24 hours before surgery.
No pharmacokinetic interaction has been observed in healthy volunteers between alfuzosin and the following drugs: warfarin and digoxin,
This section is not applicable given the therapeutic indications.
No data are available concerning the effect on ability to drive or use machines. Side-effects such as, vertigo, dizziness or asthenia may occur, in particular, at the start of treatment. This should be taken into consideration when driving vehicles or using machines.
Tabulated list of adverse reactions
The adverse reactions considered at least possibly related to treatment are listed below by body system organ class and absolute frequency. Frequencies are defined as very common (≥1/10); common (>1/100 to <1/10); uncommon (>1/10000 to ≤1/1000); very rare (≤1/10000), 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
Faintness/ dizziness, headache, vertigo
Syncope, drowsiness
Eye disorders
vision abnormal
Intraoperative floppy iris syndrome
Cardiac disorders
tachycardia, palpitations,
Angina pectoris in patients with pre-existing coronary artery disease
Atrial fibrillation
Vascular disorders
Hypotension (postural)
Flushing
Respiratory, thoracic and medicinal disorders
rhinitis
Gastrointestinal disorders
nausea, abdominal pain, diarrhoea, dry mouth
vomiting
Hepatobiliary disoders
hepatotoxicity
Hepatocellular injury, cholestatic liver disease
Reproductive system and breast disorders
Priapism
Skin and subcutaneous tissue disorders
rashe pruritus,
urticaria, angioedema
General disorders and administration site conditions
Asthenia, malaise
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. Website: 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 easily dialysable because of its high degree of protein binding. Gastric lavage is a possibility followed by administration of activated carbon and a laxative.
Ask anything about Alfuzosin HCl 2.5 mg film-coated 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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