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.

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Alfuzosin HCl 2.5 mg film-coated 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.

Active substance: Alfuzosin hydrochloride

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for Alfuzosin belongs to a group of medicines called alpha-blockers, medicines for problems with urination in the case of prostate disorders. Use for:

  • Alfuzosin HCl is indicated for treatment of functional symptoms of benign prostatic hyperplasia.
  • Problems with urination in the case of benign prostate enlargement.

What you need to know before you take it

e Alfuzosin HCl Do not use Alfuzosin HCl

  • If you are allergic (hypersensitive) to alfuzosin, other quinazolines (e.g. terazosin, doxazosin) or any of the other ingredients of this medicine (listed in section 6).
  • suffer (have suffered) from dizziness, particularly when standing up from a sitting or lying position.
  • are also using other alpha1-blockers such as doxazosin and / or other dopamine receptor agonists such as ropinirole.
  • have serious liver disease. Warnings and precautions Talk to your doctor or pharmacist or nurse before using 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:

  • elderly patients
  • patients with an increased sensitivity to alpha1-blockers
  • patients who are treated for high blood pressure in some patients, a drop in blood pressure can occur on standing or sitting up within the first few hours of taking the tablet, particularly when sitting or standing up from a lying position. In this case, you should lie down until the symptoms have completely disappeared. This symptom usually occurs at the start of the treatment and is usually of a temporary nature. It is usually possible to continue with the treatment

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Black

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:

  • other alpha1-blockers (concomitant use should be avoided)
  • antihypertensives (it might be necessary to adjust the dose of these because of the possibility of a drop in blood pressure)
  • nitrates (anti-anginal medicines) (it might be necessary to adjust the dose of these because of the possibility of a drop in blood pressure)
  • products such as ketoconazole and itraconazole which treat fungal infections or ritonavir which is used for HIV. These products affect the way that alfuzosin works
  • medicines for bacterial infections (such as clarithromycin, telithromycin).
  • medicines for treatment of depression (such as nefazodone).
  • general anaesthetics. If you are to undergo an operation which requires a general anaesthetic you should tell the anaesthetist, as your blood pressure could fall too low. Tell your doctor or pharmacist if you are using, have recently taken or might take any other medicines. Pregnancy and breast-feeding As Alfuzosin HCl is not used in women, this section does not apply. Driving and using machines The use of Alfuzosin HCl can sometimes result in dizziness or general weakness (see "Possible side effects"). If you suffer from these side effects, do not drive any vehicle and/or operate any machinery which requires you to be alert. Alfuzosin HCl contains lactose: This medicinal product 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 Alfuzosin HCl Aurobindo contains sodium: This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially 'sodium-free.'

How to take it

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:

•

P1540043

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

• •

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):

  • nausea, abdominal pain, diarrhoea and dry mouth
  • weakness, dizziness (vertigo), malaise and headache
  • low blood pressure (orthostatic hypotension)
  • asthenia (general weakness of the body). Uncommon (may affect up to 1 in 100 people):
  • rapid heartbeat (tachycardia), palpitations and fainting episodes
  • drowsiness
  • disturbances of vision
  • blocked nose, sneezing and nasal discharge (rhinitis)
  • skin rash and itching
  • accumulation of fluid (oedema), flushes and chest pain. Very rare (may affect up to 1 in 10,000 people):
  • people with pre-existing disease of the blood vessels of the heart may either experience heart pain (angina pectoris) for the first time or aggravate existing angina
  • hives
  • hepatotoxicity Additional side effects (Not known: frequency cannot be estimated from the available data) which may occur are:
  • decrease in white blood cells (neutropenia). Signs may include more frequent infections, sore throat or mouth ulcers.
  • increased risk of bleeding (including nose bleeds and/or bleeding gums) and bruising. This could be a problem called 'thrombocytopenia' which is a reduced number of platelets in the blood
  • abnormal liver function (liver problem). Signs may include yellowing of your skin or the whites of your eyes.

Possible side effects

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)

How to store it

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.

Contents of the pack and other information

What Alfuzosin HCl contains

  • The active ingredient of Alfuzosin HCl 2.5 mg is alfuzosin hydrochloride.
  • The other ingredients (excipients) are Tablet core: Sodium starch glycolate (Type A), cellulose microcrystalline, lactose monohydrate, povidone, magnesium stearate. Coating: Hypromellose, macrogol 400, titanium dioxide (E 171). What Alfuzosin HCl looks like and contents of the pack Film-coated tablet White to off-white round, biconvex, film-coated tablets debossed with 'X' on one side and '31' on other side. Alfuzosin HCl is packed in PVC / PVdCAluminium foil blister packs or (HDPE) bottle packs. Pack sizes: Blister pack: 15, 30, 50, 60, 90 and 100 filmcoated tablets Bottle pack: 100, 250 and 1000 film-coated tablets Not all pack sizes may be marketed. Marketing Authorisation Holder Milpharm Limited 1 Roundwood Avenue, Stockley Park, Uxbridge, UB11 1AF United Kingdom Manufacturer APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000. Malta or Milpharm Limited 1 Roundwood Avenue, Stockley Park, Uxbridge, UB11 1AF United Kingdom This leaflet was last revised in 10/2025.

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).

Frequently asked questions about Alfuzosin HCl 2.5 mg film-coated tablets

How do I take Alfuzosin HCl 2.5 mg film-coated tablets?

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.

What is the active substance in Alfuzosin HCl 2.5 mg film-coated tablets?

The active substance in Alfuzosin HCl 2.5 mg film-coated tablets is alfuzosin hydrochloride.

Are there equivalent medicines to Alfuzosin HCl 2.5 mg film-coated tablets?

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.

Where does this information come from?

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.

Can I get Alfuzosin HCl 2.5 mg film-coated 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.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Alfuzosin hydrochloride (6 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Treatment of the functional symptoms of benign prostatic hyperplasia (BPH).

4.2. Posology and method of administration

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.

4.3. Contraindications

- 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

4.4. Special warnings and precautions for use

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.'

4.5. Interaction with other medicinal products and other forms of interaction

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,

4.6. Fertility, pregnancy and lactation

This section is not applicable given the therapeutic indications.

4.7. Effects on ability to drive and use machines

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.

4.8. Undesirable effects

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.

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 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 about this leaflet

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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