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 Zochek belongs to a group of medicines called alpha-blockers. Zochek is 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 Zochek Do not take Zochek if
Black A/s : 150 x 420 mm
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You ever get painful erections of the penis, unrelated to sexual activity that will not go away, before or during treatment.
Other medicines and Zochek Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Zochek can affect the way some other medicines work. Some medicines can also have an effect on the way that Zochek works. Do not take Zochek if you are taking:
Zochek 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.
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Package leaflet: Information for the user
You should stop taking Zochek the day after the catheter is removed (3-4 days in total).
If you take more Zochek than you should Contact your doctor or 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 Zochek Do not take a double dose to make up for a forgotten tablet. If you stop taking Zochek 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.
Like all medicines, this medicine can cause 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. 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 include: Common (affects less than 1 in 10 people)
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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).
Reporting of side effects If you get any side effects, talk to doctor or pharmacist. 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.
Zochek Keep this medicine out of the sight and reach of children. This medicine does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the label, carton, bottle 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.
What Zochek contains
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Zochek 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 Zochek 10 mg Prolonged Release Tablets is alfuzosin hydrochloride.
Medicines with the same active substance, strength and form include: Besavar XL 10mg Tablets, Vasran XL 10 mg prolonged-release tablets, Xatral XL 10mg prolonged release tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Zochek 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.
Zochek 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.
Zochek 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 Zochek has not been demonstrated in children aged 2 to 16 years (see section 5.1). Therefore Zochek is not indicated for use in the paediatric population.
• 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.
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 Zochek 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. Zochek 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 Zochek 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.
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 Zochek 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.
In view of the area 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).
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.
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 Zochek 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.
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