Zochek 10 mg Prolonged Release Tablets

• 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Zochek is and what it is used for
2. What you need to know before you take Zochek
3. How to take Zochek
4. Possible side effects
5. How to store Zochek
6. Contents of the pack and other information

• You are allergic (hypersensitive) to alfuzosin or any of the other ingredients of this medicine (listed in section 6).
• You are taking another alpha-blocker. See section below on ‘Other medicines and Zochek’.
• You have something called orthostatic hypotension. This is a drop in blood pressure which usually happens when you stand up. It can make you feel dizzy, light-headed or faint when you stand or sit up quickly.
• You have liver problems.
• You are taking Ritonavir alone or in combination with ombitasvir/paritaprevir, lopinavir, nirmatrelvir. See section “Other medicines and Zochek” below.

If you are not sure if any of these apply to you do not take and talk to your doctor.

Talk to your doctor or pharmacist before taking Zochek if:

• You have chest pain (angina).
• 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)
• You are over 65. This is due to the increased sensitivity to develop 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.

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:

• Other alpha-blockers such as doxazosin, indoramin, prazosin, terazosin, tamsulosin or phenoxybenzamine.
• Ritonavir (a medicine used for treatment of Chronic Hepatitis C infection) alone or as a combination drug of ombitasvir/paritaprevir. These medicines will lead to more quantity of alfuzosin in blood due to decrease of liver function to remove alfuzosin from the body.

Check with your doctor or pharmacist before taking your medicine if:

• In the past, you have had a large fall in blood pressure while taking an alpha-blocker (this could include previous use of alfuzosin. See paragraph immediately above for examples of other alpha-blockers).
• You are taking a medicine for high blood pressure, as you may get dizzy, weak or start sweating within a few hours of taking this medicine. If this happens, lie down until the symptoms have completely gone. Tell your doctor as the dose of your medicine may be changed.
• You are taking medicines for chest pain (angina).
• You are taking medicines for fungal infections (such as ketoconazole, itraconazole).
• You are taking medicines for HIV (such as ritonavir).
• You are taking medicines for bacterial infections (such as clarithromycin, telithromycin).
• You are taking medicines for treatment of depression (such as nefazodone).
• You are taking ketoconazole tablets (used to treat Cushing’s syndrome - when the body produces an excess of cortisol.

• If you are going to have an operation that needs a general anaesthetic, tell your doctor you are taking Zochek before the operation. Your doctor may decide to stop you having Zochek 24 hours before the operation. This is because it can be dangerous as it can lower your blood pressure.
• If you are being treated for high blood pressure, your doctor should measure your blood pressure regularly, especially at the start of treatment.
• If you are going to have an operation on the eye because of cataract (cloudiness of the eye), tell your eye specialist you are using or have used Zochek in the past. This is because Zochek may cause complications during your operation. This can be managed if your eye specialist knows before carrying out the operation.

• Take Zochek after a meal.
• You may feel dizzy and weak while taking Zochek. If this happens do not drink any alcohol.

You may feel dizzy and weak while taking Zochek. Adverse reactions such as significant drop in blood pressure when standing up, along with dizziness, vertigo, visual disturbances and asthenia may occur essentially at the beginning of treatment. If this happens, do not drive or operate any tools or machines.

The usual dose is one Zochek once a day.

• Zochek will be given to you by your doctor on the day you have the catheter inserted.
• You should continue taking Zochek once a day.
• You should stop taking Zochek the day after the catheter is removed (3-4 days in total).

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.

Do not take a double dose to make up for a forgotten tablet.

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.

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.

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.

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.

Common (affects less than 1 in 10 people)

• Feeling dizzy or faint
• Headache
• Feeling sick (nausea)
• Stomach pain
• Weakness or tiredness

Uncommon (affects less than 1 in 100 people)

• Feeling dizzy, lightheaded, or faint when you stand or sit up quickly (postural hypotension).
• Fast heartbeat (tachycardia) and palpitations (pounding in the chest) and uneven heartbeat.
• Chest Pain
• Drowsiness
• Runny nose, itching, sneezing, and stuffy nose.
• Diarrhoea
• Dry mouth
• Rash and itching
• Water retention (may cause swollen arms or legs)
• Flushes
• General feeling of being unwell.
• Problems with your vision.

Very rare (affects less than 1 in 10,000 people)

• Itchy, lumpy rash also called hives or nettle rash (urticaria).

Other side effects (frequency not known) which may occur are:

• Increased risk of bleeding (including nose bleeds and/or bleeding gums) and bruising. This could be a blood problem called 'thrombocytopenia' which is a reduced number of platelets in the blood.
• Liver problems. Signs may include yellowing of your skin or the whites of your eyes.
• If you are having an operation on your eyes because of cataracts (where the lens of the eye is cloudy) and are already taking or have taken Xatral XL in the past, the pupil may dilate poorly and the iris (the coloured part of the eye) may become floppy during the procedure. This only happens during the operation and it is important for the eye specialist to be aware of this as the operation may need to be carried out differently.
• 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).

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.

• The active substance is alfuzosin hydrochloride. Each prolonged-release tablet contains 10 mg alfuzosin hydrochloride.
• The other ingredients

Tablet Core: Hypromellose (E464), hydrogenated vegetable oil, povidone (K-30) (E1201), calcium hydrogen phosphate anhydrous, carbomer, silica colloidal anhydrous (E551), magnesium stearate (E572).

Film-coating: Hypromellose (E464), propylene glycol, titanium dioxide (E 171).

The tablet has a prolonged effect which means that after taking the active substance is not released immediately but gradually from the tablet and therefore acts longer.

Prolonged-release tablet

White to off-white round, biconvex, film-coated tablets debossed with ‘X’ on one side and ‘47’ on other side.

Zochek tablets are available in clear PVC/ PVdC-Aluminium blister packs and white opaque round HDPE bottles containing silica gel.

Pack sizes:

Blister pack: 30, 50, 90 and 100 tablets

HDPE bottle pack: 30, 500 and 1000 tablets

Not all pack sizes may be marketed

or