XATRAL XL Tablet

To treat an enlarged prostate (benign prostatic hyperplasia):

- to ease your difficulty urinating

- or in addition to the urine being drained using a thin, flexible tube (vesical catheter), when it is impossible to urinate.

This medicine is intended for use by men only.

Dosage

The usual dosage is 1 tablet daily, to be taken immediately after the evening meal. Your doctor will tell you how long you should take the medicine for.

Always take the dose prescribed by your doctor. If you are unsure of anything, talk to your doctor or pharmacist.

If you have a thin, flexible tube used to drain urine (vesical catheter), take this medicine from the first day the catheter is inserted.

The tablet must be swallowed whole with a glass of water. These are prolonged-release tablets, i.e. the active ingredient diffuses slowly inside your body. For the tablets to retain all their properties, you must not crunch, chew, crush or grind them into a powder.

Children

Xatral XL 10mg tablet must not be used in children aged 2-16 years.

- if you are allergic to the active ingredient or any of the other ingredients of Xatral XL 10mg prolonged-release tablets.

- if you have orthostatic hypotension. This is a drop in blood pressure which happens when you stand up. It can make you feel dizzy or faint.

- if you have a serious liver disease (liver failure) or a serious kidney disease (severe kidney failure).

- if you are taking certain other medicines to treat HIV (e.g. protease inhibitor in combination with ritonavir or cobicistat), hepatitis C (e.g. telaprevir or boceprevir), certain fungal infections (e.g. ketoconazole, itraconazole, posaconazole), or certain bacterial infections (e.g. clarithromycin, erythromycin, telithromycin).

Common

- lightheadedness, dizzy spells, fainting, headache,

- digestive disorders such as nausea, stomach pain,

- tiredness.

Uncommon

- dizziness, drowsiness, syncope (sudden loss of consciousness),

- drop in blood pressure when you stand up from a lying down position,

- accelerated heart rate, palpitations,

- diarrhea,

- dry mouth,

- nasal congestion or runny nose (rhinitis),

- outbreaks of spots or itching,

- swelling (edema), chest pain,

- redness of the face.

Very rare

- angina pectoris in patients with a history of coronary disorders,

- hives, sudden swelling of an organ, the face and/or the neck that can make it difficult to breathe and the life-threatening (angioedema).

Unknown frequency

- liver disease (hepatitis), particularly due to biliary tract obstruction,

- painful, prolonged erection,

- floppy pupil during cataract surgery,

- irregular heartbeat (atrial fibrillation),

- vomiting,

- decreased number of white blood cells (neutropenia).

See the package insert about the details below:

You must not take Xatral XL 10mg in combination with:

medicines used to treat HIV (eg. protease inhibition in combination with ritonavir or cobicistat, hepatitis (eg. telaprevir or boceprevir), certain fungal infections (eg. ketoconazole, itraconazole, posaconazole), or certain bacterial infections (eg. clarithromycin, erythromycin, telithromycin).

You should avoid taking Xatral XL 10mg in combination with:

certain medicines used to treat high blood pressure (blood pressure-lowering agents such as doxazosin, prazosin and urapidil).

This medicine is not intended for use in women.

Take special care with this medicine

Before beginning treatment, inform your doctor if you have heart disease (particularly if you have angina pectoris, acute heart failure or heart rhythm disorders) or if you have ever experienced a significant drop in blood pressure with another medicine from the same group of medicines as Xatral XL 10mg tablets.

During treatment

Orthostatic hypotension (drop in blood pressure when standing up) may develop in the first few hours after taking the medicine and be accompanied by dizziness, tiredness or sweating. If this effect occurs, lie down until these symptoms, which are temporary, completely wear off, and contact your doctor.

This effect is seen particularly in elderly patients and patients who are also taking medicine to treat high blood pressure, or nitrate derivatives (medicines for angina pectoris).

This medicine should be avoided in combination with certain medicines used to treat high blood pressure (blood pressure-lowering agents such as doxazosin, prazosin and urapidil).

If you are going to have eye surgery (on a cataract): see the package insert.

This medicine contains castor oil, which can cause digestive disorders (mild laxative effect, diarrhoea).

Alfuzosin belongs to a group of medicines called alpha-blockers.

It has an effect on the bladder, the urethra (the tube through which urine is released from the body) and the prostate.