10 mg prolonged-release tablet er
alfuzosin hydrochloride
What Xatral OD is and what it is used for
The name of these tablets is Xatral OD. They belong to a group of medicines called alpha-blockers.
Xatral OD can be used to treat the symptoms of benign prostatic hyperplasia. This is when the prostate gland is enlarged ( hyperplasia ), but the enlargement is not the same as cancer (it is benign). It can cause problems with passing water (urine).
- The prostate gland sits below the bladder and encloses the urethra. The urethra carries the urine to the outside of the body.
- If the prostate becomes larger, it presses on the urethra and causes it to become narrower, making it difficult to pass through water.
- Your tablets have a relaxing effect on the muscles in the prostate gland, which causes the urethra to widen and thus makes it easier to pass water.
In a few patients with benign prostatic hyperplasia, the prostate gland becomes so large that it stops urine flow completely. It is called acute urinary retention. This is very painful and you may need to go to the hospital.
- A thin flexible tube ( catheter ) is inserted into the bladder. It empties the urine and relieves the pain.
- In the meantime, Xatral OD can be used to help the urine pass again.
Alfuzosin hydrochloride contained in Xatral OD may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Xatral OD
Do not take Xatral OD
- if you are allergic to alfuzosin or any of the other ingredients of this medicine (listed in section 6).
- if you are taking other alpha-blockers. See the section below “Other medicines and Xatral OD”.
- if you have something called postural hypotension. This is a drop in blood pressure that usually occurs when you stand up. It can make you feel dizzy or faint when you stand up or sit up quickly.
- if you have liver problems.
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Xatral OD.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:
- you have severe kidney problems.
- you have a heart condition.
- you have chest pain (angina).
- it is known that you have an abnormality on the electrocardiogram ( ECG ), so-called QT prolongation.
Some patients, especially those also taking medicines for high blood pressure or chest pain (angina), may experience dizziness, weakness, or sweating within a few hours of the first dose. If this occurs, you should lie down until the symptoms have completely disappeared. Inform your doctor as the dose may need to be adjusted.
In case of an erection (often painful), which is not related to sexual activity and persists for more than 4 hours, you should contact a doctor or go to the hospital immediately as you may need treatment. See the section below “Possible side effects”.
Other medicines and Xatral OD
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those without a prescription.
Xatral OD can affect how other medicines work. Some medicines can also affect how Xatral OD works.
Do not use Xatral OD if you are taking:
- other alpha-blockers such as doxazosin , indoramin, prazosin, terazosin, tamsulosin or phenoxybenzamine.
Talk to your doctor or pharmacist before taking your medicine if:
- you have previously suffered from a severe drop in blood pressure et when taking other alpha-blockers (this may include previous use of alfuzosin). See the section directly above this for examples of other alpha-blockers.
- you are taking any blood pressure-lowering medicine as you may experience dizziness, weakness, or sweating within a few hours of taking this medicine. If this occurs, you should lie down until the symptoms have completely disappeared. Contact your doctor as the dose of your medicine may need to be changed.
- you are taking medicine for chest pain (angina).
- you are taking medicines for fungal infections (such as itraconazole).
- you are taking medicines for HIV (such as ritonavir).
- you are taking medicines for bacterial infections (such as clarithromycin, and telithromycin).
- you are taking medicines to treat depression (such as nefazodone).
- you are taking ketoconazole tablets (used to treat Cushing’s syndrome – when the body produces an excess of cortisol ).
Surgery while taking Xatral OD
- If you are going to have an operation that requires general anesthesia (sedation), tell your doctor that you are taking Xatral OD before the operation. This is because it can be dangerous as the medicine can lower your blood pressure.
- If you are going to have eye surgery due to cataracts (cloudiness of the lens of the eye), you should tell your eye specialist before the operation that you are taking or have taken Xatral OD. This is because the use of Xatral OD can cause complications during the surgery which can be managed if your specialist is informed.
Xatral OD with food and drink
Driving ability and use of machinery
You may feel dizzy and weak while taking Xatral OD. If this happens, do not drive or use tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Xatral OD contains hydrogenated castor oil which can cause stomach upset and diarrhea.
How to take Xatral OD
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Dosage
Benign prostate enlargement
- The recommended dose is one prolonged-release tablet of Xatral OD daily.
- Take the tablet after the evening meal.
Acute urinary retention
- Xatral OD will be given to you by your doctor on the day the catheter is inserted.
- You should continue to take Xatral OD once daily after a meal. Follow the doctor’s instructions on the prescription.
Mode of administration
- Swallow the tablets whole with plenty of water.
- You must not split, crush or chew the tablets. This can affect the release of one of the medicines into the body.
- Take the medicine after a meal.
Use for children
Xatral OD is not recommended for children.
If you have taken too much Xatral OD
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. Tell the doctor how many tablets you have taken. Lie down as much as possible to stop the side effects. Do not attempt to drive yourself to the hospital.
If you forget to take Xatral OD
Do not take a double dose to make up for a missed tablet. Skip it and then proceed as usual.
If you stop using Xatral OD
Continue to take the tablets even if the symptoms improve. Stop only if your doctor tells you to. Symptoms are better controlled if you continue to take the same dose of the medication.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These side effects usually occur at the beginning of treatment.
- Chest pain (angina)
Normally this only happens if you have had angina in the past. If you experience chest pain, stop taking the tablets and contact a doctor or go to the hospital immediately. This may affect up to 1 in 10,000 users.
- Allergic reactions
You may have symptoms of angioedema, such as a red and bumpy skin rash, swelling (of the eyelids, face, lips, mouth, and tongue), and difficulty breathing, or swallowing.
These are symptoms of an allergic reaction. If this happens, stop taking the tablets and contact a doctor or go to the hospital immediately. This may affect up to 1 in 10,000 users. - Persistent erection (priapism)Priapism is an abnormal, often painful, persistent erection of the penis that is not related to sexual activity. If you should get an erection like the one described here that lasts longer than 4 hours, contact a doctor or go to the hospital immediately as you may need treatment. This condition can lead to permanent impotence if not treated properly.
Other side effects include:
Common (may affect up to 1 in 10 users)
- Dizziness.
- Headache.
- Nausea.
- Unpleasant feeling in the stomach and indigestion ( dyspepsia ).
- Stomach pains.
- Weakness or tiredness.
Uncommon (may affect up to 1 in 100 users)
- Dizziness or lightheadedness when standing up or sitting up quickly.
- Fast heart rate ( tachycardia ).
- Drowsiness.
- Runny nose, itchy nose, sneezing, and stuffy nose.
- Diarrhea and vomiting.
- Dry mouth.
- Skin rash and itching.
- Retention of water in the body (can cause swollen arms or legs).
- Chest pains.
- Hot flashes.
Additional side effects ( occurring in an unknown number of users) that may arise are:
- Irregular and fast heartbeats.
- Decreased number of white blood cells. Symptoms of this can be frequent infections, sore throat, or mouth ulcers.
- Low platelet count. Signs of this can be bleeding from the gums and nose, bruising, prolonged bleeding from cuts, and rashes (point-shaped red spots called petechiae ).
- Abnormal liver function (liver problems). Symptoms may include yellowing of the skin or the whites of the eyes.
- If you are having eye surgery due to cataracts (cloudiness of the lens of the eye) and if you are taking or have taken Xatral OD, the pupil may dilate poorly and the iris (the colored part of the eye) may lose elasticity during surgery. This only occurs during surgery and the eye specialist must be aware of this possibility as the surgery may need to be performed differently (see section Operations while taking Xatral OD ).
How to store Xatral OD
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is alfuzosin hydrochloride. Each prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.
- Other ingredients are ethyl cellulose, hydrogenated castor oil, hypromellose, yellow iron oxide (E172), magnesium stearate, microcrystalline cellulose, povidone, colloidal silicon dioxide, and mannitol.
Appearance and package sizes of the medicine
Round, biconvex, three-layer tablet: a white layer between two yellow layers. Your prolonged-release tablet is available in packs of 10, 30, and 90 tablets in blisters (aluminum/PVC) and 100 tablets (in a tin).
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Sanofi AB, Box 30052, 104 25 Stockholm
This medicine is approved in the European Economic Area under the names:
Austria: Xatral Uno 10 mg Retardtabletten