Uriwel 0,4 mg Capsules

Uriwel acts by relaxing the muscles in the prostate and urethra (the tube that carries urine to the outside), and lets urine pass more readily through the urethra and assist with urination. In the prostate gland, bladder, and urethra there are specialised cells containing alpha 1A - receptors that cause the muscles in the urethra to tighten. Uriwel is an alpha 1A - adrenoceptor blocker, which reduces the action of these specialised cells and relaxes the muscles making it easier to pass water. Uriwel is used in men to treat the symptoms associated with benign prostatic hyperplasia (BPH) which is enlargement of the prostate. These symptoms include difficulty in starting to pass water, frequent trips to the toilet to pass water, a feeling of not completely emptying the bladder and having to get up several times in the night to pass water.

Do not take Uriwel if:

• you are allergic (hypersensitive) to tamsulosin or any of the other ingredients of Uriwel,
• you have a severe liver condition,
• you have ever fainted or felt dizzy when suddenly sitting or standing up. Dizziness can sometimes occur when taking Uriwel, particularly if you are also taking other alpha1 - blockers (medicine used to treat high blood pressure). If you do feel weak or dizzy make sure you sit or lie down straight away until the symptoms have disappeared,
• you are on medicines which block the function of an important enzyme (CYP3A), used to help the body get rid of toxins. Examples of such medicines are ketoconazole (used to treat fungal infections), antiretroviral medicines (used to treat HIV), erythromycin (used to treat bacterial infection).

Do not take Uriwel if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Uriwel.

Take special care with Uriwel: Tell your doctor or your healthcare provider before taking Uriwel:

• If you have low blood pressure that happens when you are standing up from sitting or lying down (orthostatis),
• If you have serious liver problems,
• If you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eye (glaucoma). Please inform your eye specialist that you have previously used, are using, or are planning to use tamsulosin hydrochloride. The specialist can then take appropriate precautions with respect to medicine and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens (cataract) or increased pressure in the eye (glaucoma),
• If you are taking medicines such as ketoconazole (medicine used to treat fungal infection), erythromycin (medicine used to treat bacterial infection), cimetidine (medicine used to treat ulcer), medicines used to treat high blood pressure, warfarin (medicine used to thin the blood),
• Uriwel can lead to a prolonged, painful erection of the penis for longer than usual,
• Patients likely to have prostate cancer and enlarged prostate must be screened before taking Uriwel.
• If you are allergic to antibiotics containing sulfa, such as sulfonamide (medicine used treat infections).

Do not share medicines prescribed for you with any other person. Always take Uriwel exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure. For adults and the elderly, the dose is one capsule per day to be taken after breakfast or the first meal of each day. Swallow the capsule whole. Do not crunch or chew. Your doctor may want to examine you from time to time whilst you are taking Uriwel.

If you take more Uriwel than you should: If you take more Uriwel capsules than you should, you will feel dizzy and faint due to the low blood pressure that the Uriwel may cause. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take Uriwel: You may take your capsule later the same day if you have forgotten to take it earlier. If you have missed a day, just continue to take your daily capsule from the next day. Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of Uriwel, ask your doctor or pharmacist. If you stop taking Uriwel: Do not stop taking Uriwel unless your doctor or pharmacist tells you to stop.

Uriwel can have side effects. Not all side effects reported for Uriwel are included in this leaflet. Should your general health worsen or if you experience any of the untoward effects while taking Uriwel please consult your doctor, pharmacist or other healthcare professional for advice. If any of the following happens, stop taking Uriwel and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the face, throat or tongue with breathing problems linked to allergy,
• Serious skin rashes (erythema multiform, dermatitis exfoliative), rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens - Johnson syndrome), itching, redness,
• Fainting (syncope)

These are all very serious side effects. If you have them, you may have had a serious reaction to Uriwel. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Less frequent side - effects:

• Chest pain
• Palpitations (rapid or irregular heartbeat), difficult breathing (dyspnoea), abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia)

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side - effects:

• dizziness, drowsiness, sluggishness (lethargy)
• Abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.

Less frequent side - effects:

• Abnormal physical weakness, headache, depression (persistent feeling of sadness), nervousness, sleeping problems, hallucinations,
• Dizziness as you sit or stand up,
• Runny or blocked nose, inflammation of the nasal mucous membrane due to virus infection (rhinitis), nose bleeds (epistaxis),
• tingling sensation, ringing in the ears,
• Gastro - intestinal symptoms such as nausea and vomiting (feeling or being sick), diarrhoea or constipation, and inflammation of the pancreas,
• Persistent painful erection usually unrelated to sexual activity,
• Abnormal sweating, hair loss (alopecia) and joint pain,
• Reddened eyes, complication during lens (cataract) surgery

Frequency not unknown:

• blurred vision, impaired vision
• dry mouth

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 25 °C (Room temperature). Store in the original package. Keep the container in the outer carton. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and the blister. Do not throw away any medicines in drains or sewage systems. Return all unused medicine to the pharmacist.