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• Alfuzosin Orion 10 mg prolonged release tablet ENG PL

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Package leaflet: Information for the user

Alfuzosin Orion 10 mg prolonged-release tablets

Alfuzosin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

What is in this leaflet

1. What Alfuzosin Orion is and what it is used for

2. What you need to know before you take Alfuzosin Orion

3. How to take Alfuzosin Orion

4. Possible side effects

6. Contents of the pack and other information

Alfuzosin Orion belongs to a group of medicines called alpha-1-blockers. Alfuzosin is used to treat moderate to severe symptoms of Benign Prostatic Hyperplasia. This is a condition where the prostate gland enlarges (hyperplasia), but the growth in itself is not cancerous (it is benign). It is more common in older men.

The prostate gland is situated under the bladder surrounding the urethra (the tube that takes your urine to the outside of the body). With age, the prostate gland may grow and press on the urethra making it smaller. This may cause problems with urination such as frequent urination and difficulty in passing urine.

Alfuzosin works by relaxing the prostate gland muscle. This reduces the narrowing of the urethra and so makes it easier to pass urine.

Do not take Alfuzosin Orion

• If you are allergic to alfuzosin or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, swelling of your lips, throat, or tongue, difficulty in swallowing or breathing.

• If you have, or have had in the past, low blood pressure when standing up from a sitting or lying position (the medical term for this is orthostatic hypotension). It can make you feel dizzy, light-headed or faint when you stand or sit up quickly.

• If you have liver problems.

• If you are already taking another alpha-1-blocker (such as terazosin, doxazosin). See section below on “Other medicines and Alfuzosin Orion”. If in doubt please ask your pharmacist or doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking your medicine if:

• You have severe kidney problems.

• You have a heart disease.

• You have chest pain (angina).

• You are known to have an abnormality of electrocardiogram (ECG), called “QT prolongation”.

Some patients, particularly those who are also taking medicine for high blood pressure or medicines for chest pain (angina pectoris) may get dizziness, weakness or sweating within a few hours of taking a dose. If this happens, you should lie down until the symptoms have completely disappeared. Let your doctor know as he may decide to adjust your dose.

Other medicines and Alfuzosin Orion

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Alfuzosin Orion if you are taking:

Talk to 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).

Operations while taking Alfuzosin Orion

• If you are going to have an operation that needs a general anaesthetic, tell your doctor you are taking Alfuzosin Orion before the operation. This is because it can be dangerous as it can lower your blood pressure.

• If you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used Alfuzosin Orion. This is because Alfuzosin Orion may cause complications during the surgery which can be managed if your specialist is prepared in advance.

Driving and using machines

You may feel dizzy and weak while taking Alfuzosin Orion. If this happens do not drive or operate any tools or machines.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Swallow your tablets whole with plenty a fluid (for instance a glass of water).

• Do not break, crush or chew your tablets. This can affect the release of your medicine into the body

• Take this medicine just before bedtime.

Adults

The usual dose is one 10 mg tablet once a day.

Older patients (> 65 years)

The usual dose is one 10 mg tablet once a day. The dose does not need to be adjusted for elderly (over 65 years).

Patients with mild to moderate kidney problems

The usual dose is one 10 mg tablet once a day. The dose does not need to be adjusted for mild to moderate kidney problems.

If you notice that Alfuzosin Orion has too strong or too weak an effect, consult your doctor or pharmacist.

Use in children

Alfuzosin Orionis not recommended for children (aged 16 years or younger).

If you take more Alfuzosin Orion than you should

Contact your local hospital 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 Alfuzosin Orion

Do not take a double dose to make up for a forgotten dose. Skip the missed dose and take the next tablet as directed.

If you stop taking Alfuzosin Orion

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.

4. Possible side effects

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.

Stop taking Alfuzosin Orion and contact a doctor or go to a hospital immediately if you get any of the following serious side effects:

Normally, this only happens if you have had angina before.

You could notice symptoms of angioedema, such as a red and lumpy skin rash, swelling (on the eyelids, face, lips, mouth and tongue), difficulty breathing or swallowing.

Other side effectsinclude:

Common (may affect up to 1 in 10 people)

• Feeling dizzy.

• Headache.

• Feeling sick (nausea).

• Uncomfortable feeling in the stomach and indigestion (dyspepsia).

• Stomach pain.

• Weakness or tiredness.

Uncommon (may affect up to 1 in 100 people)

• Feeling dizzy, lightheaded, or faint when you stand or sit up quickly.

• Fast heart beat (tachycardia).

• Drowsiness.

• Runny nose, itching, sneezing, and stuffy nose.

• Diarrhoea and being sick (vomiting).

• Dry mouth.

• Rash and itching.

• Water retention (may cause swollen arms or legs).

• Chest pain.

• Hot flushes.

Additional side effects(frequency cannot be estimated from the available data) which may occur are:

• Irregular and fast heart beat

• Decrease in white blood cells. Signs may include more frequent infections, sore throat or mouth ulcers.

• Low numbers of blood platelets. Signs may include bleeding from your gums and nose, bruising, prolonged bleeding from cuts, rash (pinpoint red spots called petechia).

• Abnormal liver function (liver problem). Signs may include yellowing of your skin or the whites of your eyes.

• If you are undergoing eye surgery because of cataract (cloudiness of the lens) and are using or have previously used Alfuzosin Orion, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure. This only occurs during the operation and it is important for the eye specialist to be aware of this possibility as the operation may need to be performed differently (see section “Operations while taking Alfuzosin Orion”).

• Abnormal, often painful, persistent erection of the penis unrelated to sexual activity (priapism).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Alfuzosin Orion

Keep this medicine out of the sight and reach of children.

Do not use this medicineafter the expiry date which is stated on the blister, bottle or carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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.

6. Contents of the pack and other information

What Alfuzosin Orion contains

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

• The other ingredients are in tablet core: Hypromellose, hydrogenated vegetable oil, povidone (K-30), anhydrous calcium hydrogen phosphate, carbomers, colloidal anhydrous silica, magnesium stearate and in film-coating: Hypromellose, propylene glycol, titanium dioxide (E 171).

What Alfuzosin Orion looks like and contents of the pack

Prolonged-release tablet.

White to off-white round, biconvex, film-coated tablets debossed with ‘X’ on one side and ‘47’ on other side. Diameter of the tablet is 8.1 mm.

Pack-sizes:

Blister pack: 10, 20, 30, 50, 60 and 90 tablets.

Bottle pack: 30 and 90 tablets.

The container contains a silica gel desiccant.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

This leaflet was last revised on 20 May 2016