PACKAGE LEAFLET: INFORMATION FOR THE USER

BRUNDEEL XL 400 microgram Prolonged-Release Hard capsules

(Tamsulosin 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.

What is in this leaflet

1.    What BRUNDEEL XL is and what it is used for

2.    What you need to know before you take BRUNDEEL XL

3.    How to take BRUNDEEL XL

4.    Possible side effects

5.    How to store BRUNDEEL XL

6.    Contents of the pack and other information

1. What BRUNDEEL XL is and what is it used for

The active ingredient in BRUNDEEL XL    is tamsulosin.

This is a selective alpha1A/1D-adrenoceptor antagonist. It reduces tension of the smooth muscles in the prostate and the urethra, enabling urine to pass more readily through the urethra and facilitating urination. In addition, it diminishes sensations of urge.

BRUNDEEL XL    is used in men for the treatment of the complaints of the lower urinary

tract associated with an enlarged prostatic gland (benign prostatic hyperplasia). These complaints may include difficulty urinating (poor stream), dribbling, urgency and having to urinate frequently at night as well as during the day.

2. What you need to know before you take BRUNDEEL XL

Do not take BRUNDEEL XL

•    If you are allergic to tamsulosin hydrochloride or any of the other ingredients in this medicine (listed in section 6). Hypersensitivity may present as sudden local swelling of soft tissues of the body (e.g. the throat or tongue), difficult breathing and/or itching and rash (angioedema).

•    If you suffer from severe liver problems.

•    If you suffer from fainting due to reduced blood pressure when changing posture (going to sit or stand up).

Warnings and precautions

Talk to your doctor or pharmacist before taking BRUNDEEL XL.

• Periodic medical examinations are necessary to monitor the development of the condition you are being treated for.

•    Rarely, fainting can occur during the use of Tamsulosin, as with other medicinal products of this type. At the first signs of dizziness or weakness you should sit or lie down until they have disappeared.

•    If you suffer from severe kidney problems, tell your doctor.

•    If you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataracts). Please inform your eye specialist that you have previously used, or are planning to use, BRUNDEEL XL. The specialist can then take appropriate precautions with respect to medication 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.

Other medicines and BRUNDEEL XL

Taking BRUNDEEL XL together with other medicines from the same class (alpha1-adrenoceptor blockers) may cause an unwanted decrease in blood pressure.

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

It is especially important to inform your doctor if you are being treated at the same time with medicines that may decrease the removal of tamsulosin from the body (for example, ketoconazole, erythromycin).

BRUNDEEL XL with food and drink and alcohol

Take your medicine after the first meal of the day. Taking your medicine on an empty stomach may increase the number and severity of side effects.

Pregnancy, breast-feeding and fertility

This section is not relevant, because BRUNDEEL XL is intended for male patients only.

Driving and using machines

There is no evidence that tamsulosin affects the ability to drive or to operate machinery. However, you should bear in mind dizziness can occur, in which case you should not undertake in these activities that requires attentiveness.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years because it does not work in this population

3. How to take BRUNDEEL XL

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

•    The recommended dose is one capsule (0.4 mg of tamsulosin hydrochloride) a day, after the first meal of the day.

•    The capsule should be taken whilst standing or sitting upright (not lying down) and should be swallowed whole with a glass of water.

•    The capsule must not be chewed.

•    The dose does not need to be adjusted for the elderly.

Your doctor has prescribed a suitable dose for you and your illness, and has specified the duration of the treatment.

You should not change the dose without speaking to your doctor first.

If you have the impression that the effect of your medicine is too strong or too weak, talk to your doctor or pharmacist.

If you take more BRUNDEEL XL than you should

Taking too many BRUNDEEL XL capsules may lead to an unwanted decrease in blood pressure and an increase in heart rate, with feelings of faintness. Contact your doctor immediately if you have taken too much BRUNDEEL XL.

If you forget to take BRUNDEEL XL

You may take your daily BRUNDEEL XL later the same day if you have forgotten to take it as recommended. If you have missed a day, just continue to take your daily capsule as prescribed. Never take a double dose to make up for the forgotten dose.

If you stop taking BRUNDEEL XL

When treatment with BRUNDEEL XL is stopped prematurely, your original complaints may return. Therefore use BRUNDEEL XL as long as your doctor prescribes, even if your complaints have disappeared already. Always consult your doctor, if you consider stopping this therapy.

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.

Stop taking your medicine and seek medical help immediately, if you have any of the

following allergic reactions:

•    Difficulties in breathing

•    Swollen face, tongue or throat (angioedema)

•    Itch and rash

Common (may affect up to 1 in 10 people):

•    Dizziness, particularly when going to sit or stand up.

•    Abnormal ejaculation. This means that semen does not leave the body via the urethra, but instead goes into the bladder. This phenomenon is harmless.

Uncommon (may affect up to 1 in 100 people):

•    headache

•    palpitations (the heart beats more rapidly than normal and it is also noticeable)

•    reduced blood pressure e.g. when getting up quickly from a sitting or lying position sometimes associated with dizziness

•    runny or blocked nose (rhinitis)

•    constipation

•    diarrhoea

•    feeling sick and vomiting

•    weakness (asthenia)

•    rashes

•    itching and hives (urticaria).

Rare (may affect up to 1 tin 1,000 people):

•    faintness and sudden local swelling of the soft tissues of the body (e.g. the throat or tongue)

•    difficult breathing and/or itching and rash, often as an allergic reaction (angioedema)

Very rare (may affect up to 1 in 10,000 people):

•    priapism (painful prolonged unwanted erection for which immediate medical treatment is required)

•    Rash, inflammation and blistering of the skin and/ or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens- Johnson syndrome)

•    Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficulty breathing (dyspnoea).

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store BRUNDEEL XL

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

This medicinal product does not require any special temperature storage conditions.

Store in the original package in order to protect from moisture.

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

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines which you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What BRUNDEEL XL contains

The active substance is tamsulosin hydrochloride.

Each prolonged-release capsule hard contains 0.4 mg of tamsulosin hydrochloride.

The other ingredients are:

Capsule content:

Cellulose microcrystalline, talc, methacrylic acid-ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, triacetin and calcium stearate.

Capsule shell:

Indigo carmine (E 132), iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), sodium lauryl sulfate, gelatin.

Printing Ink:

Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide.

What BRUNDEEL XL looks like and contents of the pack

Prolonged-release capsules, hard

Olive green opaque/Orange opaque size ‘0’ hard gelatin capsules imprinted with ‘D’ on cap and ‘53’ on body with black edible ink. The capsules are filled with white to off-white beadlets.

BRUNDEEL XL    400 microgram prolonged-release capsules, hard are available in:

PVC/PE/PVDC/Aluminium blister pack: 10, 20, 30, 50, 60, 90, 100 or 200 capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder

Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland

Manufacturer:

• Pfizer Service Company BVBA, Hoge Wei 10, 1930, Zaventem. Belgium,,

or

• Pfizer Italia s.r.l.,

Localita Marino Del Tronto, 63100 - Ascoli Piceno (AP), Italy,

or

• Pfizer PGM,

Zone industrielle, 29, route des Industries, 37530 Poce -Sur-Cisse, France.

This leaflet was last revised in 03/2014