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BRUNDEEL XL 400 MICROGRAM PROLONGED-RELEASE HARD CAPSULES

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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

is tamsulosin.
The active ingredient in BRUNDEEL XL
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.
is used in men for the treatment of the complaints of the lower urinary
BRUNDEEL XL
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 (alpha1adrenoceptor 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.

White opaque round HDPE bottle with white opaque polypropylene closure: 250 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.,
Località Marino Del Tronto, 63100 - Ascoli Piceno (AP),
Italy,
or



Pfizer PGM,
Zone industrielle, 29, route des Industries, 37530 Pocé -Sur-Cisse,
France.

This leaflet was last revised in 03/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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