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TAMFREX XL 400 MICROGRAM CAPSULES

Active substance(s): TAMSULOSIN HYDROCHLORIDE

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TAMFREX XL 400 microgram 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.
See section 4
What is in this leaflet:
1. What TAMFREX XL is and what it is used for
2. What you need to know before you take TAMFREX XL
3. How to take TAMFREX XL
4. Possible side effects
5. How to store TAMFREX XL
6. Contents of the pack and other information
1. WHAT TAMFREX XL IS AND WHAT IT IS USED FOR
The active ingredient in TAMFREX 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.
TAMFREX 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
TAMFREX XL
Do not take TAMFREX XL

if you are allergic to tamsulosin hydrochloride or any of the
other ingredients in TAMFREX XL (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 TAMFREX 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 from severe kidney problems, tell your doctor

if you are undergoing or have been scheduled for eye surgery
because of cloudiness of the lens (cataract). Please inform
your eye specialist that you have previously used, are planning
to use TAMFREX 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.
Children
Do not give this medicine to children or adolescent under 18 years
because it does not work in this population.

Black

P150

P150

TAMFREX XL
400 microgram capsules

PACKAGE LEAFLET: INFORMATION FOR THE USER

TAMFREX XL
400 microgram capsules

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

Other medicines and TAMFREX XL
Taking TAMFREX 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 TAMFREX XL from the body (for example,
ketoconazole, erythromycin).
TAMFREX XL with food and drink
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 and breast-feeding
This section is not relevant, because TAMFREX XL is intended for
male patients only.
Ejaculation disorders have been observed in short and long term
clinical studies with tamsulosin. Events of ejaculation disorder,
retrograde ejaculation and ejaculation failure have been reported in
the post authorization phase.
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.
3. HOW TO TAKE TAMFREX XL
Always take TAMFREX XL exactly as your doctor has told you to.
You should check with your doctor or pharmacist if you are not
sure.

the usual 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 TAMFREX XL than you should
Taking too many TAMFREX XL 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 TAMFREX XL.
If you forget to take TAMFREX XL
You may take your daily TAMFREX 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 TAMFREX XL
When treatment with TAMFREX XL is stopped prematurely, your
original complaints may return. Therefore use TAMFREX 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

5. HOW TO STORE TAMFREX XL

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

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

Common (affects 1 to 10 users in 100):

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.

Ejaculation failure

Retrograde ejaculation
Uncommon (affects 1 to 10 users in 1,000):

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
seating 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 (affects 1 to 10 users in 10,000):

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 (affects less than 1 user in 10,000):

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).
Not known (cannot be estimated from the available data):

Visual disturbances and blurred vision

Nose bleeding

Dry mouth

Skin rash, which may blister, and looks like small targets
(central dark spots surrounded by a paler area, with a dark ring
around the edge) called erythema multiforme

Widespread red skin rash with small pus-containing blisters
(buloous exfoliative dermatitis)
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 (see details below). By reporting
side effects you can help provide more information on the safety of
this medicine.
The United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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 no
longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What TAMFREX 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 TAMFREX XL looks like and contents of the pack
Prolonged-release capsules, hard
Olive green opaque/Orange opaque size ‘1EL’ 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.
TAMFREX XL 400 microgram capsules are available in:
PVC/PE/PVDC blister pack: 1, 2, 4, 7, 10, 14, 15, 20, 28, 30, 50,
56, 60, 90, 98, 100 & 200 hard, capsules.
White opaque round HDPE bottle with white opaque polypropylene
closure: 10 & 250 hard, capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 05/2015.
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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

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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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