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FLECTONE XL 400 MICROGRAM PROLONGED-RELEASE TABLETS

Active substance(s): TAMSULOSIN HYDROCHLORIDE

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PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER

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 of the side effects, talk to
your doctor or pharmacist. This includes
any possible side effects not listed in this
leaflet. See section 4.

inform your eye specialist that you have
been or are taking Flectone XL. The
specialist can then take appropriate
precautions with respect to medication
and surgical techniques to be used.
Consult your doctor if any of these warnings
apply or would have applied to you in the
past.
Children and adolescents
Do not give this medicine to children or
adolescents under 18 years because it does
not work in this population.

Other medicines and Flectone XL

Pharma code 305

Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, especially if you are
taking any of the following:
• Diclofenac (an anti-inflammatory medicine
used to treat pain)
WHAT IS IN THIS LEAFLET:
• Warfarin (used to prevent blood clotting)
1. What Flectone XL is and what it is used for • Ketoconazole (used to treat fungal
infections).
2. What you need to know before you take
Flectone XL
No interactions have been reported, but
3. How to take Flectone XL
using Flectone XL at the same time as other
4. Possible side effects
medicines belonging to the same class may
5. How to store Flectone XL
6. Contents of the pack and other information lead to a drop in blood pressure.

1 WHAT FLECTONE XL IS AND WHAT

Flectone XL with food and drink
You may take your Flectone XL independently
of food.

The active ingredient of Flectone XL is
tamsulosin. Tamsulosin is an alpha1-receptor
blocker which reduces the tension in the
muscles of the prostate and urethra (the tube
that carries urine to the outside). As a result,
the urethra, which runs through the prostate,
is less contracted and urination is easier.

Pregnancy and breast-feeding
Flectone XL is not indicated for use in women.

IT IS USED FOR

Driving and using machines
Flectone XL may cause dizziness. If you
experience this symptom, do not drive or
use any tools or machinery the handling of
which requires concentration.

Flectone XL is intended for use in men to
treat lower urinary tract symptoms caused
HOW TO TAKE FLECTONE XL
by benign prostatic hyperplasia (BPH), which 3
is an enlargement of the prostate gland.
Always take this medicine exactly as your
doctor or pharmacist has told you. You
should check with your doctor or pharmacist
2 WHAT YOU NEED TO KNOW
BEFORE YOU TAKE FLECTONE XL
if you are not sure.
Do NOT take Flectone XL
• If you are allergic (hypersensitive) to
tamsulosin or to any of the other ingredients
listed in section 6. Contents of the pack
and other information.
• If you have serious liver disease
• If you suffer from orthostatic hypotension
(feeling dizzy because of low blood
pressure when sitting or standing).

The recommended dose is one tablet per
day, by mouth. No dose adjustment is
required if you have impaired kidney
function or mild to moderate liver disease
(see also ‘Do not take Flectone XL‘ in section
2 above).

Warnings and precautions
Talk to your doctor or pharmacist before
taking tamsulosin
• If you have serious kidney disease
• In rare cases, Flectone XL may cause
fainting when sitting down or standing up.
If you feel dizzy or weak, lie or sit down
until these symptoms disappear.
• Before you start taking Flectone XL, your
doctor will examine you to make sure you
do not have another illness likely to cause
symptoms similar to those of a
non-cancerous enlargement of the
prostate. Your doctor will examine your
prostate manually to look for possible
abnormalities and will order tests for a
chemical produced by the prostate
(prostate-specific antigen, PSA) in your
blood before you start treatment, and at
regular intervals afterwards.
• In rare cases, a serious allergic reaction
may occur with swelling of the face, lips,
tongue and throat, which may make it hard
to breathe, talk or swallow (angioedema).
If this happens, stop taking Flectone XL
immediately and consult your doctor.
• If you are undergoing eye surgery because
of cloudiness of the lens (cataract), please

Do not forget to take your medicine. Your
doctor will tell you how long you need to
keep taking Flectone XL.

Swallow the tablet whole with a glass of
water, without crunching or chewing.

Always take this medicine exactly as
described in this leaflet or as your doctor or
pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
If you take more Flectone XL than you should
If you take too much Flectone XL, contact
your doctor or pharmacist or go to the nearest
hospital casualty department immediately.
Take along this leaflet and any remaining
tablets with you. An overdose of Flectone XL
may cause dizziness, fainting and headache.
If you forget to take Flectone XL
If you forget to take your daily tablet of
Flectone XL, you may take it later on the
same day. If you forget to take it at all one
day, continue with your treatment the next
day with the normal dose at the usual time.
Do not take a double dose to make up for a
forgotten one.

Top of page cut-off to middle of registration mark: 44 mm.

FLECTONE XL 400 microgram
PROLONGED-RELEASE TABLETS
Tamsulosin hydrochloride

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you stop taking Flectone XL
If you stop taking Flectone XL earlier than
your doctor recommends, the initial
symptoms may reappear. You must therefore
keep taking Flectone XL for as long as your
doctor tells you to, even if your symptoms
have gone. Always talk to your doctor if you
are considering stopping treatment.

Reporting of side effects
If you get 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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

If you have any further questions on the use By reporting side effects you can help
provide more information on the safety of
of this medicine, ask your doctor or
this medicine.
pharmacist.

4 POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
See your doctor or go to a hospital
immediately if you experience any of the
following rare side effects (you may be
experiencing an allergic reaction):
• Rash, itching, inflamed or red skin
(especially if your whole body is affected)
• Swelling of the face, lips, tongue or throat,
which may cause difficulty swallowing or
breathing (angioedema).
The following side effects have been
observed with Tamsulosin:
Common side effects (may affect up to 1 in
10 people):
• Dizziness
• Ejaculation disorders
• Abnormal ejaculation (e.g. less, or no
noticeable, semen ejaculated).
Uncommon side effects (may affect up to 1
in 100 people):
• Headache
• Pounding heart beat (palpitations)
• Orthostatic hypotension (feeling dizzy
because of low blood pressure when
sitting or standing)
• Runny or stuffy nose (rhinitis)
• Feeling or being sick (nausea or vomiting),
diarrhoea, constipation
• Allergic reactions such as rash, itching and
local inflammation
• Weakness.

5 HOW TO STORE FLECTONE XL
Keep out of the sight and reach of children.
Do not use Flectone XL after the expiry date
which is stated on the carton and blister
after EXP. The expiry date refers to the last
day of that month.
There are no special precautions for storage.
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
to protect the environment.

6 CONTENTS OF THE PACK AND
OTHER INFORMATION

What Flectone XL contains
• The active substance is tamsulosin
hydrochloride. Each prolonged-release
tablet contains 0.40 mg tamsulosin
hydrochloride equivalent to 0.367 mg
tamsulosin.
• The other ingredients are cellulose
microcrystalline, polyethylene oxide, silica
colloidal anhydrous and magnesium
stearate in the core and hypromellose 6cP,
titanium dioxide (E171), macrogol 8000
and red and yellow iron oxide (E172) in
the film-coating.

What Flectone XL looks like and contents of
the pack
• Prolonged-release tablet
• Yellow, biconvex, oval, film-coated tablet,
debossed ‘T04’ on one side and plain on
the other
Rare side effects (may affect up to 1 in 1,000 • Available in pack sizes of 10, 14, 20, 28, 30,
people):
50, 56, 60, 90, 100, 200 Tablets and 50 x 1
• Fainting
(hospital pack) prolonged-release tablets.
• Nettle rash (hives) on the whole body with
Not all pack sizes may be marketed.
swelling of the hands, feet, lips, tongue,
throat, airways (angioedema).
Marketing Authorisation Holder and
Manufacturer
Very rare side effects (may affect up to 1 in
Teva UK Limited, Eastbourne, BN22 9AG.
10,000 people):
• A severe skin rash which develops with
This leaflet was last revised in 11/2013
flu-like symptoms (Stevens-Johnson
syndrome)
PL 00289/1142
• Priapism (persistent painful erection in the
absence of sexual stimulation; this side
effect requires immediate treatment).
Not known (frequency cannot be estimated
from the available data):
• Blurred vision, problems with sight
• Nose bleeds
• Itchy, pink-red blotches on your limbs
(Erythema multiforme)
• Redness and scaling of the skin
(Dermatitis exfoliativa)
• Abnormal irregular heart rhythm (atrial
fibrillation, arrhythmia, tachycardia)
• Difficult breathing (dyspnoea)
• Dry mouth.
If you are undergoing eye surgery because
of cloudiness of the lens (cataract) and have
been or are taking Flectone XL, your pupil
may not dilate right and your iris (the
coloured part of the eye) may become
floppy during the operation (see also
‘Warnings and precautions’ above).

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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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