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LOSINATE MR 400 MICROGRAM MODIFIED RELEASE CAPSULES

Active substance(s): TAMSULOSIN HYDROCHLORIDE

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Package leaflet: Information for the user

Losinate MR 400 microgram
modified-release capsule, hard
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 further questions, ask your doctor or your 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.

In this leaflet:
1. What Losinate MR is and what it is used for
2. What you need to know before you take
Losinate MR
3. How to take Losinate MR
4. Possible side effects
5. How to store Losinate MR
6. Contents of the pack and other information

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

Losinate MR with food and drink
You should take tamsulosin with a glass of water
after breakfast or after your first meal of the day.

Pregnancy, breast-feeding and fertility

Tamsulosin is not indicated for use in women.
In men, abnormal ejaculation has been reported
1. What Losinate MR is and
(ejaculation disorder). This means that the semen
what it is used for
does not leave the body via the urethra, but instead
Losinate MR is an alpha1A-adrenoreceptor blocker.
goes into the bladder (retrograde ejaculation) or the
It relaxes the muscles in the prostate and urinary tract. ejaculation volume is reduced or absent (ejaculation
failure). This phenomenon is harmless.
Tamsulosin is prescribed to alleviate urinary
symptoms caused by an enlarged prostate (benign
Driving and using machines
prostatic hyperplasia).
There is no information on the effects of
By relaxing the muscle, it enables easier passage of
tamsulosin on the ability to drive and use machines.
urine and helps urination.
You should take into account that tamsulosin may

2. What you need to know
before you take Losinate MR
Do not take Losinate MR if you:
• are allergic to tamsulosin or any of the other
ingredients of this medicine (listed in section 6)
(symptoms may include: swelling of your face
and throat (angio-oedema)).
• have a history of a fall in blood pressure on
standing up, which causes dizziness, lightheadedness or fainting.
• have severe liver problems.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Losinate MR
• if you experience dizziness or light-headedness,
especially after standing up. Tamsulosin may
lower your blood pressure, causing these
symptoms. You should sit or lie down until the
symptoms have gone.
• if you suffer from severe kidney problems.
The normal dose of tamsulosin may not have the
expected effect when your kidneys are not
functioning normally.
• if you are undergoing eye surgery because of
cloudiness of the lens (cataract). An eye condition
called Intraoperative Floppy Iris Syndrome may
occur (see section 4, Possible side effects), please
inform your eye specialist that you are using or
have previously used tamsulosin hydrochloride.
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 (cataract) or increased pressure of
the eye (glaucoma).
Before starting therapy with Losinate MR, your
doctor should examine you to confirm your
symptoms are truly caused by an enlarged prostate.

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 Losinate MR
Other medicines may be affected by tamsulosin.
They, in turn, may affect how well tamsulosin works.
Tamsulosin can interact with:
• 
diclofenac, a pain killer and anti-inflammatory
medicine. This medicine can speed up the removal
of tamsulosin from your body, thereby shortening
the time tamsulosin is effective.
• 
warfarin, a medicine to prevent blood clotting.
This medicine can speed up the removal of
tamsulosin from your body, thereby shortening
the time tamsulosin is effective.
• 
another α1-adrenoreceptor blocker.
The combination may lower your blood pressure,
causing dizziness or light-headedness.
• 
ketoconazole, a medicine to treat fungal skin
infections. This medicine may increase the effect
of tamsulosin.

cause dizziness and light-headedness. Only drive or
use machines if you feel alright.

3. How to take Losinate MR
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
The usual dose is one capsule per day taken after
breakfast or after your first meal of the day.
Swallow the capsule whole with a glass of water,
while standing or sitting (not while lying down).
It is important that you do not break or crush the
capsule as this may influence how well
tamsulosin works.
If you suffer from mild to moderate kidney or liver
disease, you can take the usual dose of tamsulosin.

If you take more Losinate MR than
you should
Your blood pressure may suddenly drop if you take
more tamsulosin than you should. You may
experience dizziness, weakness and fainting,
vomiting and diarrhoea. Lie down to minimise the
effects of low blood pressure and then contact your
doctor. Your doctor may give you medicines to
restore your blood pressure and fluid level, and may
monitor your body function. When necessary your
doctor may empty your stomach and give you a
laxative to remove any tamsulosin not yet taken up in
the blood from your body.

If you forget to take Losinate MR
Do not take a double dose to make up for a forgotten
dose. Just take the next dose at the usual time.

If you stop taking Losinate MR
When treatment with tamsulosin is stopped
prematurely, your original complaints may return.
Therefore use tamsulosin 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.
Serious reactions are rare. Contact your doctor
immediately if you experience a serious allergic
reaction which causes swelling of the face or
throat (angio-oedema). You should not be restarted
on Losinate MR (see Section 2, Do not take
Losinate MR).
Common side effects
(may affect up to 1 in 10 people)
• Dizziness, particularly when going to sit or
stand up
• Abnormal ejaculation (ejaculation disorder). This
means that semen does not leave the body via the
urethra, but instead goes into the bladder (retrograde
ejaculation) or the ejaculation volume is reduced
or absent (ejaculation failure). This phenomenon
is harmless.

Uncommon side effects
(may affect up to 1 in 100 people)
• Headache
• Feeling your heart beat (palpitations)
• A fall in blood pressure on standing up, which
causes dizziness, light-headedness or fainting
(orthostatic hypotension)
• Swelling and irritation inside the nose (rhinitis)
• Constipation
• Diarrhoea
• Feeling sick (nausea)
• Vomiting
• Rash
• Hives (urticaria)
• Feeling of weakness (asthenia)
• Itching
Rare side effects
(may affect up to 1 in 1000 people)
• Fainting (syncope)
Very rare side effects
(may affect up to 1 in 10,000 people)
• Painful erection (priapism)
• Serious illness with blistering of the skin, mouth,
eyes and genitals (Stevens-Johnson syndrome)
Not known side effects (frequency cannot be
estimated from the available data)
• Blurred vision
• Vision loss
• Nose bleeds (epistaxis)
• Dry mouth
• Serious skin rashes (erythema multiforme,
dermatitis exfoliative)
• Abnormal irregular heart rhythm (atrial fibrillation,
arrhythmia, tachycardia), difficult breathing
(dyspnoea)
During eye surgery, because of cloudiness of the
lens (cataract) or increased pressure in the eye
(glaucoma) a condition called Floppy Iris Syndrome
(IFIS) may occur: the pupil may dilate poorly and the
iris (the coloured circular part of the eye) may
become floppy during surgery.
For more information see Section 2, Warnings
and precautions.
Reporting of side effects
If you get other 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
(website: www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more
information on the safety of this medicine.

6. Contents of the pack and
other information

5. How to store Losinate MR

This leaflet was last revised in
04/2016

Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date which
is stated on the carton and the blister or container
after ‘EXP’. The first two digits indicate the month
and the last four digits indicate the year. The expiry
date refers to the last day of that month.
Store the blisters in the original package.
Keep the container tightly closed.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away any medicines you no longer use. These
measures will help protect the environment.

What Losinate MR contains
• The active substance is tamsulosin
hydrochloride 0.4mg.
• The other ingredients are:

Capsule: Microcrystalline cellulose, Methacrylic
acid-ethyl acrylate copolymer, Polysorbate 80,
Sodium laurilsulfate, Triethyl citrate, Talc

Capsule body: Gelatine, Indigotine (E 132),
Titanium dioxide (E 171), Yellow iron oxide
(E 172), Red iron oxide (E 172), Black iron
oxide (E 172)

What Losinate MR looks like and
contents of the pack
Orange/olive-green modified-release capsule
(19.3 x 6.4mm).
The capsules contain white to off-white pellets.
They are supplied in blister packs or containers
with 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 or 200
modified-release capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
and Manufacturer
Marketing Authorisation Holder:
Synthon BV,
Microweg 22,
6545 CM Nijmegen,
Netherlands
Manufacturer(s):
Synthon BV,
Microweg 22,
6545 CM Nijmegen,
Netherlands
or
Synthon Hispania S.L.,
Castelló,
Polígono las Salinas,
08830 Sant Boi de Llobregat,
Spain
Distributor:
Aspire Pharma Limited,
Bellamy House,
Winton Road,
Petersfield,
Hampshire,
GU32 3HA,
United Kingdom.

1010097-P9.3

Artwork for:
Aspire Pharma Limited
Product name:
Losinate MR 400 microgram modified-release capsules
Size:
PL/PA no:
PL 14048/0250
Type: Leaflet
Artwork dimensions: 400mm x 150mm
Profile supplied: Yes
Date of first artwork: 9 June 2010
Reason for request: Text edit
Version no: 9.3
Date of revision:
31 March 2016
Colours:
As swatch
Font(s):
Text 9pt Helvetica Condensed Headings VAG Rounded
Artwork software:
InDesign CS6
BAC ref:
T958 (formerly S766)

Black

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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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