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TAMSUMAC 0.4 MG PROLONGED RELEASE CAPSULES HARD

Active substance(s): TAMSULOSIN HYDROCHLORIDE

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Package Leaflet: Information for the user

Tamsumac 0.4 mg prolonged release capsules,
hard
tamsulosin hydrochloride
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
Ÿ Keep this leaflet. You may need to read it again
Ÿ If you have any further questions, ask your doctor or pharmacist.
Ÿ 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.
Ÿ 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 Tamsumac is and what it is used for
2. What you need to know before you take Tamsumac
3. How to take Tamsumac
4. Possible side effects
5. How to store Tamsumac
6. Contents of the pack and other information
1. What Tamsumac is and what it is used for
The active ingredient in Tamsumac is tamsulosin hydrochloride. It
acts by relaxing the muscles in the prostate and urethra (the tube that
carries urine to the outside), and lets urine pass more readily through
the urethra and aids urination.
In the prostate gland, bladder and urethra there are specialised cells
containing alpha1A-receptors that cause the muscles in the urethra to
tighten. Tamsumac is an alpha1A-adrenoceptor blocker, which reduces
the action of these specialised cells and relaxes the muscles making it
easier to pass water.
Tamsumac 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 symptoms include difficulty in starting to
pass water, frequent trips to the toilet to pass water, a feeling of not
completely emptying the bladder and having to get up several times in
the night to pass water.
2. What you need to know before you take Tamsumac
Do not take Tamsumac:
Ÿ If you are allergic (hypersensitive) to tamsulosin or any of the
other ingredients of Tamsumac (listed in section 6).
Ÿ if you have a severe liver condition.
Ÿ if you have ever fainted or felt dizzy when suddenly sitting or
standing up. Dizziness can sometimes occur when taking
Tamsumac, particularly if you are also taking other alpha1blockers. If you do feel weak or dizzy make sure you sit or lie
down straight away until the symptoms have disappeared.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tamsumac.
Take special care with Tamsumac (and speak to your doctor)

Ÿ If you have kidney problems
Ÿ If you are undergoing or have been scheduled for eye surgery
because of cloudiness of the lens (cataract) or increased pressure
in the eye (glaucoma).

Please inform your eye specialist that you have previously used, are
using or are planning to use tamsulosin. 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 to increased
pressure in the eye (glaucoma).
Children and adolescents
Do not give this medicine to children or adolescent under 18 years
because it does not work in this population.
Other medicines and Tamsumac
- Taking Tamsumac together with other medicines from the same
class (α1-adrenoceptor antagonists) may cause an unwanted
decrease in blood pressure.
- 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 Tamsumac from the body (for example,
ketoconazole, erythromycin).
Tell your doctor or pharmacist if you are taking or have recently taken
or might take any other medicines.
Tamsumac with food and drink
Tamsumac must be taken after breakfast or the first meal of the day.
Pregnancy, breast-feeding and fertility
Tamsumac is not indicated for use in women.
In men, abnormal ejaculation has been reported (ejaculation disorder).
This means that semen does not leave the body via the urethra, but
instead goes into the bladder (retrograde ejaculation) or ejaculate
volume is reduced or absent (ejaculatory failure). This phenomenon is
harmless.
Driving and using machines
There is no evidence that Tamsumac affects the ability to drive or to
operate machinery or equipment. However, you should bear in mind
that dizziness can occur, in which case you should not undertake
activities that require attentiveness.
3. How to take Tamsumac
Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
The recommended dose is 1 capsule per day to be taken after breakfast
or the first meal of each day. The capsule must be swallowed whole
and not be crunched or chewed. Usually, Tamsumac is prescribed for
long periods of time. The effects on the bladder and on urination are
maintained during long-term treatment with Tamsumac.
If you take more Tamsumac than you should
Taking too much Tamsumac 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
Tamsumac.
If you forget to take Tamsumac
You may take your daily Tamsumac 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 a forgotten capsule.
If you stop taking Tamsumac
When treatment with Tamsumac is stopped prematurely, your original

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.
Common (may affect up to 1 in 10 people)
Ÿ Dizziness, particularly when going to sit or stand up.
Ÿ 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 ejaculate volume is
reduced or absent (ejaculatory failure). This phenomenon is
harmless.
Uncommon (may affect up to 1 in 100 people)
Ÿ Headache Palpitations (the heart beats more rapidly than normal
and it is also noticeable)
Ÿ Reduced blood pressure e.g. when getting up quickly from a
seating or lying position sometimes associated with dizziness.
Ÿ Runny or blocked nose (rhinitis).
Ÿ Diarrhoea.
Ÿ Feeling sick and vomiting.
Ÿ Constipation.
Ÿ Weakness (asthenia).
Ÿ Rashes, itching and hives (urticaria).
Rare (may affect upto 1 in 1,000 people)
Ÿ Faintiness 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)
Ÿ Priapism (painful prolonged unwanted erection for which
immediate medical treatment is required).
Ÿ Rash, inflammation and blistering of the skin and/or mucous
membranes of the lips, eyes, mouth, nasal passages or genitals
(Stevens-Johnson syndrome).
Not Known (frequency cannot be estimated from the available data)
Ÿ Blurred vision or impaired vision
Ÿ Nose bleeds
Ÿ Dry mouth
Ÿ Serious skin rashes (erythema multiforme, dermatitis
exfoliative)
Ÿ Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia,
tachycardia),
Ÿ Difficult breathing (dyspnoea).
Ÿ If you are undergoing eye surgery because of cloudiness of the
lens (cataract) or increased pressure in the eye (glaucoma) and
are already taking or have previously taken Tamsumac, the pupil
may dilate poorly and the iris (the coloured circular part of the
eye) may become floppy during the procedure.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store Tamsumac
Keep this medicine out of the sight and reach of children
Tamsumac does not require any special storage conditions
Do not use this medicine after the expiry date which is stated on the
blister pack and on the carton after EXP. The expiry date refers to the
last day of that month.
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 protect the environment.
6. Contents of the pack and other information
What Tamsumac contains
Ÿ The active substance is tamsulosin hydrochloride.
Ÿ The other ingredients are Polysorbate 80, Methacrylic acid
copolymer dispersion, Triacetin, Sodium lauryl sulfate, Purified
water, Microcrystalline cellulose and Calcium stearate. These all
help to make the granules which are in the capsule
Ÿ The capsule shell contains FD & C Blue 2 (E 132), Iron oxide
black (E 172), Iron oxide red (E 172), Iron oxide yellow (E 172),
Titanium dioxide (E 171), Gelatin, Purified water, Sodium lauryl
sulfate; Printing ink is Shellac (E904), Dehydrated alcohol,
Isopropyl alcohol, Butyl alcohol, Propylene glycol, Strong
ammonia solution, Black iron oxide (E172), Potassium hydroxide
and Purified water.
What Tamsumac looks like and contents of the pack
Tamsumac capsules are Olive green opaque / Orange opaque, Size
"2", hard gelatin capsules, containing free flowing white to off white
spheroids with "CL 23" on cap and "0.4" on the body imprinted with
black ink.
The capsules are packaged in Clear PVC/PE/PVdC – Aluminium
Blister.
The capsules are supplied in blister packs of 14, 20, 28, 30, 50, 56, 90,
98 and 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Macleods Pharma UK Limited
Wynyard Park House,
Wynyard Avenue,
Wynyard, Billingham,
TS22 5TB
United Kingdom
Manufacturer
Mawdsleys Brooks and Co Ltd
Unit 22, Quest Park,
Wheatley Hall Road,
Doncaster,
DN2 4LT,
United Kingdom.
PL 34771/0170
This leaflet was last revised in {06/2016}

ARTWORK CODE 01

complaints may return. Therefore take Tamsumac as long as your
doctor prescribes, even if your complaints have disappeared already.
Always consult your doctor, if you consider stopping this therapy.

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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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