STRONAZON 400 MICROGRAMS MR CAPSULES

Active substance: TAMSULOSIN HYDROCHLORIDE

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Stronazon 400micrograms
MR capsules
tamsulosin hydrochloride
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
•  eep this leaflet. You may need to read it again.
K
•  f you have any further questions, ask your doctor or
I
your pharmacist.
•  his medicine has been prescribed for you only. Do
T
not pass it on to others. It may harm them even if
their signs of illness are the same as yours.
•  f you get any side effects, talk to your doctor or
I
pharmacist. This includes any possible side effects
not listed in this leaflet

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

2 What you need to know before you take

Stronazon

Do not take Stronazon:
•  f you are allergic to tamsulosin hydrochloride or any
I
of the other ingredients of this medicine (listed in
section 6). Symptoms include sudden swelling of hands
or feet, difficulty in breathing and/or itch and rash
(angioedema).
•  f you have a history of being dizzy or fainting when
I
standing suddenly caused by low blood pressure
(orthostatic hypotension).
•  f you have severe liver problems.
I

Warnings and precautions
Talk to your doctor or pharmacist before taking Stronazon
if you:
• suffer from severe kidney problems
• experience dizziness or fainting whilst taking your
medicine. Please sit or lie down straight away until the
symptoms disappear.
• have experienced rapid swelling of the hands or feet,
breathing difficulties (angioedema) and/or skin rash and
itching due to an allergic reaction.
• are planning to have cataract surgery (cataract removal
eye surgery): Tell you ophthalomologist if you have
used or are currently using this drug (or any other
tamsulosin containing drug). This will influence your
doctor’s decisions concering your medication as well as
the surgery technique to be used. Ask your doctor if you
should stop taking the medication for the duration of the
surgery.

1 What Stronazon is and what it is used for

Stronazon modified-release capsules are used to treat
symptoms caused by an enlarged prostate gland (benign
prostatic hyperplasia BPH).
The prostate gland surrounds the urethra (the tube with
which urine passes from the bladder). When the prostate
gland is enlarged it presses on the urethra causing it to
narrow, so that it is difficult to pass urine.

Children and adolescents
Do not give this medicine to children or adolescents under
18 years because it does not work in this population.

Stronazon modified-release capsules relax the muscles in
the prostate gland, making the urethra wider and easing
the passing of urine.

Other medicines and Stronazon

Before starting treatment with Stronazon, your doctor may
want to carry out tests to check that you do not have any
other conditions which are causing your symptoms.

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
• When used with other alpha 1A‑blockers e.g. doxazosin,
prazosin and indoramin. If you take these with Stronazon
your blood pressure may fall.
• Diclofenac (an anti-inflammatory painkiller) and warfarin
(used to thin blood) may affect the way that Stronazon is
handled by your body.

Stronazon with food and drink
Tamsulosin should be taken after the first meal of the day.
Taking tamsulosin on an empty stomach may aggravate its
adverse effects.
Continued over page

Continued top of next column
AAAE3366

Tamsulosin (Stronazon) 0.4mg Capsules 30pk PIL - UK

colours/plates:
1. Black

item no:
print proof no:
origination date:

AAAE3366
5
17.12.12

originated by:
approved for print/date

02.01.13

170x240

min pt size:

revised by:
supplier:

DR
Synthon Spain

2.
3.

pharmacode:

4.
8pts

5.
6.

DR

revision date:

dimensions:

Non Printing Colours

Technical Approval
date sent:

24.09.12

technically app. date:

01.10.12

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

Pregnancy and breast-feeding
Stronazon is intended for males only.

Driving and using machines
Stronazon should not affect your ability to drive or use
machinery. However, in some people Stronazon may cause
dizziness, if you are affected do not drive or use machinery.

3 How to take Stronazon

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Take after the first meal of the day whilst standing or
sitting upright (not lying down). Swallow whole with a
glass of water. Do not open the capsule this will affect
how the medicine works.

· Rare (occurs in less than 1 in 1,000 users): swelling of hands
or feet, difficulties in breathing and/or itch and rash
(angioedema). Symptoms of low blood pressure (dizziness,
fainting or weakness) occur rarely, sit or lie down straight
away until the symptoms disappear. If you do not feel
better please contact your doctor.
· Very rare (occurs in less than 1 in 10,000 users): painful,
prolonged, unwanted erection (priapism), severe skin
flushing (Stevens-Johnson syndrome).
• Frequency not known: There have been reports of
irregular heart beat/pulse rate, racing heart and difficulty
breathing associated with Tamsulosin use.
Changes in the eye have been noticed during cataract
surgery.
If you get any side effects, talk to your doctor or pharmacist.
This includes any side effects not listed in this leaflet.

The recommended dose is one capsule a day.

5 How to store Stronazon

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.

Keep this medicine out of the sight and reach of children.
Store in the original package.
Keep the container tightly closed.
Do not use Stronazon after the expiry date which is stated on
the label, blister and 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 to protect the environment.

If you take more than you should
The symptoms of overdose are low blood pressure,
vomiting and diarrhoea.
If you (or someone else) swallow a lot of capsules at the
same time, or you think a child may have swallowed any,
contact your nearest hospital casualty department or tell
your doctor immediately.

6 Contents of the pack and other information
What Stronazon contains

If you forget to take the capsules

• The active substance (the ingredient that makes the
capsule work) is tamsulosin hydrochloride.
• The other ingredients are microcrystalline cellulose,
methacrylic acid-ethyl acrylate copolymer (1:1), polysorbate
80, sodium laurilsulfate, triethyl citrate and talc. The capsule
body ingredients are gelatine, indigo carmine (E 132),
titanium dioxide (E 171), yellow iron oxide (E 172), red iron
oxide (E 172), black iron oxide (E 172), and printing ink
(black iron oxide E 172, shellac, propylene glycol).

Do not take a double dose to make up for a forgotten
dose. If you forget to take a dose after the first meal of the
day, it can be taken later the same day after food. If you
have missed a day skip the forgotten dose and then take
the next dose at the right time.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4 Possible side effects

What Stronazon looks like and contents of the pack

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

The Stronazon modified-release capsules are orange/olivegreen in colour with a black stripe at both ends of the capsule
body and marked with black “TSL 0.4”.

Stop taking Stronazon and contact your doctor at
once if you experience sudden swelling of hands or feet,
difficulties in breathing and/or itch and rash, caused by an
allergic reaction (angio-oedema).

Pack sizes are 30
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK.

Tell your doctor if you notice any of the following side
effects or notice any other effects not listed:
• Common (occurs in less than 1 in 10 users): dizziness,
ejaculation disorders.
• Uncommon (occurs in less than 1 in 100 users):
headache, rapid or irregular heart beat, dizziness
especially when sitting or standing up, nasal
inflammation causing a runny nose, constipation,
diarrhoea, feeling sick, being sick, rash, itching,
feeling of weakness.

Manufacturer
Synthon Hispania S. L., Castelló, 1, Polígono
Las Salinas, Sant Boi de Llobregat, Spain.
Date of revision: December 2012

Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column
AAAE3366

Tamsulosin (Stronazon) 0.4mg Capsules 30pk PIL - UK

colours/plates:
1. Black

item no:
print proof no:
origination date:

AAAE3366
5
17.12.12

originated by:
approved for print/date

02.01.13

170x240

min pt size:

revised by:
supplier:

DR
Synthon Spain

2.
3.

pharmacode:

4.
8pts

5.
6.

DR

revision date:

dimensions:

Non Printing Colours

Technical Approval
date sent:

24.09.12

technically app. date:

01.10.12

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

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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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