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PETYME 400 MICROGRAMS MR CAPSULES

Active substance(s): TAMSULOSIN HYDROCHLORIDE

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PETYME 400 micrograms
MR CAPSULES

• Rarely, fainting can occur during the use of
Petyme 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
Tamsulosin Hydrochloride
disappeared
PACKAGE LEAFLET: INFORMATION FOR THE USER • If you suffer from severe kidney problems, tell
your doctor
Read all of this leaflet carefully before you start
• If you are undergoing or have been scheduled
taking this medicine because it contains
for eye surgery because of cloudiness of the
important information for you.
lens (cataract) or increased pressure in the eye
• Keep this leaflet. You may need to read it again.
(glaucoma), please inform your eye specialist
• If you have any further questions, ask your
that you have previously used, are using, or are
doctor or pharmacist.
planning to use Petyme. The specialist can then
• This medicine has been prescribed for you only.
take appropriate precautions with respect to
Do not pass it on to others. It may harm them,
medication and surgical techniques to be used.
even if their signs of illness are the same as
Ask your doctor whether or not you should
yours.
postpone or temporarily stop taking this
• If you get any side effects, talk to your doctor or
medicine when undergoing eye surgery
pharmacist. This includes any possible side
because of a cloudy lens (cataract) or increased
effects not listed in this leaflet. See section 4.
pressure in the eye (glaucoma).
Children and adolescents:
WHAT IS IN THIS LEAFLET:
Do not give this medicine to children or
1. What Petyme is and what it is used for
adolescents under 18 years because it does not
2. What you need to know before you take Petyme work in this population.
3. How to take Petyme
Other medicines and Petyme
4. Possible side effects
Tell your doctor or pharmacist if you are taking,
5. How to store Petyme
have recently taken or might take any other
6. Contents of the pack and other information
medicines.
WHAT PETYME IS AND WHAT IT IS USED Talk to your doctor if you are taking any of the
following:
FOR
• any other alpha1-adrenoceptor antagonists
Petyme is the brand name of your medicine. It is
(medicines used to treat prostatic disease)
sometimes known by the name of the active
e.g. alfuzosin, doxazosin or terazosin
ingredient, tamsulosin hydrochloride.
• diclofenac (an anti-inflammatory painkiller)
The active ingredient in Petyme is tamsulosin. This • warfarin (used to prevent blood clotting)
is a selective α 1A/1D-adrenoceptor antagonist. It
• ketoconazole (used to treat fungal infections).
reduces tension of the smooth muscles in the
Pregnancy, breast-feeding and fertility
prostate and the urethra, enabling urine to pass
Petyme is not indicated in women.
more readily through the urethra and facilitating
In men, abnormal ejaculation has been reported
urination. In addition, it diminishes sensations of
(ejaculation disorder).This means that the semen
urge.
does not leave the body via the urethra, but instead
Petyme is used in men for the treatment of the
goes
into the bladder (retrograde ejaculation) or
complaints of the lower urinary tract associated
with an enlarged prostatic gland (benign prostatic the ejaculation volume is reduced or absent
(ejaculation failure). This phenomenon is harmless.
hyperplasia). These complaints may include
Driving and using machines
difficulty urinating (poor stream), dribbling,
There is no evidence that Petyme affect the ability
urgency and having to urinate frequently at night
to drive or to operate machinery or equipment.
as well as during the day.
However, you should bear in mind that dizziness
WHAT YOU NEED TO KNOW BEFORE YOU can occur, in which case you should not undertake
activities that require attentiveness.
TAKE PETYME
DO NOT take Petyme if you:
HOW TO TAKE PETYME
• are allergic to tamsulosin hydrochloride or any
of the other ingredients of this medicine (listed
Always take this medicine exactly as your doctor
in section 6). Hypersensitivity may present as
has told you. Check with your doctor or
sudden local swelling of the soft tissues of the
pharmacist if you are not sure.
body (e.g. the throat or tongue), difficult
Adult males including older people
breathing and / or itching and rash (angioedema). • The recommended dose is one capsule a day,
• suffer from fainting due to reduced blood
which should be taken after breakfast or the first
pressure when changing posture (e.g. when
meal of the day
sitting up from lying down or when standing up) • The capsule should be swallowed whole and
• suffer from severe liver problems.
not be crunched or chewed
Warnings and precautions
• Usually, Petyme is prescribed for long periods
Talk to your doctor or pharmacist before taking
of time. The effects on the bladder and on
Petyme:
urination are maintained during long-term
• Periodic medical examinations are necessary to
treatment with Tamsulosin Modified-Release
monitor the development of the condition you
Capsules.
are being treated for

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If you take more Petyme than you should
Taking too many Petyme 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 many
Tamsulosin Modified-Release Capsules.
If you forget to take Petyme
You may take your daily Petyme 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 capsule.
If you stop taking Petyme
When treatment with Petyme is stopped
prematurely, your original complaints may return.
Therefore use Tamsulosin Modified-Release
Capsules 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.
Stop taking the capsules and tell your doctor
immediately or go to the casualty department at
your nearest hospital if the following happens:
• an allergic reaction (swelling of the lips, face or
neck leading to severe difficulty in breathing;
skin rash or hives)
• a serious illness with blistering of the skin,
mouth, eyes and genitals called
Stevens-Johnson syndrome (may affect up to 1
in 10,000 people).
These are very serious but rare side effects. You may
need urgent medical attention or hospitalisation.
The following side effects have been reported.
Common (may affect up to 1 in 10 people):
• dizziness
• 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 (may affect up to 1 in 100 people):
• headache
• rapid heart beat
• dizziness (due to low blood pressure) especially
when sitting or standing up
• runny and itchy nose
• diarrhoea, constipation, nausea (feeling sick),
vomiting
• itching, rash including nettle rash (hives)
• feeling of weakness.
Rare (may affect up to 1 in 1000 people):
• fainting
• serious allergic reaction which causes swelling
of the face or throat.
Very rare (may affect up to 1 in 10,000 people):
• prolonged and painful erection that can last
from several hours up to a few days.
Not known (frequency cannot be estimated from
the available data)

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• abnormal irregular heart rhythm (atrial
fibrillation, arrhythmia, tachycardia)
• difficult breathing (dyspnoea)
• blurred vision
• impaired vision
• nose bleed (epistaxis)
• retrograde ejaculation, ejaculation failure
• serious skin rashes (erythema multiform,
dermatitis exfoliative)
• dry mouth.
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 Petyme, the pupil
may dilate poorly and the iris (the coloured
circular part of the eye) may become floppy during
the procedure.
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 via the Yellow Card Scheme at:
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 PETYME

Keep this medicine out of the sight and reach of
children. Store in the original container and keep
the container tightly closed. Do not transfer to
another container.
Do not use this medicine after the expiry date
which is stated on the outer packaging. 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 Petyme capsules contain:
• The active ingredient is tamsulosin
hydrochloride 400 micrograms
The other ingredients are microcrystalline
cellulose, methacrylic acid-ethyl acrylate
copolymer, polysorbate 80, sodium laurilsulfate,
triethyl citrate, talc, gelatin, indigotin (E132),
titanium dioxide (E171), yellow iron oxide (E172),
red iron oxide (E172), black iron oxide (E172).
What Petyme capsules look like and contents of
the pack:
• The Petyme Modified-Release Capsules are
Hard gelatin capsules with an orange coloured
body and olive coloured cap. The capsules are
filled with white to off-white pellets.
• The product is available in pack sizes of 10, 14, 20,
28, 30, 50, 56, 60, 90, 100, 180 or 200 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is TEVA UK
Limited, Eastbourne, BN22 9AG and the company
responsible for manufacture is Synthon Hispania
S.L., Sant Boi de Llobregat, Spain.
This leaflet was last revised: 06/2015
PL 00289/0860
84170-ZD

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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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