DICYNENE 500 TABLETS

Active substance: ETAMSYLATE

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Etamsylate

Read all of this leaflet carefully before you start
taking this medicine
• 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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• 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.
In this leaflet:
1. What Dicynene is and what it is used for
2. Before you take Dicynene
3. How to take Dicynene
4. Possible side effects
5. How to store Dicynene
6. Further information
1. What Dicynene is and what it is used for
Dicynene contains a medicine called etamsylate. This
belongs to a group of medicines called haemostatics. It
works by stopping the flow of blood from the small tubes
(vessels) in the womb (uterus).
It is used to treat:
• Unusually heavy bleeding during a menstrual period
(menorrhagia)
• Unusually heavy bleeding caused by an intrauterine
contraceptive device (IUCD) such as the coil
2. Before you take Dicynene
Do not take this medicine and tell your doctor if:
 You are allergic (hypersensitive) to etamsylate or any of
the other ingredients of Dicynene (listed in Section 6:
Further information)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue.
 You have benign (not cancerous) growths in your
womb (fibroids)
 You have a rare illness called ‘porphyria’ which
affects your metabolism
 You are pregnant or breast-feeding (see ‘Pregnancy and
breast-feeding’ below)
Do not take this medicine if any of the above apply to
you. If you are not sure, talk to your doctor or
pharmacist before taking Dicynene.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines you buy without a prescription, including
herbal medicines. This is because Dicynene can affect the
way some other medicines work. Also some medicines
can affect the way Dicynene works.
Pregnancy and breast-feeding
Do not take Dicynene if you are pregnant, might become
pregnant or think you may be pregnant.
Do not breast-feed if you are taking Dicynene. This is
because small amounts may pass into mothers’ milk. If
you are breast-feeding or planning to breast-feed, talk to
your doctor or pharmacist before taking any medicine.

If you forget to take Dicynene
Do not take a double dose to make up for a forgotten
tablet.
If you stop taking Dicynene
Keep taking Dicynene until your doctor tells you to stop.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects

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Important information about some of the
ingredients of Dicynene
Dicynene contains:
• Small amounts of sulphites. These may cause
severe allergic (hypersensitivity) reactions and
difficulty in breathing (bronchospasm). This is more
likely to happen if you have a history of asthma or
allergies. The chances of this happening are rare.
Stop taking the tablets if you get a rash, swallowing
or breathing problems and swelling of your lips, face,
throat or tongue
• Wheat starch. People with wheat allergy should not
take this medicine. Wheat allergy is not the same as
Coeliac disease. Dicynene can be taken by people
with Coeliac disease
3. How to take Dicynene

Taking this medicine
• If you feel the effect of your medicine is too weak or
too strong, do not change the dose yourself, but ask
your doctor
• Take this medicine by mouth
• Swallow the tablets whole with a drink of water. Do
not crush or chew your tablets
• Take the tablets after food. This is to stop you from
feeling sick
How much to take
• One tablet four times each day
from the start of your menstrual
period. It is important to start
taking the tablets only once your
period has started and not before
• Continue taking the tablets until
your period has finished and
bleeding stops
Turn
Over

6. Further information
What Dicynene contains
• Each tablet contains 500 mg of the active substance,
etamsylate
• The other ingredients are sodium sulphite anhydrous
(E221), sodium dihydrogen citrate, microcrystalline
cellulose, povidone, wheat starch and stearic acid
What Dicynene looks like and contents of the pack
The tablets are white and capsule-shaped with D500
imprinted on one side and a breakline on the other side.
The tablets are available in blister packs of 28 and 100
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

Also you can help to make sure that medicines remain as
safe as possible by reporting any unwanted side effects via
the internet at www.mhra.gov.uk/yellowcard. Alternatively
you can call Freephone 0808 100 3352 (available from 10
a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form
available from your local pharmacy.

Marketing Authorisation Holder
OM PHARMA S.A.
Rua da Indústria n°2
Quinta Grande
2610-088 Amadora
Lisbon - Portugal
Tel.: +351 21 470 85 00
Fax: +351 21 470 85 06
e-mail: mailbox@ompharma.pt

Stop taking Dicynene and see a doctor or go to a
hospital straight away if:
• You have an allergic reaction. The signs may include:
a rash, swallowing or breathing problems, swelling of
your lips, face, throat or tongue

Manufacturer
Sanofi Winthrop Industrie
6 Boulevard de L’Europe
21800 Quetigny
France

Stop taking Dicynene and see a doctor as soon as
possible if:
• You have a high temperature (fever)

This leaflet does not contain all the information about
your medicine. If you have any questions or are not sure
about anything, ask your doctor or pharmacist.

Tell your doctor or pharmacist if any of the following
side effects get serious or lasts longer than a few
days. Also tell them if you notice any side effects not
listed in this leaflet:
• Headache
• Skin rashes
• Feeling sick or being sick, diarrhoea

This leaflet was last revised in April 2013.

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

5. How to store Dicynene
Keep this medicine in a safe place where children cannot
see or reach it
Do not use Dicynene after the expiry date which is stated
on the carton after ‘EXP:’. The expiry date refers to the
last day of that month.
Do not take Dicynene if you notice your tablets are
crumbling, broken or discoloured.

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Do not store above 25°C. Store in the original packaging.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.

Notice Uro-Vaxom
GB
210 x 148 mm
GB-DI500 notice 0813
258679
39
13-08-2013

Pantone Reflex Blue

Polices de caractères:
Texte:
OCEAN SANS-ZAPF DINGBATS

Always take Dicynene exactly as your doctor has told you.
You should check with your doctor or pharmacist if you
are not sure.

1

If you take more Dicynene than you should
If you take more tablets than you should, tell a doctor or
go to a hospital casualty department straight away. Take
the medicine pack with you. This is so the doctor knows
what you have taken. The following effects may happen:
headache, feeling or being sick, diarrhoea, rash.

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G RAPHISME P UBLICITÉ E DITION
4, RTE DES J EUNES - 1227 L ES A CACIAS
T ÉL . +4122 345 16 65 - F AX +4122 345 16 67

*200014*

Dicynene® 500 Tablets

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

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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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