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MENSTRALITE 500 MG TABLETS

Active substance(s): TRANEXAMIC ACID

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Size: 148 x 285 mm
Patient Information Leaflet

GB 674-5244-APIL

MENSTRALITE™ 500 mg tablets
Tranexamic acid

Do not take this medicine if:
• you are allergic to tranexamic acid or any of the other
ingredients (please refer to section 6, Further
Information, for the full list of ingredients) of this
medicine (allergic reactions include mild symptoms
such as itching and/or rash. More severe symptoms
include swelling of the face, lips, tongue and/or throat
with difficulty in swallowing or breathing);
• Please keep this leaflet. You may
• you are under 18 years of age;
need to read it again.
• you have irregular menstrual bleeding;
• If you have any further questions, ask your doctor or • you are pregnant;
pharmacist.
• you are taking oral contraceptives ("the pill");
• You must contact a doctor if your symptoms worsen or • you have kidney disease;
do not improve.
• you have blood in your urine between your periods;
• If any of the side effects becomes severe, or if you
• you have or have ever had a blood clot in your blood
notice any side effects not listed in this leaflet, please
vessels (called a "thrombosis");
tell your doctor or pharmacist.
See immediately below for the warning signs of a blood
• In this leaflet, Menstralite 500 mg tablets will be called clot.
Menstralite.
• anyone in your family has suffered from blood clots in
their blood vessels;
In this leaflet:
• you are taking medicines known as anticoagulants
1. What this medicine is and what it is used for
which stop your body making blood clots (e.g.
2. Before you take this medicine
warfarin);
3. How to take this medicine
• You have a history of convulsions.
4. Possible side effects
If any of the above applies to you, do not take
5. How to store this medicine
this medicine.
6. Further information
Read all of this leaflet carefully
because it contains important
information for you.
This medicine is available without
prescription. However, you still need to
use these tablets carefully to get the
best results from them.

Warning signs of a blood clot to look out for:
• pains or feelings of heaviness in your chest;
• unusual pains or swellings of your arms or one of your
legs;
• sudden shortness of breath;
Tranexamic acid belongs to a group of medicines known
• fainting;
as anti-fibrinolytics which are used to prevent or reduce
• coughing up blood.
bleeding. When you bleed your body forms clots as part of If you experience any of these symptoms you
the healing process. In some people these blood clots do
should see your doctor immediately.
not stay in place long enough, causing too much bleeding
to occur. Tranexamic acid helps these clots to stay in place. Take special care with this medicine and tell your
doctor or pharmacist if:
This medicine is only used for the reduction of
• you have recently noticed a change in your normal
heavy menstrual bleeding over several cycles in
bleeding pattern;
women aged 18 to 45 with regular menstrual
• you are over 45 years old;
cycles.
• you have a close female relative who has had
endometrial cancer;
2. BEFORE YOU TAKE THIS MEDICINE

you are diabetic;
You must only take this medicine if your periods
• you are very overweight (obese);
are heavy AND regular.
• you have polycystic ovary syndrome (PCOS);
• you have abnormal bleeding between your periods;
How do I know if my periods are heavy?
• you bleed after sexual intercourse;
Your periods are heavy if:
• you thought you had gone through the menopause,
• you bleed through to your clothes or onto bedding at
but now you have started bleeding again;
night – called "flooding";
• you have pain during sexual intercourse;
• you need to change your sanitary protection every 2
• you have pain before the start of your period (also
hours or more often;
known as premenstrual pain);
• you need to use double sanitary protection (tampon
• you have pelvic pain (pain in the lower abdomen).
plus towels);
Your doctor may prescribe a different medicine
• you pass large blood clots;
• your periods prevent you from doing normal activities, which is better for treating your symptoms.
such as going out, working or shopping.
Do not take this medicine if your periods are not Warning signs of endometrial cancer
Occasionally heavy periods may be due to an abnormality
heavy.
of the lining of the womb. One of the most serious
conditions is endometrial cancer. There are almost always
How do I know if my periods are regular?
Your periods are regular if both of the following apply to you: other warning signs of endometrial cancer such as:
• your menstrual cycle (i.e. the number of days between • irregular periods;
the 1st day of one period and the 1st day of the next) is • prolonged periods;
• abnormal bleeding between periods.
between 21 and 35 days long;
If any of the above applies to you, see your
• your menstrual cycle is about the same number of
doctor.
days long each time (i.e. does not change by more
Important: Regular AND heavy periods alone are
than 3 days each time).
Do not take this medicine if your periods are not unlikely to be caused by endometrial cancer.
regular.
1. WHAT THIS MEDICINE IS AND WHAT IT IS
USED FOR
The name of your medicine is Menstralite 500 mg tablets.
The active ingredient is tranexamic acid.

Received Date:
CDL JOB No. :
Required By :

PRODUCT NAME:
PIP CODE:
COMPONENT:
SIZE:
MARKET:
PRODUCT SITE:
SCALE:
COLOURS:
DATE:
FONT SIZE:
VERSION NO:
AMENDED BY:
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Taking other medicines
Before taking this medicine, tell your d
if 21/09/2017
you are taking any other medicines,
following:
60632
• 29/09/2017
the "pill" (a combined oral contrace
not take Menstralite if you are alre
medicine;
• fibrinolytic drugs such as streptokin
dissolve blood clots);
• tamoxifen (a drug used to treat br
• an oestrogen;
• any other medicine, including med
MENSTRALITE
without a prescription.
500 MG TABLETS

Pregnancy
and breast-feeding
GB 674-5244-APIL
DoLeaflet
not take this medicine if you are pr
cause
problems
148x285
mm for your unborn baby.
If Great
you are
breast-feeding, you should a
Britain
advice
TBC before taking this medicine.
100%

Driving
and using machines
Black
This
medicine is not expected to interfe
26/09/2017
to10
drive
pt or use machines.

3.1 HOW TO TAKE THIS MEDICIN
VK
Remember:
Medical
• Sovereign
This medicine
should only be taken
your period is heavy.
• Do not take this medicine before y
as it will not work properly
REGULATORYstarted
AUTHORITY
Swallow the tablets whole, with wa
APPROVAL •CONFIRMATION
Do not
takeapproved
this medicine
for more
Confirmation that this •
artwork
has been
by
the appropriate market authority
e.g.
each of(if applicable,
your periods.
MHRA, IMB, etc and that Waymade Plc have license
approval to distribute this component for sale in the
relevent market.

Adults:
• The usual dose is two tablets taken
in the morning, afternoon and eve
Accept Artwork .................................................................
days.
• If your bleeding is not reduced, yo
Reject Artwork ..................................................................
2 tablets at night.
• Heavy bleeding usually only lasts f
Signature ..........................................................................
of your period. When the bleeding
should reduce the number of table
Name .................................................................................
example, to 2 tablets twice a day.
• Do not take more than 8 tablets pe
Date ...................................................................................

Children under 18 years of age:
• Do not give to children under 18 y

PAGEElderly:
1 OF 2

• This medicine is not for use in the e

Using Menstralite every month
• This medicine may be used every m
continues to reduce your bleeding
changes in your bleeding pattern.

If your medicine is not working
See your doctor if:
• your bleeding has not been reduce
after using it for 3 periods in a row
• your medicine seems to have stopp

If you take more tablets than yo
If you accidentally take too many tabl
contact your doctor immediately, or go
hospital casualty department.

If you forget to take your medici
Do not take a double dose to make up
Take your next dose at the usual time.

If you have any further questions on t
product, ask your pharmacist.

Taking other medicines
Before taking this medicine, tell your doctor or pharmacist
if you are taking any other medicines, especially the
following:
• the "pill" (a combined oral contraceptive). You must
not take Menstralite if you are already taking this
medicine;
• fibrinolytic drugs such as streptokinase (used to
dissolve blood clots);
• tamoxifen (a drug used to treat breast cancer);
• an oestrogen;
• any other medicine, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant as it may
cause problems for your unborn baby.
If you are breast-feeding, you should ask your doctor for
advice before taking this medicine.
Driving and using machines
This medicine is not expected to interfere with your ability
to drive or use machines.
3. HOW TO TAKE THIS MEDICINE
Remember:
• This medicine should only be taken on the days when
your period is heavy.
• Do not take this medicine before your period has
started as it will not work properly.
• Swallow the tablets whole, with water if needed.
• Do not take this medicine for more than 4 days during
each of your periods.
Adults:
• The usual dose is two tablets taken 3 times a day (e.g.
in the morning, afternoon and evening) for up to 4
days.
• If your bleeding is not reduced, you can take an extra
2 tablets at night.
• Heavy bleeding usually only lasts for the first two days
of your period. When the bleeding becomes less, you
should reduce the number of tablets you take, for
example, to 2 tablets twice a day.
• Do not take more than 8 tablets per day.
Children under 18 years of age:
• Do not give to children under 18 years of age.
Elderly:
• This medicine is not for use in the elderly.
Using Menstralite every month
• This medicine may be used every month as long as it
continues to reduce your bleeding AND there are no
changes in your bleeding pattern.
If your medicine is not working
See your doctor if:
• your bleeding has not been reduced by this medicine
after using it for 3 periods in a row;
• your medicine seems to have stopped working.
If you take more tablets than you should
If you accidentally take too many tablets you should
contact your doctor immediately, or go to the nearest
hospital casualty department.
If you forget to take your medicine
Do not take a double dose to make up for a missed dose.
Take your next dose at the usual time.
If you have any further questions on the use of this
product, ask your pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines these tablets can cause unwanted side
effects in some people, although it is generally well
tolerated.
Stop taking this medicine and go immediately to
hospital if you experience any of the following
rare symptoms:
• pain or feelings of heaviness in your chest;
• sudden shortness of breath;
• coughing up blood;
• unusual pain or swelling in your arms or legs;
• fainting.
You may have developed a blood clot in your leg or lungs.
Stop taking this medicine and tell your doctor
immediately if you experience these rare side effects:
• problems with your eyesight, especially your colour
vision;
• an allergic skin reaction (mild symptoms include
itching and/or rash: more severe symptoms include
swelling of the face, lips, tongue and/or throat with
difficulty in swallowing or breathing).
Other side effects include:
• nausea;
• vomiting;
• diarrhoea.
If any of the side effects becomes severe, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist immediately.
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
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 THIS MEDICINE
Do not store above 25°C. Keep the container tightly closed
and store in the original container. Do not use after the
expiry date that is stated on the carton.
KEEP ALL MEDICINES OUT OF THE SIGHT AND
REACH OF CHILDREN.
Return any unused medicine to your pharmacist.
6. FURTHER INFORMATION
What these tablets contain
Each tablet contains 500 mg of the active substance,
tranexamic acid. The other ingredients are:
microcrystalline cellulose, povidone K90, croscarmellose
sodium, colloidal anhydrous silica, talc, magnesium
stearate, methacrylate polymers, titanium dioxide (E171),
macrogol 8000 and vanillin.
What these tablets look like and the contents of
the pack
Menstralite 500 mg tablets are white to off-white, oblong
and biconvex with a breakline and marked “TA” on one
side of the breakline. They are available in packs of 12
and 18 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:
Waymade Plc trading as Sovereign Medical, Sovereign
House, Miles Gray Road, Basildon, Essex SS14 3FR, United
Kingdom.
Date of preparation: August 2017

Received Date:
CDL JOB No. :
Required By :

21/09/2017
60632
29/09/2017

PRODUCT NAME:

MENSTRALITE
500 MG TABLETS
GB 674-5244-APIL
Leaflet
148x285 mm
Great Britain
TBC
100%
Black
26/09/2017
10 pt
1
VK
Sovereign Medical

PIP CODE:
COMPONENT:
SIZE:
MARKET:
PRODUCT SITE:
SCALE:
COLOURS:
DATE:
FONT SIZE:
VERSION NO:
AMENDED BY:
PROJECT:

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Waymade Plc have license
approval to distribute this component for sale in the
relevent market.
Accept Artwork .................................................................
Reject Artwork ..................................................................
Signature ..........................................................................
Name .................................................................................
Date ...................................................................................

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