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MENSTRALITE 500 MG TABLETS

Active substance(s): TRANEXAMIC ACID

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Patient Information Leaflet

GB 726-8881-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
If any of the above applies to you, do not take
4. Possible side effects
this medicine.
5. How to store this medicine
6. Further information
Warning signs of a blood clot to look out for:
• pains or feelings of heaviness in your chest;
1. WHAT THIS MEDICINE IS AND WHAT IT IS
• unusual pains or swellings of your arms or one of your
USED FOR
legs;
The name of your medicine is Menstralite 500 mg tablets.
• sudden shortness of breath;
The active ingredient is tranexamic acid.
• fainting;
Tranexamic acid belongs to a group of medicines known
• coughing up blood.
as anti-fibrinolytics which are used to prevent or reduce
If you experience any of these symptoms you
bleeding. When you bleed your body forms clots as part of should see your doctor immediately.
the healing process. In some people these blood clots do
not stay in place long enough, causing too much bleeding Take special care with this medicine and tell your
to occur. Tranexamic acid helps these clots to stay in place. doctor or pharmacist if:
• you have recently noticed a change in your normal
This medicine is only used for the reduction of
bleeding pattern;
heavy menstrual bleeding over several cycles in
• you are over 45 years old;
women aged 18 to 45 with regular menstrual
• you have a close female relative who has had
cycles.
endometrial cancer;
• you are diabetic;
2. BEFORE YOU TAKE THIS MEDICINE
• you are very overweight (obese);
You must only take this medicine if your periods
• you have polycystic ovary syndrome (PCOS);
are heavy AND regular.
• you have abnormal bleeding between your periods;
• you bleed after sexual intercourse;
How do I know if my periods are heavy?
• you thought you had gone through the menopause,
Your periods are heavy if:
but now you have started bleeding again;
• you bleed through to your clothes or onto bedding at
• you have pain during sexual intercourse;
night – called "flooding";
• you have pain before the start of your period (also
• you need to change your sanitary protection every 2
known as premenstrual pain);
hours or more often;
• you have pelvic pain (pain in the lower abdomen).
• you need to use double sanitary protection (tampon
Your doctor may prescribe a different medicine
plus towels);
which is better for treating your symptoms.
• you pass large blood clots;
• your periods prevent you from doing normal activities,
Warning signs of endometrial cancer
such as going out, working or shopping.
Do not take this medicine if your periods are not Occasionally heavy periods may be due to an abnormality
of the lining of the womb. One of the most serious
heavy.
conditions is endometrial cancer. There are almost always
other warning signs of endometrial cancer such as:
How do I know if my periods are regular?
Your periods are regular if both of the following apply to you: • irregular periods;
• your menstrual cycle (i.e. the number of days between • prolonged periods;
the 1st day of one period and the 1st day of the next) is • abnormal bleeding between periods.
If any of the above applies to you, see your
between 21 and 35 days long;
doctor.
• your menstrual cycle is about the same number of
Important: Regular AND heavy periods alone are
days long each time (i.e. does not change by more
unlikely to be caused by endometrial cancer.
than 3 days each time).
Do not take this medicine if your periods are not
regular.
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.

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:
PROJECT:

Taking other medicines
Before taking this medicine, tell your doctor or pharmaci
if 11/11/2014
you are taking any other medicines, especially the
following:
56668
• 13/11/2014
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
MENSTRALITE
without a prescription.
500 MG TABLETS

Pregnancy
and breast-feeding
GB 726-8881-APIL
DoLeaflet
not take this medicine if you are pregnant as it may
cause
problems
148x285
mm for your unborn baby.
If Great
you are
breast-feeding, you should ask your doctor for
Britain
advice
TBC before taking this medicine.
100%

Driving
and using machines
Black
This
medicine is not expected to interfere with your abilit
11/11/2014
to10
drive
pt or use machines.

3.17HOW TO TAKE THIS MEDICINE
VK
Remember:
Medical
• Sovereign
This medicine
should only be taken on the days when
your period is heavy.
• Do not take this medicine before your period has
as it will not work properly.
REGULATORYstarted
AUTHORITY
Swallow the tablets whole, with water if needed.
APPROVAL•CONFIRMATION
Do has
not been
takeapproved
this medicine
for more than 4 days durin
Confirmation that this •
artwork
by
the appropriate market authority
(if applicable,
e.g.
each of
your periods.
MHRA, IMB, etc and that Amdipharm have license
approval to distribute this component for sale in the
relevent market.

Adults:
• The usual dose is two tablets taken 3 times a day (e.g
in the morning, afternoon and evening) for up to 4
Accept Artwork .................................................................
days.
• If your bleeding is not reduced, you can take an extra
Reject Artwork ..................................................................
2 tablets at night.
• Heavy bleeding usually only lasts for the first two day
Signature ..........................................................................
of your period. When the bleeding becomes less, you
should reduce the number of tablets you take, for
Name .................................................................................
example, to 2 tablets twice a day.
• Do not take more than 8 tablets per day.
Date ...................................................................................
Children under 18 years of age:
• Do not give to children under 18 years of age.

PAGEElderly:
1 OF 2

• 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.

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: October 2014

Received Date:
CDL JOB No. :
Required By :

11/11/2014
56668
13/11/2014

PRODUCT NAME:

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

MENSTRALITE
500 MG TABLETS
GB 726-8881-APIL
Leaflet
148x285 mm
Great Britain
TBC
100%
Black
11/11/2014
10 pt
17
VK
Sovereign Medical

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 Amdipharm have license
approval to distribute this component for sale in the
relevent market.
Accept Artwork .................................................................
Reject Artwork ..................................................................
Signature ..........................................................................
Name .................................................................................
Date ...................................................................................

PAGE 2 OF 2

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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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