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FEMSTRUAL 500MG TABLETS

Active substance(s): TRANEXAMIC ACID

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PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER

Femstrual 500mg Tablets
Tranexamic Acid

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 Femstrual carefully to get the best
results from it.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
You must contact a doctor or pharmacist if your symptoms
worsen or do not improve.
If any of the side effects gets serious, or if you notice any side
effect not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet, Femstrual 500mg Tablets will be called Femstrual.
In this leaflet
1. What Femstrual is and what it is used for
2. Before you take Femstrual
3. How to take Femstrual
4. Possible side effects
5. How to store Femstrual
6. Further information

1. What Femstrual is and what it is used for
Femstrual is an antifibrinolytic agent and is used to help reduce
bleeding. When you bleed your body forms clots or plugs as part of
healing. In some people these plugs do not stay in place long enough.
This can cause too much bleeding. Femstrual helps these plugs to
stay in place.
Femstrual is used only when your periods are regular to control
heavy menstrual bleeding (see section 2 if you are unsure whether or
not you have regular periods). Femstrual reduces the amount of blood
lost during your period but may not help other symptoms such as
period pain.
Heavy menstrual bleeding can cause anaemia (reduction in red blood
cells). People with anaemia may look pale and feel tired, weak and
dizzy or faint. If you think you have anaemia, you should see your
doctor.

2. Before you take Femstrual
How do I know if my periods are heavy?
Your periods are heavy if:
you bleed through to your clothes or onto bedding at night called "flooding"
you need to change your sanitary protection every 2 hours or
more often
you need to use double sanitary protection (tampon plus towels)
you pass large blood clots
your periods prevent you from doing normal activities, such as
going out, working or shopping.
Do not take Femstrual if your periods are not heavy.
How do I know if my periods are regular?
Your periods are regular if both of the following apply to you:
your menstrual cycle (i.e. the number of days between the 1st day
of one period and the 1st day of the next) is between 21 and 35
days long
your menstrual cycle is about the same number of days long each
time (i.e. does not change by more than 3 days each time).
Do not take Femstrual if your periods are not regular.

Do not take Femstrual if:
you are allergic to tranexamic acid or any of the other ingredients
in Femstrual (listed in section 6)
you are under 18 years of age
your periods are irregular
you are pregnant
you are taking the combined oral contraceptive ("the pill")
you have kidney disease
you have blood in your urine between your periods
you have disseminated intravascular coagulation (DIC), a disease
where your blood starts to clot throughout your body
you have or have ever had a blood clot, for example in your leg or
lungs. See immediately below for the warning signs of a blood
clot.
anyone in your family has suffered from blood clots in their
blood vessels
you are taking medicines to prevent or treat blood clots (e.g.
warfarin).
If any of the above applies to you, do not take Femstrual.
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
fainting
coughing up blood.
If you experience any of these symptoms you should see your
doctor immediately.
Check with your doctor before starting Femstrual if:
you have recently noticed a change in your normal bleeding
pattern
you are over 45 years old
your mother, grandmother, aunt or sister has suffered from
endometrial cancer
you are diabetic
you are very overweight (obese)
you have polycystic ovary syndrome (PCOS)
you have abnormal bleeding between your periods
you bleed after sexual intercourse
you thought you had gone through the menopause, but now you
have started bleeding again
you have pain during sexual intercourse
you have pain before the start of your period (also known as
premenstrual pain)
you have pelvic pain (pain in the lower abdomen).
Your doctor may prescribe a different medicine which is better for
treating your symptoms.
Warning signs of endometrial cancer
Occasionally heavy periods may be due to an abnormality of the lining
of the womb. One of the most serious conditions is endometrial
cancer. There are almost always other warning signs of endometrial
cancer such as:
irregular periods
prolonged periods
abnormal bleeding between periods.
If any of the above applies to you, see your doctor.
Important: Regular AND heavy periods alone are unlikely to be
caused by endometrical cancer.
(continued overleaf)

Tell your doctor or pharmacist before starting Femstrual if you are
taking any of the following medicines:
the "pill" (a combined oral contraceptive). You must not take
Femstrual 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 Femstrual 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 Femstrual.
Driving and using machines
Femstrual should not have an effect on your ability to drive or use
machinery.

3. How to take Femstrual
Remember:
Femstrual should only be taken on the days when your period is
heavy.
Do not take Femstrual before your period has started as it will not
work properly.
Swallow the tablets whole, with water if needed. Do not crush or
chew them.
Do not take Femstrual 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:
Femstrual is not for use in the elderly.
Using Femstrual every month
Femstrual may be used every month as long as it continues to reduce
your bleeding AND there are no changes in your bleeding pattern.
If Femstrual is not working
See your doctor if:
your bleeding has not been reduced by Femstrual after using it for
3 periods in a row
Femstrual seems to have stopped working.
If you take more Femstrual than you should
As with all medicines, an overdose of Femstrual could be dangerous.
If you have taken an overdose tell your doctor or go to the nearest
hospital casualty department immediately.
If you forget to take Femstrual
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, Femstrual can cause side effects, although not
everybody gets them.

Stop taking Femstrual and go immediately to hospital if you
experience any of the following rare symptoms:
pain or feelings of heaviness in your chest
unusual pain or swelling in your arms or legs
sudden shortness of breath
fainting
coughing up blood.
You may have developed a blood clot in your leg, kidney or lungs.
If you experience any of the following rare symptoms, stop taking
Femstrual immediately and speak to your doctor:
problems with your eyesight, especially your colour vision
a blood clot in the eye. This may cause bleeding in the eye, or a
loss of vision
itchy, red or swollen skin (allergic reaction)

a blood clot in your blood vessels (thrombosis) or kidney
(leading to renal problems)
fits
low blood pressure that may make you faint or feel dizzy.

Common side effects:
feeling sick
being sick
diarrhoea.
These are usually mild and pass very quickly, but if they continue, stop
taking Femstrual and tell your doctor or pharmacist.
If any of the side effects gets serious, or you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
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.

5. How to store Femstrual
Keep out of the sight and reach of children.
This product should not be used after the expiry date which
appears on the carton and blister strips. The expiry date refers to
the last day of that month.
Do not store above 250C. Store in the original carton.
Medicines should not be disposed of via wastewater or household
waste. Ask you pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. Further Information
What Femstrual contains
Each tablet contains 500mg of tranexamic acid. The tablets also
contain calcium hydrogen phosphate anhydrous, croscarmellose
sodium, povidone, talc and magnesium stearate.
What Femstrual looks like and contents of the pack
The tablets are white and capsule shaped. They are engraved with
"TXA 26" on one side, and are plain on the other side.
They are supplied in cartons containing 18 tablets.
Marketing Authorisation Holder
Manx Healthcare Ltd., Taylor Group House, Wedgnock Lane, Warwick,
CV34 5YA, United Kingdom.
Manufacturer
Recipharm Ltd, Vale of Bardsley, Ashton-under-Lyne, Lancashire,
OL7 9RR, UK or Manx Healthcare Ltd., Taylor Group House,
Wedgnock Lane, Warwick, CV34 5YA,
United Kingdom.
This leaflet was last revised in February 2014
WIP URN: 180214-FM01-PIL-04

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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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