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.

• Please keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    You must contact a doctor if your symptoms worsen or do not improve.

•    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.

•    In this leaflet, Menstralite 500 mg tablets will be called Menstralite.

In this leaflet:

1.    What this medicine is and what it is used for

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further information

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.

Tranexamic acid belongs to a group of medicines known as anti-fibrinolytics which are used to prevent or reduce bleeding. When you bleed your body forms clots as part of the healing process. In some people these blood clots do not stay in place long enough, causing too much bleeding to occur. Tranexamic acid helps these clots to stay in place.

This medicine is only used for the reduction of heavy menstrual bleeding over several cycles in women aqed 18 to 45 with reqular menstrual cycles.

2.    BEFORE YOU TAKE THIS MEDICINE

You must only take this medicine if your periods are heavy AND reqular.

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 this medicine if your periods are not heavy.

How do I know if my periods are reqular?

Your periods are regular if noth of the following apply to you:

•    your menstrual cycle (i.e. the number of days between the 1^st day of one period and the 1^st day of the next) is between 2l 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 this medicine if your periods are not reqular.

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);

•    you are under 18 years of age;

•    you have irregular menstrual bleeding;

•    you are pregnant;

•    you are taking oral contraceptives ("the pill");

•    you have kidney disease;

•    you have blood in your urine between your periods;

•    you have or have ever had a blood clot in your blood vessels (called a "thrombosis");

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 known as anticoagulants which stop your body making blood clots (e.g. warfarin).

If any of the above applies to you, do not take this medicine.

Warninq siqns 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.

Take special care with this medicine and tell your doctor or pharmacist if:

•    you have recently noticed a change in your normal bleeding pattern;

•    you are over 45 years old;

•    you have a close female relative who has had 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 treatinq your symptoms.

Warninq siqns 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: Reqular AND heavy periods alone are unlikely to be caused by endometrial cancer.

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 nignt.

•    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

M SOVEREIGN

Medical