Femstrual 500mg Tablets
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.
I You must contact a doctor or pharmacist if your symptoms
worsen or do not improve.
I 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 i 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)
MANX
Pharma
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 i 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