NOTICE
ANSM - Updated on : 15/09/2025
Product name
HAIMA 1000 mg, coated granules in sachet
Tranexamic acid
Capsule
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- If the expected effect (reduction in bleeding) has not occurred after the first day, stop treatment and talk to your doctor.
What does this leaflet contain?
1. What is HAIMA 1000 mg, coated granules in sachet and what is it used for?
2. What do I need to know before taking HAIMA 1000 mg, coated granules in a sachet?
3. How do I take HAIMA 1000 mg, coated granules in a sachet?
4. What are the possible side effects?
5. How to store HAIMA 1000 mg, coated granules in sachet?
6. Package contents and other information.
1. WHAT IS HAIMA 1000 mg, coated granules in sachet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Antifibrinolytics - ATC code: B02AA02.
HAIMA is used to reduce heavy menstrual periods and should only be used if you have regular cycles lasting 21 to 35 days, with individual variability of 3 days or less, and you are over 15 years of age.
It contains tranexamic acid, which inhibits the action of the enzyme that dissolves blood clots. This reduces the volume and duration of blood loss.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING HAIMA 1000 mg, coated granules in sachet?
Please note that you should only use HAIMA if you have regular cycles and heavy periods. To find out if this is the case, answer yes to the following two questions:
1. Are your cycles regular, i.e. do they last between 21 and 35 days (with individual variability less than or equal to 3 days)?
2. To avoid leakage, do you need to use double sanitary protection (e.g. two sanitary towels or one sanitary towel plus one tampon) or replace your sanitary protection very frequently?
Never take HAIMA 1000 mg, coated granules in sachet
- if you are taking treatment for blood clots, e.g. in the legs, lungs or brain.
- if you have kidney failure.
- if you have a history of convulsions (epilepsy or seizures).
- if you are taking a combined hormonal contraceptive (pill, vaginal ring or patch).
- if you are allergic to tranexamic acid or any of the other ingredients of this product (listed in section 6).
Warnings and precautions
Talk to your doctor before taking HAIMA if any of the following apply to you:
- You have irregular cycles.
- You or your parents and/or siblings have already had a blood clot.
- You have had blood in your urine between periods.
- You have severe kidney failure.
If you have heavy periods while using a combined hormonal contraceptive ("pill", vaginal ring or patch), you should consult your healthcare professional before taking tranexamic acid.
Certain diseases of the luteus, such as myoma or polyps, may explain the appearance of heavy periods.
If treated, menstrual flow may decrease. If in doubt, consult your gynecologist.
Regular gynecological check-ups are recommended.
Children and adolescents
No clinical data are available on the use of HAIMA in menorrhagic children under 15 years of age.
Other medicinal products and HAIMA 1000 mg, coated granules in sachet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
If HAIMA is taken at the same time as anticoagulants, this could potentially affect the way HAIMA or these anticoagulants work.
HAIMA 1000 mg, coated granules in sachet with food and drink
Not applicable.
Pregnancy and breast-feeding
HAIMA is indicated in cases of repeated heavy menstrual bleeding and is not intended for use during pregnancy. An adverse effect in breast-feeding infants seems unlikely at therapeutic doses. Ask your doctor or pharmacist for advice if you are breast-feeding.
Driving vehicles and operating machinery
Undesirable effects that may affect your ability to drive and use machines have been reported. If you experience dizziness or vision problems, do not drive or operate machinery until the symptoms have disappeared.
HAIMA 1000 mg, coated granules in sachet contains sucrose.
If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
3. HOW DO I TAKE HAIMA 1000 mg, coated granules in sachet?
Always take HAIMA exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The coated granules can be swallowed with a glass of water.
Treatment should be started when you start your period. The recommended dose for adults and teenagers aged 15 and over is 1 sachet 3 times a day for as long as necessary, up to a maximum of 4 days. The dose may be increased if the flow is very heavy. Do not take more than 4 sachets a day (1 sachet every 6 to 8 hours). Your doctor may prescribe a different dose.
If the expected effect (reduction in bleeding) has not occurred after the first day, stop treatment and talk to your doctor.
If you have taken more HAIMA 1000 mg, coated granules in sachet, than you should have
If you have taken more HAIMA than you should have, or if a child has accidentally swallowed it, contact your doctor or hospital immediately for medical advice and appropriate action. Signs of overdose may include dizziness, headache, nausea, diarrhea, low blood pressure, myopathy (damage to the muscular system) and convulsions. An overdose may increase the risk of thrombosis (blood clot formation) if you have a predisposition.
If you forget to take HAIMA 1000 mg, coated granules in sachet
Do not take a double dose to make up for the one you forgot to take;
If you stop taking HAIMA 1000 mg, coated granules in sachet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, HAIMA may cause undesirable effects, but these do not always occur in everyone.
Common (affecting up to 1 in 10 people): nausea, vomiting, diarrhea, stomach ache, headache, dizziness. These side effects are often mild and transient.
Uncommon (affecting up to 1 in 100 people): allergic skin reactions.
Undetermined frequency (frequency cannot be estimated on the basis of available data): rare cases of blood clots, changes in color vision and other visual problems, convulsions.
If the effect of HAIMA is not sufficient or if you cannot tolerate HAIMA, there are other methods of treating heavy periods. Contact your gynecologist for information on these methods.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE HAIMA 1000 mg, coated granules in sachet?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging after EXP. The expiration date refers to the last day of that month.
No special storage precautions are required.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What HAIMA 1000 mg coated granules in sachet contains
- The active substance is :
Tranexamic acid...................................................................................................... 1000 mg
For one sachet.
- The other components are :
Sugar spheres (sucrose, corn starch), povidone K30 (E1201), sucralose (E955), colloidal anhydrous silica (E551), 30 percent polyacrylate dispersion, talc (E553B).
What HAIMA 1000 mg coated granules in sachet is and what it contains
1,750 mg coated granules in sachet (PEBD/Aluminium/PEBD/paper).
White to off-white coated granules.
Box of 12 sachets.
Marketing authorization holder
CEMAG CARE
55 RUE DE TURBIGO
75003 PARIS
Marketing authorization holder
CEMAG CARE
55 RUE DE TURBIGO
75003 PARIS
Manufacturer
INPHARMASCI
Z.I N°2 PROUVY-ROUVIGINIES
1 RUE NUNGESSER
59121 PROUVY
Product names in member states of the European Economic Area
This product is authorized in the member states of the European Economic Area under the following names: In accordance with current regulations.
[To be completed subsequently by the holder].
The last date on which this leaflet was revised was :
[to be completed later by the holder]
{month YYYY}.
Other
Detailed information on this drug is available on the ANSM (France) website.
The latest version of the patient leaflet for this product is available by scanning this QR code and on request from your pharmacist.
