Haixa

Haixa, 1000 mg, coated granules in a sachet
Acidum tranexamicum
Please read the following information carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Haixa is and what it is used for
2. Important information before taking Haixa
3. How to take Haixa
4. Possible side effects
5. How to store Haixa
6. Contents of the pack and other information

1. What Haixa is and what it is used for

Haixa is a medicine used to reduce heavy menstrual bleeding
and should only be used in women over 15 years of age who have regular menstrual cycles
lasting between 21 and 35 days, with a variation in cycle length not exceeding 3 days.
The medicine contains tranexamic acid, which inhibits the action of the enzyme that dissolves blood clots.
As a result, blood loss is reduced and the duration of menstruation is shortened.

2. Haixa Important information before using Haixa

It should be remembered that Haixa should only be used in cases of regular and heavy
menstrual bleeding. To ensure its suitability, the patient must answer "yes" to both of the
following questions:

1. Are the patient's periods regular, i.e. does her menstrual cycle last between 21 and 35 days (with an individual variation in cycle length not exceeding 3 days)?
2. Does the patient need to use double sanitary protection (pads and tampons or double pads) to prevent leakage, or does she need to change sanitary protection very frequently?

Haixa must not be taken in the following cases:

• if the patient is being treated for blood clots, e.g. in the legs, lungs, or brain;
• if the patient has severe kidney function disorders;
• if the patient has a history of seizures (epileptic fits or convulsions);
• if the patient is using combined hormonal contraception (the "pill", vaginal ring, or patch);
• if the patient is allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting Haixa, consult a doctor if any of the following conditions apply:

• irregular menstrual periods;
• history of blood clots in the patient or in her parents and/or siblings;
• presence of blood in urine between periods;
• kidney function disorders.

If heavy bleeding occurs while using combined hormonal contraceptives (the "pill", vaginal ring, or patch), tranexamic acid should not be started without first consulting a doctor.
Heavy menstrual bleeding may be caused by uterine disorders such as fibroids or polyps.
With appropriate medical care, heavy menstrual bleeding usually decreases. In case of any doubts, consult a gynecologist.
Regular gynecological health check-ups are recommended.

Children and adolescents
There are no clinical data on the use of Haixa in children under 15 years of age with menstrual bleeding.

Haixa and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
If Haixa is taken together with anticoagulant medicines, it may potentially affect the way Haixa or the anticoagulants work.

Pregnancy and breastfeeding
Haixa is indicated for regular, heavy menstrual bleeding and is not intended for use during pregnancy. The effect of breastfeeding on the infant appears unlikely when therapeutic doses are used. However, if breastfeeding, consult a doctor or pharmacist.

Driving and operating machinery
Adverse effects affecting the ability to drive or operate machinery have been reported. If dizziness or visual disturbances occur, the patient should not drive or operate machinery until these symptoms have resolved.

Haixa contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to take Haixa

This medicine should always be taken exactly as directed by the doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The coated granules can be swallowed with a glass of water.
Treatment should be started after the onset of menstruation. The recommended dose for adults
and adolescents over 15 years of age is 1 sachet 3 times daily, for as long as necessary,
but no longer than 4 days. The dose may be increased in case of very heavy bleeding. Do not use
more than 4 sachets per day (1 sachet every 6–8 hours). Your doctor may recommend a different dose.
If there is no improvement (reduction in bleeding) after the first day, treatment should be discontinued
and medical advice sought.
Taking more Haixa than recommended
If you take more Haixa than recommended, or if the medicine is accidentally taken by a child,
contact your doctor or hospital for advice on the potential risks and what actions should be taken.
Symptoms of overdose may include dizziness, headache, nausea, diarrhoea, low blood pressure, myopathy,
and seizures. In individuals predisposed to it, there may be an increased risk of thrombosis.
Missing a dose of Haixa
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Common (may occur in up to 1 in 10 patients): nausea, vomiting, diarrhoea, stomach pain, headache, dizziness. These types of adverse effects are usually mild and temporary.
Uncommon (may occur in up to 1 in 100 people): allergic skin reactions.
Frequency not known (frequency cannot be estimated from the available data): rare cases of blood clots, changes in colour vision and other visual disturbances, seizures.
If Haixa is not effective enough or if the patient does not tolerate this medicine, there are alternative treatments for heavy menstrual bleeding. Please consult your gynaecologist, who can provide information on such treatment options.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Haixa

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP".
The expiry date refers to the last day of that month.
There are no special requirements for the storage of this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Haixa contains

• The active substance is tranexamic acid. Each sachet contains 1000 mg of tranexamic acid.
• The other ingredients are: sucrose, beads, povidone K30, sucralose, colloidal anhydrous silica, polyacrylate dispersion 30%, talc.

What Haixa looks like and contents of the pack
Coated granules in a sachet made of LDPE/Aluminum/LDPE/Paper foil, packed in a cardboard box.
White or almost white in colour.
The box contains 12 sachets.

Marketing Authorisation Holder
Cemag Care
55 Rue De Turbigo
75003 Paris
France
Tel: +33 (0) 1 58 28 16 83

Manufacturer
Inpharmasci
Zone Industrielle N 2
1 Rue Nungesser
59121 Prouvy
France

This medicinal product is authorised in the following names in the countries of the European Economic Area:

Belgium: Nimra 1000 mg granulés enrobés en sachet / omhuld granulaat in sachet / überzogenes Granulat im Beutel
Estonia: Nexag
France: Haima 1000 mg, granulés enrobés en sachet
Italy: Nexag
Spain: Nexag 1000 mg, granulado recubierto en sobres
Netherlands: Nexag 1000 mg, omhuld granulaat in sachet
Lithuania: Haixa 1000 mg dengtos granulės paketėlyje
Latvia: Haixa 1000 mg apvalkotās granulas paciņā
Poland: Haixa
Portugal: Nexag 1000 mg, grânulos revestidos em saqueta
Romania: Nimra 1000 mg Granule drajefiate în plic
Sweden: Nexag
Hungary: Nimra 1000 mg, bevonatos granulátum tasakban