NEXAG 1.000 MG COATED GRANULES IN SACHETS

Introduction

Package Leaflet: Information for the User

Nexag 1,000mg coated granules in sachets

tranexamic acid

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Nexag and what is it used for
2. What you need to know before taking Nexag
3. How to take Nexag
4. Possible side effects
5. Storage of Nexag
6. Package Contents and Additional Information

1. What is Nexag and what is it used for

This medication is used to reduce heavy menstrual bleeding and should only be used when your menstrual cycle is regular, 21-35 days, with no more than 3 days of individual variability in duration, and you are over 15 years old.

It contains tranexamic acid, which prevents the action of the enzyme that dissolves blood clots. This results in less blood loss and a faster healing rate.

2. What you need to know before taking Nexag

Note that this medication should only be used if your menstrual cycles are regular and heavy. To be sure, the answer to the following two questions should be affirmative:

1. Are your menstrual cycles regular, i.e., your menstrual cycle lasts between 21 and 35 days (with no more than 3 days of individual variability in duration)?
2. Do you need to use double sanitary protection, pads plus tampons, or double pads to prevent bleeding through, or do you need to change your sanitary protection very often?

Do not take Nexag

• if you are being treated for a blood clot, e.g., in the legs, lungs, or brain
• if you have severe kidney failure
• if you have a history of seizures (attacks or crises)
• if you are taking a combined hormonal contraceptive ("the pill", vaginal ring, or patch)
• if you are allergic to tranexamic acid or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor before taking this medication if:

• Your menstrual cycles are irregular
• You have ever had a blood clot and your parents or siblings have had a blood clot
• You have had blood in your urine between menstrual cycles
• You have kidney failure.

If you experience heavy bleeding while using combined hormonal contraceptives ("the pill", vaginal ring, or patch), you should not start taking tranexamic acid; consult your healthcare professional.

Heavy menstrual bleeding can be caused by uterine diseases, e.g., fibroids or polyps.

If they are treated, heavy menstrual bleeding is reduced. If in doubt, you should ask your gynecologist.

Regular gynecological check-ups are recommended.

Children and Adolescents

There is no clinical experience with tranexamic acid in menorrhagic girls under 15 years of age.

Other Medications and Nexag

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

If this medication is taken at the same time as anticoagulant medications, it may affect the way this medication or the anticoagulants work.

Pregnancy and Breastfeeding

This medication is indicated for regular heavy menstrual bleeding and is not intended for use during pregnancy. The impact of breastfeeding on the infant appears unlikely at therapeutic doses. Ask your doctor or pharmacist for advice if you are breastfeeding.

Driving and Using Machines

Side effects have been reported that may affect your ability to drive and use machines. If you feel dizzy or have vision problems, do not drive or use machines until the symptoms have passed.

Nexag contains sucrose.

If your doctor has informed you that you have an intolerance to some sugars, contact them before taking this medication.

3. How to Take Nexag

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The coated granules can be taken with a glass of water.

Treatment should be started when your menstrual cycle begins. The recommended dose for adult women and adolescents over 15 years old is 1 sachet 3 times a day as needed, for a maximum of 4 days. It is possible to increase the dose if the bleeding is very heavy. Do not use more than 4 sachets per day (1 sachet every 6 to 8 hours). Your doctor may prescribe a different dose.

If the effect (reduction of bleeding) has not occurred after the first day, discontinue treatment and discuss it with your doctor.

If you take more Nexag than you should

If you have taken more medication than you should, or if children have taken the medication accidentally, contact your doctor or hospital for advice on the risk and measures to take. Signs of an overdose may include dizziness, headache, nausea, diarrhea, hypotension, myopathy, and seizures. It may include a risk of thrombosis if you are predisposed.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Nexag

Do not take a double dose to make up for the forgotten dose.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Common(may affect up to 1 in 10 people): nausea, vomiting, diarrhea, stomach pain, headache, dizziness. These side effects are usually mild and transient.

Uncommon(may affect up to 1 in 100 people): allergic skin reaction.

Rare(cannot be estimated from the available data): cases of blood clots, changes in color vision, and other vision problems, seizures.

If the effect of this medication is not sufficient or if you do not tolerate this medication, there are other methods to treat heavy menstrual bleeding. Contact your gynecologist, who will inform you about these methods.

Reporting Side Effects

If you experience side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report side effects directly through the national reporting system included in the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Nexag

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date refers to the last day of that month.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Nexag Composition

• The active substance is tranexamic acid. Each sachet contains 1,000 mg of tranexamic acid.
• The other ingredients are: sugar spheres (sucrose, cornstarch), povidone K30 (E1201), sucralose (E955), colloidal anhydrous silica (E551), 30% polyacrylate dispersion, talc (E553B).

Appearance of the Product and Package Contents

Coated granules in sachets (low-density polyethylene (PEBD)/aluminum/PEBD/paper).

White to off-white coated granules.

12 sachets

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cemag Care

55 rue de Turbigo

75003 Paris

France

Manufacturer

Inpharmasci

Z.I. n°2 Prouvy-Rouvignies,

1 Rue Nungesser,

59121 Prouvy

France

This medication is authorized in the Member States of the European Economic Area under the following names:

Spain Nexag 1000 mg coated granules in sachets

France Haima 1000 mg, coated granules in sachets

Italy Nexag

Netherlands Nexag 1000 mg, coated granules in sachets

Portugal Nexag 1000 mg, coated granules in sachets

Sweden Nexag

Date of the Last Revision of this Package Leaflet: 04/2024

Other Sources of Information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)