Package leaflet: information for the user

Nexag 1000 mg, coated granules in sachet

Tranexamic acid
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Nexag is and what it is used for
What you need to know before taking Nexag
How to take Nexag
Possible side effects
How to store Nexag
Package contents and other information

1. What Nexag is and what it is used for

Nexag is used to reduce heavy menstrual bleeding and should only be used when menstrual cycles are regular, occurring every 21–35 days, with an individual cycle length variation of no more than 3 days, and when the patient is over 15 years of age.
It contains tranexamic acid, which prevents the action of the enzyme that dissolves blood clots. This results in reduced blood loss and faster healing.

2. What you should know before taking Nexag

Please keep in mind that Nexag should only be used if your menstrual periods are regular and heavy.
To be sure, you must answer "yes" to both of the following questions:

Are your periods regular, meaning your menstrual cycle lasts between 21 and 35 days (with an individual variation in cycle length of no more than 3 days)?
Do you need to use double sanitary protection, such as pads plus tampons or double pads, to prevent leakage, or do you need to change your sanitary protection very frequently?

Do not take Nexag

if you are being treated for a blood clot, for example in the legs, lungs, or brain
if you have severely reduced kidney function
if you have a history of seizures (seizure attacks or epilepsy)
if you are taking a combined hormonal contraceptive ("the pill", vaginal ring, or contraceptive patch)
if you are allergic to tranexamic acid or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before taking Nexag, consult your doctor if you have any of the following conditions:

Your periods are irregular
You have previously had a blood clot, or if your parents and/or siblings have had a blood clot
You have noticed blood in your urine between periods
You have reduced kidney function.

If you experience heavy bleeding while using combined hormonal contraceptives ("the pill", vaginal ring, or patch), you must not start taking tranexamic acid, but should consult your doctor.
Heavy menstrual bleeding may be caused by uterine disorders such as polyps or fibroids.
If these conditions are treated, heavy menstrual bleeding usually decreases. If anything is unclear to you, consult your gynecologist.
Regular gynecological check-ups are recommended.
Children and adolescents
There is no clinical experience with Nexag in girls with menorrhagia under the age of 15.
Other medicines and Nexag
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If Nexag is taken at the same time as anticoagulants, this may affect the mechanism of action of Nexag or of the anticoagulants.
Pregnancy and breastfeeding
Nexag is indicated for regular, heavy menstrual bleeding and is not suitable for use during pregnancy. The impact of breastfeeding on the infant appears unlikely at therapeutic doses. Please consult your doctor or pharmacist if you are breastfeeding.
Driving and using machines
Adverse effects have been reported that may impair the ability to drive or operate machinery. If you experience dizziness or vision problems, you should not drive or operate machinery until symptoms have resolved.
Nexag contains sucrose.
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Nexag

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The coated granulate can be taken with a glass of water.
Treatment should begin at the start of menstruation. The recommended dose for adults and adolescents
from 15 years of age is 1 sachet 3 times a day for as long as necessary, up to a maximum of 4
days. The dosage may be increased if bleeding is very heavy. Do not use more than
4 sachets per day (1 sachet every 6–8 hours). Your doctor may prescribe a different dose.
If the effect of the medicine (reduction of bleeding) has not occurred after the first day,
discontinue treatment and consult your doctor.
If you take more Nexag than you should
If you have taken more Nexag than recommended, or if children have accidentally taken the medicine,
contact your doctor or hospital for advice regarding the risk and actions to take. Signs of overdose may include dizziness, headache, nausea, diarrhoea, low blood pressure, myopathy and seizures. In those predisposed, there may be an increased risk of thrombosis.
If you forget to take Nexag
Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Common (may affect up to 1 in 10 people): Nausea, vomiting, diarrhoea, stomach ache, headache, dizziness. These side effects are often mild and temporary.
Uncommon (may affect up to 1 in 100 people): Allergic dermatitis.
Frequency not known (frequency cannot be estimated from the available data): Rare cases of blood clots, changes in colour vision and other vision problems, seizures.
If Nexag is not effective enough or is not tolerated, there are other methods available to treat heavy menstrual bleeding. Please consult your gynaecologist, who can provide you with information on these methods.
Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the system

https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nexag

Keep this medicine out of the 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.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nexag contains

The active substance is tranexamic acid. Each sachet contains 1000 mg of tranexamic acid.
The other ingredients are: Sugar spheres (sucrose, maize starch), Povidone K30 (E1201), Sucralose (E955), Anhydrous colloidal silica (E551), 30% polyacrylate dispersion, Talc (E553B).

Description of the appearance of Nexag and package contents
Coated granules in sachet (LDPE / aluminium / LDPE / paper).
Coated granules, white to off-white in colour.
Box containing 12 sachets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cemag Care
55 rue de Turbigo
75003 Paris
France

Manufacturer
Inpharmasci
Zone Industrielle n°2, 1 Rue Nungesser,
59121 Prouvy
France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
France Haima 1000 mg, granulés enrobés en sachet
Italy Nexag
Netherlands Nexag 1000 mg, omhuld granulaat in sachet
Portugal Nexag 1000 mg, grânulos revestidos em saqueta
Spain Nexag 1000 mg, granulado recubierto en sobre
Sweden Nexag

Other sources of information
More detailed information on this medicinal product is available on the website of AIFA (www.aifa.gov.it)