Tranexamic acid Adamed

Package leaflet: Information for the user

Tranexamic Acid Adamed

500 mg film-coated tablets
tranexamic acid
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• 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, tell your doctor, pharmacist, or nurse. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

1. What Tranexamic Acid Adamed is and what it is used for
2. What you need to know before taking Tranexamic Acid Adamed
3. How to take Tranexamic Acid Adamed
4. Possible side effects
5. How to store Tranexamic Acid Adamed
6. Contents of the pack and other information

1. What Acido Tranexamico Adamed is and what it is used for

Acido Tranexamico Adamed is indicated for the reduction of heavy and prolonged menstrual bleeding (menorrhagia) that recurs over multiple cycles in women with regular menstrual cycles of 21–35 days and an individual cycle length variability not exceeding 3 days.
Acido Tranexamico Adamed is a medication that reduces bleeding. It contains tranexamic acid, which prevents the enzyme that dissolves blood clots from acting. This results in reduced blood loss and improvement of symptoms.

2. What you need to know before taking Acido Tranexamico Adamed

Acido Tranexamico Adamed 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:

1. Are your menstrual periods regular, meaning your menstrual cycle occurs every 21–35 days?
2. Do you need the protection of double sanitary protection—external pad plus tampon or double pad—to prevent blood leakage, or alternatively, do you need to change your sanitary protection very frequently?

Do not take Acido Tranexamico Adamed

• if you are allergic to tranexamic acid or to any of the other ingredients of this medicine (listed in section 6)
• if you have or have ever had blood clots in blood vessels (a condition called “thrombosis”)
• if you have severe kidney problems (severe renal failure)
• if you have had or have seizures
• if you have cerebral haemorrhage (subarachnoid haemorrhage)
• if you are at risk of excessive bleeding due to a coagulation disorder known as consumption coagulopathy
• if you are taking combined oral contraceptives.

Warnings and precautions
Talk to your doctor or pharmacist before taking Acido Tranexamico Adamed:

• if your menstrual cycles are irregular
• if you or your family members have ever had blood clots in blood vessels (a condition called “thrombosis”)
• if you have noticed blood in your urine between menstrual cycles
• if you are taking oral contraceptives (there is an increased risk of blood clot formation).
  In rare cases, impaired colour vision and other visual disturbances have occurred after taking Acido Tranexamico Adamed. Usually, vision returns to normal after stopping Acido Tranexamico Adamed. Discontinue taking Acido Tranexamico Adamed and contact your doctor immediately if you notice any changes in your vision (e.g. changes in colour vision).

In patients with renal impairment, the concentration of tranexamic acid in the blood increases; therefore, the dose must be reduced in patients with renal failure.
Children and adolescents
There are no data available on the use of tranexamic acid in girls under 15 years of age with heavy and prolonged menstrual bleeding (menorrhagia).
Other medicines and Acido Tranexamico Adamed
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially the following:

• fibrinolytic agents (used to help dissolve blood clots), such as streptokinase, alteplase, anistreplase. This is because Acido Tranexamico Adamed may prevent these medicines from working
• oral contraceptives.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine should be avoided in pregnant women.
Tranexamic acid passes into breast milk. Breastfeeding is not recommended while taking this medicine.
Driving and using machines
Acido Tranexamico Adamed is likely to have negligible influence on the ability to drive vehicles or operate machinery. No studies have been conducted.
When taking Acido Tranexamico Adamed, you should exercise caution when driving or operating machinery.

3. How to take Tranexamic Acid Adamed

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Treatment should begin at the start of your period. Take 2 tablets three times a day for as long as needed, up to a maximum of 4 days.
The maximum daily dose must not exceed 8 tablets.
Swallow the tablets with water.

Use in patients with kidney problems:
Your doctor will tell you how much to take. Your dose may be lower than the usual adult dose.

If you take more Tranexamic Acid Adamed than you should
If you accidentally take too high a dose of this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
Taking an excessive dose of Tranexamic Acid Adamed may cause nausea, vomiting or dizziness, or make you feel lightheaded when standing up.

If you forget to take Tranexamic Acid Adamed
Do not take a double dose to make up for the forgotten dose. Take the next dose as scheduled.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people): Nausea, vomiting, diarrhoea, stomach ache, headache. These side effects are often mild and temporary.
Uncommon (may affect up to 1 in 100 people): Allergic skin reactions.
Rare (may affect up to 1 in 1,000 people): Dizziness, rare cases of blood clots, thrombocytopenia (platelet count too low), and abnormal bleeding time.
Not known (frequency cannot be estimated from the available data): Changes in colour vision and other vision problems, seizures, allergic reactions (hypersensitivity), including anaphylaxis.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at 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 Tranexamic Acid Adamed

Keep this medicine out of the sight and reach of children.
Do not use Tranexamic Acid Adamed after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
Do not dispose of any medicine 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 Acido Tranexamico Adamed contains

• The active substance is tranexamic acid. Each tablet contains 500 mg of tranexamic acid.
• The other components are:
  Tablet core: microcrystalline cellulose 101 (E460), microcrystalline cellulose 102 (E460), low-substituted hydroxypropylcellulose, povidone K29/32, colloidal anhydrous silica, talc, magnesium stearate (vegetable).
  Film coating: OPADRY II pink, consisting of polyvinyl alcohol – partially hydrolysed, titanium dioxide (E171), macrogol 4000, talc, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Acido Tranexamico Adamed and contents of the pack
Acido Tranexamico Adamed 500 mg film-coated tablets are pink, oval, biconvex film-coated tablets with a score line on one side.
The score line on the tablet is intended only to facilitate breaking the tablet for ease of swallowing and does not allow for dividing the tablet into equal doses.
The tablets are supplied in blister packs containing 15, 20, 30, or 45 film-coated tablets in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czonsów
Poland
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland