Package leaflet: information for the patient

Deporium, 1000 mg, coated tablets
Acidum tranexamicum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents

What is Deporium and what is it used for
Important information before taking Deporium
How to take Deporium
Possible side effects
How to store Deporium
Contents of the pack and other information

1. What is Deporium and what is it used for

Tranexamic acid belongs to a group of medicines known as antifibrinolytic agents. These are used to stop or reduce unwanted bleeding. During bleeding, the body forms clots to stop the blood loss. In some individuals, clots break down, leading to excessive bleeding. Tranexamic acid inhibits the breakdown of clots and thereby reduces unwanted bleeding.
Deporium is used short-term for the prevention and reduction of bleeding in various medical conditions. This medicine may have been prescribed for one of the following reasons:

after prostate gland surgery (after prostatectomy) and after bladder surgery;
heavy menstrual bleeding;
cervical conization (cervical cone biopsy);
tooth extraction in patients with haemophilia (persons more prone to bleeding). The patient will be informed if any of the above situations apply.
hereditary angioedema (HAE), a hereditary disease. The doctor will inform the patient if this condition applies.

2. Important information before taking Deporium

When not to take Deporium

if the patient is allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6),
if the patient has ever had a blood clot in the blood vessels (thrombosis),
if the patient has subarachnoid haemorrhage: a certain type of brain bleed,
if the patient has severe kidney disease (renal failure),
if the patient has a history of seizures.

If any of the above situations apply to the patient, talk to a doctor or
pharmacist before starting Deporium.
Warnings and precautions
Before starting Deporium, discuss with a doctor or pharmacist:

if the patient has blood in the urine,
if the patient has ever experienced uncontrolled bleeding,
if the patient is taking oral contraceptives. There is an increased risk of thrombosis,
if the patient has disseminated intravascular coagulation (DIC), a condition in which blood clots form throughout the body,
if the patient has irregular menstruation,
if the patient or a family member has ever had a blood clot in the blood vessels (thrombosis),
if the patient has kidney disease,
if the patient experiences seizures. The doctor will use the lowest possible dose to help avoid seizures occurring after taking Deporium.

In rare cases, vision loss and colour vision disturbances are side effects of
Deporium. Normal vision usually returns after stopping Deporium. If the patient
takes Deporium for a prolonged period, the doctor will monitor them accordingly.
Children and adolescents
There are no clinical data available on the use of tranexamic acid in girls under 15 years of age with heavy menstrual bleeding.
Deporium and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform the doctor if the patient is taking:

fibrinolytic medicines (used to dissolve blood clots), e.g. streptokinase, alteplase, anistreplase. This is because Deporium counteracts the effects of these medicines.
other medicines that promote blood clotting, known as antifibrinolytic agents.
chlorpromazine in subarachnoid haemorrhage.
oral contraceptives.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, thinks she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Deporium should only be given to pregnant and breastfeeding women if absolutely necessary.
Driving and operating machinery
Studies on the effect of the medicine on the ability to drive and operate machinery have not been conducted. Dizziness and malaise may occur during treatment with Deporium. If such symptoms occur, the patient should not drive or operate machinery.

3. How to take Deporium

This medicine should always be taken as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Important:
The correct dose of the medicine will be determined by your doctor. The dose will be clearly indicated on the medicine’s packaging.
Otherwise, consult your doctor or pharmacist.

The appropriate dose of the medicine depends on the reason for which it has been prescribed.
Always follow your doctor's instructions regarding the number of tablets to take, when to take the medicine, and for how long.
The medicine should always be taken with a glass of water.

Adults:

Local fibrinolysis: The recommended standard dose is 15–25 mg/kg body weight, 2–3 times daily. For the following indications, the following doses may be used:
1a. Prostatectomy: Prophylaxis and treatment of bleeding in high-risk patients should begin before or after surgery with intravenous tranexamic acid; subsequently, 1 g three to four times daily until macroscopic hematuria resolves.
1b. Heavy menstrual bleeding (menorrhagia): The recommended dose is 1–1.5 g three to four times daily for 3 to 4 days. Treatment with tranexamic acid should be initiated when bleeding becomes heavy.
1c. Cervical conization: 1.5 g three times daily for 12–14 days after the procedure.
Hereditary angioedema: Some patients recognize the onset of an attack; appropriate treatment for these patients is intermittent administration of 1–1.5 g two to three times daily for several days. Other patients are treated with this dose continuously.
Haemophilia: In dental extraction procedures – dosing usually begins with intravenous tranexamic acid prior to the procedure. After the procedure, 25 mg/kg body weight is administered orally three to four times daily for 6–8 days.

Patients with renal impairment
Your treating physician will advise you on the appropriate dose. The dose may be lower than that normally taken by healthy adults.

Taking more Deporium than recommended
If you take more Deporium than recommended, contact your doctor immediately or go to the nearest hospital emergency department.
Taking an overdose of Deporium may cause nausea, vomiting, or dizziness, which may also occur while standing.

If you miss a dose of Deporium
Do not take a double dose to make up for a missed dose. Take the next dose according to your regular schedule.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common (affects up to 1 in 10 patients)

nausea,
vomiting,
diarrhoea.

Uncommon (affects up to 1 in 100 patients)

itching, redness or swelling of the skin.

Rare (affects between 1 and 10 in 1,000 patients)

blood clot in blood vessels (thrombosis),
thrombocytopenia (decrease in platelet count) and prolonged bleeding time,
visual disturbances, particularly colour vision,
dizziness.

Frequency not known (frequency cannot be estimated from the available data)

seizures, particularly when high doses are used.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Deporium

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
There are no special requirements regarding the storage temperature of the medicine.
Medicines must 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 Deporium contains

The active substance is tranexamic acid. One tablet contains 1000 mg of tranexamic acid.
The other ingredients are: Tablet core: microcrystalline cellulose 101, microcrystalline cellulose 102, low-substituted hydroxypropylcellulose, povidone K29/32, colloidal anhydrous silica, talc, magnesium stearate. Film-coating Opadry II white containing polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc.

What Deporium looks like and contents of the pack
Deporium 1000 mg, coated tablets are white or almost white, oval, biconvex coated tablets with a breakline on one side. The tablet can be divided into equal doses.
Deporium 1000 mg, coated tablets are packed in PVC/PVDC/Aluminium blisters.
Pack sizes: 15, 20, 30, 45, 60, 75, 90 or 100 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: + 48 22 732 77 00
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice