Deporium

Package Leaflet: Information for the Patient

Deporium, 1000 mg, Coated Tablets

Tranexamic Acid

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Deporium and what is it used for
• 2. Important information before taking Deporium
• 3. How to take Deporium
• 4. Possible side effects
• 5. How to store Deporium
• 6. 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 called antifibrinolytics. They are used to stop or prevent unwanted bleeding. During bleeding, the body forms clots to stop the bleeding. In some people, these clots dissolve, causing excessive bleeding. Tranexamic acid prevents the dissolution of clots and thus limits unwanted bleeding.
Deporium is used for a short time to prevent and reduce bleeding in many different disease states. This medicine may have been prescribed for one of the following reasons:

• after prostate surgery (after prostatectomy) and after bladder surgery;
• heavy menstrual bleeding;
• cervical surgery (cervical conization);
• tooth extraction in people with hemophilia (people more prone to bleeding). The patient will be informed if any of the above situations apply to them.
• a hereditary disease called hereditary angioedema (HAE). The doctor will inform the patient if they have this disease.

2. Important information before taking Deporium

When not to take Deporium

• if you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6),
• if you have ever had a blood clot in the blood vessels (thrombosis),
• if you have a subarachnoid hemorrhage: a type of brain hemorrhage,
• if you have severe kidney disease (renal failure),
• if you have a history of seizures.

If you have any of the above conditions, you should talk to your doctor or pharmacist before taking Deporium.

Warnings and precautions

Before taking Deporium, you should discuss it with your doctor or pharmacist:

• if you have blood in your urine,
• if you have ever had uncontrolled bleeding,
• if you are taking oral contraceptives. There is an increased risk of thrombosis,
• if you have disseminated intravascular coagulation (DIC), a disease in which blood clots throughout the body,
• if you have irregular menstrual periods,
• if you or a family member have ever had a blood clot in the blood vessels (thrombosis),
• if you have kidney disease,
• if you have seizures. The doctor will use the smallest possible dose to avoid seizures in the patient after taking Deporium.

In rare cases, vision loss and color vision disturbances are side effects of Deporium. Usually, normal vision returns after stopping Deporium. If you take Deporium for a long time, your doctor will monitor you for this.

Children and adolescents

There are no clinical data on the administration of tranexamic acid to heavily menstruating girls under 15 years of age.

Deporium and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
In particular, inform your doctor if you are taking:

• fibrinolytic medicines (used to dissolve blood clots), such as streptokinase, alteplase, anistreplase. This is because Deporium counteracts the effect of these medicines.
• other medicines that facilitate blood clotting, called antifibrinolytic medicines.
• chlorpromazine in subarachnoid hemorrhage.
• oral contraceptives.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Deporium should only be given to pregnant or breastfeeding women if it is absolutely necessary.

Driving and using machines

No studies have been conducted on the effects of the medicine on the ability to drive and use machines. When taking Deporium, dizziness and malaise may occur. If you experience these symptoms, do not drive or operate machinery.

3. How to take Deporium

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Important:

Your doctor will decide the right dose for you. The dose will be clearly marked on the medicine packaging. If not, ask your doctor or pharmacist.

• The correct dose will depend on the reason why the medicine has been prescribed.
• Follow your doctor's instructions about how many tablets to take, when to take them, and for how long.
• Always take the medicine with a glass of water.

Adults:

• 1. Local fibrinolysis:The recommended standard dose is 15-25 mg/kg body weight, 2-3 times a day. For the indications listed below, the following doses can be used: 1a. Prostatectomy:Prophylaxis and treatment of bleeding in high-risk patients should be started before or after surgery, administering tranexamic acid by injection; then 1 g three to four times a day until macroscopic hematuria resolves. 1b. Heavy menstrual bleeding (menorrhagia):The recommended dose is 1-1.5 g three to four times a day for 3 to 4 days. Treatment with tranexamic acid should be started when bleeding becomes heavy. 1c. Cervical conization:1.5 g three times a day for 12-14 days after surgery.
• 2. Hereditary angioedema:Some patients are aware of the onset of the disease; appropriate treatment for these patients is periodic 1-1.5 g two to three times a day for several days. Other patients are treated with this dose continuously.
• 3. Hemophilia:In the management of tooth extraction - dosing usually precedes intravenous administration of tranexamic acid. After the procedure, 25 mg/kg body weight is given orally three to four times a day for 6-8 days.

Patients with renal impairment

Your doctor will inform you about the correct dose. The dose may be lower than that taken by adults.

Overdose of Deporium

If you take more than you should, tell your doctor or go to the nearest hospital emergency department immediately.
Taking too much Deporium may cause nausea, vomiting, or dizziness, which also occur when standing up.

Missed dose of Deporium

Do not take a double dose to make up for a forgotten dose. Take the next dose as scheduled.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Deporium can cause side effects, although not everybody gets them.
Common (affects up to 1 in 10 people)

• nausea,
• vomiting,
• diarrhea.

Uncommon (affects up to 1 in 100 people)

• itching, redness, or swelling of the skin.

Rare (affects 1 to 10 people in 1000)

• blood clot in the blood vessels (thrombosis),
• thrombocytopenia (reduced platelet count) and prolonged bleeding time,
• vision disturbances, especially color vision,
• dizziness.

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

• seizures, especially with high doses.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Deporium

Keep this medicine out of the 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 month stated.
There are no special storage precautions for 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 pack 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, hypromellose, povidone K29/32, colloidal anhydrous silica, talc, magnesium stearate. Coating Opadry II whitecontaining 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 dividing line on one side. The tablet can be divided into equal doses.
Deporium, 1000 mg, coated tablets are packaged in PVC/PVDC/Aluminum blisters.
Pack sizes: 15, 20, 30, 45, 60, 75, 90, or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
phone: + 48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Date of last revision of the leaflet: