Deporium Comfort

Package Leaflet: Information for the Patient

Deporium Comfort, 500 mg, Film-Coated Tablets

Acidum tranexamicum

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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Deporium Comfort and what is it used for
• 2. Important information before taking Deporium Comfort
• 3. How to take Deporium Comfort
• 4. Possible side effects
• 5. How to store Deporium Comfort
• 6. Contents of the pack and other information

1. What is Deporium Comfort and what is it used for

Deporium Comfort is used to treat heavy and prolonged menstrual bleeding. The medicine should only be used by women with regular menstrual bleeding.
Deporium Comfort is an anti-bleeding medicine. It contains tranexamic acid, which prevents the action of an enzyme that dissolves blood clots. This results in less blood loss and faster relief from symptoms.

2. Important information before taking Deporium Comfort

Remember that Deporium Comfort should only be used in case of regular and heavy menstrual bleeding. To be sure, answer "yes" to both of the following questions:

• 1. Does the patient have regular menstrual periods, i.e., a menstrual cycle lasting from 21 to 35 days?
• 2. Does the patient need to use double sanitary protection, pads, and tampons, or change sanitary products frequently to prevent leakage?

When not to take Deporium Comfort

• 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 had a subarachnoid hemorrhage: a type of brain hemorrhage,
• if the patient has severe kidney disease (renal failure),
• if the patient has or has had seizures.

Warnings and precautions

Before starting to take Deporium Comfort, discuss it with your doctor or pharmacist:

• if the patient has irregular menstrual periods,
• if the patient or a close family member has ever had a blood clot in the blood vessels (thrombosis),
• if the patient has blood in the urine between menstrual periods,
• if the patient has disseminated intravascular coagulation (DIC), a condition in which blood clots throughout the body,
• if the patient is taking oral contraceptives (which increases the risk of thrombosis).

In rare cases, color vision disturbances and other vision disturbances are a side effect of Deporium Comfort. Normal vision usually returns after stopping Deporium Comfort.
Stop taking Deporium Comfort and immediately inform your doctor if you notice any changes in vision (e.g., changes in color vision).

Children and adolescents

There are no data on the use of tranexamic acid in girls under 15 years of age with menstrual bleeding.

Deporium Comfort and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and 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 Comfort 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

Deporium Comfort is not intended for use during pregnancy and breastfeeding. Do not use it during this period.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines. During treatment with Deporium Comfort, dizziness and malaise may occur. If such symptoms occur, do not drive or operate machinery.

3. How to take Deporium Comfort

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Treatment should only be started after the onset of menstrual bleeding. Take 2 tablets 3 times a day for as long as necessary, but no more than 4 days.
Do not take more than 8 tablets per day.
Swallow the tablets with water.

Patients with renal impairment

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

Overdose of Deporium Comfort

If you have taken too much of the medicine, immediately inform your doctor or go to the nearest hospital emergency department.
Taking too much of the medicine Deporium Comfort may cause nausea, vomiting, or dizziness, which also occurs when standing.

Missed dose of Deporium Comfort

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (affects up to 1 in 10 people):nausea, vomiting, diarrhea, abdominal pain, headache, dizziness. These side effects are usually mild and temporary.
Uncommon (affects up to 1 in 100 people):allergic skin reaction.
Frequency not known (frequency cannot be estimated from the available data):there have been reports of blood clots, color vision disturbances, and other vision disturbances, seizures.

Reporting side effects

If you experience any side effects, including any 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, 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Deporium Comfort

Keep the 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 the 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 Comfort contains

• The active substance is tranexamic acid. One tablet contains 500 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. Opadry II pinkcoating containing polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc, yellow iron oxide, red iron oxide.

What Deporium Comfort looks like and contents of the pack

Deporium Comfort, 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 only to facilitate breaking the tablet to make it easier to swallow, and not to divide it into equal doses.
Deporium Comfort, 500 mg, film-coated tablets are packaged in PVC/PVDC/Aluminum blisters in a cardboard box.
Pack sizes: 15, 20, 30, 45, 60, or 100 film-coated tablets.
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 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: