Deporium comfort

Patient Information Leaflet: Read this leaflet carefully before using the medicine, as it contains important information for the patient.

Deporium Comfort, 500 mg, coated tablets
Acidum tranexamicum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Deporium Comfort is and what it is 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 package and other information

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

Deporium Comfort is used in the treatment of heavy and prolonged menstrual bleeding.
This medicine should be used only by women who have regular menstrual cycles.
Deporium Comfort is an antifibrinolytic agent. It contains tranexamic acid, which inhibits the action of the enzyme that breaks down blood clots. This results in reduced blood loss and faster relief of symptoms.

2. Important information before taking Deporium Comfort

Please remember that Deporium Comfort should only be used in cases of regular and heavy menstrual bleeding. To be sure, the patient should be able to answer "yes" to both of the following questions:

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

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 blood vessels (thrombosis),
• if the patient has subarachnoid haemorrhage: a type of brain bleed,
• if the patient has severe kidney disease (kidney failure),
• if the patient currently has or has had seizures.

Warnings and precautions
Before starting Deporium Comfort, discuss with a 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 blood vessels (thrombosis),
• if the patient has blood in the urine between periods,
• if the patient has disseminated intravascular coagulation (DIC), a condition in which blood clots form throughout the body,
• if the patient is taking oral contraceptive medicines (as this increases the risk of thrombosis).

Rarely, colour vision disturbances and other visual disturbances may occur as side effects of Deporium Comfort. Normal vision usually returns after stopping Deporium Comfort.
The patient should stop taking Deporium Comfort and immediately inform the doctor if any changes in vision (e.g. changes in colour vision) occur.

Children and adolescents
There is no data available on the use of tranexamic acid in girls under 15 years of age with heavy menstrual bleeding.

Deporium Comfort and other medicines
Inform 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 Comfort counteracts the effect of these medicines.
• other medicines that promote blood clotting, known as antifibrinolytic medicines.
• chlorpromazine in subarachnoid haemorrhage.
• oral contraceptive medicines.

Pregnancy, breastfeeding and fertility
Deporium Comfort is not intended for use during pregnancy or breastfeeding. It should not be used during these periods.

Driving and operating machinery
No studies have been conducted on the effects of this medicine on the ability to drive or operate machinery. Dizziness and malaise may occur during treatment with Deporium Comfort. If these symptoms occur, the patient should not drive or operate machinery.

3. How to take Deporium Comfort

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Treatment should begin only after the onset of menstrual bleeding. Take
2 tablets three times a day for as long as necessary, for a maximum of 4 days.
Do not take more than 8 tablets per day.
The tablets should be swallowed with water.
Patients with impaired kidney function
Your doctor will advise you on the appropriate dose. The dose may be lower than that usually taken
by adults.
Taking more Deporium Comfort than recommended
If you take more medicine than prescribed, contact your doctor immediately or go to the nearest hospital emergency department.
Taking an overdose of Deporium Comfort may cause nausea,
vomiting, or dizziness, which may also occur when standing up.
Missed dose of Deporium Comfort
Do not take a double dose to make up for a missed dose. Take the next dose according to the schedule.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Common (affects up to 1 in 10 patients): nausea, vomiting, diarrhoea, abdominal pain, headache, dizziness.
These adverse effects are often mild and temporary.
Uncommon (affects up to 1 in 100 patients): allergic skin reaction.
Frequency unknown ( frequency cannot be estimated from the available data): blood clots have been reported, colour vision changes and other visual disturbances, seizures.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorization holder.
By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store Deporium Comfort

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.
No special temperature storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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, low-substituted hydroxypropyl cellulose, povidone K29/32, colloidal anhydrous silica, talc, magnesium stearate. Film-coating Opadry II pink 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 break line on one side. The break line on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure equal dose division.
Deporium Comfort 500 mg, film-coated tablets are packed in blisters made of PVC/PVDC/Aluminium, contained in a cardboard box.
Pack sizes: 10, 20 or 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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