Tranexamic acid Sunho

Package Leaflet: Information for the User

Tranexamic acid Sunho, 100 mg/mL, Solution for Injection/Infusion

Tranexamic acid

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

• Keep this package 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 package leaflet, please inform your doctor or nurse. See section 4.

Package Leaflet Contents

• 1. What is Tranexamic acid Sunho and what is it used for
• 2. Important information before using Tranexamic acid Sunho
• 3. How to use Tranexamic acid Sunho
• 4. Possible side effects
• 5. How to store Tranexamic acid Sunho
• 6. Package contents and other information

1. What is Tranexamic acid Sunho and what is it used for

Tranexamic acid Sunho contains tranexamic acid, which belongs to a group of medicines called antifibrinolytics (haemostatics).
Tranexamic acid Sunho is used in adults and children over 1 year of age to prevent and treat bleeding caused by a process that prevents blood clotting, called fibrinolysis.
Detailed indications for use include:

• Heavy menstrual bleeding in women;
• Gastrointestinal bleeding;
• Bleeding disorders of the urinary tract following prostate surgery or surgical procedures in the urinary tract;
• Surgical procedures in the ear, nose, and throat;
• Surgical procedures in the heart, abdominal cavity, or gynaecological surgery;
• Bleeding after the use of other medicines that dissolve blood clots.

2. Important information before using Tranexamic acid Sunho

When not to use Tranexamic acid Sunho:

• if you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6),
• if you have a disease that leads to the formation of blood clots,
• if you have a condition called "consumption coagulopathy" that causes blood clotting throughout the body,
• if you have kidney problems,
• if you have ever had seizures.

Due to the risk of cerebral oedema and seizures, intrathecal and intracerebral injections, as well as intracerebral administration, are not recommended.
If any of the above applies to you, or if you are not sure whether the above text applies to you, you should consult your doctor before taking Tranexamic acid Sunho.

Warnings and precautions

Tell your doctor if any of the following apply to you, to help him decide whether Tranexamic acid Sunho is suitable for you:

• If you have had blood in your urine, Tranexamic acid Sunho may lead to urinary tract obstruction.
• If you are at risk of blood clots.
• If you have excessive blood clotting or bleeding throughout the body (disseminated intravascular coagulation), Tranexamic acid Sunho may not be suitable for you, unless you have severe bleeding and blood tests have shown that the process that prevents blood clotting, called fibrinolysis, has been activated.
• If you have had seizures, you should not use Tranexamic acid Sunho. Your doctor will use the smallest possible dose to avoid seizures after using Tranexamic acid Sunho.
• If you are taking Tranexamic acid Sunho for a long time, you should be aware of possible vision disturbances and, if necessary, your doctor may recommend stopping the treatment. During long-term use of tranexamic acid, regular ophthalmological examinations (eye examinations, including visual acuity, colour vision, fundus examination, visual field examination, etc.) are recommended. In case of pathological ophthalmological changes, especially in case of retinal diseases, the doctor, after consulting a specialist, must decide whether it is necessary to continue using Tranexamic acid Sunho.

Tranexamic acid Sunho and other medicines

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

• other medicines that promote blood clotting, called antifibrinolytics,
• medicines that prevent blood clotting, called thrombolytics,
• oral contraceptives.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Tranexamic acid passes into human milk. Therefore, Tranexamic acid Sunho should not be used during breastfeeding.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

3. How to use Tranexamic acid Sunho

Tranexamic acid Sunho is administered as a slow injection or infusion into a vein.
Your doctor will decide on the correct dose and duration of treatment.

Use in children

If Tranexamic acid Sunho is administered to children over 1 year of age, the dose will be calculated based on the child's body weight.
Your doctor will decide on the correct dose for the child and how long it should be used.

Use in elderly patients

Dose reduction is not necessary, unless there is evidence of renal impairment.

Use in patients with renal impairment

If you have kidney problems, the dose of tranexamic acid will be reduced according to the results of a blood test (serum creatinine level).

Use in patients with hepatic impairment

Dose reduction is not necessary.

Method of administration

Tranexamic acid Sunho should only be administered as a slow intravenous injection/infusion.
Tranexamic acid Sunho must not be injected intramuscularly.

Overdose

If you have been given too much Tranexamic acid Sunho, you may experience a temporary decrease in blood pressure. Contact your doctor or pharmacist immediately.

4. Possible side effects

Like all medicines, Tranexamic acid Sunho can cause side effects, although not everybody gets them.

Side effects reported with Tranexamic acid Sunho

The following side effects have been observed with Tranexamic acid Sunho:
Common (may affect up to 1 in 10 people):

• gastrointestinal disorders: nausea, vomiting, diarrhoea

Uncommon (may affect up to 1 in 100 people):

• skin disorders: rash

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

• blood and lymphatic system disorders: feeling unwell with low blood pressure, with or without loss of consciousness, usually after too rapid intravenous injection; blood clots
• nervous system disorders: seizures
• eye disorders: vision disturbances, including colour vision disturbances
• immune system disorders: allergic reactions

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
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 authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tranexamic acid Sunho

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label of the ampoule/vial after "EXP". The expiry date refers to the last day of that month.
Do not freeze.
After first opening: the solution for injection/infusion is for single use only. Any unused solution for injection/infusion should be discarded.
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.
Chemical and physical stability of the product has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

6. Package contents and other information

What Tranexamic acid Sunho contains

The active substance of Tranexamic acid Sunho is tranexamic acid.
1 mL of solution for injection/infusion contains 100 mg of tranexamic acid.
Each 5 mL ampoule/vial contains 500 mg of tranexamic acid.
Each 10 mL ampoule/vial contains 1000 mg of tranexamic acid.
The other ingredients are water for injections.

What Tranexamic acid Sunho looks like and contents of the pack

Tranexamic acid Sunho is a clear, colourless solution for injection/infusion.
Packaging containing 5 ampoules of type I glass, 5 mL, in an outer packaging, each ampoule contains 500 mg of tranexamic acid.
Packaging containing 5 ampoules of type I glass, 10 mL, in an outer packaging, each ampoule contains 1000 mg of tranexamic acid.
Packaging containing 10 vials of type I glass, 5 mL, in an outer packaging, each vial contains 500 mg of tranexamic acid.
Packaging containing 10 vials of type I glass, 10 mL, in an outer packaging, each vial contains 1000 mg of tranexamic acid.
Not all pack sizes may be marketed.

Marketing authorisation holder

Sunho Pharma Europe Sp. z o.o.
ul. Długa 29
00-238 Warsaw
e-mail: [email protected]

Importer

Health-Med Sp. z o.o. sp. k.
ul.Chełmska 30/34
00-725 Warsaw

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany, Poland: Tranexamic acid Sunho

Date of last revision of the package leaflet: