Tranexamic acid sunho

Patient Information Leaflet

Tranexamic acid Sunho, 100 mg/mL, solution for injection / infusion
Acidum tranexamicum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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, tell your doctor or nurse. See section 4.

Table of contents

1. What Tranexamic acid Sunho is and what it is used for
2. What you need to know before using Tranexamic acid Sunho
3. How to use Tranexamic acid Sunho
4. Possible side effects
5. How to store Tranexamic acid Sunho
6. Contents of the pack and other information

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

Tranexamic acid Sunho contains tranexamic acid, which belongs to a group of medicines called
antifibrinolytic agents (haemostatic agents).
Tranexamic acid Sunho is used in adults and children over 1 year of age to prevent and treat bleeding caused by a process that inhibits blood clotting,
called fibrinolysis.
Specific indications include:

• Heavy menstrual bleeding in women;
• Gastrointestinal bleeding;
• Haemorrhagic disorders of the urinary tract following prostate surgery or other urological surgical procedures;
• Ear, nose and throat surgical procedures;
• Cardiac, abdominal or gynaecological surgical procedures;
• Bleeding following administration of other medicines that dissolve blood clots.

2. Important information before using Tranexamic acid Sunho

When not to use Tranexamic acid Sunho:

• if the patient is allergic to tranexamic acid or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has a disease causing blood clots,
• if the patient has a condition called "disseminated intravascular coagulation" (DIC), which causes blood to clot throughout the body,
• if the patient has kidney function disorders,
• if the patient has ever experienced seizures.

Due to the risk of cerebral edema and seizures, intrathecal, intraventricular, and intracerebral injections are not recommended.
If any of the above apply to the patient, or if the patient is unsure whether the above applies to them, they should consult a doctor before taking Tranexamic acid Sunho.
Warnings and precautions
Inform the doctor if any of the following situations apply to the patient, to help them decide whether Tranexamic acid Sunho is appropriate:

• If the patient has had blood in the urine, Tranexamic acid Sunho may lead to obstruction of the urinary tract.
• If the patient is at risk of developing blood clots.
• If the patient has excessive blood clotting or bleeding throughout the body (disseminated intravascular coagulation), Tranexamic acid Sunho may not be suitable for the patient, except in cases of acute severe bleeding when blood tests have shown that the process inhibiting blood clotting, called fibrinolysis, has been activated.
• If the patient has a history of seizures, Tranexamic acid Sunho should not be used. The doctor will use the lowest possible dose to avoid the occurrence of seizures after administration of Tranexamic acid Sunho.
• If the patient is undergoing long-term treatment with Tranexamic acid Sunho, possible disturbances in color vision should be monitored, and the doctor may recommend discontinuation of treatment if necessary. During prolonged use of tranexamic acid, regular ophthalmological examinations (eye examinations, including visual acuity, color vision, fundoscopy, visual fields, etc.) are recommended. In the event of pathological ophthalmological findings, especially retinal diseases, the doctor must, after consultation with a specialist, decide whether long-term use of Tranexamic acid Sunho is necessary for the patient.

Tranexamic acid Sunho and other medicines
Tell the doctor, nurse, or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking:

• other medicines that promote blood clotting, known as antifibrinolytic agents,
• medicines that prevent blood clotting, known as thrombolytic agents,
• oral contraceptive medicines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Tranexamic acid passes into human milk. Therefore, the use of Tranexamic acid Sunho during breastfeeding is not recommended.
Driving and operating machinery
No studies have been conducted regarding the effect on the ability to drive vehicles and operate machinery.

3. How to use Tranexamic acid Sunho

Tranexamic acid Sunho is administered as a slow intravenous injection or infusion.
The doctor will decide the correct dose and duration of treatment.
Use in children
If Tranexamic acid Sunho is administered to children from the age of 1 year, the dose will be calculated based on the child's body weight.
The doctor will determine the appropriate dose for the child and specify how long it should be administered.
Use in elderly patients
Dose reduction is not necessary unless there is evidence of renal impairment.
Use in patients with renal impairment
If renal function impairment is diagnosed in a patient, the dose of tranexamic acid will be reduced according to the results of blood tests (serum creatinine concentration).
Use in patients with hepatic impairment
Dose reduction is not necessary.
Method of administration
Tranexamic acid Sunho must be administered only as a slow intravenous injection/infusion.
Tranexamic acid Sunho must not be administered by intramuscular injection.
Administration of a higher than recommended dose of Tranexamic acid Sunho
If an excessive dose of the medicine is administered to a patient, transient lowering of arterial blood pressure may occur. Immediate contact with a doctor or pharmacist is required.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions reported after use of Tranexamic acid Sunho
The following adverse reactions have been observed with Tranexamic acid Sunho:
Common (may occur in less than 1 out of 10 people):

• Gastrointestinal disorders: nausea, vomiting, diarrhoea

Uncommon (may occur in less than 1 out of 100 people):

• Skin disorders: rash

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

• Blood system disorders: malaise with hypotension (low blood pressure), with or without loss of consciousness, usually after too rapid intravenous injection; blood clots
• Nervous system disorders: convulsions
• Eye disorders: visual disturbances, including disturbances of colour vision
• Immune system disorders: allergic reactions

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 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 authorization holder.
Reporting adverse reactions helps to 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 stated on the cardboard box and on the ampoule/vial label after "EXP". The expiry date refers to the last day of the specified month.
Do not freeze.
After first opening: the injection/infusion solution is intended for single use only. Any unused injection/infusion solution should be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
Chemical and physical stability of the product has been demonstrated for 24 hours at 25°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions prior to use.

6. Contents of the package and other information

What Tranexamic acid Sunho contains
The active substance in Tranexamic acid Sunho is tranexamic acid.
1 mL of injection/infusion solution 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 ingredient is 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.
Pack sizes containing 5 ampoules made of Type I glass with a capacity of 5 mL in an outer package,
each ampoule contains 500 mg of tranexamic acid.
Pack sizes containing 5 ampoules made of Type I glass with a capacity of 10 mL in an outer package,
each ampoule contains 1000 mg of tranexamic acid.
Pack sizes containing 10 vials made of Type I glass with a capacity of 5 mL in an outer package,
each vial contains 500 mg of tranexamic acid.
Pack sizes containing 10 vials made of Type I glass with a capacity of 10 mL in an outer package,
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 medicinal product is authorised in the European Economic Area countries under the following names:
Germany, Poland: Tranexamic acid Sunho