MEDSAMIC 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Medsamic 100 mg/ml Solution for Injection EFG

tranexamic acid

Read this package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Medsamic and what is it used for
2. What you need to know before you use Medsamic
3. How to use Medsamic
4. Possible side effects
5. Storage of Medsamic

Contents of the pack and further information

1. What is Medsamic and what is it used for

Medsamic solution for injection contains tranexamic acid, which belongs to a group of medicines called antihemorrhagics, antifibrinolytics, amino acids.

This medicine is used in adults and children over 1 year of age to prevent and treat bleeding due to a process that inhibits blood coagulation called fibrinolysis.

The specific indications include the following:

• Heavy menstrual bleeding in women
• Gastrointestinal bleeding
• Hemorrhagic disorders of the urinary tract, after prostate surgery or surgical procedures that affect the urinary tract
• Ear, nose, or throat surgery
• Cardiac, abdominal, or gynecological surgery

Bleeding after treatment with another medicine to dissolve blood clots.

2. What you need to know before you use Medsamic

Do not use Medsamic:

• If you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6)
• If you currently have a disease that leads to blood clots
• If you have a condition called "consumption coagulopathy" where the blood throughout the body starts to clot
• If you have kidney problems
• If you have a history of seizures.

Due to the risk of cerebral edema and seizures, intrathecal and intraventricular injection and intracerebral application are not recommended.

If you think any of these situations apply to you, or if you have any doubts, talk to your doctor before using this medicine.

Warnings and precautions

Talk to your doctor before you start using Medsamic.

Tell your doctor if you are in any of these situations to help them decide if Medsamic is suitable for you:

• If you have had blood in your urine, this could lead to obstruction of the urinary tract.
• If you are at risk of forming blood clots.
• If you suffer from excessive clotting or bleeding in the body (disseminated intravascular coagulation), this medicine may not be suitable for you, unless you have acute severe bleeding and blood tests show that the process that inhibits blood coagulation called fibrinolysis has been activated.
• If you have had seizures, tranexamic acid should not be administered. Your doctor should use the lowest possible dose to avoid seizures after treatment with this medicine.
• If you are on long-term treatment with this medicine, attention should be paid to possible changes in color vision, and if necessary, treatment should be discontinued. With the long-term use of this medicine, periodic ophthalmological examinations (eye exams, such as visual acuity, color vision, fundus examination, visual field, etc.) are indicated. In the event of pathological eye changes, especially retinal diseases, your doctor should decide, after consulting with a specialist, on the need for long-term use of this medicine in your case.

Other medicines and Medsamic

Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines.

Specifically, you should tell them if you use:

• other medicines that help blood to clot, called antifibrinolytics
• medicines that prevent blood from clotting, called thrombolytics
• oral contraceptives.

Pregnancy, breastfeeding, and fertility

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 using this medicine.

Tranexamic acid is excreted in breast milk, therefore, the use of this medicine is not recommended during breastfeeding.

Driving and using machines

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

3. How to use Medsamic

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure.

Use in adults

The Medsamic solution for injection will be administered to you by slow injection into a vein.

Your doctor will decide the correct dose for you and for how long you should receive it.

Use in children

If this medicine is given to a child over 1 year of age, the dose should be based on the child's weight. The doctor will decide the correct dose for the child and for how long they should receive it.

Use in elderly patients

No dose reduction is necessary unless there are signs of renal insufficiency.

Use in patients with kidney problems

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 liver insufficiency

No dose reduction is necessary.

Method of administration

This medicine should only be administered slowly into a vein.

This medicine should not be injected into a muscle.

If you use more Medsamic than you should

If you have received a higher dose of Medsamic than recommended, you may experience a temporary drop in blood pressure. Talk to your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects reported with tranexamic acid are as follows:

Common (may affect up to 1 in 10 people)

• Gastrointestinal effects: nausea, vomiting, diarrhea.

Uncommon (may affect up to 1 in 100 people)

• Skin effects: rash.

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

• Discomfort with hypotension (low blood pressure), with or without loss of consciousness, especially after a too rapid intravenous injection
• Blood clots
• Nervous system effects: seizures
• Eye effects: vision disorders including color vision impairment
• Immune system effects: allergic reactions.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Medsamic

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the label after "EXP". The expiry date is the last day of the month shown.

Medicines should 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.

6. Contents of the pack and further information

Composition of Medsamic

• The active substance is tranexamic acid.

Each 1 ml of solution contains 100 mg of tranexamic acid.

Each 5 ml ampoule contains 500 mg of tranexamic acid.

Each 10 ml ampoule contains 1000 mg of tranexamic acid.

• The other ingredients are: water for injections.

Appearance and packaging

5 ml glass ampoules type I. Boxes of 5 ampoules x 5 ml.

10 ml glass ampoules type I. Boxes of 5 ampoules x 10 ml.

5 ml glass ampoules type I. Boxes of 10 ampoules x 5 ml.

10 ml glass ampoules type I. Boxes of 10 ampoules x 10 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Medochemie Limited

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

Manufacturer

Medochemie Ltd. - Ampoule Injectable Facility

48 Iapetou Street, Agios Athanassios Industrial Area

4101 Limassol

Cyprus

You can ask for more information about this medicine from the local representative of the marketing authorization holder:

Local representative:

Medochemie Iberia S.A., Sucursal en España

Avenida de las Águilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

SPAIN

Date of last revision of this package leaflet: 01/2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/