Prospect: information for the user

Medsamic 100 mg/ml injectable solution EFG

tranexamic acid

Read this prospect thoroughly before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

Contents of the package and additional information

Medsamic injectable solution contains tranexamic acid, which belongs to a group of medications called antihemorrhagics, antifibrinolytics, and amino acids.

This medication is used in adults and children over one year old to prevent and treat bleeding caused by a process of blood coagulation inhibition called fibrinolysis.

The specific indications include the following:

• Heavy menstrual bleeding in women
• Gastrointestinal bleeding
• Urinary tract hemorrhagic disorders, after prostate surgery or surgical procedures affecting the urinary tract
• Surgery of the ear, nose, or throat
• Cardiac, abdominal, or gynecological surgery

Bleeding after undergoing treatment with another medication to dissolve blood clots.

Do not use Medsamic:

• If you are allergic to tranexamic acid or any of the other components of this medication (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 in your entire 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 believe any of these situations apply to you, or if you have any doubts, speak with your doctor before using this medication.

Warnings and precautions

Consult your doctor before starting to use Medsamic.

Inform 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 have an excessive formation of clots or bleeding in the body (disseminated intravascular coagulation), this medication may not be suitable for you, except if you have a severe acute hemorrhage and blood tests show that the process that inhibits blood clotting called fibrinolysis has been activated.
• If you have had seizures, do not administer tranexamic acid. Your doctor should use the minimum possible dose to avoid seizures after treatment with this medication.
• If you are on long-term treatment with this medication, be aware of possible color vision alterations, and if necessary, treatment should be suspended. With long-term continuous use of this medication, it is indicated to perform periodic ophthalmological examinations (eye exams, such as visual acuity, color vision, fundus examination, visual field, etc.). In the event of pathological ocular changes, especially retinal diseases, your doctor should decide, after consulting with a specialist, whether long-term use of this medication is necessary in your case.

Other medications and Medsamic

Inform your doctor, nurse, or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Specifically, you must inform them if you use:

• Other medications that help to coagulate blood, called antifibrinolytics
• Medications that prevent blood clotting, called thrombolytics
• Oral contraceptives.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Tranexamic acid is excreted in breast milk, therefore, it is not recommended to use this medication during breastfeeding.

Driving and operating machines

No studies have been conducted regarding the ability to drive and operate machines.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Consult with your doctor or pharmacist if you are unsure.

Use in adults

Medsamic injectable solution will be administered to you via a slow injection into a vein.

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

Use in children

If this medication is administered to a child over one year old, the dose should be based on the child's weight. Your doctor will decide on 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.

Administration form

This medication should only be administered slowly into a vein.

This medication should not be injected into a muscle.

If you use more Medsamic than the recommended dose

If you have received a dose of Medsamic greater than the recommended dose, you may experience a temporary drop in blood pressure. Speak immediately with your doctor or pharmacist.

In case of overdose or accidental ingestion, consult immediately with your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The adverse effects reported with tranexamic acid are as follows:

Frequent (may affect up to 1 in 10 patients)

• Gastrointestinal effects: nausea, vomiting, diarrhea.

Rare (may affect up to 1 in 100 patients)

• Dermatological effects: skin rash.

Unknown frequency (cannot be estimated from 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 disturbances, including color vision loss
• Immune system effects: allergic reactions.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the label after “CAD”. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Medsamic

• The active ingredient 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 1,000 mg of tranexamic acid.

• The other components are: water for injection preparations.

Appearance of the product and contents of the packaging

Transparent type I glass ampoules of 5 ml capacity. Boxes of 5 ampoules × 5 ml.

Transparent type I glass ampoules of 10 ml capacity. Boxes of 5 ampoules × 10 ml.

Transparent type I glass ampoules of 5 ml capacity. Boxes of 10 ampoules × 5 ml.

Transparent type I glass ampoules of 10 ml capacity. Boxes of 10 ampoules × 10 ml.

Only some sizes of packaging may be commercially marketed.

Marketing Authorization Holder

Medochemie Limited

1-10 Constantinoupoleos Street

3011 Limassol

Cyprus

Responsible for Manufacturing

Medochemie Ltd. - Ampoule Injectable Facility

48 Iapetou Street, Agios Athanassios Industrial Area

4101 Limassol

Cyprus

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Local Representative:

Medochemie Iberia S.A., Branch in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

Last review date of this leaflet: 01/2022

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/