MedSamic 100 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Medsamic 100 mg/ml injection solution EFG

tranexamic acid

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

Pack contents and other information

1. What Medsamic is and what it is used for

Medsamic injectable solution contains tranexamic acid, which belongs to a group of medicines known as haemostatics, antifibrinolytics, and amino acids.

This medicine is used in adults and children over one year of age to prevent and treat bleeding caused by a process of blood clot breakdown called fibrinolysis.

The specific indications include the following:

• Heavy menstrual bleeding in women
• Gastrointestinal bleeding
• Haemorrhagic disorders of the urinary tract following prostate surgery or surgical procedures affecting the urinary tract
• Ear, nose, or throat surgery
• Cardiac, abdominal, or gynaecological surgery

Bleeding after receiving treatment with another medicine used to dissolve blood clots.

2. What you need to know before using Medsamic

Do not use Medsamic:

• If you are allergic to tranexamic acid or to any of the other components of this medicine (listed in section 6)
• If you currently have a condition that causes blood clots
• If you have a disorder called “consumption coagulopathy,” in which blood begins clotting throughout the body
• If you have kidney problems
• If you have a history of seizures.

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

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

Warnings and precautions

Talk to your doctor before starting to use Medsamic.

Inform your doctor if you are in any of the following situations so they can determine whether Medsamic is suitable for you:

• If you have had blood in your urine, as this may lead to obstruction of the urinary tract.
• If you are at risk of forming blood clots.
• If you have a condition involving excessive clotting or bleeding in the body (disseminated intravascular coagulation), this medicine may not be appropriate for you, except in cases of acute severe bleeding and blood tests show activation of the process that inhibits blood clotting, known as fibrinolysis.
• If you have had seizures, tranexamic acid should not be administered. Your doctor should use the lowest possible dose to avoid seizures following treatment with this medicine.
• If you are undergoing long-term treatment with this medicine, possible disturbances in color vision should be monitored, and if necessary, treatment should be discontinued. With long-term continuous 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 ocular changes, especially retinal diseases, your doctor should decide, after consulting with a specialist, whether long-term use of this medicine is necessary in your case.

Other medicines and Medsamic

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

Specifically, you should inform them if you are using:

• Other medicines that promote blood clotting, known as antifibrinolytics
• Medicines that prevent blood clotting, known as thrombolytics
• Oral contraceptives.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist 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 conducted regarding the ability to drive or operate machinery.

3. How to use Medsamic

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you are unsure.

Use in adults

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

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

Use in children

If this medicine is administered to a child over one year of age, the dose should be based on the child's weight. The doctor will determine the correct dose for the child and how long it should be administered.

Use in elderly patients

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

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 hepatic impairment

A dose reduction is not required.

Method of administration

This medicine must only be administered slowly into a vein.

This medicine must not be injected into a muscle.

If you use more Medsamic than the recommended dose

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The adverse effects reported with tranexamic acid are as follows:

Frequent (may affect up to 1 in 10 patients)

• Effects on the stomach and intestine: nausea, vomiting, diarrhoea.

Uncommon (may affect up to 1 in 100 patients)

• Effects on the skin: skin rash.

Frequency not known (cannot be estimated from available data)

• Malaise with hypotension (low blood pressure), with or without loss of consciousness, especially after too rapid intravenous injection
• Blood clots
• Effects on the nervous system: seizures
• Effects on the eyes: visual disturbances including impaired colour vision
• Effects on the immune system: allergic reactions

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other 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 1,000 mg of tranexamic acid.

• The other component is: water for injections.

Appearance of the product and contents of the pack

Clear type I glass ampoules with a capacity of 5 ml. Packs of 5 ampoules × 5 ml.

Clear type I glass ampoules with a capacity of 10 ml. Packs of 5 ampoules × 10 ml.

Clear type I glass ampoules with a capacity of 5 ml. Packs of 10 ampoules × 5 ml.

Clear type I glass ampoules with a capacity of 10 ml. Packs of 10 ampoules × 10 ml.

Only certain 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Local representative:

Medochemie Iberia S.A., Sucursal en España
Avenida de las Águilas, nº 2 B; 5th floor, office 6
28044 Madrid
SPAIN

Date of the most recent review of this leaflet: 01/2022

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