Tranexamic Acid LumaCina

Tranexamic Acid LumaCina

Active ingredient(s): tranexamic acid

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Tranexamic Acid LumaCina. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about being given Tranexamic Acid LumaCina.

Where to find information in this leaflet:

1. Why am I given Tranexamic Acid LumaCina?
2. What should I know before I am given Tranexamic Acid LumaCina?
3. What if I am taking other medicines?
4. How is Tranexamic Acid LumaCina given?
5. What should I know after receiving Tranexamic Acid LumaCina?
6. Are there any side effects?
7. Product details

1. Why am I given Tranexamic Acid LumaCina?

Tranexamic Acid LumaCina contains the active ingredient tranexamic acid. Tranexamic acid is an antifibrinolytic that works by slowing the processes that cause bleeding.

Tranexamic Acid LumaCina is used to reduce bleeding and the need for blood transfusion in patients undergoing heart surgery, total knee replacement and total hip replacement surgery.

2. What should I know before I am given Tranexamic Acid LumaCina?

Warnings

You must not be given Tranexamic Acid LumaCina if:

• you are allergic to tranexamic acid, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.
• you are being treated for stroke.
• you have ever had a blood clot in a vein (deep vein thrombosis) or in your lungs (pulmonary embolism) or anywhere else in your body.
• you have a problem with colour vision that developed after you were born.

Check with your doctor if you:

• or someone in your family, has ever suffered from blood clots
• have severe bruising
• have kidney disease with or without blood in the urine
• have irregular periods and the reason is not known
• have or have ever suffered from convulsion, fits or seizures.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Tranexamic Acid LumaCina and affect how it works. These include:

• other medicines used to prevent bleeding
• medicines used to thin the blood
• oral contraceptives.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Tranexamic Acid LumaCina.

4. How is Tranexamic Acid LumaCina given?

How much is given

Your doctor will decide what dose and how often you will receive Tranexamic Acid LumaCina. The dosage you will be given will depend on your weight, what it is being used for and other factors, such as your age, and whether you suffer from diseases relating to the kidneys.

How is it given

Tranexamic Acid LumaCina will be given to you by a doctor or nurse as an injection or infusion into a vein.

If you are given too much

This rarely happens as Tranexamic Acid LumaCina will be given to you in hospital under the care of a highly trained doctor. In the unlikely event that you are given too much (an overdose), you may experience some of the effects listed under Section 6. Are there any side effects?

The signs of overdose are dizziness, headache, nausea, diarrhoea, low blood pressure, convulsions, fits or seizures.

Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have any concerns.

5. What should I know after receiving Tranexamic Acid LumaCina?

Things you should do

Tell your doctor or nurse if you do not feel well after you have been given Tranexamic Acid LumaCina.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Tranexamic Acid LumaCina affects you. Tranexamic acid may cause dizziness.

Looking after your medicine

Your doctor, pharmacist or nurse is responsible for storing Tranexamic Acid LumaCina in a cool dry place, protected from light where the temperature stays below 25°C and disposing of any unused product correctly.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
nausea vomiting diarrhoea giddiness or dizziness	Tell your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing fast, slow or irregular heart beats difficulty breathing, chest pain which may spread to the neck and shoulders (signs of heart attack or blood clot in your lungs) dizziness and light headedness, rapid, weak pulse, white skin, sweating, restlessness, loss of consciousness, fainting, rapid, shallow breathing, cold clammy skin and weakness (signs of cardiogenic shock) collapse, numbness or weakness of the arms or legs, headache, dizziness and confusion, visual disturbance, difficulty swallowing, slurred speech and loss of speech (signs of a stroke) convulsions, fits or seizures passing little or no urine, drowsiness, nausea, vomiting and breathlessness (signs of kidney problems or failure). difficulty breathing build-up of fluid in the lungs pain and swelling in the large veins, usually in your legs but may occur in the arm (signs of deep vein thrombosis (DVT)) severe abdominal pains and may pass bloody stools (signs of bowel obstruction) changes in your eyesight

Tell your doctor or nurse immediately straight away, if you experience any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Tranexamic Acid LumaCina contains

Active ingredient (main ingredient)	Tranexamic acid
Other ingredients (inactive ingredients)	water for injections
Potential allergens	n/a

You should not be given this medicine if you are allergic to any of these ingredients.

What Tranexamic Acid LumaCina looks like

Tranexamic Acid LumaCina a clear and colourless solution in glass or plastic ampoules. It is available in packs of 1 or 10 ampoules (AUST R 166415)

* Not all presentations and pack sizes may be available.

Who distributes Tranexamic Acid LumaCina

Bridgewest Perth Pharma Pty Ltd
15 Brodie Hall Drive
Bentley WA 6102
Telephone: 1800 161 156
safety@lumacina.com

This leaflet was prepared in September 2023.