Protamine Sulphate Drug / Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Consumer Medicine Information (CMI) summary

1. Why am I being given FISONS PROTAMINE SULFATE?

2. What should I know before being given FISONS PROTAMINE SULFATE?

3. What if I am taking other medicines?

4. How is FISONS PROTAMINE SULFATE given?

5. What should I know while being given FISONS PROTAMINE SULFATE?

Things you should do

Tell your doctor or nurse straight away if you develop itching with swelling or skin rash, difficulty breathing, dizziness or abnormal heart beats while you are receiving FISONS PROTAMINE SULFATE.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how FISONS PROTAMINE SULFATE affects you.

Looking after your medicine

FISONS PROTAMINE SULFATE will be stored in the hospital or clinic pharmacy.

6. Are there any side effects?

Consumer Medicine Information (CMI)

1. Why am I being given FISONS PROTAMINE SULFATE?

2. What should I know before I being given FISONS PROTAMINE SULFATE?

Warnings

You should not be given FISONS PROTAMINE SULFATE if:

Check with your doctor if you:

Tell your doctor if you:

Pregnancy and breastfeeding

Children

3. What if I am taking other medicines?

4. How is FISONS PROTAMINE SULFATE given?

How much is given

If you are given too much FISONS PROTAMINE SULFATE

(by calling 13 11 26), or

5. What should I know while using FISONS PROTAMINE SULFATE?

Things you should do

Tell your doctor or nurse straight away if you:

Looking after your medicine

6. Are there any side effects?

Less serious side effects

Less serious side effects

What to do

Alertness and sleep-related:

dizziness.

Skin and muscle-related:

flushing and/or a feeling of warmth

back pain.

Stomach-related:

stomach disturbances.

Other:

weakness or generally feeling unwell.

Speak to your doctor or nurse if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Allergy-related:

signs of an allergic reaction, such as shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.

Heart-related:

Abnormal heart beats.

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

Reporting side effects

7. Product details

What FISONS PROTAMINE SULFATE contains

Active ingredient

(main ingredient)

Each 5 mL ampoule contains protamine sulfate 50 mg

Other ingredients

(inactive ingredients)

sodium chloride

hydrochloric acid

sodium hydroxide

water for injections