Streptokinase Karma 250 000 Powder for solution for infusion

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

1. What Streptokinase Karma is and what it is used for.
2. What you need to know before you are given Streptokinase Karma.
3. How Streptokinase Karma is given to you.
4. Possible side effects.
5. How Streptokinase Karma is stored.
6. Contents of the pack and further information.

Talk to your doctor or nurse before you are given Streptokinase Karma if you:

• have recently had severe bleeding in your stomach (e.g. an ulcer) or any other stomach or intestinal disorder that causes bleeding
• have recently had a severe injury and have been resuscitated
• are at risk of severe local bleeding for example if you have recently had an invasive operation (e.g. where you have had a tube or drip inserted into your body)
• have recently given birth or had a miscarriage or an abortion
• have any problems in the genital area or urinary tract, especially those with bleeding
• have had blood poisoning that could cause clotting (septic thrombotic disease)
• have a disease of the arteries or a disease affecting the blood vessels of your brain (cerebrovascular disease)
• have tuberculosis or similar lung diseases or severe bronchitis
• have any heart or circulation problems or high blood pressure
• have received any drug containing streptokinase or have had an infection caused by streptococcal bacteria such as rheumatic fever or a throat infection
• have damage to the eye caused by diabetes

It is not recommended to use Streptokinase Karma in children, infants and neonates.

Tell your doctor or nurse if you are taking or have recently taken any other medicines, including those obtained without a prescription.

In particular tell the doctor or nurse if you have been treated with any drugs that prevent blood clotting (anticoagulants). Examples of such drugs are heparins, coumarin derivatives, dipyridamole and dextrans.

You should not be given Streptokinase Karma if you are pregnant or have recently had a baby, miscarriage or abortion unless there is no other, safer treatment.

You should not breastfeed your child while you are being treated with Streptokinase Karma.

Breast milk should be thrown away if you have been given streptokinase within the last 24 hours.

If this medicine is given for too long, bleeding problems may occur. You may be at risk of another blood clot (thrombosis). The symptoms are listed in section 4 under possible side effects.

Tell your doctor or nurse if you think you have been given too much.

Symptoms of a blood clot include:

• unusual pain or swelling in your legs
• sudden sharp pain in your chest
• sudden difficulty breathing
• an unusual, severe, or long-lasting headache
• dizziness or fainting.

IF YOU EXPERIENCE ANY OF THESE SIDE EFFECTS TELL YOUR DOCTOR OR NURSE IMMEDIATELY.

VERY COMMON SIDE EFFECTS

(may affect more than 1 in 10 people)

• development of antibodies (proteins in the blood that help fight disease) against the active ingredient streptokinase

COMMON SIDE EFFECTS

(may affect up to 1 in 10 people)

• bleeding, especially at the injection site, bruising of the skin, bleeding into the stomach, reproductive and urinary systems, nosebleed
• slow or fast heartbeat
• feeling or being sick, diarrhoea, stomach pain
• headache, muscle pain including back pain, fever, chills, weakness, generally feeling unwell

UNCOMMON SIDE EFFECTS

(may affect up to 1 in 100 people)

• bleeding into eyes, liver, abdomen or joints, tearing of the spleen
• stroke (cerebrovascular haemorrhage)

RARE SIDE EFFECTS

(may affect up to 1 in 1,000 people)

• dizziness, confusion, agitation
• seizures
• weakness or paralysis on one or both sides of the body

VERY RARE SIDE EFFECTS

(may affect up to 1 in 10,000 people)

• bleeding into the space around the heart, including tearing of the heart muscle
• delayed allergic reactions, e.g. serum sickness (pain and swelling in joints and lymph nodes, rash, fall in blood pressure and shock), arthritis, inflammation of blood vessels and kidneys, numbness or pins and needles feeling in arms or legs
• blockage of blood vessels caused by cholesterol crystals
• fluid in the lungs (not caused by heart failure)
• inflammation in the eyes

The following events have been reported in patients being treated with streptokinase, but they may not have been caused by the medicine: irregular heartbeat, chest pain, lack of oxygen to the heart, heart failure, heart attack, heart shock, inflammation around the heart, fluid around the heart, stopping of heartbeat, heart valve insufficiency, blockage of a blood vessel.

If you get any side effects, talk to your doctor or nurse immediately. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is streptokinase 250 000 IU or 750 000 IU (International Units).
• The other ingredients are human albumin, glycine and mannitol.

The medicine comes in glass vials as a white to slightly yellow powder. It is mixed with a liquid to make a solution to be used for infusion.

Each pack contains one vial with 250 000 IU or 750 000 IU of streptokinase.