PACKAGE LEAFLET: INFORMATION FOR THE USER

Urokinase medac 10,000 I.U.

powder for solution for injection or infusion

Urokinase medac 50,000 I.U.

powder for solution for injection or infusion

Urokinase medac 100,000 I.U.

powder for solution for injection or infusion

Urokinase medac 250,000 I.U.

powder for solution for injection or infusion

Urokinase medac 500,000 I.U.

powder for solution for injection or infusion

Human urokinase

Read all of this leaflet carefully before you start using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Urokinase medac is and what it is used for

2.    Before you are given Urokinase medac

3.    How Urokinase medac is used

4.    Possible side effects

5.    How to store Urokinase medac

6.    Further information

1. WHAT UROKINASE MEDAC IS AND WHAT IT IS USED FOR

The name of your medicine is Urokinase medac.

The active substance is urokinase which is a

thrombolytic medicine that can help to dissolve

blood clots in:

•    lungs

•    deep veins

•    peripheral arteries (such as in the leg)

•    intravenous central catheters (catheter placed into a large vein in the neck, chest, or groin) and haemodialysis shunts (surgically created connection between an artery and a vein that is used to filter blood)

2. BEFORE YOU ARE GIVEN UROKINASE MEDAC

Urokinase medac treatment is administered by a doctor or nurse who is experienced in this type of treatment. You will not be asked to administer Urokinase medac to yourself.

Urokinase medac will not be used if you

•    are allergic (hypersensitive) to urokinase or any of the other ingredients of Urokinase medac

•    are currently bleeding

•    have any abnormal blood vessel

•    have any cancer that has a risk of bleeding

•    have abnormal blood clotting, or are taking anticoagulant (blood thinning) medicines

•    have severe uncontrolled high blood pressure

•    have infection of the pancreas, heart, or any other severe infection

•    have had a stroke in the past 2 months

•    have recently had any major surgery or medical investigations such as lumbar puncture

Special care will be taken with Urokinase medac if you

•    have recently had bleeding from the stomach or elsewhere in the intestines

•    have recently had surgery

•    have cavities in your lungs

•    have problems with your urinary tract that could result in bleeding (e.g. bladder catheter)

•    have problems with your heart, particularly the mitral valve, or have abnormal heart rhythm e.g. atrial fibrillation

•    have a severe liver or kidney disease

•    are pregnant or have recently given birth

•    have a severe blood vessel disease especially in the brain

•    are elderly, particularly if you are aged over 75 years

In these circumstances your doctor will decide whether or not you should be given Urokinase medac.

Whilst receiving Urokinase medac, special care will also be taken if you need repeated blood tests taken or intramuscular injections or any other procedures which may be associated with a high risk of bleeding, such as any procedure performed on an artery.

Taking or using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines, or any other medicines, even those obtained without a prescription:

•    heparin, dipyridamole and other anticoagulants or other medicines that may affect clotting

•    acetylsalicylic acid (aspirin)

•    non-steroidal anti-inflammatory drugs

•    dextrans

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Urokinase medac must not be used in pregnancy or immediately after delivery unless clearly necessary.

It is unknown whether urokinase is excreted into human breast milk. For this reason, do not breastfeed during treatment with Urokinase medac.

Driving and using machines

If your medicine makes you have side effects that may reduce your ability to concentrate, do not drive or operate machinery.

3. HOW UROKINASE MEDAC IS USED

The amount and duration of Urokinase medac treatment will be decided by your doctor and will depend on the condition for which you are being treated. Urokinase medac must never be injected into a muscle or under the skin.

If you are being treated for blood clots in your lungs or deep veins, Urokinase medac will be injected into a vein (usually in the arm) during several hours and up to 3 days. Progress of the treatment may be checked by special X-rays. After the clot has been dissolved, you may be put on anticoagulant (blood thinning) therapy to prevent a recurrence.

If you are being treated for blood clots in an artery, Urokinase medac will be injected directly into the artery until dissolution of the clot.

If you are being treated for a blocked central venous catheter Urokinase medac may be injected directly into the catheter and left for up to an hour before removing the fluid. This may be repeated several times.

If you are being treated for a blocked haemodialysis shunt, Urokinase medac will be instilled into both branches of the shunt. This may be repeated several times.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Urokinase medac can cause side effects, although not everybody gets them.

Urokinase medac can on rare occasions cause severe reactions. Tell your doctor immediately if you:

•    observe any spontaneous bleeding, since urokinase may increase the risk for bleeding.

•    get symptoms of an allergic reaction/ hypersensitivity such as

-    tightness of the chest or difficulty with breathing

-    swelling of eyelids, face or lips

-    skin rashes or lumps, itchiness

-    collapse (fall in blood pressure) or turning blue (cyanosis)

Other side effects that may occur:

Some patients may experience a sensation of warmth or cold (fever or chills), nausea and vomiting (feeling or being sick), back pain or shortness of breath within one hour of starting the infusion.

Very common side effects (occur in more than 1 in 10 people)

•    bleeding

-    unusual bleeding, particularly from recent cuts or puncture wounds

-    small amounts of blood in the urine

-    nose bleeds

-    bleeding gums

-    bruising

•    changes in some blood tests

Common side effects (occur in between 1 in 10 and 1 in 100 people)

•    fever

•    chills

•    bleeding (into the brain, from the stomach, in the urine, into the muscles)

•    some smaller fragments of the clot or even cholesterol crystals may be released and pass along the blood vessel and cause a blockage elsewhere.

Uncommon side effects (occur in between 1 in 100 people and 1 in 1000 people)

•    bleeding into the liver

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

5. HOW TO STORE UROKINASE MEDAC

Keep out of the reach and sight of children.

Do not store above 25 °C.

Store in the original container and package in order to protect from light.

Do not use after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not use Urokinase medac if the contents of the vial are discoloured.

Use reconstituted medicine immediately. Do not keep reconstituted material for later use.

6. FURTHER INFORMATION

What Urokinase medac contains

There are different strengths available and each vial contains the active substance human urokinase. The other ingredients are: disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, human albumin.

What Urokinase medac looks like and contents of the pack

Each vial contains white powder for solution for injection or infusion.

Each pack contains one vial. There are different strengths of Urokinase medac approved for marketing:

Urokinase medac 10,000 I.U.

Urokinase medac 50,000 I.U.

Urokinase medac 100,000 I.U.

Urokinase medac 250,000 I.U.

Urokinase medac 500,000 I.U.

Not all strengths may be marketed.

Marketing Authorisation Holder and Manufacturer

medac

Gesellschaft fur klinische Spezialpraparate mbH Theaterstr. 6 22880 Wedel Germany

Phone: +49 (0)4103 8006-0 Fax:    +49 (0)4103 8006-100

This leaflet was last revised in 04/2015.

82100-VP1GB

BA