CinnaStim®


(Enoxaparin sodium)


What is it?

What is CinnaStim?

CinnaStim® syringes contain an active substance called Enoxaparin sodium. This belongs to a group of medicines called Low Molecular Weight Heparin or LMWH.

How do CinnaStim® syringes work?

CinnaStim® syringes work in two ways:

1) Stopping existing blood clots from getting any bigger. This helps your body to break them down and stops them from causing you harm.

2) Stopping new blood clots from forming in your blood.

Indications

CinnaStim® can be used to:

• Treat blood clots that are in your blood.

• Stop blood clots from forming in your blood in the following situations:

- before and after an operation.

- when you have a short-term illness and will not be able to move around for some time.

• Stop blood clots from forming when you have unstable angina (where not enough blood gets to your heart) or after a heart attack

• Stop blood clots from forming in the tubes of your dialysis machine (used for people with severe kidney problems).

Contraindications

Do not use CinnaStim® if

• you are allergic to:

- CinnaStim® or any of the other ingredients of this medicine

- Heparin or other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin.

• you have signs of allergic reactions, including rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, oral cavity, throat or eyes.

• you have had a reaction to heparin that caused a severe drop in the number of your clotting cells (platelets) within the last 100 days

• you have antibodies against enoxaparin in your blood

• you are bleeding heavily or have a condition with a high risk of bleeding, such as:

- stomach ulcer, recent surgery of the brain or eyes, or recent bleeding stroke.

• you have malignant neoplasm at high risk of bleeding, recent spinal surgery known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms, major intraspinal or intracerebral vascular abnormalities.

• you are using CinnaStim® to treat blood clots and are going to have within 24 hours:

- a spinal or lumbar puncture

- an operation with epidural or spinal anaesthesia.

Do not use CinnaStim® if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using CinnaStim®.

Important information

What should I know Before treatment?

CinnaStim® should not be interchanged with other ‘low molecular weight heparins’ such as nadroparin, tinzaparin or dalteparin.

Talk to your doctor or pharmacist before using CinnaStim® if:

• you have ever had: a reaction to heparin that caused a severe drop in the number of platelets, heart valve fitted, endocarditis, a history of gastric ulcer, a recent stroke, high blood pressure, diabetic retinopathy, an operation recently on your eyes or brain, kidney problems, liver problems, high levels of potassium in your blood, any problem with your spine or you have had spinal surgery, Skin necrosis / cutaneous vasculitis, Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.

• you are elderly (over 65 years old), underweight or overweight

• This drug has caused a problem called heparin-induced thrombocytopenia (HIT). HIT that leads to blood clots is called heparin-induced thrombocytopenia and thrombosis (HITTS). They can happen up to several weeks after stopping this drug. If you have questions, talk with the doctor.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using CinnaStim®.

What should I know During treatment?

If you use more CinnaStim® than you should:

If you think that you have used too much or too little CinnaStim®, tell your doctor or pharmacist or nurse immediately, even if you have no signs of a problem.

If you forget to use CinnaStim®:

If you forget to give yourself a dose, have it as soon as you remember. Do not give yourself a double dose on the same day to make up for a forgotten dose.

If you stop using CinnaStim®:

It is important for you to keep having CinnaStim® injections until your doctor decides to stop them. If you stop, you could get a blood clot which can be very dangerous.

Is it possible to perform operations and use anaesthetics while taking CinnaStim®?

If you are going to have a spinal or lumbar puncture, or an operation where an epidural or spinal anaesthetic is used, tell your doctor that you are using CinnaStim®.

Is CinnaStim® safe during pregnancy and breast-feeding?

• If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• If you are pregnant and have a mechanical heart valve, you may be at an increased risk of developing blood clots. Your doctor should discuss this with you.

• If you are breast-feeding or plan to breast-feed, you should ask your doctor for advice before taking this medicine.

What other drugs could affect CinnaStim®?

If you take other medicines, supplements and herbal products or herbs consult with your doctor or pharmacist.

How to use CinnaStim®?

• Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• CinnaStim® syringes are usually given by injection underneath the skin (subcutaneous) on the right or left side of your stomach at least 5 cm away from your belly button and out towards your sides.

• Do not inject CinnaStim® syringes into a muscle.

• If you are able to give CinnaStim® to yourself, your doctor or nurse will show you how to do this. Do not try to inject yourself if you have not been trained on how to do so. If you are not sure what to do, talk to your doctor or nurse immediately.

Side Effects

What are some side effects of CinnaStim®?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using CinnaStim® and talk to a doctor straight away if you have:

  • Any signs of a severe allergic reaction (such as rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, oral cavity, throat or eyes), a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment.

Talk to your doctor straight away if you have:

  • Any bleeding that does not stop by itself.
  • Any signs of too much bleeding such as throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger. Being very weak, tired, pale, or dizzy with headache or unexplained swelling.

You should tell your doctor straight away:

  • If you have any sign of blockage of a blood vessel by a blood clot such as cramping pain, redness, warmth, or swelling in one of your legs, breathlessness, chest pain, fainting
  • If you have a painful rash of dark red spots under the skin which do not go away when you put pressure on them.

Other important side effects (very common and common):

Anemia, Bleeding, increases in liver enzymes, Peripheral edema, Nausea, Hematuria, Confusion, Fever, bruising more easily than usual, Pink patches on your skin, Skin rash (hives, urticaria), Itchy red skin, Bruising or pain at the injection site, decreased red blood cell count, High platelet counts in the blood, Headache.

Storage

How to store CinnaStim®?

• Keep this medicine out of the sight and reach of children.

• Do not store above 25°C. Do not freeze.

• Store in the original package in order to protect it from light.

• Do not use this medicine after the expiry date which is stated on the label.

• Do not use this medicine if you notice any visible signs of deterioration such as if the solution is no longer clear or if it contains particles.

• Do not use any medicine pack that is damaged or shows signs of tampering.