What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL20417/0109 .


Heparin sodium 1000 IU/ml ampoule, solution for infusion

PACKAGE LEAFLET: INFORMATION FOR THE USER

Heparin sodium 1,000 IU/ml ampoule, solution for infusion

heparin sodium

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

What is in this leaflet

1. What Heparin infusion is and what it is used for
2. What you need to know before you use Heparin infusion
3. How to use Heparin infusion
4. Possible side effects
5. How to store Heparin infusion
6. Contents of the pack and other information

1. WHAT HEPARIN INFUSION IS AND WHAT IT IS USED FOR

Heparin infusion belongs to a group of medicines called anticoagulants.

Heparin changes the way your blood clots. This means your blood keeps flowing smoothly inside your blood vessels. These are the tubes that carry blood around your body and are called arteries and veins.

Heparin infusion is used:

  • to help stop harmful blood clots in your veins growing bigger (treatment).
  • to help stop harmful blood clots forming in the tubing of an artificial kidney machine during kidney dialysis (haemodialysis).

An example is a harmful blood clot in a vein deep inside your body. This is usually in your leg (deep vein thrombosis or DVT for short). Another example is a clot which blocks the blood supply to your lungs (pulmonary embolism).

It is more likely these clots will form if you are either overweight, pregnant, have certain blood disorders or have already had a pulmonary embolism, DVT, heart attack or stroke. It can also happen if you do not move around for long periods of time. This could be because you have had surgery or you have another illness.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE HEPARIN INFUSION

Do not use Heparin Infusion:

  • If you are allergic (hypersensitive) to heparin or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.
  • If you know that you have, or have ever had, a big drop in the clotting cells (platelets) in your blood, caused by having any type of heparin (reaction called heparin-induced thrombocytopenia).
  • If you are currently bleeding from anywhere in the body, (apart from your normal period which does not stop you being given heparin injection)
  • If you have any condition which makes you bleed severely, such as haemophilia.
  • If you bruise easily (fragile capillaries) or have lots of purple spots that look like bruises (purpura)
  • If you have very high blood pressure.
  • If you have severe liver problems, which can lead to bleeding into the oesophagus (gullet)
  • If you have a stomach ulcer.
  • If you know that you have a condition called endocarditis (an inflammation of the lining of the heart and heart valves).
  • If you have had a brain haemorrhage (bleeding inside your brain).
  • If you have an injury to your spine, head, eyes or ears.
  • If you have recently had, or are about to have an operation involving your spine, head, eyes or ears, a lumbar puncture or local anaesthetic nerve block, or some other procedure where bleeding could be a problem
  • If you may be having a miscarriage.
  • If you are suffering from tuberculosis.
  • If you drink large amounts of alcohol.

Important: If you are having an epidural or spinal anaesthetic

You must remind your doctor that you are having Heparin infusion before you receive any anaesthetic.

If you are pregnant please also read the section of this leaflet “Pregnancy, breast-feeding and fertility”.

After you have the anaesthetic your doctor or nurse will make regular checks. This is to check if you are getting any major bleeding or bruising around your spine. This may cause paralysis that could be permanent. Any signs this may be happening to you include tingling, weakness or numbness in your lower legs or body, back pain or problems in going to the toilet. This happens very rarely.

After you have the anaesthetic your doctor will tell you when you can take your medicine again.

Take special care with Heparin infusion

Before you have Heparin infusion, tell your doctor:

  • If you have any condition which makes you more likely to bleed more easily (for example a stomach ulcer, hiatus hernia, inflammation of the heart, problems in the back of your eye, haemorrhoids (piles), cancer, or threatened miscarriage). Ask your doctor if you are unsure.
  • If you are allergic (hypersensitive) to low molecular weight heparins, such as tinzaparin, enoxaparin or dalteparin.
  • If you have kidney problems.
  • If you have liver problems.
  • If you have problems with your blood pressure (hypertension).
  • If you know you have a condition called diabetes mellitus.
  • If you know you have a condition called metabolic acidosis.
  • If you know you have any medical condition which may cause high levels of potassium in your blood (hyperkalaemia). Ask your doctor if you are unsure.
  • If you are taking a medicine from the group called potassium-sparing diuretics, such as amiloride or spironolactone.
  • If you are taking another medicine that may affect your blood clotting. For a list of these medicines see the section “Taking other medicines”.

Your doctor may take a blood test before you start having this medicine, and while you are having it. This is so the doctor can check you are having the right dose. This is also to check the level of the clotting cells (platelets) and potassium in your blood.

This medicine may make you bleed more easily. The doctor or nurse should take care when giving you any other injections or procedures. This medicine must not be injected into your muscles.

Your doctor will take particular care if:

  • the patient is an infant or child under three years old
  • you have an epidural or an anaesthetic given into the spine.

Other medicines and Heparin

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.

You must tell your doctor or pharmacist if you are taking any of the following medicines:

  • ACE inhibitors or angiotensin II antagonists, such as enalapril, losartan or valsartan: for treating high blood pressure or heart problems. You may get too much potassium in your blood.
  • Non-steroidal anti-inflammatory drugs, such as ibuprofen, diclofenac or Ketorolac: for arthritis or aches or pains. You may be likely to bleed more easily.
  • Salicylates, such as aspirin: for reducing pain and inflammation, or for stopping harmful blood clots forming. You may be likely to bleed more easily.
  • Platelet aggregation inhibitors, such as clopidogrel, dipyridamole, epoprostenol or ticlopidine: for stopping harmful blood clots forming. You may be likely to bleed more easily.
  • Thrombolytic agents, such as streptokinase: for dissolving blood clots. You may be likely to bleed more easily.
  • Vitamin K antagonists, such as warfarin: for stopping harmful blood clots. You may be likely to bleed more easily.
  • Glyceryl trinitrate infusion: for treating angina. This may reduce the effect of Heparin infusion.
  • Activated protein C: for getting rid of blood clots. You may be likely to bleed more easily.
  • Dextrans: for increasing your blood volume, used to treat shock. You may be likely to bleed more easily.
  • Probenecid, used in the treatment of gout
  • Cephalosporins, used to treat infections
  • aminoglycoside antibiotics (e.g. gentamicin, amikacin, neomycin or tobramycin)
  • Medicine that may increase the potassium level in your blood (e.g. amiloride, triamterene, eplerenone or spironolactone)

Your doctor may carry out check-ups on you, including blood tests, if you take any of these medicines at the same time as Heparin infusion.

Tobacco smoke can also interfere with the working of heparin. You should inform your doctor if you smoke.

The presence of Heparin in the blood can affect the results of some blood tests such as thyroid tests and the levels of calcium or some antibiotics (e.g. gentamicin) in the blood.

Pregnancy, breast-feeding and fertility

If you are pregnant or might be pregnant, tell your doctor before you are given Heparin infusion.

If you become pregnant while having this medicine, tell your doctor.

If you are being given heparin injection bleeding may be a problem during pregnancy or after delivery. Your bones may get thinner if you receive heparin for a long time during pregnancy.

If you are pregnant and are going to have an epidural anaesthetic, you should stop having your medicine. Ask your doctor for advice.

If you are breast-feeding, ask your doctor for advice before having Heparin infusion.

Driving and using machines

Usually your medicine may have little effect on your ability to drive or use machines. However, you should check with your doctor if you feel any side effect that may stop you from driving or using machines.

Important information about some of the ingredients of Heparin infusion

This medicine contains:

  • Sodium. This medicine is nearly “sodium free”. Your medicine contains less than 23 milligrams (mg) of sodium in each 1,000 International Units (IU) dose.

Please ask your doctor if you are worried about any of the ingredients in this medicine.

3. HOW TO USE HEPARIN INFUSION

Heparin infusion will be given to you by a doctor or a nurse.

Heparin infusion should not be mixed with any other injection.

It may be given under your skin or into your vein.

Treatment of thrombo-embolic disorders:

Adults

500 IU/kg bodyweight daily or 5,000 - 10,000 IU every 4 hours as a continuous infusion in sodium chloride injection or dextrose injection. The dose should be individually adjusted according to coagulation tests.

Elderly

Lower doses may be used in the elderly

Treatment of clotting during haemodialysis:

Adults

Initially: 1,000 - 5,000 IU.

1,000 - 2,000 IU per hour, adjusted to maintain clotting time greater than 40 minutes.

The recommended dose of Heparin Infusion

Your doctor will prescribe the right dose for you.

If you take more Heparin Infusion than you should:

Your doctor or nurse will give you this medicine. If you think you may have been given too much, tell your doctor or nurse straight away.

You may start to haemorrhage (bleed severely). Please read section 4 so you can spot any signs this may be happening to you.

You may be given another injection of a medicine called protamine sulphate.

If you have missed a dose of Heparin infusion

Your doctor or nurse will give you this medicine. If you think that you have missed a dose then tell your doctor or nurse.

If you have any further questions about taking this medicine, please ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Heparin infusion can cause side effects, although not everybody gets them.

Important side effects to look out for

You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:

  • You have difficulty breathing, wheezing
  • Fever, chills
  • Your face or throat swell
  • Your skin develops a severe itchy rash
  • Your skin develops blisters at the site of your injection.
  • You develop blue tinge to the lips
  • Swelling of eyes and lips.
  • Shock

You must get urgent medical help if you have any of the following symptoms after having an epidural or spinal anaesthetic. You may be developing paralysis:

  • Tingling, weakness or numbness in your legs or lower body
  • Back pain
  • Problems in going to the toilet.

You should tell your doctor straight away if you spot any of the following signs which mean you may be starting to bleed severely:

  • Red or brown urine
  • Black tarry stools
  • Unusual bruising or purple spots on your skin
  • Bleeding from your nose, mouth or any operation wound that will not stop

Other possible side effects

Common side effects (probably affect up to 1 in 10 people)

  • Bruising at the site of the injection.
  • Irritation at the site of the injection.
  • Bleeding (haemorrhage). This may be more likely if you are taking a high dose of Heparin infusion.
  • Changes in your blood test results - raised transaminase, lipid level. Your doctor can explain this more.
  • Reduction in the number of cells that help your blood clot-Thrombocytopenia

Uncommon side effects (probably affect less than 1 in 100 people)

  • Rash.
  • Itchy raised rash (hives).
  • Osteoporosis. Your bones become less strong and can break more easily. This has been seen in patients taking heparin for a long time.
  • Loss of hair (alopecia) this has been in patients with prolonged dosing with heparin.

Rare side effects (probably affect less than 1 in 1,000 people)

  • Bruising or bleeding more easily. Your blood may also form more harmful clots. A big drop in clotting cells (platelets) in your blood may give you these symptoms. Your doctor can explain this more.
  • Changes in your blood test results. The amount of potassium may be increased. This is more likely to happen if you have severe kidney problems or diabetes. Your doctor can explain this more.
  • The amount of hormone aldosterone may be lower than normal. Your doctor can explain this more.
  • Skin necrosis - complication that results in death of the skin tissue

Very rare side effects (probably affect less than 1 in 10,000 people)

  • Prolonged, painful erections in men.

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed on this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.

5. HOW TO STORE HEPARIN INFUSION

  • Keep out of the sight and reach of children.
  • Do not use Heparin infusion after the expiry date on the label. The expiry date is the last day of that month.
  • Store below 25°C.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Heparin Infusion contains:

  • The active ingredient is heparin sodium.
  • This product contains 1,000 IU of heparin sodium in each millilitre (ml).
  • The other ingredients are sodium chloride, sodium citrate and water for injections.

You can find important information about some of the ingredients near the end of section 2, just before section 3.

What Heparin Infusion looks like and contents of the pack:

Heparin infusion is a clear, colourless or pale yellow liquid.

This medicine comes in glass ampoules containing 5, 10 or 20 ml.

There are 10 ampoules in a carton.

Marketing Authorisation Holder:

Fannin (UK) Limited
DCC Vital
Westminster Industrial Estate
Repton Road
Measham
DE12 7DT
England

Manufacturer:

Laboratorio Reig Jofre
SA, Gran Capita, 10
08970 SANT JOAN DESPI
Barcelona
Spain

This leaflet was last revised in June 2018.

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