Heparin Mucous Injection Bp
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Heparin (mucous) Injection BP
1,000 and 5,000 Units/ml
heparin sodium
Please read all of this leaflet carefully before you start having 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 become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• In this leaflet Heparin (mucous) Injection will be called heparin.
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In this leaflet:
1. What heparin is and what it is used for
2. Before you have heparin
3. How to use heparin
4. Possible side effects
5. How to store heparin
6. Further information
1. WHAT HEPARIN IS AND WHAT IT IS USED FOR
Heparin belongs to a group of medicines called anticoagu lants.
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 is used:
• to help stop harmful blood clots in your veins growing bigger (treatment).
• to help stop harmful blood clots forming in your veins (prevention).
• 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. BEFORE YOU HAVE HEPARIN
Do not have heparin
• 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 have any condition which makes you bleed severely, such as haemophilia.
• If you have very high blood pressure.
• If you have severe liver problems.
• 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.
• If you may be having a miscarriage.
Do not give this medicine to a premature baby, a newborn baby, or a baby up to a month old. Important: If you are having an epidural or spinal anaesthetic
You must remind your doctor that you are having heparin before you receive any anaesthetic.
If you are pregnant please also read the section of this leaflet “Pregnancy and breast-feeding”.
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
Before you have heparin, tell your doctor:
• If you have any condition which makes you more likely to bleed more easily.
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. These are commonly called water tablets.
• If this medicine is for a child who is between one month and three years old.
• If you are taking another medicine that may affect your blood clotting. For a list of these medicines see the section “Taking other medicines”.
• If you know that you are sensitive to methylparahydroxy benzoate or propylpara-hydroxybenzoate. Read the information
in the section “Important information about some of the ingredients of heparin”.
• If you are pregnant, or think you are pregnant. Read the information about benzyl alcohol in the section “Important information about some of the ingredients of heparin”.
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.
Taking other medicines
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 or diclofenac: 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: 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
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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.
• Activated protein C: for getting rid of blood clots. You may be likely to bleed more easily.
• Dextrans: for increasing your blood volume. You may be likely to bleed more easily.
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.
Pregnancy and breast-feeding Unless your doctor has told you it is essential, you must not have heparin if you are pregnant, or think you are pregnant. Read the information about benzyl alcohol in the section “Important information about some of the ingredients of heparin”.
If you become pregnant while having this medicine, tell your doctor.
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.
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
This medicine contains:
• Benzyl alcohol. This is a preservative. It may harm a newborn baby. It must not be given to premature babies or babies under one month old.
Your doctor will decide if you can have heparin if you are pregnant. It may be possible for your doctor to use another type of heparin that does not contain this ingredient.
• Methylparahydroxybenzoate and propylpara-hydroxybenzoate. These are preservatives.
They may give you an allergic reaction. This may happen at any time after you have your medicine. Please read section 4 so you can spot any signs this may be happening to you.
• Sodium. This medicine is nearly “sodium free”. Your medicine contains less than 23 milligrams (mg) of sodium in each 25,000 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
Heparin will be given to you by a doctor or nurse. Heparin should not be mixed with any other injection. It may be given under your skin or into your vein.
How much heparin to have
Your doctor will prescribe the right dose for you.
If you have more heparin 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
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 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
• Your face or throat swell
• Your skin develops a severe rash
• Your skin develops blisters at the site of your injection.
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
• Bleeding from your nose, mouth or 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.
• Changes in your blood test results. Your doctor can explain this more.
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.
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.
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.
5. HOW TO STORE HEPARIN
• Keep out of the reach and the sight of children.
• Do not use the injection after the expiry date on the vial. 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. FURTHER INFORMATION
What heparin contains
• The active ingredient is heparin sodium.
There are two strengths of this product containing either 1,000 or 5,000 IU of heparin sodium in each millilitre (ml).
• The other ingredients are benzyl alcohol, methylparahydroxybenzoate, propylparahydroxy-benzoate, sodium citrate dihydrate, sodium chloride 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 looks like and contents of the pack
Heparin is a clear, colourless or pale yellow liquid. This medicine comes in glass vials containing 5 ml. There are 10 vials of heparin 1,000 and 5,000 IU/ml in a carton.
Marketing Authorisation Holder / Manufacturer
Marketing Authorisation Holder:
LEO Laboratories Limited, Hurley, Berkshire SL6 6RJ, UK.
Manufacturer: LEO Pharma A/S, DK 2750 Ballerup, Denmark.
This leaflet was last revised in October 2013.