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MULTIPARIN 5 000 I.U./ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): HEPARIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

HEPARIN SODIUM 5,000 I.U./ml solution for
injection or concentrate for solution for infusion
HEPARIN SODIUM 25,000 I.U./ml solution for
injection or concentrate for solution for infusion
Contains Preservative

Clearly mark any amendments on one proof and return to MPS

artwork.leicester@multipkg.com
Customer

Heparin 5,000 / 25,000 Leaflet

Wockhardt UK Limited

Measure bar should be 150mm at 100% scale

Description

105013/4

As per uploaded pdf

Item Code

Profile

7.5pt (main body) / 7.5pt (variables)

UK

148 x 560mm

Market

English

Size

Language

niallmcateer-lee

Min. Point Size

Proof By

4

Colours Used

Process Black

Keylines

105013/4

02/12/2015

Dosage reduction may be advisable

Proof No.

Elderly:

Date

4.4 Special warnings and precautions for use
Platelet counts should be measured in patients receiving heparin treatment
for longer than 5 days and the treatment should be stopped immediately in
those who develop thrombocytopenia.
In patients with advanced renal or hepatic disease, a reduction in dosage
may be necessary. The risk of bleeding is increased with severe renal
impairment and in the elderly (particularly elderly women).
Although heparin hypersensitivity is rare, it is advisable to give a trial dose
of 1,000 I.U. in patients with a history of allergy. Caution should be
exercised in patients with known hypersensitivity to low molecular weight
heparins.
Heparin injection contains benzyl alcohol (10mg/ml) and methyl
parahydroxybenzoate as preservatives. Caution should be used if
prescribing Heparin injection to susceptible patients. Benzyl alcohol may
cause toxic reactions and anaphylactoid reactions in infants and children up
to three years old. Methyl parahydroxybenzoate may cause allergic
reactions (possibly delayed) and, exceptionally, bronchospasm.
In most patients, the recommended low-dose regimen produces no
alteration in clotting time. However, patients show an individual response
to heparin, and it is therefore essential that the effect of therapy on
coagulation time should be monitored in patients undergoing major
surgery.
Caution is recommended in spinal or epidural anaesthesia (risk of spinal
haematoma).
Heparin can suppress adrenal secretion of aldosterone leading to
hyperkalemia, particularly in patients such as those with diabetes mellitus,
chronic renal failure, pre-existing metabolic acidosis, a raised plasma
potassium, or taking potassium sparing drugs. The risk of hyperkalemia
appears to increase with duration of therapy but is usually reversible.
Plasma potassium should be measured in patients at risk before starting
heparin therapy and in all patients treated for more than 7 days.
Heparin resistance
There is considerable variation in individual anticoagulant responses to
heparin.
Heparin resistance, defined as an inadequate response to heparin at a
standard dose for achieving a therapeutic goal occurs in approximately
5 to 30% of patients.
Factors predisposing to the development of heparin resistance, include:
· Antithrombin III activity less than 60% of normal (antithrombin
III-dependent heparin resistance):
Reduced antithrombin III activity may be hereditary or more commonly,
acquired (secondary to preoperative heparin therapy in the main, chronic
liver disease, nephrotic syndrome, cardiopulmonary bypass, low grade
disseminated intravascular coagulation or drug induced, e.g. by aprotinin,
oestrogen or possibly nitroglycerin)
· Patients with normal or supranormal antithrombin III levels (antithrombin
III- independent heparin resistance)
· Thromboembolic disorders
· Increased heparin clearance
· Elevated levels of heparin binding proteins, factor VIII, von Willebrand
factor, fibrinogen, platelet factor 4 or histidine-rich glycoprotein
· Active infection (sepsis or endocarditis)
· Preoperative intra-aortic balloon counterpulsation
· Thrombocytopenia

5,000 units subcutaneously every
8-12 hours, for 7-10 days or until the
patient is fully ambulant.
No laboratory monitoring should be necessary during low dose heparin
prophylaxis. If monitoring is considered desirable, anti-Xa assays should be
used as the activated partial thromboplastin time (APTT) is not
significantly prolonged.
During pregnancy:
5,000 - 10,000 units every 12 hours,
subcutaneously, adjusted according
to APTT or anti-Xa assay.
Elderly:
Dosage reduction and monitoring of APTT may be advisable.
Children:
No dosage recommendations.
Treatment of deep vein thrombosis and pulmonary embolism:
Adults:
Loading dose:
5,000 units intravenously (10,000 units
may be required in severe pulmonary
embolism)
Maintenance:
1,000-2,000 units/hour by intravenous
infusion, or 10,000-20,000 units
12 hourly subcutaneously, or
5,000-10,000 units 4-hourly by
intravenous injection.
Elderly:
Dosage reduction may be advisable.
Children and small adults:
Loading dose:
50 units/kg intravenously
Maintenance:
15-25 units/kg/hour by intravenous
infusion,
or 250 units/kg 12 hourly
subcutaneouslyor 100 units/kg 4-hourly
by intravenous injection
Treatment of unstable angina pectoris and acute peripheral arterial
occlusion:
Adults:
Loading dose:
5,000 units intravenously
Maintenance:
1,000-2,000 units/hour by intravenous
infusion, or 5,000-10,000 units 4-hourly
by intravenous injection.
Elderly:
Dosage reduction may be advisable.
Children and small adults:
Loading dose:
50 units/kg intravenously
Maintenance:
15-25 units/kg/hour by intravenous
infusion, or 100 units/kg 4-hourly by
intravenous injection
Daily laboratory monitoring (ideally at the same time each day, starting
4-6 hours after initiation of treatment) is essential during full-dose heparin
treatment, with adjustment of dosage to maintain an APTT value
1.5-2.5 x midpoint of normal range or control value.
Prophylaxis of mural thrombosis following myocardial infarction
Adults:
12,500 units 12 hourly subcutaneously
for at least 10 days.

4.9 Overdose
A potential hazard of heparin therapy is haemorrhage, but this is usually
due to overdosage and the risk is minimised by strict laboratory control.
Slight haemorrhage can usually be treated by withdrawing the drug.
If bleeding is more severe, clotting time and platelet count should be
determined. Prolonged clotting time will indicate the presence of an
excessive anticoagulant effect requiring neutralisation by intravenous
protamine sulphate, at a dosage of 1 mg for every 100 I.U. of heparin to be
neutralised. The bolus dose of protamine sulphate should be given slowly
over about 10 minutes and not exceed 50 mg. If more than 15 minutes
have elapsed since the injection of heparin, lower doses of protamine will
be necessary.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Heparin is an anticoagulant and acts by inhibiting thrombin and by
potentiating the naturally occurring inhibitors of activated Factor X (Xa).
5.2 Pharmacokinetic properties
As heparin is not absorbed from the gastrointestinal tract and sublingual
sites it is administered by injection. After injection heparin extensively
binds to plasma proteins.
Heparin is metabolised in the liver and the inactive metabolic products are
excreted in the urine.
The half life of heparin is dependent on the dose.
5.3 Preclinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are
additional to those already included in other sections.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzyl alcohol
Methyl parahydroxybenzoate (E218)
Water for injections
Sodium hydroxide solution
Hydrochloric acid
6.2 Incompatibilities
Heparin is incompatible with many injectable preparations e.g. some
antibiotics, opioid analgesics and antihistamines.
The following drugs are incompatible with heparin;
Alteplase, amikacin sulphate, amiodarone hydrochloride, ampicillin
sodium, aprotinin, benzylpenicillin potassium or sodium, cefalotin sodium,
chlorpromazine hydrochloride, ciprofloxacin lactate, cisatracurium besilate,
cytarabine, dacarbazine, daunorubicin hydrochloride, diazepam,
doxorubicin hydrochloride, droperidol, erythromycin lactobionate,
gentamicin sulphate, haloperidol lactate, hyaluronidase, hydrocortisone
sodium succinate, kanamycin sulphate, labetolol hydrochloride, meticillin
sodium, methotrimeprazine, netilmicin sulphate, nicardipine
hydrochloride, oxytetracycline hydrochloride, pethidine hydrochloride,
polymyxin B sulphate, promethazine hydrochloride, streptomycin sulphate,
tobramycin sulphate, triflupromazine hydrochloride, vancomycin
hydrochloride and vinblastine sulphate.
Dobutamine hydrochloride and heparin should not be mixed or infused
through the same intravenous line, as this causes precipitation.
Heparin and reteplase are incompatible when combined in solution.
If reteplase and heparin are to be given through the same line this,
together with any Y-lines, must be thoroughly flushed with a 0.9% saline
or a 5% glucose solution prior to and following the reteplase injection.
6.3 Shelf life
36 months
Chemical and physical in use stability has been demonstrated for 28 days at
25°C.
From a microbiological point of view, once opened, the product may be
stored for a maximum of 28 days at 25°C. Other in use storage times and
conditions are the responsibility of the user.
6.4 Special precautions for storage
Do not store above 25°C.
Store in the original package
6.5 Nature and contents of container
5ml multidose neutral glass (Type 1, Ph Eur) vial. Carton containing 10 vials.
6.6 Special precautions for disposal
Each multidose vial should be restricted to use in a single patient.
7. MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd, Ash Road North, Wrexham , LL13 9UF, UK.
8. MARKETING AUTHORISATION NUMBER(S)
Heparin sodium injection 5,000 I.U./ml –
PL 29831/0110, PA 1339/9/7
Heparin sodium injection 25,000 I.U./ml –
PL 29831/0108, PA 1339/9/8
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation:
Heparin sodium injection 5,000 I.U./ml
- 20 September 2007 (UK)
-16 November 2007 (Ireland)
Heparin sodium injection 25,000 I.U./ml
- 15 October 2007 (UK)
-16 November 2007 (Ireland)
10. DATE OF REVISION OF THE TEXT
December 2015.

N/A

Followed by:

· Thrombocytosis
· Advanced age
· Plasma albumin concentration ≤ 35g/dl
· Relative hypovolaemia
Heparin resistance is also often encountered in acutely ill patients, in
patients with malignancy and during pregnancy or the post-partum
period.
4.5Interaction with other medicinal products and other forms
of interaction
Analgesics: Drugs that interfere with platelet aggregation eg. aspirin and
other NSAIDs, should be used with care. Increased risk of haemorrhage
with ketorolac (avoid concomitant use even with low-dose heparin).
Anticoagulants, platelet inhibitors, etc: Increased risk of bleeding with oral
anticoagulants, epoprostenol, clopidogrel, ticlopidine, streptokinase,
dipyridamole, dextran solutions, or any other drug which may interfere
with coagulation.
Cephalosporins: Some cephalosporins, e.g. cefaclor, cefixime and
ceftriaxone, can affect the coagulation process and may therefore increase
the risk of haemorrhage when used concurrently with heparin.
ACE inhibitors: Hyperkalaemia may occur with concomitant use.
Nitrates: Reduced activity of heparin has been reported with simultaneous
intravenous glyceryl trinitrate infusion.
Probenecid: May increase the anticoagulant effects of heparin.
Tobacco smoke: Nicotine may partially counteract the anticoagulant effect
of heparin. Increased heparin dosage may be required in smokers.
Interference with diagnostic tests may be associated with
pseudo-hypocalcaemia (in haemodialysis patients), artefactual increases in
total thyroxine and triiodothyronine, simulated metabolic acidosis and
inhibition of the chromogenic lysate assay for endotoxin. Heparin may
interfere with the determination of aminoglycosides by immunoassays.
4.6 Pregnancy and lactation
Heparin is not contraindicated in pregnancy. Heparin does not cross the
placenta or appear in breast milk. The decision to use heparin in pregnancy
should be taken after evaluation of the risk/benefit in any particular
circumstances. Reduced bone density has been reported with prolonged
heparin treatment during pregnancy.
Haemorrhage may be a problem during pregnancy or after delivery.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Haemorrhage (see also Special Warnings and Precautions and Overdosage
Information).
Adrenal insufficiency secondary to adrenal haemorrhage has been
associated with heparin (rarely).
Thrombocytopenia has been observed occasionally (see also Special
Precautions and Warnings). Two types of heparin-induced
thrombocytopenia have been defined. Type I is frequent, mild (usually
>50 x 109/L) and transient, occurring within 1-5 days of heparin
administration. Type II is less frequent but often associated with severe
thrombocytopenia (usually <50 x 109/L). It is immune-mediated and
occurs after a week or more (earlier in patients previously exposed to
heparin). It is associated with the production of a platelet-aggregating
antibody and thromboembolic complications which may precede the onset
of thrombocytopenia. Heparin should be discontinued immediately.
There is some evidence that prolonged dosing with heparin (ie. over many
months) may cause alopecia and osteoporosis. Significant bone
demineralisation has been reported in women taking more than 10,000
I.U. per day of heparin for at least 6 months.
Heparin products can cause hypoaldosteronism which may result in an
increase in plasma potassium. Rarely, clinically significant hyperkalemia
may occur particularly in patients with chronic renal failure and diabetes
mellitus (see Warnings and Precautions).
Hypersensitivity reactions to heparin are rare. They include urticaria,
conjunctivitis, rhinitis, asthma, cyanosis, tachypnoea, feeling of oppression,
fever, chills, angioneurotic oedema and anaphylactic shock. In some
instances the precipitating agent will prove to be the preservative rather
than the heparin itself.
Local irritation and skin necrosis may occur but are rare. Erythematous
nodules, or infiltrated and sometimes eczema-like plaques, at the site of
subcutaneous injections are common, occurring 3-21 days after starting
heparin treatment.
Priapism has been reported. Increased serum transaminase values may
occur but usually resolve on discontinuation of heparin. Heparin
administration is associated with release of lipoprotein lipase into the
plasma; rebound hyperlipidaemia may follow heparin withdrawal.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk
balance of the medicinal product. Healthcare professionals are asked to
report any suspected adverse reactions via the national reporting system:
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

Pharma
Code

In extracorporeal circulation and haemodialysis
Adults:
Cardiopulmonary bypass:
Initially 300 units/kg intravenously,
adjusted thereafter to maintain the
activated clotting time (ACT) in the range
400-500 seconds.
Haemodialysis and
haemofiltration:
Initially 1,000-5,000 units,
Maintenance:
1,000-2,000 units/hour, adjusted to
maintain clotting time >40 minutes.
Heparin resistance
Patients with altered heparin responsiveness or heparin resistance may
require disproportionately higher doses of heparin to achieve the desired
effect. Also refer to section 4.4, Special warnings and precautions for use.
4.3 Contraindications
Known hypersensitivity to heparin or any of the other ingredients.
Must not be given to premature babies or neonates (contains benzyl
alcohol).
Patients who consume large amounts of alcohol, who are sensitive to the
drug, who are actively bleeding or who have haemophilia or other bleeding
disorders, severe liver disease (including oesophageal varices), purpura,
severe hypertension, active tuberculosis or increased capillary permeability.
Patients with present or previous thrombocytopenia. The rare occurrence
of skin necrosis in patients receiving heparin contra-indicates the further
use of heparin either by subcutaneous or intravenous routes because of the
risk of thrombocytopenia. Because of the special hazard of post-operative
haemorrhage heparin is contra-indicated during surgery of the brain,
spinal cord and eye, in procedures at sites where there is a risk of bleeding,
in patients that have had recent surgery, and in patients undergoing
lumbar puncture or regional anaesthetic block.
The relative risks and benefits of heparin should be carefully assessed in
patients with a bleeding tendency or those patients with an actual or
potential bleeding site eg. hiatus hernia, peptic ulcer, neoplasm, bacterial
endocarditis, retinopathy, bleeding haemorrhoids, suspected intracranial
haemorrhage, cerebral thrombosis or threatened abortion.
Menstruation is not a contra-indication.

616837

105013/4

1. NAME OF THE MEDICINAL PRODUCT
Heparin sodium 5,000 I.U./ml solution for injection or concentrate for
solution for infusion
Heparin sodium 25,000 I.U./ml solution for injection or concentrate for
solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Heparin sodium 5,000 I.U./ml - Heparin sodium 5,000 I.U./ml
(25,000 I.U. in 5ml)
Heparin sodium 25,000 I.U./ml - Heparin sodium 25,000 I.U./ml
(125,000 I.U. in 5ml)
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection or concentrate for solution for infusion
A colourless or straw-coloured liquid, free from turbidity and from matter
that deposits on standing.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Prophylaxis of deep vein thrombosis and pulmonary embolism
Treatment of deep vein thrombosis, pulmonary embolism, unstable angina
pectoris and acute peripheral arterial occlusion.
Prophylaxis of mural thrombosis following myocardial infarction.
In extracorporeal circulation and haemodialysis.
4.2 Posology and method of administration
Route of administration
By continuous intravenous infusion in 5% glucose or 0.9% sodium chloride
or by intermittent intravenous injection, or by subcutaneous injection.
The intravenous injection volume of heparin injection should not exceed
15ml.
As the effects of heparin are short-lived, administration by intravenous
infusion or subcutaneous injection is preferable to intermittent intravenous
injections.
Recommended dosage
Prophylaxis of deep vein thrombosis and pulmonary embolism:
Adults:
2 hours pre-operatively:
5,000 units subcutaneously

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

• irritation or sloughing of skin which may occur around
the injection site.
Side effects with unknown frequency:
• loss of hair (alopecia) if heparin sodium injection is given
over many months
• weakening of the bones (osteoporosis) if heparin sodium
injection is given over many months
• persistent erection of the penis (priapism)
• abnormal liver tests
• the amount of a hormone called aldosterone may be
lower than normal Your doctor can explain this more.
• high lipid levels on stopping heparin
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 national reporting systems
listed below.
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE HEPARIN INJECTION
Keep this medicine out of the reach and sight of children.
Your doctor or nurse will usually be responsible for storing and
preparing heparin injection before use and for checking that the vials
have not passed their expiry date stated on the carton and the label.
The medicine must not be used after the expiry date which is stated
on the carton and the label. The expiry date refers to the last day of
the month.
Heparin injection should not be given if it shows signs of
deterioration such as discolouration.
Do not store above 25°C. Store in the original packaging in order to
protect the product from light.
After opening, heparin vials may be kept for 28 days at 25°C, after
which they should be discarded.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What heparin injection contains
The active substance is heparin sodium.
1ml of solution of heparin sodium injection 5,000 I.U./ml contains
5,000 international units of the active ingredient. It is available in 5ml
multidose vials containing 25,000 I.U. in 5ml of solution.
1ml of solution of heparin sodium injection 25,000 I.U./ml contains
25,000 international units of the active ingredient. It is available in
5ml multidose vials containing 125,000 I.U. in 5ml of solution.
Other ingredients include benzyl alcohol (10mg/ml), methyl
parahydroxybenzoate (E218), water for injections, hydrochloric acid
and sodium hydroxide.
What heparin injection looks like and contents of the pack
Heparin injection is a colourless or straw-coloured liquid.
Each carton contains 10 glass vials.
Other formats
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product Name
Reference Number
29831/0110
Heparin sodium 5,000 I.U./ml
solution for injection or
concentrate for solution for infusion
Heparin sodium 25,000 I.U./ml
29831/0108
solution for injection or concentrate
for solution for infusion
This is a service provided by the Royal National Institute of
Blind People.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Wockhardt UK Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham,
LL13 9UF, UK.
This leaflet was last revised in 12/2015

Artwork No.

Small adults and children
Small adults and children will be given 50 units/kg body weight
injected into a vein followed by:
• 15-25 units/kg body weight/hour injected slowly into a vein
or
• 250 units/kg body weight 12 hourly injected under the skin
or
• 100 units/kg body weight 4 hourly injected all at once
into a vein
To TREAT chest pains (unstable angina pectoris) and severe
blood clots in the arteries (acute peripheral arterial
occlusion)
Adults
The usual dose in adults is 5,000 units injected into a vein. This is
followed by:
• 1,000-2,000 units/hour injected slowly into a vein
or
• 5,000-10,000 units 4 hourly injected all at once into a vein
Elderly
Lower doses may be used in the elderly
Small adults and children
Small adults and children will be given 50 units/kg body weight
injected into a vein followed by:
• 15-25 units/kg body weight/hour injected slowly into a vein
or
• 100 units/kg body weight 4 hourly injected all at once into a vein
You will have blood tests every day to check the effects of your
heparin
To prevent a blood clot in the heart following a heart attack.
Adults
The usual dose for adults is 12,500 units 12 hourly injected under the
skin for at least 10 days.
Elderly
A lower dose may be needed.
During Heart and Lung Surgery (Adults)
Initially you will be given 300 units/kg body weight. This will be
changed according to the results of your blood tests.
During kidney dialysis (Adults)
Initially you will be given 1,000-5,000 units. This will be changed
according to the results of your blood tests.
If you think you have been given too much heparin injection
Your doctor will decide which dose is best for you. Too much heparin
can cause bleeding. Slight bleeding can be stopped by stopping your
heparin treatment. However if you have more severe bleeding you
may need blood tests and an injection of a medicine called protamine
sulphate. If you think too much medicine has been given to you
contact your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, heparin injection may cause side effects in some
patients, although not everybody gets them. These are most likely to
occur when treatment is first started. You should inform your doctor
or nurse immediately if you feel unwell.
Important side effects to look out for:
• Severe allergic reactions
Heparin can cause a severe allergic reaction with wheezing, difficulty
breathing, a blue tinge to the lips, fever, chills, swelling of the eyes
and lips and shock.
Allergic reactions may be due to the ingredients in your heparin
rather than the heparin itself. This occurs particularly in infants or
children up to three years old.
If you think you are having a severe allergic reaction (see
symptoms above) you must tell your doctor or nurse
immediately.
• Bleeding and Bruising
Heparin injection can reduce the number of cells that help your blood
clot (thrombocytopenia) and so can cause bleeding and bruising.
This is most likely to occur within the first few days of treatment but
may occur later too. The risk of bleeding is increased in the elderly
(particularly elderly women).
Signs that you are bleeding more easily include:
• unusual bruising or purple spots on your skin
• unusual bleeding from your gums
• unusual nose bleeds
• blood in your urine (which may cause this to go dark)
• black, tarry-looking stools
• bleeding that will not stop from any operation site or
other injury
If you are concerned about unusual bleeding you must tell
your doctor or nurse immediately as you may need to stop
your heparin.
Other side effects include:
Common side effects (affects 1 to 10 users in 100):
• red lumps or red, itchy patches like eczema often develop
3-21 days after the start of heparin treatment, where
injections have been given under the skin
Rare side effects (affects 1 to 10 users in 10.000):
• raised levels of potassium in the blood, particularly in
patients with kidney failure or diabetes. If affected you
may feel tired and weak.
• allergic reactions including an itchy skin rash, eye
irritation, runny nose, wheezing, rapid breathing, a blue
tinge to the lips, fever, chills, swelling of the eyes and lips,
and shock.

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Read all of this leaflet carefully before you start taking
this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or nurse.
- 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.
The name of your medicine is either heparin sodium 5,000 I.U./ml or
heparin sodium 25,000 I.U./ml solution for injection or concentrate
for solution for infusion. In the rest of this leaflet it is called heparin
injection.
In this leaflet:
1. What heparin injection is and what it is used for
2. Before you are given heparin injection
3. How heparin injection is given
4. Possible side effects
5. How to store heparin injection
6. Further information
1. WHAT HEPARIN INJECTION IS AND WHAT IT IS USED FOR
Heparin belongs to a group of drugs that are called anticoagulants.
These help to stop blood clotting. Heparin injection 5,000 I.U./ml or
25,000 I.U./ml is used in conditions where blood vessels may become
blocked by blood clots. It is therefore used to treat and prevent:
• blood clots in leg veins (deep vein thrombosis)
• blood clots in the lung (pulmonary embolism) as well as for:
• the treatment of chest pains resulting from disease of the heart
arteries (unstable angina pectoris)
• the treatment of severe blockages affecting arteries in the legs
(acute peripheral arterial occlusion)
• the prevention of blood clots in the heart following a heart attack
(mural thrombosis).
It is also used during heart and lung operations and during kidney
dialysis.
2. BEFORE YOU ARE GIVEN HEPARIN INJECTION
Heparin injection should not be given if you:
• are allergic to heparin or any of the other ingredients in your
medicine, (see ‘What heparin injection contains’ section 6 and
‘Important information about some of the ingredients of heparin
injection’ below)
• drink large amounts of alcohol
• are currently bleeding from anywhere in the body, (apart from
your normal period which does not stop you being given heparin
injection)
• have haemophilia (a genetic disorder which may cause you to
bleed excessively) or any other bleeding problem
• have or have ever had thrombocytopenia (a serious blood disorder
which prevents blood from clotting properly)
• bruise easily (fragile capillaries) or have lots of purple spots that
look like bruises (purpura)
• have very high blood pressure
• are suffering from tuberculosis (TB)
• have had severe skin problems resulting from previous heparin
treatment
• are about to have surgery of the brain, spine or eye, a lumbar
puncture or local anaesthetic nerve block, or some other
procedure where bleeding could be a problem
• have recently had an operation
• suffer from severe liver problems which can lead to
bleeding into the oesophagus (gullet)
• have bleeding into the brain.
Heparin injection must not be given to premature or
newborn babies.
Speak to your doctor before heparin injection is given if you:
• are over 60 years of age
• have any condition which makes you 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),
a stroke, cancer or threatened miscarriage), If you are unsure,
ask your doctor or nurse.
• suffer from diabetes
• suffer from excess acid or high levels of potassium in your blood or
are taking a medicine that may increase the potassium level in
your blood (e.g. amiloride, triamterene, eplerenone or
spironolactone). If any of these apply you may need to have a
blood test before the start of your heparin treatment. If you are
unsure, ask your doctor or nurse
• have kidney or liver disease. Your doctor may decide that a lower
dose is necessary
• suffer from allergies or have previously had an allergic reaction to
low molecular weight (LMW) heparin. A small test dose of
heparin sodium injection may be given first.
Your doctor will check your blood if you receive treatment for longer
than five days and may do other blood tests if you have major
surgery.
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.

Taking other medicines
It is very important that you inform your doctor if you are taking,
or have recently taken, any other medicines, including those
medicines obtained without a prescription, as some medicines may
affect the way heparin injection works. Taking some medicines at the
same time as heparin may mean you may be likely to bleed more.
In particular, tell your doctor if you are taking any of the following:
• aspirin or other non-steroidal anti-inflammatory drugs
(e.g diclofenac or ibuprofen)
• dextran solutions (used to treat shock)
• medicines which may interfere with the proper clotting of the
blood (e.g. dipyridamole, epoprostenol, clopidogrel or
streptokinase)
• cephalosporins, used to treat infections
• medicines called ACE inhibitors used for high blood pressure and
heart failure (e.g. captopril enalapril, lisinopril or ramapril)
• medicines that may increase the potassium level in your blood
(e.g. amiloride, triamterene, eplerenone or spironolactone
• glyceryl trinitrate given into a vein (for coronary heart disease)
• aminoglycoside antibiotics (e.g. gentamicin, amikacin, neomycin
or tobramycin)
• probenecid, used in the treatment of gout
If you need one of the above medicines your doctor may decide to
alter the dose of heparin injection or the other medication. If you have
any doubts about whether this medicine should be administered
then discuss things more fully with your doctor or nurse before it is
given.
Tobacco smoke can also interfere with the working of heparin
injection. 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.
Important information about the ingredients benzyl alcohol
and methyl parahydroxybenzoate
The benzyl alcohol in heparin injection may cause toxic reactions and
allergic reactions in infants and children up to three years old.
The methyl parahydroxybenzoate in heparin injection may cause
allergic reactions (possibly delayed) and exceptionally bronchospasm
Pregnancy and breast-feeding
You should let your doctor or nurse know before you are given
heparin injection if you are pregnant or wish to become pregnant.
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.
Ask your doctor or nurse for advice if you wish to breast-feed
Driving and using machines
Heparin injection has not been reported to affect ability to drive or
operate machines.
3. HOW HEPARIN INJECTION SHOULD BE GIVEN
Your doctor or nurse will inject your dose of heparin into a vein either
all at once or over a longer period of time (usually via a drip).
Alternatively they may inject your heparin underneath your skin.
The amount injected all at once into a vein should not be greater than
15ml.
You may need to have blood tests if you are receiving higher doses of
heparin or if you are pregnant to check on the effects of your heparin
treatment.
Heparin injection must not be given to premature or
newborn babies.
You may require a lower dose if you have kidney or liver disease.
To PREVENT blood clots in leg veins (deep vein thrombosis)
and blood clots in the lung (pulmonary embolism)
Adults
The usual dose of heparin injection in adults is 5,000 units injected
under the skin 2 hours before your operation, followed by 5,000 units
injected under the skin every 8-12 hours, for 7-10 days or until you
are fully able to move about.
Pregnancy
During pregnancy the dosage is 5,000-10,000 units injected under
the skin every 12 hours. The dose may be adjusted according to your
blood tests.
Elderly
Lower doses may be used in the elderly. You may need to have blood
tests if you are elderly, to check on the effects of your heparin
treatment.
Children
No specific doses are recommended.
To TREAT blood clots in leg veins (deep vein thrombosis) and
blood clots in the lung (pulmonary embolism).
Adults
The usual dose in adults is 5,000 units injected into a vein. This is
followed by:
• 1,000-2,000 units/hour injected slowly into a vein
or
• 10,000-20,000 units 12 hourly injected under the skin
or
• 5,000-10,000 units 4 hourly injected all at once into a vein
Elderly
Lower doses may be used in the elderly

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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