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Clexane Multidose Vial

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Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient weight	Kg	Dose (mg)		Injection volume (ml)
300mg/3ml	40	40	bd	0.40
Solution for Injection	45	45	bd	0.45
Clexane Multidose Vial	50	5C	bd	0.50
	55	55	bd	0.55
	60	6C	bd	0.60
	65	65	bd	0.65
	70	7C	bd	0.70
	75	75	bd	0.75
	80	8C	bd	0.80
	85	85	bd	0.85
	90	9C	bd	0.90
	95	95	bd	0.95
	100	10C	bd	1.00
	105	105	bd	1.05
	110	11C	bd	1.10
	115	115	bd	1.15
	120	12C	bd	1.20
	125	125	bd	1.25
	130	13C	bd	1.30
	135	135	bd	1.35
	140	14C	bd	1.40
	145	145	bd	1.45
	150	150	bd	1.50

(1) Not to be given forthe first two doses - (maximum 100mg for the first two doses only, followed by1mg/kg dosing for the remaining doses)

Treatmentwith Clexane in these patients should be prescribed fora minimum of2 daysand continued until clinical stabilisation. The usual duration of treatment is2to8 days.

Dosage chart for 1mg/kg SC treatment of STEMI
Patient weight	Kg	Dose (mg)	Injection volume (ml)
300mg/3ml	40	40 bd	0.40
Solution for	45
Injection Clexane	50	50 bd	0.50
Multidose Vial	55
	60	60 bd	0.60
	65	65 bd	0.65
	70	70 bd	0.70
	75	75 bd	0.75
	80	80 bd	0.80
	85	85 bd	0.85
	90	90 bd	0.90
	95	95 bd	0.95
	100	100 bd	1.00
	105 (1)	105 bd (1)	1.05(1)
	110 (1)	110 bd (1)	1.10(1)
	115 (1)	115 bd (1)	1.15(1)
	120 (1)	120 bd (1)	1.20 (1)
	125 (1)	125 bd (1)	¹-25 (1)
	130 (1)	130 bd (1)	1.30 (1)
	135 (1)	135 bd (1)	1.35(1)
	140 (1)	140 bd (1)	1.40(1)
	145 (1)	145 bd (1)	1.45(1)
	150 (1)	150 bd (1)	1.50 (1)

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY

CLEXANE® 100mg/ml multidose vial

enoxaparin sodium Ph. Eur

SANOFlO

Clexane 100mg/ml multidose vial

enoxaparin sodium

The following information is extracted from the SPC Technical information for the administration of Clexane Syringes

1 NAME OF THE MEDICINAL PRODUCT

Clexane® Multidose Vial

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Vials containing 300 mg enoxaparin (equivalent to 30,000 IU

anti-Xa activity) in 3.0 ml

Contains benzyl alcohol (45mg in 3.0 ml)

For full list of excipients, seesection 6.1

3 PHARMACEUTICAL FORM

Sterile pyrogen-freesolution for injection contained ina multidose vial for single patient use.

Clear, colourless to slightly yellowsolution

4.2 Posology and method of administration Adults:

Prophylaxis ofvenous thromboembolism:

In patients with a low to moderate risk ofvenous thromboembolism the recommended dosage is 20 mg (2,000 IU) once daily by subcutaneous injection for 7 to 10 days, or until the risk of thromboembolism has diminished. In patients undergoingsurgery, the initial dose should be given approximately 2 hours pre-operatively.

In patients with a higher risk, such as in orthopaedic surgery, the dosageshould be40 mg (4,000 IU) daily by subcutaneous injection with the initial doseadministered approximately12 hours before surgery.

Prophylaxis ofvenous thromboembolism in medical patients: The recommended dose of enoxaparin sodium is40 mg (4,000 IU) once daily by subcutaneous injection. Treatmentwith enoxaparin sodium is prescribed fora minimum of 6 daysand continued until the return to full ambulation, fora maximum of 14 days. Treatment ofvenous thromboembolism:

Clexane should be administered subcutaneously asa single daily injection of 1.5 mg/kg (150 IU/kg). Clexane treatment is usually prescribed for at least 5 daysand until adequate oral anticoagulation is established.

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
			Injection
Patient weight	Kg	Dose (mg)	volume (ml) (1)
300mg/3ml	40	60 od	0.60
Solution for Injection		67.5 od
Clexane Multidose Vial	50	75 od	0.75
	55	82.5 od	0.825
	60	90 od	0.90
	65	97.5 od	0.975
	70	105 od	1.05
	75	112.5 od	1.125
	80	120 od	1.20
	85	127.5 od	1.275
	90	135 od	1.35
	95	142.5 od	1.425
	100	150 od	1.50

(1) the injection volumesare those needed toachieve the required dose. However, roundingup dose adjustments may need to betaken into consideration depending on the graduations of the syringe used.

Treatment ofunstableangina and non-O-wave myocardial infarction

The recommended dose is 1 mg/kg Clexane every 12 hours by subcutaneous injection, administered concurrentlywith oral aspirin (100 to 325 mg once daily).

Treatment ofacute ST-segment Elevation Myocardial Infarction: The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg SC dose followed by 1mg/kgadministered SC every12 hours (max 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining doses). For dosage in patients >75 years ofage, seesection 4.2 Posologyand method of administration: Elderly.

When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific) enoxaparin sodiumshould be given between 15 minutes beforeand 30 minutesafter the start of fibrinolytic therapy. All patients should receiveacetylsalicylic acid (ASA) as soon as theyare identified as having STEMIand maintained under (75 to 325mg once daily) unless contraindicated. The recommended duration of enoxaparin sodiumtreatment is 8 days or until hospital discharge, whichever comesfirst.

For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium SCadministrationwas given less than 8 hours before balloon inflation, no additional dosing is needed. If the last SCadministration was given more than 8 hours before balloon inflation,an IV bolus of0.3mg/kg of enoxaparin sodium should be administered.

11502569-07

FOR THE USER

multidose vial SANOFI^

PACKAGE LEAFLET: INFORMATION

CLEXANE* 100mg/ml

enoxaparin sodium

Is this leaflet hard to see or read? Phone 0845 372 7101 for help

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 anyfurther questions, askyourdoctoror pharmacist

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

• If any ofthe side effectsget serious, or if you notice any side effects not listed in this leaflet, pleasetell your doctororpharmacist

In this leaflet:

1. What Clexane is and what it is used for

2. Beforeyou have Clexane

3. HowClexane is given

4. Possible side-effects

5. Howto store Clexane

6. Further information

1. What Clexane is and what it is used for

The nameofyourmedicine isClexane100mg/ml Multidose Vial (called Clexane in this leaflet). Clexane containsa medicine called enoxaparin sodium. This belongsto a group of medicines called Low MolecularWeight Heparins.

Clexane works in two ways.

1) Stopping existing blood clotsfrom getting any bigger. This helpsyour bodyto breakthem down and stop them causingyou harm

2) Stopping blood clotsforming in your blood

Clexane can be used to:

• Treat blood clots that are inyourblood

• Stop blood clotsforming inyour blood in thefollowing situations:

• Unstable angina (where not enough blood getsto your heart)

• Afteran operation or long periodsof bed rest dueto illness

• Afteryou have had a heart attack

• Stop blood clotsforming in the tubes of your dialysis machine (used for peoplewith kidney problems)

2. Before you have Clexane

BDo not have this medicine and tell your doctor, pharmacist or nurse if:

x Youare allergic (hypersensitive) to:

- enoxaparin sodium orany ofthe other ingredients of Clexane (listed in Section 6: Further information)

- heparin or other Low MolecularWeight Heparins such as tinzaparin or dalteparin Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling ofyour lips, face, throat ortongue

x You have a problem with bruising or bleeding too easily

x You have an ulcer in yourstomach or gut (intestine) x You have had a stroke caused by bleeding in the brain x You have an infection in your heart x You are using heparinto treat blood clots (see “Taking other medicines") x The patient is under3years old Do not takethis medicine if any of the above apply to you. If you are not sure, talkto yourdoctor, pharmacist or nurse before having Clexane.

^3 Take special care with Clexane

Check with your doctor or pharmacist or nurse before

having this medicine if:

a. You have high blood pressure a You have kidney problems (see “Peoplewith kidney problems" in Section 3 - page 2) a You have had a heartvalvefitted a You have ever had bruising and bleeding caused by the medicine 'heparin' a You have ever had a stroke a You have ever had a stomach ulcer a You have recently had an operation on your eyes or brain

a You are a diabetic or have a illness known as 'diabetic retinopathy’ (problems with the blood vessels in the eye caused by diabetes)

a You have any problemswith yourblood a You are underweight oroverweight a You are elderly (over 65 years old) and especially if you are aged over 75 years old

If you are not sure if any ofthe above appliestoyou, talk toyour doctor, or pharmacist or nurse before having Clexane.

Taking or using other medicines

Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Clexane can affect theway some other medicineswork. Also some medicines can affect the way Clexane works.

Do not take and tell your doctor if you are taking the following medicine:

• Heparin - used totreat blood clots

Tell your doctor if you are taking any of the following medicines:

• Warfarin - used forthinningthe blood

• Aspirin, dipyridamole, clopidogrel or other medicines - used to stop blood clotsforming

• Dextran injection - used to replace blood volume

• Ibuprofen, diclofenac, ketorolac orother medicines -used totreat pain and swelling in arthritis and other illnesses

• Prednisolone, dexamethasone orother medicines -used totreat asthma, rheumatoid arthritis and other conditions

• Water tablets (diuretics) such as spironolactone, triamterene oramiloride. These may increasethe levels of potassium in your blood when taken with Clexane

Yourdoctor may change one of your medicines or take regular blood tests to checkthat takingthese medicines with Clexane is not causingyou any harm.

Operations and anaesthetics

Ifyou are goingto have a spinal puncture oran operation where an epidural or spinal anaesthetic is used, tell your doctorthatyou are having Clexane. Tell alsoyour doctor if you have any problem with yourspine or if you have ever had spinal surgery.

Pregnancy and breast-feeding

Talktoyour doctor beforeyou are given this medicine if you are pregnant, might become pregnant, orthinkyou may be pregnant.

You should not usethis medicine ifyou are pregnant and have a mechanical heartvalve as you may be at increased risk of developing blood clots. Your doctor should discuss this withyou.

You should not breast-feed whilst usingClexane. Ifyou are planningto breast-feed, talktoyourdoctor, pharmacist or nurse.

Askyourdoctoror pharmacistforadvice beforetakingany medicine ifyou are pregnant or breast-feeding.

Important information about some of the ingredients of Clexane

Clexane Multidose Vial contains benzyl alcohol. It must not be given to premature or newborn babies. Benzyl alcohol may causetoxic reactions and allergic reactions in infantsand children upto3yearsold.

3. How Clexane is given

Having this medicine

• Yourdoctorornursewill normallygiveyouClexane. This is because it needsto be given as an injection

• Clexane is usually given by injection underneath the skin (subcutaneous)

• Clexane can be given by injection into yourvein (intravenous) after certain types of heart attack or operation

If you are not sure why you are receiving Clexane or have any questions about how much Clexane is being given toyou, speaktoyour doctor, pharmacist or nurse.

How much will be given to you Yourdoctorwill decide how much to give you. The amount of Clexane given to you will depend on the reason it is being used

1) Treating blood clots that are in your blood

• The usual dose is1.5mgforevery kilogram ofyour weight, each day

• Clexane will usually given forat least 5 days

2) Stopping blood clots forming in your blood in the following situations:

a) Unstable angina

• The usual amount islmgfor every kilogram of weight, every12 hours

• Clexane will usually be given for2 to 8 days. Your doctor will normally askyou to take aspirin aswell

b) After an operation or long periods of bedrest due to illness

The usual dose is 20mgor40mg each day. The dose will depend on how likely you aretodevelop a clot

• Ifyou have a lowto medium risk of getting a clot, you will be given 20mg of Clexane each day. If you aregoingto havean operation, yourfirst injection will usually be given 2 hours beforeyouroperation

• If you have a higher risk of getting a clot, you will be given 40mg each day. If you are going to have an operation, yourfirst injection will usually be given 12 hours beforeyouroperation

Clexane each day for6to14days

Patient weight	Kg	0.75mg/kg Dose (mg)	Injection volume (ml) (1)
	115	86.25 bd (2)	0.8625 (2)
	120	90 bd (2)	0.90 (2)
	125	93.75 bd (2)	0.9375 (2)
	130	97.5 bd (2)	0.975 (2)
	135	101.25 bd (2)	1.0125(2)
	140	105 bd (2)	1.05(2)
	145	108.75 bd (2)	1.0875 (2)
	150	112.5 bd (2)	1.125(2)

Dosageadjustments for therapeutic dosage ranges

Standard dosing	Severe renal impairment
1 mg/kg SC twice daily	1 mg/kgSConcedaily
1.5 mg/kg SC once daily	1 mg/kgSConcedaily
For treatment ofacute STEMI in patients <75 years ofage
30mg-single IV bolus plus a 1mg/kg SC dose followed by 1mg/kg twice daily. (MaxIOOmg for each of the first two SC doses)	30mg-single IV bolus plus a 1mg/kg SC dose followed by 1mg/kg once daily. (Max 100mg forfirst SC dose only)
For treatment ofacute STEMI in elderly patients >75years ofage
0.75mg/kg SCtwice daily without initial bolus. (Max 75mg for each of the first two SC doses)	1mg/kg SC once daily without initial bolus. (MaxIOOmg forfirst SC dose only)

Dosageadjustments for prophylactic dosage ranges

Standard dosing	Severe renal impairment
40 mg once daily	20 mg once daily
20 mg once daily	20 mg once daily

Prevention of extracorporeal thrombus formation during haemodialysis:

A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial lineatthe beginning ofa dialysis session is usually sufficient fora 4 hoursession. Iffibrin rings are found, such as after a longerthan normalsession.a furtherdose of0.5 to 1 mg/kg (50 to100 IU/kg) may be given. For patients ata high risk of haemorrhage the doseshould be reduced to 0.5 mg/kg (50 IU/kg) for double vascularaccess or 0.75 mg/kg (75 IU/kg) for single vascularaccess.

Elderly:

For treatment ofacute ST-segment Elevation Myocardial Infarction in elderly patients >75 years ofage, do not usean initial IV bolus. Initiate dosing with 0.75mg/kg SC every 12 hours (maximum75mg for thefirst two doses only, followed by 0.75mg/kg dosing for the remaining doses).

For other indications, no dosageadjustmentsare necessary in the elderly, unless kidney function is impaired (seealsosection

4.2 Posologyand method ofadministration: Renal Impairment; section 4.4 Special warnings and precautions for use: Haemorrhage in the elderly; Renal impairment and Monitoring; section 5.2 Pharmacokinetic properties).

Dosage chart for 0.75mg/kg SC treatment of STEMI (elderly patients aged >75 years only)
Patient weight	Kg	0.75mg/kg Dose (mg)	Injection volume (ml) (1)
300mg/3ml	40	30 bd	0.30
Solution for Injection	45
Clexane Multidose Vial	50
	55	41.25 bd	0.4125
	60	45 bd	0.45
	65	48.75 bd	0.4875
	70	52.5 bd	0.525
	75	56.25 bd	0.5625
	80	60 bd	0.60
	85	63.75 bd	0.6375
	90	67.5 bd	0.675
	95	71.25 bd	0.7125
	100	75 bd	0.75
	105	78.75 bd (2)	0.7875 (2)
	110	82.5 bd (2)	0.825 (2)

_ _______________

c) After you have had a heart attack

Clexane can be used fortwo differenttypes of heart attack called NSTEMI orSTEMl.Theamount of Clexane given to you will depend on your age and the kind of heart attackyou have had.

i) NSTEMI type of heart attack

• The usual amount is 1mg for every kilogram of weight, every 12 hours

• Clexane will usually be given for2to 8 days. Yourdoctorwill normally askyou totake aspirin aswell

ii) STEMI type of heart attack

If you are under 75 years old

• 30mgofClexanewill begivenasan injection intoyourvein (intravenous injection)

• Atthe same time, you will also be given Clexaneasan injection underyourskin (subcutaneous injection). The usual dose is Imgforevery kilogram ofyourweight.

• Thenyou will be givenlmgforevery kilogram of yourweight every12 hours after that

• The maximum amount of Clexane givenfor the first two injections islOOmg

• The injections will normally be given forup to 8 days

If you are aged 75 years or older

• Yourdoctor or nurse will give you injections of Clexane underyourskin (subcutaneous injection)

• The usual dose is0.75mgforevery kilogram ofyourweight, every12 hours

• The maximum amount of Clexane givenfor the first two injections is 75mg

For patients having an operation called

Percutaneous Coronary Intervention (PCI)

• Depending on when you were last given Clexane, yourdoctor may decide to give an additional dose of Clexane before a PCI operation. This is by injection intoyourvein (intravenous)

3) Stop blood clots forming in the tubes of your

dialysis machine

• The usual dose is 1 mgforevery kilogram ofyour weight

• Clexane is added to the tube leaving the body (arterial line) atthe start ofthe dialysis session

• This amount is usually enough for a 4 hour session. However, yourdoctor may give you a furtherdose of 0.5to Imgforevery kilogram of yourweight if necessary

(1) the injection volumes are those needed toachieve the required dose. However, roundingup dose adjustments may need to be taken into consideration depending on the graduations of the syringe used.

(2) not to be given for thefirst two doses - (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses)

Children: Not recommended, as dosage not established.

Renal impairment: (See alsosection 4.4 Specialwarningsand precautions for use: Renal impairment and Monitoring; section

5.2 Pharmacokinetic properties).

Severe renal impairment:

A dosageadjustment is required for patients with severe renal impairment (creatinine clearance < 30 ml/min), according to the following tables, since enoxaparin sodium exposure is significantly increased in this patient population:

The recommended dosage adjustments do not apply to the haemodialysis indication.

Moderate and mild renal impairment:

Although no dosage adjustmentsare recommended in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) or mild renal impairment (creatinine clearance 50-80 ml/min), careful clinical monitoring isadvised. Spinal/epidural anaesthesia:

For patients receiving spinal/epidural anaesthesia see section 4.4 Specialwarningsand precautions for use: Spinal/epidural anaesthesia.

Hepatic impairment: In the absence of clinical studies, caution should be exercised.

Body weight: Nodosageadiustmentsare recommended in obesity or low body weight (seealso section 4.4 Specialwarnings and precautions for use: Low body weight and Monitoring; section 5.2 Pharmacokinetic properties).

Clexane is administered by subcutaneous injection for the prevention of venous thromboembolicdisease, the treatment of deep vein thrombosis or for the treatment ofunstableangina, non-Q-wave myocardial infarctionandacuteST elevation myocardial infarction (STEMI); through the arterial line ofa dialysis circuit for the prevention ofthrombus formation in the extra-corporeal circulation during haemodialysis; and via intravenous (bolus) injection through an intravenous line only for the initial dose ofacute STEMI indication and before PCI when needed. It must not beadministered by the intramuscular route. Subcutaneous Injection Technique When using vials ofenoxaparin sodium, the volume to be injected should be measured precisely with a graduated syringe fitted withanappropriate needle forsubcutaneous injection. Clexane should be administered when the patient is lying down by deep subcutaneous injection. The administration should be alternated between the left and right anterolateral or posterolateral abdominalwall. Thewhole length of the needle should be introduced vertically intoa skin fold held between the thumband index finger. The skin fold should not be released until the injection is complete. Do not rub the injection site afteradministration.

Intravenous (Bolus) Injection Technique (foracute STEMI indication only):

Forintravenous injection, either the Multidose Vial or 60mg, 80mg orlOOmg prefilled syringescan be used. Enoxaparin sodiumshould beadministered throughan intravenous line. It should not be mixed or co-administered with other medications. Toavoid the possible mixture of enoxaparin sodiumwithall otherdrugs, the intravenousaccess chosen should be flushed with a sufficient amount ofsaline or dextrosesolution prior to and following the intravenous bolus administration of enoxaparin sodium to clear the port of the drug. Enoxaparin sodium may be safely administered with normalsalinesolution (0.9%) or 5% dextrose in water.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients Benzyl alcohol (45mg/3ml)

Water for injections

6.2 Incompatibilities Subcutaneous Injection

Clexane should not be mixed withany other injections or infusions.

Intravenous (Bolus) Injection for acute STEMI indication only: Enoxaparin sodium may be safely administered with normalsaline solution (0.9%) or 5% dextrose in water.

6.3 Shelf life 2 years

6.4 Special precautions for storage

Store below 25°C.

The contents of the multidose vial should be used within 28 days ofopening.

6.5 Nature and contents of container

Boxes containinga single 3 ml multidose glass vial for single patient use.

6.6 Special precautions for disposal

Seesection 4.2 Posologyand method ofadministration

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 18August 1997 Date of latest renewal: 06 September 2002

10 DATE OF REVISION OF THE TEXT

10/2014

11502569-07

People with kidney problems

If you have problems with your kidneys, you may be given a smalleramount of Clexane.

If you have more Clexane than you should

Yourdoctorwill carefully calculate how much Clexaneyou should get. Therefore it is unlikely yourdoctor, nurse or pharmacist will giveyou too much ofthis medicine. But, if you think that you have been given too much ortoo little Clexane, tell yourdoctor, nurse or pharmacist.

If you stop using Clexane

It is importantforyou to keep having Clexane injections until yourdoctordecidesto stopthem. If you stop, you could get a blood clotwhich can bevery dangerous.

Blood Tests

Using Clexane may affect the results of some blood tests.

If you are goingto have a blood test, it is importantto tell yourdoctoryou are having Clexane.

4. Possible side-effects

Like all medicines, Clexane can cause side-effects,

although not everybody getsthem.

Tell a nurse or doctor straight away if you notice any of the following side-effects:

Very common (affects morethan 1in10 people)

• Bleedingalotfromawound

Common (affects 1to10 people in a 100)

• A painful rash ofdarkred spots undertheskin which do not go awaywhen you put pressureon them.You mayalso notice pink patches on your skin. These are more likely to appearin thearea you have been injected with Clexane

Uncommon (affects 1 to10 people in a 1,000)

• Sudden severe headache. This could be a sign of bleeding in the brain

• A feeling oftendernessand swelling in yourstomach. You may have bleeding inside your stomach

Rare (affects less than 1 in a 1000 people)

• If you have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

Frequency unknown

• Ifyou have had a spinal puncture ora spinal anaestheticand notice tingling, numbnessand muscular weakness, particularly in the lower part of your body. Also if you lose control over your bladder or bowel (so you cannot control when you go to the toilet)

Tell a nurse or doctor as soon as possible if you notice any of the following side effects:

Common (affects 1to10 people in a 100)

• You bruise more easily than usual. This could be becauseofa blood problem (thrombocytopenia)

• You have pain, swelling or irritation in the area you have been injected with Clexane. This normally gets betteraftera fewdays

Rare (affects less than 1 ina 1000 people)

• Ifyou haveamechanicalheartvalve, treatmentwith Clexane might not be sufficient to prevent blood clots. You may notice that you have difficulty breathing, tiredness or difficulty exercising, chest pain, numbness, feeling sick or loss of consciousness. This could be due to a blood clot on the heartvalve

Frequency unknown

• Feeling tired, faint, dizzy, having pale skin. These could be symptoms of anaemia.

• You noticeyellowing oryourskin oreyesand your urine becomes darker in colour. This could be a liver problem.

Other side effects that you should discuss with your doctor if you are concerned about them:

Very common (affects morethan 1in10 people)

• Changes in the results of blood tests done to check how your liver isworking. These usually go backto normal afteryou stop having Clexane

Rare (affects less than 1 ina 1000 people)

• Changes in the potassium levels in your blood. This is more likely to happen in people with kidney problems or diabetes. Your doctor will be ableto check this by carrying out a blood test

Frequency unknown

• If Clexane is used fora long period oftime (more than 3 months), it may increase the riskofyou getting a condition called 'osteoporosis’. This is when your bones are more likely to break

• Headache

• Hair loss

Reporting of side effects

If you get any side effects, talktoyourdoctor, 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 effectsyou can help provide more information on the safety ofthis medicine.

5. How to store Clexane

Keep this medicine in a safe placewhere children cannot see or reach it.

Do not use Clexane after the expiry datewhich is stated on the carton. The expiry date refers to the last day of that month.

Store below 25°C. The contentsofthevial should not be used for more than 28 days after opening. Medicinesshould not be disposed ofvia wastewater or household waste. Askyourpharmacist howto dispose of medicines no longer required. These measureswill help to protect the environment.

6. Further Information

What Clexane contains

• Each multidose vial contains 300mg (30 000 IU) ofthe active substance, enoxaparin sodium in 3ml

• The other ingredients are benzyl alcohol (45mg/3ml) and waterfor injections

What Clexane looks like and contents of the pack

Clexane Multidose Vial contains a clear, colourlessto slightly yellow solution, it is available as single glass vials only.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Tel: 0845 372 7101

email: uk-medicalinformation@sanofi.com Manufacturer

FAMAR HEALTH CARE SERVICES MADRID, S.A.U.

Avda. Leganes, 62, Alcorcon 28923 (Madrid) Spain

This leaflet does not contain all the information about your medicine. Ifyou have any questionsorare not sure about anything, askyourdoctoror pharmacist.

This leaflet was last revised in 12/2013