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Package leaflet: Information for the user

Exembol 1 mg/ml solution for infusion
argatroban monohydrate
Read all of this leaflet carefully before you start
using 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.
• 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 Exembol is and what it is used for
2. What you need to know before you use Exembol
3. How to use Exembol
4. Possible side effects
5. How to store Exembol
6. Contents of the pack and other information

1. What Exembol is and what it is used for
Exembol is an anticoagulant (a drug that helps to prevent
blood clots from forming in your blood circulation). It
works by blocking the action of thrombin, a substance in
your blood that is important in blood clotting.
Exembol is used if you are suffering from a disorder known
as heparin-induced thrombocytopenia type II (HIT type II).
If you have HIT type II, you are at risk of developing blood
clots in your blood circulation that can cause heart attacks,
stroke, breathing problems and problems with the blood
supply to your limbs. Exembol can prevent these problems
or prevent them from becoming worse.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, you should ask
your doctor for advice before Exembol is given to you.
As a precautionary measure, it is preferable to avoid the
use of Exembol during pregnancy.
Avoid breast-feeding while you are being given Exembol
(see also “Exembol contains alcohol”).
Driving and using machines
Since Exembol contains alcohol you should not drive a car
or use machines in connection with the treatment (see also
“Exembol contains alcohol”).
Exembol contains alcohol
This product contains 4 mg/ml or 0.5% by volume of
alcohol (ethanol). The daily dose may therefore contain
up to 5 ml (4 g) of alcohol, corresponding to 100 ml beer
or 40 ml wine. This may be harmful for persons suffering
from liver disease, alcoholism or epilepsy as well as for
pregnant and nursing women and their children. This may
also influence the effect of other medicines.
Exembol contains sorbitol
If you are intolerant to certain sugars, you must tell your
Exembol contains sodium
This medicinal product contains 3.6 mg sodium per ml, to
be taken into consideration by patients on a controlled
sodium diet.

3. How to use Exembol
Exembol will always be given to you by medical personnel.
Exembol will be given to you intravenously (into a vein) by
continuous infusion. The doctor will decide the dose and
how long you will be treated.

4. Possible side effects
2. What you need to know before you use

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

Do not use Exembol
Exembol will not be given to you:
• If you have uncontrolled bleeding
• If you are allergic (hypersensitive) to argatroban or to
any of the other ingredients of Exembol
• If you have severely impaired liver function

The most common side-effects are bleeding. Major
bleeding can occur in about 5% of patients and minor
bleeding in about 39% of patients. You must tell your
doctor immediately if you experience any of the
following symptoms:

Warnings and precautions
Exembol will be given to you with special care:
• If there is an increased risk of bleeding
• If you have recently had injections or infusions of other
anticoagulants such as heparin
• If you have liver disease
Children and Adolescents
It is not advised to give this medicine to children or
adolescents as the safe or effective dose of Exembol has
not been clearly established.
Other medicines and Exembol
Please tell your doctor if you are taking, have recently
taken, or might take any other medicines, including
medicines obtained without prescription.
Combined use with other blood thinning or blood clot
dissolving medicines can increase the risk of bleeding.
Because Exembol contains ethanol, this can influence the
effect of other medicines containing metronidazole (for
infections) or disulfiram (for alcoholism).

• bleeding or bruising,
• blood in urine or stools
• vomiting or coughing up blood
• black stools
• difficulty in breathing
• cold sweaty skin
• dry mouth
• dilated pupils and/or weak rapid pulse.
These symptoms could indicate that you are experiencing
bleeding problems.
Common side effects (may affect up to 1 in 10 people):
• anaemia
• blood clotting
• bleeding, including numerous small bleedings in skin and
mucus membranes (purpura)
• nausea

Uncommon side effects (may affect up to 1 in 100
• infections such as urinary tract infection
• changes in blood values
• blood clotting
• lack of appetite
• low blood sugar levels
• low sodium levels in the blood
• confusion
• dizziness
• fainting
• headache
• stroke
• muscle disorders
• speech disorder
• vision problems
• deafness
• heart attack
• fluid in the heart sac
• abnormal heart rhythm
• fast heartbeat
• low blood pressure
• high blood pressure
• inflammation of veins
• shock
• reduced oxygen supply to the tissues
• breathing difficulties
• fluid around the lungs
• hiccup
• blood in cough, vomit or stools
• constipation
• diarrhoea
• stomach inflammation
• difficulty in swallowing
• tongue disorder
• abnormal liver function
• jaundice (yellowing of the skin and eyes)
• changes in blood tests for liver function
• rash including including nettle rash
• itching
• increased sweating
• hair loss
• muscle weakness
• muscle pain
• kidney failure
• fever
• pain
• tiredness
• injection site reactions
• swelling of the legs
• increased wound drainage
• abnormal laboratory results.

Do not use Exembol after the expiry date which is stated
on the carton/vial after “EXP”. The expiry date refers to
the last day of that month.

Not known (frequency cannot be estimated from the
available data).
Cases of bleeding into the brain have been reported,

The following information is intended for healthcare
professionals only.

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 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 Exembol
Keep this medicine out of the sight and reach of children.
Keep vial in the outer carton in order to protect from
Do not refrigerate or freeze.
The solution should be used immediately after opening.
In-use the solution should not be exposed to direct
Solutions should not be used if they are cloudy or contain
any particles.

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other
What Exembol contains
The active substance is argatroban monohydrate 1 mg/ml.
1 ml solution for infusion contains 1 mg argatroban
1 vial with 50 ml solution for infusion contains 50 mg
argatroban monohydrate.
The other ingredients are anhydrous ethanol, sorbitol,
sodium chloride and water for injections.
This medicinal product must not be mixed with other
medicinal products.
What Exembol looks like and contents of the pack
This medicinal product is a clear colourless to pale yellow
solution for infusion. Each vial contains 50 ml of solution
and the vials are packed in cardboard boxes of 4 or 12
Not all pack sizes may be marketed.
Marketing authorisation holder
Mitsubishi Tanabe Pharma Europe Ltd, Dashwood House,
69 Old Broad Street, London, EC2M 1QS, United Kingdom.
Central Pharma (Contract Packing) Limited
Caxton Road, Bedford, MK41 0XZ, United Kingdom.
This medicinal product is authorised in the Member
States of the EEA under the following names:
United Kingdom Exembol
This leaflet was last revised in: September 2017

Instructions for use, handling and disposal
Exembol 1 mg/ml Solution for Infusion is ready to use
and requires no dilution before administration. It is
recommended for use with a syringe driver to control the
rate of administration.
The drug product is unpreserved and intended for single
use only. The solution should be used immediately after
opening. Any unused solution should be discarded.
If the solution is cloudy, or if an insoluble precipitate is
noted, the vial should be discarded.
Light resistant measures such as foil protection for
intravenous lines are not necessary. No significant potency
losses have been noted following simulated delivery of the
solution through intravenous tubing.
Any unused product or waste material should be disposed
of in accordance with local requirements.




Mitsubishi Tanabe Pharma Europe Ltd


10 November 2014 — (as Issue 01)

Product Name

Exembol PIL - RTU (Previously Novastan)


200 x 300 mm


United Kingdom - (UK)


5 mm



Pharmacode No.


QRD Doc Ref.

2017 SE_H_0483_004_IAIN_042_PIL_UK_tracked.doc

Font details

Client Job No.:


Main title: (custom EPS graphic)
Sub-titles: Frutiger LT Std - 75 Black — 11 pt
Body copy: Frutiger LT Std - 55 Roman — 9 pt

Item Code



Black - K

Manufacturer Code
PD Ref.

PD-UK-RTU-PIL0000-v07 - (** to follow final proof)




20 September 2017

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.