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MYOCRISIN 20MG/ML SOLUTION FOR INJECTION

Active substance(s): SODIUM AUROTHIOMALATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Myocrisin® 20mg/ml &
100mg/ml Solution for
Injection
Sodium aurothiomalate

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 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 gets serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Myocrisin is and what it is used for
2. Before you have Myocrisin
3. How Myocrisin is given
4. Possible side effects
5. How to store Myocrisin
6. Further information

1. What Myocrisin is and
what it is used for

3. How Myocrisin is given

i

The name of your medicine is Myocrisin®
20mg/ml & 100mg/ml Solution for Injection
(called Myocrisin in this leaflet). Myocrisin
contains a medicine called sodium
aurothiomalate. This belongs to a group of
medicines called antiarthritics.
It works by a number of different ways to
reduce the pain and swelling in arthritic
joints.
Myocrisin can be used to treat arthritis in
adults and children when:
• You have had arthritis for a long time
• Your arthritis is gradually getting worse
• Your arthritis affects lots of joints in your
body

2. Before you have Myocrisin
Do not have this medicine and
tell your doctor if:
X You are allergic (hypersensitive) to sodium
aurothiomalate or any of the other
ingredients of Myocrisin (listed in Section
6 below). Signs of an allergic reaction
include: a rash, swallowing or breathing
problems, swelling of your lips, face,
throat or tongue.
X You are pregnant, might become pregnant
or think you may become pregnant (see
‘Pregnancy and breast-feeding’ below)
X You have liver or kidney problems
X You have ever had a blood problem
X You have ever had a problem where your
skin is scaling, itchy and red - something
called ‘exfoliative dermatitis’
X You have a condition called ‘systemic
lupus erythematosus’ (SLE)
Do not have this medicine if any of the
above apply to you. If you are not sure, talk
to your doctor or pharmacist before having
Myocrisin.
Take special care with Myocrisin
Check with your doctor or
pharmacist before having your
medicine if:
▲ You are aged 65 years or older
▲ You have or ever had an itchy, lumpy
rash (called urticaria)
▲ You have ever had eczema. Signs include
itchy, scaly skin with red appearance and
blistering
▲ You have or ever had ‘colitis’. Signs
include pain in the stomach, diarrhoea,
or blood and mucus in your stool
▲ You have not had a blood, urine and skin
test before taking this medicine. Your doctor
should check the results of these tests
before prescribing this medicine for you
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before having Myocrisin.

CROMinFOTO s.n.c.

Via G. Tartini, 2 - 2 0 1 5 8 - M I L A N O
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

TYPE OF MATERIAL:

LEAFLET

Your medicine will normally be given to you
by a doctor or nurse. This is because it needs
to be given by deep injection into a muscle.
If you are not sure why you are being given
Myocrisin or have any questions about how
much Myocrisin is being given to you, speak
to your doctor or nurse.
Having this medicine
• Myocrisin will be injected into a muscle.
This area will then be massaged gently
• Your doctor or nurse will keep an eye on you
for 30 minutes after having the injection
• If the treatment is successful, it may be
continued for 1 to 5 years
How much Myocrisin to have
• The amount of Myocrisin you are given
and how often you are given it will be
decided by your doctor. It will depend on
if and when your symptoms improve
• If your symptoms improve within the first
20 weeks of treatment, you will be given
the injections less often
• If your symptoms do not improve after the
first 20 weeks of treatment, your doctor
may increase the amount of Myocrisin you
are given
• If your symptoms still do not improve,
your doctor may decide to use another
medicine instead
Adults and the elderly
• Test dose: a dose of 10mg is given in the
first week before starting the course of
treatment
• If the test dose is successful: the usual
starting dose is 50mg every week until
your symptoms start to improve
If your symptoms improve within 20 weeks:
• The time between injections will be
increased to every 2 weeks until your
symptoms have gone
• Then the time between injections will
gradually increase to every 3 weeks, then
every 4 weeks
• After you have been having Myocrisin for
18 to 24 months, you will only have an
injection every 6 weeks
If symptoms do not improve after 20 weeks:
• The dose may be increased to 100mg
every week
• This is continued for up to 6 weeks
• If your symptoms still do not improve
after this, your doctor may try other
medicines instead
Children
• The usual weekly dose will be based on
1mg for every kg of body weight
• A maximum of 50mg per week can
be given
• A smaller test dose may be given for the
first 2-3 weeks before starting the course
of treatment

89029187
(int. version 1)

DESCRIPTION:

89029187

VERSION:

1 a

OLD CODE:

89027063

30 APR 2015

COUNTRY:

MYOCRISIN 10 & 50 MG

MIN. FONT SIZE: CODE:

11 pt.

Taking other medicines
Please tell your doctor or pharmacist 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 Myocrisin can affect the way
some other medicines work. Also some
medicines can affect the way Myocrisin works.
In particular, tell your doctor if you are
taking any of the following medicines.
These can increase the chance of you getting
side effects, when taken with Myocrisin:
• Aspirin used for pain, swelling and to thin
the blood
• Some medicines for high blood pressure
(angiotensin-converting enzyme inhibitors) such as, captopril, enalapril, fosinopril or
perindopril
• Medicines used to relieve pain and
swelling of the joints and ligaments - such
as phenylbutazone and oxyphenbutazone
Pregnancy and breast-feeding
Do not have Myocrisin if:
• You are pregnant, might become pregnant
or think you may be pregnant
• You are breast-feeding or planning to
breast-feed
Ask your doctor or pharmacist for advice
before taking any medicine if you are
pregnant or breast-feeding.
Important information about some of
the ingredients of Myocrisin
This medicine contains phenylmercuric
nitrate as a preservative. This may cause an
allergic reaction.
Tell your doctor if you have any known
allergies.

LOGO VERSION:

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U.K.
DIMENSION mm:

160 x 420

COLOURS N°:

1

COLOUR 1:

REFLEX BLUE

If your child’s symptoms improve within
20 weeks:
• The time between injections will be
increased to every 2 weeks until your
child’s symptoms have gone
• Then the time between injections will
gradually be increased to every 3 weeks,
then every 4 weeks
If your child’s symptoms do not improve
after 20 weeks:
• If your child’s symptoms do not improve
after 20 weeks, the dose may be increased
slightly or the doctor may try another
medicine instead
Sunlight
Avoid sunlight while using Myocrisin.
Cover your skin with appropriate clothing
and high factor sun cream. This is because
Myocrisin can cause a greyish-blue
pigmentation to areas of your skin exposed
to the sun. This can be permanent.
If you have more Myocrisin than you should
It is unlikely that your doctor or nurse will
give you too much medicine. Your doctor
will be checking your progress and checking
the medicine that you are given. Always ask
if you are not sure why you are getting a
dose of medicine.
Using too much Myocrisin can lead to the
following symptoms: itchy, lumpy or bubbly
rash that worsens, tiredness with sore throat
or a sore mouth, bleeding more easily or
getting infections more easily. If these
symptoms happen, tell a doctor or go to
hospital straight away.
If you forget to have Myocrisin
Your doctor or nurse will have instructions
on when to give you this medicine. It is
unlikely that you will not be given the
medicine as it has been prescribed.
However if you do think you have missed a
dose, tell your doctor or nurse.
Blood tests
Your doctor will do regular blood tests
before and while you are using Myocrisin.
This is to check that your blood is normal.
This is because Myocrisin can lower the
amount of cells in your blood. This can
increase the chances of you getting an
infection and bruising.
Urine tests
Your doctor will do regular urine tests while
you are using Myocrisin. This is to check that
your kidneys are working properly. This is
because Myocrisin can affect the way your
kidneys work.
X-rays
Your doctor may do an x-ray once a year
while you are using Myocrisin. This is to
check that your lungs are working properly.
This is because Myocrisin can affect your
lungs.
If you have any further questions on
the use of this product, ask your
doctor, nurse or pharmacist.

Stop having Myocrisin and see a doctor
straight away if you notice any of the
following serious side effects - you may
need urgent medical treatment:
• Numbness, tingling, prickling or burning
sensations in the hands, feet or skin,
muscle weakness. These could be signs of
problems with your nerves - something
called ‘peripheral neuropathy’
• Yellow colouring of the whites of the eyes
and the skin, fever and the colour of your
water (urine) becomes darker. These could
be signs of problems with your liver
• Temporary loss of the feeling and movement
in your legs. These could be signs of an illness
called ‘Guillain-Barre syndrome’
• Difficulty breathing such as feeling
breathless, dry cough and/or chest pain.
These could be signs of a problem with your
lungs - something called ‘pulmonary fibrosis’
• Weight gain, swollen ankles, water
retention and loss of appetite. These could
be signs of a problem with your kidneys something called ‘nephrotic syndrome’
• Greyish-blue pigmentation of your skin
especially after you have been in the
sunlight. These could be signs of
something called ‘chrysiasis’
Tell your doctor as soon as possible if you
have any of the following side effects:
• Hair loss or balding
Talk to your doctor or pharmacist if any of
the side effects gets serious or lasts longer
than a few days, or if you notice any side
effects not listed in this leaflet.
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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety of
this medicine.

4. Possible side effects

What Myocrisin contains
• Each 100mg/ml injection contains 50mg of
the active substance, sodium aurothiomalate
• Each 20mg/ml injection contains 10mg of the
active substance, sodium aurothiomalate
• The other ingredients are phenylmercuric
nitrate and water for injections
What Myocrisin looks like and contents
of the pack
Myocrisin 100mg/ml & 20mg/ml are packaged
in cartons containing 10 sealed glass ampoules,
each containing 0.5ml of a clear injection
solution.
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
Sanofi S.P.A., Loc. Valcanello,
03012 Anagni (FR), Italy
This leaflet does not contain all the
information about your medicine. If you
have any questions or are not sure about
anything, ask your doctor or pharmacist.
This leaflet was last revised in 02/2015

Like all medicines, Myocrisin can cause side
effects, although not everybody gets them.
Stop having Myocrisin and see a doctor
or go to a hospital straight away if:
• You have an allergic reaction. The signs may
include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat
or tongue, weakness, flushing, feeling dizzy,
light-headed or faint, increased or rapid
heartbeat, very fast, uneven or forceful
heartbeat (palpitations), breathing problems
and stomach pain
• You are very tired, have a sore throat,
swollen tongue, mouth ulcers, nose
bleeds, bleeding gums, metallic taste,
bruise or bleed more easily, diarrhoea
and/or heavy periods.
These could be signs of a blood problem
• You have an itchy skin rash or bumps on
your skin that look like bubbles and are
filled with water which may be itchy, scaly
or red. These could be signs of a serious
allergy to the medicine
• You have a fever and stomach pain,
diarrhoea or blood and mucus in your
stools. These could be signs of something
called ‘enterocolitis’
• You have a low attention span and are
unable to control your movements. These
could be signs of something called
‘encephalopathy’

CROMinFOTO s.n.c.

Via G. Tartini, 2 - 2 0 1 5 8 - M I L A N O
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

TYPE OF MATERIAL:

LEAFLET

Keep out of the reach and sight of children.
Do not use Myocrisin after the expiry date
which is stated on the carton after EXP. The
expiry date refers to the last day of that month.
Do not use Myocrisin if you notice that the
liquid in the ampoule is darker than a pale
yellow colour (see section 6 ‘Further
information’).
Store below 25°C. Protect from light.
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

© Sanofi, 2005 – 2015

89029187
(int. version 1)

DESCRIPTION:

89029187

VERSION:

1 a

OLD CODE:

89027063

30 APR 2015

COUNTRY:

MYOCRISIN 10 & 50 MG

MIN. FONT SIZE: CODE:

11 pt.

5. How to store Myocrisin

LOGO VERSION:

//

U.K.
DIMENSION mm:

160 x 420

COLOURS N°:

1

COLOUR 1:

REFLEX BLUE

89029187

Expand view ⇕

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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