MYOCRISIN 100MG/ML SOLUTION FOR INJECTION

Active substance: SODIUM AUROTHIOMALATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

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.

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

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

3. How Myocrisin is given
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

2. Before you have Myocrisin
Do not have this medicine
and tell your doctor if:
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 ‘Pregnanc y 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.
X

CROMinFOTO s.n.c.

Via G. Tartini, 2 - 20158 - MILANO
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

TYPE OF MATERIAL:

LEAFLET

COUNTRY:

UK

MYOCRISIN 10 & 50 MG

MIN. FONT SIZE: CODE:

10 pt.

89027063
(int. version 2)

DESCRIPTION:

89027063

VERSION:

2 a

OLD CODE:

89025309

DIMENSION mm:

125 x 420

COLOUR 1:

REFLEX BLUE

24 OTT 2013
LOGO VERSION:

//

COLOUR 2:

• 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’
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.

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
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.

5. How to store Myocrisin
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
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-AVENTIS 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 10/2013
© Sanofi, 2005 – 2013

4. Possible side effects
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

89027063

CROMinFOTO s.n.c.

Via G. Tartini, 2 - 20158 - MILANO
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

TYPE OF MATERIAL:

LEAFLET

COUNTRY:

UK

MYOCRISIN 10 & 50 MG

MIN. FONT SIZE: CODE:

10 pt.

89027063
(int. version 2)

DESCRIPTION:

89027063

VERSION:

2 a

OLD CODE:

89025309

DIMENSION mm:

125 x 420

COLOUR 1:

REFLEX BLUE

24 OTT 2013
LOGO VERSION:

//

COLOUR 2:

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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