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SOLU-CORTEF 100MG

Active substance(s): HYDROCORTISONE SODIUM SUCCINATE

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RECTO

PACKAGE LEAFLET: INFORMATION FOR
THE PATIENT

Solu-Cortef® 100 mg
hydrocortisone sodium succinate

PAA067592
30

Read all of this leaflet carefully before you
start taking 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 please ask your
doctor, nurse or pharmacist.
• 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 Solu-Cortef is and what it is used for
2. What you need to know before you are
given Solu-Cortef
3. How Solu-Cortef is given to you
4. Possible side effects
5. How to store Solu-Cortef
6. Contents of the pack and other
information

1. What Solu-Cortef is and what it is
used for
Solu-Cortef contains hydrocortisone sodium
succinate.
Hydrocortisone belongs to a group of medicines
called corticosteroids or steroids. Corticosteroids are
produced naturally in your body and are important for
many body functions.
Boosting your body with extra corticosteroid such as
Solu-Cortef can help when injected by a doctor or
nurse if your body cannot produce enough
corticosteroid due to problems with your adrenal
glands (e.g. adrenal insufficiency).

The following information is intended for healthcare
professionals only:

Solu-Cortef® 100 mg

Process Black

hydrocortisone sodium succinate

For further information, consult the Summary of
Product Characteristics (SPC).
Posology and method of administration.
Solu-Cortef may be administered by intravenous
injection, by intravenous infusion, or by intramuscular
injection, the preferred method for initial emergency
use being intravenous injection. Following the initial
emergency period, consideration should be given to
employing a longer-acting injectable preparation or
an oral preparation.

Corticosteroids can also help treat shock following
surgery, injuries, hypersensitivity (anaphylactic)
reactions or other stressful conditions. These include
inflammatory or allergic conditions affecting the:
• bowel and gut e.g. Crohn’s disease
(inflammation of the gut) or ulcerative colitis
(inflammation of the lower bowel)
• lungs e.g. bronchial asthma or inflammation
caused by breathing in (aspirating) vomit or
stomach contents
• skin e.g. Stevens-Johnson syndrome (an
autoimmune disorder in which an immune system
causes the skin to blister and peel), or systemic
lupus erythematosus (lupus)
Solu-Cortef may be prescribed to treat conditions
other than those listed above, such as adrenal
insufficiency and other medical emergencies like
treatment of shock associated with this.
You must talk to a doctor if you do not feel better or if
you feel worse or are unsure why you have been
given this medicine.

2. What you need to know before you are
given Solu-Cortef
Do not use Solu-Cortef:
• If you think you have ever suffered an allergic
reaction, or any other type of reaction after being
given Solu-Cortef, or any other medicine
containing a corticosteroid, or any of the other
ingredients of this medicine (listed in section 6). An
allergic reaction may cause a skin rash or
reddening, swollen face or lips or shortness of
breath.
• If you have any fungal infection (such as thrush)
which is not being treated.
• If you have recently had, or are about to have any
vaccination.
See your doctor immediately if you have any
of the above.
Warnings and precautions
Talk to your doctor or nurse before taking this
medicine if you have any of the following conditions.
Your doctor may also have to monitor your treatment
more closely, alter your dose or give you another
medicine.
• You are suffering from a traumatic brain injury
or stroke.
• Chickenpox, measles, shingles or a herpes
eye infection. If you think you have been in contact
with someone with chickenpox, measles or
shingles and you have not already had these
illnesses, or if you are unsure if you have had them.
• Severe depression or manic depression
(bipolar disorder). This includes having had
depression before while taking steroid medicines
like Solu-Cortef, or having a family history of these
illnesses.

Dosage usually ranges from 100 mg to 500 mg
depending on the severity of the condition,
administered by intravenous injection over a period of
one to ten minutes.
This dose may be repeated at intervals of 2, 4 or
6 hours as indicated by the patient’s response and
clinical condition.
In general high-dose corticosteroid therapy should be
continued only until the patient’s condition has
stabilised - usually not beyond 48 to 72 hours. If
hydrocortisone therapy must be continued beyond
48 to 72 hours hypernatraemia may occur, therefore
it may be preferable to replace Solu-Cortef with a
corticosteroid such as methylprednisolone sodium
succinate as little or no sodium retention occurs.
Although adverse effects associated with high dose,
short-term corticoid therapy are uncommon, peptic
ulceration may occur. Prophylactic antacid therapy
may be indicated.

• Diabetes (or if there is a family history of
diabetes).
• Epilepsy.
• Glaucoma (increased pressure in the eye) or if
there is a family history of glaucoma.
• You have recently suffered a heart attack.
• Heart problems, including heart failure or
infections.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
• Kaposi’s sarcoma (a type of skin cancer).
• Kidney or liver disease.
• Muscle problems (pain or weakness) have
happened while taking steroid medicines in the
past.
• Myasthenia gravis (a condition causing tired
and weak muscles).
• Osteoporosis (brittle bones).
• Pheochromocytoma (a rare tumour of adrenal
gland tissue. The adrenal glands are located
above the kidneys).
• Skin abscess.
• Stomach ulcer or other serious stomach or
intestinal problems.
• Thrombophlebitis - vein problems due to
thrombosis (clots in the veins) resulting in phlebitis
(red, swollen and tender veins).
• Tuberculosis (TB) or if you have suffered
tuberculosis in the past.
Caution should be exercised with corticosteroids as
they can cause an eye condition (central serous
chorioretinopathy) where a collection of fluid forms
under the light-sensitive layer of tissue at the back of
the inner eye (retina) causing visual impairment and
may lead to retinal detachment.
Long term therapy of corticosteroids in high doses
can cause an abnormal amount of fat deposition on
or outside the lining of the spine (epidural
lipomatosis).
Other medicines and Solu-Cortef
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
You should tell your doctor if you are taking any of
the following medicines which can affect the way
Solu-Cortef or the other medicine works:
• Acetazolamide - used to treat glaucoma and
epilepsy
• Aminoglutethimide – used for treating cancer
• Anticoagulants - used to ‘thin’ the blood such
as acenocoumarol, phenindione and warfarin
• Anticholinesterases - used to treat myasthenia
gravis (a muscle condition) such as distigmine and
neostigmine
• Antibiotics (such as erythromycin)
• Aspirin and non-steroidal anti-inflammatory
medicines (also called NSAIDs) such as ibuprofen
used to treat mild to moderate pain

• Barbiturates, carbamazepine, phenytoin
and primidone – used to treat epilepsy
• Carbenoxolone and cimetidine - used for
heartburn and acid indigestion
• Ciclosporin - used to treat conditions such as
severe rheumatoid arthritis, severe psoriasis or
following an organ or bone marrow transplant
• Digoxin - used for heart failure and/or an irregular
heart beat
• Diltiazem or mibefradil – used for heart
problems or high blood pressure
• Diuretics – sometimes called water tablets
• Ketoconazole or itraconazole – used to treat
fungal infections
• Pancuronium – or other medicines called
neuromuscular blocking agents which are used in
some surgical procedures
• Rifampicin and rifabutin – antibiotics used to
treat tuberculosis (TB)
• Vaccines - tell your doctor or nurse if you have
recently had, or are about to have any vaccination.
You should not have ‘live’ vaccines while using
this medicine. Other vaccines may be less
effective.
If you are taking long term medication(s)
If you are being treated for diabetes, high blood
pressure or water retention (oedema) tell your doctor
as he/she may need to adjust the dose of the
medicines used to treat these conditions.
Before you have any operation tell your doctor,
dentist or anaesthetist that you are taking this
medicine.
If you require a test to be carried out by your
doctor or in hospital it is important that you tell
the doctor or nurse that you are taking Solu-Cortef.
This medicine can affect the results of some tests.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are
planning to have a baby, ask your doctor for advice
before taking this medicine, because it could slow
the baby’s growth.
Tell your doctor if you are breast-feeding as small
amounts of corticosteroid medicines may get into
breast milk.
If you continue breast-feeding while you are having
treatment, your baby will need extra checks to make
sure he or she is not being affected by your medicine.
Driving and using machines
The effect of this class of medicines on the ability to
drive or use machinery has not been studied. There
are undesirable effects observed with the use of this
medicine such as syncope (fainting), vertigo
(sensation of rotation or movement of oneself or the
surrounding), and convulsions (seizures). If you are
affected by any of them, you should not drive or
operate machinery.

Solu-Cortef contains sodium
Each vial of Solu-Cortef contains 10.14 mg of
sodium per dose. This is to be taken into
consideration by patients on a controlled sodium
diet.

Patients subjected to severe stress following
corticoid therapy should be observed closely for
signs and symptoms of adrenocortical insufficiency.
Corticosteroid therapy is an adjunct to, and not a
replacement for, conventional therapy.
In patients with liver disease, there may be an
increased effect (see section 4.4 of the SPC) and
reduced dosing may be considered.
Elderly patients:
Solu-Cortef is primarily used in acute short-term
conditions. There is no information to suggest that a
change in dosage is warranted in the elderly.
However, treatment of elderly patients should be
planned bearing in mind the more serious
consequences of the common side effects of
corticosteroids in old age and close clinical
supervision is required (see section 4.4 of the SPC).

Paediatric population:
While the dose may be reduced for infants and
children, it is governed more by the severity of the
condition and response of the patient than by age or
body weight, but should not be less than 25 mg daily
(see section 4.4 of the SPC).
Preparation of solutions:
For intravenous or intramuscular injection prepare the
solution aseptically by adding not more than 2 ml of
sterile water for injections to the contents of one vial
of Solu-Cortef 100 mg, shake and withdraw for use.
For intravenous infusion, first prepare the solution by
adding not more than 2 ml of sterile water for
injections to the vial; this solution may then be added
to 100 ml - 1000 ml (but not less than 100 ml) of 5%
dextrose in water (or isotonic saline solution or 5%
dextrose in isotonic saline solution if patient is not on
sodium restriction).
When reconstituted as directed the pH of the solution
will range from 7.0 to 8.0.

Shelf-life
The shelf life is printed on labels and cartons. Do
not use Solu-Cortef after this date.
After reconstitution with sterile water for injections,
use immediately, discard any remainder.
Storage of the product
Store below 25°C.
Refer to Posology and method of administration
section above.
Reconstituted solutions should be used
immediately. No diluents other than those referred
to are recommended. Parenteral drug products
should be inspected visually for particulate matter
and discolouration prior to administration.
This leaflet was last revised in April 2015.
Ref: SC 11_0

3. How Solu-Cortef is given to you
Steroid Cards
Remember to always carry a Steroid
Treatment Card. Make sure your doctor or
pharmacist has filled out the details of your
medicine, including the dose and how long
you will require steroid treatment.
You should show your steroid card to anyone who
gives you treatment (such as a doctor, nurse or
dentist) while you are taking this medicine, and for
3 months after your last injection.
If you are admitted to hospital for any reason always
tell your doctor or nurse that you are taking this
medicine. You can also wear a medic-alert bracelet
or pendant to let medical staff know that you are
taking a steroid if you have an accident or become
unconscious.
Dosage information
Your doctor will decide on the site of injection, how
much of the medicine and how many injections you
will receive depending on the condition being
treated and its severity. Your doctor will inject you
with the lowest dose for the shortest possible time
to get effective relief of your symptoms.
Adults
Solu-Cortef will be given as an injection by your
doctor or nurse, either into a vein (intravenous) or
into a muscle (intramuscular). Usually the first dose
is given into a vein, especially in an emergency.
It will be given slowly over a period of between
1 – 10 minutes. Depending on your condition a
repeat dose may be injected at intervals of between
2 to 6 hours. Large doses should normally be used
for only two to three days.
The medicine is first dissolved in sterile water for
injections. If the medicine is to be given by infusion
(using a pump or drip) it is then mixed with another
suitable fluid. No other medicines should be mixed
with it.
Elderly
Treatment will normally be the same as for younger
adults. However your doctor may want to see you
more regularly to check how you are getting on with
this medicine.
Use in children and adolescents
Corticosteroids can affect growth in children so
your doctor will prescribe the lowest dose (should
not be less than 25mg a day) that will be effective
for your child.

VERSO

If you are given more Solu-Cortef than you
should have
If you think you have been given too many injections
of this medicine please speak to your doctor
immediately.
Stopping/reducing the dose of your
Solu-Cortef
Your doctor will decide when it is time to stop your
treatment.
You will need to come off this treatment slowly if
you:
• have been given more than 160 mg of
hydrocortisone, such as Solu-Cortef, for more
than 3 weeks,
• have been given high doses of corticosteroids,
such as Solu-Cortef, over 32 mg (0.8 ml) daily,
even if it was only for 3 weeks or less,
• have already had a course of corticosteroid
tablets or injections in the last year,
• already have problems with your adrenal glands
(adrenocortical insufficiency) before you started
this treatment.
You will need to come off this medicine slowly to
avoid withdrawal symptoms. These symptoms
may include itchy skin, fever, muscle and joint
pains, runny nose, sticky eyes, sweating and weight
loss.
If your symptoms seem to return or get worse as
your dose of this medicine is reduced tell your
doctor immediately.
Mental problems while taking Solu-Cortef
Mental health problems can happen while taking
steroids like Solu-Cortef (see also section 4,
Possible side effects).
• These illnesses can be serious.
• Usually they start within a few days or weeks of
starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is
lowered or the medicine is stopped. However if
the problems do happen they might need
treatment.
Talk to a doctor if you (or someone using this
medicine) show any signs of mental problems. This
is particularly important if you are depressed, or
might be thinking about suicide. In a few cases
mental problems have happened when doses are
being lowered or stopped.
If you have any further questions on the use of this
medicine, ask your doctor or nurse.

4. Possible side effects

lead to congestive heart failure (when the heart
cannot pump properly).
Digestive system
• Nausea (feeling sick) or vomiting (being sick).
• Ulcers or thrush in the gullet (discomfort on
swallowing).
• Indigestion.
• Bloated stomach.
• Persistent hiccups, especially when high doses
are taken.
Eyes
• Glaucoma (raised pressure within the eye, causing
pain in the eyes and headaches).
• Swollen optic nerve (causing a condition called
papilloedema, and which may cause sight
disturbance).
• Damage to the optic nerve or cataracts (indicated
by failing eyesight).
• Thinning of the clear part at the front of the eye
(cornea) or of the white part of the eye (sclera).
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).
• Blurred or double vision.
• eye condition (central serous chorioretinopathy)
where a collection of fluid forms under the
light-sensitive layer of tissue at the back of the
inner eye (retina) causing visual impairment and
may lead to retinal detachment..
Hormones and metabolic system
• Slowing of normal growth in infants, children and
adolescents which may be permanent.
• Irregular or no periods in women.
• Increased hair on the body and face in women
(hirsutism).
• Round or moon-shaped face (Cushingoid facies).
• Increased appetite.
• Weight increased
• Diabetes or worsening of existing diabetes.
• Prolonged therapy can lead to lower levels of
some hormones which in turn can cause low
blood pressure and dizziness. This effect may
persist for months.
• The amount of certain chemicals (enzymes) called
alanine transaminase, aspartate transaminase and
alkaline phosphatase that help the body digest
drugs and other substances in your body may be
raised after treatment with a corticosteroid. The
change is usually small and the enzyme levels
return to normal after your medicine has cleared
naturally from your system. You will not notice any
symptoms if this happens, but it will show up if
you have a blood test.
Immune system
• Increased susceptibility to infections which can
hide or change normal reactions to skin tests,
such as that for tuberculosis.
Muscles and bones
• Muscle weakness or wasting.
• Brittle bones (bones that break easily).

• Broken bones or fractures.
• Breakdown of bone due to poor circulation of
blood, this causes pain in the hip.
• Torn muscle tendons causing pain and/or
swelling.
• Muscle cramps or spasms.
Nerves and mood issues
Steroids, including Solu-Cortef, can cause serious
mental health problems.
These are common in both adults and children. They
can affect about 5 in every 100 people taking
medicines like Solu-Cortef.
• Feeling depressed, including thinking about
suicide.
• Feeling high (mania) or moods that go up and
down.
• Feeling anxious, having problems sleeping,
difficulty in thinking or being confused and losing
your memory.
• Feeling, seeing or hearing things which do not
exist. Having strange and frightening thoughts,
changing how you act or having feelings of being
alone.
• Other nervous system side effects may include
breathing problems, convulsions, dizziness,
drowsiness, difficulty breathing, sensation of cold,
heat or numbness, tinnitus or unconsciousness.
• Abnormal amount of fat deposition on or outside
the lining of the spine (epidural lipomatosis)
Skin
• Abscess, especially near injection sites.
• Acne.
• Poor wound healing.
• Thinning of skin with stretch marks.
• Bruising.
• Small purple/red patches on the skin.
• Pale or darker patches on your skin, or raised
patches which are an unusual colour.
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.

Your doctor will check that the solution contains no
particles and is not discoloured before using it.

6. Contents of the pack and other
information
What Solu-Cortef contains
The active substance is hydrocortisone sodium
succinate (equivalent to 100 mg hydrocortisone).
The other ingredients are sodium biphosphate and
sodium phosphate.
What Solu-Cortef looks like and contents of
the pack
Solu-Cortef is a white freeze dried powder in a clear
glass vial fitted with a rubber cap and metal seal.
Solu-Cortef is available in packs containing 1 or
10 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer:
Marketing Authorisation Holder:
Pfizer Limited, Ramsgate Road, Sandwich,
Kent CT13 9NJ, UK.
Manufacturer:
Pharmacia NV/SA, Rijksweg 12, B-2870, Puurs,
Belgium, and Laboratoires Pharmacia SAS,
Parc Industriel d’Incarville, BP 606,
27106 Val De Reuil, Cedex, France
Company contact address:
For further information on your medicine contact
Medical Information at the following address:
Pfizer Limited, Walton Oaks, Dorking Road,
Tadworth, Surrey, KT20 7NS.
Tel: 01304 616161.
This leaflet was last revised in April 2015
Ref: SC 11_1

5. How to store Solu-Cortef
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the label and carton after EXP. The
expiry date refers to the last day of that month.
This medicine must be stored below 25°C.
Once the medicine has been mixed with sterile water
for injections the solution should be used straight
away. Any unused liquid should be disposed of
safely.

Process Black

Like all medicines, this medicine can cause side
effects, although not everybody gets them. Your
doctor will have given you this medicine for a
condition which if not treated properly could
become serious.

In certain medical conditions, medicines like
Solu-Cortef (steroids) should not be stopped
abruptly. If you suffer from any of the
following symptoms seek IMMEDIATE
medical attention. Your doctor will then
decide whether you should continue taking
your medicine:
• Allergic reactions, such as skin rash, swelling
of the face or wheezing and difficulty breathing.
This type of side effect is rare, but can be serious.
• Acute pancreatitis, stomach pain which may
spread through to your back, possibly
accompanied by vomiting, shock and loss of
consciousness.
• Ulcers or bleeding ulcers, symptoms of which
are severe stomach pain which may go through to
the back and could be associated with bleeding
from the back passage, black or bloodstained
stools and/or vomiting blood.
• Infections. This medicine can hide or change the
signs and symptoms of some infections, or
reduce your resistance to the infection, so that
they are hard to diagnose at an early stage.
Symptoms might include a raised temperature
and feeling unwell. Symptoms of a flare up of a
previous TB infection could be coughing up blood
or pain in the chest. This medicine may also make
you more likely to develop a severe infection.
• Pulmonary embolus (blood clot in the lung)
symptoms include sudden sharp chest pain,
breathlessness and coughing up blood.
• Raised pressure within the skull of children
(pseudotumour cerebri) symptoms of which are
headaches with vomiting, lack of energy and
drowsiness. This side effect usually occurs after
treatment is stopped.
• Thrombophlebitis (blood clots or thrombosis in
a leg vein), symptoms of which include painful
swollen, red and tender veins.
If you experience any of the following side
effects, or notice any other unusual effects
not mentioned in this leaflet, tell your doctor
straight away.
The frequency of the side effects is not known. The
frequency cannot not be estimated from the available
data.
Blood, heart and circulation
• Problems with the pumping of your heart (heart
failure) symptoms of which are swollen ankles,
difficulty in breathing and palpitations (awareness
of heart beat) or irregular beating of the heart,
irregular or very fast or slow pulse.
• Increased numbers of white blood cells
(leucocytosis).
Body water and salts
• Swelling and high blood pressure, caused by
increased levels of water and salt content.
• Cramps and spasms, due to the loss of
potassium from your body. In rare cases this can

PAA067592

inks on file

Process structure
Black

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Text Free area

RECTO

Solu-Cortef® 100 mg
hydrocortisone sodium succinate

PAA067593
557

Read all of this leaflet carefully before
you start taking 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 please
ask your doctor, nurse or pharmacist.
• 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 Solu-Cortef is and what it is
used for
2. What you need to know before you
are given Solu-Cortef
3. How Solu-Cortef is given to you
4. Possible side effects
5. How to store Solu-Cortef
6. Contents of the pack and other
information

1. What Solu-Cortef is and what it
is used for
Solu-Cortef contains hydrocortisone sodium
succinate.
Hydrocortisone belongs to a group of
medicines called corticosteroids or steroids.
Corticosteroids are produced naturally in
your body and are important for many body
functions.
Boosting your body with extra corticosteroid
such as Solu-Cortef can help when injected
by a doctor or nurse if your body cannot
produce enough corticosteroid due to
problems with your adrenal glands
(e.g. adrenal insufficiency).
Corticosteroids can also help treat shock
following surgery, injuries, hypersensitivity

The following information is intended for healthcare
professionals only:

Solu-Cortef® 100 mg

Process Black

hydrocortisone sodium succinate

For further information, consult the Summary
of Product Characteristics (SPC).
Posology and method of
administration.
Solu-Cortef may be administered by
intravenous injection, by intravenous infusion,
or by intramuscular injection, the preferred
method for initial emergency use being
intravenous injection. Following the initial
emergency period, consideration should be
given to employing a longer-acting injectable
preparation or an oral preparation.

(anaphylactic) reactions or other stressful
conditions. These include inflammatory or
allergic conditions affecting the:
• bowel and gut e.g. Crohn’s disease
(inflammation of the gut) or ulcerative colitis
(inflammation of the lower bowel)
• lungs e.g. bronchial asthma or
inflammation caused by breathing in
(aspirating) vomit or stomach contents
• skin e.g. Stevens-Johnson syndrome (an
autoimmune disorder in which an immune
system causes the skin to blister and peel),
or systemic lupus erythematosus (lupus)
Solu-Cortef may be prescribed to treat
conditions other than those listed above, such
as adrenal insufficiency and other medical
emergencies like treatment of shock
associated with this.
You must talk to a doctor if you do not feel
better or if you feel worse or are unsure why
you have been given this medicine.

2. What you need to know before
you are given Solu-Cortef
Do not use Solu-Cortef:
• If you think you have ever suffered an
allergic reaction, or any other type of
reaction after being given Solu-Cortef, or
any other medicine containing a
corticosteroid, or any of the other
ingredients of this medicine (listed in section
6). An allergic reaction may cause a skin
rash or reddening, swollen face or lips or
shortness of breath.
• If you have any fungal infection (such as
thrush) which is not being treated.
• If you have recently had, or are about to
have any vaccination.
See your doctor immediately if you have
any of the above.
Warnings and precautions
Talk to your doctor or nurse before taking this
medicine if you have any of the following
conditions.
Your doctor may also have to monitor your
treatment more closely, alter your dose or give
you another medicine.
• You are suffering from a traumatic brain
injury or stroke.
• Chickenpox, measles, shingles or a
herpes eye infection. If you think you have
been in contact with someone with
chickenpox, measles or shingles and you
have not already had these illnesses, or if
you are unsure if you have had them.
• Severe depression or manic
depression (bipolar disorder). This
includes having had depression before while
taking steroid medicines like Solu-Cortef, or
having a family history of these illnesses.
• Diabetes (or if there is a family history of
diabetes).

Dosage usually ranges from 100 mg to 500 mg
depending on the severity of the condition,
administered by intravenous injection over a
period of one to ten minutes.
This dose may be repeated at intervals of
2, 4 or 6 hours as indicated by the patient’s
response and clinical condition.
In general high-dose corticosteroid therapy
should be continued only until the patient’s
condition has stabilised - usually not beyond
48 to 72 hours. If hydrocortisone therapy must
be continued beyond 48 to 72 hours
hypernatraemia may occur, therefore it may be
preferable to replace Solu-Cortef with a
corticosteroid such as methylprednisolone
sodium succinate as little or no sodium
retention occurs. Although adverse effects
associated with high dose, short-term corticoid
therapy are uncommon, peptic ulceration may
occur. Prophylactic antacid therapy may be
indicated.

• Epilepsy.
• Glaucoma (increased pressure in the eye)
or if there is a family history of glaucoma.
• You have recently suffered a heart attack.
• Heart problems, including heart failure or
infections.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
• Kaposi’s sarcoma (a type of skin cancer).
• Kidney or liver disease.
• Muscle problems (pain or weakness)
have happened while taking steroid
medicines in the past.
• Myasthenia gravis (a condition causing
tired and weak muscles).
• Osteoporosis (brittle bones).
• Pheochromocytoma (a rare tumour of
adrenal gland tissue. The adrenal glands are
located above the kidneys).
• Skin abscess.
• Stomach ulcer or other serious stomach
or intestinal problems.
• Thrombophlebitis - vein problems due to
thrombosis (clots in the veins) resulting in
phlebitis (red, swollen and tender veins).
• Tuberculosis (TB) or if you have suffered
tuberculosis in the past.
Caution should be exercised with
corticosteroids as they can cause an eye
condition (central serous chorioretinopathy)
where a collection of fluid forms under the
light-sensitive layer of tissue at the back of the
inner eye (retina) causing visual impairment and
may lead to retinal detachment.
Long term therapy of corticosteroids in high
doses can cause an abnormal amount of fat
deposition on or outside the lining of the spine
(epidural lipomatosis).
Other medicines and Solu-Cortef
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
You should tell your doctor if you are taking
any of the following medicines which can affect
the way Solu-Cortef or the other medicine
works:
• Acetazolamide - used to treat glaucoma
and epilepsy
• Aminoglutethimide – used for treating
cancer
• Anticoagulants - used to ‘thin’ the blood
such as acenocoumarol, phenindione and
warfarin
• Anticholinesterases - used to treat
myasthenia gravis (a muscle condition) such
as distigmine and neostigmine
• Antibiotics (such as erythromycin)
• Aspirin and non-steroidal
anti-inflammatory medicines (also called
NSAIDs) such as ibuprofen used to treat
mild to moderate pain

• Barbiturates, carbamazepine,
phenytoin and primidone – used to treat
epilepsy
• Carbenoxolone and cimetidine - used
for heartburn and acid indigestion
• Ciclosporin - used to treat conditions
such as severe rheumatoid arthritis, severe
psoriasis or following an organ or bone
marrow transplant
• Digoxin - used for heart failure and/or an
irregular heart beat
• Diltiazem or mibefradil – used for heart
problems or high blood pressure
• Diuretics – sometimes called water tablets
• Ketoconazole or itraconazole – used to
treat fungal infections
• Pancuronium – or other medicines called
neuromuscular blocking agents which are
used in some surgical procedures
• Rifampicin and rifabutin – antibiotics
used to treat tuberculosis (TB)
• Vaccines - tell your doctor or nurse if you
have recently had, or are about to have any
vaccination. You should not have ‘live’
vaccines while using this medicine. Other
vaccines may be less effective.
If you are taking long term medication(s)
If you are being treated for diabetes, high
blood pressure or water retention (oedema) tell
your doctor as he/she may need to adjust the
dose of the medicines used to treat these
conditions.
Before you have any operation tell your
doctor, dentist or anaesthetist that you are
taking this medicine.
If you require a test to be carried out by
your doctor or in hospital it is important
that you tell the doctor or nurse that you are
taking Solu-Cortef. This medicine can affect
the results of some tests.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant
or are planning to have a baby, ask your
doctor for advice before taking this medicine,
because it could slow the baby’s growth.
Tell your doctor if you are breast-feeding as
small amounts of corticosteroid medicines may
get into breast milk.
If you continue breast-feeding while you are
having treatment, your baby will need extra
checks to make sure he or she is not being
affected by your medicine.
Driving and using machines
The effect of this class of medicines on the ability
to drive or use machinery has not been studied.
There are undesirable effects observed with the
use of this medicine such as syncope (fainting),
vertigo (sensation of rotation or movement of
oneself or the surrounding), and convulsions
(seizures). If you are affected by any of them, you
should not drive or operate machinery.

Solu-Cortef contains sodium
Each vial of Solu-Cortef contains 10.14 mg
of sodium per dose. This is to be taken into
consideration by patients on a controlled
sodium diet.

Patients subjected to severe stress following
corticoid therapy should be observed closely
for signs and symptoms of adrenocortical
insufficiency.
Corticosteroid therapy is an adjunct to, and not
a replacement for, conventional therapy.
In patients with liver disease, there may be an
increased effect (see section 4.4 of the SPC)
and reduced dosing may be considered.
Elderly patients:
Solu-Cortef is primarily used in acute
short-term conditions. There is no information
to suggest that a change in dosage is
warranted in the elderly. However, treatment of
elderly patients should be planned bearing in
mind the more serious consequences of the
common side effects of corticosteroids in old
age and close clinical supervision is required
(see section 4.4 of the SPC).

Paediatric population:
While the dose may be reduced for infants and
children, it is governed more by the severity of
the condition and response of the patient than
by age or body weight, but should not be less
than 25 mg daily (see section 4.4 of the SPC).
Preparation of solutions:
For intravenous or intramuscular injection prepare
the solution aseptically by adding not more than
2 ml of sterile water for injections to the contents
of one vial of Solu-Cortef 100 mg, shake and
withdraw for use.
For intravenous infusion, first prepare the solution
by adding not more than 2 ml of sterile water for
injections to the vial; this solution may then be
added to 100 ml - 1000 ml (but not less than
100 ml) of 5% dextrose in water (or isotonic
saline solution or 5% dextrose in isotonic saline
solution if patient is not on sodium restriction).
When reconstituted as directed the pH of the
solution will range from 7.0 to 8.0.

Shelf-life
The shelf life is printed on labels and cartons.
Do not use Solu-Cortef after this date.
After reconstitution with sterile water for
injections, use immediately, discard any
remainder.
Storage of the product
Store below 25°C.
Refer to Posology and method of
administration section above.
Reconstituted solutions should be used
immediately. No diluents other than those
referred to are recommended. Parenteral
drug products should be inspected visually
for particulate matter and discolouration prior
to administration.
This leaflet was last revised in April 2015.
Ref: SC 11_0

3. How Solu-Cortef is given to you
Steroid Cards
Remember to always carry a Steroid
Treatment Card. Make sure your
doctor or pharmacist has filled out the
details of your medicine, including the
dose and how long you will require
steroid treatment.
You should show your steroid card to
anyone who gives you treatment (such as a
doctor, nurse or dentist) while you are taking
this medicine, and for 3 months after your
last injection.
If you are admitted to hospital for any reason
always tell your doctor or nurse that you are
taking this medicine. You can also wear a
medic-alert bracelet or pendant to let
medical staff know that you are taking a
steroid if you have an accident or become
unconscious.
Dosage information
Your doctor will decide on the site of
injection, how much of the medicine and how
many injections you will receive depending
on the condition being treated and its
severity. Your doctor will inject you with the
lowest dose for the shortest possible time to
get effective relief of your symptoms.
Adults
Solu-Cortef will be given as an injection by
your doctor or nurse, either into a vein
(intravenous) or into a muscle (intramuscular).
Usually the first dose is given into a vein,
especially in an emergency.
It will be given slowly over a period of
between 1 – 10 minutes. Depending on your
condition a repeat dose may be injected at
intervals of between 2 to 6 hours. Large
doses should normally be used for only two
to three days.
The medicine is first dissolved in sterile water
for injections. If the medicine is to be given
by infusion (using a pump or drip) it is then
mixed with another suitable fluid. No other
medicines should be mixed with it.
Elderly
Treatment will normally be the same as for
younger adults. However your doctor may
want to see you more regularly to check how
you are getting on with this medicine.
Use in children and adolescents
Corticosteroids can affect growth in children
so your doctor will prescribe the lowest dose
(should not be less than 25mg a day) that will
be effective for your child.

VERSO

4. Possible side effects

Body water and salts
• Swelling and high blood pressure, caused
by increased levels of water and salt
content.
• Cramps and spasms, due to the loss of
potassium from your body. In rare cases
this can lead to congestive heart failure
(when the heart cannot pump properly).
Digestive system
• Nausea (feeling sick) or vomiting (being sick).
• Ulcers or thrush in the gullet (discomfort on
swallowing).
• Indigestion.
• Bloated stomach.
• Persistent hiccups, especially when high
doses are taken.
Eyes
• Glaucoma (raised pressure within the eye,
causing pain in the eyes and headaches).
• Swollen optic nerve (causing a condition
called papilloedema, and which may cause
sight disturbance).
• Damage to the optic nerve or cataracts
(indicated by failing eyesight).
• Thinning of the clear part at the front of the
eye (cornea) or of the white part of the eye
(sclera).
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).
• Blurred or double vision.
• eye condition (central serous
chorioretinopathy) where a collection of fluid
forms under the light-sensitive layer of
tissue at the back of the inner eye (retina)
causing visual impairment and may lead to
retinal detachment..
Hormones and metabolic system
• Slowing of normal growth in infants, children
and adolescents which may be permanent.
• Irregular or no periods in women.
• Increased hair on the body and face in
women (hirsutism).
• Round or moon-shaped face (Cushingoid
facies).
• Increased appetite.
• Weight increased
• Diabetes or worsening of existing diabetes.
• Prolonged therapy can lead to lower levels
of some hormones which in turn can cause
low blood pressure and dizziness. This
effect may persist for months.
• The amount of certain chemicals (enzymes)
called alanine transaminase, aspartate
transaminase and alkaline phosphatase that
help the body digest drugs and other
substances in your body may be raised
after treatment with a corticosteroid. The
change is usually small and the enzyme
levels return to normal after your medicine
has cleared naturally from your system. You
will not notice any symptoms if this
happens, but it will show up if you have a
blood test.

Immune system
• Increased susceptibility to infections which
can hide or change normal reactions to skin
tests, such as that for tuberculosis.
Muscles and bones
• Muscle weakness or wasting.
• Brittle bones (bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation
of blood, this causes pain in the hip.
• Torn muscle tendons causing pain and/or
swelling.
• Muscle cramps or spasms.
Nerves and mood issues
Steroids, including Solu-Cortef, can cause
serious mental health problems.
These are common in both adults and children.
They can affect about 5 in every 100 people
taking medicines like Solu-Cortef.
• Feeling depressed, including thinking about
suicide.
• Feeling high (mania) or moods that go up
and down.
• Feeling anxious, having problems sleeping,
difficulty in thinking or being confused and
losing your memory.
• Feeling, seeing or hearing things which do
not exist. Having strange and frightening
thoughts, changing how you act or having
feelings of being alone.
• Other nervous system side effects may
include breathing problems, convulsions,
dizziness, drowsiness, difficulty breathing,
sensation of cold, heat or numbness,
tinnitus or unconsciousness.
• Abnormal amount of fat deposition on or
outside the lining of the spine (epidural
lipomatosis)
Skin
• Abscess, especially near injection sites.
• Acne.
• Poor wound healing.
• Thinning of skin with stretch marks.
• Bruising.
• Small purple/red patches on the skin.
• Pale or darker patches on your skin, or
raised patches which are an unusual colour.
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.

5. How to store Solu-Cortef
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the label and
carton after EXP. The expiry date refers
to the last day of that month.
This medicine must be stored below
25°C.
Once the medicine has been mixed with
sterile water for injections the solution
should be used straight away. Any
unused liquid should be disposed of
safely.
Your doctor will check that the solution
contains no particles and is not
discoloured before using it.

6. Contents of the pack and
other information
What Solu-Cortef contains
The active substance is hydrocortisone
sodium succinate (equivalent to 100 mg
hydrocortisone).
The other ingredients are sodium
biphosphate and sodium phosphate.
What Solu-Cortef looks like and
contents of the pack
Solu-Cortef is a white freeze dried powder in
a clear glass vial fitted with a rubber cap and
metal seal.
Solu-Cortef is available in packs containing
1 or 10 vials. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and
Manufacturer:
Marketing Authorisation Holder:
Pfizer Limited, Ramsgate Road, Sandwich,
Kent CT13 9NJ, UK.
Manufacturer:
Pharmacia NV/SA, Rijksweg 12, B-2870,
Puurs, Belgium, and Laboratoires Pharmacia
SAS,
Parc Industriel d’Incarville, BP 606,
27106 Val De Reuil, Cedex, France
Company contact address:
For further information on your medicine
contact Medical Information at the following
address:
Pfizer Limited, Walton Oaks, Dorking Road,
Tadworth, Surrey, KT20 7NS.
Tel: 01304 616161.
This leaflet was last revised in April 2015
Ref: SC 11_1

Process Black

Like all medicines, this medicine can cause
side effects, although not everybody gets
them. Your doctor will have given you this
medicine for a condition which if not treated
properly could become serious.

In certain medical conditions,
medicines like Solu-Cortef (steroids)
should not be stopped abruptly. If you
suffer from any of the following
symptoms seek IMMEDIATE medical
attention. Your doctor will then decide
whether you should continue taking
your medicine:
• Allergic reactions, such as skin rash,
swelling of the face or wheezing and
difficulty breathing. This type of side effect is
rare, but can be serious.
• Acute pancreatitis, stomach pain which
may spread through to your back, possibly
accompanied by vomiting, shock and loss
of consciousness.
• Ulcers or bleeding ulcers, symptoms of
which are severe stomach pain which may
go through to the back and could be
associated with bleeding from the back
passage, black or bloodstained stools
and/or vomiting blood.
• Infections. This medicine can hide or
change the signs and symptoms of some
infections, or reduce your resistance to the
infection, so that they are hard to diagnose
at an early stage. Symptoms might include
a raised temperature and feeling unwell.
Symptoms of a flare up of a previous TB
infection could be coughing up blood or
pain in the chest. This medicine may also
make you more likely to develop a severe
infection.
• Pulmonary embolus (blood clot in the
lung) symptoms include sudden sharp
chest pain, breathlessness and coughing up
blood.
• Raised pressure within the skull of
children (pseudotumour cerebri) symptoms
of which are headaches with vomiting, lack
of energy and drowsiness. This side effect
usually occurs after treatment is stopped.
• Thrombophlebitis (blood clots or
thrombosis in a leg vein), symptoms of
which include painful swollen, red and
tender veins.
If you experience any of the following
side effects, or notice any other
unusual effects not mentioned in this
leaflet, tell your doctor straight away.
The frequency of the side effects is not known.
The frequency cannot not be estimated from
the available data.
Blood, heart and circulation
• Problems with the pumping of your heart
(heart failure) symptoms of which are
swollen ankles, difficulty in breathing and
palpitations (awareness of heart beat) or
irregular beating of the heart, irregular or
very fast or slow pulse.
• Increased numbers of white blood cells
(leucocytosis).

Text Free area

If you are given more Solu-Cortef than
you should have
If you think you have been given too many
injections of this medicine please speak to
your doctor immediately.
Stopping/reducing the dose of your
Solu-Cortef
Your doctor will decide when it is time to
stop your treatment.
You will need to come off this treatment
slowly if you:
• have been given more than 160 mg of
hydrocortisone, such as Solu-Cortef, for
more than 3 weeks,
• have been given high doses of
corticosteroids, such as Solu-Cortef, over
32 mg (0.8 ml) daily, even if it was only for
3 weeks or less,
• have already had a course of
corticosteroid tablets or injections in the
last year,
• already have problems with your adrenal
glands (adrenocortical insufficiency)
before you started this treatment.
You will need to come off this medicine
slowly to avoid withdrawal symptoms.
These symptoms may include itchy skin,
fever, muscle and joint pains, runny nose,
sticky eyes, sweating and weight loss.
If your symptoms seem to return or get
worse as your dose of this medicine is
reduced tell your doctor immediately.
Mental problems while taking
Solu-Cortef
Mental health problems can happen while
taking steroids like Solu-Cortef (see also
section 4, Possible side effects).
• These illnesses can be serious.
• Usually they start within a few days or
weeks of starting the medicine.
• They are more likely to happen at high
doses.
• Most of these problems go away if the
dose is lowered or the medicine is
stopped. However if the problems do
happen they might need treatment.
Talk to a doctor if you (or someone using this
medicine) show any signs of mental
problems. This is particularly important if you
are depressed, or might be thinking about
suicide. In a few cases mental problems have
happened when doses are being lowered or
stopped.
If you have any further questions on the use
of this medicine, ask your doctor or nurse.

PAA067593

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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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