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HYDROCORTISONE SOLUTION FOR INJECTION

Active substance(s): HYDROCORTISONE SODIUM PHOSPHATE / HYDROCORTISONE SODIUM PHOSPHATE

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22585036

Patient Information Leaflet
102451-52/LF/057/03
YOU SHOULD ALWAYS CARRY THIS CARD
WITH YOU as it must be shown to any of
the following persons:

EfcortesolTM injection
hydrocortisone sodium phosphate
Read all of this leaflet carefully before
you start taking this medicine. It
provides a summary of the information
available on your medicine. If you have
any questions or are not sure about
anything ask your doctor or pharmacist.
- Efcortesol is a steroid medicine,
prescribed for many different
conditions, including serious illnesses.
- You need to take it regularly to get
the maximum benefit.
- Don’t stop taking this medicine
without talking to your doctor.
- You may need to reduce the dose
gradually.
- Efcortesol can cause side effects
in some people (read section 4
below). Some problems such as
mood changes (feeling depressed, or
‘high’) or stomach problems can
happen straight away. If you feel
unwell in any way, keep taking your
injection, but see your doctor
straight away.
- Some side effects only happen
after weeks or months. These
include weakness of arms and legs,
or developing a rounder face (read
section 4 for more information).
- If you take this medicine for more
than three weeks, you will get a
blue ‘steroid card’: always keep it
with you and show it to any doctor
or nurse treating you.
- Keep away from people who have
chicken-pox or shingles, if you have
never had them. They could affect you
severely. If you do come into contact
with chicken-pox or shingles, see
your doctor straight away.
Now read the rest of this leaflet. It
includes other important information on
the safe and effective use of this
medicine that may be especially
important for you.
Hydrocortisone - benefit information
Hydrocortisone belongs to a group of
medicines called steroids. Their full name
is corticosteroids. These corticosteroids
occur naturally in the body, and help to
maintain health and well-being. Boosting
your body with extra corticosteroid (such
as hydrocortisone) is an effective way to
treat various illnesses involving
inflammation in the body.
Hydrocortisone
reduces
this
inflammation, which could otherwise go
on making your condition worse. You
must take this medicine regularly to get
maximum benefit from it.
In this leaflet:
1. What Efcortesol Injection is and
what it is used for
2. Before you are given Efcortesol
Injection
3. How Efcortesol Injection will be
given
4. Possible side effects
5. How to store Efcortesol Injection
6. Further information
1. WHAT EFCORTESOL INJECTION IS
AND WHAT IT IS USED FOR.
Efcortesol Injection is used to treat
swollen, painful joints and tendons in
conditions such as, tennis elbow and
golfer’s elbow.
Efcortesol Injection can also be used to
treat conditions such as severe asthma,
allergic reactions, severe shock due to
injury or infection or failure of the adrenal
glands.
2. BEFORE YOU ARE GIVEN
EFCORTESOL INJECTION
Do not receive the injection if:
• You are allergic to hydrocortisone or
any of the other ingredients of
Efcortesol Injection (allergic
reactions include mild symptoms
such as itching and/or rash. More
severe symptoms include swelling of
the face, lips, tongue and/or throat
with difficulty in swallowing or
breathing);
• You just had a vaccination or have
a vaccination planned;
• You have a viral infection such as
measles, chickenpox or shingles
or any other infection. Tell your
doctor immediately if you have
come into contact with anyone
suffering with measles, chickenpox
or shingles in the last three months.

Take special care if you:
• have or have ever had:
- severe depression or
manic-depressive illness (bipolar
disorder).
This includes having had depression
before while taking steroid
medicines like hydrocortisone, or if
anyone in your family has suffered
from these illnesses;
- TB (tuberculosis);
- diabetes;
- epilepsy;
- an eye disease caused by a rise of
pressure within the eye (glaucoma);
- osteoporosis (thinning of the bones);
- muscle problems when steroids
have been taken before;
- stomach ulcers;
- high blood pressure or heart failure;
- any liver or kidney problems.
If any of the above applies to you, or
you are not sure please tell your
doctor or pharmacist before you use
this medicine.
Contact your doctor if you experience
blurred vision or other visual
disturbances.
Mental health problems while taking
hydrocortisone
Mental health problems can occur while
taking steroids like hydrocortisone (see
also section 4 Possible Side Effects).
• These illnesses can be severe.
• 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 problems do
occur they might need treatment.
Talk to a doctor if you (or someone taking
this medicine) show any signs of mental
health problems. This is particularly
important if you are depressed, or might
be thinking about suicide. In a few cases,
mental health problems have happened
when doses are being lowered or the
medicine stopped altogether.
Taking other medicines
Please tell your doctor if you are taking or
have recently taken any other medicines,
including medicines obtained without a
prescription.
Some medicines may increase the
effects of Efcortesol Injection and your
doctor may wish to monitor you carefully
if you are taking these medicines
(including some medicines for HIV:
ritonavir, cobicistat).
Efcortesol Injection and some other
medicines can affect the way each other
work. In particular, tell your doctor if you
are taking any of the following:
• Medicines for epilepsy such as
carbamazepine, phenobarbital,
phenytoin or primidone;
• Antibiotics such as rifampicin,
rifabutin;
• Oral contraceptives;
• Medicines for diabetes such as
insulin, glibenclamide or metformin;
• Medicines to treat high blood
pressure, such as diuretics (water
tablets) like bendroflumethiazide
and furosemide;
• Warfarin or other medicines used to
thin the blood;
• Aspirin or similar medicines;
• Acetazolamide (used to treat
glaucoma);
• Carbenoxolone (used to treat
stomach ulcers);
• Medicines used to treat myasthenia
gravis;
• Orally ingested chemicals used to
make x-rays clearer.
Pregnancy and breast-feeding
Tell your doctor before being given this
medicine if you are, or think you may be
pregnant, or if you are breast-feeding.
Driving and using machinery
This medicine should not affect your
ability to drive or use machines.
Carrying a Steroid card
Your doctor or pharmacist will have given
you a Steroid Treatment Card with your
prescription or medicine.

Doctor or Nurse
- before having any surgery or
emergency treatment or if any new
treatment is prescribed.
Dentist
- before having any dental surgery.
Pharmacist
- before buying any medicine.
Optician
- it is advisable to have regular eye
tests.
3. HOW EFCORTESOL INJECTION
WILL BE GIVEN
Efcortesol Injection will be given by a
doctor or nurse. Your doctor will decide
upon the most suitable dose for your
condition. The injection can be given in
the following ways:
Adults:
For soft tissue conditions: 100 mg to 200
mg injected into or around the soft tissue
daily. This daily dose may be repeated on
up to three occasions.
For other conditions: 100 mg to 500 mg
injected into a muscle, or injected slowly
into a vein over at least 30 seconds
(through a ‘drip’ into the vein), up to four
times a day.
Children: 25 mg to 100 mg injected into a
vein. This may be repeated up to four times
a day depending on the patient response.
If you receive more Efcortesol
Injection than you should
Overdosing is unlikely. If it does happen
the doctor will treat any symptoms that
follow.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Efcortesol Injection
can cause side effects although not
everybody gets them.
Steroids including hydrocortisone can
cause severe mental health problems.
These are common in both adults and
children. They can affect about five in
every 100 people taking medicines like
hydrocortisone.
• Feeling depressed, including
thinking about suicide.
• Feeling high (mania) or having
moods that go up and down.
• Feeling anxious, having problems
sleeping, having 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.
If you notice any of these problems talk
to a doctor immediately.
If you notice:
• itching or skin rashes;
• swelling of the face, lips or throat;
• difficulty in breathing or wheeziness.
Tell your doctor immediately. These
may be signs of an allergic reaction.
If you are given the injection into a vein,
you may experience a ‘pins and needles’
type sensation. This reaction is
unpleasant but harmless. It can occur in
the genital area, or over the whole body.
If this happens, tell your doctor or nurse.
High doses of steroids taken for a long
time, or repeated in short courses, can
lead to side effects. The doctor will
always give you the lowest dose possible
to prevent these.
The side effects which can occur if
steroids are given in high doses for a
long time are:
• generally feeling unwell;
• feeling sick (nausea);
• flushing;
• indigestion;
• stomach ulcer (which can rupture
and bleed);
• thrush;
• inflammation of the pancreas
causing abdominal pain
(pancreatitis);
• muscle weakness;
• thinning of bones which makes
fractures more likely (osteoporosis);
• damage to tendons;
• joint stiffness causing limited
motion, pain and muscle spasms;
• fluid retention causing swelling;
• feeling dehydrated;

• high blood pressure;
• slow healing of wounds, thinning of
the skin, bruising, marks which look
like stretch marks and acne;
• small red, purple or blue spots found
along the surface of the skin
(caused by blood vessels under the
skin);
• low adrenal gland function;
• slowed growth in infants, children
and teenagers;
• irregular or stopped menstrual
periods;
• swollen, round face (Cushingoid
faces);
• excess hair growth;
• increased appetite and weight gain;
• intolerance to carbohydrates;
• mood changes, dependence,
depression, difficulty sleeping,
worsening of schizophrenia;
• worsening of epilepsy;
• raised pressure in the eyes
(glaucoma), cataracts, thinning and
inflammation of the cornea (part of
the eye), worsening of viral or fungal
eye diseases, Not known: (frequency
cannot be estimated from the
available data)- Blurred vision;
• changes in body chemistry;
• an increase in the number of white
blood cells;
• formation of blood clots.
Injections like these can make it easier
for you to pick up infections. Infections
such as chicken-pox and measles can be
made worse, or TB (tuberculosis) may
recur.
In the elderly, the side effects caused by
corticosteroids may be more serious.
This is especially in cases of
osteoporosis (thinning of the bones), high
blood pressure, low potassium levels in
the blood, diabetes, higher risk of
infections and thinning of the skin.
Older people being given Efcortesol
Injection will be monitored closely by
their doctor in order to avoid any serious
side effects.
If any of the side effects becomes severe,
or if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist immediately.
5. HOW TO STORE EFCORTESOL
INJECTION
Efcortesol Injection ampoules will be
stored at the healthcare centre.
They should be stored at room
temperature not above 25°C and kept in
the carton to protect them from light.
The doctor or nurse will check that the
expiry date on the label has not passed
before you are given the injection.
KEEP ALL MEDICINES OUT OF THE
REACH AND SIGHT OF CHILDREN
6. FURTHER INFORMATION
What Efcortesol Injection contains
Each 1 ml Efcortesol Injection ampoule
contains 100 mg of the active ingredient
hydrocortisone
(as
hydrocortisone
sodium phosphate)
Each 5 ml Efcortesol Injection ampoule
contains 500 mg of the active ingredient
hydrocortisone
(as
hydrocortisone
sodium phosphate)
The other ingredients are: disodium
edetate, sodium formaldehyde bisulphite
monohydrate,
disodium
hydrogen
phosphate anhydrous, sodium acid
phosphate, phosphoric acid and water
for injections.
What Efcortesol Injection looks like
and the contents of the pack:
Efcortesol Injection is a clear, colourless
to pale yellow solution, which is available
in 1 ml or 5 ml clear glass ampoules.
It is available in packs containing 5 x 1
ml (100 mg) or 5 x 5 ml (500 mg)
ampoules.
Marketing Authorisation Holder and
Manufacturer responsible for release:
Amdipharm UK Limited,
Capital House,
85 King William Street,
London EC4N 7BL,
UK
This leaflet was last revised in April 2017

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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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