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EFCORTESOL INJECTION

Active substance: HYDROCORTISONE SODIUM PHOSPHATE

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Patient Information Leaflet
103212-13/LF/1

Hydrocortisone 100mg/1ml Solution for
Injection and Hydrocortisone 500mg/5ml
Solution for Injection
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.
The name of your medicine is
Hydrocortisone 100mg/1ml Solution for
Injection and Hydrocortisone 500mg/5ml
Solution for Injection;it will be called
Hydrocortisone Injection for ease here after.
- Hydrocortisone Injection 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.
- Hydrocortisone Injection 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 Hydrocortisone Injection is and
what it is used for
2. Before you are given Hydrocortisone
Injection
3. How Hydrocortisone Injection will
be given
4. Possible side effects
5. How to store Hydrocortisone Injection
6. Further information
1. WHAT HYDROCORTISONE INJECTION
IS AND WHAT IT IS USED FOR.
Hydrocortisone Injection is used to treat
swollen, painful joints and tendons in
conditions such as, tennis elbow and
golfer’s elbow.
Hydrocortisone 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
HYDROCORTISONE INJECTION
Do not receive the injection if:
• You are allergic to hydrocortisone or
any of the other ingredients of
Hydrocortisone 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 manicdepressive 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);

3. HOW HYDROCORTISONE INJECTION
WILL BE GIVEN
Hydrocortisone 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.

- osteoporosis (thinning of the bones);

If you receive more Hydrocortisone
Injection than you should

- muscle problems when steroids have
been taken before;

Overdosing is unlikely. If it does happen the
doctor will treat any symptoms that follow.

- 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.
Mental health problems while taking
hydrocortisone
Mental health problems can occur while
taking steroids like hydrocortisone (see
also section 4 Possible Side Effects).

4. POSSIBLE SIDE EFFECTS
Like all medicines, Hydrocortisone 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.

• These illnesses can be severe.

• Feeling depressed, including thinking
about suicide.

• Usually they start within a few days or
weeks of starting the medicine.

• Feeling high (mania) or having moods
that go up and down.

• They are more likely to happen at high
doses.

• Feeling anxious, having problems
sleeping, having difficulty in thinking or
being confused and losing your memory.

• 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.
This is especially important if you are taking:
• 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

• worsening of epilepsy;

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• raised pressure in the eyes (glaucoma),
cataracts, thinning and inflammation of
the cornea (part of the eye), worsening
of viral or fungal eye diseases;

PIP CODE:
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AMENDED BY:
PROJECT:

• 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

Older people being given Hydrocortisone
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.
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 HYDROCORTISONE
INJECTION
Hydrocortisone 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.

If you notice any of these problems talk to
a doctor immediately.

The doctor or nurse will check that the
expiry date on the label has not passed
before you are given the injection.

• 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;

KEEP ALL MEDICINES OUT OF THE REACH
AND SIGHT OF CHILDREN
6. FURTHER INFORMATION
What Hydrocortisone Injection contains
Each 1 ml Hydrocortisone Injection
ampoule contains 100 mg of the active
ingredient hydrocortisone (as
hydrocortisone sodium phosphate)
Each 5 ml Hydrocortisone 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 Hydrocortisone Injection looks like
and the contents of the pack:
Hydrocortisone Injection is a clear,
colourless to pale yellow solution, which is
available in 1 ml or 5 ml clear glass
ampoules.

• inflammation of the pancreas causing
abdominal pain (pancreatitis);

It is available in packs containing 5 x 1 ml
(100 mg) or 5 x 5 ml (500 mg) ampoules.

• muscle weakness;

Marketing Authorisation Holder and
Manufacturer responsible for release:

• thinning of bones which makes fractures
more likely (osteoporosis);

Amdipharm UK Limited,

Tell your doctor before being given this
medicine if you are, or think you may be
pregnant, or if you are breast-feeding.

• damage to tendons;
• joint stiffness causing limited motion,
pain and muscle spasms;

85 King William Street,

Driving and using machinery

• fluid retention causing swelling;

London EC4N 7BL,

This medicine should not affect your ability
to drive or use machines.

• feeling dehydrated;

Carrying a Steroid card
Your doctor or pharmacist will have given
you a Steroid Treatment Card with your
prescription or medicine.
YOU SHOULD ALWAYS CARRY THIS CARD
WITH YOU as it must be shown to any of
the following persons:
Doctor or Nurse
- before having any surgery or emergency
treatment or if any new treatment is
prescribed.

• 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;

Dentist
- before having any dental surgery.

• increased appetite and weight gain;

Pharmacist
- before buying any medicine.

• mood changes, dependence,
depression, difficulty sleeping,
worsening of schizophrenia;

Optician
- it is advisable to have regular eye tests.

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UK

• high blood pressure;
• slow healing of wounds, thinning of the
skin, bruising, marks which look like
stretch marks and acne

• intolerance to carbohydrates;

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Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Amdipharm have license
approval to distribute this component for sale in the
relevent market.
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blood, diabetes, higher risk of infections
and thinning of the skin.

• 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;
• itching or skin rashes;

Hydrocortisone Solution
for Injection
103212-13/LF/1
Leaflet
140 x 600 mm
Great Britain
TBC
100%
Black, Cutter guide
11/02/2014
10 pt
1
AMCo
CNC

Date of preparation of leaflet: February 2014

Name _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Date _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

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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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