Skip to Content

HYDROCORTISONE ACETATE SUSPENSION FOR INJECTION 25MG/ML

Active substance(s): HYDROCORTISONE ACETATE UF POWDER

View full screen / Print PDF » Download PDF ⇩
Transcript
PRODUCT NAME:

Hydrocortisone 25mg/ml
Suspension for Inj

Patient Information Leaflet
GB727-1547LF-AM01

PIP CODE:

22595254

Hydrocortisone Acetate 25mg/ml
Suspension for Injection
Hydrocortisone Acetate
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 Acetate
25mg/ml Suspension 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 tablets, 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 chickenpox 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 might be especially important for you.
Hydrocortisone Acetate - benefit information.
Hydrocortisone Acetate 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 acetate) is an
effective way to treat various illnesses involving
inflammation in the body. Hydrocortisone Acetate 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
The name of your medicine is Hydrocortisone Injection.
Hydrocortisone Injection contains the active ingredient
hydrocortisone acetate which belongs to a group of
medicines called corticosteroids or ‘steroids’. Steroids work
by reducing inflammation and lowering the body’s
immune response.
Hydrocortisone Injection is used to treat swollen, painful
joints and tendons in conditions such as arthritis and
osteoarthritis (inflammation of the joints).
2. BEFORE YOU ARE GIVEN HYDROCORTISONE
INJECTION
Do not receive this injection if you:
• are allergic to hydrocortisone acetate 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);
• have recently had a vaccination or have a vaccination
planned;
• 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 acetate 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, heart failure or recently
suffered a heart attack;
- 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
acetate
Mental health problems can occur while taking steroids like
Hydrocortisone acetate (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 prescription.
This is especially important if you are taking:
• Medicines for epilepsy such as phenytoin;
• Antibiotics such as rifampicin;
• 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;
• Medicines to treat fungal infections such as
amphotericin;
• Acetazolamide (used to treat glaucoma);
• Methotrexate (used for rheumatoid arthritis, psoriasis
and certain types of cancer).

GB727-1547LF-AM01

COMPONENT:

Leaflet

SIZE:

148 x 240 mm

MARKET:

GB

PRODUCT SITE:

Haupt

SCALE:

100%

COLOURS:

Black

DATE:

07/01/2014

FONT SIZE:

8 pt

VERSION NO:

4

AMENDED BY:

AMCo

PROJECT:

CNC

REGULATORY AUTHORITY
APPROVAL CONFIRMATION

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.
Accept Artwork_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Reject Artwork _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Signature _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Name _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Date _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

PAGE 1 OF 2

PRODUCT NAME:

Hydrocortisone 25mg/ml
Suspension for Inj

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.
Important information about some of the ingredients of
Hydrocortisone Injection
This product contains benzyl alcohol which is not normally
recommended in infants and young children of up to 3 years
old. The doctor will decide if treatment is needed for
children of this age.
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 of 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 HYDROCORTISONE INJECTION WILL BE GIVEN
Hydrocortisone Injection will be injected into or around a
joint. It will be given to you by a doctor or nurse. The doctor
will decide upon the most suitable dose for you, but the
usual doses are as follows:
Adults: 5 to 50 mg daily depending on the size of the joint.
Children: 5 to 30 mg daily (in divided doses).
Not more than 3 joints should be treated in one day. The
injection(s) may be repeated at intervals of around three
weeks, if needed.
If you receive more Hydrocortisone Injection than you
should
Over dosing is unlikely. If it does happen the doctor will treat
any symptoms that follow.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Hydrocortisone Injection can cause side
effects, although not everyone gets them.
Steroids including hydrocortisone acetate 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 stranger 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 breathing or wheeziness.
Tell your doctor immediately. These may be signs of an
allergic reaction.
The most likely side effect is increased pain and swelling
after the injection. This usually goes away after a few hours,
and you should rest the joint as much as possible.
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);
• indigestion or stomach discomfort;
• stomach ulcer ( which can rupture and bleed ) or ulcer

in the oesophagus (gullet);
• 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,
acne, marks which look like stretch marks;
• 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;
• severe headaches with blurred vision or temporary
visual problems in children (usually after stopping
treatment);
• 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;
• heart attack (sudden severe chest pain);
• changes in body chemistry;
• an increase in the number of white blood cells in the
blood
• formation of blood clots.
Injections like these can make it easier for you to pick up
infections. Infections such as chickenpox and measles can
be made worse, or TB (tuberculosis) may recur.
If any of the side effects become 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 15 - 25ºC and kept in the carton
to protect them form 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 Hydrocortisone Injection contains
Each 1ml ampoule contains 25 mg of the active
ingredient Hydrocortisone Acetate Ph.Eur.
The other ingredients are: water for injections, benzyl
alcohol, sodium chloride, sodium carboxymethylcellulose
and polysorbate 80, with sodium hydroxide and/or
hydrochloric acid as pH adjusters.
What Hydrocortisone Injection looks like and the
contents of the pack
Hydrocortisone Injection is a white suspension. It is
available in 1ml ampoules in packs containing 10x 1ml
ampoules.
Marketing Authorisation Holder and Manufacturer
responsible for release:
Amdipharm UK Limited,
Capital House,
85 King William Street,
London EC4N 7BL, UK
Date of preparation of leaflet: January 2014.

PIP CODE:

GB727-1547LF-AM01

COMPONENT:

Leaflet

SIZE:

148 x 240 mm

MARKET:

GB

PRODUCT SITE:

Haupt

SCALE:

100%

COLOURS:

Black

DATE:

07/01/2014

FONT SIZE:

8 pt

VERSION NO:

4

AMENDED BY:

AMCo

PROJECT:

CNC

REGULATORY AUTHORITY
APPROVAL CONFIRMATION

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.
Accept Artwork_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Reject Artwork _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Signature _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Name _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Date _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

PAGE 2 OF 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.

Hide