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HYDROCORTISTAB INJECTION 25MG/ML

Active substance(s): HYDROCORTISONE ACETATE UF POWDER / HYDROCORTISONE ACETATE UF POWDER / HYDROCORTISONE ACETATE UF POWDER

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Patient Information Leaflet
102675/LF/057/04

22595254

Hydrocortistab Injection
Hydrocortisone acetate 25 mg/ml

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.
- Hydrocortistab 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.
- Hydrocortistab 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
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 Hydrocortistab Injection is and what it is used for
2. Before you are given Hydrocortistab Injection
3. How Hydrocortistab Injection will be given
4. Possible side effects
5. How to store Hydrocortistab Injection
6. Further information
1. WHAT HYDROCORTISTAB INJECTION IS AND WHAT
IT IS USED FOR
The name of your medicine is Hydrocortistab Injection.
Hydrocortistab 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.
Hydrocortistab 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 HYDROCORTISTAB
INJECTION
Do not receive this injection if you:
• are allergic to hydrocortisone or any of the other
ingredients of Hydrocortistab 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 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.
Contact your doctor if you experience blurred vision or other
visual disturbances.
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).
• 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
Hydrocortisone and your doctor may wish to monitor you
carefully if you are taking these medicines (including
some medicines for HIV: ritonavir, cobicistat).
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).
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 Hydrocortistab 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 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 HYDROCORTISTAB INJECTION WILL BE GIVEN
Hydrocortistab 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 Hydrocortistab 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 Hydrocortistab Injection can cause side
effects, although not everyone 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 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 in 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:
Not known: frequency cannot be estimated from the
available data
• 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;
• 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;
• blurred vision;
• dependence.
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.
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 HYDROCORTISTAB INJECTION
Hydrocortistab Injection ampoules will be stored at the
healthcare centre.
They should be stored at 15 - 25ºC 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 this medicine out of the sight and reach of
children.
6. FURTHER INFORMATION
What Hydrocortistab 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 Hydrocortistab Injection looks like and the
contents of the pack
Hydrocortistab Injection is a white suspension. It is
available in 1ml ampoules in packs containing 10 x 1ml
ampoules.
Marketing Authorisation Holder and Manufacturer
responsible for release
Amdipharm UK Limited
Regency House, Miles Gray Road, Basildon, Essex SS14 3AF.
Date of preparation of leaflet: June 2017.

This artwork is Not Technically Approved
and technical approval needs to be taken,
from the CMO, before Implementation.

Version No.:
Revision No.:
Revision Date:
Product Description:

102675/LF/057/04

Revised by:

2
23-Jun-2017
Hydrocortistab
Injection 25 mg/ml
10 x 1 ml
Leaflet
102675
UK
Haupt
PR 11616
PR 9599
ADD

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148 x 240 mm
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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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