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HYDROCORTISONE 10 MG TABLETS

Active substance: HYDROCORTISONE

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Package leaflet: Information for the user
Hydrocortisone 10 mg Tablets
Hydrocortisone
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, ask your
doctor or pharmacist.
− This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
− If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
− Hydrocortisone Tablets are 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 Tablets can cause side
effects in some people (read ‘Possible side
effects’ section 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 ‘Possible side effects’ section for more
information).
− If you take it for more than 3 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 chickenpox 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 might be especially important
for you.
What is in this leaflet
1. What Hydrocortisone Tablets are and what they
are used for
2. What you need to know before you take
Hydrocortisone Tablets
3. How to take Hydrocortisone Tablets
4. Possible side effects
5. How to store Hydrocortisone Tablets
6. Contents of the pack and other information

1. What Hydrocortisone Tablets are
and what they are used for
Hydrocortisone Tablets contain a medicine
called hydrocortisone. 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.
Hydrocortisone Tablets are used for:
− children and adolescents to replace
hydrocortisone because part of the adrenal
gland is not working properly
− emergency treatment of severe asthma, drug
hypersensitivity reactions, serum sickness
(hypersensitivity reaction to proteins), localised
swelling of the skin and/or mucous membranes
(angioedema), and life-threatening allergic
reactions (anaphylaxis).

2. What you need to know before you
take Hydrocortisone Tablets
Do not take Hydrocortisone Tablets:
− if you are allergic to hydrocortisone or any of
the other ingredients of this medicine (listed in
section 6)
− if you have tuberculosis or any other acute
or chronic bacterial, fungal, viral or parasitic
infections without appropriate antimicrobial
drug therapy.
High doses of corticosteroid may weaken your
immune system. If this is the case, you must not be
given vaccines containing live, attenuated viruses
or bacteria as this might cause you an infection.
Before you take Hydrocortisone Tablets
Check with your doctor first if
− You have ever had severe depression or
manic depression (bipolar disorder). This
includes having had depression before or while
taking steroid medicines like hydrocortisone.
− Any of your close family has had these
illnesses.
If either of these applies to you, talk to a doctor
before taking hydrocortisone.
Warnings and precautions
Talk to your doctor before taking Hydrocortisone
Tablets, if you have or have had:
− diabetes
− stomach or bowel ulcers
− osteoporosis (thinning of the bones)
− glaucoma – increased eye pressure
− heart problems (heart failure, recent heart
attack)
− high blood pressure
− kidney or liver problems
− epilepsy
− inflammatory bowel diseases
− recently undergone a surgery in which an
artificial opening between two normally
separate spaces is created (anastomosis)
− mood disorder
− thyroid problems
− myasthenia gravis (a condition affecting
the muscles) and use concomitantly
anticholinesterases
− chicken pox, measles, or shingles. Avoid contact
with people who are infected or have chicken
pox, measles or shingles. If you are exposed to
these diseases, contact a doctor straight away.
− an infection caused by gut worms (e.g.
amebiasis or strongyloidiasis). Hydrocortisone
may activate or exacerbate such infections.
− tuberculosis
− herpes simplex infection in the eye.
Hydrocortisone may activate or exacerbate
fungal and viral eye infections
− muscle weakness after taking steroids in the
past.
Contact your doctor if you develop any new
infections while taking Hydrocortisone Tablets.
Taking hydrocortisone for a long time and at
high doses may increase the chances of getting
infections as hydrocortisone treatment can hide
the usual symptoms of infection.
Mental problems while taking hydrocortisone
Mental health problems can happen while taking
steroids like hydrocortisone (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 may be 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 happen, they might need
treatment.
Talk to a doctor if you (or someone taking this
medicine), show any signs of mental problems.
This is particularly important if you are depressed,
or might be thinking about suicide and when
doses are being lowered or stopped. In a few cases,
mental problems have happened during this time.
Stress, injuries, surgeries
If you are taking or have recently been taking
Hydrocortisone Tablets and you become ill, suffer
stress, get injured or are about to have surgery, tell
your doctor. Your dose of Hydrocortisone Tablets
may need to be increased (or you may have to start
taking it again for a short time) to prevent a sharp
fall in blood pressure.
Vaccines
If you need vaccines during corticosteroid
treatment, you should be aware that vaccine
protection may not be as effective as usually. Some
vaccines need to be avoided during corticosteroid
treatment, see section “Do not use Hydrocortisone
Tablets”.
Blood coagulation
Corticosteroid therapy may affect blood
coagulation, so caution is advised if you use
concomitantly any medicines affecting blood
coagulation (see section “Other medicines and
Hydrocortisone Tablets”).

Children
Corticosteroid treatment may cause growth
retardation and increase risks of side effects.
Other medicines and Hydrocortisone Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
In particular do not take this medicine and tell your
doctor or pharmacist if you are taking any of the
following:
− phenytoin, carbamazepine and barbiturates
(antiepileptics)
− rifampicin and rifabutin (antitubercular drugs)
− herbal medicines containing St. John’s wort
(Hypericum perforatum)
− ritonavir, efavirenz and nevirapine (HIV
medicines)
− antifungal medicines (ketoconazole,
itraconazole, posaconazole, voriconazole,
amphotericin B)
− erythromycin, telithromycin, clarithromycin,
fluoroquinolones (antibiotics)
− oestrogen products and oral contraceptives
− antihypertensive medication
− medicines that thin the blood (anticoagulants),
e.g. warfarin
− acetyl salicylic acid (aspirin)
− medicines used to treat diabetes
− anticholinesterases (e.g. pyridostigmine)
− “water tablets” (diuretics)
− cardiac glycosides (treatment of heart failure),
e.g. digoxin
− theophylline and beta2 sympathomimetics e.g.
bambuterol, fenoterol, formoterol, ritodrine,
salmeterol, salbutamol, terbutaline (used to
treat asthma or other breathing problems)
− anti-inflammatory analgesics (i.e. NSAIDs), e.g.
ibuprofen, diclofenac or naproxen
− somatropin (growth hormone)
− mifepristone (termination of pregnancy)
− vaccines. Corticosteroids may reduce efficacy
of vaccines and increase the risk of neurological
complications. Vaccines containing live,
attenuated viruses or bacteria should be
avoided altogether (see section “Do not take
Hydrocortisone Tablets”).
Hydrocortisone Tablets with food and drink
Hydrocortisone Tablets can be taken with or
without food.
Avoid drinking grapefruit juice during treatment as
this might raise blood hydrocortisone levels.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
Pregnancy
Hydrocortisone crosses the placenta. Besides
replacement therapy, other corticosteroid therapy
affecting the whole body should be regarded
with caution during pregnancy. If you have
received hydrocortisone in treatment doses during
pregnancy, the neonate should be monitored for
inadequate hormone production by the adrenal
gland.
Breast-feeding
The active substance of Hydrocortisone Tablets
is excreted in breast milk. Prolonged use of high
doses of Hydrocortisone Tablets during breastfeeding may weaken the infant’s ability to produce
adequate amounts of steroid hormones.
Fertility
Corticosteroids may affect fertility as they may
impair semen quality and cause loss of menstrual
periods (amenorrhoea).
Driving and using machines
Hydrocortisone Tablets does not usually impair
the ability to drive or use machines. However,
in some patients steroids may cause a feeling of
movement, even while you are still and this can
cause you to feel dizzy (vertigo). Changes in your
eyesight or muscle weakness may also happen. If
you are affected you should not drive or operate
machinery.
Information you should carry while you are
taking Hydrocortisone Tablets
All patients taking Hydrocortisone Tablets for more
than a few weeks should carry a steroid card, which
is available from your doctor or pharmacist. This
card shows the details of the medicine you are
taking. Always keep it with you and show it to any
doctor or nurse treating you.
Hydrocortisone Tablets contain lactose
One Hydrocortisone Tablet contains 64.6 mg
lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact
your doctor before taking this medicine.

3. How to take Hydrocortisone Tablets
Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
Dosage and duration of treatment will depend on
your illness.
In replacement therapy, the first dose in the
morning is usually higher than the other doses,
to simulate the normal rhythm of corticosteroid
secretion during a day.
The score line is not intended for breaking the
tablet.
Swallow the tablets with some liquid, with or
without meals.
If you feel that the effect of the treatment is too
strong or too weak, discuss this with your doctor.
Adults for emergency treatment
− Take 6 to 8 tablets (60–80 mg) every 4–6 hours
for 24 hours. Then gradually reduce the dose as
instructed by the doctor over several days.
Children and adolescents (aged 1 month to 18
years) for replacement therapy
Hydrocortisone 10 mg Tablets can be used in
children aged from 1 month to 18 years where the
dose of 10 mg and tablet formulation is considered
appropriate.
− Inherently increased number of adrenal gland
cells (congenital adrenal hyperplasia): The doctor
will determine an individual dose based on the
patient’s height and weight. The daily dose is
divided into 3 doses. The doctor will adjust the
dose according to the patient’s response to the
treatment.
- Inadequate production of steroid hormones
by the adrenal gland (adrenal insufficiency):
The doctor will determine an individual dose
based on the patient’s height and weight. The
daily dose is divided into 3 doses. The doctor
will adjust the dose according to the patient’s
response to the treatment: higher doses may
be needed.
Use in special patient groups or special situations
Your doctor may want to change the dose or
monitor your treatment carefully if you are elderly,
have liver problems, or problems with the adrenal
glands, stress, injuries or infections, or if a surgery is
planned for you.
If you take more Hydrocortisone Tablets than
you should
Contact your doctor or emergency unit if you have
taken more Hydrocortisone Tablets than your
doctor has prescribed.
If a large overdose has been taken, activated
charcoal can be administered as first aid, but in
addition to that a doctor must be contacted as
soon as possible for other treatment.
If you forget to take Hydrocortisone Tablets
Skip the missed dose and then take the next dose
as normal. Do not take a double dose to make up
for a forgotten dose.
If you stop taking Hydrocortisone Tablets
You may only discontinue or stop the treatment
following consultation with your doctor. It is
dangerous to reduce your dose of Hydrocortisone
Tablets too quickly. Your doctor will gradually
reduce your dose.
Stopping Hydrocortisone Tablets may leave you
without enough steroid hormones in your body. If
you suddenly stop taking Hydrocortisone Tablets,
you may experience withdrawal symptoms like
pains in muscles or joints, fever, weakness, feeling
sick, raised pressure within the skull, and low blood
pressure.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Side effects may be stronger in elderly patients and
in children.
People taking hydrocortisone to replace similar
naturally occurring hormones, should be less likely
to get side effects than people taking it for other
illnesses. Your doctor will want to see you now and
then to look out for these effects.

Continued overleaf...

Treatment with this medicine may sometimes
cause serious side effects. Tell your doctor
straight away if you notice any of these
problems, or if you think you are at increased
risk of infection (e.g. you have been in contact
with someone who has an infection):
− a possibly life-threatening allergic reaction
which causes e.g. skin rash, swelling of the face
or wheezing
− irregular or very fast or slow pulse, faintness
− in children, headaches with vomiting,
listlessness and drowsiness. These are
symptoms of pseudotumour cerebri that can
raise pressure within the skull and that usually
occurs after treatment is stopped
− burst or bleeding gut ulcers (indicated by
stomach pain, especially if it seems to spread
to your back, bleeding from the back passage,
black stools or blood in the vomit)
− acute inflammation of the pancreas (abdominal
pain, possibly accompanied by shock, i.e. low
blood pressure with decreased output of urine
and often loss of consciousness)
− a blood clot in a vein (thrombosis) in your leg,
symptoms of which are a swollen, red, hot,
tender muscle
− heart failure – problems with the pumping of
your heart indicated by swollen ankles, chest
pain, difficulty in breathing and palpitations or
irregular beating of the heart, irregular or very
fast or slow pulse; hypertension (high blood
pressure, indicated by headaches, or generally
feeling unwell).
Serious effects: tell a doctor straight away
Steroids including hydrocortisone 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
hydrocortisone.
− 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.
If you notice any of these problems talk to a
doctor straight away.
Other side effects reported with hydrocortisone:
Common (may affect up to 1 in 10 people)
− high blood pressure
− increased susceptibility to infections, masked
infection symptoms
− inadequate hormone secretion by the pituitary
gland (adrenocorticotropin hormone, ACTH)
and by the adrenal gland (cortisol) in long-term
use
− round or moon-shaped face
− worsening or development of diabetes
− cramps and spasms due to the loss of the
potassium salts from your body. In rare cases,
loss of potassium can lead to palpitations (an
uneven beating of your heart that you become
aware of )
− accumulation of sodium in the body
− thin or delicate skin, slow healing of cuts and
wounds, scarring, red or purple spots, acne,
stretch marks, bruising
− muscle weakness or wasting, osteoporosis
(brittle bones - bones that break easily).
Uncommon (may affect up to 1 in 100 people)
− increase in appetite
− mood changes, depression, mania (feeling
high), psychoses (feeling, seeing or hearing
things which do not exist, or having strange
and frightening thoughts, changing how
you act or having feelings of being alone),
sleeplessness
− changes in vision as a result of cataracts or
glaucoma (increased eye pressure).
Rare (may affect up to 1 in 1,000 people)
− convulsions
− breakdown of bone due to poor circulation
of blood, torn muscle tendons (pain and/or
swelling).
Not known (the frequency of side effects cannot be
estimated from the available data)
− increase in the number of white blood cells
− poor response to stress (like injury, surgery or
illness)
− increase in blood sugar levels
− loss of potassium and calcium, loss of nitrogen
due to breakdown of body protein stores, fluid
retention
− mood disorders, behavioural problems, feeling
irritated or anxious, having problems sleeping,
difficulty in thinking (including being confused
and losing your memory)
− vertigo, headache
− blurred vision, thinning of the surface of the
eyes, bulging eyes
− rupture of the heart muscle following recent
heart attack
− hiccups
− ulcerative inflammation of the gullet, bloating,
indigestion, thrush in the gullet
− small round spots in the skin or mucous
membranes, redness of the skin, permanent
dilation of small blood vessels in the skin or
mucous membranes, increased sweating,
allergic skin inflammation, hives, increased hair
on the body and face in women
− muscle disease caused by steroids, broken
bones or fractures
− irregular or no periods in women
− weight gain, feeling sick, feeling of bodily
discomfort and tiredness.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 Tablets
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 blister and the outer carton
after EXP. The expiry date refers to the last day of
that month.
This medicine does not require any special
temperature storage conditions.
Keep tablets in the blister in order to protect from
light and moisture.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other information
What Hydrocortisone Tablets contains
− The active substance is hydrocortisone. Each
tablet contains 10 mg hydrocortisone.
− The other ingredients are lactose monohydrate,
maize starch, talc, gelatin, and magnesium
stearate.
What Hydrocortisone Tablets looks like and
contents of the pack
White, smooth, scored tablets with flat, bevelled
edges and diameter of about 7 mm, marked
‘ORN35’.
Hydrocortisone 10 mg Tablets are available as
blister packs of 30 and 100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Distributed in the UK by:
Alissa Healthcare Research Limited
Unit 5, Fulcrum 1, Solent Way
Whiteley, Fareham
Hampshire
PO15 7FE
This leaflet was last revised in
11/2014

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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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