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HYDROCORTISONE 10 MG TABLETS

Active substance(s): HYDROCORTISONE / HYDROCORTISONE

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• The other ingredients (excipients) are:
- Lactose monohydrate (see section 2).
- Maize starch
- Colloidal silicone dioxide
- Povidone
- Microcrystalline cellulose
- Magnesium stearate

Metabolism and nutrition
Weight gain, increased appetite.

What Hydrocortisone Tablets look like and
contents of the pack
Hydrocortisone 10 mg tablets are white, oval, flat,
bevelled tablets with imprinted “H” on one side and
plain on the other side.

Skin
Slow healing of cuts or wounds, thin or delicate skin,
redness, stretch marks, bruising, red or purple spots,
acne, sweating, wrong results from skin tests, growth
of body hair.
General
Generally feeling unwell (malaise).
Investigations
Changes in the levels of various chemicals in the blood
which are usually detected by blood or urine tests,
intolerance to carbohydrates, high blood glucose levels
(may be seen as an excessive thirst and increased
passing or urine), breakdown of body protein stores
(loss of weight and loss of muscle in arms and legs),
loss of calcium and nitrogen. Loss of potassium salts
from your body may result in cramps and spasms.
Because of these potential side effects, your doctor
may want to monitor you at intervals during your
treatment. If any of the above does occur, or you
notice any other unusual feelings or symptoms or
the side effects become severe, keep taking your
tablets but contact your doctor or pharmacist as
soon as possible.
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 in the UK via the Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard or in Ireland
via HPRA Pharmacovigilance, Earlsfort Terrace, IRL Dublin 2. Tel: +353 1 6764971. Fax: +353 1 6762517.
Website: www.hpra.ie. e-mail: medsafety@hpra.ie.
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 carton and bottle or blister strip after ‘EXP’.
The expiry date refers to the last day of that month.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Hydrocortisone 10mg & 20mg Tablets

Hydrocortisone 20 mg tablets are white, oval, flat,
bevelled tablets with imprinted “H” on one side and a
single break line on the other side.
Hydrocortisone tablets are available in HDPE bottles
with a polypropylene closure containing 100 tablets,
or in PVC/Aluminium foil blister packs containing 30
tablets (each pack contains 3 x 10 tablet blister strips).
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Renata (UK) Limited
Koh-i-nor, Kings Lane
Chipperfield, Hertfordshire,
WD4 9EN
United Kingdom
Distributed by:
Flynn Pharma Ltd
Hertlands House, Primett Road
Stevenage, Hertfordshire
SG1 3EE
United Kingdom
Manufacturer:
Alterno AD d.o.o., PE
Brnčičeva ulica 29,
Ljubljana-Črnuče, 1231
Slovenia
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Ireland : Hydrocortisone 10mg & 20mg Tablets
United Kingdom : Hydrocortisone 10mg & 20mg Tablets
This leaflet was revised in August 2017
105214543/V01

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.
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
- Hydrocortisone 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 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 it for more than 3 weeks, you will get a
blue ‘Steroid Treatment 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, even if you had them previously (see section
2 for further information). 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.
1. What Hydrocortisone Tablets are and what they
are used for
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.

This medicinal product does not require any special
storage conditions.
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.

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.

6. Contents of the pack and other information
What Hydrocortisone Tablets contain
• The active substance is Hydrocortisone:
Each 10 mg Tablet contains 10 mg Hydrocortisone.
Each 20 mg Tablet contains 20 mg Hydrocortisone.

Hydrocortisone Tablets are used:
- as replacement therapy for children with congenital
adrenal hyperplasia which affects the natural level
of steroids in your body.
- Pre-operatively, and during serious trauma or
illness in children with known adrenal insufficiency
or doubtful adrenocortical reserve
Hydrocortisone which is contained in this product is
also authorised to treat other sub-groups of patients
which are not mentioned in this leaflet. Ask your
doctor or pharmacist if you have further questions.
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 in this medicine (listed in
section 6). An allergic reaction may be recognised
as a rash, itching, swollen face or lips, or shortness
of breath.
• If you have thrush, Candida or any other
fungal infection
• If you have any other infection.
• If you have been vaccinated recently or are going to
have any vaccinations.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Hydrocortisone Tablets:
• If you have ever had severe depression or
manic-depressive illness (bipolar disorder). This
includes having had symptoms of depression in the
past, including while taking steroid medicines like
Hydrocortisone Tablets.
• If any of your close family has had these illnesses.
Check with your doctor before taking this medicine if
you currently have or have had any of the following:
• tuberculosis
• liver problems
• kidney problems
• high blood pressure
• heart problems including recent heart attacks
• diabetes (or a family history of diabetes)
• osteoporosis (thinning of the bones)
• glaucoma (increased pressure in the eye) or a
family history of glaucoma.
• epilepsy
• stomach ulcers or other digestive problems
• muscle weakness with steroids
• existing or previous history of severe mood
related disorders
• thyroid problems
• chicken pox, shingles or measles
• a weakened immune system
• amoebic dysentery and an infestation of a gut
worm (strongyloidiasis), it may be activated or
become worse by hydrocortisone tablets.
You should see your doctor if you develop any new
infections whilst taking these tablets.
Taking hydrocortisone for a long period of time
increases your chance of getting infections, which might
be worse than normal and may very rarely be fatal.
If you are taking or have recently taken (within the last
3 months) Hydrocortisone Tablets and you become
ill, suffer stress, get injured or are about to have a
surgical procedure you must tell your doctor

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Endocrine system
Development of ‘Cushingoid’ state (cheeks and
stomach increase in size, limbs become thin with
flushed face and increased appetite); stunted growth in
children; failure of the adrenal and pituitary glands to
produce hormones, particularly after surgery, an
accident or illness.

If you have been on Hydrocortisone Tablets for longer
than 3 weeks and wish to stop taking them, do not stop
suddenly as this could result in a severe drop in blood
pressure which could be fatal. Your doctor will advise
on how to reduce the number of tablets you are taking.
It is important to avoid exposure to people who have
chicken pox, measles or shingles, especially if you
have not already had these illnesses or are not sure if
you have had them. Hydrocortisone increases the risk
of a severe bout of chicken pox. If exposed you must
contact your doctor immediately.
Children
For children, it is important that a doctor monitors
their growth and development at intervals throughout
the treatment.
Mental
health
problems
while
taking
hydrocortisone
Mental health problems can occur while taking
steroids like hydrocortisone (see also section 4).
• 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.
Important - Steroid treatment card
All patients taking steroids for more than a few weeks
should carry a ‘steroid treatment card’, which is
available from your doctor or pharmacist. These cards
have the details of the medicine you are taking.
Always keep it with you and show it to any doctor or
nurse treating you.
Other Medicines and Hydrocortisone Tablets
Tell your doctor or pharmacist before taking
Hydrocortisone Tablets if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.
This is because some medicines can affect or be
affected by the use of Hydrocortisone Tablets.
The side effects of this medicine may be increased if
certain medicines are taken at the same time. On the
other hand, this medicine may increase or decrease the
effect of other medicines or increase their side effects
when taken at the same time.
Please tell your doctor or pharmacist if you are taking:
• anticoagulants such as warfarin
(medicines used to thin the blood)
• salicylates such as aspirin
• non-steroidal anti-inflammatory drugs
(NSAIDs) such as ibuprofen, diclofenac or
naproxen (medicines used to treat mild to
moderate pain)

• cough and cold medicines that contain a
decongestant called ephedrine
• medicines for diabetes (including insulin)
• erythromycin (a medicine used to treat
bacterial infections)
• an oral contraceptive pill
• somatropin (a type of growth hormone)
• ritonavir (a medicine used in the treatment of HIV
infections)
• acetazolamide (a medicine used to treat glaucoma)
• amphotericin or ketoconazole (used to treat
fungal infections)
• mifepristone (a medicine used to assist medical
termination of pregnancy)
• diuretics (water tablets)
• carbenoxolone (a medicine used to treat ulcers)
• methotrexate (a medicine used to treat rheumatoid
arthritis)
• medicines used to treat epilepsy such as
phenoytoin, phenobarbital, carbamazepine
and primidone
• rifabutin and rifampicin (antibiotics used to treat TB)
• aminoglutethimide (a medicine used in the
treatment of cancer)
• cardiac glycosides, such as digoxin (used to
treat heart failure and irregular heartbeat)
• theophylline and sympathomimetics such as
bambuterol, fenoterol, formoterol, ritodrine,
salbutamol, salmeterol and terbutaline (used to
treat asthma and other breathing problems)
• antihypertensives (medicines used to treat
high blood pressure)
Test Results while taking Hydrocortisone Tablets
Hydrocortisone tablets could affect the results of some
tests performed by your doctor or in the hospital, so
tell your doctor or nurse that you are taking these
tablets before any tests are carried out.
Hydrocortisone with food, drink and alcohol
Hydrocortisone can be taken with or without food.
Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Your doctor will decide whether you should take
Hydrocortisone during this time.
Breast feeding
Small amounts of hydrocortisone may pass into breast
milk. Please ask your doctor for advice before taking these
tablets if you are breast-feeding or intend to breast-feed.
Fertility
If you are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Driving and using machines
Hydrocortisone may have minor influence on your
ability to drive and use machines. Extreme tiredness
and episodes of short-lasting dizziness (vertigo) have
been reported. Poorly treated or untreated adrenal
insufficiency reduces your ability to concentrate and
will affect your ability to drive and use machines. It is
therefore important to take this medicine as directed
by your doctor when driving or using machines. If you
are affected do not drive or use machines, until you
have discussed the issue with your doctor.
Hydrocortisone Tablets contain lactose
This medicine contains lactose (a kind of sugar). If
you have been told by your doctor that you have an
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intolerance to some sugars, contact your doctor before
taking this medicinal product.
3. How to take Hydrocortisone Tablets
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. You should take this
medicine by mouth. The amount you take each day
will depend on your illness.
Remember to always carry a Steroid Treatment
Card. Make sure your doctor or pharmacist gives
you this and has filled out the details, including the
dose and how long you will have the treatment.
Taking this medicine
You should take this medicine by mouth. The amount
you take each day will depend on your illness. The
number of tablets to be taken will be on the label of
your medicine. If you are unsure about the dose you
should take, you must talk to your doctor or pharmacist.
The usual doses of Hydrocortisone Tablets are:
Use in Children
0.4 to 0.8 mg/kg given as two or three doses per day.
Children will be prescribed the lowest possible dose.
The doctor will keep an eye on their growth and
development.
The 20 mg tablet can be divided into equal doses.
If you take more Hydrocortisone Tablets than you
should
If you take more Hydrocortisone Tablets than you
should, contact your doctor or nearest
hospital/emergency department.
If you forget to take Hydrocortisone Tablets
If you forget to take a dose, wait and take the next dose
as usual.. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Hydrocortisone Tablets
Do not stop taking this medicine just because you feel
better. You must follow your doctor’s instructions on
stopping these tablets. Your doctor may want you to
reduce gradually the number of tablets before you
finally stop taking them. Never let your tablets run out
before receiving the next prescription. It may be
dangerous to stop treatment without your doctor’s
advice (see section 2).
Stopping Hydrocortisone tablets may leave you
without enough steroid hormones in your body. This
may cause withdrawal symptoms such as fever,
muscle and joint pain, blocked/runny nose, swelling
of the eye, painful itchy skin rash and weight loss.
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 everyone gets them. If you are
taking the medicine as a replacement steroid, you
should be less likely to get side effects than people
taking steroids for other illnesses.
Tell your doctor immediately if you notice:
• Itching or skin rashes
• Swelling of the face, lips or throat
Difficulty breathing or wheeziness
These may be signs of an allergic reaction.

Severe side effects:
Steroids including hydrocortisone can cause severe
mental health problems. These side effects are
common in both adults and children. They can affect
about 5 in every 100 people taking medicines like
hydrocortisone.
Tell your doctor immediately if you are:
• depressed including thinking about suicide
• high (mania) or having moods that go up and
down
• 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
Other side effects
Tell your doctor if you experience any of the
following:
Heart problems
Increased damage to the heart in the event of a heart
attack, heart failure; high blood pressure; blood clots.
Infections
Taking hydrocortisone can make it easier for you to
pick up infections which may very rarely be fatal.
Infections such as chicken pox and measles can be
made worse, or tuberculosis may recur.
Digestive system
Bleeding ulcers (indicated by stomach pain, bleeding
from the back passage, black stools or being sick with
blood present), inflammation of the pancreas causing
abdominal pain, stomach pain and discomfort, bloated
feeling, infection or ulceration of the gullet
(discomfort on swallowing, which can cause chest
pain), indigestion, feeling sick, being sick.
Nervous system
Fits (convulsions), headache (sometimes severe).
Raised pressure within the skull (pseudotumor
cerebri, indicated by headaches with vomiting,
listlessness and drowsiness) has been reported in
children; this usually occurs after treatment has
stopped.
Bones, muscles and joints
Muscle weakness or wasting, osteoporosis (thinner
bones with a higher risk of breaking them, especially
in older women); broken bones or fractures, hip or
shoulder pain due to poor blood circulation, risk of
torn tendons, joint inflammation in the knee and groin
(aseptic necrosis).
Eyes
Changes in vision as a result of cataract, blurred
vision, thinning of the surface of the eye, existing eye
infections may get worse, glaucoma (increased
pressure inside the eye), bulging eyes.
Blood and lymphatic system
Increased number of white blood cells.
Psychiatric disorders
Psychological dependence, worsening of schizophrenia.
Reproductive system
In women: Irregular or lack of periods.
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immediately that you are taking Hydrocortisone
Tablets. Your dose of hydrocortisone 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.

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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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