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FLUDROCORTISONE ACETATE 0.1 MG TABLETS

Active substance(s): FLUDROCORTISONE ACETATE

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Package Leaflet: Information for the User

Fludrocortisone acetate
0.1mg Tablets
Please read this leaflet carefully before you start taking your
medicine. This leaflet provides a summary of the information
available on your medicine. This medicine has been prescribed for
you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours. If you want to know more or are
not sure ask your Doctor or Pharmacist.

• Fludrocortisone acetate 0.1mg tablet 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.
Fludrocortisone acetate 0.1mg tablet 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
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.
In this leaflet:
1. What Fludrocortisone acetate is and what it is used for
2. Before you take Fludrocortisone acetate
3. How to take Fludrocortisone acetate
4. Possible side effects
5. How to store your Fludrocortisone acetate
6. Further Information

1. What Fludrocortisone acetate is and
what it is used for
The name of this medicine is Fludrocortisone acetate. Each tablet
contains 0.1mg of the active ingredient, fludrocortisone acetate.
Fludrocortisone acetate tablets belong 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 Fludrocortisone
acetate tablets) is an effective way to treat various illnesses involving
inflammation (swelling) in the body. Fludrocortisone acetate tablets
reduce this inflammation, which could otherwise go on making your
condition worse. You must take this medicine regularly to get maximum
benefit from it.
Fludrocortisone acetate is used to replace the hormones that are normally
produced by glands attached to your kidneys. These hormones will not
be produced by your body if you suffer from a condition called Addison’s
disease.
Fludrocortisone acetate is also used to treat a condition called ‘salt losing
adrenogenital syndrome’ which is a different form of hormone
imbalance.

2. Before you take Fludrocortisone acetate
Do not take this medicine if you:

• Have ever had an allergic (hypersensitivity) reaction to any of the



ingredients in Fludrocortisone acetate or any other similar medicines
(listed in section 6).
Are suffering from an infection and are not taking any prescribed
medication for it.
Have a peptic ulcer, active tuberculosis or a mental illness in which
you lose touch with reality and are unable to think and judge clearly.

Take Special Care
You must tell your doctor before taking this medicine if:

• you have or have recently had any bacterial, viral or fungal infection








that is not being treated
if you have or ever have had tuberculosis
if you have had any intestinal, bowel disorder or stomach ulcer
you have an infection or inflammation of the veins in your leg
(thrombophlebitis)
you have had any mental disorders or epilepsy
you have had any kidney, liver or thyroid problems
you have recently suffered from any form of cancer
you have thin or brittle bones (osteoporosis)

• you have myasthenia gravis (a disease which causes weak muscles)










or any other muscle weakness
you have high blood pressure or heart failure
you or someone in your family has glaucoma (increased pressure in
the eye)
you are diabetic as your insulin dose may need to be changed or
have a family history of diabetes
you have a skin rash typically caused by viral infection (e.g. measles)
you have muscle damage caused by steroid treatment
you are elderly (over 65 years old) as you may be more susceptible to
side effects (see section 4 Possible side effects)
you are younger than 18 years old, as Fludrocortisone acetate may
lead to slowing of growth
you are suffering from stress (such as trauma, surgery or severe
illness), as you may require supportive corticosteroid therapy both
during the treatment period and for a year afterwards
you are to have or have had intestinal surgery

Check with your doctor first:
• If you have ever had severe depression or manic-depression
(bipolar disorder). This includes having had depression before while
taking steroid medicines like Fludrocortisone acetate tablets
• If any of your close family has had these illnesses.
If either of these applies to you, talk to a doctor before taking
Fludrocortisone acetate tablets.
Steroid medicines suppress your body’s natural immune response.
Therefore, if you come into contact with anyone who has an infectious
disease such as chickenpox, shingles or measles, consult your doctor as
soon as possible.
Your doctor may want to send you for blood tests from time to time and
check your salt intake regularly to make sure you do not develop high
blood pressure, fluid retention or become overweight.
Taking Fludrocortisone acetate with other medicines
Always tell your doctor about any medicines you are taking, or have
recently taken, including those obtained without a prescription. This is
especially important if you are taking:
• Aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs
(NSAIDs) as corticosteroids can increase the chance of bleeding from
the gut
• Any antifungals (e.g. ketoconazole, amphotericin)
• Warfarin or other medicines to thin the blood

• Oral contraceptive pill or hormone replacement therapy (HRT)
• Human growth hormone
• Muscle relaxants e.g. atracurium. These drugs are used during



anaesthesia for surgery. Please inform your anaesthetist if you’re on
Fludrocortisone acetate
A medicine called cyclosporin
Barbiturates. These drugs are used as sedatives (to produce a calming
effect), as hypnotics (to produce sleep), or as an adjunct in
anaesthesia.

or medicines to treat:

• High blood pressure (e.g. sodium phenylbutyrate, clonidine,














methyldopa, ACE inhibitors, α and β-blockers, angiotensin ll receptor
antagonists, calcium-channel blockers and diuretics)
Irregular heartbeat (e.g. digoxin)
Epilepsy or other sorts of fits (e.g. phenytoin, primidone,
carbamazepine)
Tuberculosis (TB) (e.g. isoniazid, rifampicin, rifabutin)
Diabetes
Thyroid problems
Anti-progestogenic steroids (e.g. mifepristone)
Cushing’s syndrome (e.g. aminoglutethimide)
Glaucoma (e.g. acetazolamide)
Intestinal pain (e.g. hyoscine)
Asthma and Chronic Obstructive Pulmonary Disease (e.g. tiotropium)
Urinary retention (e.g. doxazosin)
Alzheimer’s dementia (e.g. donepezil, galantamine)
Myasthenia Gravis (e.g. neostigmine)

While you are being treated with this medicine (or if you have recently
stopped a course of treatment) do not have any vaccination without
consulting your doctor.
Important information about some of the ingredients of
Fludrocortisone acetate
Fludrocortisone acetate contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars, you should discuss
this with them before taking this medicine.
Pregnancy and breastfeeding
If you are pregnant, planning to become pregnant, or if you are breastfeeding you should make sure you discuss this with your doctor before
taking Fludrocortisone acetate.

Steroid Treatment 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

Mental problems while taking Fludrocortisone acetate tablets
Mental health problems can happen while taking steroids like
Fludrocortisone acetate tablets (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 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 happen they might need
treatment.
Talk to a doctor if you (or someone taking this medicine), shows any
signs of mental problems. This is particularly important if you are
depressed, or might be thinking about suicide. In a few cases, mental
problems have happened when doses are being lowered or stopped.

3. How to take Fludrocortisone acetate

4. Possible side effects

Take the tablets exactly as your doctor has instructed.
Adults and the Elderly
To treat Addison’s Disease the usual daily dose range is:
0.05mg (one-half tablet) to 0.3mg (3 tablets) to be taken once a day.
Patients on long term treatment may require the addition of a different
type of steroid tablet during times of illness or stress.
To treat Adrenal hyperplasia the usual daily dose range is:
0.1mg (one tablet) to 0.2mg (2 tablets).
Children
The dose is adjusted according to size and weight but is always kept as
low as possible.
Make sure you take the full course as prescribed by your doctor. Do not
suddenly stop taking Fludrocortisone acetate as this may make you ill.
If you take more Fludrocortisone acetate than you should
If you take too many tablets contact your doctor or go to your nearest
hospital emergency department immediately. Take the container and
any remaining medicine with you.
If you forget to take Fludrocortisone acetate
If you forget to take a dose, do not worry, just take it as soon as you
remember unless it is nearly time for your next dose then you should miss
the forgotten dose and continue as before.
Do not take a double dose to make up for the forgotten dose.

The following side effects are presented in order of severity. The
most severe side effects are listed first. Side effects that are
considered to be of the same severity are listed on the same line.
Stop taking Fludrocortisone acetate tablets and contact your doctor
straight away/immediately if the following happen as these may be
signs of an allergic reaction (hypersensitivity reaction including
anaphylaxis):
• Difficulty breathing
• Swelling of the face, lips or tongue
• Severe pains in your stomach or abdomen
• Skin rash
Serious effects: Tell your doctor straight away:
Steroids including fludrocortisone acetate 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
Fludrocortisone acetate.
• Feeling depressed, including thinking about suicide
• Feeling high (mania) or have 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.

Driving or operating machinery
Fludrocortisone acetate has not been shown to impair your ability to drive
or operate machinery.

Tell your doctor if the following occur:
• An increased susceptibility to infections (lowered resistance to
infections)
• Infection of the veins in the legs
• Blood clots (thromboembolism)
• Thrush (white patches) or fungal infections (or sores in your mouth)
• Muscle weakness, pain or wasting, tendon rupture (where muscles
connect to bones)
• Bone problems, including thinning or wasting or fractures and
delays in bone healing
• Pancreatitis (inflammation of the pancreas) which causes severe pain
in the abdomen and back
• Diverticulitis which is an inflammatory condition which may cause
abdominal pain or diarrhoea
• Ulcers of the stomach or intestine (which can lead to perforation or
bleeding), pain or burning in your stomach or esophagus
• Ulcers of the windpipe (pain in your windpipe)
• Indigestion
• Swelling of the stomach (feeling full or bloated)
• Increased appetite
• Skin problems including thinning of the skin and eye, bruising, facial
redness, stretch marks, increased facial hair, acne
• Poor wound healing
• Increased sweating
• Reactions to skin tests may be reduced
• Heart failure (shortness of breath with activity, or after lying down for a
while)
• Irregular heartbeats
• High blood pressure
• Epilepsy or seizures
• Fainting
• Diarrhoea
• Vertigo (spinning feeling)
• Fits
• Sleep problems

























Headaches
Pins and needles
Severe blood loss
Increased number of white cells or other blood disorders
Irregular or absent periods
Failure to grow
Water and sodium (salt) retention
Glaucoma
Clouding of the lens (cataract)
Problems with vision
Infection of the cornea
Problems in the way your body manages your glucose levels including
diabetes
Changes in your body’s mineral levels for example, calcium
High blood sugar levels
Tired
Weight gain
An imbalance in your body’s sodium, potassium or chloride levels
Low blood urea nitrogen levels
Problems with your endocrine system, which controls your hormones,
including those which regulate your body’s growth and metabolism.
Symptoms include increased appetite, weight gain, sweating and
tiredness
Decreased pituitary function (a change in the levels of some hormones,
mineral balance or protein in blood tests)
Hormone imbalance causing Cushing’s Syndrome (typical symptoms:
a round face often called a ‘moon face’, upper body weight gain and
rash on the face)
Increase in blood clotting

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 Fludrocortisone acetate
Store in a refrigerator (2ºC-8ºC). Keep the bottle tightly closed to protect
from light and moisture.
If you are unable to store your tablets between 2ºC and 8ºC, then they
may be stored at room temperature (25ºC) for up to 30 days. Any tablets
stored at room temperature should be disposed of after 30 days.
Do not use after the expiry date which is stated on the bottle label after
‘EXP’. The expiry date refers to the last day of that month.
Keep your medicines out of the sight and reach of children
If you are told to stop taking this medicine, return any unused tablets to
your pharmacist.
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.
Do not use if the tablets are discoloured or if any signs of deterioration
are seen.

6. Further Information
What Fludrocortisone acetate Tablets contain
Each tablet contains 0.1mg of fludrocortisone acetate.The other
ingredients are: maize starch, dibasic calcium phosphate, lactose
anhydrous, talc, sodium benzoate (E211), magnesium stearate.
What Fludrocortisone acetate Tablets look like and contents of the
pack
Fludrocortisone acetate tablets are white, round, biconvex tablets scored
on one side and engraved on the other side with “SQUIBB and 429”.
The tablets are supplied in amber glass bottles of 100 tablets with a
cotton plug.
PL holder: Manx Healthcare Ltd, Taylor Group House, Wedgnock Lane,
Warwick, CV34 5YA
PL 14251/0054
Procured from within the EU
POM
Manufacturer: Haupt Pharma Amareg GmbH, Donaustaufer Straβe 378,
93055 Regensburg, Germany
To request a copy of this leaflet in large print, audio or Braille, please call
01926 482511
This leaflet was last revised on 10/10/2016
WIP URN: 101016-XXXX-PIL-01

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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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