Skip to Content

FLUDROCORTISONE 0.1 MG TABLETS

Active substance(s): FLUDROCORTISONE ACETATE

View full screen / Print PDF » Download PDF ⇩
Transcript
500016/PL1c

Florinef® 0.1 mg Tablets
(fludrocortisone acetate)

Patient Information Leaflet
The name of your medicine is Florinef 0.1 mg Tablets.
Throughout this leaflet it will be referred to as Florinef.
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.
• Florinef 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.
• Florinef 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 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.
In this leaflet:
1. What Florinef is and what it is used for
2. Before you take Florinef
3. How to take Florinef
4. Possible side effects
5. How to store your Florinef
6. Further Information
1. WHAT FLORINEF IS AND WHAT IT IS USED FOR
The name of this medicine is Florinef. Each tablet contains
0.1mg of the active ingredient, fludrocortisone acetate.
Florinef 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 wellbeing. Boosting your body with extra corticosteroid (such as
Florinef tablets) is an effective way to treat various illnesses
involving inflammation (swelling) in the body. Florinef 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.
Florinef 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.
Florinef is also used to treat a condition called ‘salt losing
adrenogenital syndrome’ which is a different form of hormone
imbalance.
2. BEFORE YOU TAKE FLORINEF
Do not take this medicine if you:
• Have ever had an allergic (hypersensitivity) reaction
to any of the ingredients in Florinef 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 have ever 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 your eyes)
• 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 Florinef 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 manicdepression (bipolar disorder). This includes having had
depression before while taking steroid medicines like
Florinef tablets.
• If any of your close family has had these illnesses.
If either of these applies to you, talk to a doctor before
taking Florinef 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 Florinef 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 antiinflammatory 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 Florinef.
• 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 anesthesia.
or medicines to treat:
• High blood pressure (e.g. sodium phenylbutyrate,
clonidine, methyldopa, ACE inhibitors, α and ßblockers, angiotensin II receptor antagonists, calciumchannel 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
Florinef
Florinef 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 breast-feeding you should make sure you discuss this
with your doctor before taking Florinef.
Driving or operating machinery
Florinef has not been shown to impair your ability to drive or
operate machinery.
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
3. HOW TO TAKE FLORINEF
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 Florinef as this may make you ill.
If you take more Florinef 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.

Continued overleaf

If you forget to take Florinef
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.
Mental problems while taking Florinef tablets
Mental health problems can happen while taking steroids like
Florinef 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.
4. POSSIBLE SIDE EFFECTS
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 Florinef 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 Florinef.
• 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.
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 FLORINEF
• Tablets should be stored in a refrigerator (2-8°C).
If you are unable to store your tablets between 2°C
and 8°C, then they may be stored at room temperature
(25°C) 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 the bottle tightly closed in order to protect from
moisture.
• 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.
• If you notice any signs of discolouration or
deterioration of your medicine, tell your pharmacist
immediately.
6. FURTHER INFORMATION
What Florinef Tablets contain
Each tablet contains 0.1 mg of fludrocortisone acetate.
The other ingredients are: maize starch, dibasic calcium
phosphate, lactose anhydrous, talc, sodium benzoate (E211),
magnesium stearate.
What Florinef Tablets look like and contents of the pack
Florinef tablets are white in colour, round, biconvex, 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.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd. Repackager Ginova UK Ltd. Both of St James' House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer:
Haupt Pharma Amareg GmbH, Donaustaufer Strasse 378,
93055 Regensburg, Germany.
®

Florinef 0.1 mg Tablets
PL No: 18067/0471

POM

®

Florinef is a registered trademark of Bristol-Myers Squibb
Pharmaceuticals Ltd.
rd

This leaflet was last revised on 3 March 2016.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

500016/PL1c

504525/PL1c

Fludrocortisone 0.1 mg Tablets
(fludrocortisone acetate)
Patient Information Leaflet
The name of your medicine is Fludrocortisone 0.1 mg Tablets.
Throughout this leaflet it will be referred to as Fludrocortisone.
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 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 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 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.
In this leaflet:
1. What Fludrocortisone is and what it is used for
2. Before you take Fludrocortisone
3. How to take Fludrocortisone
4. Possible side effects
5. How to store your Fludrocortisone
6. Further Information
1. WHAT FLUDROCORTISONE IS AND WHAT IT IS USED
FOR
The name of this medicine is Fludrocortisone. Each tablet
contains 0.1mg of the active ingredient, fludrocortisone
acetate.
Fludrocortisone 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 tablets) is an effective
way to treat various illnesses involving inflammation (swelling)
in the body. Fludrocortisone 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 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 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
Do not take this medicine if you:
• Have ever had an allergic (hypersensitivity) reaction
to any of the ingredients in Fludrocortisone 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 have ever 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 your eyes)
• 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
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 manicdepression (bipolar disorder). This includes having had
depression before while taking steroid medicines like
Fludrocortisone 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 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 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 antiinflammatory 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.
• 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 anesthesia.
or medicines to treat:
• High blood pressure (e.g. sodium phenylbutyrate,
clonidine, methyldopa, ACE inhibitors, α and ßblockers, angiotensin II receptor antagonists, calciumchannel 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
Fludrocortisone 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 breast-feeding you should make sure you discuss this
with your doctor before taking Fludrocortisone.
Driving or operating machinery
Fludrocortisone has not been shown to impair your ability to
drive or operate machinery.
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
3. HOW TO TAKE FLUDROCORTISONE
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 as this may
make you ill.
If you take more Fludrocortisone 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.

Continued overleaf

If you forget to take Fludrocortisone
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.
Mental problems while taking Fludrocortisone tablets
Mental health problems can happen while taking steroids like
Fludrocortisone 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.
4. POSSIBLE SIDE EFFECTS
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 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.
• 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.
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
• Tablets should be stored in a refrigerator (2-8°C).
If you are unable to store your tablets between 2°C
and 8°C, then they may be stored at room temperature
(25°C) 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 the bottle tightly closed in order to protect from
moisture.
• 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.
• If you notice any signs of discolouration or
deterioration of your medicine, tell your pharmacist
immediately.
6. FURTHER INFORMATION
What Fludrocortisone Tablets contain
Each tablet contains 0.1 mg of fludrocortisone acetate.
The other ingredients are: maize starch, dibasic calcium
phosphate, lactose anhydrous, talc, sodium benzoate (E211),
magnesium stearate.
What Fludrocortisone Tablets look like and contents of
the pack
Fludrocortisone tablets are white in colour, round, biconvex,
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.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd. Repackager Ginova UK Ltd. Both of St James' House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer:
Haupt Pharma Amareg GmbH, Donaustaufer Strasse 378,
93055 Regensburg, Germany.
Fludrocortisone 0.1 mg Tablets
PL No: 18067/0471

POM

rd

This leaflet was last revised on 3 March 2016.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

504525/PL1c

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