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FLUDROCORTISONE 0.1 MG TABLETS

Active substance(s): FLUDROCORTISONE ACETATE

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500016/PL1e

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.
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.
• Don’t stop taking this medicine without talking to
your doctor – you may need to reduce the dose
gradually.
• 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.
What is in this leaflet:
1. What Florinef is and what it is used for
2. What you need to know before you take Florinef
3. How to take Florinef
4. Possible side effects
5. How to store Florinef
6. Contents of the pack and other 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.
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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
FLORINEF
Do not take Florinef
- if you:
• Are allergic to fludrocortisone acetate or any of the
other ingredients of this medicine (listed in section 6)
or any other similar medicines
• Are suffering from an infection and are not taking any
prescribed medication for it.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Florinef
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
• you have or ever have had tuberculosis
• you have or 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 health problems 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 have ocular herpes simplex (eye infection
caused by a type of herpes)
• 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
• Contact your doctor if you experience blurred vision or
other visual disturbances.
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.
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.

Other medicines and Florinef
Please tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. 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 taking Florinef.
• A medicine called ciclosporin (normally used after a
transplant)
• Barbiturates. These drugs are used as sedatives (to
produce a calming effect), as hypnotics (to produce
sleep), or as an adjunct in anaesthesia.
• Some medicines may increase the effects of Florinef
and your doctor may wish to monitor you carefully if
you are taking these medicines (including some
medicines for HIV: ritonavir, cobicistat).
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
• 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.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Driving and using machines
Florinef has not been shown to impair your ability to drive or
use machines.
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
Florinef contains lactose
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.
3. HOW TO TAKE FLORINEF
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Adults and the Elderly
The recommended 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.
Use in Children
The recommended dose is one-half tablet (0.05mg) to one
tablet (0.1mg) daily. 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.
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 health problems while taking Florinef tablets
Mental health problems can happen while taking steroids like
Florinef tablets (see also section 4).
• 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.

Continued overleaf

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 health problems have
happened when doses are being lowered or stopped.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Serious 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
- if the following happen as these may be signs of a serious
mental health problem. 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 having 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
(hallucinations). Having strange and frightening
thoughts, changing how you act or feeling lonely.
Less serious side effects
Tell your doctor if the following occur:
Very common (these may affect more than 1 in 10 people)
• Heart failure (shortness of breath with activity, or after
lying down for a while)
• High blood pressure
Common: (These may affect up to 1 in 10 people)
• Muscle weakness, pain or wasting, tendon rupture
(where muscles connect to bones)
• Headaches
• Increased swelling
Uncommon: (These may affect up to 1 in 100 people)
• Irregular heartbeats
• Epilepsy or seizures (fits)
• Fainting or loss of consciousness
• Diarrhoea
Other side-effects (Frequency not known: frequency cannot
be estimated from the available data)
• Infection of the veins in the legs
• Thrush (white patches) or fungal infections (or sores in
your mouth)
• 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
• Abdominal pain
• Ulcers of the stomach or intestine (which can lead to
perforation or bleeding), pain or burning in your
stomach or oesophagus
• Ulcers of the windpipe (pain in your windpipe)
• Indigestion
• Swelling of the stomach (feeling full or bloated)
• Increased or decreased appetite
• Skin problems including thinning of the skin and eye,
bruising, facial redness, stretch marks, increased facial
hair, acne
• Poor wound healing
• Increased sweating
• Vertigo (spinning feeling)
• Sleep problems
• Pins and needles
• Irregular or absent periods
• Glaucoma
• Clouding of the lens (cataract)
• Problems with vision
• Blurred vision
• Infection of the cornea
• Problems in the way your body manages your glucose
levels including diabetes
• High blood sugar levels
• Tired
• Weight gain
• Increased pain
• Fever (increased temperature) and sweating
• Abnormal taste
• Tingling (lips, fingers, tongue or feet)
• Nausea (feeling sick)
• Vomiting (getting sick)
• Skin turning yellow
• 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 or search for
MHRA Yellow Card in the Google Play or Apple App Store.
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. CONTENTS OF THE PACK AND OTHER 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 Aspen Global
Incorporated.
th

This leaflet was last revised on 7 November 2017.

To request a copy of this leaflet in
Braille, large print or audio please
call 01622 690172.

Additional side effects in children and adolescents
• Failure to grow

500016/PL1e

504525/PL1d

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.
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.
• Don’t stop taking this medicine without talking to
your doctor – you may need to reduce the dose
gradually.
• 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.
What is in this leaflet:
1. What Fludrocortisone is and what it is used for
2. What you need to know before you take
Fludrocortisone
3. How to take Fludrocortisone
4. Possible side effects
5. How to store Fludrocortisone
6. Contents of the pack and other 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.
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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
FLUDROCORTISONE
Do not take Fludrocortisone:
- if you:
• Are allergic to fludrocortisone acetate or any of the
other ingredients of this medicine (listed in section 6)
or any other similar medicines
• Are suffering from an infection and are not taking any
prescribed medication for it.
Warnings and Precautions
Talk to your doctor or pharmacist before taking
Fludrocortisone
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
• you have or ever have had tuberculosis
• you have or 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 health problems 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 have ocular herpes simplex (eye infection
caused by a type of herpes)
• 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
• Contact your doctor if you experience blurred vision or
other visual disturbances.
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.
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.

Other medicines and Fludrocortisone
Please tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. 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 taking Fludrocortisone.
• A medicine called ciclosporin (normally used after a
transplant)
• Barbiturates. These drugs are used as sedatives (to
produce a calming effect), as hypnotics (to produce
sleep), or as an adjunct in anaesthesia.
• Some medicines may increase the effects of
Fludrocortisone and your doctor may wish to monitor
you carefully if you are taking these medicines
(including some medicines for HIV: ritonavir,
cobicistat).
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
• 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.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Driving and using machines
Fludrocortisone has not been shown to impair your ability to
drive or use machines.
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
Fludrocortisone contains lactose
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.
3. HOW TO TAKE FLUDROCORTISONE
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Adults and the Elderly
The recommended 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.
Use in Children
The recommended dose is one-half tablet (0.05mg) to one
tablet (0.1mg) daily. 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.
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 health problems while taking Fludrocortisone
tablets
Mental health problems can happen while taking steroids like
Fludrocortisone tablets (see also section 4).
• 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.

Continued overleaf

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 health problems have
happened when doses are being lowered or stopped.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Serious 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
- if the following happen as these may be signs of a serious
mental health problem. 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 having 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
(hallucinations). Having strange and frightening
thoughts, changing how you act or feeling lonely.
Less serious side effects
Tell your doctor if the following occur:
Very common (these may affect more than 1 in 10 people)
• Heart failure (shortness of breath with activity, or after
lying down for a while)
• High blood pressure
Common: (These may affect up to 1 in 10 people)
• Muscle weakness, pain or wasting, tendon rupture
(where muscles connect to bones)
• Headaches
• Increased swelling
Uncommon: (These may affect up to 1 in 100 people)
• Irregular heartbeats
• Epilepsy or seizures (fits)
• Fainting or loss of consciousness
• Diarrhoea
Other side-effects (Frequency not known: frequency cannot
be estimated from the available data)
• Infection of the veins in the legs
• Thrush (white patches) or fungal infections (or sores in
your mouth)
• 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
• Abdominal pain
• Ulcers of the stomach or intestine (which can lead to
perforation or bleeding), pain or burning in your
stomach or oesophagus
• Ulcers of the windpipe (pain in your windpipe)
• Indigestion
• Swelling of the stomach (feeling full or bloated)
• Increased or decreased appetite
• Skin problems including thinning of the skin and eye,
bruising, facial redness, stretch marks, increased facial
hair, acne
• Poor wound healing
• Increased sweating
• Vertigo (spinning feeling)
• Sleep problems
• Pins and needles
• Irregular or absent periods
• Glaucoma
• Clouding of the lens (cataract)
• Problems with vision
• Blurred vision
• Infection of the cornea
• Problems in the way your body manages your glucose
levels including diabetes
• High blood sugar levels
• Tired
• Weight gain
• Increased pain
• Fever (increased temperature) and sweating
• Abnormal taste
• Tingling (lips, fingers, tongue or feet)
• Nausea (feeling sick)
• Vomiting (getting sick)
• Skin turning yellow
• 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 or search for
MHRA Yellow Card in the Google Play or Apple App Store.
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. CONTENTS OF THE PACK AND OTHER 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

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This leaflet was last revised on 7 November 2017.

To request a copy of this leaflet in
Braille, large print or audio please
call 01622 690172.

Additional side effects in children and adolescents
• Failure to grow

504525/PL1d

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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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