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FLORINEF 0.1MG TABLETS

Active substance(s): FLUDROCORTISONE ACETATE / FLUDROCORTISONE ACETATE

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Florinef® 0.1mg Tablets/
Fludrocortisone acetate 0.1mg Tablets
(fludrocortisone acetate)
Your medicine is known by any of the above names, but will be referred to as
Fludrocortisone acetate throughout this leaflet.
Patient Information Leaflet
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 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 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 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
Each tablet contains 0.1mg of the active ingredient, fludrocortisone acetate.
Fludrocortisone acetate belongs to a group of medicines called steroids.
Their full name is corticosteroids. These corticosteroids occur naturally in the
body, and help to maintain health and well-being. Boosting your body with
extra corticosteroid (such as Fludrocortisone acetate) is an effective way to
treat various illnesses involving inflammation (swelling) in the body.
Fludrocortisone acetate 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 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 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.
• 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.
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
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines 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 anesthesia.
• Some medicines may increase the effects of Fludrocortisone acetate 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 ß-blockers, angiotensin II 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.
Driving or operating machinery
Fludrocortisone acetate 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 acetate
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.
Mental problems while taking Fludrocortisone acetate
Mental health problems can happen while taking steroids like Fludrocortisone
acetate (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 acetate 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.
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 your Fludrocortisone acetate
• Keep out of the sight and reach of children.
• Do not use after the expiry date printed on the carton or bottle label after
‘EXP’. The expiry date refers to the last day of that month.
• Store in a refrigerator between 2°C and 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.
• Keep the bottle tightly closed in order to protect from moisture.
• If you are told to stop taking this medicine, return any unused tablets to
your pharmacist.
• Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6) Further Information
What Fludrocortisone acetate contains:
The active substance is fludrocortisone acetate. Each tablet contains 0.1mg
fludrocortisone acetate.
The other ingredients are: lactose anhydrous, lactose monohydrate, maize
starch, calcium hydrogen phosphate dihydrate, talc, sodium benzoate
(E211), magnesium stearate.
What Fludrocortisone acetate looks like and contents of the pack
Fludrocortisone acetate tablets are white, round, biconvex, scored on one
side and engraved with ‘SQUIBB 429’ on the other.
They are available in glass bottles containing 100 tablets with a cotton plug.
PL 10383/2222

Florinef 0.1mg Tablets/
Fludrocortisone acetate 0.1mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Haupt Pharma Amareg GmbH,
Donaustaufer Straβe 378, 93055 Regensburg, Germany. Procured from
within the EU and repackaged by Product Licence Holder: Primecrown Ltd.,
4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 04.04.2017
Florinef® is a registered trademark of Aspen Global Incorporated, Mauritius.

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Expand Transcript

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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