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FLORINEF 0.1MG TABLETS

Active substance(s): FLUDROCORTISONE ACETATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Florinef® 0.1mg Tablets /
Fludrocortisone acetate 0.1mg Tablets
(fludrocortisone acetate)
This product is available using either of the above names but will be referred to as
Florinef throughout this 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.










Florinef 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 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.
2.
3.
4.
5.
6.

What Florinef is and what it is used for
Before you take Florinef
How to take Florinef
Possible side effects
How to store your Florinef
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 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 Florinef)
is an effective way to treat various illnesses involving inflammation (swelling) in the
body. Florinef 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.

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
Florinef.
 If any of your close family has had these illnesses.
If either of these applies to you, talk to a doctor before taking Florinef.
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 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 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 andß -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 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

2. Before you take Florinef
Do not take this medicine if you:

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.

 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.

Driving or operating machinery

Take Special Care

Your doctor or pharmacist will have given you a Steroid Treatment Card with your
prescription or medicine.

Florinef has not been shown to impair your ability to drive or operate machinery.
Steroid Treatment Card

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 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

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.
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
Mental health problems can happen while taking steroids like
Florinef (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 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

















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
 Keep out of the sight and reach of children.
 Tablets should be stored 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 light and moisture.
 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.
 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 your medicine become discoloured or show signs of any deterioration, consult
your doctor or pharmacist who will tell you what to do.
6. Further Information

Serious effects: Tell your doctor straight away:

What Florinef contain

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.

Each tablet contains 0.1mg Fludrocortisone acetate.
The other ingredients are: maize starch, dibasic calcium phosphate, lactose
anhydrous, talc (E553b), magnesium stearate (E470b), and sodium benzoate (E211).

 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.

What Florinef look like and contents of the pack

If you notice any of these problems talk to a doctor straight away.

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 an amber glass
bottle of 100 tablets with a cotton plug and tamper-evident plastic screw cap.
Manufactured by Haupt Pharma Amareg GmbH, Regensburg, Germany.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.

Tell your doctor if the following occur:
PL: 15814/1148































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

POM

Leaflet revision and issue date (Ref.) 21.03.2016
To request a copy of this letter in Braille, large print or audio please call 01923 332
796.

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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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