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FLORINEF 0.1 MG TABLETS

Active substance(s): FLUDROCORTISONE ACETATE

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Florinef®

0.1mg Tablets /
Fludrocortisone acetate 0.1mg Tablets
(Fludrocortisone acetate)

Package Leaflet: Information for the user
This product is available using either of the above names but will be referred to as
Florinef throughout this leaflet.
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 your 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 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.
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 Florinef 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.

• 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 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
• 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.

Warnings and Precautions

3. How to take Florinef

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.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.

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.
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.

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

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 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)

continued overleaf

4. Possible side effects

5. How to store Florinef

Like all medicines, this medicine can cause side effects, although not everybody gets
them.

Tablets should be stored in a refrigerator between 2ºC and 8ºC.

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 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 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 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

If you cannot store your tablets in a refrigerator (between 2ºC and 8ºC), they may be
stored at room temperature (25ºC) for up to 30 days. Do not return these to the
refrigerator. Any tablets stored out of the refrigerator and not used within 30 days should
be returned to the pharmacy for destruction.
Do not use this medicine 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 medicine out of the sight and reach of children.
If the tablets become discoloured or show any other signs of deterioration, you should
ask your doctor or pharmacist for advice.
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.
6. Contents of the pack and other information
What Florinef contains
Each tablet contains 0.1mg fludrocortisone acetate.
The other ingredients are: corn starch, calcium hydrogen phosphate (E341), lactose
anhydrous, talc (E553b), magnesium stearate (E470b) and sodium benzoate (E211).
What Florinef looks 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 an amber glass bottle of 100 tablets with a cotton plug.
Manufacturer and Product Licence Holder:
This product is manufactured by Haupt Pharma Amareg GmbH, Donaustaufer Strasse
378, 93055 Regensburg, Germany.
It is procured from within the EU by the Product Licence Holder: Swinghope Ltd, and
repackaged by YMD Pharma Ltd, both at Commerce Way, Edenbridge TN8 6ED, UK.
PL No: 10380/1615 Florinef 0.1mg Tablets / Fludrocortisone acetate 0.1mg Tablets
POM

Leaflet revision date: 21/01/2018
Florinef® is a registered trademark of Aspen Global Incorporated.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 02030969700 to obtain the leaflet in a
format suitable for you.

Additional side effects in children and adolescents
• Failure to grow
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.

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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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