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FLORINEF 0.1MG TABLETS

Active substance(s): 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
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 acetate is and what it is used for
2) What you need to know before you take Fludrocortisone acetate
3) How to take Fludrocortisone acetate
4) Possible side effects
5) How to store your Fludrocortisone acetate
6) Contents of the pack and other information

1) What Fludrocortisone acetate is and what it is used for
The name of this medicine is Fludrocortisone acetate. Each tablet contains
0.1mg of the active ingredient, fludrocortisone acetate.
Fludrocortisone acetate 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 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) What you need to know before you take Fludrocortisone
acetate
Do not take Fludrocortisone acetate:

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.

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 acetate
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)
• 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 acetate
• 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 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
• 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 vaccinations without
consulting your doctor.

Warnings and Precautions
Talk to your doctor or pharmacist before taking Fludrocortisone acetate.
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 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
• Contact your doctor if you experience blurred vision or other visual
disturbances.

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.

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 tablets.
• If any of your close family has had these illnesses.

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 acetate as this may make you ill.

Driving and using machines
Fludrocortisone acetate 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 acetate contains lactose
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.

3) How to take Fludrocortisone acetate
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.

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 health problems while taking Fludrocortisone acetate tablets
Mental health problems can happen while taking steroids like Fludrocortisone
acetate 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.
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 acetate 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 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 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

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.

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) Contents of the pack and other 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: 19.02.2018
Florinef® is a registered trademark of Aspen Global Incorporated, Mauritius.

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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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