You doctor has prescribed Florinef tablets for you. This leaflet gives a summary of information about your medicine. If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

REMEMBER: This medicine is for YOU. Only a doctor can prescribe it. Never give it to anyone else. It may harm them even if they have the same symptoms as you.

Q. WHAT IS IN FLORINEF TABLETS?

A Florinef tablets contain fludrocortisone acetate which is a member of the group of medicines known as steroids.

The tablets contain 0.1 mg fludrocortisone acetate. They are supplied in blister packs of 56 tablets and bottles of 56 or 100 tablets

The other ingredients are dicalcium phosphate, erythrosine, lactose, magnesium stearate, maize starch, sodium benzoate and talc.

UK PRODUCT LICENCE

Held by; E R Squibb & Sons Limited, 141-149 Staines Road, Hounslow TW3 3JA

Ireland Product Authorisation

Held by Bristol Myers Squibb Pharmaceuticals Ltd., Swords, Co. Dublin, Ireland.

MANUFACTURER

Bristol Myers Squibb Pharmaceuticals Ltd., Reeds Lane, Moreton, Wirral, Merseyside L46 1QW

Q. WHAT IS THIS MEDICINE FOR?

A. Florinef tablets are used to replace hormones normally produced by glands attached to your kidneys. These hormones are missing if you suffer from Addison’s disease. Florinef tablets are also used to treat salt-losing adrenogenital syndrome, which is a different form of hommone imbalance.

BEFORE TAKING YOUR MEDICINE

Q. Should I be taking Florinef tablets?

A. You should not take this medicine if you have ever had an allergic reaction to similar medicines or to any of the ingredients in Florinef tablets.

You should not take this medicine if you are suffering from an infection unless your doctor has also prescribed a treatment for the infection.

You should not take this medicine for the treatment of any condition other than those stated.

Your doctor should 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 or fluid retention or become overweight.

Q. Is there anything else I should discuss with my doctor before taking Florinef tablets?

A Check with your doctor before taking Florinef tablets if you have had any recent infection, tuberculosis (TB), bowel disorders, an ulcer, blood clots, cancer, thin (brittle) bones, high blood pressure or heart failure, mental disorders, epilepsy, myasthenia gravis or glaucoma (increased pressure in your eyes).

Q. What if I have been in contact with someone who has Chickenpox or Shingles?

A. Tell your doctor immediately if you have not had chickenpox yourself as these diseases can be dangerous to patients taking steroid medicines as the steroids suppress your body’s natural Immune responses

Q. Can I be immunised (vaccinated)?

A. While you are being treated with this medicine (or if you have recently stopped a course of treatment) do not have any immunisation without consulting your doctor.

Q. What if I am pregnant or think I may be pregnant?

What if I am planning to become pregnant?

What if I am breast feeding?

A. You should make sure you discuss this with your doctor as soon as possible before taking Florinef tablets.

Q. What if I have had problems with my kidneys, liver or thyroid?

A. Remind your doctor as the dose of Florinef may need to be adjusted.

Q. Can I take other medicines?

A Do not take aspirin with Florinef tablets if you have blood disorders. Always tell your doctor about all other medicines you are taking even those you have bought at a pharmacy or other places, e.g. supermarket. Some medicines used to treat epilepsy, tuberculosis or breast cancer can reduce the effectiveness of Florinef. On the other hand, Florinef can affect the action of some medicines used to treat diabetes, high blood pressure or to thin the blood.

Q. Is it all right to drive?

A. These tablets do not usually affect your ability to drive but they can effect your eyesight. Tell your doctor immediately if you have any pain in the eyes or visual disturbances.

Q. Is it all right to drink alcohol?

A. There is no known interaction between Florinef and alcohol.

Q. What if I am diabetic?

A. Remind your doctor as your insulin dose may need to be changed.

Q. Who should tell that I taking these tablets?

A. 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 medicines.

Optician - it is advisable to have regular eye tests

TAKING YOUR MEDICINE

Q. How should I take Florinef tablets?

A. Swallow the tablets whole with a glass of water.

Adults including the elderly:

The daily dose ranges from 0.05mg to 0.3mg taken once a day in the morning. Once your condition starts to respond your doctor will gradually reduce the dose to the lowest possible level which will relieve the symptoms. Patients on long-term treatment may require the addition of a different type of steroid tablet during illness or illness or stress.

Children: The dose is adjusted according to size and weight but is always kept as low as possible.

Q. Should I take the medicine before or after meals?

A. It is best to take your tablets with or after food

Q. How long should I continue taking Florinef tablets?

A. Take the course prescribed by your doctor.

DO NOT SUDDENLY STOP taking Florinef tablets as this may make you ill.

Q. What if I take too many tablets or a child swallows some.

A. Go to your nearest hospital Casualty Department or tell your doctor immediately. If you are going to the hospital, take the empty container and any remaining medicine with you.

Q. What if I miss a dose?

A. Do not worry, take it as soon as possible. Never take a double dose to make up for one you missed.

UNDESIRABLE EFFECTS

Q. Are there any unwanted effects of Florinef tablets?

A. All medicines may cause some unwanted or "side effects". Some which can occur with steroid treatment are as follows. Tell your doctor immediately if you get ulcer pains in your stomach or severe pain in your abdomen. Patients have reported increased appetite, weight gain, indigestion, sickness, feeling tired or weak. Steroid treatment may cause increased risk of infection, thinning of bones or tendons causing fractures or torn muscles, water retention, irregular heart beat, high blood pressure or blood clots. Skin or eye problems may occur and wounds or broken bones may be slow to heal. Treatment with steroids can stop the body from producing some hormones and may slow or stop children’s growth rate. If you are female, your periods may become irregular. Elevation or depression of mood, sleeplessness and severe headaches have been reported. When steroid treatment is stopped, patients have noticed flu-like symptoms, runny nose or itchy eyes or skin. Remember you must not stop taking your medicine too suddenly. Tell your doctor or pharmacist if you notice any other troublesome side-effects.

LOOKING AFTER YOUR MEDICINE

Do not use after the expiry date shown on the outer packaging of this medicine. Keep the tablets in a locked cupboard or medicine cabinet OUT OF CHILDREN’S REACH. The tablets should be stored below 25°C.

DATE OF LAST REVISION December 1995

E.R. Squibb & Sons Ltd.,

Hounslow Middlesex England