The wording of leaflets is regularly updated. This electronic text is the most up-to-date version and may differ from the leaflet in your pack. If you have any questions about the information provided, please ask your doctor or pharmacist.
FLORINEF 0.1MG TABLETS
Fludrocortisone acetate
- Florinef 0.1mg tablet 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 0.1mg tablet 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.
Your 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
NOTE: The colour of Florinef tablets has changed from pink to white and there are minor changes in the formulation. There is no change to the effectiveness of the Florinef tablets previously prescribed to you.
Q. What Is In Florinef Tablets?
A. Florinef 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. Boosting your body with extra corticosteroid (such as Florinef tablets) is an effective way to treat various illnesses involving inflammation in the body. Florinef tablets reduce this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it. The tablets contain 0.1mg fludrocortisone acetate. They are supplied in bottles of 100 tablets. The other ingredients are dibasic calcium phosphate, lactose anhydrous and monohydrate, magnesium stearate, maize starch, sodium benzoate (E211), talc.
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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 hormone 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.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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).
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 tablets.
- If any of your close family has had these illnesses.
- If either of these applies to you, talk to a doctor before taking Florinef tablets.
Q. What if I have been or am in contact with someone who has Chickenpox, Shingles or Measles?
A. 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 promptly, especially if you have not had the disease before. You should take particular care to avoid these diseases.
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. Corticosteroids can increase the chance of bleeding from the gut caused by aspirin, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs). If you have hypothrombinaemia (a tendency to bleed), your doctor will be more careful about giving you Florinef Tablets if you are taking ibuprofen or another NSAID.
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.
Always tell your doctor if you are taking oral contraceptives, hormone replacement therapy (HRT), growth hormone, thyroid drugs, cyclosporin, or medicines for treating fungal infections, or if you are to be vaccinated or to be given an anaesthetic.
Q. Is it all right to drive ?
A. These tablets do not usually affect your ability to drive but they can affect 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 I tell that I am 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 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 times of 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.
Mental problems while taking Florinef tablets
Mental health problems can happen while taking steroids like Florinef tablets (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.
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, facial swelling or an unexpected rash 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.
Serious effects: tell a doctor straight away
Steroids including Florinef tablets 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 tablets.
- Feeling depressed, including thinking about suicide.
- Feeling high (mania) or 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.
Looking After Your Medicine
Do not use after the expiry date shown on the bottle label of this medicine. All medicines should be kept OUT OF THE REACH AND SIGHT OF CHILDREN. Store in refrigerator (2–8°C). Keep the conatiner tightly closed in order to protect from moisture.
DATE OF LAST REVISION April 2008
YF002/1
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