0.1 mg tablets
fludrocortisone acetate

1. What Florinef is and what it is used for

Florinef is a cortisone preparation with a particularly strong effect on the salt and water balance in the body.

Florinef is used for special conditions in the adrenal glands.

Fludrocortisone acetate contained in Florinef may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Florinef

Do not take Florinef

  • if you are allergic to fludrocortisone acetate or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before taking Florinef.

Several disease states can be affected by treatment with Florinef and sometimes the dosage must be changed depending on the disease, so it is important to inform the treating physician about all diseases, both before and during treatment. This is especially true for infections, gastrointestinal disease, kidney and liver disease, blood clots, high blood pressure, heart failure, diabetes, osteoporosis, Cushing’s syndrome, mental illness, convulsions, various skin rashes, tumor diseases, and myasthenia gravis (muscle weakness). 

The doctor can advise on the amount of salt and protein in the diet as well as give extra potassium tablets.

Consult a physician before vaccination during treatment with Florinef.

Contact a doctor if you experience blurred vision or other visual disturbances.

Other medicines and Florinef

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 

The treatment effect may be affected if Florinef is taken at the same time as certain other medicines. These include medicines for epilepsy (seizures), diabetes and blood clots, antibiotics for tuberculosis and fungi, digitalis (heart medicine), hormonal preparations (eg birth control pills ), tablets for pain and inflammation, diuretics, medicines that affect the immune system, medicines for myasthenia gravis (muscle weakness), agents that contain barbiturate (used for example against seizures and under anesthesia) and vaccines.

Some medicines may increase the effects of Florinef and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, 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 no or negligible influence on the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Florinef contains lactose and sodium benzoate

Florinef contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

This medicine contains 0.01 mg sodium benzoate per tablet. Benzoate may increase the risk of jaundice (yellowish skin and eyes) in newborns (up to 4 weeks of age).

How to take Florinef

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose for adults: Dose one is individual, usually 1-2 tablets daily. It is often given together with another cortisone preparation.

The recommended dose for children and adolescents <18 years: The recommended dose is ½-1 tablet daily. Dose one is adjusted according to age, weight, and disease state.

If you take more Florinef than you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Overdose can cause fluid retention in the body, severe weight gain, decreased amount of potassium in the blood, high blood pressure, heart effects, muscle weakness.

If you forget to take Florinef 

A missed dose is taken as soon as possible unless it is exactly the time for the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Florinef 

The treatment must not be terminated without contact with the doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects have been reported with Florinef (occurring in an unknown number of users):

Decreased amount of potassium in the blood, heart failure, high blood pressure.

Headache, muscle weakness, fluid accumulation in the body.

Loss of appetite, diarrhea, hallucinations, seizures, fainting, taste changes, enlargement of the heart, loss of muscles, effect on the body’s acid/base balance, blurred vision.

When using higher doses than recommended, the following side effects have also been reported:
the decrease in the body’s own production of cortisone, altered sodium balance, altered egg white balance, diabetes ( diabetes ), Cushing’s-like symptoms (eg increased amount of fat on the face and torso, stretch marks and bleeding in the skin, muscle wasting, high blood pressure and sometimes diabetes ), mental disorders, reduced infection defense, infection such as tuberculosis can flare up, impaired wound healing, increased pressure in the eye ( glaucoma ), cataracts ( cataracts )), osteoporosis, thinning of the skin, blood clots, height growth in children can be inhibited, increased pressure in the brain, insomnia, menstrual disorders, disorders of the gastrointestinal tract (eg gastric ulcer ) and infection of the eye.

5. How to store Florinef

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2 ° C – 8 ° C). Close the jar tightly.

Florinef can be stored at room temperature (25 ° C) for a maximum of 30 days for dose dispensing purposes. Unused tablets should not be returned to the refrigerator and destroyed as directed.

Do not use this medicine after the expiry date which is stated on the carton and label after “EXP”. The expiration date is the last day of the specified month.

The medicine 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 packaging and other information

Content declaration

One tablet contains:

The active substance is fludrocortisone acetate 0.1 mg.

The other ingredients (excipient) are anhydrous lactose 58.9 mg, lactose monohydrate 0.7 mg, corn starch, calcium hydrogen phosphate, talc, sodium benzoate (E 211), magnesium stearate.

What the medicine looks like and the contents of the pack

White, round, biconvex tablets with a notch on one side and marked “FT01” on the other. Glass jar containing 100 tablets.

Manufacturer

Swords Laboratories

T / A Lawrence Laboratories

Unit 12, Distribution Center

Shannon Free Zone, Shannon Industrial Estate

County Clare

Ireland

Haupt Pharma Amareg GmbH

Donaustaufer Straβe 378

93055 Regensburg

Germany

Muhammad Nadeem

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