Package leaflet: Information for the patient

Fludrocortisone Adamed, 0.1 mg, tablets
Fludrocortisoni acetas
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Do not stop taking this medicine without consulting your doctor – it may be necessary to gradually reduce the dose.
If you are taking this medicine for longer than 3 weeks, you will receive a blue "steroid card". You must always carry this card and show it to any doctor or nurse treating you.

Contents of the leaflet

What Fludrocortisone Adamed is and what it is used for
Important information before taking Fludrocortisone Adamed
How to take Fludrocortisone Adamed
Possible side effects
How to store Fludrocortisone Adamed
Contents of the pack and other information

1. What Fludrocortisone Adamed is and what it is used for

Fludrocortisone Adamed is a cortisone-based product with a particularly strong effect on the body's salt and water balance.
Fludrocortisone Adamed is used in certain conditions and diseases of the adrenal glands.
Fludrocortisone acetate, present in Fludrocortisone Adamed, may also be used to treat other diseases not mentioned in this leaflet.
To obtain maximum benefit from this medicine, it should be taken regularly.
For any further questions, please consult your doctor, pharmacist, or other healthcare professional and always follow their instructions.

2. Important information before taking Fludrocortisone Adamed

When not to take Fludrocortisone Adamed:

If the patient is allergic to fludrocortisone or any of the other ingredients of this medicine (listed in section 6).
If the patient has low blood pressure caused by organic heart disease,
If the patient has low potassium levels in the blood (hypokalaemia),
If the patient has metabolic alkalosis,
If the patient has diseases in which high blood pressure or fluid retention pose an increased risk. These include: coronary artery disease, heart failure, aortic aneurysm, liver cirrhosis, kidney failure, pulmonary oedema, or phaeochromocytoma.

Warnings and precautions
Before starting treatment with Fludrocortisone Adamed, discuss this with your doctor or
pharmacist.
In rare cases, allergy to cortisone may occur. People who already have allergies to other
medicines may be more likely to develop an allergic reaction to Fludrocortisone Adamed. You should
contact your doctor immediately if any reactions occur after taking Fludrocortisone Adamed,
such as swelling, shortness of breath, or severe skin rash (see section 4).
Treatment with Fludrocortisone Adamed may cause several disorders, and in some
cases the dose may need to be adjusted depending on the disease. It is therefore important to
inform your doctor about all your health conditions, both before and during treatment, especially if:

the patient currently has or recently had any untreated bacterial, viral or fungal infections
the patient has ever had any intestinal disorders or peptic ulcer
the patient has had psychiatric disorders or epilepsy (seizures) in the past
the patient has been diagnosed with Cushing's syndrome
the patient has had any kidney, liver or thyroid diseases
the patient has problems with blood clots
the patient has recently had any form of cancer
the patient has thin or brittle bones (osteoporosis)
the patient has myasthenia (a disease causing muscle weakness) or any other muscle weakness
the patient has high blood pressure or heart failure
the patient has diabetes – insulin dosage may need to be changed, or if there is a family history of diabetes
the patient has a skin rash, usually caused by a viral infection (e.g. measles)
contact your doctor if blurred vision or other visual disturbances occur.

Your doctor may give advice regarding salt and protein intake in your diet and may also prescribe
potassium supplements in tablet form.
If vaccination is planned during treatment with Fludrocortisone Adamed, consult your doctor.
If the patient is unsure whether any of the above points apply to them, they should
speak with their doctor or pharmacist before taking this medicine.
Long-term treatment with high doses of cortisone-containing products (corticosteroids) may
lead to impaired adrenal cortex function and consequently reduced cortisol production by the body. To prevent acute adrenal insufficiency during stress (such as severe trauma, surgery, or serious illness), the dose of
corticosteroids may need to be increased. For up to one year after stopping treatment, corticosteroid supplementation may still be necessary during periods of stress, as the body's cortisol production may not yet be fully restored.

Children and adolescents
Fludrocortisone Adamed is also used in children with primary adrenal insufficiency and confirmed aldosterone deficiency.
Caution is advised in cases of exposure to chickenpox, measles or other infectious diseases.
In some children and adolescents taking Fludrocortisone Adamed, growth may be slower than normal. The doctor will monitor growth during regular check-ups.

Fludrocortisone Adamed and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription. This is particularly important if you are taking or being treated with:

Aspirin, ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), because corticosteroids may increase the risk of gastrointestinal bleeding;
Any antifungal medicines (e.g. ketoconazole, amphotericin);
Warfarin or other anticoagulant (blood-thinning) medicines;
Oral contraceptive pills or if you are receiving hormone replacement therapy (HRT);
Medicines affecting the immune system (e.g. cyclosporine);
Barbiturates. These medicines are used as sedatives (calming agents), hypnotics (to induce sleep), or to support anaesthesia;
Muscle relaxants, e.g. atracurium. These are used during anaesthesia for surgery; inform the anaesthetist that you are taking fludrocortisone acetate;
Some medicines may enhance the effect of Fludrocortisone Adamed, so your doctor may wish to monitor you more closely if you are taking these (including some HIV medicines: ritonavir, cobicistat);
Human growth hormones;
Diuretics (water tablets);
Medicines used for irregular heartbeat (e.g. digoxin);
Medicines used for epilepsy or other types of seizures (e.g. phenytoin, primidone, carbamazepine);
Medicines used to treat tuberculosis (TB) (e.g. isoniazid, rifampicin, rifabutin);
Medicines used for diabetes;
Medicines used for thyroid disorders;
Vaccinations;
Medicines used in the treatment of Myasthenia Gravis (e.g. neostigmine);
Mifamurtide.

During treatment with this medicine (or shortly after stopping therapy), do not get vaccinated
without consulting your doctor.
If you have any doubts about the medicines you are taking, consult your doctor or pharmacist.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, you should consult your doctor before taking this medicine.

Driving and using machines
Fludrocortisone Adamed has not been shown to affect the ability to drive or operate machinery.
However, each patient is personally responsible for assessing whether they are able to drive a vehicle or perform work requiring concentration. One of the factors that may affect such abilities is the use of medicines due to their effects and/or occurrence of side effects. Descriptions of these effects and side effects can be found in the following sections. Therefore, please read all information in this leaflet carefully. If in doubt, consult your doctor or pharmacist.

Fludrocortisone Adamed contains sodium. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

Steroid Treatment Card
Your doctor or pharmacist will provide you with a Steroid Treatment Card along with the prescription or medicine.
ALWAYS CARRY THIS CARD WITH YOU, as you must show it to the following individuals:
Doctor or nurse – before any surgical procedure or emergency treatment, or when being prescribed new medication.
Dentist – before any dental procedure
Pharmacist – before purchasing any medicine
Ophthalmologist – regular eye examinations are recommended

3. How to take Fludrocortisone Adamed

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
This medicine is intended for oral use.
Use in adults and elderly patients
In the treatment of Addison's disease, the typical daily dose range is: 0.05 mg (half a tablet) to
0.2 mg (2 tablets) once daily. Patients on long-term therapy may require additional
steroid tablets during illness or periods of stress.
In the treatment of congenital adrenal hyperplasia, the typical daily dose range is: 0.1 mg (one tablet)
to 0.2 mg (2 tablets).
Use in children and adolescents
The dose should be adjusted according to body size and weight, but should always be the lowest possible effective dose.
The recommended dose is half a tablet (0.05 mg) to one tablet (0.1 mg) daily.
Ensure that the full prescribed dose is taken as directed by the doctor. Do not stop taking Fludrocortisone Adamed suddenly, as this may cause illness.
Taking more Fludrocortisone Adamed than prescribed
If too much medicine has been taken, contact a doctor or go to the nearest hospital immediately.
Bring the container and any remaining medicine with you.
Overdose may cause fluid retention, significant weight gain, low blood potassium levels, high blood pressure, heart disturbances, and muscle weakness.
Missed dose of Fludrocortisone Adamed
If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose. Then continue with the regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Fludrocortisone Adamed
Do not stop taking this medicine unless instructed by your doctor. Symptoms may return if treatment is stopped too early.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions are listed in order of severity. The most serious adverse reactions
are listed first.
You must stop taking Fludrocortisone Adamed immediately and contact your doctor
immediately if you experience any of the following symptoms, as they may be signs of
an allergic reaction (hypersensitivity reaction, including anaphylaxis):

Difficulty breathing
Swelling of the face, lips or tongue
Severe stomach or abdominal pain
Skin rash

You must inform your doctor immediately about the following serious adverse reactions:
Steroids, including Fludrocortisone Adamed, can cause serious psychiatric disturbances.
These occur with similar frequency in both adults and children. Such symptoms occur in approximately
5 out of 100 people taking medicines like Fludrocortisone Adamed. These include:

Feelings of depression, including suicidal thoughts.
Manic feelings or mood swings (shifting from mania to depression).
Feelings of anxiety, sleep disturbances, difficulty thinking, disorientation and memory loss.
Sensing, seeing or hearing things that do not exist. Disturbing or paralyzing thoughts, changes in behavior, and feelings of loneliness.

If the patient notices any of these symptoms, contact your doctor immediately.
Inform your doctor if any of the following symptoms occur:

Increased susceptibility to infections (reduced resistance to infections), including tuberculosis
Weakness, pain or wasting of muscles, tendon rupture (at sites of attachment to bone)
Bone disorders, including thinning of bone structure, atrophy or bone fractures
Stomach or intestinal ulcers (which may lead to perforation or bleeding), stomach or esophageal pain or burning, indigestion
Skin disorders, including thinning of the skin and eyes, bruising, facial redness, stretch marks, excessive facial hair growth, acne
Poor wound healing
Heart failure (shortness of breath during activity or after prolonged inactivity)
Enlargement of the heart
Irregular heartbeat
High blood pressure
Blood clots
Hallucinations
Seizures or convulsions (fits)
Fainting
Diarrhea
Loss of appetite
Taste disturbances
Dizziness (spinning sensation)
Sleep disturbances
Headaches
Increased intracranial pressure
Increased white blood cell count or other blood disorders
Irregular or absent menstrual periods
Growth suppression in children
Fluid and sodium (salt) retention (edema)
Increased intraocular pressure (glaucoma)
Lens opacity (cataract)
Corneal infections
Impaired glucose regulation, including diabetes, high blood sugar
Imbalance of sodium, potassium or chloride levels in the body (low potassium levels in blood)
Effect on the body's acid-base balance
Reduced pituitary function (altered activity of certain hormones, mineral balance or protein levels in blood tests)
Hormonal imbalance leading to Cushing's syndrome (typical symptoms: round face often called "moon face", stretch marks and skin bleeding, muscle wasting, high blood pressure and sometimes diabetes)
Psychiatric disorders
Visual disturbances

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices
and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Fludrocortisone Adamed

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Fludrocortisone Adamed contains
The active substance (responsible for the therapeutic effect) is fludrocortisone acetate. Each tablet contains 100 micrograms of the active substance.
The tablets also contain microcrystalline cellulose type 102, mannitol type 100, hypromellose 6cP, sodium croscarmellose, colloidal anhydrous silica, and magnesium stearate.

What Fludrocortisone Adamed looks like and contents of the pack
Fludrocortisone Adamed is white or almost white, oblong tablets approximately 9 mm in length and 4 mm in width, with a division line on one side.
The tablet can be divided into equal doses.
Fludrocortisone Adamed is available in packs of 30, 50, 60, and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00

Manufacturer:
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice