Fludrocortisone Adamed

Leaflet attached to the packaging: patient information

Fludrocortisone Adamed, 0.1 mg, tablets

Fludrocortisone acetate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• - Do not stop taking this medicine without consulting a doctor - it may be necessary to gradually reduce the dose.
• - If you will be taking this medicine for more than 3 weeks, you will receive a blue "steroid card": please always carry it with you and show it to any doctor or nurse who treats you.

Table of contents of the leaflet

• 1. What is Fludrocortisone Adamed and what is it used for
• 2. Important information before taking Fludrocortisone Adamed
• 3. How to take Fludrocortisone Adamed
• 4. Possible side effects
• 5. How to store Fludrocortisone Adamed
• 6. Contents of the pack and other information

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

Fludrocortisone Adamed is a cortisone-based product with a particularly strong effect on the balance of salts and water in the body.
Fludrocortisone Adamed is used in the case of certain adrenal gland disorders and diseases.
Fludrocortisone acetate, present in Fludrocortisone Adamed, may also be used to treat other diseases not listed in this leaflet.
To get the most benefit from taking this medicine, it should be taken regularly.
If you have any further questions, consult a 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 allergicto fludrocortisone or any of the other ingredients of this medicine (listed in section 6).
• If the patient has low blood pressure due to organic heart disease,
• If the patient has low potassium levels in the blood (hypokalemia),
• If the patient has metabolic alkalosis,
• If the patient has diseases in which high blood pressure or water retention pose an increased risk. These include: coronary artery disease, heart failure, aortic aneurysm, liver cirrhosis, kidney failure, water retention in the lungs, pheochromocytoma.

Warnings and precautions

Before starting treatment with Fludrocortisone Adamed, discuss it with your doctor or pharmacist.
Treatment with Fludrocortisone Adamed may cause several diseases, and in some cases, the dose may need to be adjusted depending on the disease. Therefore, it is essential to inform your doctor about all your ailments, both before and during treatment, especially if:

• the patient has or has recently had any bacterial, viral, or fungal infectionthat is not being treated
• there have been any gastrointestinal disordersor stomach ulcers
• there have been psychiatric disordersor epilepsy (seizures)
• the patient has been diagnosed with Cushing's syndrome
• the patient has had any kidney, liver, or thyroid disease
• the patient has blood clotting problems
• the patient has recently had any form of cancer
• the patient has thin or fragile bones(osteoporosis)
• the patient has myasthenia(a disease that causes muscle weakness) or any other muscle weakness
• the patient has high blood pressureor heart failure
• the patient has diabetes- in which case it may be necessary to change the insulin dose or the occurrence of diabetes in the family.
• the patient has a skin rash, usually caused by a viral infection (e.g., measles)
• you should contact your doctor if you experience blurred vision or other vision disturbances.

Your doctor may give you advice on salt and protein content in your diet and may prescribe potassium supplements in tablets.
If you are vaccinated during treatment with Fludrocortisone Adamed, consult your doctor.
If you are not sure if any of the above points apply to you, talk to your doctor or pharmacist before taking this medicine.

Children and adolescents

Fludrocortisone Adamed is also a medicine used in children with primary adrenal insufficiency and confirmed aldosterone deficiency.
Caution should be exercised in case of exposure to chickenpox, measles, or other infectious diseases.
In some children and adolescents taking Fludrocortisone Adamed, growth may occur more slowly than normal. The doctor will monitor growth during regular visits.

Fludrocortisone Adamed and other medicines

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

• Aspirin, ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), as corticosteroids may increase the risk of gastrointestinal bleeding;
• Any antifungal drugs (e.g., ketoconazole, amphotericin);
• Warfarin or other blood-thinning medicines;
• Oral contraceptives or if you are undergoing hormone replacement therapy (HRT);
• Medicines that affect the immune system (cyclosporine);
• Barbiturates. These medicines are used as sedatives (causing a calming effect), sleep aids (inducing sleep), or to support anesthesia;
• Muscle relaxants, e.g., atracurium. These medicines are used during anesthesia for surgery; you should inform the anesthesiologist about taking fludrocortisone acetate;
• Some medicines may enhance the effect of Fludrocortisone Adamed, which should prompt your doctor to monitor your condition more closely when taking these medicines (including some HIV medicines: ritonavir, cobicistat);
• Human growth hormones;
• Diuretics;
• Medicines used in case of irregular heartbeat (e.g., digoxin);
• Medicines used in case of epilepsy or other types of seizures (e.g., phenytoin, primidone, carbamazepine);
• Medicines used to treat tuberculosis (TB) (e.g., isoniazid, rifampicin, rifabutin);
• Medicines used to treat diabetes;
• Medicines used to treat thyroid diseases;
• Vaccines;
• Medicines used in case of Myasthenia Gravis (e.g., neostigmine);
• Mifamurtide.

During treatment with this medicine (or in case of recent discontinuation of therapy) do not get vaccinated
withoutconsulting your doctor.
In case of doubts about the type of medicines being taken, consult a doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.

Driving and using machines

It has not been shown that Fludrocortisone Adamed impairs the ability to drive and use machines.
The patient is responsible for assessing their ability to drive a vehicle or perform work that requires concentration. One of the factors that may affect this ability is the use of medicines due to their effect and (or) the occurrence of side effects. A description of these effects and side effects can be found in the following points.
Therefore, please read all the information contained in this leaflet. In case of doubts, consult a doctor or pharmacist.
Fludrocortisone Adamed contains sodium. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

Steroid Treatment Card

Your doctor or pharmacist will give you a Steroid Treatment Cardwith the prescription or medicine.
ALWAYS CARRY THIS CARD WITH YOU, as you need to show it to the following persons:
Doctor or nurse- before any surgical procedure or emergency procedure or when prescribing new treatment.
Dentist- before any dental procedure
Pharmacist- before buying any medicine
Optician- regular eye exams are recommended

3. How to take Fludrocortisone Adamed

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, consult a doctor or pharmacist.
This medicine is intended for oral use.

Administration to adults and the elderly

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 a day. Patients who have been treated for a long time may require the use of another type of steroid tablets during illness or stress.
In the treatment of adrenal hyperplasia, the typical daily dose range is: from 0.1 mg (one tablet) to 0.2 mg (2 tablets).

Administration to children and adolescents

The dose is adjusted according to the size and body weight, but it should always be as small as possible. The recommended dose is half a tablet (0.05 mg) to one tablet (0.1 mg) per day.
Make sure to take the full dose as recommended by your doctor. Do not suddenly stop taking Fludrocortisone Adamed, as this may cause the disease to recur.

Taking a higher dose of Fludrocortisone Adamed than recommended

In case of taking too much of the medicine, immediatelyconsult a doctor or the nearest hospital. Take the container and any remaining medicines with you.

Missing a dose of Fludrocortisone Adamed

In case of missing a dose, take it as soon as you remember, unless it is almost time for the next dose. Then continue with the scheduled dosing. Do not take a double dose to make up for the missed dose.

Stopping treatment with Fludrocortisone Adamed

Do not stop taking the medicine unless your doctor advises you to do so. Symptoms may return if treatment is stopped too early.
In case of further doubts about taking this medicine, consult a 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 are presented in order of their severity. The most severe side effects are listed first.

Stop taking Fludrocortisone Adamed immediately and contact your doctor

contact your doctorif you experience any of the following symptoms, as they may be signs of an allergic reaction (hypersensitivity, including anaphylaxis):

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

Tell your doctor immediately about the following symptoms:

Steroids, including Fludrocortisone Adamed, can cause serious mental problems. These occur with a similar frequency in both adults and children. Such symptoms include:

• Feeling depressed, including suicidal thoughts.
• Manic or mood swings (switching from mania to depression).
• Feeling anxious, sleep problems, difficulty concentrating, or disorientation and memory loss.
• Feeling, seeing, or hearing things that do not exist. Disturbing or paralyzing thoughts, changes in behavior, and feelings of loneliness.

If you notice any of these symptoms, contact your doctor immediately.

Tell your doctor if you experience any of the following symptoms:

• Increased susceptibility to infections (reduced resistance to infections), which may lead to tuberculosis
• Weakness, pain, or atrophy of muscles, tendon rupture or tear (at the attachment to the bone)

• Bone problems, including thinning of bone structure, atrophy, or fractures
• Stomach or intestinal ulcers (which can lead to perforation or bleeding), stomach or esophageal pain or burning, indigestion
• Skin problems, including thinning of the skin and eyes, bruising, redness of the face, stretch marks, excessive hair growth on the face, acne
• Impaired wound healing
• Heart failure (shortness of breath during activity or after a longer period of rest)
• Enlargement of the heart
• Irregular heartbeat
• High blood pressure
• Blood clots
• Hallucinations
• Seizures or convulsions (fits)
• Fainting
• Diarrhea
• Lack of appetite
• Changes in taste
• Dizziness (feeling of spinning)
• Sleep disturbances
• Headaches
• Increased pressure in the brain
• Increased white blood cell count or other blood disorders
• Irregular or absent menstrual periods
• Suppressed growth in children
• Water and sodium (salt) retention (edema)
• Increased pressure in the eye (glaucoma)
• Clouding of the lens (cataract)
• Corneal infections
• Problems with maintaining normal blood sugar levels, including increased blood sugar levels (diabetes)
• Disruption of sodium, potassium, or chloride balance (decreased potassium levels in the blood)
• Effect on the body's acid-base balance
• Weakening of pituitary function (change in the activity of certain hormones, mineral balance, or protein in blood tests)
• Hormonal imbalance causing Cushing's syndrome (typical symptoms: round face often called "moon face", stretch marks, and skin bruising, muscle wasting, high blood pressure, and sometimes diabetes)
• Psychiatric disorders
• Visual disturbances

Reporting side effects

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

5. How to store Fludrocortisone Adamed

Keep the 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 month.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Fludrocortisone Adamed contains

The active substance (which produces 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, silicon dioxide, magnesium stearate.

What Fludrocortisone Adamed looks like and what the pack contains

Fludrocortisone Adamed is a white or almost white, elongated tablet with a length of about 9 mm and a width of about 4 mm, with a dividing line on one side.
The tablet can be divided into equal doses.
Fludrocortisone Adamed is available in boxes of 30, 50, 60, 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer:

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

Date of last revision of the leaflet: