Fludrocortisone acetate novumgen

Package leaflet: Information for the patient

Fludrocortisone Acetate Novumgen, 0.1 mg, tablets
Fludrocortisone Acetate
Read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• Do not stop taking this medicine without consulting your doctor – gradual dose reduction may be necessary.
• If you are to take this medicine for longer than 3 weeks, you will receive a blue “steroid card”. Always carry this card and show it to any doctor or nurse involved in your care.

Table of contents

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

1. What Fludrocortisone Acetate Novumgen is and what it is used for

Fludrocortisone Acetate Novumgen is a cortisone-based medicine with a particularly strong effect on the body's salt and water balance.
Fludrocortisone Acetate Novumgen is used in certain conditions and diseases of the adrenal glands. The fludrocortisone acetate contained in Fludrocortisone Acetate Novumgen may also be used to treat other diseases not mentioned in this leaflet.
To obtain maximum benefit from this medicine, it must be taken regularly.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or other healthcare professional and always follow their instructions.

2. Important information before taking Fludrokortyzonu octan Novumgen

When not to take Fludrokortyzonu octan Novumgen:

• 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 (hypokalemia),
• 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 or cerebral arteriosclerosis, heart failure, aortic aneurysm, liver cirrhosis, kidney failure, pulmonary edema, or pheochromocytoma.

Warnings and precautions
Before starting treatment with Fludrokortyzonu octan Novumgen, discuss this with your doctor or pharmacist.
Treatment with Fludrokortyzonu octan Novumgen may cause several disorders, and in some cases, the dose should be adjusted depending on the disease. Therefore, it is important to inform your doctor about all your medical conditions, both before and during treatment, especially if:

• the patient has or recently had any bacterial, viral, or fungal infections that are untreated,
• there have been any intestinal disorders or peptic ulcer disease,
• there has been a history of psychiatric disorders or epilepsy (seizures),
• the patient has been diagnosed with Cushing's syndrome,
• the patient has had any diseases of the kidneys, liver, or thyroid gland,
• the patient has experienced blood clots,
• the patient has recently been treated for any form of cancer,
• the patient has thin or fragile 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, in which case insulin dosage may need to be adjusted, or if diabetes runs in the family,
• the patient has skin rash, usually caused by viral infection (e.g., measles),
• the patient should contact a doctor if blurred vision or other visual disturbances occur.

The doctor may give advice regarding salt and protein content in the diet and may prescribe potassium supplements in tablet form.
If vaccination is planned during treatment with Fludrokortyzonu octan Novumgen, consult your doctor.
If the patient is unsure whether any of the above points apply, they should speak with their doctor or pharmacist before using this medicine.

Children and adolescents
Fludrokortyzonu octan Novumgen is also used in children with primary adrenal insufficiency and confirmed aldosterone deficiency.
Caution should be exercised regarding exposure to chickenpox, measles, or other infectious diseases.
In some children and adolescents receiving Fludrokortyzonu octan Novumgen, growth may be slower than normal. The doctor will monitor growth during regular visits.
Psychiatric disturbances may occur during corticosteroid therapy. These may include insomnia, depression (sometimes severe), euphoria, mood swings, psychotic symptoms, or personality changes. Corticosteroids may worsen pre-existing emotional instability or psychosis. Antidepressants do not help with steroid-induced depression and may worsen its symptoms.
During corticosteroid treatment, immunity and the ability to localize infections may be impaired. Infections may be masked and reactivated. In case of infection, causal treatment should be initiated.
Viral infections such as chickenpox and shingles may develop into severe or life-threatening conditions in non-immune individuals. In Strongyloides infestation (roundworm), corticosteroid treatment may lead to dissemination of intestinal inflammation and subsequently to Gram-negative sepsis.
In active tuberculosis, restrictive treatment is recommended.

Use in athletes
The use of fludrocortisone may be prohibited for participants in sports competitions. Athletes receiving fludrocortisone as replacement therapy should be informed that the product contains an active substance that may result in a positive outcome in anti-doping tests.

Fludrokortyzonu octan Novumgen with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription. This is particularly important if the patient is taking:

• acetylsalicylic acid (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 medicines;
• oral contraceptives or if the patient is receiving hormone replacement therapy (HRT);
• immunosuppressive medicines (cyclosporine);
• barbiturates (these medicines are used as sedatives to induce calming effects, as hypnotics to induce sleep, or as an adjunct to anesthesia);
• muscle relaxants, e.g., atracurium (these medicines are used during anesthesia for surgery. Inform the anesthesiologist about fludrocortisone acetate use);
• some medicines may enhance the effect of Fludrokortyzonu octan Novumgen, and the doctor may wish to closely monitor the patient taking these medicines (including some HIV medications: ritonavir, cobicistat);
• human growth hormones;
• diuretics;
• medicines used for irregular heartbeat (e.g., digoxin);
• medicines used in the treatment of epilepsy or other types of seizures (e.g., phenytoin, primidone, carbamazepine);
• medicines used in the treatment of tuberculosis (e.g., isoniazid, rifampicin, rifabutin);
• medicines used in the treatment of diabetes;
• medicines used in the treatment of thyroid disorders;
• vaccines;
• medicines used in the treatment of myasthenia (e.g., neostigmine);
• mifamurtide.

Do not get vaccinated during treatment with this medicine (or shortly after stopping therapy) without consulting your doctor.
If in doubt about the type of medicines being taken, consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

Driving and operating machinery
It has not been shown that Fludrokortyzonu octan Novumgen affects the ability to drive or operate machinery.
The patient is responsible for self-assessing whether they are able to drive or perform work requiring concentration. One of the factors that may affect these abilities is the use of medicines due to their effects and/or occurrence of adverse reactions. Descriptions of these effects and adverse reactions can be found in the following sections of this leaflet. Therefore, it is important to read all information contained in this leaflet. In case of doubt, consult your doctor or pharmacist.

Fludrokortyzonu octan Novumgen contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

Fludrokortyzonu octan Novumgen contains benzoate salt
The medicine contains 0.5 mg of benzoic acid salt per tablet. Increased bilirubinemia resulting from displacement from albumin may increase the risk of jaundice in newborns, which may progress to kernicterus (deposition of unconjugated bilirubin in brain tissue).

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

3. How to take Fludrokortyzonu octan Novumgen

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Oral administration.
The tablets have a score line. The tablet can be divided into equal doses.

Use in adults and elderly patients
In the treatment of Addison's disease, the usual 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 periods of illness or stress.
In the treatment of congenital adrenal hyperplasia, the usual 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 as low as possible.
The recommended dose is half a tablet (0.05 mg) to one tablet (0.1 mg) daily.
Newborns (during the first year of life): 0.05 mg to 0.2 mg, and exceptionally 0.2 mg to 0.3 mg.
Ensure that the full prescribed dose is taken as directed by the doctor. Do not suddenly stop taking
Fludrokortyzonu octan Novumgen, as this may cause illness.

Taking more Fludrokortyzonu octan Novumgen than prescribed
If you take more medicine than prescribed, contact your doctor or go to the nearest hospital
immediately. Bring the container and any remaining medicine with you.

Missing a dose of Fludrokortyzonu octan Novumgen
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 Fludrokortyzonu octan Novumgen
Do not stop taking this medicine unless advised by your doctor. Symptoms may return if treatment
is stopped too early.

If you have 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, with the most serious listed first.
You should stop taking Fludrokortyzonu octan Novumgen tablets 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 should immediately inform your doctor if you experience any of the following symptoms:
Steroids, including fludrokortyzonu octan, 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 Fludrokortyzonu octan Novumgen.
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.
• Sensations, seeing, or hearing things that are not real. Having strange and frightening thoughts, changes in behavior, and feelings of isolation.

If a patient notices any of these symptoms, seek immediate medical advice.
Tell your doctor if any of the following symptoms occur (frequency unknown):

• Metabolic and nutritional disorders: hypokalemic alkalosis, loss of appetite
• Nervous system disorders: headache, hallucinations, convulsions, fainting, taste disturbances
• Eye disorders: blurred vision
• Cardiac disorders: heart failure, cardiac hypertrophy
• Vascular disorders: hypertension
• Gastrointestinal disorders: diarrhea
• Musculoskeletal and connective tissue disorders: muscle weakness, muscle atrophy
• General disorders and administration site conditions: swelling
• Investigations: hypokalemia.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fludrokortyzonu octan Novumgen

Store below 30°C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the label after "EXP". The expiry date refers to the last day of the specified month.
Keep the medicine out of sight and reach of children.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Fludrokortyzonu octan Novumgen contains
The active substance is fludrocortisone acetate. One tablet contains 0.1 mg of fludrocortisone acetate.
The other ingredients are: anhydrous lactose, monohydrate lactose, calcium hydrogen phosphate dihydrate, sodium benzoate (E 211), corn starch, talc (E 553b) and magnesium stearate (E 572).

What Fludrokortyzonu octan Novumgen looks like and contents of the pack
Fludrokortyzonu octan Novumgen is a white or almost white, round, biconvex, uncoated tablet, with a score line on one side and smooth on the other, with a diameter of approximately 6.2 mm.
The tablets are supplied in packs of 20, 30 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Novumgen Limited
Office 2, 12a Lower Main Street
K78 X5P8 Lucan, Dublin, Ireland
+44 0203 096 2886

Manufacturer
Santa S.A
Str. Panselelor, nr. 25, nr. 27 si nr. 29
500419 Municipiul Brasov
Romania

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Fludrokortyzonu octan Novumgen
Germany: Fludrocortisonacetat 0,1 mg Tabletten
Spain: Fludrocortisona 0,1 mg comprimidos EFG