Package leaflet: Information for the patient

Cortineff, 100 μg, tablets
Fludrocortisone acetate
Please read the entire leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, 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.

Table of contents:

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

1. What Cortineff is and what it is used for

Cortineff belongs to a group of medicines called steroids (more precisely, mineralocorticosteroids).
These are hormones naturally produced in the body by the adrenal cortex.
They have a strong effect on the metabolism of salts and minerals in the body.
They also regulate the distribution of water (fluids) in the body.
Cortineff contains a synthetic (artificial) adrenal cortex hormone.
Cortineff is indicated for the treatment of:

Primary adrenal insufficiency (known as Addison's disease),
Secondary adrenal insufficiency,
Congenital adrenal hyperplasia with salt-wasting form.

2. Important information before using Cortineff

When not to use Cortineff

if the patient is allergic to fludrocortisone or any of the other ingredients of this medicine (listed in section 6),
if there are systemic infections affecting multiple tissues and/or organs and appropriate treatment has not been initiated.

Warnings and precautions
Before starting treatment with Cortineff, discuss this with your doctor or pharmacist.
While using Cortineff, some patients may experience:

atrophy of the adrenal cortex, which may persist for many years after discontinuation of treatment,
increased blood pressure, weight gain, and edema due to sodium and fluid retention,
worsening of symptoms in certain diseases such as pneumonia, hepatitis, and disseminated intravascular coagulation (a blood clotting disorder),
more severe course of certain infectious diseases such as chickenpox, shingles, and measles. In case of infection, the doctor will recommend appropriate management. Patients who have never had these diseases should avoid exposure to infection,
reduced resistance to infection. The medicine may mask (hide) signs of infection,
irregular menstrual bleeding in women.

Before using Cortineff, the patient should inform the doctor if they have:

peptic ulcer of the stomach or duodenum,
intestinal disorders (e.g., recent intestinal anastomoses, diverticulosis),
thrombophlebitis,
diseases characterized by skin rash (red, itchy bumps or spots on the skin),
chronic kidney inflammation or kidney failure,
osteoporosis (especially in postmenopausal women),
excessive muscle weakness and fatigue (muscle asthenia),
fungal or viral infections,
glaucoma (or if someone in the family has glaucoma),
elevated cholesterol and triglyceride levels,
decreased blood protein levels,
high blood pressure,
congestive heart failure,
epilepsy,
impaired liver function, liver cirrhosis,
acute psychosis or psychiatric disorders. The medicine may worsen symptoms of these conditions,
tuberculosis,
hypothyroidism,
diabetes,
deficiency of blood clotting factor (prothrombin), especially if the patient is also taking aspirin.

During treatment with Cortineff, the doctor will recommend regular blood tests (to monitor salt retention and serum electrolyte levels).
Inform your doctor about all medicines currently used or recently taken, including those available without a prescription.
Some medicines may enhance the effect of Cortineff, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).
If the patient experiences blurred vision or other visual disturbances, contact the doctor immediately.
During treatment with this medicine, it is essential to strictly follow the doctor's instructions.

Children and adolescents
Regular medical check-ups are recommended. Cortineff may impair growth and development in infants and children (especially with long-term use).

Cortineff and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient intends to take.
The patient should inform the doctor if they are taking any of the following medicines:

barbiturates (medicines used to treat insomnia and epilepsy),
phenytoin, carbamazepine, primidone (medicines used to treat epilepsy),
rifampicin, rifabutin (medicines used to treat tuberculosis),
aminoglutethimide (a medicine used in the treatment of breast cancer),
insulin and oral antidiabetic medicines,
diuretics,
coumarin derivatives, indandione, heparin (medicines preventing blood clotting),
streptokinase, urokinase (medicines dissolving blood clots),
painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen,
aspirin, polopirin (acetylsalicylic acid) – a painkiller and anti-inflammatory medicine,
antihistamines (used to treat allergies, migraine headaches, nausea),
anabolic steroids, androgens (medicines used to treat hormonal disorders),
contraceptive medicines containing estrogens,
vaccines containing live viruses (Cortineff reduces their effectiveness),
other glucocorticosteroids.

Cortineff with food and drink
Cortineff should be taken between meals.
This medicine increases sodium retention in the body, which may lead to edema and increased blood pressure. Therefore, salt intake in the diet should be limited.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
Cortineff must not be used in pregnant women.
Small amounts of the medicine pass into breast milk. It should be considered whether to discontinue the medicine during breastfeeding or to refrain from breastfeeding due to the necessity of treatment.

Driving and operating machinery
There is no data available on the effect of fludrocortisone on the ability to drive or operate machinery.

Cortineff contains lactose
One tablet contains 57.90 mg of monohydrate lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Cortineff

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
The dosage of Cortineff and duration of treatment are determined by the doctor.
Recommended dose:
1 to 3 tablets (from 100 micrograms to 300 micrograms) daily
or
2 to 3 tablets (from 200 micrograms to 300 micrograms) every second or third day.
Do not divide the tablets.
The medicine should be taken orally.
Taking a higher than recommended dose of Cortineff
If you take more than the recommended dose of the medicine, stop using it immediately and contact
your doctor without delay.
Missing a dose of Cortineff
If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Cortineff
The decision to discontinue treatment with Cortineff should be made by the doctor.
Stopping treatment after prolonged use of the medicine may lead to acute adrenal insufficiency,
hypotension, and death.
The following symptoms of glucocorticoid withdrawal syndrome may occur:
fever, muscle and joint pain, malaise, catarrh, conjunctivitis, itchy nodules, and weight loss.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact a doctor immediately if any of the following symptoms occur:

allergic reaction (rash, facial swelling, difficulty breathing), especially in patients who have previously experienced allergic reactions to medicines,
vomiting with blood, black stool or stool containing fresh blood,
high fever, weakness, feeling unwell (signs of infection),
psychiatric disturbances (abnormally excessive elation, deep sadness, personality changes, worsening of psychotic symptoms).

Other adverse reactions:

Frequency unknown:
swelling of feet and legs,
congestive heart failure,
increased blood pressure,
disturbances in heart function (sensation of rapid or slow heartbeat),
increased excretion of calcium,
blurred vision.

The risk of the adverse reactions listed below primarily concerns patients
receiving Cortineff for a prolonged period or concurrently with other corticosteroids.
Frequency unknown:

muscle weakness, osteopor游戏副本

5. How to store Cortineff

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the label and carton after "Expiry date".
The expiry date refers to the last day of the stated month.
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 package and other information

What Cortineff contains
The active substance is fludrocortisone acetate.
Each tablet contains 100 micrograms of fludrocortisone acetate.
The other ingredients are: lactose monohydrate, potato starch, gelatin, magnesium stearate.

What Cortineff looks like and contents of the pack
Cortineff tablets are white to off-white, circular, biconvex with a smooth, uniform surface. They are engraved on both sides: one side bears the letter "F", the other side a dash "-".
The pack contains 20 tablets in an amber glass bottle closed with a polyethylene stopper, or 20 tablets in a blister pack made of PVC/Al foil.

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

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