Cortineff

Package Leaflet: Information for the Patient

Cortineff, 100 μg, Tablets

Fludrocortisone Acetate

Read the Leaflet Carefully Before Taking the Medication, 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 medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Cortineff and what is it used for

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

• primary adrenal insufficiency (also known as Addison's disease),
• secondary adrenal insufficiency,
• adrenogenital syndrome with salt loss.

2. Important information before taking Cortineff

When not to take Cortineff

• if you are allergic to fludrocortisone or any of the other ingredients of this medication (listed in section 6),
• if you have infections involving multiple tissues and/or organs and no treatment has been applied.

Warnings and precautions

Before starting Cortineff, discuss it with your doctor or pharmacist.
During treatment with Cortineff, some patients may experience:

• adrenal cortex atrophy, which may persist for many years after treatment is stopped,
• increased blood pressure, weight gain, edema caused by sodium and fluid retention in the body,
• exacerbation of symptoms of certain diseases such as pneumonia, hepatitis, and disseminated intravascular coagulation (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 action. Patients who have not had these diseases before should avoid exposure to infection,
• decreased immunity to infection. The medication may mask (hide) symptoms of infection,
• irregular menstrual bleeding in women.

Before taking Cortineff, inform your doctor if you have:

• peptic ulcer disease of the stomach and duodenum,
• intestinal diseases (e.g., recent intestinal anastomosis, diverticulitis),
• thrombophlebitis,
• diseases characterized by a rash (red, itchy bumps or spots on the skin),
• chronic kidney disease or kidney failure,
• osteoporosis (especially in postmenopausal women),
• excessive weakness and muscle fatigue (muscle weakness),
• fungal or viral infections,
• glaucoma (or if someone in your family has glaucoma),
• increased cholesterol and triglyceride levels,
• decreased protein levels in the blood,
• high blood pressure,
• congestive heart failure,
• epilepsy,
• liver dysfunction, liver cirrhosis,
• acute psychosis and mental disorders. The medication may exacerbate symptoms of these diseases,
• tuberculosis,
• hypothyroidism,
• diabetes,
• blood coagulation factor deficiency (prothrombin) and if you are also taking aspirin.

During treatment with Cortineff, your doctor may recommend a blood test (monitoring of salt uptake and electrolyte levels in serum).
Inform your doctor about all medications you are currently taking or have recently taken, including those available without a prescription.
Certain medications may enhance the effect of Cortineff, and your doctor may want to closely monitor your condition while taking such medications (including certain HIV medications: ritonavir, cobicistat).
If you experience blurred vision or other vision disturbances, contact your doctor.
During treatment with this medication, follow your doctor's instructions carefully.

Children and adolescents

Regular medical check-ups are necessary. Cortineff may cause growth and development disorders in infants and children (especially if the medication is used for a long time).

Cortineff and other medications

Inform your doctor or pharmacist about all medications you are currently taking or plan to take.
You should inform your doctor if you are taking any of the following medications:

• barbiturates (medications used to treat insomnia and epilepsy),
• phenytoin, carbamazepine, primidone (medications used to treat epilepsy),
• rifampicin, rifabutin (medications used to treat tuberculosis),
• aminoglutethimide (a medication used to treat breast cancer),
• insulin and oral medications used to treat diabetes,
• diuretics,
• coumarin derivatives, indandione, heparin (medications that prevent blood clotting),
• streptokinase, urokinase (medications that dissolve blood clots),
• non-steroidal anti-inflammatory medications (NSAIDs), e.g., ibuprofen,
• aspirin, acetylsalicylic acid - a pain reliever and anti-inflammatory medication,
• antihistamines (used to treat allergies, migraines, nausea),
• anabolic steroids, androgens (medications used to treat hormonal disorders),
• oral contraceptives containing estrogens,
• vaccines containing live viruses (Cortineff reduces their effectiveness),
• other glucocorticosteroids.

Cortineff with food and drink

Cortineff should be taken between meals.
This medication increases sodium retention in the body, which may cause edema and increased blood pressure. Therefore, you should limit your salt intake in food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking Cortineff.
Cortineff should not be used in pregnant women.
Small amounts of the medication pass into breast milk. You should consider whether to stop breastfeeding or not to breastfeed due to the need for treatment.

Driving and using machines

There is no data on the effect of fludrocortisone on the ability to drive and use machines.

Cortineff contains lactose

One tablet contains 57.90 mg of lactose monohydrate (a type of sugar). If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medication.

3. How to take Cortineff

This medication should always be taken as directed by your doctor. In case of doubts, consult your doctor or pharmacist.
The dose of Cortineff and the duration of treatment are determined by your doctor.
Recommended dose:
1 to 3 tablets (from 100 micrograms to 300 micrograms) per day
or
2 to 3 tablets (from 200 micrograms to 300 micrograms) every other or every third day.
Tablets should not be divided.
The medication should be taken orally .

Overdose of Cortineff

In case of taking a higher dose than recommended, stop taking the medication and consult your doctor immediately.

Missing a dose of Cortineff

If you miss a dose, take the medication as soon as possible. If it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Cortineff

Stopping treatment with Cortineff is decided by your doctor.
Stopping treatment after long-term use of the medication may lead to acute adrenal insufficiency, decreased blood pressure, and death.
The following symptoms of glucocorticosteroid withdrawal syndrome may occur:
fever, muscle and joint pain, malaise, runny nose, conjunctivitis, itching hives, and weight loss.
In case of any further doubts about the use of this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Cortineff can cause side effects, although not everybody gets them.
Consult your doctor immediatelyif you experience any of the following symptoms:

• allergic reaction (rash, facial swelling, difficulty breathing), especially in patients who have previously experienced allergic reactions to medications,
• vomiting with blood, black stool or stool with fresh blood,
• high fever, weakness, malaise (infection symptoms),
• psychiatric disorders (unusual excessive joy, deep sadness, personality disorders, exacerbation of psychotic symptoms).

Other side effects:

• Frequency not known:
• edema of the feet and legs,
• congestive heart failure,
• increased blood pressure,
• heart rhythm disorders (feeling of rapid or slow heartbeat),
• increased calcium excretion
• blurred vision.

The risk of side effects listed below is mainly related to patients receiving Cortineff for a long time or in combination with other corticosteroids.
Frequency not known:

• muscle weakness, osteoporosis, increased risk of bone fractures, aseptic necrosis of the femoral and humeral head,
• increased appetite, weight gain, nausea, abdominal pain, bloating, heartburn,
• gastric ulcer, gastrointestinal bleeding, pancreatitis, oral thrush (white coating on the mucous membranes of the mouth),
• impaired wound healing, increased tendency to bleeding and bruising, excessive hair growth, acne, wide purple stripes on the skin, thinning of the skin,
• edema, redness of the skin on the leg, pain worsening during walking, increased skin temperature (thrombophlebitis),
• insomnia, dizziness, and headaches, seizures,
• unusual sensations (tingling, prickling, burning),
• irregular menstrual bleeding or amenorrhea,
• Cushing's syndrome - characteristic silhouette: moon face, rounded torso, thin limbs,
• growth inhibition in children,
• increased blood sugar levels (diabetes),
• onset or exacerbation of eye disease symptoms,
• increased risk of blood clot formation.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 gather more information on the safety of the medication.

5. How to store Cortineff

Keep the medication out of sight and reach of children.
Store in a temperature below 25°C.
Store in the original packaging to protect from light and moisture.
Do not use this medication after the expiry date stated on the label and carton after "Expiry Date".
The expiry date stated is the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Cortineff contains

The active substance of Cortineff is fludrocortisone acetate.
One 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 with a creamy tint, round, flat on both sides, with a smooth surface. They are engraved on both sides: with the letter "F" on one side and a "-" sign on the other.
The packaging contains 20 tablets in a brown glass bottle with a polyethylene cap or 20 tablets in a PVC/Al blister.

Marketing authorization 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
Date of last revision of the leaflet:03.2023