Hydrocortisone jelfa

Package leaflet: Information for the patient

HYDROCORTISONUM JELFA, 20 mg,
tablets (Hydrocortisonum)
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor, pharmacist, or nurse if you have any further questions.
• 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 any of the adverse effects worsen or if any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Table of contents of the leaflet:

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

1. What is Hydrocortisonum Jelfa and what is it used for

Hydrocortisone belongs to the group of glucocorticosteroids (corticosteroids) – synthetic compounds exhibiting the activity of hormones secreted by the adrenal cortex.
Hydrocortisone has anti-inflammatory, antiallergic, antishock, and immunosuppressive effects.
Indications for use:

• Hormone replacement in adrenal insufficiency of various origins (Addison's disease);
• Pituitary insufficiency with secondary adrenal insufficiency (Sheehan's syndrome);
• Nelson's syndrome after adrenalectomy (removal of one or both adrenal glands);
• Adrenogenital syndrome;
• Diseases of autoimmune origin.

2. Important information before using Hydrocortisonum Jelfa

When not to use Hydrocortisonum Jelfa:

• if the patient is allergic to the active substance hydrocortisone or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has systemic fungal infection.

Warnings and precautions
Before starting treatment with Hydrocortisonum Jelfa, discuss this with your doctor or
pharmacist.
Adverse effects associated with hydrocortisone use can be minimized by using only the necessary minimum dose for the shortest possible duration.
If the patient uses Hydrocortisonum Jelfa long-term:

• adrenal insufficiency may develop, which may persist for several months after discontinuation of treatment. The medicine should not be stopped abruptly, as symptoms of acute adrenal insufficiency (reduced adrenal function) may occur;
• in case of concomitant illness, injury, or surgical procedure, consult a doctor

to increase the hydrocortisone dose;

• after prolonged treatment, discontinuation of corticosteroids may cause various symptoms, including fever, muscle pain, joint pain, and malaise.

If the patient has a viral or bacterial infection:

• hydrocortisone may mask symptoms of viral or bacterial infections;
• atypical clinical forms of new infections may occur during hydrocortisone treatment.

If the patient had or has been in contact with someone suffering from chickenpox or shingles and is currently being treated or has been treated with corticosteroids (e.g. Hydrocortisonum Jelfa) within the last 3
months:

• this may pose a life-threatening risk, as corticosteroids suppress the body's immune response. In such cases, passive immunization is required. For this purpose, varicella-zoster immunoglobulin (VZIG) should be administered within 10 days of contact with a person suffering from chickenpox or shingles. A patient infected with chickenpox requires specialized care and treatment.

If the patient suffers from tuberculosis and is receiving anti-tuberculosis drugs:

• corticosteroid treatment should be limited to fulminant laryngeal tuberculosis. If corticosteroids are necessary in patients with latent tuberculosis or tuberculin hypersensitivity, they must remain under medical supervision due to the risk of disease reactivation. Patients undergoing long-term glucocorticoid therapy (glucocorticoid treatment) should receive anti-tuberculosis drugs.

If the patient suffers from fungal infections:

• corticosteroids should not be used in systemic fungal infections, as they may exacerbate such infections, unless necessary to control life-threatening reactions to antifungal drugs (amphotericin). Concurrent use of amphotericin and hydrocortisone may lead to cardiac enlargement and congestive heart failure.

If the patient has had a heart attack:

• corticosteroids should be used with extreme caution after a recent myocardial infarction, as a possible association between corticosteroid use and rupture of the free wall of the left ventricle has been reported in the literature.

If the patient has hypertension:

• moderate and high doses of hydrocortisone or cortisone may increase blood pressure, cause sodium and water retention, and increase potassium excretion. The likelihood of such adverse effects is lower with synthetic derivatives, except when high doses are used. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

If the patient is to be vaccinated:

• administration of vaccines containing live viruses is contraindicated in individuals receiving immunosuppressive doses of corticosteroids;
• in patients receiving immunosuppressive doses of corticosteroids, expected serum antibody response after vaccination with inactivated viral or bacterial vaccines may not occur. However, vaccination may be performed in patients receiving corticosteroids as replacement therapy (e.g. in Addison's disease).

If the patient receives high doses of glucocorticoids:

• symptoms of peritoneal irritation after gastrointestinal tract perforation may be absent or minimal;
• fat embolism may occur, described as a potential complication of cortisone excess.

If the patient suffers from cerebral malaria:

• corticosteroid use has been associated with prolonged coma and increased incidence of pneumonia and gastrointestinal bleeding.

If the patient is taking heart medications such as digoxin:

• caution is advised, as hydrocortisone causes electrolyte disturbances (potassium loss).

If the patient experiences blurred vision or other visual disturbances, consult a
doctor.
If hydrocortisone is administered to premature infants, monitoring of cardiac function and myocardial imaging may be required.
If the patient has hyperthyroidism (thyrotoxicosis)
If the patient develops muscle weakness, muscle pain, cramps, or muscle stiffness during hydrocortisone treatment, contact a doctor immediately. These may be symptoms of a disorder called periodic thyrotoxic paralysis, which may occur in patients with hyperthyroidism (hyperthyroidism) treated with hydrocortisone. Additional treatment may be necessary to alleviate symptoms of this disorder.
Special caution and frequent medical monitoring are required in the following cases:

• suppurative infections;
• active or latent peptic ulcer with risk of perforation;
• osteoporosis (especially in postmenopausal women);
• hypertension;
• congestive heart failure;
• diabetes;
• previous steroid-induced myopathy;
• previous severe manic-depressive psychosis (especially steroid-induced psychosis);
• glaucoma (also if the disease runs in the family);
• liver cirrhosis or liver damage;
• renal failure;
• epilepsy;
• gastrointestinal mucosal ulcers;
• recent intestinal anastomosis;
• ulcerative colitis;
• intestinal diverticulosis;
• muscle weakness ( myasthenia gravis) ;
• ocular herpes threatening corneal perforation;
• hypothyroidism;
• previous tuberculosis;
• predisposition to thrombophlebitis.

Corticosteroids may:

• increase or decrease sperm motility and count in some patients;
• reactivate latent amoebiasis or echinococcosis, or exacerbate active disease; therefore, latent or active amoebiasis and echinococcosis should be ruled out before starting corticosteroid treatment in every patient at risk or with symptoms suggestive of either disease.

Prolonged use of corticosteroids may cause posterior subcapsular cataracts, glaucoma with potential optic nerve damage, and may increase the risk of secondary fungal or viral infections of the eye.

Children and adolescents
Hydrocortisone may delay growth. Treatment should be limited to the minimum effective dose for the shortest possible duration. Growth and development of the child should be closely monitored.

Elderly patients
Adverse effects may be more pronounced in elderly patients, especially in the presence of concomitant osteoporosis, hypertension, hypokalemia (reduced potassium concentration in blood serum), diabetes, increased susceptibility to infections, and skin thinning. Close clinical monitoring of these patients is required to prevent life-threatening reactions.

Other medicines and Hydrocortisonum Jelfa
Inform your doctor about all medicines currently or recently taken by the patient, including those available without a prescription. Some medicines may enhance the effect of Hydrocortisonum Jelfa, and the doctor may need to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).
Hydrocortisone:

• retains sodium and water, which may lead to edema;
• causes potassium loss – decreased potassium concentration in blood may increase the toxicity of concurrently administered cardiac glycosides;
• increases blood glucose concentration (during treatment with this medicine, patients with diabetes may require adjustment of insulin or oral antidiabetic drug doses);
• suppresses immune system function and reduces the body's response to vaccines and toxoids;
• reduces the effect of drugs inhibiting cholinesterase activity used in the treatment of muscle weakness ( myasthenia gravis) ;
• may accelerate isoniazid metabolism;
• may decrease or increase the effect of oral anticoagulants; therefore, blood coagulation should be monitored during concomitant use of these drugs;
• reduces the effectiveness of antihypertensive drugs and diuretics;
• accelerates urinary excretion of salicylates and other nonsteroidal anti-inflammatory drugs. Phenytoin, phenobarbital, rifampicin, pyrimethamine, and carbamazepine accelerate hydrocortisone metabolism and reduce its effect. Erythromycin and ketoconazole may inhibit hydrocortisone metabolism; in such cases, hydrocortisone dose reduction may be necessary. Concurrent use of cyclosporine and hydrocortisone slows the metabolism of both drugs and intensifies their effects; the doctor should order monitoring of cyclosporine concentration.

Pregnancy, breastfeeding, and effects on fertility
During pregnancy, breastfeeding, or if pregnancy is suspected or planned, consult a doctor before using this medicine.
Pregnancy
The medicine may be used during pregnancy only if clearly recommended by a doctor when, in his or her opinion, the expected benefit to the mother outweighs the potential risk to the fetus. Hydrocortisone crosses the placenta and there is a small risk of cleft palate and intrauterine growth retardation in the fetus. Newborns born to mothers who received significant doses of hydrocortisone during pregnancy should remain under observation due to the risk of adrenal insufficiency.
Breastfeeding
Hydrocortisone passes into breast milk and may reduce endogenous glucocorticoid production in the breastfed infant, inhibit growth, and cause other adverse effects.
It is recommended to discontinue breastfeeding during treatment with high doses of the medicine.
Driving and operating machinery
No effects of the medicine on the ability to drive vehicles and operate machinery have been observed.

3. How to use Hydrocortisonum Jelfa

This medicine should always be used as directed by the physician. In case of doubts, consult a
physician or pharmacist.
Do not use doses or a dosing regimen different from those recommended by the physician.
Oral administration
The recommended dose is:

• Adults and children over 14 years of age: 20 mg to 30 mg per day; in severe cases, the daily dose may be higher;
• Children up to 14 years of age: 36 mg/m^2 of body surface area divided into 3 doses.

Dosing is individual, depending on the indication, patient's condition, and response to the medicine. Usually,
initial doses are higher and, after achieving the desired therapeutic effect, are gradually reduced until
the lowest effective dose is established—the minimum dose required to maintain a favorable therapeutic effect (or
until complete discontinuation of the medicine).
If a patient undergoing long-term therapy experiences a stressful situation, an increase in the dose of the medicine
may be necessary.
Oral administration should follow the circadian rhythm of adrenal secretion.
The maintenance dose should be administered between 6 a.m. and 8 a.m.
After long-term therapy, the medicine should be discontinued gradually.
The dose reduction regimen depends on the indication, duration of treatment, dose used, and the patient's
response to the medicine.
Use of a higher than recommended dose of Hydrocortisonum Jelfa
Long-term use of high doses requires careful dose reduction to prevent acute adrenal insufficiency.
Hydrocortisone can be removed from the body by dialysis.
Anaphylactic reactions and hypersensitivity, depending on their severity, may be treated with antihistamines,
and, if indicated, adrenaline simultaneously.
Discontinuation of Hydrocortisonum Jelfa
Withdrawal syndrome (see section 4: Possible adverse effects).
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects after hydrocortisone use can be minimized by using the shortest possible duration and the necessary minimal dose.
The risk of adverse effects increases with prolonged treatment duration.
The following may occur:
General disorders:

• Sodium and fluid retention, congestive heart failure, potassium loss, hypokalemic alkalosis, arterial hypertension, decreased blood calcium levels (hypocalcemia).

Musculoskeletal and connective tissue disorders:

• Aseptic necrosis of the femoral and humeral head, muscle weakness, steroid-induced myopathy, loss of muscle mass, osteoporosis, spontaneous fractures including compression fractures of the spine and pathological fractures of long bones.

Gastrointestinal disorders:

• Nausea, vomiting, loss of appetite which may lead to weight loss; increased appetite which may lead to weight gain; diarrhoea or constipation, abdominal distension, gastric irritation and oesophagitis with ulceration; peptic ulcer with possible perforation and haemorrhage; perforation of the small and large intestine, particularly in inflammatory bowel diseases.

Skin and subcutaneous tissue disorders:

• Impaired wound healing, skin thinning which becomes fragile and susceptible to damage, petechiae and haemorrhagic rashes, facial flushing, striae, excessive male-pattern hair growth (hirsutism), acneiform eruptions, decreased reactivity in skin tests, hypersensitivity reactions such as allergic dermatitis, urticaria, angioedema.

Nervous system disorders:

• Seizures; upon discontinuation of glucocorticoids, increased intracranial pressure with papilledema (pseudotumour cerebri), peripheral neuritis, paraesthesiae (abnormal sensations such as tingling, pricking, burning, etc.), insomnia.

Endocrine disorders:

• Menstrual irregularities, Cushing's syndrome symptoms, growth suppression in children, secondary suppression of the hypothalamic-pituitary-adrenal axis, decreased carbohydrate tolerance, unmasking of latent diabetes mellitus, increased insulin or oral antidiabetic drug requirements in diabetic patients.

Eye disorders:

• Increased intraocular pressure, secondary glaucoma, exophthalmos, optic nerve damage, posterior subcapsular cataract, blurred vision.

Metabolism and nutrition disorders:

• Negative nitrogen balance due to enhanced protein catabolism.

Psychiatric disorders:

• Dizziness and headache, hallucinations, psychoses, euphoria, mood changes, symptoms of pseudotumour cerebri due to increased intracranial pressure and papilledema.

Vascular disorders:

• Thrombosis with embolism, fat embolism, increased cholesterol levels (hypercholesterolemia), accelerated atherosclerosis, necrotizing vasculitis, thrombophlebitis.

Cardiac disorders:

• Arrhythmias or ECG changes related to potassium deficiency, syncope, worsening of arterial hypertension, cardiac rupture as a consequence of recent myocardial infarction; there are reports of sudden cardiac arrest; myocardial hypertrophy (hypertrophic cardiomyopathy) in premature infants.

Blood and lymphatic system disorders:

• Increased white blood cell count (leukocytosis if leukocytes, lymphopenia if lymphocytes), decreased platelet count (thrombocytopenia).

Infections and infestations:

• Exacerbation or masking of infection symptoms.

Immune system disorders:

• Anaphylactic reactions.

Investigations:

• Weight gain.

Possible adverse effects (occurring in 1 out of 100 patients) with frequency "not uncommon":
blurred vision.
Possible adverse effects with frequency "unknown" (cannot be estimated from available data): myocardial hypertrophy (hypertrophic cardiomyopathy) in premature infants, weight gain.
Withdrawal syndrome
Occurs after abrupt discontinuation of hydrocortisone following prolonged use. It is caused by acute adrenal insufficiency and may be life-threatening.
Withdrawal syndrome may also include: fever, muscle pain, joint pain, rhinitis, conjunctivitis, painful skin nodules, and weight loss.
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Hydrocortisonum Jelfa

Store below 25°C. Protect from light.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
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
what to do with medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Hydrocortisonum Jelfa contains
The active substance is hydrocortisone. One tablet contains 20 mg of hydrocortisone.
The other ingredients are: calcium hydrogen phosphate dihydrate, potato starch,
magnesium stearate, povidone K-25.

What Hydrocortisonum Jelfa looks like and contents of the pack
Hydrocortisonum Jelfa are white, round tablets with a division line on one side.
Aluminium/PVC orange foil blisters in a cardboard box
20 tablets (1 blister with 20 tablets)
PP/PE container in a cardboard box
20 tablets (1 container with 20 tablets)

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:
Przedsiębiorstwo Farmaceutyczne Jelfa SA
58-500 Jelenia Góra, ul. Wincentego Pola 21
Poland