Hidrocortisonum Ielfa

Leaflet accompanying the packaging: patient information

HYDROCORTISONE JELFA, 20 mg,
tablets(Hydrocortisone)
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• -Keep this leaflet, so that you can read it again if necessary.
• -Consult a doctor, pharmacist, or nurse if you have any further doubts.
• -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 any of the side effects worsen or if any side effects not mentioned in the leaflet occur, tell your doctor, pharmacist, or nurse.

Table of contents of the leaflet:

• 1. What is Hydrocortisone Jelfa and what is it used for
• 2. Important information before taking Hydrocortisone Jelfa
• 3. How to take Hydrocortisone Jelfa
• 4. Possible side effects
• 5. How to store Hydrocortisone Jelfa
• 6. Package contents and other information

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

Hydrocortisone belongs to the group of glucocorticosteroids (corticosteroids) - synthetic compounds with the action of hormones secreted by the adrenal cortex.
Hydrocortisone has anti-inflammatory, anti-allergic, anti-shock, and immunosuppressive effects.
Indications for use:

• substitution (supplementation) of the hormone in adrenal cortex insufficiency of various origins (Addison's disease);
• hypopituitarism with secondary adrenal cortex insufficiency (Sheehan's syndrome);
• Nelson's syndrome after adrenalectomy (removal of one or both adrenal glands);
• adrenogenital syndrome;
• autoimmune diseases.

2. Important information before taking Hydrocortisone Jelfa

When not to take Hydrocortisone Jelfa:

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

Warnings and precautions

Side effects that occur after taking hydrocortisone can be limited by using only the necessary, minimal dose for as short a time as possible.
If the patient is taking Hydrocortisone Jelfa for a long time:

• adrenal cortex insufficiency may develop, which can persist for several months after the end of treatment. The medicine should not be stopped suddenly, as symptoms of acute adrenal cortex insufficiency may occur;
• in the event of concomitant disease, injury, or surgery, the patient should consult a doctor to increase the dose of hydrocortisone;
• after long-term 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 the symptoms of viral or bacterial infections;
• while taking hydrocortisone, new infections with an atypical clinical course may occur.

If the patient has had contact with a person suffering from chickenpox or shingles
and is being treated, or has been treated with corticosteroids (e.g., Hydrocortisone Jelfa)
within the last 3 months:

• this may be a life-threatening condition, as corticosteroids weaken the body's immune system. In such a case, the patient must be given passive immunization. For this purpose, varicella-zoster immunoglobulin (VZIG) is used, which 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 has tuberculosis and is receiving anti-tuberculosis drugs:

• corticosteroid treatment should be limited to cases of fulminant tuberculous meningitis. If it is necessary to use corticosteroids in patients with latent tuberculosis or hypersensitivity to tuberculin, they must remain under medical supervision due to the risk of reactivating the disease. During long-term glucocorticosteroid therapy, such patients should receive anti-tuberculosis drugs.

If the patient has fungal infections:

• corticosteroids should not be used in the case of systemic fungal infections, as they can exacerbate the course of these infections, unless it is necessary to control life-threatening reactions to antifungal drugs (amphotericin). Concurrent use of amphotericin and hydrocortisone may lead to increased heart size and congestive heart failure.

If the patient has had a heart attack:

• after a recent heart attack, corticosteroids should be used with great caution, as there is a possible link between corticosteroid use and rupture of the free wall of the left ventricle.

If the patient has hypertension:

• medium and high doses of hydrocortisone or cortisone may cause an increase in blood pressure, sodium and water retention, and increased potassium excretion. The likelihood of such side effects is lower when using synthetic derivatives, except when using high doses. It may be necessary to limit the amount of salt in the diet and supplement potassium. All corticosteroids increase calcium excretion.

If the patient is to be vaccinated:

• the administration of live virus vaccines is contraindicated in individuals receiving immunosuppressive doses of corticosteroids;
• in patients receiving immunosuppressive doses of corticosteroids, after vaccination with inactivated viral or bacterial vaccines, the expected amount of antibodies in the serum may not be produced. However, patients receiving corticosteroids for replacement therapy (e.g., in Addison's disease) can be vaccinated.

If the patient is taking high doses of glucocorticosteroids:

• symptoms of peritoneal irritation after perforation (rupture) of the gastrointestinal tract may not occur or may be minimal;
• fat embolism may occur, described as a potential complication of excess cortisol.

If the patient has cerebral malaria:

• corticosteroid use is associated with prolonged coma and increased frequency

of pneumonia and gastrointestinal bleeding.
If the patient is taking heart medications, such as digoxin:

• caution should be exercised, as hydrocortisone causes electrolyte disturbances (potassium loss).

If the patient experiences blurred vision or other vision disturbances, they should consult a doctor.
If hydrocortisone is administered to premature infants, it may be necessary to monitor heart function and cardiac muscle image.
Special caution and frequent medical monitoring are required in the following cases:

• -purulent infections;
• -active or latent peptic ulcer with perforation risk;
• -osteoporosis (especially in postmenopausal women);
• -hypertension;
• -congestive heart failure;
• -diabetes;
• -a history of post-infectious myopathy;
• -a history of severe manic-depressive psychosis (especially post-infectious psychosis);
• -glaucoma (even if it occurs in the family);
• -cirrhosis or liver damage;
• -renal failure;
• -epilepsy;
• -gastrointestinal ulcers;
• -recent intestinal anastomosis;
• -ulcerative colitis;
• -diverticulitis;
• -muscle weakness (myasthenia gravis);
• -eye herpes, threatening to perforate the cornea;
• -hypothyroidism;
• -a history of tuberculosis;
• -predisposition to thrombophlebitis.

Corticosteroids may:

• -increase or decrease sperm motility and count in some patients;
• -lead to the activation of latent strongyloidiasis and toxoplasmosis, or exacerbate the course of active disease; therefore, it is recommended to rule out latent or active strongyloidiasis and toxoplasmosis before starting corticosteroid therapy in every patient at risk or with symptoms suggesting one of these diseases.

Prolonged use of corticosteroids may cause posterior subcapsular cataract, glaucoma with possible optic nerve damage, and may increase the risk of secondary infections of the eye caused by fungi or viruses.

Children and adolescents

Hydrocortisone causes growth retardation. Treatment should be limited to the minimum dose for as short a time as possible. The child's growth and development should be closely monitored.

Elderly

In elderly patients, side effects may be more pronounced, especially in the presence of osteoporosis, hypertension, hypokalemia (decreased potassium levels in the blood), diabetes, and increased susceptibility to infections and skin thinning.
Close clinical monitoring of these patients is required to avoid life-threatening reactions.

Other medicines and Hydrocortisone Jelfa

Tell your doctor about all medicines you are currently taking or have recently taken, including those available without a prescription.
Some medicines may enhance the effect of Hydrocortisone Jelfa, and your doctor may want to closely monitor your condition when taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
Hydrocortisone:

• -retains sodium and water, which can lead to edema;
• -causes potassium loss - decreased potassium levels in the blood may increase the toxicity of concurrently administered cardiac glycosides;
• -increases blood glucose levels; during treatment with this medicine in diabetic patients, it may be necessary to change the dose of insulin or oral antidiabetic drugs;
• -suppresses the immune system and reduces the body's response to vaccines and anatoxins;
• -reduces the effect of drugs that inhibit acetylcholinesterase activity used in the treatment of muscle weakness (myasthenia gravis);
• -may accelerate the metabolism of isoniazid;
• -may decrease or increase the effect of oral anticoagulants, so it is necessary to monitor blood coagulation when taking these medicines;
• -weakens the effect of antihypertensive drugs and diuretics;
• -accelerates the excretion of salicylates and other non-steroidal anti-inflammatory drugs in the urine. Phenytoin, phenobarbital, rifampicin, pyrimidine, carbamazepine accelerate the metabolism of hydrocortisone and weaken its effect. Erythromycin and ketoconazole may inhibit the metabolism of hydrocortisone, in which case it may be necessary to reduce the dose of hydrocortisone. Concurrent use of cyclosporine and hydrocortisone leads to slowed metabolism of both drugs and increased effect; the doctor should order monitoring of cyclosporine levels.

Pregnancy, breastfeeding, and fertility

In pregnancy and breastfeeding, or if pregnancy is suspected or planned, consult a doctor before taking this medicine.
Pregnancy
The medicine may be used in pregnancy only if clearly indicated by a doctor, when in their 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 be monitored due to the risk of adrenal cortex insufficiency.
Breastfeeding
Hydrocortisone passes into breast milk and may reduce the production of endogenous glucocorticosteroids in the breastfed child, slow growth, and cause other side effects.
It is recommended to stop breastfeeding during treatment with high doses of the medicine.

Driving and using machines

No effect of the medicine on the ability to drive and use machines has been observed.

3. How to take Hydrocortisone Jelfa

Take this medicine always as directed by your doctor. In case of doubt, consult a doctor or pharmacist.
Do not take doses or a dosing regimen other than those recommended by your doctor.
Oral administration
The recommended dose is:

• adults and children over 14 years20 mg to 30 mg per day, in severe cases the daily dose may be higher;
• children under 14 years36 mg/m² body surface area in 3 divided doses.

Dosing is individual, depending on the indication, patient condition, and response to the medicine. Initial doses are usually higher, and after achieving the desired therapeutic effect, they are reduced to the smallest dose that allows maintaining a beneficial therapeutic effect (or until the medicine is discontinued).
If during long-term therapy the patient is in a stressful situation, it may be necessary to increase the dose of the medicine.
Oral administration should be done according to the circadian rhythm of adrenal secretion.
The maintenance dose is given between 6 and 8 am.
After long-term treatment, the medicine should be discontinued gradually.
The dose reduction scheme depends on the indication, treatment period, dose used, and patient response to the medicine.

Taking a higher dose of Hydrocortisone Jelfa than recommended

Long-term use of high doses requires cautious dose reduction to prevent the occurrence of acute adrenal cortex insufficiency.

Hydrocortisone can be removed from the body through dialysis.
Anaphylactic reactions and hypersensitivity, depending on their severity, can be treated with antihistamines and, if necessary, adrenaline.

Stopping Hydrocortisone Jelfa

Withdrawal syndrome (see section 4: Possible side effects).

In case of any further doubts about the use of 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.
Side effects that occur after taking hydrocortisone can be limited by using only the necessary, minimal dose for as short a time as possible.
The risk of side effects increases with the duration of treatment.
The following may occur:
General disorders:

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

Musculoskeletal and connective tissue disorders:

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

Gastrointestinal disorders:

• nausea, vomiting, loss of appetite, which may cause weight loss; increased appetite, which may lead to weight gain; diarrhea or constipation, abdominal distension, stomach irritation, and esophagitis with ulcers; gastric ulcer with possible perforation and bleeding; perforation of the small and large intestine, especially in inflammatory bowel diseases.

Skin and subcutaneous tissue disorders:

• impaired wound healing, thinning of the skin, which becomes sensitive and prone to damage, bruising, and petechiae, facial erythema, striae, excessive hair growth (hirsutism), acne-like eruptions, decreased skin test reactivity, hypersensitivity reactions such as allergic dermatitis, urticaria, angioedema.

Nervous system disorders:

• seizures, increased intracranial pressure with papilledema (pseudotumor cerebri), nerve inflammation, paresthesia (unusual sensation - tingling, pricking, burning, etc.), insomnia.

Endocrine disorders:

• menstrual disorders, Cushing's syndrome, growth retardation in children, secondary adrenal cortex insufficiency, decreased glucose tolerance, manifestation of latent diabetes, 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.

Metabolic and nutritional disorders:

• negative nitrogen balance due to increased protein breakdown.

Psychiatric disorders:

• dizziness and headaches, hallucinations, psychoses, euphoria, mood changes, symptoms of pseudotumor cerebri caused by increased intracranial pressure and papilledema.

Vascular disorders:

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

Cardiac disorders:

• arrhythmias or ECG changes associated with potassium deficiency, syncope, exacerbation of hypertension, heart rupture as a consequence of a recent myocardial infarction; there are reports of sudden cardiac arrest; hypertrophic cardiomyopathy in premature infants.

Blood and lymphatic system disorders:

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

Infections and infestations:

• exacerbation or masking of infection symptoms.

Immune system disorders:

• anaphylactic reactions.

Diagnostic tests:

• -weight gain.

Possible side effects (may occur in 1 in 100 patients) with a frequency of "uncommon":
blurred vision.
Possible side effects with a frequency of "unknown" (cannot be estimated from available data): hypertrophic cardiomyopathy in premature infants,
weight gain.

Withdrawal syndrome

Occurs after sudden discontinuation of hydrocortisone during long-term use. It is caused by acute adrenal cortex insufficiency and can be life-threatening.
In the withdrawal syndrome, the following may also occur: fever, muscle pain, joint pain, rhinitis, conjunctivitis, painful skin nodules, and weight loss.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor, 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
Tel.: + 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hydrocortisone Jelfa

Store in a temperature below 25°C. Protect from light.
Store in a place 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 month stated.
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. Package contents and other information

What does Hydrocortisone Jelfa contain

The active substance of the medicine 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 Hydrocortisone Jelfa looks like and what the package contains

Hydrocortisone Jelfa is a white, round tablet with a dividing line on one side.
Aluminum/PVC orange blisters in a cardboard box
20 tablets (1 blister of 20 tablets)
PP/PE container in a cardboard box
20 tablets (1 container of 20 tablets)

Marketing authorization holder and manufacturer

Marketing authorization 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

Date of last revision of the leaflet: