Hidrocortisonum-sf

Package Leaflet: Information for the Patient

Hydrocortisonum-SF, 10 mg, Tablets

Hydrocortisonum

Read the leaflet carefully before taking the medicine, 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 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Hydrocortisonum-SF and what is it used for

Hydrocortisonum-SF contains hydrocortisone as the active substance. Hydrocortisone belongs to a group of medicines called glucocorticosteroids. Glucocorticosteroids occur naturally in the body and help maintain its normal functioning. Hydrocortisonum-SF reduces inflammation and should be taken as directed by a doctor to achieve the proper treatment effect. Hydrocortisonum-SF is used:

• in cases of adrenal cortex disorders in patients who do not have enough hydrocortisone (replacement therapy),
• before surgery and during severe injuries or illnesses in patients with diagnosed adrenal cortex insufficiency or uncertain adrenal cortex hormone reserve.

If the patient is unsure why they have been prescribed Hydrocortisonum-SF, they should discuss it with their doctor.

2. Important information before taking Hydrocortisonum-SF

When not to take Hydrocortisonum-SF:

• if the patient is allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6),
• if the patient has a fungal infection, such as thrush or candidiasis.

Warnings and precautions

Before starting treatment with Hydrocortisonum-SF, the patient should inform their doctor:

• if they have or have had depression, manic-depressive illness (bipolar disorder). They should also tell their doctor if they have had depression before or during treatment with glucocorticosteroid medicines like Hydrocortisonum-SF.
• if any of the above conditions have occurred in the patient's close family members.

Special caution should be exercised when taking Hydrocortisonum-SF in the following cases (the patient should inform their doctor before starting treatment with Hydrocortisonum-SF):

• recent myocardial infarction,
• heart disease called congestive heart failure,
• septicemia, tuberculosis, or a history of these diseases,
• peptic ulcer disease or other gastrointestinal disorders,
• chickenpox or shingles,
• contact with a person suffering from chickenpox or shingles, especially if the patient has not had these diseases before or is unsure if they have had chickenpox or shingles,
• herpes simplex virus infection in the eye,
• muscle weakness after taking steroids in the past,
• recent travel to tropical countries,
• gastrointestinal diseases, such as ulcerative colitis,
• epilepsy,
• phlebitis (swelling and redness along a vein with increased pain when touched),
• urticaria (a skin disease, rash),
• cancer with metastases to other parts of the body,
• long-term, previous use of glucocorticosteroid medicines due to increased susceptibility to infections,
• amebiasis (amoebiasis) or infection with intestinal worms (anisakiasis) due to the possibility of the disease worsening.

In addition, the patient should consult their doctor if any of the following conditions occur in the patient or their family members:

• diabetes,
• heart disease,
• hypertension,
• glaucoma,
• kidney or liver dysfunction,
• myasthenia (a disease characterized by muscle weakness),
• osteoporosis,
• low thyroid hormone levels (hypothyroidism).

Taking this medicine may cause a crisis in the course of a pheochromocytoma (a rare adrenal gland tumor), which can lead to death. A pheochromocytoma crisis may manifest as headache, excessive sweating, palpitations, and increased blood pressure. If these symptoms occur, the patient should immediately contact their doctor. Before starting treatment with Hydrocortisonum-SF, the patient should discuss it with their doctor if they suspect or have been diagnosed with a pheochromocytoma (adrenal gland tumor). If the patient experiences blurred vision or other vision disturbances, they should contact their doctor. If hydrocortisone is administered to premature infants, it may be necessary to monitor heart function and cardiac muscle image. In case of doubts about whether the mentioned conditions occur in the patient or their family members, the patient should consult their doctor or pharmacist before taking the medicine.

Psychiatric disorders during treatment with Hydrocortisonum-SF

During treatment with glucocorticosteroids, such as Hydrocortisonum-SF, psychiatric disorders may occur (see section 4). These disorders can be serious. They usually occur within a few days or weeks of starting treatment. The higher the dose of the medicine, the greater the likelihood of their occurrence. Most of these disorders disappear after the dose is reduced or the medicine is discontinued. If the disorders persist, it may be necessary to use appropriate treatment. The patient should tell their doctor if they experience any symptoms of psychiatric disorders, especially if they have a low mood or suicidal thoughts. In rare cases, psychiatric disorders may occur when the dose is reduced or after the medicine is discontinued.

Hydrocortisonum-SF and infections

During treatment with Hydrocortisonum-SF, the patient is more susceptible to infections and may have difficulty recognizing them. The patient should avoid contact with people who have:

• chickenpox,
• shingles,
• measles. If the patient suspects they are infected, they should consult their doctor.

Vaccinations and diagnostic tests during treatment with Hydrocortisonum-SF

The patient should inform their doctor about taking Hydrocortisonum-SF if they are to be vaccinated or undergo any diagnostic tests or laboratory tests, as this medicine may affect the results of some tests.

Surgery during treatment with Hydrocortisonum-SF

In the case of surgery requiring anesthesia, the patient should inform their doctor about taking Hydrocortisonum-SF.

Hydrocortisonum-SF and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, including those available without a prescription. This also applies to herbal medicines. Both Hydrocortisonum-SF and these medicines may interact with each other. Some medicines may enhance the effect of Hydrocortisonum-SF, and the doctor may want to closely monitor the patient's condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat). In particular, the patient should not take Hydrocortisonum-SF if they are taking any of the following medicines (they should inform their doctor or pharmacist):

• acetylsalicylic acid (aspirin),
• medicines used to treat epilepsy, such as phenytoin, phenobarbital, carbamazepine, and primidone,
• ephedrine (a medicine used to reduce swelling in nasal mucosa inflammation),
• medicines used to treat tuberculosis, such as rifabutin or rifampicin,
• anticoagulant medicines, such as warfarin,
• diuretic medicines,
• certain medicines used to treat fungal infections, such as amphotericin and ketoconazole,
• aminoglutethimide (a medicine used in cancer diseases),
• certain medicines used in heart failure, such as digoxin, furosemide,
• erythromycin (a medicine used to treat certain infections),
• medicines belonging to oral contraceptives or hormone replacement therapy (HRT),
• somatropin (growth hormone),
• certain medicines used to treat hypertension,
• certain medicines used in heart diseases, such as guanethidine, isosorbide mononitrate, isosorbide dinitrate, theophylline,
• sympathomimetic medicines (used, for example, in asthma, hypotension, cough, or to reduce swelling in nasal mucosa inflammation),
• preparations containing calcium,
• pain and anti-inflammatory medicines, known as nonsteroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen, diclofenac, or naproxen,
• phenylbutyrate sodium - a medicine used in urea cycle disorders (usually prescribed by a specialist),
• medicines used in diabetes,
• ritonavir (a medicine used to treat HIV infection),
• methotrexate (a medicine used to treat rheumatoid arthritis),
• cyclosporine (a medicine used to treat psoriasis or in patients after organ transplantation),
• minoxidil and hydralazine (medicines used to reduce blood pressure).

If the patient is unsure whether they are taking any of these medicines, they should consult their doctor or pharmacist before taking Hydrocortisonum-SF.

Hydrocortisonum-SF with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The medicine may be used during pregnancy only if, in the doctor's opinion, the potential benefit to the mother outweighs the potential risk to the fetus. In infants of mothers taking long-term, high doses of systemic corticosteroids, adrenal cortex insufficiency may occur. The patient should consult their doctor or pharmacist if they are unsure about any of the above.

Driving and using machines

The medicine may cause dizziness and changes in vision and muscle weakness. If these symptoms occur, the patient should not drive or operate machinery.

Hydrocortisonum-SF contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free". When taking Hydrocortisonum-SF, the patient should always carry information about their treatment with them.Information about the patient's treatment with this medicine may be important in case of an emergency. During each visit to the doctor, the patient should inform their doctor about taking Hydrocortisonum-SF.

3. How to take Hydrocortisonum-SF

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. Hydrocortisonum-SF is taken orally. The tablets can be divided into equal doses. The tablets can be taken with or without food. AdultsThe usual recommended dose is 20 to 30 mg (2 to 3 tablets) per day. Sometimes the medicine is used with 4 to 6 g of sodium chloride or 50 to 300 micrograms of fludrocortisone. Children and adolescentsThe usual recommended dose is 0.4 to 0.8 mg/kg body weight per day in 2 or 3 divided doses. In children, the smallest effective doses are used. The patient should carefully monitor the child's growth and development. If the patient has doubts about the dosage of the medicine, they should consult their doctor or pharmacist.

Taking a higher dose of Hydrocortisonum-SF than recommended

In case of taking a higher dose of Hydrocortisonum-SF than recommended, the patient should immediately consult their doctor.

Missing a dose of Hydrocortisonum-SF

If a dose of Hydrocortisonum-SF is missed, the next dose should be taken at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Hydrocortisonum-SF

Stopping treatment with Hydrocortisonum-SF too quickly can be dangerous. Suddenly stopping treatment with Hydrocortisonum-SF may cause the body to not have enough hormones. This can lead to the occurrence of so-called withdrawal symptoms, such as:

• muscle and joint pain,
• fever,
• general malaise. The patient should strictly follow their doctor's instructions regarding the reduction of the Hydrocortisonum-SF dose.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Hydrocortisonum-SF can cause side effects, although not everybody gets them. The occurrence of side effects in patients taking glucocorticosteroids for replacement therapy is less likely than in patients taking glucocorticosteroids for other diseases. If any of the following conditions occur or if the patient suspects an increased risk of infection (e.g., contact with an infected person), they should immediately inform their doctor:

• allergic reactions, such as skin rash, facial swelling, wheezing,
• irregular, very fast or slow heartbeat, fainting,
• muscle cramps and spasms,
• pseudotumor cerebri in children (increased intracranial pressure manifesting as headaches with vomiting, lack of energy, and drowsiness) - usually occurs after treatment is completed,
• nausea, vomiting,
• perforation or bleeding of stomach ulcers - manifesting as abdominal pain (especially if the pain radiates to the back), rectal bleeding, black stools, and vomiting with blood,
• acute pancreatitis (abdominal pain with possible accompanying shock, i.e., low blood pressure, reduced urine output, and often loss of consciousness),
• worsening vision,
• thrombosis (blood clot in a leg vein manifesting as swelling, redness, increased temperature, and pain in the leg),
• thromboembolic disorders (blood clot that can travel to the lungs and cause sudden chest pain and coughing up blood),
• heart failure - heart function disorders manifesting as swelling around the ankles, chest pain, difficulty breathing, palpitations, irregular heartbeat, irregular, very fast or slow pulse; hypertension manifesting as headaches and general malaise.

Glucocorticosteroids, including Hydrocortisonum-SF, can cause serious psychiatric disorders:

• low mood, including suicidal thoughts,
• feeling of excitement (mania) or mood swings,
• feeling of anxiety, sleep disturbances, cognitive disturbances, including feelings of disorientation and memory disturbances,
• visual and auditory hallucinations; strange and frightening thoughts, changes in behavior, and feelings of loneliness. These disorders are common in both adults and children. They may occur in about 5 out of 100 patients taking such medicines as Hydrocortisonum-SF.

The patient should inform their doctor if they experience any of the following conditions: Effect on the digestive system

• bloating
• esophageal ulcers or thrush (discomfort when swallowing)
• indigestion
• bloating
• nausea
• pancreatitis

Effect on muscles and bones

• muscle weakness and atrophy
• osteoporosis (change in bone structure and increased risk of fractures)
• bone fractures or cracks
• aseptic bone necrosis (death of bone tissue)
• tendon rupture

Effect on water and electrolyte balance

• cramps and spasms caused by potassium loss. In rare cases, potassium loss can lead to arrhythmias (irregular heartbeat).

Effect on hormones and metabolism

• inhibition of normal growth in children
• in women: irregular menstrual periods or their absence
• excessive hair growth on the body and face in women
• round or "moon-shaped" face
• increased appetite
• increased blood sugar levels, reduced protein storage in the body (weight loss and muscle mass loss in legs and arms), loss of calcium and nitrogen

Effect on the skin

• thin and delicate (parchment-like) skin, bruising, red and purple spots
• delayed wound healing
• acne, excessive sweating, redness
• stretch marks

Effect on the eyes

• vision disturbances as a result of cataracts or glaucoma (increased intraocular pressure)
• thinning of the cornea
• increased risk of eye infections
• exophthalmos (bulging eyes)
• blurred vision

Effect on the blood

• leukocytosis (increased white blood cell count)

Effect on the respiratory system

• hiccups

Frequency not known (cannot be estimated from the available data):

• hypertrophic cardiomyopathy (heart muscle thickening) in premature infants
• weight gain.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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, more information can be collected on the safety of the medicine.

5. How to store Hydrocortisonum-SF

The medicine should be stored out of sight and reach of children. Do not store above 30°C. 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Hydrocortisonum-SF contains

• The active substance of the medicine is hydrocortisone. One tablet contains 10 mg of hydrocortisone. Half a tablet contains 5 mg of hydrocortisone. The dividing line on the tablet allows it to be divided into equal parts, enabling the dose to be adjusted according to the patient's needs.
• The other ingredients are: lactose monohydrate, potato starch, talc, sodium carboxymethylcellulose (type A), gelatin, magnesium stearate, purified water.

What Hydrocortisonum-SF looks like and contents of the pack

Hydrocortisonum-SF is a white, round, flat tablet with a dividing line on one side and the imprint "H" on the other side. Hydrocortisonum-SF is available in PVC/PVDC/Aluminum blisters in a cardboard box containing 60 or 180 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o. ul. Dolna 21 05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel Münchener Straße 15 06796 Brehna Germany SUN-FARM Sp. z o.o. ul. Dolna 21 05-092 Łomianki

Date of last revision of the leaflet: