HYDROCORTISONE MOMAJA

Package leaflet: Information for the user

Hydrocortisone Momaja, 100 mg, powder and solvent for solution for injection/infusion
Hydrocortisonum
Please read this leaflet carefully before using this medicine, because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Hydrocortisone Momaja is and what it is used for
2. Important information before using Hydrocortisone Momaja
3. How to use Hydrocortisone Momaja
4. Possible side effects
5. How to store Hydrocortisone Momaja
6. Contents of the package and other information

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

Hydrocortisone Momaja reduces symptoms of inflammation and allergy and suppresses the immune system response.
Hydrocortisone Momaja is used as an adjunct to standard therapy in the treatment of, among others, the following conditions:

• Addisonian crisis (severe adrenal insufficiency);
• Shock-like states;
• Acute allergic reactions, such as acute severe asthma and drug-induced allergic reactions;
• Inflammatory conditions requiring treatment with hydrocortisone;
• Certain life-threatening conditions which may lead to irreversible shock.

The medicine contains hydrocortisone, which may sometimes also be used for other indications not listed in this package leaflet. Please consult your doctor, pharmacist, or other healthcare professional if you need advice. Always follow the instructions given by them.

2. Important information before using Hydrocortisone Momaja

When not to use Hydrocortisone Momaja

• if the patient is allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6),
• if the patient has systemic fungal infection,
• if the patient has recently been vaccinated or is due to be vaccinated,
• if the patient has herpes simplex keratitis (viral infection of the cornea), acute psychosis, Cushing's syndrome, peptic ulcers of the stomach or duodenum, or chickenpox.

Warnings and precautions
Before starting treatment with Hydrocortisone Momaja, discuss with your doctor or
pharmacist if the patient has:

• allergy to certain medicines
• herpes simplex keratitis (viral infection of the cornea)
• acute or chronic psychosis
• Cushing's syndrome (a hormonal disorder in which the body produces excessive amounts of cortisol)
• gastric or small intestinal ulcers
• chickenpox
• diabetes
• osteoporosis (weakening of the bones)
• active tuberculosis (lung infection)
• kidney problems
• predisposition to venous thrombosis (blood clot inflammation in veins)
• history of thrombosis (e.g. venous thrombosis) or predisposition to thrombosis (blood clotting)
• recent vaccination or planned vaccination
• smallpox
• ulcerative colitis or diverticulitis (inflammatory bowel conditions)
• recent intestinal anastomosis (surgical procedure involving the intestines)
• high blood pressure
• paralytic muscle weakness (myasthenia)
• liver disease (in such cases the doctor may decide to reduce the dose)
• suspected or diagnosed pheochromocytoma (a tumor of the adrenal medulla)
• hyperthyroidism (overactive thyroid).

When corticosteroids are used during cancer treatment, tumor lysis syndrome (TLS) may occur. Inform the doctor if the patient has cancer and develops symptoms of tumor lysis syndrome such as muscle cramps, muscle weakness, confusion, irregular heartbeat, vision loss or visual disturbances, and shortness of breath.
If the patient develops muscle weakness, muscle pain, cramps, or muscle stiffness while taking hydrocortisone, contact the doctor immediately. These may be symptoms of a condition called periodic paralysis thyrotoxic, which may occur in patients with hyperthyroidism (hyperthyroidism) treated with hydrocortisone. Additional treatment may be necessary to relieve symptoms of this disorder.
Corticosteroids may mask objective signs of infection and suppress the immune system. Long-term daily treatment with glucocorticoids may inhibit growth in children. Therefore, glucocorticoid therapy should be limited to the most severe cases.
If hydrocortisone is administered to premature infants, monitoring of heart function and myocardial imaging may be necessary.

Hydrocortisone Momaja and other medicines
Tell your doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Hydrocortisone Momaja may affect the effectiveness of other medicines, and other medicines may affect the effectiveness of hydrocortisone. These include:

• phenobarbital and phenytoin (medicines used for epilepsy)
• rifampicin (a medicine used for tuberculosis)
• troleandomycin (an antibiotic)
• ketoconazole tablets (used in the treatment of Cushing's syndrome, a condition in which the body produces excess cortisol)
• acetylsalicylic acid (an anti-inflammatory medicine)
• anticoagulants (medicines preventing blood clotting).

If the patient is taking any of these medicines, discuss this with the doctor before starting treatment with Hydrocortisone Momaja.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Before administering this medicine during pregnancy or breastfeeding, the benefits of treatment should be carefully weighed against potential risks to the mother or fetus.

Driving and operating machinery
In most cases, Hydrocortisone Momaja does not affect the ability to drive or operate machinery. However, if the patient experiences fainting, dizziness (sensation of spinning or movement), or seizures, driving and operating machinery should be avoided.

Hydrocortisone Momaja contains sodium
This medicine contains 0.4 mmol (8.1–8.8 mg) of sodium per vial containing 100 mg of hydrocortisone. This means the sodium content should be taken into account for patients on a controlled sodium diet when the hydrocortisone dose exceeds 250 mg.

3. How to use Hydrocortisone Momaja

Hydrocortisone Momaja will be administered by a doctor or nurse as an intravenous (into a vein) or intramuscular (into a muscle) injection.
The recommended dose is 100 mg of hydrocortisone. If necessary, a further dose of 50 to 100 mg of hydrocortisone may be given 1, 3, 6, or 10 hours after the initial dose.
In the treatment of shock, a dose of 250 mg to 1000 mg is given by slow intravenous injection.
In general, high-dose corticosteroid therapy should not last longer than 48 to 72 hours.
Use in children
The dose used in children with severe diseases is determined based on the severity of the disease. Intravenous or intramuscular treatment should be switched to oral treatment as soon as possible.
Use of a higher than recommended dose of Hydrocortisone Momaja
It is very unlikely that a doctor or nurse would administer too high a dose of Hydrocortisone Momaja. However, acute overdose of Hydrocortisone Momaja does not cause any symptoms.
If you have any further questions about the use of this medicine, please consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been observed (typical for all corticosteroids administered
systemically), with frequency unknown (cannot be estimated from available data):

• pheochromocytoma crisis, infections due to suppression of the immune system function;
• a certain type of blood vessel tumor (Kaposi's sarcoma);
• hypersensitivity (allergic) reactions, including severe hypersensitivity reactions;
• Cushing's syndrome-like state (e.g. weight gain, facial rounding, fat deposition on the back of the neck, muscle weakness, skin atrophy), lack of production of certain hormones (hypopituitarism);
• sodium and fluid retention, impaired glucose tolerance, alkalosis due to potassium deficiency;
• psychiatric or psychotic disorders (e.g. euphoria, insomnia, mood changes, personality changes, depression, increased emotional instability or psychotic tendencies);
• increased intracranial pressure, convulsions, lipomas or atypical fat deposition;
• cataract, ocular proptosis (bulging eyes), fluid accumulation under the retina (central serous chorioretinopathy);
• heart failure;
• hypertrophic cardiomyopathy in preterm infants;
• venous thrombosis, increased blood pressure;
• pulmonary embolism, acute respiratory distress syndrome;
• gastric and intestinal ulcers, pancreatitis, esophagitis, intestinal perforation;
• red or purple spots on the skin (petechiae), bruising, skin thinning;
• muscle weakness, various bone disorders (osteonecrosis, osteoporosis, atypical fractures), growth suppression;
• menstrual disorders;
• impaired wound healing;
• increased intraocular pressure, impaired tolerance to certain sugars, increased insulin requirement or need for oral antidiabetic drugs, nitrogen imbalance due to muscle protein breakdown, increased calcium in urine, changes in blood test results (e.g. elevated liver function test values, decreased blood potassium concentration, increased white blood cell count);
• vertebral compression fracture, tendon rupture (especially Achilles tendon);
• weight gain.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Hydrocortisone Momaja

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the label and carton following EXP.
The expiry date refers to the last day of the stated month.
After mixing the medicine with water for injections, the solution should be used immediately. Any unused portion of the solution must be disposed of according to local regulations.
Before use, the healthcare professional will check whether the solution contains any particles or has changed colour.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What Hydrocortisone Momaja contains
The active substance is hydrocortisone in the form of hydrocortisone sodium succinate.
The other ingredients are: sodium dihydrogen phosphate, disodium phosphate, sodium hydroxide or sodium carbonate (for pH adjustment).
After reconstitution with 2 ml of water for injections supplied in the pack, the solution contains 50 mg/ml of hydrocortisone.
Solvent: water for injections

What Hydrocortisone Momaja looks like and contents of the pack
Hydrocortisone Momaja is available in a single pack (1 vial of powder and 1 ampoule of solvent containing 2 ml of water for injections).
Powder for solution for injection/infusion: Hydrocortisone is a white or almost white powder for parenteral administration, stored in colourless glass vials with a rubber stopper and an aluminium cap.
Solvent: water for injections, stored in colourless glass ampoules with a volume of 2 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
PANPHARMA
Z.I. du Clairay
35133 Luitré
France

Manufacturer:
PANPHARMA
10 rue du Chênot
Parc d’Activité du Chênot
56380 Beignon
France

This medicinal product is authorised in the European Economic Area countries under the following names:

Information intended exclusively for healthcare professionals:

Instructions for use
Hydrocortisone Momaja 100 mg, powder and solvent for solution for injection/infusion

Composition
Active substance:
Each vial contains 100 mg of hydrocortisone (equivalent to 133.7 mg of sodium hydrocortisone succinate).
After reconstitution with 2 ml of water for injections supplied in the package, the solution contains 50 mg/ml of hydrocortisone.

Excipients:
Powder for solution for injection/infusion: disodium dihydrogen phosphate, disodium hydrogen phosphate, sodium hydroxide or sodium carbonate.
Solvent: water for injections.

Route of administration
For intravenous injection or intravenous infusion, or intramuscular injection. Intravenous injection is recommended in emergency situations.

Compatibility
Hydrocortisone Momaja may be added to infusion solutions: injected directly into the infusion line (for rapid effect) or mixed with an infusion solution (slow drip infusion).
The following infusion solutions may be used for intravenous infusion: 5% aqueous glucose solution, isotonic saline solution, or 5% glucose in isotonic saline solution, provided the patient is not on a sodium-restricted diet.

Instructions for use, handling, and disposal
Reconstitution instructions:
Hydrocortisone should be reconstituted by adding no more than 2 ml of water for injections to the contents of one vial. Gently shake to obtain a uniform solution. The product contains no preservative and is intended for single use only. After opening, the vial contents should be used immediately.

• Parenteral medicinal products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Only completely clear solutions should be used.
• Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
• Do not use after the expiry date.
• Medicinal products beyond their expiry date should be disposed of as medical waste.
• Keep out of the sight and reach of children.

Special precautions for storage
Reconstituted solution:
The reconstituted solution should be used immediately after preparation.

Reconstituted and diluted solution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C and for 72 hours between 2°C and 8°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions, provided that the storage time after opening does not usually exceed 24 hours between 2°C and 8°C, and the product has been reconstituted and diluted under controlled and validated aseptic conditions.