Hidrocortisone Momaia

Leaflet attached to the packaging: information for the user

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

for injection/infusion
Hydrocortisone

Read the leaflet carefully before using 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, pharmacist, or nurse.
• 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 any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Hydrocortisone Momaja and what is it 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 packaging and other information

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

Hydrocortisone Momaja relieves symptoms of inflammatory and allergic conditions and suppresses the immune system response.
Hydrocortisone Momaja is used as an adjunct to standard therapy in the treatment of, among others, the following diseases and conditions:

• Addison's crisis (severe adrenal insufficiency);
• Shock-like states;
• Severe allergic reactions, such as acute, severe asthma and allergic reactions to drugs;
• Inflammatory conditions requiring hydrocortisone treatment;
• Certain life-threatening conditions that may cause irreversible shock.

The medicine contains hydrocortisone, which may also be used for other indications not listed in this leaflet. Consult a doctor, pharmacist, or other healthcare professional if advice is needed. Always follow the instructions received from these persons.

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 a systemic fungal infection,
• if the patient has been vaccinated recently or is to be vaccinated,
• if the patient has herpes simplex keratitis, acute psychoses, Cushing's syndrome, gastric or duodenal ulcers, and chickenpox.

Warnings and precautions

Before starting treatment with Hydrocortisone Momaja, discuss it with your doctor or nurse if the patient has:

• a history of allergic reactions to certain medicines
• herpes simplex keratitis
• acute or chronic psychoses
• Cushing's syndrome (a hormonal disease in which the body produces excessive amounts of cortisol)
• gastric or intestinal ulcers
• chickenpox
• diabetes
• osteoporosis (excessive bone weakness)
• active tuberculosis (lung infection)
• kidney problems
• a tendency to venous thrombosis (blood clot inflammation)
• previously treated thrombosis (e.g., deep vein thrombosis) or a tendency to thrombosis (blood clotting)
• recently vaccinated or to be vaccinated
• cowpox
• ulcerative colitis or diverticulitis (inflammatory bowel disease)
• recently created intestinal anastomosis (surgical procedure in the intestines)
• high blood pressure
• paralytic muscle weakness (myasthenia)
• liver disease (in which case the doctor may decide to reduce the dose)
• suspected or diagnosed pheochromocytoma (adrenal gland tumor).

In the case of corticosteroid use during cancer treatment, tumor lysis syndrome (TLS) may occur. Tell your doctor if you have cancer and experience symptoms of TLS, such as muscle cramps, muscle weakness, confusion, irregular heartbeat, loss of vision, or shortness of breath.
Corticosteroids may mask objective symptoms of infection and cause immune system suppression. Long-term daily treatment with glucocorticoids may inhibit growth in children. Therefore, glucocorticoid use should be limited to the most severe cases.
If hydrocortisone is administered to premature infants, it may be necessary to monitor heart function and cardiac muscle image.

Hydrocortisone Momaja and other medicines

Tell your doctor or nurse about all medicines the patient is 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. Such medicines include:

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

If the patient is taking any of these medicines, they should discuss it with their doctor before starting treatment with Hydrocortisone Momaja.

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 before using this medicine.
Before using the medicine during pregnancy or breastfeeding, the benefits of using the medicine should be carefully weighed against the potential risks to the mother or fetus.

Driving and using machines

In most cases, Hydrocortisone Momaja does not affect the ability to drive or use machines. If the patient experiences fainting, dizziness (feeling of spinning or movement), or seizures, they should not drive or use machines.

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 that the sodium content must be taken into account by patients on a controlled sodium diet if 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 subsequent dose of 50 to 100 mg of hydrocortisone can be administered 1, 3, 6, or 10 hours after the initial dose.
In the treatment of shock, a dose of 250 mg to 1000 mg is administered as a slow intravenous injection.
Essentially, treatment with high doses of corticosteroids should not last longer than 48 to 72 hours.

Use in children

The dose administered to children with severe diseases is determined based on the severity of the disease. Intravenous or intramuscular treatment should be replaced with oral treatment as soon as possible.

Using a higher dose of Hydrocortisone Momaja than recommended

It is very unlikely that a doctor or nurse will administer too high a dose of Hydrocortisone Momaja. However, acute overdose of Hydrocortisone Momaja does not cause any symptoms.
If you have any further doubts about using this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Observed side effects (typical for all corticosteroids administered systemically), the frequency of which is unknown (cannot be determined from available data), include:

• tumor lysis syndrome (associated with adrenal gland tumor), infections associated with immune system suppression;
• a certain type of blood vessel tumor (Kaposi's sarcoma);
• hypersensitivity reactions (allergic), including severe hypersensitivity reactions;
• a condition similar to Cushing's syndrome (e.g., weight gain, rounding of the face, fat accumulation on the neck, muscle weakness, skin thinning), lack of production of certain hormones (hypopituitarism);
• sodium and fluid retention in the body, glucose tolerance problems, excessively alkaline blood as a consequence of potassium deficiency;
• psychiatric or psychotic disorders (euphoria, insomnia, mood changes, personality changes, depression, exacerbation of emotional instability or psychotic tendencies);
• increased intracranial pressure, seizures, fatty tissue tumors or fat accumulation in unusual locations;
• cataracts, exophthalmos (bulging eyes), fluid accumulation under the retina (central serous chorioretinopathy);
• heart failure;
• hypertrophic cardiomyopathy (heart muscle thickening) in premature infants;
• blood clots in veins (venous thrombosis), increased blood pressure;
• blood clots in the lungs (pulmonary embolism), fatal respiratory disorders;
• gastric and intestinal ulcers, pancreatitis, esophagitis, intestinal perforation;
• red or purple spots on the skin (purpura); bruising, skin thinning;
• muscle weakness, various bone diseases (osteonecrosis, osteoporosis, atypical bone fractures), growth inhibition;
• menstrual disorders;
• wound healing problems;
• increased intraocular pressure, impaired tolerance to certain sugars, increased insulin or oral antidiabetic requirements, nitrogen balance disorders caused by muscle protein breakdown, increased calcium levels in urine, changes in blood test results (e.g., elevated liver test values, decreased potassium levels in blood, high white blood cell count);
• spinal compression fracture, tendon rupture (especially Achilles tendon rupture);
• weight gain.

Reporting side effects

If you experience any side effects, including any side effects not listed in this 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
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 to gather more information on the safety of this 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 after: EXP.
The expiry date refers to the last day of the month.
After mixing the medicine with water for injections, the solution should be used immediately. Any unused solution should be disposed of in accordance with local regulations.
Before use, the doctor will check that the solution does not contain solid particles and is not discolored.
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. Contents of the packaging and other information

What Hydrocortisone Momaja contains

The active substance of the medicine is hydrocortisone in the form of hydrocortisone sodium succinate.
The other ingredients are: sodium dihydrogen phosphate, disodium phosphate, sodium hydroxide, or sodium carbonate (to adjust pH).
After reconstitution in 2 ml of water for injections provided with the packaging, the solution contains 50 mg/ml of hydrocortisone.
Solvent:water for injections

What Hydrocortisone Momaja looks like and contents of the packaging

Hydrocortisone Momaja is available in a single packaging (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 colorless glass vials with a rubber stopper and an aluminum cap.
Solvent: water for injections stored in colorless glass ampoules with a capacity of 2 ml.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 05/2024

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Information intended for healthcare professionals only:

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 hydrocortisone sodium succinate).
After reconstitution in 2 ml of water for injections provided with the packaging, the solution contains 50 mg/ml of hydrocortisone.
Excipients:
Powder for solution for injection/infusion: sodium dihydrogen phosphate, disodium phosphate, sodium hydroxide, or sodium carbonate.
Solvent:water for injections

Method of administration

For intravenous or intramuscular injection, or for intravenous infusion. Intravenous injection is recommended in emergency situations.

Compatibility

Hydrocortisone Momaja can be added to infusion solutions: by injecting directly into the infusion line (rapid action) or by mixing with the infusion solution (slow drip infusion).
In the case of intravenous infusion, the following solutions can be used: 5% glucose solution, isotonic saline solution, or 5% glucose solution in isotonic saline solution, provided the patient is not on a sodium-controlled 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 shaking will result in a uniform solution. The product does not contain a preservative and is intended for single use only. After opening, the vial contents should be used immediately.

• Parenteral medicines should always be inspected before use for the presence of solid particles and discoloration, if the solution and packaging allow.
• Only use completely clear solutions.

• Any unused product or waste should be disposed of in accordance with local regulations.
• Do not use the product after the expiry date.
• Products with expired dates should be disposed of as other medical waste.
• Store the medicine in a place out of 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 stability of the product has been demonstrated for 24 hours at 25°C and for 72 hours at 2-8°C.
From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the responsibility for the storage time and conditions lies with the user, but the storage time after opening should not normally exceed 24 hours at 2-8°C, provided the product has been reconstituted and diluted under controlled and validated aseptic conditions.