B.PROSPECTUS

Prospectus: information for the user

Lorien 100 mg Hydrocortisone Powder for Injectable Solution and for Infusion EFG

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed to you alone, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

The active ingredient of Lorien Hydrocortisone is hydrocortisone, a glucocorticoid (a natural hormone) produced in humans by the adrenal cortex. The primary effect of hydrocortisone is the suppression of inflammatory and immune reactions (immune system reactions against foreign substances). Additionally, it has an effect on sugar and protein metabolism.

When the adrenal cortex does not function correctly, for example, in Addison's disease or adrenogenital syndrome, this medication can be used in combination with other adrenal cortex hormones. It can also be used if the adrenal cortex does not function due to another condition.

This medication can also be used for a short period of time when other methods do not help or do not help enough:

• in severe exacerbations of asthma, chronic bronchitis, or emphysema;

• in status asthmaticus (a persistent asthma attack);

• in combination with other agents for severe hypersensitivity reactions.

No use Hidrocortisona Lorien

• If you are allergic to hydrocortisone or any of the other components of this medication (listed in section 6);
• If you have an acute viral, fungal, or parasitic infection. Bacterial infections must be treated first before starting treatment with this medication;
• If you have a gastric or duodenal ulcer;
• If you received or need to receive live or attenuated virus vaccines, do not use this medication at a dose that weakens your immune system.

This medication should not be injected:

• into the spinal cord (intrathecal) or epidurally.

The general conditions for not using corticosteroids and the precautions that apply when using systemic corticosteroid therapy also apply to this medication.

Warnings and Precautions

Since the risk of side effects with the use of corticosteroids increases as the dose and duration of treatment increase, the advantages and disadvantages of treatment will be carefully weighed between them in determining the dose and duration of treatment.

The use of this medication should not be stopped suddenly, but rather withdrawn gradually.

Consult your doctor or pharmacist before starting to use this medication.

- Patients undergoing surgery, experiencing an accident, or contracting an infection during or after treatment with hydrocortisone may occasionally need to be treated with rapid-acting glucocorticoids.

- Glucocorticoids can suppress the symptoms of an infection and new infections may occur during their use, as their resistance may decrease. In the case of a bacterial infection, your doctor will first determine the type of bacteria and treat the infection before you receive treatment with glucocorticoids.

- If you use immunosuppressive medications, you may be more susceptible to infections than healthy people.

- If you have a pre-existing risk factor for cardiovascular disease, high doses and prolonged use of this medication may increase the risk of cardiovascular disease. Examples include increased blood pressure and increased or decreased levels of one or more fats in the blood (lipids, cholesterol, triglycerides).

- If you have congestive heart failure.

- Hydrocortisone can cause elevated blood pressure, water retention, and increased potassium excretion. Your doctor may prescribe a low-sodium diet with potassium supplements for this. You may need to restrict salt in your diet and administer potassium dietary supplements. All corticosteroids increase calcium excretion.

- If you have septic shock. This is an illness caused by an infection that is characterized by a sudden drop in blood pressure, pallor, restlessness, rapid and weak pulse, moist skin, and reduced consciousness. In that case, routine use of this medication is not recommended.

- Do not vaccinate with a live virus vaccine during high-dose hydrocortisone treatment.

- If you have active tuberculosis or are being treated for tuberculosis, your doctor will closely monitor you during treatment with this medication.

- If you have ever had an allergic reaction to a medication, your doctor will take necessary precautions before starting treatment.

- If you have an ocular herpes infection, your ophthalmologist should monitor you periodically during treatment.

- Corticosteroid treatment can cause retinal detachment and cataracts. Contact your doctor if you experience blurry vision or other visual changes.

- Systemic corticosteroid therapy can cause retinal detachment and cataracts.

- During treatment, you may experience psychiatric changes, such as lightheadedness, insomnia, irritability, personality changes, and depression.

- There have been reported cases of spinal cord canal fat accumulation with prolonged use of high-dose corticosteroids.

- If you have gastric or intestinal inflammation, high blood pressure, active or latent gastric ulcer, renal insufficiency, adrenal gland tumor, Kaposi's sarcoma (a specific type of skin cancer), osteoporosis, myasthenia gravis (a muscular disease), or if you have or are at higher risk of thrombosis, your doctor will be very careful when prescribing this medication.

- If you have liver disease, your doctor may prescribe a lower dose, as the effect of hydrocortisone may be potentiated.

- If you have Cushing's disease (a condition caused by excessive cortisol levels in the blood).

- If you have reduced thyroid function (hypothyroidism).

- If you have diabetes.

- If you have a condition associated with seizures/convulsions (e.g., epilepsy).

- If you use certain analgesics with anti-inflammatory and antipyretic effects (NSAIDs).

- If you have pancreatitis, with severe pain in the upper part of the stomach that radiates to the back, nausea, and vomiting.

- If hydrocortisone is administered to a premature baby, it may be necessary to monitor the heart's function and structure.

Use in Sports

This medication contains substances that may establish a positive analytical result in a doping control.

Children and Adolescents

Long-term treatment with glucocorticoids can cause growth retardation in children and adolescents. Therefore, your doctor will usually treat children with alternate doses.

Babies and children treated with corticosteroids for a long time have a higher risk of increased intracranial pressure.

High doses of corticosteroids can cause pancreatitis in children.

Other Medications and Hidrocortisona Lorien

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

You should inform your doctor about any other medication, such as:

- Isoniazid: used to treat bacterial infections.

- Rifampicin: an antibiotic used to treat tuberculosis.

- Oral anticoagulants.

- Barbiturates, carbamazepine, and phenytoin used to treat epilepsy.

- Substances used to treat certain nervous system diseases (anticholinergics).

- Substances used to treat myasthenia gravis (anticholinesterases).

- Substances used to treat diabetes (antidiabetics).

- Aprepitant and fosaprepitant: used to prevent nausea and vomiting.

- Itraconazole and ketoconazole: used to treat fungal infections.

- Some medications may increase the effects of hydrocortisone, and your doctor may want to monitor you closely if you are taking these medications (including some HIV medications: indinavir, ritonavir, cobicistat).

- Aminoglutethimide and cyclophosphamide: used to treat cancer.

- Tacrolimus: used after an organ transplant to prevent organ rejection.

- Diltiazem: used to treat heart problems or high blood pressure.

- Digoxin: a heart medication that belongs to a group of medications called cardiac glycosides.

- Estrogens (including oral contraceptives that contain estrogens).

- Cyclosporine: used to treat conditions such as severe joint inflammation (rheumatoid arthritis), severe skin conditions associated with dry and scaly skin eruptions (psoriasis), and to prevent rejection of a transplanted organ.

- Clarithromycin, erythromycin, and/or troleandomycin: substances used to prevent/combat certain infections.

- Aspirin (acetylsalicylic acid) and certain group of analgesics that also have anti-inflammatory and antipyretic effects (NSAIDs).

- Potassium-reducing substances, such as diuretics.

Hidrocortisona Lorien with Food and BeveragesandDrinks

The juice of a grapefruit may change the effects of this medication. Always consult your doctor or pharmacist about drinking grapefruit juice with this medication.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

This medication can be used according to approved indications. It should be avoided as much as possible to use chronic high doses.

Breastfeeding

Corticosteroids pass into breast milk. Therefore, breastfeeding is not recommended during corticosteroid treatment, unless you consult your doctor.

Fertility

There is no evidence that corticosteroids interfere with fertility.

Driving and Operating Machines

Several possible side effects of this medication, such as blurry vision, mood changes, muscle weakness, and involuntary muscle contractions, may negatively affect your ability to drive and operate machines.

Hidrocortisona Lorien contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per vial (9.46 mg per dose); that is, it is essentially "sodium-free". This should be taken into account in patients with sodium-controlled diets.

Your doctor or nurse will administer this medication. It can be administered through a vein (with a syringe or through infusion) or into a muscle (with a syringe).

Your doctor will determine the appropriate dose for you based on your condition and situation.

If you use moreLorien Hydrocortisonethan you should

No data are available on acute overdosing of this medication. Hydrocortisone is dialyzable. This means that, in case of an overdose, excess hydrocortisone can be removed from the blood with the help of an artificial kidney. With repeated long-term use (daily or several times a week), Cushing's syndrome (including a "moon face") may occur.

If you forgot to use Lorien Hydrocortisone

Normally, your doctor will ensure that you receive the next dose on time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Lorien Hydrocortisone

If treatment with this medication is interrupted suddenly or if you need to undergo surgery during treatment, an accident, or a severe infection, your adrenal cortex may not function as well. This would allow the symptoms of the disease you are being treated for to reappear. Seizures, dizziness, and headaches, especially in children, may occur if treatment is stopped too soon. Therefore, your doctor will usually gradually reduce treatment with this medication.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects have been reported with unknown frequencies, meaning that the frequency cannot be determined based on the available data:

- Hydrocortisone suppresses the symptoms of an inflammatory response, making infections difficult to detect, latent infections can be activated, and new infections can occur.

- Rare infections (opportunistic infections) may occur.

- A form of skin cancer (Kaposi's sarcoma).

- Severe increase in blood pressure due to adrenal gland inflammation (pheochromocytoma).

- Elevated white blood cell count in the blood (leukocytosis).

- Severe allergic reaction to certain substances, involving a sudden drop in blood pressure, pallor, anxiety, rapid and weak pulse, moist skin, and reduced consciousness after a significant and sudden vasodilation (anaphylactic reaction).

- Sudden drop in blood pressure, pallor, anxiety, rapid and weak pulse, moist skin, and reduced consciousness due to significant and sudden vasodilation without an existing allergy (anaphylactoid reaction).

- Hypersensitivity to medications.

- Development of obesity (head, trunk), moon face, and high blood pressure (Cushing's syndrome).

- Suppression of one or more hormones secreted by the pituitary gland (suppression of the hypothalamic-pituitary-adrenal axis).

- Syndrome associated with withdrawal symptoms that may appear after stopping corticosteroid treatment (steroid withdrawal syndrome).

- Metabolic acidosis.

- Sodium retention by the kidneys (sodium retention).

- Excess fluid retention in the body (fluid retention).

- Alteration of lipid metabolism (dyslipidemia).

- Alkalosis due to excessive potassium loss (hypokalemic alkalosis).

- Reduced glucose tolerance.

- Disregulation of blood sugar levels that can detect latent diabetes or increase the need for insulin or other medications to reduce blood sugar levels.

- Increased appetite.

- Accumulation of adipose tissue in various parts of the body (lipomatosis).

- Psychotic disorders, such as excessive lightness associated with excessive energy (mania), delusions, hallucinations, and severe mental illness (schizophrenia) characterized by a gradual change in personality.

- Mood disorders such as depressed mood, extreme happiness (euphoria), emotional lability, drug dependence, suicidal thoughts.

- Mental disorder.

- Confusion.

- Fear.

- Change in personality.

- Mood swings.

- Abnormal behavior.

- Insomnia.

- Irritability.

- Worsening of existing psychotic behavior.

- Accumulation of fat in the spinal canal (epidural lipomatosis).

- Increased intracranial pressure.

- Increased intracranial pressure with inflammation of the mucous membranes (benign intracranial hypertension).

- Seizures with loss of consciousness and muscle spasms (convulsions).

- Memory loss (amnesia).

- Alteration of cognitive functions such as perception, attention, concentration, memory, orientation, language use, and skills (cognitive decline).

- Dizziness.

- Headache.

- Retinopathy and choroidopathy (choriorretinopathy).

- Blurred vision.

- Cloudy lens (cataracts).

- Increased intraocular pressure (glaucoma).

- Abnormal bulging of the eye (exophthalmos).

- Dizziness.

- Reduced heart pumping force in high-risk patients (congestive heart failure).

- Increased blood coagulation (thrombosis).

- Reduced blood pressure (hypotension).

- Increased blood pressure (hypertension).

- Pulmonary embolism.

- Persistent hiccups.

- Gastric/duodenal ulcers with possible perforation and bleeding.

- Intestinal perforation and bleeding.

- Gastric bleeding.

- Pancreatitis with severe pain in the upper abdomen that radiates to the back, nausea, and vomiting.

- Esophagitis with or without ulcers.

- Abdominal pain (abdominal pain).

- Distended stomach (abdominal distension).

- Diarrhea.

- Altered digestion with a feeling of fullness in the upper stomach, stomach pain, belching, nausea, vomiting, and heartburn (dyspepsia).

- Nausea.

- Rapid accumulation of fluid in the skin and mucous membranes (e.g., throat or tongue), difficulty breathing, and/or itching and skin rash, often as an allergic reaction (angioedema).

- Excessive hair growth in women (hirsutism).

- Small hemorrhagic spots under the skin (petechiae).

- Small hemorrhagic spots on a mucous membrane (ecchymosis).

- Thin, fragile, and wrinkled skin (cutaneous atrophy).

- Skin redness (erythema).

- Excessive sweating (hyperhidrosis).

- Striae in the skin.

- Skin rash.

- Itching (pruritus).

- Intense itching skin rash with the formation of nodules (urticaria).

- (Adolescents) Acne.

- Muscle weakness.

- Muscle pain (myalgia).

- Muscle disease (myopathy).

- Muscle atrophy due to a muscle not being used or no longer being able to be used due to a nervous system disease.

- Bone fracture (osteonecrosis).

- Bone decalcification (osteoporosis).

- Pathological bone fracture.

- Joint disease due to a nervous system disorder (neuropathic arthropathy).

- Joint pain (arthralgia).

- Growth delay.

- Compressed vertebrae (spinal compression fracture).

- Torn tendons.

- Irregular menstruation.

- Altered wound healing.

- Accumulation of fluid in the arms and legs (peripheral edema).

- Fatigue.

- General feeling of discomfort.

- Skin reactions at the injection site.

- Increased intraocular pressure.

- Reduced ability to process sugars (carbohydrates), which can lead to a greater need for insulin or other substances to reduce blood sugar levels.

- Reduced potassium level in the blood, which is severe and recognizable by muscle spasms or muscle weakness and fatigue (hypokalemia).

- Increased calcium level in the urine.

- Abnormal results of blood tests (elevated alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase in the blood).

- Increased amount of waste products in the blood due to protein degradation (elevated blood urea).

- Suppression of skin allergy test reactions.

- Hypertrophic cardiomyopathy in premature infants.

- Weight gain.

Other adverse effects in children and adolescents

Growth inhibition may occur in children.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the label after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store the vials in the original packaging to protect them from light.

Once the medication has been mixed with sterile water for injectable preparations, the solution must be used immediately. Any unused liquid must be disposed of safely.

Your doctor will check that the solution does not contain particles and does not discolor before using it.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Hydrocortisone Lorien

• The active ingredient is hydrocortisone. Each vial contains 100 mg of hydrocortisone (as hydrocortisone succinate sodium).
• The other components are: sodium dihydrogen phosphate dihydrate, anhydrous disodium phosphate, and sodium hydroxide.

Appearance of Hydrocortisone Lorien and packaging contents

Hydrocortisone Lorien is a white or almost white powder for injectable/perfusion solution. It is presented in a colourless glass vial containing 100 mg of hydrocortisone, closed with a rubber stopper and sealed with an aluminium capsule.

Hydrocortisone Lorien is available in the following packaging sizes:

Carton box with 1 vial or carton box with 2 PVC protective trays covered with a PET/PE sheet with 5 vials each and a leaflet.

.

Only some packaging sizes may be commercially available.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Laboratorios Lorien, S.L.

Av. Josep Tarradellas, 8, Ático 1ª 08029 Barcelona, Spain

Manufacturer:

S.C. Rompharm Company S.R.L.

Eroilor Street, no. 1A, Otopeni, Ilfov County, 075100, Romania

This medicinal product is authorised in the member states of the European Economic Area with the following names:

Following names:

Hungary: Hydrocortison Rompharm 100 mg for intravenous/intramuscular injection

Romania: Hidrocortizon Rompharm 100 mg powder for injectable/perfusion solution

Bulgaria: ????????????? ??????? 100 mg ???? ?? ???????????/?????????? ???????

Spain: Hidrocortisona Lorien 100 mg powder for injectable and perfusion solution EFG

Last review date of this leaflet:May 2023

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This information is intended solely for healthcare professionals:

Dosage and administration:

This medicinal product may be administered by intravenous or intramuscular injection, or by intravenous perfusion. Intravenous injection is the preferred method for emergency use.

After the initial emergency period, consideration should be given to the possibility of using a prolonged-acting injectable preparation or an oral preparation. The duration of intravenous administration depends on the dose; it may vary from 30 seconds (e.g. 100 mg) to 10 minutes (e.g. 500 mg or more).

High doses of corticosteroids should only be administered until the patient's condition has stabilised (usually within 48-72 hours).

Although adverse effects associated with short-term treatment with high doses of corticosteroids are rare, peptic ulceration may occur. Prophylactic therapy with anti-acids is indicated.

If it is necessary to continue treatment with hydrocortisone for periods exceeding 48-72 hours, hypernatremia may occur, and it may be preferable to replace this medicinal product with another corticosteroid, such as methylprednisolone succinate sodium, as there is little or no sodium retention.

The initial dose of this medicinal product is 100 mg to 500 mg or more, depending on the severity of the condition. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patient's clinical condition. Corticosteroid therapy is a complement and not a replacement for conventional therapy.

In patients with liver disease, there may be an increased effect, and a reduction in dose may be considered.

Pediatric population

The dose of this medicinal product in pediatrics is governed more by the severity of the condition and the patient's response than by age or body weight. The dose may be reduced for these patients, but should not be less than 25 mg per day.

Preparation of solutions:

Parenteral medicines should be visually inspected to detect particles and colour changes before administration.

After reconstitution, the solution is transparent with no visible particles or precipitates. The formulation does not contain preservatives and is for single use. Once opened, the contents of a vial should normally be used immediately.

Instructions:

Do not add more than 2 ml of sterile water for injectable preparations to the contents of a vial with sterile powder, in aseptic conditions.

For intravenous or intramuscular injection:

Prepare the solution as described above. For intravenous or intramuscular injection, no further dilution is required, shake and discard for use.

For intravenous perfusion:

First prepare the solution as described above, adding no more than 2 ml of sterile water for injectable preparations to the vial. This solution containing 100 mg of hydrocortisone may be added to 100-1000 ml (but not less than 100 ml) of one of the following solutions:

• 5% glucose solution

• 0.9% sodium chloride solution

When reconstituted as indicated, the pH of the solution will vary from 7.0 to 8.0.

Shelf life:

Unopened vial:

2 years.

The stability in use of the solution after reconstitution with 2 ml of sterile water for injectable preparations has not been investigated. Therefore, the reconstituted solution should be used immediately.

After reconstitution and dilution:

After reconstitution and dilution with 100 ml and 1000 ml of 0.9% sodium chloride solution, the chemical and physical stability in use has been demonstrated for 4 hours at 25°C.

After reconstitution and dilution with 100 ml and 1000 ml of 5% glucose solution, the chemical and physical stability in use has been demonstrated for 4 hours at 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the times and conditions of storage in use are the responsibility of the user.

Special precautions for storage:

Do not store at a temperature above 25°C.

Store the vial in the outer packaging to protect it from light.

For further information, see the Medicinal Product Information.